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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
| | | | | |
☒ | Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
For the quarterly period ended June 30, 2023
or
| | | | | |
☐ | Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
For the transition period from ______to ______.
Commission file number: 001-39311
POINT BIOPHARMA GLOBAL INC.
(Exact name of registrant as specified in its charter)
| | | | | | | | |
Delaware | 85-0800493 |
(State or other jurisdiction of | (IRS Employer Identification No.) |
incorporation or organization) | |
| | |
4850 West 78th Street | |
Indianapolis, | IN | 46268 |
(Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (317) 543-9957
Securities registered pursuant to Section 12(b) of the Act:
| | | | | | | | | | | | | | |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
Common Stock | PNT | The | Nasdaq | Capital Market |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| | | | | | | | | | | | | | | | | |
Large accelerated filer | | ☐ | Accelerated filer | | ☐ |
Non-accelerated filer | | ☒ | Smaller reporting company | | ☒ |
| | | Emerging growth company | | ☒ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.
Common Stock, par value $0.0001 per share – 105,765,954 shares outstanding as of August 9, 2023.
INDEX
PART I. FINANCIAL INFORMATION
ITEM 1 – FINANCIAL STATEMENTS
POINT Biopharma Global Inc.
Interim Condensed Consolidated Balance Sheets
(In U.S. dollars)
| | | | | | | | | | | |
| June 30, 2023 | | |
| (Unaudited) | | December 31, 2022 |
| $ | | $ |
ASSETS | | | |
Current assets | | | |
Cash and cash equivalents | 57,293,338 | | | 286,428,371 | |
Short-term investments | 365,932,523 | | | 238,783,470 | |
Prepaid expenses and other current assets | 5,750,433 | | | 5,610,889 | |
Income taxes receivable | 3,399,009 | | | — | |
Total current assets | 432,375,303 | | | 530,822,730 | |
| | | |
Non-current assets | | | |
Long-term investments | 11,570,701 | | | 16,119,430 | |
Note receivable | 5,028,767 | | | — | |
Property, plant and equipment, net | 48,394,217 | | | 31,380,576 | |
Operating lease right-of-use asset | 405,784 | | | — | |
Total non-current assets | 65,399,469 | | | 47,500,006 | |
| | | |
Total assets | 497,774,772 | | | 578,322,736 | |
| | | |
LIABILITIES & STOCKHOLDERS' EQUITY | | | |
Current liabilities | | | |
Accounts payable | 13,899,941 | | | 7,703,150 | |
Accrued liabilities | 10,099,052 | | | 19,094,454 | |
Deferred revenue | 15,899,770 | | | 23,242,290 | |
Income taxes payable | — | | | 29,698,546 | |
Finance lease current liability | 1,011,217 | | | — | |
Operating lease current liability | 245,814 | | | — | |
Total current liabilities | 41,155,794 | | | 79,738,440 | |
| | | |
Deferred revenue, net of current portion | 3,197,547 | | | 10,178,147 | |
Long-term income taxes payable | 1,452,356 | | | 1,452,356 | |
Finance lease liability, net of current portion | 4,348,112 | | | — | |
Operating lease liability, net of current portion | 169,045 | | | — | |
Total liabilities | 50,322,854 | | | 91,368,943 | |
| | | |
Commitments and contingencies (Note 12) | | | |
| | | |
Stockholders’ equity | | | |
Common Stock, par value $0.0001 per share, 430,000,000 authorized, 105,765,954 and 105,649,741 issued and outstanding as of June 30, 2023 and December 31, 2022, respectively | 10,576 | | | 10,565 | |
Additional paid-in capital | 451,443,330 | | | 448,391,574 | |
Retained earnings | (2,933,005) | | | 39,008,505 | |
Accumulated other comprehensive loss | (1,068,983) | | | (456,851) | |
Total stockholders’ equity | 447,451,918 | | | 486,953,793 | |
| | | |
Total liabilities and stockholders’ equity | 497,774,772 | | | 578,322,736 | |
See accompanying notes to the unaudited interim condensed consolidated financial statements
POINT Biopharma Global Inc.
Unaudited Interim Condensed Consolidated Statements of Operations
(In U.S. dollars, except share amounts)
| | | | | | | | | | | | | | | | | | | | | | | |
| For the three months ended | | For the six months ended |
| June 30, 2023 | | June 30, 2022 | | June 30, 2023 | | June 30, 2022 |
| $ | | $ | | $ | | $ |
Revenue | | | | | | | |
| | | | | | | |
Other revenue | 4,865,856 | | | — | | | 14,323,120 | | | — | |
Total revenue | 4,865,856 | | | — | | | 14,323,120 | | | — | |
| | | | | | | |
Operating expenses | | | | | | | |
Research and development | 31,276,573 | | | 20,813,882 | | | 58,187,045 | | | 33,314,730 | |
General and administrative | 5,088,403 | | | 4,080,401 | | | 10,098,532 | | | 7,888,343 | |
Total operating expenses | 36,364,976 | | | 24,894,283 | | | 68,285,577 | | | 41,203,073 | |
Loss from operations | (31,499,120) | | | (24,894,283) | | | (53,962,457) | | | (41,203,073) | |
| | | | | | | |
Other income (expenses) | | | | | | | |
Investment income | 5,335,753 | | | 509,700 | | | 11,099,967 | | | 557,673 | |
Foreign currency loss | (168,770) | | | (12,259) | | | (238,960) | | | (43,900) | |
Total other income (expenses) | 5,166,983 | | | 497,441 | | | 10,861,007 | | | 513,773 | |
| | | | | | | |
Loss before income taxes | (26,332,137) | | | (24,396,842) | | | (43,101,450) | | | (40,689,300) | |
Income tax benefit (provision) | 921,298 | | | (183,405) | | | 1,159,940 | | | (271,521) | |
Net loss | (25,410,839) | | | (24,580,247) | | | (41,941,510) | | | (40,960,821) | |
| | | | | | | |
Net loss per basic and diluted common share: | | | | | | | |
Basic and diluted net loss per common share | $ | (0.24) | | | $ | (0.27) | | | $ | (0.40) | | | $ | (0.45) | |
Basic and diluted weighted average common shares outstanding | 105,724,215 | | | 90,124,295 | | | 105,692,615 | | | 90,123,288 | |
| | | | | | | |
See accompanying notes to the unaudited interim condensed consolidated financial statements
POINT Biopharma Global Inc.
Unaudited Interim Condensed Consolidated Statements of Comprehensive Loss
(In U.S. dollars)
| | | | | | | | | | | | | | | | | | | | | | | |
| For the three months ended | | For the six months ended |
| June 30, 2023 | | June 30, 2022 | | June 30, 2023 | | June 30, 2022 |
| $ | | $ | | $ | | $ |
Net loss | (25,410,839) | | | (24,580,247) | | | (41,941,510) | | | (40,960,821) | |
Other comprehensive income, net of tax | | | | | | | |
Net unrealized loss on available-for-sale debt securities | (813,426) | | | (342,378) | | | (612,132) | | | (342,378) | |
Total comprehensive loss | (26,224,265) | | | (24,922,625) | | | (42,553,642) | | | (41,303,199) | |
See accompanying notes to the unaudited interim condensed consolidated financial statements
POINT Biopharma Global Inc.
Unaudited Interim Condensed Consolidated Statements of Stockholders’ Equity
(In U.S. dollars, except share amounts)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Common Stock | | Additional Paid-in Capital | | Accumulated Deficit | | Accumulated Other Comprehensive Loss | | Total Equity |
| Number | | Amount | | | | |
| # | | $ | | $ | | $ | | $ | | $ |
Balance at December 31, 2022 | 105,649,741 | | | 10,565 | | | 448,391,574 | | | 39,008,505 | | | (456,851) | | | 486,953,793 | |
Issuance of shares of Common Stock in connection with stock option exercises | 32,936 | | | 3 | | | 145,861 | | | — | | | — | | | 145,864 | |
Stock-based compensation | — | | | — | | | 1,009,496 | | | — | | | — | | | 1,009,496 | |
Net loss | — | | | — | | | — | | | (16,530,671) | | | — | | | (16,530,671) | |
Other comprehensive income, net of tax | — | | | — | | | — | | | — | | | 201,294 | | | 201,294 | |
Balance at March 31, 2023 | 105,682,677 | | | 10,568 | | | 449,546,931 | | | 22,477,834 | | | (255,557) | | | 471,779,776 | |
Issuance of shares of Common Stock in connection with stock option exercises | 83,277 | | | 8 | | | 186,050 | | | — | | | — | | | 186,058 | |
Stock-based compensation | — | | | — | | | 1,710,349 | | | — | | | — | | | 1,710,349 | |
Net loss | — | | | — | | | — | | | (25,410,839) | | | — | | | (25,410,839) | |
Other comprehensive loss, net of tax | — | | | — | | | — | | | — | | | (813,426) | | | (813,426) | |
Balance at June 30, 2023 | 105,765,954 | | | 10,576 | | | 451,443,330 | | | (2,933,005) | | | (1,068,983) | | | 447,451,918 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Common Stock | | Additional Paid-in Capital | | Accumulated Deficit | | Accumulated Other Comprehensive Loss | | Total Equity |
| Number | | Amount | | | | |
| # | | $ | | $ | | $ | | $ | | $ |
Balance at December 31, 2021 | 90,121,794 | | | 9,012 | | | 314,488,782 | | | (59,284,708) | | | — | | | 255,213,086 | |
Issuance of shares of Common Stock in connection with stock option exercises | 678 | | | — | | | 942 | | | — | | | — | | | 942 | |
Stock-based compensation | — | | | — | | | 440,450 | | | — | | | — | | | 440,450 | |
Net loss | — | | | — | | | — | | | (16,380,574) | | | — | | | (16,380,574) | |
Balance at March 31, 2022 | 90,122,472 | | | 9,012 | | | 314,930,174 | | | (75,665,282) | | | — | | | 239,273,904 | |
Issuance of shares of Common Stock in connection with stock option exercises | 2,490 | | | — | | | 3,461 | | | — | | | — | | | 3,461 | |
Stock-based compensation | — | | | — | | | 1,027,563 | | | — | | | — | | | 1,027,563 | |
Net loss | — | | | — | | | — | | | (24,580,247) | | | — | | | (24,580,247) | |
Other comprehensive loss, net of tax | — | | | — | | | — | | | — | | | (342,378) | | | (342,378) | |
Balance at June 30, 2022 | 90,124,962 | | | 9,012 | | | 315,961,198 | | | (100,245,529) | | | (342,378) | | | 215,382,303 | |
See accompanying notes to the unaudited interim condensed consolidated financial statements
POINT Biopharma Global Inc.
Unaudited Interim Condensed Consolidated Statements of Cash Flows
(In U.S. dollars)
| | | | | | | | | | | |
| For the six months ended |
| June 30, 2023 | | June 30, 2022 |
| $ | | $ |
Cash flows from operating activities | | | |
Net loss: | (41,941,510) | | | (40,960,821) | |
Adjustments to reconcile net loss to net cash used in operating activities: | | | |
Depreciation on property, plant and equipment | 1,322,329 | | | 584,076 | |
Stock-based compensation expense | 2,719,845 | | | 1,468,013 | |
Operating lease expense | 50,499 | | | — | |
Payments on operating lease | (49,321) | | | — | |
Amortization of premiums (accretion of discounts) on investments, net | (7,066,456) | | | (128,150) | |
Changes in operating assets and liabilities: | | | |
Prepaid expenses and other current assets | (139,544) | | | (441,829) | |
Accounts payable | 4,285,143 | | | 4,290,469 | |
Accrued liabilities | (9,178,905) | | | 3,734,644 | |
Deferred revenue | (14,323,120) | | | — | |
Income taxes receivable and payable | (33,097,555) | | | 258,425 | |
Change in accrued interest and dividends within investments | 691,359 | | | 126,192 | |
Net cash used in operating activities | (96,727,236) | | | (31,068,981) | |
| | | |
Cash flows from investing activities | | | |
Purchase of investments, net of sales and maturities | (116,749,966) | | | (126,563,131) | |
Purchase of property, plant and equipment | (10,856,112) | | | (3,080,040) | |
Purchase of note receivable | (5,000,000) | | | — | |
Net cash used in investing activities | (132,606,078) | | | (129,643,171) | |
| | | |
Cash flows from financing activities | | | |
Issuance of shares of Common Stock in connection with stock option exercises | 331,922 | | | 4,403 | |
Payments on finance lease | (133,641) | | | — | |
Net cash provided by financing activities | 198,281 | | | 4,403 | |
| | | |
Net decrease in cash and cash equivalents | (229,135,033) | | | (160,707,749) | |
Cash and cash equivalents, beginning of period | 286,428,371 | | | 238,815,991 | |
Cash and cash equivalents, end of period | 57,293,338 | | | 78,108,242 | |
| | | |
Supplemental disclosure of cash flow information: | | | |
Cash paid for income taxes | 31,913,750 | | | 3,022 | |
Non-cash investment activities: | | | |
Purchase of property, plant and equipment recorded in accounts payable and accrued liabilities | 3,504,652 | | | 3,345,729 | |
See accompanying notes to the unaudited interim condensed consolidated financial statements
Notes to the Unaudited Interim Condensed Consolidated Financial Statements
1. Nature of business
POINT Biopharma Global Inc., together with its consolidated subsidiaries ("POINT" or the “Company”), is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. The Company was founded on a mission to make radioligand therapy applicable to more cancers and available to more people, thereby improving the lives of cancer patients and their families everywhere.
The Company has four wholly-owned subsidiaries, POINT Biopharma Inc., POINT Biopharma USA Inc. and West 78th Street, LLC, each located in the U.S., and POINT Biopharma Corp., located in Canada (collectively the "Subsidiaries"). The Company’s headquarters is located at 4850 West 78th Street, Indianapolis, Indiana, 46268.
2. Summary of significant accounting policies
Basis of presentation
The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 270, Interim Reporting and include the accounts of the Company and the Subsidiaries, for financial information and pursuant to the rules and regulations of the Securities and Exchange Commission ("SEC"). Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America (“GAAP”). All intercompany accounts and transactions have been eliminated in consolidation. In the opinion of management, the unaudited interim condensed consolidated financial statements reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the balances and results for the periods presented. Except as described below, the accounting policies and methods of computation applied in the unaudited interim condensed consolidated financial statements and related notes contained therein are consistent with those applied by the Company in its audited consolidated financial statements as of and for the year ended December 31, 2022 contained in our Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the SEC on March 27, 2023 (the “2022 Financial Statements”). These unaudited interim condensed consolidated financial statements should be read in conjunction with the 2022 Financial Statements.
These unaudited interim condensed consolidated financial statements and accompanying notes have been prepared in accordance with the provisions of ASC Topic 205-40, Presentation of Financial Statements—Going Concern on the basis that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business.
Impact of COVID-19 Pandemic, macroeconomics and other geopolitical events
Although the World Health Organization declared in early May of 2023 that COVID-19 no longer constitutes a public health emergency, the Company continues to actively monitor the COVID-19 developments and potential impact on the Company's employees, business and operations. The impact from global economic conditions and potential and continuing disruptions to and volatility in the credit and equity markets in the United States and worldwide are highly uncertain and cannot be predicted. The Company is currently operating in a period of significant economic uncertainty, resulting from, among other things, the impact of the COVID-19 pandemic, geopolitical tensions, such as the ongoing military conflict between Russia and Ukraine and heightened tensions between China and Taiwan, trade uncertainty, including changes in tariffs, sanctions, international treaties, and other trade restrictions, rising inflation and interest rates, and uncertainty and liquidity concerns in the broader financial services industry, including those caused by certain recent banking failures.
The Company is continuing to monitor the development and potential impact of these global economic and geopolitical events on its business and unaudited interim condensed consolidated financial statements. To date, the Company has not experienced any material business disruptions or incurred any impairment losses in the carrying values of its assets as a result of these events and it is not aware of any specific related event or circumstance that would require it to revise its estimates reflected in these unaudited interim condensed consolidated financial statements. However, estimates and assumptions about future events and their effects cannot be determined with certainty and therefore require the exercise of judgment; as a result, the Company’s estimates may change as new events occur and additional information is obtained.
Risks and uncertainties
Except for the upfront payment received pursuant to the Lantheus License Agreements (as defined in Note 3 below), the Company has incurred significant net losses and has funded operations primarily through equity financings. Operating losses and negative cash flows were incurred in the three and six months ended June 30, 2023 and are expected to continue
to be incurred in future periods. The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, successful discovery and development of its product candidates, regulatory approval of its product candidates, development by competitors of new technological innovations, dependence on key personnel, the ability to attract and retain qualified employees, protection of proprietary technology, compliance with governmental regulations, the impact of macroeconomic disruptions, such as those arising from public health crisis or military conflicts and adverse developments affecting the financial services industry, the ability to secure additional capital to fund operations and commercial success of its product candidates. Product candidates currently under development will require extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of capital, adequate personnel, and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s drug development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales.
Use of estimates
The preparation of the unaudited interim condensed consolidated financial statements in conformity with GAAP requires management to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, related disclosure of contingent assets and liabilities at the date of the unaudited interim condensed consolidated financial statements, and the reported amounts of expenses for the periods presented. Significant estimates and assumptions reflected in these unaudited interim condensed consolidated financial statements include, but are not limited to, the allocation of consideration and the recognition of revenues in respect of the performance obligations under the Lantheus License Agreements, the accrual of research and development expenses, incremental borrowing rates determined in connection with finance and operating lease obligations and the valuations of stock options. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates when there are changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results may differ from those estimates or assumptions.
Leases
The Company accounts for leases in accordance with ASC Topic 842, Leases ("ASC 842"). At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present. The Company has elected not to recognize leases with an original term of one year or less in the unaudited interim condensed consolidated balance sheets. The Company has also elected to account for the lease and non-lease components as a combined lease component for its current lease portfolio. Right-of-use assets and lease liabilities are recognized at the commencement date based on the present value of lease payments over the lease term. Options to renew or early terminate a lease are included in the initial lease term of a lease when there is reasonable certainty that the option will be applied.
ASC 842 requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its incremental borrowing rate. The Company's incremental borrowing rate is determined using a secured borrowing rate for the same currency and term as the associated lease in a similar economic environment.
Lease expense for operating leases is recognized on a straight-line basis over the lease term and included in operating expenses in the unaudited interim condensed consolidated statements of operations and comprehensive loss.
Recent accounting pronouncements
The Company has evaluated accounting pronouncements recently issued but not yet adopted and believes that the current accounting pronouncements currently do not apply to the Company’s operations and are not expected to have a material impact on the Company’s unaudited interim condensed consolidated financial statements or disclosures.
3. Revenue
In November 2022, POINT announced strategic collaboration and exclusive license agreements with Lantheus Holdings Inc. ("Lantheus") for exclusive worldwide rights for POINT's programs in prostate cancer (PNT2002) and neuroendocrine tumors (PNT2003), excluding certain territories (Japan, South Korea, Singapore, Indonesia, and China including Hong Kong, Macau and Taiwan) (the "PNT2002 Agreement" and the "PNT2003 Agreement", respectively, and collectively the "Lantheus License Agreements"). The collaboration pairs POINT's expertise in next generation radioligand development and manufacturing with Lantheus’ commercial leadership in Prostate-Specific Membrane Antigen ("PSMA") PET and radiopharmaceuticals.
In December 2022, closing conditions for the transaction, including Hart-Scott-Rodino antitrust clearance, were satisfied. POINT received a $250.0 million upfront payment under the PNT2002 Agreement and will receive an additional payment of up to $250.0 million upon U.S. regulatory approval. In addition, once certain return on investment financial thresholds have been achieved and other conditions satisfied, POINT will be eligible to receive royalties of 20% on all net sales (prior to which there is a period of sales in which the royalty may be based on only a portion of the gross profit), and contingent upon the satisfaction of certain net sales milestones, additional payments of up to $1.3 billion. POINT received a $10.0 million upfront payment under the PNT2003 Agreement, and will receive up to an additional $30.0 million upon U.S. regulatory approval. The PNT2003 Agreement also provides that POINT will receive royalties of 15% on net sales and, contingent upon the satisfaction of certain net sales milestones, an additional payment of up to $275.0 million.
In connection with the PNT2002 Agreement, the Company is responsible for completing the Company's multi-center, randomized, open label phase 3 Study evaluating metastatic castration-resistant Prostate cancer using 177Lu-PNT2002 PSMA therapy After Second-line Hormonal treatment (“SPLASH") trial and the parties will work together to file the New Drug Application (“NDA”), with the costs incurred in connection with the U.S. Food and Drug Administration ("FDA") submission being borne by Lantheus. Thereafter, Lantheus will be responsible for all additional clinical and regulatory costs in the U.S., as well as all costs for development, clinical trials and regulatory approval in the rest of its territories outside the U.S., except Asia.
To determine the appropriate amount of revenue to be recognized under ASC Topic 606, Revenue from Contracts with Customers, the Company performs the following steps: (i) identify the promised goods or services in the contract, (ii) determine whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract, (iii) measure the transaction price, including the constraint on variable consideration, (iv) allocate the transaction price to the performance obligations and (v) recognize revenue when (or as) the Company satisfies each performance obligation.
In connection with the PNT2002 Agreement, the Company identified the following performance conditions: (i) the license it conveyed to Lantheus with respect to certain intellectual property, (ii) service provided to complete the SPLASH trial, support the NDA submission and participate in joint steering activities and (iii) manufacturing activities. The Company determined the transaction price under ASC Topic 606 at the inception of the PNT2002 Agreement to be the $250.0 million upfront payment and has allocated this to the first two performance obligations based on a relative standalone selling price basis. The standalone selling prices for the first two performance obligations were determined using the adjusted market assessment approach and the expected cost plus a margin assessment approach, respectively. The Company concluded that variable consideration associated with the product manufacturing relates solely to the manufacturing activities performance obligation on the basis that it believes that the expected margin associated with this consideration is in line with market standards and specifically relates to the Company's efforts to satisfy its manufacturing obligations.
In connection with the PNT2003 Agreement, the Company identified the following performance conditions: (i) the license it conveyed to Lantheus with respect to certain intellectual property, (ii) service provided to complete the necessary submissions for regulatory approval and participate in joint steering activities and (iii) manufacturing activities. The Company determined the transaction price under ASC Topic 606 at the inception of the PNT2003 Agreement to be the $10.0 million upfront payment and has allocated this to the first two performance obligations based on a relative standalone selling price basis. The standalone selling prices for the first two performance obligations were determined using the adjusted market assessment approach and the expected cost plus a margin assessment approach, respectively. The Company concluded that variable consideration associated with the product manufacturing relates solely to the manufacturing activities performance obligation on the basis that it believes that the expected margin associated with this consideration is in line with market standards and specifically relates to the Company's efforts to satisfy its manufacturing obligations.
The Company does not include variable consideration to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will occur. Variable consideration in the PNT2002 Agreement and PNT2003 Agreement consists of:
•Potential future regulatory milestone payments. The Company concluded that this variable consideration is constrained considering that achievement of the milestones is outside its control and contingent upon the future success of clinical trials and regulatory approval by the FDA and in respect of other territories outside the U.S.
•Potential future milestone payments in connection with certain sales targets as well as any future royalties. The Company concluded that these payments qualify for the royalty exception. Under the royalty exception, sales-based royalties are recognized at the later of when (1) the subsequent sale or usage occurs or (2) the performance obligation to which some or all of the sales- or usage-based royalty has been allocated is satisfied (in whole or in part). That is, an entity does not estimate the amount of a sales-based royalty at contract inception; rather, revenue would be recognized when the subsequent sales occur (under the assumption that the associated performance obligation has been satisfied or partially satisfied).
•Potential payments for the manufacturing and supply of commercial product. The Company concluded that this variable consideration is constrained as it is contingent upon future regulatory approvals and the execution of a manufacturing and supply agreement.
The estimate of the Company’s variable consideration to be included in the transaction price is updated at each reporting date as a change in estimate. For the potential future regulatory milestone payments, the Company utilizes the most likely amount approach to determine the amounts recognized and timing of recognition. For the potential payments for manufacturing and supply of commercial product, the Company utilizes the expected value approach to determine the amounts recognized and timing of recognition. Once the constraint is removed, the milestone payments will be accounted for and allocated to the performance obligations.
For the licenses conveyed to Lantheus, the Company recognized revenue upon execution and regulatory approval of the Lantheus License Agreements. The Company concluded that the licenses represent that of functional intellectual property as each has significant standalone functionality and derives a substantial portion of their utility from that standalone functionality.
For the obligations to complete the SPLASH trial, support the NDA submission and participate in joint steering activities in connection with the PNT2002 Agreement as well as the obligations to complete the necessary submissions for regulatory approval and participate in joint steering activities for the PNT2003 Agreement, the Company recognizes revenue using the cost-to-cost method, which it concluded best depicts the transfer of control to the customer. Under the cost-to-cost method, the extent of progress towards completion is measured based on the ratio of actual costs incurred to the total estimated costs expected upon satisfying the identified performance obligation. Under this method, revenue is recorded as a percentage of the estimated transaction price based on the extent of progress towards completion.
The following table presents the Company’s contract liabilities as of June 30, 2023 and December 31, 2022:
| | | | | | | | | | | |
| June 30, 2023 | | December 31, 2022 |
Deferred revenue | | | |
Deferred revenue, current | $ | 15,899,770 | | | $ | 23,242,290 | |
Deferred revenue, net of current portion | 3,197,547 | | | 10,178,147 | |
Total | $ | 19,097,317 | | | $ | 33,420,437 | |
At inception of the Lantheus License Agreements, deferred revenue of $34.8 million was recognized in connection with future performance. During the three and six months ended June 30, 2023, the Company recognized $4.9 million and $14.3 million in revenue for services performed (three and six months ended June 30, 2022 — $nil and $nil, respectively). The current portion of deferred revenue reflects the Company’s estimate of the revenue it expects to recognize within the next 12 months. The Company expects to recognize the remainder of the deferred revenue in subsequent periods through the year ending December 31, 2028. No contract assets were recognized in connection with the Lantheus License Agreements, including costs incurred in obtaining the agreements.
4. Cash, cash equivalents and investments
Cash, cash equivalents and investments consisted of the following:
| | | | | | | | | | | |
| As of June 30, 2023 | | As of December 31, 2022 |
Cash | $ | 5,540,926 | | | $ | 12,429,627 | |
Cash equivalents: | | | |
Money market funds | 47,656,269 | | | 273,998,744 | |
Commercial paper | 4,096,143 | | | — | |
Total cash and cash equivalents | 57,293,338 | | | 286,428,371 | |
Short-term investments | | | |
Commercial paper | 131,797,284 | | | 115,156,455 | |
Corporate bonds | 102,294,737 | | | 45,219,042 | |
U.S. Government agency debt securities | 56,130,624 | | | 42,577,762 | |
Asset backed securities | 75,709,878 | | | 35,830,211 | |
Total short-term investments | 365,932,523 | | | 238,783,470 | |
Long-term investments | | | |
Asset backed securities | 750,129 | | | 16,119,430 | |
Corporate bonds | 10,820,572 | | | — | |
Total long-term investments | 11,570,701 | | | 16,119,430 | |
Total cash, cash equivalents and investments | $ | 434,796,562 | | | $ | 541,331,271 | |
Available-for-sale investments
The amortized cost, gross unrealized gains, gross unrealized losses and fair value of available-for-sale investments by type of security as of June 30, 2023 were as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Amortized Cost | | Unrealized Gains | | Unrealized Losses | | Fair Value | | Current | | Non-current |
Commercial paper | $ | 131,908,748 | | | $ | 15 | | | $ | (111,479) | | | $ | 131,797,284 | | | $ | 131,797,284 | | | $ | — | |
Corporate bonds | 113,657,153 | | 705 | | $ | (542,549) | | | 113,115,309 | | 102,294,737 | | 10,820,572 | |
Asset backed securities | 76,699,026 | | — | | | (239,019) | | | 76,460,007 | | 75,709,878 | | 750,129 | |
U.S. Government agency debt securities | 56,306,438 | | — | | | (175,814) | | | 56,130,624 | | 56,130,624 | | — | |
Total available-for-sale securities | $ | 378,571,365 | | | $ | 720 | | | $ | (1,068,861) | | | $ | 377,503,224 | | | $ | 365,932,523 | | | $ | 11,570,701 | |
The following table summarizes the fair value of available-for-sale investments based on stated contractual maturities as of June 30, 2023: | | | | | | | | | | | |
| Amortized Cost | | Fair Value |
Due within one year | $ | 366,912,175 | | | $ | 365,932,523 | |
Due between one and five years | 11,659,190 | | | 11,570,701 | |
Total | $ | 378,571,365 | | | $ | 377,503,224 | |
The primary objective of our investment portfolio is to maintain safety of principal balances, provide sufficient levels of liquidity and enhance overall returns in an efficient manner with acceptable levels of risk. Our investment policy limits interest-bearing security investments to certain types of debt and money market instruments issued by institutions with primarily investment-grade credit ratings, and it places restrictions on maturities and concentration by asset class and issuer.
During the three and six months ended June 30, 2023, we had no realized gains or losses on available-for-sale investments.
5. Fair value measurements
We measure fair value based on the prices that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value measurements are based on a three-tier hierarchy that prioritizes the inputs used to measure fair value. These tiers include the following:
Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities that are accessible at the measurement date. The fair value hierarchy gives the highest priority to Level 1 inputs.
Level 2: Observable prices that are based on inputs not quoted on active markets, but corroborated by market data. These inputs include quoted prices for similar assets or liabilities; quoted market prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs.
The following table presents information about the Company’s financial assets and liabilities as of June 30, 2023 that are measured at fair value on a recurring basis and indicates the level of the fair value hierarchy used to determine such fair values:
| | | | | | | | | | | | | | | | | | | | | | | |
| Level 1 | | Level 2 | | Level 3 | | Total |
June 30, 2023 | | | | | | | |
Cash equivalents: | | | | | | | |
Money market mutual fund | $ | 47,656,269 | | | $ | — | | | $ | — | | | $ | 47,656,269 | |
Commercial paper | — | | | 4,096,143 | | | — | | | 4,096,143 | |
Available-for-sale debt securities: | | | | | | | |
Commercial paper | — | | | 131,797,284 | | | — | | | 131,797,284 | |
Corporate bonds | — | | | 113,115,309 | | | — | | | 113,115,309 | |
Asset backed securities | — | | | 76,460,007 | | | — | | | 76,460,007 | |
U.S. Government agency debt securities | 56,130,624 | | | — | | | — | | | 56,130,624 | |
Total | $ | 103,786,893 | | | $ | 325,468,743 | | | $ | — | | | $ | 429,255,636 | |
Certain of our available-for-sale debt securities, including U.S. Government agency debt securities, are valued using inputs observable in active markets for identical securities and are therefore classified as Level 1 within the fair value hierarchy.
On May 7, 2023, POINT Biopharma Inc. entered into a Convertible Note Purchase Agreement (the "Convertible Note Agreement") with Ionetix Alpha Corporation ("Ionetix-α"), a subsidiary of IONETIX Corporation. On June 1, 2023, the Company purchased $5.0 million in unsecured promissory notes (the "Note Receivable") convertible into common stock of Ionetix-α at a conversion price that is subject to certain conditions as defined in the Convertible Note Agreement. Pursuant to the Convertible Note Agreement, the Company will purchase an additional $5.0 million of the Note Receivable six months following the initial purchase. Management assessed all features in the Convertible Note Agreement to determine embedded derivatives requiring bifurcation. In accordance with the Convertible Note Agreement, Ionetix-α has a voluntary redemption option, subject to certain terms and conditions, and may provide notice to the Company upon which the Company can elect to either redeem the Note Receivable at 150% of principal and interest outstanding or convert it into common stock of Ionetix-α. Management concluded that this put option meets the definition of a derivative and it is not clearly and closely related to the Note Receivable, thus requiring bifurcation from the host instrument and recognition at fair value. Further, management concluded the Note Receivable host instrument is to be classified as a loan receivable and therefore is measured at amortized cost but disclosure of fair value is required. Management determined the fair values of both the Note Receivable and embedded derivative under Level 3 in the fair value hierarchy. Management concluded that the fair value of the Note Receivable as at June 30, 2023 was equal to its amortized cost and that the fair value of the embedded derivative was nil both at inception of the arrangement and at June 30, 2023.
We did not have any financial liabilities measured at fair value on a recurring basis as of June 30, 2023.
There have been no transfers of assets or liabilities between the fair value measurement levels as of June 30, 2023.
6. Prepaid expenses and other current assets
Prepaid expenses and other current assets consisted of the following:
| | | | | | | | | | | |
| As of June 30, 2023 | | As of December 31, 2022 |
| $ | | $ |
Prepaid clinical trial expenses | 3,418,491 | | | 4,011,419 | |
Prepaid insurance | 1,781,969 | | | 1,310,314 | |
Canadian harmonized sales tax receivable | 332,654 | | | 60,222 | |
Other | 217,319 | | | 228,934 | |
Total | 5,750,433 | | | 5,610,889 | |
7. Property, plant and equipment, net
Property, plant and equipment, net consisted of the following:
| | | | | | | | | | | |
| As of June 30, 2023 | | As of December 31, 2022 |
| $ | | $ |
Land and building | 18,976,410 | | | 18,163,962 | |
Machinery and equipment | 10,415,742 | | | 5,328,639 | |
Property, plant and equipment, in development | 15,459,230 | | | 8,434,384 | |
Facility lease | 5,384,707 | | | — | |
Furniture and fixtures | 721,595 | | | 698,728 | |
Computer equipment | 153,891 | | | 149,892 | |
| 51,111,575 | | | 32,775,605 | |
Less: Accumulated depreciation | (2,717,358) | | | (1,395,029) | |
Total | 48,394,217 | | | 31,380,576 | |
In July 2020, the Company purchased land and a building in Indianapolis, Indiana (which has been expanded to approximately 81,000 square feet) for the purpose of retrofitting the existing building into a state-of-the-art, Good Manufacturing Practices ("GMP") compliant facility that will support the Company’s drug manufacturing operations. The Company commenced the manufacture of clinical supply in the Indianapolis manufacturing facility in January 2022. Construction continues on the facility to expand capacity.
On February 2, 2023, POINT Biopharma Corp., entered into a Facility Agreement (the "UHN Agreement") with University Health Network (“UHN”), a not-for-profit corporation incorporated under the laws of Canada. Pursuant to the UHN Agreement, the Company was provided access to utilize a 7,700 square foot, licensed research and development space with cGMP manufacturing suites (the “Facility”) under a lease effective April 1, 2023, which the Company will use to develop and expand its pipeline of next-generation radioligands. The lease is accounted for as a finance lease in accordance with ASC 842 and the right-of-use asset has been included within property, plant and equipment. See Note 9 for additional details.
Property, plant and equipment that have finite lives are recorded at cost less accumulated depreciation and impairment losses. Depreciation is expensed from the month the particular asset is available for its intended use, using the straight-line method over the estimated useful life of such asset at the following rates, which in each case are intended to reduce the carrying value of the asset to the estimated residual value:
| | | | | |
Asset Category | Estimated Useful Life |
Computer equipment | 5 years |
Machinery and equipment | 7 years |
Furniture and fixtures | 7 years |
Facility lease | 7 years |
Building | 20 years |
8. Accrued liabilities
Accrued liabilities consisted of the following:
| | | | | | | | | | | |
| As of June 30, 2023 | | As of December 31, 2022 |
| $ | | $ |
Accrued personnel costs | 3,772,849 | | | 7,116,382 | |
Accrued research and development costs | 5,233,075 | | | 9,645,594 | |
Accrued corporate legal fees and other professional services | 666,995 | | | 2,068,793 | |
Accrued costs for purchases of property, plant and equipment | 289,244 | | | 105,741 | |
Other accrued costs | 136,889 | | | 157,944 | |
Total | 10,099,052 | | | 19,094,454 | |
9. Leases
Right-of-use assets and lease liabilities are recognized at the commencement date based on the present value of lease payments over the lease term. ASC 842 requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its incremental borrowing rate. As an implicit interest rate was not readily determinable in the Company’s current portfolio of leases, the incremental borrowing rate was used based on the information available at the commencement date in determining the present value of lease payments.
On February 2, 2023, POINT Biopharma Corp. entered into the UHN Agreement. The lease commencement date was determined to be April 1, 2023, the date upon which the Company was provided access to the Facility. The lease is accounted for as a finance lease in accordance with ASC 842 and the right-of-use asset has been included within property, plant and equipment. Management concluded that the lease represents a finance lease on the basis that management believes that the lease term covers a substantial portion of the economic life of the primary lease component. See Note 7 for additional details. The initial term of the UHN Agreement will run for five years from the lease commencement date, with an option to renew for additional two-year terms thereafter, subject to certain conditions described in the UHN Agreement. Management included the first option to renew for two years as part of the lease term in determining the right-of-use asset and lease liability. The agreement does not transfer any title in the Facility to the Company. During the term, the Company shall be responsible for day-to-day management, activities and decision-making regarding the Facility. General governance of the Facility will be exercised by the Company and UHN through a joint committee. The joint committee, which will meet quarterly, will have a minimum of six people and will be comprised of an equal number of members from each of the Company and UHN.
On April 12, 2023, the Company entered into an operating lease for laboratory space with a lease term of two years. The lease is recorded separately on the interim condensed consolidated balance sheet as an operating lease right-of-use asset with a related operating lease liability as of June 30, 2023. The agreement does not transfer any title in the laboratory space to the Company.
The components of lease expense are as follows:
| | | | | | | | | | | |
| For the six months ended June 30, 2023 | | For the six months ended June 30, 2022 |
Operating lease expense | $ | 50,499 | | | $ | — | |
| | | |
Finance lease cost | | | |
Amortization of right-of-use asset | 192,311 | | | — | |
Interest on lease liability | 99,199 | | | — | |
Total finance lease cost | $ | 291,510 | | | $ | — | |
Supplemental cash flow information related to leases are as follows:
| | | | | | | | | | | |
| For the six months ended June 30, 2023 | | For the six months ended June 30, 2022 |
Cash flow information: | | | |
Cash paid for amounts included in the measurement of lease liabilities: | | | |
Operating cash flow use from operating leases | $ | 49,321 | | | $ | — | |
Operating cash flow use from finance leases | $ | 99,199 | | | $ | — | |
Financing cash flow use from finance leases | $ | 133,641 | | | $ | — | |
| | | |
Non-cash activity: | | | |
Right-of-use assets obtained in exchange for lease obligations: | | | |
Operating lease | $ | 453,490 | | | $ | — | |
Finance lease | $ | 5,384,707 | | | $ | — | |
The following table summarizes the weighted average remaining lease terms for the Company’s leases:
| | | | | |
| As of June 30, 2023 |
Weighted-average remaining lease term (in years): | |
Operating lease | 1.8 |
Finance lease | 6.8 |
As the interest rate implicit in the leases was not readily determinable at the time that the leases were evaluated, the Company used its incremental borrowing rate based on the information available in determining the present value of lease payments. The Company’s incremental borrowing rate was based on the term of the lease, the economic environment of the lease and reflect the rate the Company would have had to pay to borrow on a secured basis. Below is information on the weighted average discount rates used at the time that the leases were evaluated:
| | | | | |
| As of June 30, 2023 |
Weighted-average discount rates: | |
Operating lease | 7.6 | % |
Finance lease | 7.7 | % |
The following table summarizes the future maturities of the Company's lease liabilities as of June 30, 2023:
| | | | | | | | | | | |
| Operating Lease | | Finance Lease |
2023 | $ | 121,091 | | | $ | 505,608 | |
2024 | 249,446 | | | 1,011,217 | |
2025 | 74,938 | | | 1,011,217 | |
2026 | — | | | 1,011,217 | |
2027 | — | | | 1,011,217 | |
Thereafter | — | | | 2,275,237 | |
Total lease payments | $ | 445,475 | | | $ | 6,825,713 | |
Less: imputed interest | (30,616) | | | (1,466,384) | |
Present value of lease liabilities | $ | 414,859 | | | $ | 5,359,329 | |
10. Stockholders’ equity
The Company is authorized to issue 430,000,000 shares of common stock, with a par value of $0.0001 per share ("Common Stock"), as well as 20,000,000 of shares of preferred stock, with a par value of $0.0001 per share (“Preferred Stock”).
During the three months ended June 30, 2023, the Company issued (a) 71,585 shares of Common Stock in connection with the exercise of stock options granted to non-employee consultants, resulting in total cash proceeds of $99,503 and (b)
11,692 shares of Common Stock in connection with the exercise of stock options granted to employees, resulting in total cash proceeds of $86,555. During the six months ended June 30, 2023, the Company issued (i) 86,585 shares of Common Stock in connection with the exercise of stock options granted to non-employee consultants, resulting in total cash proceeds of $120,353 and (ii) 29,628 shares of Common Stock in connection with the exercise of stock options granted to employees and directors, resulting in total cash proceeds of $211,569.
During the three months ended June 30, 2022, the Company issued 2,490 shares of Common Stock in connection with the exercise of stock options issued to non-employee consultants, resulting in total cash proceeds of $3,461. During the six months ended June 30, 2022, the Company issued 3,168 shares of Common Stock in connection with the exercise of stock options issued to non-employee consultants, resulting in total cash proceeds of $4,403.
As of June 30, 2023, the total number of issued and outstanding shares of Common Stock was 105,765,954 (December 31, 2022 — 105,649,741). As of June 30, 2023, there were no issued and outstanding shares of Preferred Stock (December 31, 2022 — nil).
Each share of Common Stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. Holders of Common Stock are entitled to receive dividends, if any, as may be declared by the Company’s board of directors (the “Board”). During the three and six months ended June 30, 2023, no cash dividends were declared or paid by the Company (June 30, 2022 — $nil).
The Board has the authority to issue shares of Preferred Stock from time to time on terms it may determine, to divide shares of Preferred Stock into one or more series and to fix the designations, preferences, privileges, and restrictions of Preferred Stock, including dividend rights, conversion rights, voting rights, terms of redemption, liquidation preference, sinking fund terms, and the number of shares constituting any series or the designation of any series to the fullest extent permitted by the Delaware General Corporation Law ("DGCL"). During the six months ended June 30, 2023, no shares of Preferred Stock were issued by the Company.
11. Stock-based compensation
In March 2020, the board of directors of POINT Biopharma Inc. approved the 2020 Equity Incentive Plan (the “2020 EIP”). The 2020 EIP provided for the granting of incentive and non-qualified stock options, stock appreciation rights, restricted stock units, performance awards and other stock-based awards to employees, directors, and consultants of POINT Biopharma Inc. Effective as of June 30, 2021, the Board adopted the POINT Biopharma Global Inc. 2021 Equity Incentive Plan (the “2021 EIP”) to replace the 2020 EIP and allow the Company to grant equity and equity-based incentive awards to officers, employees, non-employee directors and consultants of the Company. The Company assumed the outstanding equity awards under the 2020 EIP, but no further grants may be made under the 2020 EIP. The 2021 EIP provides that the number of shares reserved and available for issuance under the 2021 EIP will automatically increase each January 1, beginning on January 1, 2022, by 4% of the number of outstanding shares of Common Stock on the immediately preceding December 31, or such lesser amount as determined by the Board. As of January 1, 2023, the number of shares of Common Stock available under the 2021 EIP increased by 4,225,990 for a total of 9,129,858 shares of Common Stock authorized for issuance under the 2021 EIP as of June 30, 2023.
Stock options
The Company recorded $685,263 and $1,131,391 to research and development expenses and $1,025,086 and $1,588,454 to general and administrative expenses for stock-based compensation for the three and six months ended June 30, 2023, respectively (June 30, 2022 — $458,634 and $743,945 to research and development expenses and $568,929 and $724,068 to general and administrative expenses for the three and six months ended, respectively). The Company did not recognize a tax benefit related to stock-based compensation expense during the three and six months ended June 30, 2023 as well as during the three and six months ended June 30, 2022, as the Company had net operating loss carryforwards and recorded a valuation allowance against the deferred tax asset.
The following table summarizes the activity relating to the Company’s stock options.
| | | | | | | | | | | | | | | | | |
| Number of Shares | | Weighted Average Exercise Price Per Share ($) | | Weighted- Average Remaining Contractual Term (in years) |
Outstanding as of December 31, 2022 | 5,592,173 | | 5.85 | | |
Granted | 3,144,071 | | 7.03 | | |
Exercised | (116,213) | | 2.86 | | |
Forfeited | (122,887) | | 7.37 | | |
Expired | (13,551) | | 8.47 | | |
Outstanding as of June 30, 2023 | 8,483,593 | | 6.30 | | 4.7 |
Vested and expected to vest as of June 30, 2023 | 8,483,593 | | 6.30 | | 4.7 |
Options exercisable as of June 30, 2023 | 2,705,429 | | 4.89 | | 4.0 |
During the three months ended June 30, 2023, 304,248 stock options were granted to directors of the Company, with a weighted average grant date fair value of $4.75 per share. The vesting terms of these options are such that they vest on the one-year anniversary of the date of grant. During the six months ended June 30, 2023, 3,144,071 stock options were granted, including the 304,248 stock options discussed above as well as 2,839,823 stock options granted to employees of the Company, with a weighted average grant date fair value of $3.76 per share. The vesting terms of the options granted to employees of the Company are such that 25% of the options vest on the one-year anniversary of the date of grant and the remaining 75% of such stock options vest in three equal annual installments thereafter.
During the three months ended June 30, 2022, 243,417 stock options were granted to employees and directors of the Company, with a weighted average grant date fair value of $4.66 per share. During the six months ended June 30, 2022, 1,948,614 stock options were granted to employees and directors of the Company, with a weighted average grant date fair value of $4.59 per share. Except as provided below with respect to options granted to directors, the vesting terms of these options are such that 25% of the options vest on the one-year anniversary of the date of grant and the remaining 75% of such stock options vest in three equal annual installments thereafter. On June 6, 2022, the terms of 128,070 stock options granted to directors of the Company during the quarter were amended to reduce the vesting period to one year. This amendment was accounted for as a modification and there was no material impact to stock-based compensation recorded.
The following table presents the assumptions used in the Black-Scholes-Merton option-pricing model to determine the grant date fair value of stock options granted:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three months ended June 30, 2023 | | Three months ended June 30, 2022 | | Six months ended June 30, 2023 | | Six months ended June 30, 2022 |
Risk-free interest rate | 3.91% - 4.23% | | 2.57% - 3.13% | | 3.71% - 4.23% | | 1.24% - 3.13% |
Expected term (in years) | 3.50 | | 4.25 | | 3.50 - 4.25 | | 4.25 - 5.38 |
Expected volatility | 67% | | 74% - 75% | | 67% - 68% | | 72% - 75% |
Expected dividend yield | —% | | —% | | —% | | —% |
During the three months ended June 30, 2023, non-employee consultants of the Company exercised 71,585 stock options with an intrinsic value of $604,767 and employees of the Company exercised 11,692 stock options with an intrinsic value of $32,740, for total cash proceeds to the Company of $186,058.
During the six months ended June 30, 2023, non-employee consultants of the Company exercised 86,585 stock options with an intrinsic value of $700,217, and employees and directors of the Company exercised 29,628 stock options with an intrinsic value of $38,300, for total cash proceeds to the Company of $331,922.
During the three and six months ended June 30, 2022, non-employee consultants of the Company exercised 2,490 and 3,168 stock options with intrinsic values of $16,060 and $19,301, respectively. The exercises resulted in cash proceeds to the Company of $3,461 and $4,403, respectively.
As of June 30, 2023, the unrecognized stock-based compensation expense related to unvested stock options was $19,343,654 and the estimated weighted average remaining vesting period was 2.3 years.
Performance Share Units
During the year ended December 31, 2022, 146,044 performance share units ("PSUs") were granted to employees of the Company, with a grant date fair value of $6.61 per unit based on the closing share price of the Company's Common Stock
on the date of grant. The vesting terms of these PSUs are such that 100% vest upon the regulatory approval of PNT2002 by the FDA. During the three and six months ended June 30, 2023, the Company did not record any stock-based compensation expense related to these PSUs on the basis that they cannot be considered probable to vest as the regulatory approval requirement is outside the control of the Company and the clinical trial remains ongoing.
12. Commitments and contingencies
Indianapolis facility commitments
The Company is party to certain agreements for the continuing expansion of the manufacturing capabilities of the Indianapolis facility. Effective in the second quarter of 2022, the Company entered into an agreement for the design and build of a commercial manufacturing line. As of June 30, 2023, the Company is committed to aggregate future payments of approximately $20.0 million in connection with these agreements. During the three and six months ended June 30, 2023, approximately $7.4 million and $10.3 million, respectively, has been recorded within property, plant and equipment in connection with these agreements (three and six months ended June 30, 2022 — approximately $3.4 million and $4.0 million, respectively).
Clinical trial and commercial commitments
The Company in the normal course of business enters into various services and supply agreements in connection with its clinical trials to ensure the supply of certain products and product lines during the Company’s clinical phase. These agreements often have minimum purchase commitments and generally terminate upon the termination of the clinical trial. Minimum purchase commitments under these agreements include individual commitments up to $1.7 million. Aggregate remaining minimum commitments amount to approximately $6.2 million with payments ranging from three to eight years or upon completion of the clinical trial, if earlier. The Company recorded research and development expenses in connection with these agreements of approximately $4.8 million and $11.3 million during the three and six months ended June 30, 2023, respectively (three and six months ended June 30, 2022 — $2.6 million and $4.3 million, respectively).
The Company also has supply agreements with third parties to purchase certain products for use in the Company’s full scale production process. The Company is committed to purchase a minimum quantity of product in the amount of approximately $111.9 million ($148.3 million CAD) over the contract term. The purchase commitments are contingent upon the completion of certain milestones by the third-party suppliers. The Company recorded $nil and $nil in connection with these agreements during the three and six months ended June 30, 2023, respectively (three and six months ended June 30, 2022 — $nil and $nil, respectively).
On May 10, 2023, the Company entered into an Irradiation Services Agreement (the "Irradiation Agreement") which expands the Company's reactor network. Pursuant to the Irradiation Agreement, the Company will receive irradiation services to irradiate ytterbium-176 (“176Yb”) and has minimum purchase commitments of approximately $32.4 million over the ten year contract term. During the three and six months ended June 30, 2023, the Company did not record any research and development expenses in connection with this agreement.
The Company also has an agreement with a third party to provide certain services in connection with the Company’s SPLASH clinical phase study. The agreement expires on the date of the completion or termination of the clinical trial. The remaining minimum purchase commitment under this agreement is approximately $24.0 million with payments that range from one to five years. The Company recorded research and development expenses in connection with this agreement of approximately $6.2 million and $11.1 million during the three and six months ended June 30, 2023, respectively (three and six months ended June 30, 2022 — $2.5 million and $5.6 million, respectively).
License agreements
The Company in the normal course of business enters into license and sublicense agreements in connection with its clinical trials and product development. For additional details of the Company’s license agreements, see Note 15 to the 2022 Financial Statements.
On April 17, 2023, POINT Biopharma Inc. entered into first and second amendments (the "Amendments") to that certain Sublicense Agreement, dated November 14, 2019, between POINT Biopharma Inc. and Scintomics GmbH ("Scintomics"). Pursuant to the Amendments, the exclusive, sublicensable, license is expanded to include all geographies worldwide and the Company will have increased flexibility in connection with sublicense arrangements.
The Company recorded research and development expenses in connection to its license agreements of approximately $3.0 million and $3.5 million during the three and six months ended June 30, 2023, respectively (three and six months ended June 30, 2022 — $3.8 million and $4.6 million, respectively).
13. Net loss per share
Basic loss per share is computed by dividing the loss available to common stockholders by the weighted-average number of shares of Common Stock outstanding during the period. Diluted loss per share is computed by dividing loss available to common stockholders by the weighted-average number of shares of Common Stock outstanding during the period increased to include the number of additional shares of Common Stock that would have been outstanding if the potentially dilutive securities had been issued, using the treasury stock method.
| | | | | | | | | | | | | | | | | | | | | | | |
| Three months ended June 30, 2023 | | Three months ended June 30, 2022 | | Six months ended June 30, 2023 | | Six months ended June 30, 2022 |
Net loss attributable to common stockholders | $ | 25,410,839 | | | $ | 24,580,247 | | | $ | 41,941,510 | | | $ | 40,960,821 | |
Weighted-average common shares outstanding-basic and diluted | 105,724,215 | | | 90,124,295 | | | 105,692,615 | | | 90,123,288 | |
Net loss per share attributable to common stockholders-basic and diluted | $ | 0.24 | | | $ | 0.27 | | | $ | 0.40 | | | $ | 0.45 | |
The Company’s potentially dilutive securities, which include stock options, have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. The Company's PSU's are considered contingently issuable shares for the purpose of the computation of loss per share and have been excluded on the basis that as of June 30, 2023, the performance condition for vesting had not been achieved. Therefore, the weighted-average number of shares of Common Stock outstanding used to calculate both basic and diluted net loss per share attributable to the holders of Common Stock is the same.
14. Income Taxes
The Company calculates its interim tax provision at the end of each interim period and estimates the annual effective tax rate which is applied to its ordinary quarterly earnings. The computation of the annual estimated effective tax rate at each interim period requires certain estimates and significant judgment including, but not limited to, the expected operating income for the year, projections of the proportion of income earned and taxed in foreign jurisdictions, permanent and temporary differences between book and tax amounts, and the likelihood of recovering deferred tax assets generated in the current year. The accounting estimates used to compute the provision for income taxes may change as new events occur, additional information is obtained or as the tax environment changes.
The Company has operations in both the United States and Canada, and as such it is subject to tax in both countries. The income tax benefit and expense for the three months ended June 30, 2023 and June 30, 2022 was $921,298 and $183,405, respectively and the income tax benefit and expense for the six months ended June 30, 2023 and June 30, 2022 was $1,159,940 and $271,521, respectively. The income tax benefit for the three and six months ended June 30, 2023, consists primarily of tax benefits related to research and development tax credits partially offset by current taxes in Canada. The income tax expense for the three and six months ended June 30, 2022, consists of current taxes in Canada.
The Company files income tax returns in the U.S. federal, certain states, and Canada with varying statutes of limitations. The Company is not currently subject to tax examinations by any taxing jurisdiction. However, in the event of any such examination, there may or may not be an impact on the Company’s net operating loss carryforwards and credits. The Company does not anticipate that any potential tax adjustments resulting from such examinations would have a significant impact on its financial position or results of operations.
As of June 30, 2023, the Company believes no significant changes in the unrecognized tax benefits will occur within the next 12 months.
15. Related party transactions
The Company recognized expenses in connection with related party transactions in the unaudited interim condensed consolidated statements of operations as follows:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three months ended June 30, 2023 | | Three months ended June 30, 2022 | | Six months ended June 30, 2023 | | Six months ended June 30, 2022 |
Consulting fees on business activities to Board member | $ | 31,496 | | | $ | 102,396 | | | $ | 205,911 | | | $ | 169,092 | |
Reimbursement to Board member for occupancy costs | 17,894 | | | 17,898 | | | 35,313 | | | 35,676 | |
Total | $ | 49,390 | | | $ | 120,294 | | | $ | 241,224 | | | $ | 204,768 | |
Transactions with related parties are in the normal course of operations and have been measured at their agreed upon exchange amount.
During the three and six-month periods ended June 30, 2023 and 2022, the Company received consulting services for research and development from a Board member. As of June 30, 2023, $33,471 is recorded within accrued liabilities in relation to this consulting arrangement.
The Company currently has a lease arrangement in place with a Board member for the use of office space. The arrangement does not have a defined contractual lease term and is payable monthly. The Company has applied the short-term lease exemption under ASC 842 to this arrangement and is recording the lease payments of approximately $6,000 monthly as rent expense.
ITEM 2 – MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of our financial condition and results of operations should be read together with our unaudited interim condensed consolidated financial statements and notes thereto for the three and six months ended June 30, 2023 (the “Q2 2023 Financial Statements”) appearing elsewhere in this Quarterly Report on Form 10-Q and our audited consolidated financial statements and notes thereto for the periods ended December 31, 2022 and 2021 (the “2022 Financial Statements”) contained in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as filed with the Securities and Exchange Commission ("SEC") on March 27, 2023 (the "2022 Form 10-K"). Please also see the section entitled “Cautionary Note Regarding Forward-Looking Statements.”
Cautionary Note Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q contains “forward-looking statements” which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions (including the negative of any of the foregoing) may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. These factors include, but not limited to, the following:
•the success, cost and timing of our product development activities and clinical trials, our plans for clinical development of our product candidates and the initiation and completion of any other clinical trials and related preparatory work and the expected timing of the availability of results of the clinical trials;
•our ability to recruit and enroll suitable patients in our clinical trials;
•the potential attributes and benefits of our product candidates;
•our ability to obtain and maintain regulatory approval for our product candidates, and any related restrictions, limitations or warnings in the label of an approved product candidate;
•our ability to obtain funding for our operations, including funding necessary to complete further development, approval and, if approved, commercialization of our product candidates;
•the period over which we anticipate our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements;
•the potential for our business development efforts to maximize the potential value of our portfolio;
•our ability to identify, in-license or acquire additional product candidates;
•our ability to maintain the license agreements underlying our product candidates;
•our ability to compete with other companies currently marketing or engaged in the development of treatments for the indications that we are pursuing for our product candidates;
•our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates and the duration of such protection;
•our ability to contract with and rely on third parties to assist in conducting our clinical trials and manufacture our product candidates;
•the development and expansion of our own manufacturing facility in Indianapolis, Indiana and the ability of this facility to provide adequate production capacity to meet future clinical and commercial demands for our product candidates;
•the size and growth potential of the markets for our product candidates, and our ability to serve those markets, either alone or in partnership with others;
•the rate and degree of market acceptance of our product candidates, if approved;
•the pricing and reimbursement of our product candidates, if approved;
•regulatory developments in the United States and foreign countries;
•the impact of laws and regulations;
•our ability to attract and retain key scientific, medical, commercial or management personnel;
•our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
•our financial performance;
•the level of activity in the trading market for our common stock, par value $0.0001 per share ("Common Stock") and the volatility of the market price of our Common Stock;
•the effect of the COVID-19 pandemic, the Russo-Ukrainian conflict and/or bank failures on the foregoing; and
•other factors detailed under the section entitled “Risk Factors” in the 2022 Form 10-K.
These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting us will be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described under the heading “Risk Factors” in the 2022 Form 10-K. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Some of these risks and uncertainties may in the future be amplified by the COVID-19 outbreak, the Russo-Ukrainian conflict and/or adverse developments affecting the financial services industry and there may be additional risks that we consider immaterial or which are unknown. It is not possible to predict or identify all such risks. Readers are cautioned not to place undue reliance on forward-looking statements because of the risks and uncertainties related to them and to the risk factors. We do not undertake any obligation to update or revise any forward-looking statements, which speak only as of the date made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
Overview
Introduction
We are a globally focused radioligand company building a platform for the clinical development and commercialization of radioligands that fight cancer. We have a pipeline of product candidates and early-stage development programs, in-house manufacturing capabilities, and a secured supply for rare medical isotopes like actinium-225 ("225Ac") and lutetium-177 ("177Lu").
Our team brings decades of combined experience in radioligand clinical development and manufacturing. In a space where manufacturing is often overlooked, the Company has unique capabilities. In addition to our Center of Radioligand Excellence (CORE), a commercial-scale radioligand production campus in Indianapolis, Indiana, we also operate the POINT Institute for Radioligand Innovation (PIRI) in Toronto, Ontario, a state of the art GMP R&D center focused on bringing novel programs from discovery to the clinic. Furthermore, management has leveraged their prior relationships to assemble resilient radioisotope supply chains, which even includes processing our own no-carrier-added ("n.c.a") 177Lu isotope in-house.
Our predecessor was incorporated on September 18, 2019 as POINT Theranostics Inc. under the DGCL and subsequently amended its name to “POINT Biopharma Inc.” on November 22, 2019. POINT Biopharma Inc. became a wholly-owned subsidiary of POINT Biopharma Global Inc. (together with its consolidated subsidiaries, “POINT” or the “Company”) pursuant to a merger on June 30, 2021.
Recent Developments
PNT2002: 177Lu-based PSMA-targeted radiopharmaceutical
Enrollment in PNT2002's phase 3 Study evaluating metastatic castration-resistant Prostate cancer using 177Lu-PNT2002 PSMA therapy After Second-line Hormonal treatment (“SPLASH") trial (NCT04647526) is complete and top line data is expected in the fourth quarter of 2023. Six trial sites remain open for recruitment to complete a separate pharmacokinetic sub-study. POINT is not experiencing any supply constraints or shortages related to its lutetium-177-labeled programs.
PNT2004: fibroblast activation protein-alpha (FAP-alpha) inhibitor
In May 2023, enrollment in cohort 3 of the phase 1 FAPi Radioligand OpeN-Label, phase 1 study to evaluate safety, Tolerability and dosImetry of 177Lu-PNT6555; a dose Escalation study for tReatment of patients with select solid tumors, ("FRONTIER") trial (NCT05432193) began, and a total of seven participants have been dosed with 177Lu-PNT6555 to date. We continue to anticipate data from the full FRONTIER study to be available in the first half of 2024.
In June 2023, a Trial-in-Progress poster for FRONTIER was presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, which included trial background information, study design considerations, and a cohort enrollment status update.
Later in June 2023, we published and presented preclinical data at the 2023 Annual Meeting of the Society of Nuclear Medicine & Molecular Imaging (SNMMI). The auger electron and beta emitting isotope terbium-161 was paired with POINT’s FAP-targeted PNT6555 ligand and showed robust anti-tumor efficacy, similar to 225Ac-PNT6555 and 177Lu-
PNT6555. Also, preclinical proof-of-concept was established for synergistic interaction of immuno- and radioligand therapies with 177Lu-PNT6555.
PNT2001: 225Ac-labelled next-generation PSMA-targeted radiopharmaceutical
At our virtual Investor Day in June 2023, we unveiled the trial design for the phase 1 portion of ACCEL, the first-in-human phase 1/2 clinical trial for PNT2001's actinium-225 program. The trial was designed to enable the parallel exploration of PNT2001 in two patient populations: later-stage mCRPC patients and earlier-stage BCR or Prostate-Specific Membrane Antigen ("PSMA")-positive oligorecurrent patients. We anticipate a health authority submission in the fourth quarter of 2023, and expect the first patient dosed in this trial to be in the first quarter of 2024.
Manufacturing & Supply Chain Updates
In April 2023, we announced an agreement for the supply of actinium-225 with Eckert & Ziegler. Eckert & Ziegler will provide predetermined amounts of GMP grade actinium-225 to POINT for use in the development of POINT’s pipeline of next generation actinium-225-based radioligands.
In May 2023, we announced a collaboration to create Ionetix Alpha Corp. (Ionetix-α). Ionetix-α, a new subsidiary of IONETIX Corp., is focused on near-term, commercial-scale production of GMP grade therapeutic isotopes, such as actinium-225. IONETIX has transferred its alpha therapy isotope business assets into Ionetix-α. POINT will invest $10 million into Ionetix-α.
In June 2023, we announced the intent to collaborate with AdvanCell, an Australian clinical stage radiopharmaceutical company, for the development of a global lead-212 radioisotope and radioligand supply chain and drug manufacturing network to specifically support the clinical development and commercialization of lead-212-labeled radioligands by each company.
Risks & Liquidity
Drug research and development is very expensive and involves a high degree of risk. Only a small number of research and development programs result in the commercialization of a product. We will not generate revenue from product sales unless and until we successfully complete clinical development of, are able to obtain regulatory approval for and successfully commercialize, the product candidates we are currently developing or may develop. We currently do not have any product candidates approved for commercial sale.
Our product candidates, currently under development or that we may develop, will require significant additional research and development efforts, including extensive clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel infrastructure and extensive compliance and reporting capabilities. There can be no assurance that our research and development activities will be successfully completed, that adequate protection for our licensed or developed technology will be obtained and maintained, that products developed will obtain necessary regulatory approval or that any approved products will be commercially viable.
If we obtain regulatory approval for one or more of our product candidates, we expect to incur significant expenses related to developing our commercialization capabilities to support product sales, marketing, and distribution activities, either alone or in collaboration with others. Prior to the Lantheus License Agreements, the Company had incurred significant net losses and had funded operations primarily through equity financings. Operating losses and negative cash flows were incurred during the three and six months ended June 30, 2023 and are expected to be incurred in the future.
In September 2022, POINT closed a previously announced underwritten public offering of approximately 15,500,000 shares of Common Stock at a public offering price of $9.00 per share (the "2022 Public Offering"). The gross proceeds to the Company from the 2022 Public Offering, before deducting underwriting discounts and commissions and other estimated offering expenses, were approximately $140.0 million. We believe that the net proceeds from the 2022 Public Offering and the Lantheus License Agreements, together with our available resources and existing cash, cash equivalents and investments, are sufficient to fund our operating expenses and capital expenditure requirements into 2026.
We are subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, successful discovery and development of our product candidates, development by competitors of new technological innovations, dependence on key personnel, the ability to attract and retain qualified employees, protection of proprietary technology, compliance with governmental regulations, the impact of COVID-19, the ability to secure additional capital to fund operations and commercial success of our product candidates. Product candidates currently under
development will require extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel, infrastructure and extensive compliance-reporting capabilities. Even if our drug development efforts are successful, it is uncertain when, if ever, we will realize significant revenue from product sales.
We anticipate that our expenses will increase significantly in connection with our ongoing activities, as we:
•advance our clinical-stage product candidates 177Lu-PNT2002 and 177Lu-PNT6555 through clinical development;
•advance our preclinical-stage product candidate 225Ac-PSMA-62, along with candidates developed with our CanSEEKTM Prodrug Platform, into clinical development;
•seek to identify, acquire, and develop additional product candidates, including through business development efforts to invest in or in-license other technologies or product candidates;
•hire additional clinical, quality control, medical, scientific, and other technical personnel to support our clinical operations;
•expand our operational, financial and management systems and increase personnel to support our operations;
•meet the requirements and demands of being a public company;
•maintain, expand, and protect our intellectual property portfolio;
•make milestone, royalty, or other payments due under various in-license or collaboration agreements;
•seek regulatory approvals for any product candidates that successfully complete clinical trials; and
•undertake any pre-commercialization activities to establish sales, marketing, and distribution capabilities for any product candidates for which we may receive regulatory approval in regions where we choose to commercialize our products on our own or jointly with third parties.
COVID-19 Pandemic, macroeconomic and other geopolitical events
Although the World Health Organization declared in early May of 2023 that COVID-19 no longer constitutes a public health emergency, the Company continues to actively monitor the COVID-19 developments and potential impact on the Company's employees, business and operations. The impact from global economic conditions and potential and continuing disruptions to and volatility in the credit and equity markets in the United States and worldwide are highly uncertain and cannot be predicted. The Company is currently operating in a period of significant economic uncertainty, resulting from, among other things, the impact of the COVID-19 pandemic, geopolitical tensions, such as the ongoing military conflict between Russia and Ukraine and heightened tensions between China and Taiwan, trade uncertainty, including changes in tariffs, sanctions, international treaties, and other trade restrictions, rising inflation and interest rates, and uncertainty and liquidity concerns in the broader financial services industry, including those caused by certain recent banking failures.
We are continuing to monitor the development and potential impact of these global economic and geopolitical events on our business and financial results. To date, we have not experienced any material business disruptions or incurred any impairment losses in the carrying values of our assets as a result of these events and we are not aware of any specific related event or circumstance that would require us to revise our estimates reflected in the Q2 2023 Financial Statements. However, estimates and assumptions about future events and their effects cannot be determined with certainty and therefore require the exercise of judgment; as a result, the Company’s estimates may change as new events occur and additional information is obtained.
Components of Operating Results
See Item 7. “Management's Discussion and Analysis of Financial Condition and Results of Operations - Components of Operating Results” in our 2022 Form 10-K, for a discussion of the nature of our operating expense line items within our accompanying unaudited interim condensed consolidated statements of operations.
Results of Operations - Three Months Ended June 30
The following table summarizes our results of operations for the three months ended June 30, 2023 and 2022:
| | | | | | | | | | | | | | | | | | | | | | | |
| For the three months ended June 30, 2023 | | For the three months ended June 30, 2022 | | Change |
(In U.S. dollars) | $ | | $ | | $ | | % |
Revenue | | | | | | | |
Other revenue | 4,865,856 | | | — | | | 4,865,856 | | | 100.0 | % |
Total revenue | 4,865,856 | | | — | | | 4,865,856 | | | 100.0 | % |
Operating expenses: | | | | | | | |
Research and development | 31,276,573 | | | 20,813,882 | | | 10,462,691 | | | 50.3 | % |
General and administrative | 5,088,403 | | | 4,080,401 | | | 1,008,002 | | | 24.7 | % |
Total operating expenses | 36,364,976 | | | 24,894,283 | | | 11,470,693 | | | 46.1 | % |
Loss from operations | (31,499,120) | | | (24,894,283) | | | (6,604,837) | | | 26.5 | % |
Other income (expenses): | | | | | | | |
Investment income | 5,335,753 | | | 509,700 | | | 4,826,053 | | | 946.8 | % |
Foreign currency loss | (168,770) | | | (12,259) | | | (156,511) | | | 1,276.7 | % |
Total other income (expenses) | 5,166,983 | | | 497,441 | | | 4,669,542 | | | 938.7 | % |
Loss before income taxes | (26,332,137) | | | (24,396,842) | | | (1,935,295) | | | 7.9 | % |
Income tax benefit (provision) | 921,298 | | | (183,405) | | | 1,104,703 | | | 602.3 | % |
Net loss | (25,410,839) | | | (24,580,247) | | | (830,592) | | | 3.4 | % |
Research and Development
The following table summarizes the components of research and development expenses for the three months ended June 30, 2023 and 2022:
| | | | | | | | | | | | | | | | | | | | | | | |
| For the three months ended June 30, 2023 | | For the three months ended June 30, 2022 | | Change |
(In U.S. dollars) | $ | | $ | | $ | | % |
Clinical trials | 9,284,858 | | | 8,286,606 | | | 998,252 | | | 12.0 | % |
Salaries and benefits | 7,847,232 | | | 4,312,716 | | | 3,534,516 | | | 82.0 | % |
Contract manufacturing | 7,189,671 | | | 3,374,158 | | | 3,815,513 | | | 113.1 | % |
Depreciation and overhead | 3,548,091 | | | 975,241 | | | 2,572,850 | | | 263.8 | % |
Sponsored research & product licenses | 3,036,390 | | | 3,805,325 | | | (768,935) | | | (20.2) | % |
Regulatory consulting | 370,331 | | | 59,836 | | | 310,495 | | | 518.9 | % |
Total | 31,276,573 | | | 20,813,882 | | | 10,462,691 | | | 50.3 | % |
For the three months ended June 30, 2023, as compared to the three months ended June 30, 2022, the increase in research and development expenses was primarily due to increases in (a) costs incurred in clinical trials and contract manufacturing as we continue to increase the scale of our trials and operations, (b) personnel costs as the Company continues to expand its research and development headcount, most notably in our Indianapolis manufacturing facility and the PIRI, and (c) depreciation and overhead primarily related to our Indianapolis manufacturing facility. This was partially offset by decreased costs associated with our licensing agreements and related sponsored research in connection with our product candidates both preclinical and clinical. For the three months ended June 30, 2023, the Company incurred approximately $11.2 million and $1.4 million of direct costs associated with its PNT2002 and PNT2003 programs, respectively. These figures exclude amounts for salaries and benefits, depreciation and overhead costs which are not allocated by program.
General and administrative
General and administrative expenses increased for the three months ended June 30, 2023, as compared to the three months ended June 30, 2022, primarily in connection with increased headcount compared to the prior year period as the scale of our operations continues to increase.
Other Income (Expenses)
For the three months ended June 30, 2023 and 2022, other income (expenses) consist mainly of (a) interest and other income earned on the Company's cash, cash equivalents and investments, partially offset by (b) a foreign exchange loss primarily associated with foreign currency transactions occurring within the Company’s Canadian subsidiary. The increase in the current period reflects the increase in investments primarily in connection with cash received in connection with equity financings and the Lantheus License Agreements.
Income Tax Benefit (Provision)
For the three months ended June 30, 2023, income tax benefit consists primarily of estimated research and development tax credits available for carryback. This is partially offset by taxes owing in Canada in relation to taxable income generated through management and research and development services performed by the Canadian subsidiary of the Company. For the three months ended June 30, 2022, income tax expense consisted primarily of taxes owing in Canada in relation to taxable income generated through management and research and development services performed by the Canadian subsidiary of the Company.
Results of Operations - Six Months Ended June 30
The following table summarizes our results of operations for the six months ended June 30, 2023 and 2022:
| | | | | | | | | | | | | | | | | | | | | | | |
| For the six months ended June 30, 2023 | | For the six months ended June 30, 2022 | | Change |
(In U.S. dollars) | $ | | $ | | $ | | % |
Revenue | | | | | | | |
Other revenue | 14,323,120 | | | — | | | 14,323,120 | | | 100.0 | % |
Total revenue | 14,323,120 | | | — | | | 14,323,120 | | | 100.0 | % |
Operating expenses: | | | | | | | |
Research and development | 58,187,045 | | | 33,314,730 | | | 24,872,315 | | | 74.7 | % |
General and administrative | 10,098,532 | | | 7,888,343 | | | 2,210,189 | | | 28.0 | % |
Total operating expenses | 68,285,577 | | | 41,203,073 | | | 27,082,504 | | | 65.7 | % |
Loss from operations | (53,962,457) | | | (41,203,073) | | | (12,759,384) | | | 31.0 | % |
Other income (expenses): | | | | | | | |
Investment income | 11,099,967 | | | 557,673 | | | 10,542,294 | | | 1,890.4 | % |
Foreign currency loss | (238,960) | | | (43,900) | | | (195,060) | | | 444.3 | % |
Total other income (expenses) | 10,861,007 | | | 513,773 | | | 10,347,234 | | | 2,014.0 | % |
Loss before income taxes | (43,101,450) | | | (40,689,300) | | | (2,412,150) | | | 5.9 | % |
Income tax benefit (provision) | 1,159,940 | | | (271,521) | | | 1,431,461 | | | 527.2 | % |
Net loss | (41,941,510) | | | (40,960,821) | | | (980,689) | | | 2.4 | % |
Research and Development
The following table summarizes the components of research and development expenses for the six months ended June 30, 2023 and 2022:
| | | | | | | | | | | | | | | | | | | | | | | |
| For the six months ended June 30, 2023 | | For the six months ended June 30, 2022 | | Change |
(In U.S. dollars) | $ | | $ | | $ | | % |
Clinical trials | 18,173,278 | | | 13,015,747 | | | 5,157,531 | | | 39.6 | % |
Salaries and benefits | 14,491,043 | | | 8,051,246 | | | 6,439,797 | | | 80.0 | % |
Contract manufacturing | 15,422,020 | | | 6,083,741 | | | 9,338,279 | | | 153.5 | % |
Depreciation and overhead | 5,897,604 | | | 1,483,462 | | | 4,414,142 | | | 297.6 | % |
Sponsored research & product licenses | 3,536,390 | | | 4,555,325 | | | (1,018,935) | | | (22.4) | % |
Regulatory consulting | 666,710 | | | 125,209 | | | 541,501 | | | 432.5 | % |
Total | 58,187,045 | | | 33,314,730 | | | 24,872,315 | | | 74.7 | % |
For the six months ended June 30, 2023, as compared to the six months ended June 30, 2022, the increase in research and development expenses was due to the same or substantially same factors as noted above for the three months ended June 30, 2023. For the six months ended June 30, 2023, the Company incurred approximately $22.7 million and $2.6 million of direct costs associated with its PNT2002 and PNT2003 programs, respectively. These figures exclude amounts for salaries and benefits, depreciation and overhead costs which are not allocated by program.
General and administrative
General and administrative expenses increased for the six months ended June 30, 2023, as compared to the six months ended June 30, 2022, due to the same or substantially same factors as noted above for the three months ended June 30, 2023.
Other Income (Expenses)
For the six months ended June 30, 2023 and 2022, other income (expenses) consist mainly of (a) interest and other income earned on the Company's cash, cash equivalents and investments, partially offset by (b) a foreign exchange loss primarily associated with foreign currency transactions occurring within the Company’s Canadian subsidiary. The increase in the current period reflects the same or substantially same factors as noted above for the three months ended June 30, 2023.
Income Tax Benefit (Provision)
For the six months ended June 30, 2023, income tax benefit consists primarily of estimated research and development tax credits available for carryback. This is partially offset by taxes owing in Canada in relation to taxable income generated through management and research and development services performed by the Canadian subsidiary of the Company. For the six months ended June 30, 2022, income tax expense consisted primarily of taxes owing in Canada in relation to taxable income generated through management and research and development services performed by the Canadian subsidiary of the Company.
Liquidity and Capital Resources
Sources of Liquidity and Capital
Except for the upfront payment received pursuant to the Lantheus License Agreements, the Company has incurred significant net losses and funded operations primarily through equity financings. Operating losses and negative cash flows were incurred in the three and six months ended June 30, 2023 and are expected to be incurred in future periods. We are subject to risks and uncertainties common to early-stage companies in the biotechnology industry. Product candidates currently under development will require extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel, and infrastructure and extensive compliance-reporting capabilities. Even if our drug development efforts are successful, it is uncertain when, if ever, we will realize significant revenue from product sales.
Net losses totaled $25.4 million and $24.6 million for the three months ended June 30, 2023 and 2022 and $41.9 million and $41.0 million for the six months ended June 30, 2023 and 2022, respectively.
In connection with the 2022 Public Offering, on September 16, 2022, we issued 13,900,000 shares of Common Stock resulting in net proceeds of approximately $117.3 million, excluding certain transaction costs incurred in connection with filing the S-3 (defined below) and on October 3, 2022, we issued an additional 1,589,779 shares of Common Stock for net
proceeds to the Company of approximately $13.4 million as a result of underwriters exercising their option to purchase additional shares pursuant to the underwriting agreement. On December 22, 2022, we received $260.0 million in connection with the Lantheus License Agreements. We intend to use the net proceeds from these transactions to fulfill our obligations under the Lantheus License Agreements, for general corporate purposes, funding of development programs, payment of milestones pursuant to our license agreements, general and administrative expenses, licensing of additional product candidates, and supporting our working capital needs.
Future Funding Requirements
Our primary use of cash is to fund operating expenses, primarily related to our research and development activities. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable, accrued expenses and prepaid expenses.
Operating losses and negative cash flows are expected to continue to be incurred in the future. We may require additional capital to meet operational needs and capital requirements for clinical trials, for other research and development expenditures, and for business development activities. Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures associated with our current and anticipated clinical trials and preclinical studies.
Our future funding requirements will depend on many factors, including, but not limited to:
•the scope, progress, results and costs of researching and developing our current product candidates, as well as other additional product candidates we may develop and pursue in the future;
•the timing of, and the costs involved in, obtaining regulatory and marketing approvals for our product candidates and any other additional product candidates we may develop and pursue in the future;
•the number of future product candidates that we may pursue and their development requirements;
•subject to receipt of regulatory approval, if any, the costs of commercialization activities for our product candidates, to the extent such costs are not the responsibility of any future collaborators, including the costs and timing of establishing product sales, marketing, distribution, and manufacturing capabilities;
•subject to receipt of regulatory approval, revenue, if any, received from commercial sales of our product candidates or any other additional product candidates we may develop and pursue in the future;
•the achievement of milestones that trigger payments under our various license agreements;
•the extent to which we in-license or acquire rights to other products, product candidates or technologies;
•our ability to establish collaboration arrangements for the development of our product candidates on favorable terms, if at all;
•our headcount growth and associated costs as we expand our research and development and establish a commercial infrastructure;
•the costs of preparing, filing and prosecuting patent applications, and maintaining and protecting our intellectual property rights, including enforcing and defending intellectual property related claims; and
•the costs of operating as a public company.
As of June 30, 2023, we had cash, cash equivalents and investments of approximately $434.8 million, which is anticipated to fund operations into 2026. We have based this estimate on current assumptions that may change or prove to be wrong, which would cause us to utilize our available capital resources sooner than we expect. In addition, our cash, cash equivalents and investments are subject to the economic pressures or uncertainties associated with local or global economic recessions, and ongoing geopolitical events. The failure of one or more of the financial institutions in which our cash, cash equivalents or investments are held, any resulting inability for us to obtain the return of our funds from any of those financial institutions, or any other adverse condition suffered by those financial institutions, could impact access to our cash, cash equivalents or investments and could adversely impact our operating liquidity and financial performance.
On July 11, 2022 the SEC declared effective our shelf registration statement on Form S-3 (the “S-3”) that allows the Company to offer and sell to the public up to $400.0 million of our Common Stock, preferred stock, debt securities, warrants to purchase our Common Stock, preferred stock or debt securities, subscription rights to purchase our Common Stock, preferred stock or debt securities and/or units consisting of some or all of these securities, from time to time in one or more offerings. The details of any future offerings, along with the use of proceeds from any securities offered, will be described in a prospectus supplement or other offering materials, at the time of offering. Also covered under the S-3 as part of the $400.0 million total amount is an at-the-market offering (“ATM”) of up to $150.0 million of our Common Stock
pursuant to a distribution agreement with Piper Sandler & Co. No shares of Common Stock were issued in connection with the ATM as of June 30, 2023. Pursuant to the S-3 and in connection with the 2022 Public Offering, on September 16, 2022 we issued 13,900,000 shares of Common Stock at the price of $9.00 per share, or an aggregate of $125.1 million, resulting in net proceeds of approximately $117.3 million, excluding certain transaction costs incurred in connection with filing the S-3, and on October 3, 2022, we issued an additional 1,589,779 shares of Common Stock at a public offering price of $9.00 per share for net proceeds to the Company of approximately $13.4 million as a result of an underwriters exercising their option to purchase additional shares pursuant to the underwriting agreement.
Until such time as we can generate substantial product revenue, if ever, we expect to finance our operations through a combination of equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, our stockholders' ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect rights of our stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or drug candidates, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts, or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Going Concern
We assess and determine our ability to continue as a going concern in accordance with the provisions of ASC Topic 205-40, Presentation of Financial Statements—Going Concern. We have determined that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business.
Working Capital
Working capital is defined as current assets less current liabilities.
The following table summarizes our total working capital and current assets and liabilities as of June 30, 2023 and December 31, 2022:
| | | | | | | | | | | | | | | | | | | | | | | |
| As of June 30, 2023 | | As of December 31, 2022 | | Change |
(In U.S. dollars) | $ | | $ | | $ | | % |
Current assets | 432,375,303 | | | 530,822,730 | | | (98,447,427) | | | (18.5) | % |
Current liabilities | 41,155,794 | | | 79,738,440 | | | (38,582,646) | | | (48.4) | % |
Total working capital | 391,219,509 | | | 451,084,290 | | | (59,864,781) | | | (13.3) | % |
The decrease in working capital as of June 30, 2023, primarily reflects cash used for (a) operating expenses, including, personnel costs and research and development costs as we advance our clinical trials and continue to expand our pipeline, and (b) capital expenditures for equipment and machinery used in our manufacturing facility in Indiana. This was partially offset by interest and other income earned on the Company's cash, cash equivalents and investments. The decrease in current liabilities primarily reflects the payment of income taxes during the six months ended June 30, 2023 of approximately $31.9 million, which had an equal and offsetting impact to current assets.
Cash Flows
The following table summarizes our sources and uses of cash for the six months ended June 30, 2023 and 2022:
| | | | | | | | | | | | | | | | | | | | | | | |
| For the six months ended June 30, 2023 | | For the six months ended June 30, 2022 | | Change |
(In U.S. dollars) | $ | | $ | | $ | | % |
Net cash flows used in operating activities | (96,727,236) | | | (31,068,981) | | | (65,658,255) | | | 211.3 | % |
Net cash flows used in investing activities | (132,606,078) | | | (129,643,171) | | | (2,962,907) | | | 2.3 | % |
Net cash flows provided by financing activities | 198,281 | | | 4,403 | | | 193,878 | | | 4403.3 | % |
Net decrease in cash and cash equivalents | (229,135,033) | | | (160,707,749) | | | (68,427,284) | | | 42.6 | % |
Cash flows used in Operating Activities
Net cash flows used in operating activities represent the cash receipts and disbursements related to all of our activities other than investing and financing activities. Cash used in operating activities increased for the six months ended June 30, 2023 compared to the six months ended June 30, 2022 primarily due to a) continued advancement of our clinical trials and expansion of our pipeline, as described above and b) income taxes paid of approximately $31.9 million.
We believe that the net proceeds from the Lantheus License Agreements and the 2022 Public Offering, together with our available resources and existing cash and cash equivalents, are sufficient to fund our operating expenses and capital expenditure requirements into 2026.
Cash flows used in Investing Activities
For the six months ended June 30, 2023 and 2022, net cash used in investing activities totaled $132.6 million and $129.6 million, respectively. The increase in cash used in investing activities relates to (a) the Company's investment of its available cash resources into fixed income investments, (b) purchase of the Note Receivable from Ionetix-α and (c) increased capital expenditures for purchases in connection with our Indianapolis manufacturing facility.
Cash flows provided by Financing Activities
For the six months ended June 30, 2023 and 2022, net cash provided by financing activities totaled $198.3 thousand and $4 thousand, respectively, which consisted of the net proceeds received from the exercise of stock options and solely related to the six months ended June 30, 2023, was partially offset by payments made in connection with the Company's finance lease obligation.
Contractual Obligations and Other Commitments
The Company in the normal course of business enters into various services and supply agreements in connection with its clinical trials to ensure the supply of certain product and product lines during the Company’s clinical phase. These agreements often have minimum purchase commitments and generally terminate upon the termination of the clinical trial. For additional information, see Note 12 to the Q2 2023 Financial Statements.
For additional information related to our license agreements, please also see Note 12 to the Q2 2023 Financial Statements and Notes 14 and 15 to the 2022 Financial Statements.
Off-balance sheet arrangements
We do not have any off-balance sheet arrangements or holdings in any variable interest entities.
Critical Accounting Policies and Estimates
This management’s discussion and analysis of our financial condition and results of operations is based on our Q2 2023 Financial Statements, which have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) and include the accounts of the Company and its wholly-owned subsidiaries, POINT Biopharma Inc., POINT Biopharma Corp., POINT Biopharma USA, Inc. and West 78th Street, LLC, for financial information and pursuant to the rules and regulations of the SEC.
The preparation of the Q2 2023 Financial Statements in conformity with GAAP requires us to make estimates, judgments and assumptions that may affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities as of the date of the Q2 2023 Financial Statements and the reported amounts of expenses during the reporting
periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
There have been no significant changes to our critical accounting policies and estimates from the information provided in Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our 2022 Form 10-K except as below:
Leases
The Company accounts for leases in accordance with ASC Topic 842, Leases ("ASC 842"). At the inception of an arrangement, we determine whether the arrangement is or contains a lease based on the unique facts and circumstances present. The Company has elected not to recognize leases with an original term of one year or less on the consolidated balance sheets. We have also elected to account for the lease and non-lease components as a combined lease component for our current lease portfolio. Right-of-use assets and lease liabilities are recognized at commencement date based on the present value of lease payments over the lease term. Options to renew or early terminate a lease are included in the initial lease term of a lease when there is reasonable certainty that the option will be applied.
ASC 842 requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its incremental borrowing rate. The Company's incremental borrowing rate is determined using a secured borrowing rate for the same currency and term as the associated lease in a similar economic environment.
Lease expense for operating leases is recognized on a straight-line basis over the lease term and included in operating expenses in the unaudited interim condensed consolidated statements of operations and comprehensive loss.
ITEM 3. – QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Market risks relating to our operations result primarily from interest rate risk and foreign exchange risk. As of June 30, 2023, there were no material changes to our market risks from the information provided in Item 7A “Quantitative and Qualitative Disclosures About Market Risk” in our 2022 Form 10-K.
Inflation generally affects us by increasing our cost of labor and clinical trial costs. We do not believe that inflation had a material effect on our business, financial condition or results of operations during the three and six months ended June 30, 2023 and 2022.
ITEM 4. – CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms. Such disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.
As of June 30, 2023, our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Our Chief Executive Officer and Chief Financial Officer have concluded that, based on the evaluation described above, as of June 30, 2023, our disclosure controls and procedures were effective.
Changes in Internal Control over Financial Reporting
There was no change in our internal control over financial reporting that occurred during the fiscal quarter ended June 30, 2023 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
PART II - OTHER INFORMATION
ITEM 1. – LEGAL PROCEEDINGS
From time to time, we may be subject to legal proceedings and claims in the ordinary course of business. We are not currently aware of any such proceedings or claims that we believe will have, individually or in the aggregate, a material adverse effect on our business, financial condition or results of operations.
ITEM 1A. – RISK FACTORS
Factors that could cause our actual results to differ materially from those described in this Quarterly Report on Form 10-Q are any of the risks and uncertainties described in our 2022 Form 10-K. If any of these risks are realized, our business, financial condition, operating results and prospects could be materially and adversely affected. Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operation.
As of the date of this Quarterly Report on Form 10-Q, there have been no material changes to the risks and uncertainties disclosed in the 2022 Form 10-K. We may disclose changes to such factors or disclose additional factors from time to time in our future filings with the SEC.
ITEM 2. – UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Unregistered Sales of Equity Securities
We did not have any unregistered sales of equity securities during the quarter ended June 30, 2023.
Issuer Purchases of Equity Securities
We did not repurchase any of our equity securities during the quarter ended June 30, 2023.
ITEM 3. – DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. – MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5. – OTHER INFORMATION
None of the Company’s directors or officers adopted, modified, or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the Company’s fiscal quarter ended June 30, 2023.
ITEM 6. – EXHIBITS
The following exhibits are filed as part of this Quarterly Report on Form 10-Q.
Exhibit Index
| | | | | | | | |
Exhibit Number | | Description |
3.1 | | |
3.2 | | |
10.1† | | |
10.2* | | |
10.3*# | | |
10.4*‡ | | |
31.1* | | |
31.2* | | |
32* | | |
101.INS* | | XBRL Instance Document |
101.SCH* | | XBRL Taxonomy Extension Schema Document |
101.CAL* | | XBRL Taxonomy Extension Calculation Linkbase Document |
101.DEF* | | XBRL Taxonomy Extension Definition Linkbase Document |
101.LAB* | | XBRL Taxonomy Extension Label Linkbase Document |
101.PRE* | | XBRL Taxonomy Extension Presentation Linkbase Document |
104 | | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
* Filed herewith.
† Schedules and exhibits to this Exhibit omitted pursuant to Regulation S-K Item 601(a)(5). The Registrant agrees to furnish supplementally a copy of any omitted schedule or exhibit to the SEC upon request.
# Certain confidential portions (indicated by brackets and asterisks) have been omitted from this exhibit.
‡ Indicates a management contract or any compensatory plan, contract or arrangement.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| | | | | | | | | | | |
| | | POINT BIOPHARMA GLOBAL INC. |
| | |
Date: August 14, 2023 | | |
| | |
| | By: | /s/Joe McCann |
| | | Dr. Joe McCann, Ph.D. |
| | | Chief Executive Officer |
| | | (Principal Executive Officer) |
| | |
| | By: | /s/Bill Demers |
| | | Bill Demers |
| | | Chief Financial Officer |
| | | (Principal Financial Officer) |
First Amendment to the Exclusive Sublicense Agreement
between Point Biopharma Inc.
a Delaware Corporation with its registered agent
National Registered Agents, Inc.
160 Greentree Drive - Suite 101
Dover, DE 19904
U.S.A.
- hereinafter called "POINT" -
and Scintomics GmbH
Jahnplatz 4
82166 Gräfelfing
Germany
- hereinafter called "SCI" -
SCI and POINT are referred to individually or jointly as the "Party" or "Parties".
This First Amendment to Exclusive Sublicense Agreement (“First Amendment”) is entered into by and between SCI and Point.
Preamble
Whereas, the Parties entered into the (Sub-)License Agreement (hereinafter referred to as the “Agreement”), based on the invention with the title „Utilization of electron deficient aromatic residues to increase the internalization of PSMA inhibitors for imaging an endoratiotherapy of prostate cancer” on November 14th, 2019.
Whereas, POINT entered in to the Agreement under the name “Point Theranostics Inc.”, but changed its name after the Effective Date to “Point Biopharma Inc.”.
Whereas, Scintomics changed its place of business after the Effective Date to “Jahnplatz 4, 82166 Gräfelfing, Germany”.
Whereas, the Parties are willing to amend the Agreement as set forth below.
Now, therefore, the Parties hereto agree as follows:
A.Amendment of Agreement
1.Wherever the term “Point Theranostics Inc.” appears throughout the Agreement, it shall be replaced by “Point Biopharma Inc.”.
2.Section 2.6 is replaced in its entirety with the following
2.6 Reserved
B.Effective Date
This Amendment shall enter in to force and be effective upon the last signature of the Parties.
C.Integration
The Parties agree that except as otherwise expressly amended in this Amendment all terms and conditions of the Agreement, shall remain in full force and effect. Any ancillary agreements, modifications and supplements require the written form in the English language.
(Sub-)License SCI ./. POINT First Amendment
- Confidential - page 1 of 2
| | | | | |
Gräfelfing, this 17th day of April 2023 | Toronto, this 17th day of April 2023 |
Scintomics GmbH | Point Biopharma Inc. |
_/s/ Saskia Kropf_____________ |
_/s/ Joe McCann_____________ |
Saskia Kropf General Manager | Joe McCann CEO |
| |
Gräfelfing, this _17th April 2023 | |
Scintomics GmbH | |
_/s/ Jan Niclas Wester_______ | |
Jan Niclas Wester General Manager | |
(Sub-)License SCI ./. POINT First Amendment
- Confidential - page 2 of 2
Exhibit 10.3
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) THE TYPE THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL
Second Amendment to the Exclusive Sublicense Agreement
between Point Biopharma Inc.
a Delaware Corporation with its registered agent
National Registered Agents, Inc.
160 Greentree Drive - Suite 101
Dover, DE 19904
U.S.A. - hereinafter called "POINT" -
and Scintomics GmbH
Jahnplatz 4
82166 Gräfelfing
Germany - hereinafter called "SCI" -
SCI and POINT are referred to individually or jointly as the "Party" or "Parties".
This Second Amendment to Exclusive Sublicense Agreement (“Second Amendment”) is entered into by and between SCI and Point.
Preamble
Whereas, the Parties entered into the (Sub-)License Agreement (hereinafter referred to as the “Agreement”), based on the invention with the title „Utilization of electron deficient aromatic residues to increase the internalization of PSMA inhibitors for imaging an endoradiotherapy of prostate cancer“ on November 14th, 2019; which as amended with a First Amendment on 17 April 2023.
Whereas, POINT entered in to the Agreement under the name “Point Theranostics Inc.”, but changed its name after the Effective Date to “Point Biopharma Inc.”, and which name change has been reflected in the First Amendment .
Whereas, Scintomics changed its place of business after the Effective Date to “Jahnplatz 4, 82166 Gräfelfing, Germany”.
Whereas, the Parties are willing to amend the Agreement as set forth below.
Now, therefore, the Parties hereto agree as follows:
A.Amendment of Agreement
1.Section 1.3 is replaced its entirety with the following:
1.3 "Application Field" is all human therapeutic uses.
2.Section 1.4 is replaced in its entirety with the following:
1.4 Reserved.
3.Subsection 1.14 is replaced in its entirety with the following:
1.14 Contract Territory is world-wide.
4.Subsection 2.4 is amended as shown
(Sub-)License SCI ./. POINT Second Amendment
- Confidential - page 1 of 4
[***]= Indicates confidential information omitted from the exhibit.
2.4 The complete or partial transfer of the rights and duties under this License Agreement by POINT to any third party requires the prior written consent of SCI. The written consent may only be withheld for good cause, and shall not be unreasonably delayed or conditioned. In case of a transfer to an Affiliated Company POINT shall inform SCI immediately of such transfer and provide SCI a written summary (e.g. in form of a fact sheet) of the key points. All rights and duties under this License Agreement shall transfer to the respective legal successors.
5.Subsection 3.1 is replaced in its entirety with the following:
3.1 SCI agrees that POINT may, with the prior written consent of SCI (which consent shall not be unreasonably conditioned, delayed or withheld) issue a Sub-license to a third party. For this purpose, POINT will submit a copy of the agreement that is ready to be concluded to SCI for written consent, which shall be granted within 20 (twenty) Working Days and which may only be withheld for good cause. From the time of the issuance of a Sub-license, POINT is jointly and severally liable also for the license fees of its Sub-licensees directly vis-à-vis SCI.
6.The table in Section 4.1 “Milestone Payments” shall be amended such, that a new Milestone Event No. 6 is included as follows:
| | | | | | | | |
6 | Clinical Admission in the 2nd country | 5,000,000.00 (five million) |
7.Section 4.3 is amended as shown (underlined text is added):
4.3 Sub-license Fees. In addition, POINT shall pay to SCI a share of [***]% ([***] percent) of the Sub-license Income. For the avoidance of doubt, portions of any payments made to POINT by Sub-licensee in order to fulfil POINT’s Milestone Payment obligations under section 4.1 not be included in the calculation of Sub-license Income under this section 4.3, though the remainder of such payment shall be considered Sub-license Income.
8.A new Section 4.5 “Minimum license fee” shall be added such, that a performance obligation is integrated in the Agreement:
4.5Minimum license fee. POINT shall pay annual minimum license fees to Scintomics in an amount of:
| | | | | | | | |
-in 2023: | | [***] |
-for the years 2024 – 2026, per year: | | [***] |
-as from the year 2027 and the following years, per year: | | [***] |
The minimum license fees are due in advance on January, 31st of each year for the current Accounting Period (i.e., the 1st payment will be due on January, 31st 2023). The payment of the respective minimum license fee can be credited towards the payment of the Royalties pursuant to section 4.2 when these are due.
9.Section 9 “OBTAINING AND MAINTENANCE OF CONTRACT PROPRIETARY RIGHTS” shall be amended such, that its wording shall be deleted and replaced by the following wording:
9. OBTAINING AND MAINTENANCE OF CONTRACT PROPRIETARY RIGHTS
(Sub-)License SCI ./. POINT Second Amendment
- Confidential - page 2 of 4
[***] = Indicates confidential information omitted from the exhibit.
9.1 SCI shall permit POINT to communicate with, develop strategy and provide instructions directly with patent counsel(s) acquiring, administering, maintaining and/or enforcing the Contract Proprietary, subject to POINT adhering to the conditions to which SCI would be obliged under terms of the Main-License. That notwithstanding, POINT shall not abandon, surrender, fail to enforce, allow to lapse or enter into any settlement agreements relating to the Contract Proprietary Rights in the Contract Territory without the express written consent of SCI,
9.2 POINT shall bear (or reimburse SCI upon demand) all costs of proprietary right filings, proceedings, issuance, and maintenance (particularly the annual fees), defense and enforcement, including all lawyers' fees and other expenses incurred in this context for the Contract Proprietary Rights. Section 6. shall apply accordingly. Under no circumstances SCI is required to repay the cost reimbursement (neither entirely nor parts thereof).
9.3 If POINT does not longer wants to accept the costs of proprietary right filings, proceedings, issuance, and maintenance (particularly the annual fees), including all lawyers' fees and other expenses incurred in this context for a particular Contract Proprietary Right in a particular country and therefore intends not to initiate or no longer to maintain the particular Contract Proprietary Right in the particular country, it shall notify SCI of such in writing sufficiently in advance, that being at least 5 (five) months in advance. During such notice period POINT shall continue to bear all costs in this respect. Thereafter, that particular country in which Point discontinues support of the Contract Proprietary Right shall be removed from the definition of Contract Territory.
9.4 With the providing of the above named notification in section 9.3 by POINT, SCI in according with the Main-License, is basically free to otherwise exploit or use the respective Contract Proprietary Right(s). Such proprietary right(s)/proprietary rights application(s) shall no longer be Contract Proprietary Right(s) in terms of this License Agreement.
10.As if subject to amended section 9.2 (amended as set out above in paragraph 10), within 30 (thirty) days of the Amendment Effective Date, POINT shall reimburse SCI upon first demand for all such costs and fees, which arose in this context in the Contract Territory before the Effective Date. POINT acknowledges that these sunk patent costs include, but are not limited to, the [***] set forth in the document B77136_PNT.xlsx provided to POINT by email on [***].
11.Section 17 (MISCELLANOUS) shall be amended such, that a new section 17.6 is inserted:
17.6 For the convenience of the Parties, this License Agreement and any amendments thereto may be (a) executed in counterparts, each of which shall be deemed to be an original and both of which, taken together, shall constitute one agreement binding on both parties, and (b) delivered electronically by email (such as in the form of a .pdf file) or by facsimile transmission of signature pages or electronic signature.
12.Attachment 1, and any reference thereto, is deleted in its entirety.
B.Consideration for Amendment.
In consideration for entering into this Agreement, POINT shall pay SCI a one-time, non-refundable Amendment Fee of Two Million One Hundred Fifty Thousand Euro (€2,150,000) within 15 days of the Amendment Effective Date.
C.Amendment Effective Date
This Amendment shall enter in to force and be effective upon the last signature of the Parties, herein the “Amendment Effective Date”.
(Sub-)License SCI ./. POINT Second Amendment
- Confidential - page 3 of 4
[***] = Indicates confidential information omitted from the exhibit.
D.Integration
The Parties agree that except as otherwise expressly amended in this Amendment all terms and conditions of the Agreement, shall remain in full force and effect. Any ancillary agreements, modifications and supplements require the written form in the English language.
| | | | | |
Gräfelfing, this 17th day of April | Toronto, this 17th day of April |
Scintomics GmbH | Point Biopharma Inc. |
_/s/ Saskia Kropf_____________________ |
_/s/ Joe McCann_________________________ |
Saskia Kropf General Manager | Joe McCann CEO |
| |
Gräfelfing, this _17th April 2023_ | |
Scintomics GmbH | |
_/s/ Jan Miclas Wester________________ | |
Jan Niclas Wester General Manager | |
(Sub-)License SCI ./. POINT Second Amendment
- Confidential - page 4 of 4
[***] = Indicates confidential information omitted from the exhibit.
Personal & Confidential Neil Fleshner 610 University Ave Suite 3-130, Toronto, ON M5G 1Z5 April 28, 2023 Dear Neil: On behalf of POINT Biopharma (the “Company”), I am pleased to offer you regular fulltime employment as a member of our team. Enclosed with this letter is an Employment Agreement that sets out the details of the Company’s offer. Please carefully review the enclosed Agreement and let me know if you have any questions. If you are satisfied with the terms and conditions of employment set out in the enclosed Employment Agreement, please confirm your acceptance of the Company’s offer by signing and dating the Agreement on the last page and returning the signed copy to jmccann@pointbiopharma.com no later than May 5, 2023, after which, if not signed and returned, this offer shall be automatically withdrawn and it shall be void. Yours truly, POINT Biopharma Per: Joe McCann, CEO Enclosure: Employment Agreement Doc ID: 0e8c1064d1944de40d3f008216294afc40d1f371
EMPLOYMENT AGREEMENT B E T W E E N: Neil Fleshner (“you”) – and – POINT Biopharma (the “Company”). IN CONSIDERATION of the mutual covenants set out in this Employment Agreement (the “Agreement”), you and the Company hereby agree to the following terms and conditions of your employment by the Company. 1. Position and Place of Employment (a) You will be employed on a full-time (up to 40 hours per week) basis as Chief Medical Officer, working remotely, with the anticipation of travel, and reporting to Joe McCann, CEO. (b) You will perform such duties and responsibilities and exercise such powers related to your position as are assigned to you from time to time by your manager. A copy of a current job description for your position is enclosed. This job description is intended as a summary and is not a comprehensive listing of all the duties and responsibilities of the position. These duties and responsibilities may be reasonably altered from time to time to accommodate the needs of the Company with the mutual agreement of the parties. (c) You shall use your best endeavours to promote the interests of the Company, including ensuring that your personal conduct and any activities in which you may participate when not at work do not in any way conflict with the interests or reputation of the Company. 2. Term of Employment Your employment will commence on August 15, 2023 (your “Start Date”) and will be for an indefinite period, subject to termination in accordance with this Agreement. The parties agree that your prior service with Point shall be included in the calculation of the length or period of your employment with the Company. 3. Hours of Work and Overtime Your specific days and hours of work are flexible but must be in the best interests of the Company and its Customers, and are subject to determination and change from time to time with the mutual Doc ID: 0e8c1064d1944de40d3f008216294afc40d1f371
- 2 - agreement of the parties. Any changes to your work schedule shall be made in accordance with the requirements of the ESA. 4. Remuneration (a) Base Salary: You shall be paid during your employment a base salary at the rate of $700,000 CAD per annum (the “Base Salary”), payable in arrears in bi-weekly instalments by direct deposit, less applicable statutory deductions. The Base Salary will be reviewed on an annual basis, or as otherwise determined by the Company. Any merit increases are subject to the approval and discretion of the Board. (b) During the Term of Employment, you will be eligible for an annual target cash bonus of up to 40% of your then-current Base Salary (the “Annual Bonus”) if the Board (or the Company’s Compensation Committee), in its sole discretion, determines that the Company has met its short-term and long-term business performance objectives and that you have met your personal performance objectives (together, the “Objectives”), which Objectives will be established on an annual basis by the Board (or the Company’s Compensation Committee). Payment of the Annual Bonus (less all applicable statutory deductions and withholdings by the Company) will be made to you once approved by the Board (or Company’s Compensation Committee), and within thirty (30) days after the Board has approved the corporate yearend financial statements. Your 2023 Annual Bonus, if any, will be prorated based on your period of employment. (c) You will be eligible to participate in the Long-Term Incentive (option agreement) plan. In this position you will be eligible for up to 150% (prorated according to the period of such year you were employed). (b) You will be entitled to 20 days of vacation time each calendar year (or such greater number of weeks as may be required by the ESA from time to time during your employment), pro- rated during your first and last calendar years of employment. Vacation time may be taken at a mutually agreeable time, subject to final determination by the Company. Vacation time must be taken in the year for which it is earned and may not be carried forward. (c) You will be paid vacation pay during your vacation time in an amount equal to your regular wages, provided however that your vacation pay in each calendar year will be equal to not less than your minimum entitlement to vacation pay as calculated in accordance with the ESA. (d) Upon termination of your employment with the Company for any reason, including your resignation, the Company will reconcile your vacation pay earned against your vacation pay paid. If you have earned more vacation pay than you have been paid, the balance will be added to your final pay. If you have been paid more vacation pay than you have earned, the balance will be deducted from your final pay. (e) You will be entitled to public holidays, with public holiday pay, in accordance with the requirements of the ESA. Doc ID: 0e8c1064d1944de40d3f008216294afc40d1f371
- 3 - 5. Group Benefits Plans You be eligible to participate in the Company’s group benefits plans, effective immediately from your start date, in accordance with the terms and conditions of the insurance plans as may be amended from time to time. 6. Business Expenses In accordance with the terms and conditions of the Company’s business expense policy (as may be amended from time to time), and upon your presentation of approved expense statements or receipts and any other supporting documentation as the Company may reasonably require, the Company shall reimburse you for reasonable business-related expenses actually and properly incurred by you in the course of performing your employment duties and responsibilities. 7. Statements Made by You During the Hiring Process You certify that the statements made on your application and/or resume, which form part of your employment application, are true and complete to the best of your knowledge. You understand and agree that if any such statement is at any time found to be false such false statement shall constitute cause for immediate termination of your employment without notice or any payments or benefits continuation in lieu of notice, except as may be required by the ESA. 8. Restrictions and Limitations Arising Out of Previous Employment (a) You represent and warrant that either: (i) you are not under any restrictions or limitations arising out of any previous employment, including any conflict of interest, confidentiality, non-competition or non-solicitation provisions, that would affect your ability to fully perform your duties to the Company, or (ii) that if any such restrictions or limitations exist, you have fully disclosed them in writing to the Company in advance of accepting this offer of employment. (b) To be fair to your former employer(s), you hereby agree to the following rules of conduct: (i) you are required to comply fully with any legal obligations you owe to your former employer(s); (ii) you must not bring with you from your former employer(s) any confidential or proprietary information or documents belonging to your former employer(s); and (iii) you are required to consult closely with the Company as to any steps you may take to approach clients you serviced with your former employer(s). 9. Conflicts of Interest To avoid a conflict of interest, during the period you are employed by the Company, you must not be employed or engaged directly or indirectly in any business or activity which could possibly conflict with your employment with the Company without the Company’s prior written consent. The parties agree that the roles outlined in Appendix 2 have been approved by the Company and do not constitute a conflict with your role as Chief Medical Officer or with the Company’s interests. Doc ID: 0e8c1064d1944de40d3f008216294afc40d1f371
- 4 - 10. Other Employment To ensure the safe and effective performance of your duties for the Company, during the period you are employed by the Company, you must not be employed elsewhere, or otherwise be engaged in providing any services of any kind to anyone other than the Company, without the Company’s prior written consent, with the exception of the outside activities listed in Appendix 2. 11. Conditions of Ongoing Employment (a) This offer and your ongoing employment with the Company are conditional upon: (i) you being and remaining lawfully able to work in Canada; (ii) completion of periodic background/police, credit and/or reference checks and/or verification of your qualifications, including signing appropriate consents from time to time, each satisfactory to the Company and or its Customers; (iii) your obtaining and maintaining appropriate security clearance, as and when directed or required by the Company; (iv) your continued satisfactory performance of your duties and responsibilities; and (v) your compliance with the Company’s policies and procedures, as may be implemented and amended from time to time. (b) Failure to comply with any of the above conditions at any time during the period you are employed by the Company shall constitute cause for immediate termination of your employment without notice or any payments or benefits continuation in lieu of notice, except as may be required by the ESA. (c) If you misconduct yourself in your employment, the Company may impose reasonable disciplinary measures upon you, including paid or unpaid suspensions. You agree that imposition of reasonable discipline shall not constitute termination of your employment by the Company. 12. Company Devices, Software and Systems (a) You acknowledge that you have no reasonable expectation of privacy in any Company computer, technology system, email, handheld device, telephone, or documents. As such, the Company has the right to audit and search all such items and systems, without further notice to you, to ensure that the Company is licensed to use the software on the Company’s devices in compliance with the Company’s software licensing policies, to ensure compliance with the Company’s policies and your obligations as an employee of the Company, and for any other business-related purposes in the Company’s sole discretion. (b) You understand and agree that you are not permitted to add any unlicensed, unauthorized, or non-compliant applications to the Company’s technology systems, including, without limitation, open source or free software not authorized by the Company and that you shall refrain from copying unlicensed software onto the Company’s technology systems or using non-licensed software or websites. Doc ID: 0e8c1064d1944de40d3f008216294afc40d1f371
- 5 - (c) You understand and agree that it is your responsibility to comply with the Company’s policies governing use of the Company’s documents and the Internet, email, telephone, and technology systems to which you will have access in connection with your employment. 13. Definitions For the purposes of this Agreement, the following terms shall have the following meanings: (a) “Business” shall mean all and any trades or other commercial activities of the Company: (i) with which you have been concerned or involved to any material extent at any time during your employment by the Company which the Company carries on with a view to profit; or (ii) which the Company has, as at the Termination Date, determined to carry on with a view to profit in the immediate or foreseeable future and in relation to which you possess any Confidential Information as at the Termination Date. (b) “Competitor” shall mean any business or organization within the Province of Ontario that provides services or sells products in competition with the Business of the Company, either during your employment or as carried on by the Company as at the Termination Date, as the case may be. (c) “Confidential Information” shall mean confidential and proprietary information and trade secrets, including but not limited to customer lists, product development, patent processes, company financials, other processes, information relating to personnel, marketing, sales, pricing, costs, quotations, business, contracts, operating and financial strategies and related information, salary and remuneration information, and all other confidential or proprietary information and trade secrets belonging to and/or used by the Company in the course of its Business. Confidential Information shall also include information furnished by a third party to the Company in confidence, or in respect of which the Company owes an obligation of confidentiality. (d) “Customer” shall mean any person, entity, enterprise, association or business who, at any time during the twelve (12) months immediately prior to the Termination Date, either paid any compensation, consideration and/or remuneration to the Company for or in connection with the purchase and/or sale of services or products offered by the Company or entered into an agreement with the Company to do so, and with whom you had contact in connection with your employment with the Company. (e) “Personnel” shall mean any person or entity who was a director, officer, employee or agent of, or independent contractor to, the Company on the Termination Date, or within six (6) months prior to such date. (f) “Prior Inventions” shall mean any inventions, original works of authorship, developments, improvements, and trade secrets that you made prior to your employment with the Company that belong to you, and that relate to the Company’s actual or proposed business, services, products or research and development. (g) “Prospective Customer” shall mean any person, entity, enterprise, association or business with whom the Company was engaged in active discussions or negotiations to provide Doc ID: 0e8c1064d1944de40d3f008216294afc40d1f371
- 6 - services or products during the twelve (12) months immediately prior to the Termination Date, and with whom you had contact in connection with your employment with the Company. (h) “Restricted Services” shall mean all and any services and/or products of a kind which are provided by the Company in the ordinary course of the Business. (i) “Supplier” shall mean any individual, business or organization that, as at the Termination Date, supplies goods or services to the Company. (j) “Termination Date” shall mean the day on which you cease to perform any services for the Company as a result of the termination of your employment for any reason whatsoever, and not the date at the end of any period of notice (or payments in lieu of notice) under statute, contract, common law, or this Agreement. (k) “Work Product” shall mean all original works of authorship, developments, concepts, improvements, designs, discoveries, ideas, processes, software, documentation, code, technology, plans, designs, copyrights, trademarks, patents, inventions, techniques, know- how, trade secrets and/or other intellectual or tangible property, whether or not patentable or registrable under copyright, patent, trade-mark or similar laws, which you may solely or jointly conceive or develop or reduce to practice, or cause to be conceived or developed or reduced to practice, as well as any and all enhancements, modifications, customizations, improvements to or combinations of any of the foregoing, relating to the Business in which the Company is engaged or from time to time is considering. Subject to the Company’s review and approval of Appendix 1 to this Agreement, Work Product shall not include any Prior Inventions that may be listed in Appendix 1. 14. Confidential Information (a) The Company has invested substantial time, money and resources in developing and obtaining Confidential Information in a wide variety of areas. The Company will provide you with the Confidential Information that the Company believes necessary for you to perform well and to develop new skills. You will, as part of your normal work, also contribute to the development of the Company’s Confidential Information. (b) The disclosure or misuse of Confidential Information could be detrimental to the best interests of the Company. Therefore, both during the period you are employed by the Company and at any time thereafter, you shall not copy, use or disclose to others any Confidential Information that you may acquire or create while employed by the Company concerning any aspect of the Company’s Business, Customers or Personnel, as long as such Confidential Information remains confidential or proprietary or secret, except in the normal course of your employment or as may be specifically authorized by the Company in writing. 15. Intellectual Property Rights (a) Prior Inventions: Attached as Appendix 1 to this Agreement is a list of all Prior Inventions to be used in connection with the Company’s Business. If, in the course of your employment with the Company, you incorporate into a Company service, product or process any Prior Inventions, you hereby grant the Company a nonexclusive, royalty-free, irrevocable, perpetual, transferable, worldwide license to make, have made, modify, use Doc ID: 0e8c1064d1944de40d3f008216294afc40d1f371
- 7 - and sell such Prior Inventions as part of or in connection with such service, product or process and for any other purpose (including those for commercial purposes) deemed appropriate by the Company. If you do not list any Prior Inventions in Appendix 1, you represent and warrant that there are no Prior Inventions to be used in connection with the Company’s Business. (b) Assignment of Work Product: You hereby acknowledge that all right, title and interest in and to all Work Product which is developed, conceived, created or produced by you in the course of your employment with the Company (either alone or jointly with others, and whether during regular hours of employment or otherwise) is the property of the Company. To confirm such ownership, you hereby irrevocably and without limitation and throughout the world assign any and all rights you may have in such Work Product to the Company, including all rights to sue for past, present or future infringements thereof. All copyright, patents and other industrial or intellectual property rights in and to all Work Product shall be the property of the Company, and you hereby waive any moral rights which you may have in and to the Work Product.d (c) Third Party Rights and Restrictions: You represent and warrant that all Work Product will be free and clear of any and all third party rights and restrictions and neither the Work Product itself nor the Company’s use thereof will violate the rights of any third party. (d) Commercialization of Work Product: You understand and agree that the decision whether or not to commercialize or market any Work Product developed by you, whether solely or jointly with others, is within the Company’s sole discretion and for the Company’s sole benefit and that no royalty will be due to you as a result of the Company’s efforts to commercialize or market any such Work Product. You further agree that you shall not use, disclose, reproduce, transfer or otherwise exploit any Work Product for any purpose other than for the benefit of the Company in the fulfillment of your duties and responsibilities during your employment with the Company. (e) Maintenance of Records: You agree to keep and maintain adequate and current written records of all Work Product made by you, whether solely or jointly with others, during the term of your employment with the Company. Such records shall be available to and remain the sole property of the Company at all times. (f) Intellectual Property Registrations: You agree to assist the Company, or its designee, at the Company’s expense, in every proper way to secure the Company’s rights in the Work Product and any copyrights, patents, mask work rights or other intellectual property rights relating thereto in any and all countries, including the disclosure to the Company of all pertinent information and data with respect thereto. You further agree to execute all applications, specifications, oaths, assignments and all other instruments which the Company may deem necessary in order to apply for and obtain such rights and in order to assign and convey to the Company, its successors, assigns, and nominees the sole and exclusive rights, title and interest in and to such Work Product, and any copyrights, patents, mask work rights or other intellectual property rights relating thereto. (g) Appointment of the Company as Your Agent: You further agree that your obligation to execute or cause to be executed, when it is in your power to do so, any such instrument or papers shall continue after the Termination Date. If the Company is unable because of your mental or physical incapacity or for any other reason to secure your signature to apply for or to pursue any application for any Canadian or foreign patents, copyright or other Doc ID: 0e8c1064d1944de40d3f008216294afc40d1f371
- 8 - intellectual property registrations covering Work Product or original works of authorship assigned to the Company as above, then you hereby irrevocably designate and appoint the Company and its duly authorized officers and agents as your agent and attorney in fact, to act for and in your behalf and stead to execute and file any such applications and to do all other lawfully permitted acts to further the prosecution and issuance of letters patent or copyright registrations thereon with the same legal force and effect as if executed by you. 16. Non-Solicitation of Personnel and Suppliers Throughout your employment with the Company and for a period of six (6) months after the Termination Date, you shall not, on your own behalf or on behalf of any other person, entity, enterprise, association or business other than the Company, for any reason, directly or indirectly: (a) encourage, persuade, induce or assist (or attempt to do any of the foregoing) any Personnel or Supplier to terminate or alter his/her/its relationship with the Company; (b) contact or communicate with (or attempt to contact or communicate with) any Personnel or Supplier regarding the potential for such Personnel or Supplier to terminate or alter his/her/its relationship with the Company; or (c) recruit or solicit (or attempt to assist any person or entity in doing so) any Personnel or Supplier for the purpose of trying to persuade such Personnel or Supplier to alter his/her/its relationship with the Company. 17. Non-Solicitation of Customers and Prospective Customers Throughout your employment with the Company and for a period of six (6) months after the Termination Date, you shall not, directly or indirectly: (a) solicit or contact (or attempt to solicit or contact) any Customer or Prospective Customer of the Company for the purpose of trying to persuade such Customer or Prospective Customer to terminate, reduce, alter or divert business with or from the Company; (b) accept in any capacity whatsoever orders for any Restricted Services from any Customer or Prospective Customer; or (c) in any way interfere with the relationship between a Customer or Prospective Customer and the Company. 18. Injunctive Relief You acknowledge and agree that: (a) your obligations under the Confidential Information, Intellectual Property Rights, Non-Solicitation of Personnel and Suppliers, Non-Solicitation of Customers and Prospective Customers provisions of this Agreement are of a unique character that gives them particular value, (b) your breach of any of such obligations will result in irreparable and continuing damage to the Company for which there will be no adequate remedy at law, and (c) in the event of such breach, the Company shall be entitled to injunctive relief for specific performance, and such other and further relief as may be proper (including monetary damages if appropriate). Doc ID: 0e8c1064d1944de40d3f008216294afc40d1f371
- 9 - 19. Termination of Employment Without Cause (a) The Company may terminate your employment at any time without cause, by paying you any accrued wages (including vacation pay) that may be owing to you, calculated in accordance with the ESA, and by providing you with the following: (i) written notice of termination of employment (or termination pay in lieu of notice, or a combination of notice and termination pay in lieu of notice); and (ii) benefits continuation for a period of one (1) year (if applicable, in which case you agree that the Company may deduct your employee share of premiums (if any) from the payment(s) to be made to you under this Section); and (iii) severance pay in the amount of one (1) year’s then-current Base Salary; and (iv) payment of any full or partial Annual Bonus amounts on a pro-rated basis; and (v) any other minimum statutory entitlements; You will not, under any circumstances, be provided with anything less than your full minimum entitlements under the ESA. (b) You agree that, upon being provided with such entitlements, the Company shall be released from any and all claims whatsoever that you may have against the Company and its directors, officers, employees, and agents for any further entitlements arising from or related in any way to your employment with the Company or the termination of your employment, whether under statute (other than any minimum entitlements specifically prescribed by the ESA), common law, or contract. 20. Termination of Employment for Just Cause Your employment may be terminated by the Company at any time for just cause without notice or payments in lieu of notice, except as may be required by the ESA. In the event of such termination for just cause, the Company will provide you with any minimum entitlements that may be specifically prescribed by the ESA. For clarity, you will not, under any circumstances, receive anything less than your full minimum entitlements under the ESA. 21. Resignation of Your Employment with the Company You may resign your employment with the Company upon giving the Company not less and not more than four (4) weeks’ written notice. You agree that the Company may waive the notice period, in whole or in part, by paying to you an amount equivalent to the wages you would otherwise have received during the notice period (or part thereof) and, subject to the terms and conditions of the insurance plans, by continuing during the notice period your group insurance benefits coverage (if applicable) under the plans in which you participated at the time you gave notice of resignation. You agree that such waiver by the Company shall not constitute a termination of your employment by the Company. Doc ID: 0e8c1064d1944de40d3f008216294afc40d1f371
- 10 - 22. Bonus Upon Termination of Employment You hereby agree that if your Termination Date falls before the date on which a Bonus (if any) is to be paid, you shall have the right to receive full or partial payments of unpaid Bonus. 23. Return of Property At any time upon request by the Company, or immediately upon the termination of your employment for any reason whatsoever, you shall return to the Company all Confidential Information and all other physical or electronic files, notes and data and any laptop computer, company cell phone or device, access card, security pass, passwords, records, books, manuals, documents and other information and materials belonging to or in any way relating to the Company or to Customers or Prospective Customers or Personnel in your possession or under your control, without retaining any copies thereof. 24. No Derogatory or Misleading Statements Both during your employment with the Company and upon termination of your employment for any reason whatsoever, you agree that you will not, directly or indirectly, verbally or in writing, criticize, disparage, speak negatively of, or make any harmful statement about the Company, or its employees, products or services (including but not limited to on any social media or on Glassdoor or similar websites, blogs, etc.). Further, you agree that you will immediately cease to represent yourself as being in any way connected with, or interested in, the Company, and will immediately update any social media (including any blogs or social networking sites, including but not limited to LinkedIn) to reflect this. 25. Agreement That Terms and Conditions of Employment Are Fair and Reasonable (a) By accepting employment with the Company on the terms and conditions as described in this Agreement, you confirm that, in your opinion, the termination provisions contained in this Agreement are fair and reasonable and agree that, upon termination of your employment in accordance with such provisions, you will have no claim, statutory or otherwise, or cause of action against the Company or its Personnel, representatives, successors, assigns or insurers in respect of such termination. (b) In the event of any finding that your employment was constructively dismissed by the Company, or that the Company did not have just cause to terminate your employment, your entitlements shall be limited to those provided for in the Termination of Employment Without Cause provision, above. 26. Amendments to Terms and Conditions of Employment (a) No amendment to the terms and conditions of your employment as described in this Agreement will be valid unless set forth in writing and duly executed by you and the Company. (b) The terms and conditions of your employment as set out in this Agreement shall continue in full force and effect despite changes to your position, title, duties, responsibilities, compensation, vacation, benefits, etc. over the course of your employment with the Company. Doc ID: 0e8c1064d1944de40d3f008216294afc40d1f371
- 11 - 27. Waivers of Any Breach of Terms and Conditions of Employment No waiver of any breach of any terms or conditions of your employment will be effective or binding unless made in writing and signed by the party purporting to waive the breach. 28. Provisions Which Operate Following Termination of Employment Notwithstanding any termination of your employment under this Agreement for any reason whatsoever, this Section and the Confidential Information, Intellectual Property Rights, Non- Solicitation of Personnel and Suppliers, Non-Solicitation of Customers and Prospective Customers, Non-Competition, Return of Property, Agreement That Terms and Conditions of Employment Are Fair and Reasonable, Entire Agreement and Severability provisions, and any other provisions of this Agreement necessary to give effect to those provisions, shall continue in full force and effect following such termination. 29. Entire Agreement The terms and conditions of employment described in this Agreement and in the Company’s policies and procedures, as may be amended from time to time, constitute the entire agreement between you and the Company with respect to your employment. You agree that there are no prior or other understandings or agreements between you and the Company with respect to your employment. 30. Severability (a) If in any legal proceeding it is determined that any section, paragraph, sentence or clause of this Agreement is invalid or unenforceable, it shall be deemed to be severed from the remainder of this Agreement for the purpose only of the particular proceeding. This Agreement shall, in every other respect, continue in full force and effect. (b) It is not the Company’s intention to attempt to contract out of its obligations or your minimum entitlements under the ESA or any other applicable statute. Therefore, notwithstanding anything stated or unstated in this Agreement or in the Company’s policies and procedures, you will not at any time during your employment, upon termination of your employment for any reason (whether with or without just cause), and/or under any other circumstances, receive anything less than your full minimum entitlements under the ESA or other applicable statute. Any provision of this Agreement or such policies and procedures that provides for anything less than such entitlements shall be deemed to be replaced by the applicable minimum ESA standard or other applicable statute. 31. Governing Law The terms and conditions of your employment shall be governed by and construed in accordance with laws of the Province of Ontario and the laws of Canada applicable therein. Doc ID: 0e8c1064d1944de40d3f008216294afc40d1f371
- 12 - IN WITNESS WHEREOF, you and the Company have executed this Employment Agreement effective as of the Start Date. POINT Biopharma Per: Joe McCann, CEO I, Neil Fleshner, have had sufficient time to review the terms and conditions set out in the above Employment Agreement and to review the Agreement with a lawyer. If I did not do so, it is because I understand such terms and conditions and did not feel that I needed legal advice. I confirm that I fully understand and hereby voluntarily accept employment with the Company on the terms and conditions of employment offered as set out in the above Agreement. Signature Date 05 / 03 / 2023 Doc ID: 0e8c1064d1944de40d3f008216294afc40d1f371
Print off this one-page document for Appendix 1 – Prior Inventions, complete it and sign and scan it back to jmccann@pointbiopharma.com. This will be the only document you need to print, complete it manually and scan it back separately. Appendix 1 Prior Inventions Title Date Identifying Number or Description No Prior Inventions or improvements Additional Sheets Attached Name: Date Signature Doc ID: 0e8c1064d1944de40d3f008216294afc40d1f371
- 2 - Doc ID: 0e8c1064d1944de40d3f008216294afc40d1f371
- 3 - Appendix 2 – Outside Activities a) Research group meetings (2 hrs/week) - PhD students etc b) Biospecimen lead meetings (2 hrs/week) c) Sunnybrook Division Head Urology (rare call duty) d) Verity Pharmaceuticals - CMO - 4 hrs per week Doc ID: 0e8c1064d1944de40d3f008216294afc40d1f371
- 4 - Job Description Overview The Chief Medical Officer will report directly to the Chief Executive Officer. The primary role of the CMO will be to provide leadership and direction for POINT’s pipeline of clinical development programs in oncology, leading POINT’s Regulatory Affairs and Clinical Development departments. The CMO will be responsible for the strategy, direction and execution of the company’s regulatory and clinical development plans. The CMO will be a key member of the leadership team as a member of the company’s Executive team which determines and oversees research and drug development at POINT and sets the overall strategic direction of the company. This is a unique opportunity to be a major contributor to the success of a well-positioned, well-financed growth stage radiopharmaceutical company. Key Objectives To perform this job successfully, an individual must be able to perform the following: • Direct the development of clinical strategies and plans to develop POINT’s candidates such that they can integrate into the standard practice of oncology. • Partner closely with the discovery and R&D functions at POINT to select targets, review data and assist in the translation of drug candidates that have high potential to address areas of unmet need in oncology • Orchestrate and manage clinical aspects of regulatory strategies and interactions with Health Authorities • Oversee the analysis and interpretation of clinical trial data and the reporting of clinical trial results • Lead interactions with academic thought leaders, investigators, cooperative groups, and other clinical stakeholders • Provide clinical support and work with other members of the management team to develop and communicate the overall corporate strategy • Represent the Company and its programs to external audiences, including the investment, medical and regulatory communities, as well as pharmaceutical or radiopharma industry collaborators/partners • In addition to leading and supervising the Clinical Research Department the CMO will have direct line responsibility for the Clinical Development and Regulatory Affairs Departments Education and Experience: • MD with Board Certification in oncology or Pediatrics with Oncology training preferred • 15 years minimum experience in clinical practice treating patients and pharmaceutical and/or biotechnology industry experience as a sponsor working on investigational new drugs. • Multiple years of management experience leading a clinical group including clinical/medical affairs and clinical operations • A proven success record in Phase I-IV clinical research studies and trial design as well as the successful submission of IND’s and marketing approval-directed filings ( NDA’s, and MAA’s) Knowledge, Skills and Abilities: • Knowledge of relevant FDA regulations and guidelines as well as those of the EU and other health authorities; experience in interactions with FDA personnel is essential; experience in interactions with other health authorities a plus • Experience with, or strong knowledge of Oncology drug development Doc ID: 0e8c1064d1944de40d3f008216294afc40d1f371
- 5 - • Experience in translational medicine, clinical pharmacology and early stage development is desirable • Excellent knowledge of the competitive environment for drugs in the Oncology marketplace and in research and development pipelines • Must have a thorough knowledge of clinical research concepts, practices, and GCP and ICH Guidelines. • The successful candidate will read, write and speak fluent English, possess excellent communication skills and will be capable of articulating the Company’s clinical and regulatory strategies and progress to a wide audience including the CEO, the Board of Directors, Company employees, and the investor community. • Must have excellent leadership and interpersonal skills; should have proven skills as an effective team player who can engender credibility and confidence within and outside the company; must have outstanding executive presence. • Must be science- and data-driven • For best fit, the candidate must have the ability and strong desire to “make things happen”. Doc ID: 0e8c1064d1944de40d3f008216294afc40d1f371
Audit trail Title File name Document ID Audit trail date format Status Powered by Sign Sign Employment Contract NF Point Contract 2023 v3_.pdf 0e8c1064d1944de40d3f008216294afc40d1f371 MM / DD / YYYY Signed 04 / 28 / 2023 12:27:34 UTC Sent for signature to Neil Fleshner (nfleshner@pointbiopharma.com) from jmccann@pointbiopharma.com IP: 24.141.168.105 05 / 03 / 2023 17:22:06 UTC Viewed by Neil Fleshner (nfleshner@pointbiopharma.com) IP: 205.189.56.243 05 / 03 / 2023 17:22:20 UTC Signed by Neil Fleshner (nfleshner@pointbiopharma.com) IP: 205.189.56.243 The document has been completed.05 / 03 / 2023 17:22:20 UTC
CERTIFICATION PURSUANT TO RULES 13a-14(a) AND 15d-14(a)
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Joe McCann, certify that:
1.I have reviewed this quarterly report on Form 10-Q of POINT Biopharma Global Inc.;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
| | | | | | | | | | | |
Date: August 14, 2023 | |
| | | |
By: | | /s/Joe McCann | |
| | Dr. Joe McCann, Ph.D. | |
| | Chief Executive Officer (Principal Executive Officer) | |
CERTIFICATION PURSUANT TO RULES 13a-14(a) AND 15d-14(a)
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Bill Demers, certify that:
1.I have reviewed this quarterly report on Form 10-Q of POINT Biopharma Global Inc.;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c)Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d)Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
(a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
(b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
| | | | | | | | | | | |
Date: August 14, 2023 | |
| | | |
By: | | /s/Bill Demers | |
| | Bill Demers | |
| | Chief Financial Officer (Principal Financial Officer) | |
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of POINT Biopharma Global Inc. (the “Company”) on Form 10-Q for the period ending March 31, 2023, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), each of the undersigned hereby certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to his knowledge:
(1)The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2)The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
| | | | | | | | | | | |
Date: August 14, 2023 | By: | | /s/Joe McCann |
| | | Dr. Joe McCann, Ph.D. |
| | | Chief Executive Officer, |
| | | (Principal Executive Officer) |
| | | | | | | | | | | |
Date: August 14, 2023 | By: | | /s/Bill Demers |
| | | Bill Demers |
| | | Chief Financial Officer, |
| | | (Principal Financial Officer) |
*This certification shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liability of that section, nor shall it be deemed to be incorporated by reference into any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934.
v3.23.2
Cover - shares
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6 Months Ended |
|
Jun. 30, 2023 |
Aug. 09, 2023 |
Cover [Abstract] |
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10-Q
|
|
Document Quarterly Report |
true
|
|
Document Period End Date |
Jun. 30, 2023
|
|
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false
|
|
Entity File Number |
001-39311
|
|
Entity Registrant Name |
POINT BIOPHARMA GLOBAL INC.
|
|
Entity Incorporation, State or Country Code |
DE
|
|
Entity Tax Identification Number |
85-0800493
|
|
Entity Address, Address Line One |
4850 West 78th Street
|
|
Entity Address, City or Town |
Indianapolis,
|
|
Entity Address, State or Province |
IN
|
|
Entity Address, Postal Zip Code |
46268
|
|
City Area Code |
317
|
|
Local Phone Number |
543-9957
|
|
Title of 12(b) Security |
Common Stock
|
|
Trading Symbol |
PNT
|
|
Security Exchange Name |
NASDAQ
|
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Entity Current Reporting Status |
Yes
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v3.23.2
Interim Condensed Consolidated Balance Sheets - USD ($)
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Current assets |
|
|
Cash and cash equivalents |
$ 57,293,338
|
$ 286,428,371
|
Short-term investments |
365,932,523
|
238,783,470
|
Prepaid expenses and other current assets |
5,750,433
|
5,610,889
|
Income taxes receivable |
3,399,009
|
0
|
Total current assets |
432,375,303
|
530,822,730
|
Non-current assets |
|
|
Long-term investments |
11,570,701
|
16,119,430
|
Note receivable |
5,028,767
|
0
|
Property, plant and equipment, net |
48,394,217
|
31,380,576
|
Operating lease right-of-use asset |
405,784
|
0
|
Total non-current assets |
65,399,469
|
47,500,006
|
Total assets |
497,774,772
|
578,322,736
|
Current liabilities |
|
|
Accounts payable |
13,899,941
|
7,703,150
|
Accrued liabilities |
10,099,052
|
19,094,454
|
Deferred revenue |
15,899,770
|
23,242,290
|
Income taxes payable |
0
|
29,698,546
|
Finance lease current liability |
1,011,217
|
0
|
Operating lease current liability |
245,814
|
0
|
Total current liabilities |
41,155,794
|
79,738,440
|
Deferred revenue, net of current portion |
1,452,356
|
1,452,356
|
Long-term income taxes payable |
3,197,547
|
10,178,147
|
Finance lease liability, net of current portion |
4,348,112
|
0
|
Operating lease liability, net of current portion |
169,045
|
0
|
Total liabilities |
50,322,854
|
91,368,943
|
Commitments and contingencies (Note 12) |
|
|
Stockholders’ equity |
|
|
Common Stock, par value $0.0001 per share, 430,000,000 authorized, 105,765,954 and 105,649,741 issued and outstanding as of June 30, 2023 and December 31, 2022, respectively |
10,576
|
10,565
|
Additional paid-in capital |
451,443,330
|
448,391,574
|
Retained earnings |
(2,933,005)
|
39,008,505
|
Accumulated other comprehensive loss |
(1,068,983)
|
(456,851)
|
Total stockholders’ equity |
447,451,918
|
486,953,793
|
Total liabilities and stockholders’ equity |
$ 497,774,772
|
$ 578,322,736
|
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v3.23.2
Interim Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Statement of Financial Position [Abstract] |
|
|
Common shares, par value (in dollars per share) |
$ 0.0001
|
$ 0.0001
|
Common stock, authorized (in shares) |
430,000,000
|
430,000,000
|
Common stock, shares issued (in shares) |
105,765,954
|
105,649,741
|
Common stock, shares outstanding (in shares) |
105,765,954
|
105,649,741
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.23.2
Unaudited Interim Condensed Consolidated Statements of Operations - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Revenue |
|
|
|
|
Revenue |
$ 4,865,856
|
$ 0
|
$ 14,323,120
|
$ 0
|
Operating expenses |
|
|
|
|
Research and development |
31,276,573
|
20,813,882
|
58,187,045
|
33,314,730
|
General and administrative |
5,088,403
|
4,080,401
|
10,098,532
|
7,888,343
|
Total operating expenses |
36,364,976
|
24,894,283
|
68,285,577
|
41,203,073
|
Loss from operations |
(31,499,120)
|
(24,894,283)
|
(53,962,457)
|
(41,203,073)
|
Other income (expenses) |
|
|
|
|
Investment income |
5,335,753
|
509,700
|
11,099,967
|
557,673
|
Foreign currency loss |
(168,770)
|
(12,259)
|
(238,960)
|
(43,900)
|
Total other income (expenses) |
5,166,983
|
497,441
|
10,861,007
|
513,773
|
Loss before income taxes |
(26,332,137)
|
(24,396,842)
|
(43,101,450)
|
(40,689,300)
|
Income tax benefit (provision) |
921,298
|
(183,405)
|
1,159,940
|
(271,521)
|
Net loss |
$ (25,410,839)
|
$ (24,580,247)
|
$ (41,941,510)
|
$ (40,960,821)
|
Net loss per basic and diluted common share: |
|
|
|
|
Basic net loss per common share (in dollars per share) |
$ (0.24)
|
$ (0.27)
|
$ (0.40)
|
$ (0.45)
|
Diluted net loss per common share (in dollars per share) |
$ (0.24)
|
$ (0.27)
|
$ (0.40)
|
$ (0.45)
|
Basic weighted average common shares outstanding (in shares) |
105,724,215
|
90,124,295
|
105,692,615
|
90,123,288
|
Diluted weighted average common shares outstanding (in shares) |
105,724,215
|
90,124,295
|
105,692,615
|
90,123,288
|
X |
- DefinitionThe amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.
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v3.23.2
Unaudited Condensed Consolidated Statements of Comprehensive Loss - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Statement of Comprehensive Income [Abstract] |
|
|
|
|
Net loss |
$ (25,410,839)
|
$ (24,580,247)
|
$ (41,941,510)
|
$ (40,960,821)
|
Other comprehensive income, net of tax |
|
|
|
|
Net unrealized loss on available-for-sale debt securities |
(813,426)
|
(342,378)
|
(612,132)
|
(342,378)
|
Total comprehensive loss |
$ (26,224,265)
|
$ (24,922,625)
|
$ (42,553,642)
|
$ (41,303,199)
|
X |
- DefinitionAmount after tax of increase (decrease) in equity from transactions and other events and circumstances from net income and other comprehensive income, attributable to parent entity. Excludes changes in equity resulting from investments by owners and distributions to owners.
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v3.23.2
Unaudited Interim Condensed Consolidated Statements of Stockholders' Equity - USD ($)
|
Total |
Common Stock |
Additional Paid-in Capital |
Accumulated Deficit |
Accumulated Other Comprehensive Loss |
Beginning balance (in shares) at Dec. 31, 2021 |
|
90,121,794
|
|
|
|
Beginning balance at Dec. 31, 2021 |
$ 255,213,086
|
$ 9,012
|
$ 314,488,782
|
$ (59,284,708)
|
$ 0
|
Increase (Decrease) in Stockholders' Equity [Roll Forward] |
|
|
|
|
|
Issuance of shares of common stock in connection with stock option exercises (in shares) |
|
678
|
|
|
|
Issuance of shares of Common Stock in connection with stock option exercises |
942
|
|
942
|
|
|
Stock-based compensation |
440,450
|
|
440,450
|
|
|
Net loss |
(16,380,574)
|
|
|
(16,380,574)
|
|
Ending balance (in shares) at Mar. 31, 2022 |
|
90,122,472
|
|
|
|
Ending balance at Mar. 31, 2022 |
239,273,904
|
$ 9,012
|
314,930,174
|
(75,665,282)
|
0
|
Beginning balance (in shares) at Dec. 31, 2021 |
|
90,121,794
|
|
|
|
Beginning balance at Dec. 31, 2021 |
255,213,086
|
$ 9,012
|
314,488,782
|
(59,284,708)
|
0
|
Increase (Decrease) in Stockholders' Equity [Roll Forward] |
|
|
|
|
|
Net loss |
(40,960,821)
|
|
|
|
|
Ending balance (in shares) at Jun. 30, 2022 |
|
90,124,962
|
|
|
|
Ending balance at Jun. 30, 2022 |
215,382,303
|
$ 9,012
|
315,961,198
|
(100,245,529)
|
(342,378)
|
Beginning balance (in shares) at Mar. 31, 2022 |
|
90,122,472
|
|
|
|
Beginning balance at Mar. 31, 2022 |
239,273,904
|
$ 9,012
|
314,930,174
|
(75,665,282)
|
0
|
Increase (Decrease) in Stockholders' Equity [Roll Forward] |
|
|
|
|
|
Issuance of shares of common stock in connection with stock option exercises (in shares) |
|
2,490
|
|
|
|
Issuance of shares of Common Stock in connection with stock option exercises |
3,461
|
|
3,461
|
|
|
Stock-based compensation |
1,027,563
|
|
1,027,563
|
|
|
Net loss |
(24,580,247)
|
|
|
(24,580,247)
|
|
Other comprehensive income (loss), net of tax |
(342,378)
|
|
|
|
(342,378)
|
Ending balance (in shares) at Jun. 30, 2022 |
|
90,124,962
|
|
|
|
Ending balance at Jun. 30, 2022 |
$ 215,382,303
|
$ 9,012
|
315,961,198
|
(100,245,529)
|
(342,378)
|
Beginning balance (in shares) at Dec. 31, 2022 |
105,649,741
|
105,649,741
|
|
|
|
Beginning balance at Dec. 31, 2022 |
$ 486,953,793
|
$ 10,565
|
448,391,574
|
39,008,505
|
(456,851)
|
Increase (Decrease) in Stockholders' Equity [Roll Forward] |
|
|
|
|
|
Issuance of shares of common stock in connection with stock option exercises (in shares) |
|
32,936
|
|
|
|
Issuance of shares of Common Stock in connection with stock option exercises |
145,864
|
$ 3
|
145,861
|
|
|
Stock-based compensation |
1,009,496
|
|
1,009,496
|
|
|
Net loss |
(16,530,671)
|
|
|
(16,530,671)
|
|
Other comprehensive income (loss), net of tax |
201,294
|
|
|
|
201,294
|
Ending balance (in shares) at Mar. 31, 2023 |
|
105,682,677
|
|
|
|
Ending balance at Mar. 31, 2023 |
$ 471,779,776
|
$ 10,568
|
449,546,931
|
22,477,834
|
(255,557)
|
Beginning balance (in shares) at Dec. 31, 2022 |
105,649,741
|
105,649,741
|
|
|
|
Beginning balance at Dec. 31, 2022 |
$ 486,953,793
|
$ 10,565
|
448,391,574
|
39,008,505
|
(456,851)
|
Increase (Decrease) in Stockholders' Equity [Roll Forward] |
|
|
|
|
|
Net loss |
$ (41,941,510)
|
|
|
|
|
Ending balance (in shares) at Jun. 30, 2023 |
105,765,954
|
105,765,954
|
|
|
|
Ending balance at Jun. 30, 2023 |
$ 447,451,918
|
$ 10,576
|
451,443,330
|
(2,933,005)
|
(1,068,983)
|
Beginning balance (in shares) at Mar. 31, 2023 |
|
105,682,677
|
|
|
|
Beginning balance at Mar. 31, 2023 |
471,779,776
|
$ 10,568
|
449,546,931
|
22,477,834
|
(255,557)
|
Increase (Decrease) in Stockholders' Equity [Roll Forward] |
|
|
|
|
|
Issuance of shares of common stock in connection with stock option exercises (in shares) |
|
83,277
|
|
|
|
Issuance of shares of Common Stock in connection with stock option exercises |
186,058
|
$ 8
|
186,050
|
|
|
Stock-based compensation |
1,710,349
|
|
1,710,349
|
|
|
Net loss |
(25,410,839)
|
|
|
(25,410,839)
|
|
Other comprehensive income (loss), net of tax |
$ (813,426)
|
|
|
|
(813,426)
|
Ending balance (in shares) at Jun. 30, 2023 |
105,765,954
|
105,765,954
|
|
|
|
Ending balance at Jun. 30, 2023 |
$ 447,451,918
|
$ 10,576
|
$ 451,443,330
|
$ (2,933,005)
|
$ (1,068,983)
|
X |
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v3.23.2
Unaudited Interim Condensed Consolidated Statements of Cash Flows - USD ($)
|
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Cash flows from operating activities |
|
|
Net loss: |
$ (41,941,510)
|
$ (40,960,821)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Depreciation on property, plant and equipment |
1,322,329
|
584,076
|
Stock-based compensation expense |
2,719,845
|
1,468,013
|
Operating lease expense |
50,499
|
0
|
Payments on operating lease |
(49,321)
|
0
|
Amortization of premiums (accretion of discounts) on investments, net |
(7,066,456)
|
(128,150)
|
Changes in operating assets and liabilities: |
|
|
Prepaid expenses and other current assets |
(139,544)
|
(441,829)
|
Accounts payable |
4,285,143
|
4,290,469
|
Accrued liabilities |
(9,178,905)
|
3,734,644
|
Deferred revenue |
(14,323,120)
|
0
|
Income taxes receivable and payable |
(33,097,555)
|
258,425
|
Change in accrued interest and dividends within investments |
691,359
|
126,192
|
Net cash used in operating activities |
(96,727,236)
|
(31,068,981)
|
Cash flows from investing activities |
|
|
Purchase of investments, net of sales and maturities |
(116,749,966)
|
(126,563,131)
|
Purchase of property, plant and equipment |
(10,856,112)
|
(3,080,040)
|
Purchase of note receivable |
(5,000,000)
|
0
|
Net cash used in investing activities |
(132,606,078)
|
(129,643,171)
|
Cash flows from financing activities |
|
|
Issuance of shares of Common Stock in connection with stock option exercises |
331,922
|
4,403
|
Payments on finance lease |
(133,641)
|
0
|
Net cash provided by financing activities |
198,281
|
4,403
|
Net decrease in cash and cash equivalents |
(229,135,033)
|
(160,707,749)
|
Cash and cash equivalents, beginning of period |
286,428,371
|
238,815,991
|
Cash and cash equivalents, end of period |
57,293,338
|
78,108,242
|
Supplemental disclosure of cash flow information: |
|
|
Cash paid for income taxes |
31,913,750
|
3,022
|
Non-cash investment activities: |
|
|
Purchase of property, plant and equipment recorded in accounts payable and accrued liabilities |
$ 3,504,652
|
$ 3,345,729
|
X |
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v3.23.2
Nature of business
|
6 Months Ended |
Jun. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Nature of business |
Nature of business POINT Biopharma Global Inc., together with its consolidated subsidiaries ("POINT" or the “Company”), is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. The Company was founded on a mission to make radioligand therapy applicable to more cancers and available to more people, thereby improving the lives of cancer patients and their families everywhere. The Company has four wholly-owned subsidiaries, POINT Biopharma Inc., POINT Biopharma USA Inc. and West 78th Street, LLC, each located in the U.S., and POINT Biopharma Corp., located in Canada (collectively the "Subsidiaries"). The Company’s headquarters is located at 4850 West 78th Street, Indianapolis, Indiana, 46268.
|
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v3.23.2
Summary of significant accounting policies
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Summary of significant accounting policies |
Summary of significant accounting policies Basis of presentation The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 270, Interim Reporting and include the accounts of the Company and the Subsidiaries, for financial information and pursuant to the rules and regulations of the Securities and Exchange Commission ("SEC"). Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America (“GAAP”). All intercompany accounts and transactions have been eliminated in consolidation. In the opinion of management, the unaudited interim condensed consolidated financial statements reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the balances and results for the periods presented. Except as described below, the accounting policies and methods of computation applied in the unaudited interim condensed consolidated financial statements and related notes contained therein are consistent with those applied by the Company in its audited consolidated financial statements as of and for the year ended December 31, 2022 contained in our Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the SEC on March 27, 2023 (the “2022 Financial Statements”). These unaudited interim condensed consolidated financial statements should be read in conjunction with the 2022 Financial Statements. These unaudited interim condensed consolidated financial statements and accompanying notes have been prepared in accordance with the provisions of ASC Topic 205-40, Presentation of Financial Statements—Going Concern on the basis that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. Impact of COVID-19 Pandemic, macroeconomics and other geopolitical events Although the World Health Organization declared in early May of 2023 that COVID-19 no longer constitutes a public health emergency, the Company continues to actively monitor the COVID-19 developments and potential impact on the Company's employees, business and operations. The impact from global economic conditions and potential and continuing disruptions to and volatility in the credit and equity markets in the United States and worldwide are highly uncertain and cannot be predicted. The Company is currently operating in a period of significant economic uncertainty, resulting from, among other things, the impact of the COVID-19 pandemic, geopolitical tensions, such as the ongoing military conflict between Russia and Ukraine and heightened tensions between China and Taiwan, trade uncertainty, including changes in tariffs, sanctions, international treaties, and other trade restrictions, rising inflation and interest rates, and uncertainty and liquidity concerns in the broader financial services industry, including those caused by certain recent banking failures.
The Company is continuing to monitor the development and potential impact of these global economic and geopolitical events on its business and unaudited interim condensed consolidated financial statements. To date, the Company has not experienced any material business disruptions or incurred any impairment losses in the carrying values of its assets as a result of these events and it is not aware of any specific related event or circumstance that would require it to revise its estimates reflected in these unaudited interim condensed consolidated financial statements. However, estimates and assumptions about future events and their effects cannot be determined with certainty and therefore require the exercise of judgment; as a result, the Company’s estimates may change as new events occur and additional information is obtained. Risks and uncertainties Except for the upfront payment received pursuant to the Lantheus License Agreements (as defined in Note 3 below), the Company has incurred significant net losses and has funded operations primarily through equity financings. Operating losses and negative cash flows were incurred in the three and six months ended June 30, 2023 and are expected to continue to be incurred in future periods. The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, successful discovery and development of its product candidates, regulatory approval of its product candidates, development by competitors of new technological innovations, dependence on key personnel, the ability to attract and retain qualified employees, protection of proprietary technology, compliance with governmental regulations, the impact of macroeconomic disruptions, such as those arising from public health crisis or military conflicts and adverse developments affecting the financial services industry, the ability to secure additional capital to fund operations and commercial success of its product candidates. Product candidates currently under development will require extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of capital, adequate personnel, and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s drug development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales. Use of estimates The preparation of the unaudited interim condensed consolidated financial statements in conformity with GAAP requires management to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, related disclosure of contingent assets and liabilities at the date of the unaudited interim condensed consolidated financial statements, and the reported amounts of expenses for the periods presented. Significant estimates and assumptions reflected in these unaudited interim condensed consolidated financial statements include, but are not limited to, the allocation of consideration and the recognition of revenues in respect of the performance obligations under the Lantheus License Agreements, the accrual of research and development expenses, incremental borrowing rates determined in connection with finance and operating lease obligations and the valuations of stock options. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates when there are changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results may differ from those estimates or assumptions. Leases The Company accounts for leases in accordance with ASC Topic 842, Leases ("ASC 842"). At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present. The Company has elected not to recognize leases with an original term of one year or less in the unaudited interim condensed consolidated balance sheets. The Company has also elected to account for the lease and non-lease components as a combined lease component for its current lease portfolio. Right-of-use assets and lease liabilities are recognized at the commencement date based on the present value of lease payments over the lease term. Options to renew or early terminate a lease are included in the initial lease term of a lease when there is reasonable certainty that the option will be applied.
ASC 842 requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its incremental borrowing rate. The Company's incremental borrowing rate is determined using a secured borrowing rate for the same currency and term as the associated lease in a similar economic environment.
Lease expense for operating leases is recognized on a straight-line basis over the lease term and included in operating expenses in the unaudited interim condensed consolidated statements of operations and comprehensive loss.
Recent accounting pronouncements The Company has evaluated accounting pronouncements recently issued but not yet adopted and believes that the current accounting pronouncements currently do not apply to the Company’s operations and are not expected to have a material impact on the Company’s unaudited interim condensed consolidated financial statements or disclosures.
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- DefinitionThe entire disclosure for all significant accounting policies of the reporting entity.
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v3.23.2
Revenue
|
6 Months Ended |
Jun. 30, 2023 |
Revenue from Contract with Customer [Abstract] |
|
Revenue |
RevenueIn November 2022, POINT announced strategic collaboration and exclusive license agreements with Lantheus Holdings Inc. ("Lantheus") for exclusive worldwide rights for POINT's programs in prostate cancer (PNT2002) and neuroendocrine tumors (PNT2003), excluding certain territories (Japan, South Korea, Singapore, Indonesia, and China including Hong Kong, Macau and Taiwan) (the "PNT2002 Agreement" and the "PNT2003 Agreement", respectively, and collectively the "Lantheus License Agreements"). The collaboration pairs POINT's expertise in next generation radioligand development and manufacturing with Lantheus’ commercial leadership in Prostate-Specific Membrane Antigen ("PSMA") PET and radiopharmaceuticals. In December 2022, closing conditions for the transaction, including Hart-Scott-Rodino antitrust clearance, were satisfied. POINT received a $250.0 million upfront payment under the PNT2002 Agreement and will receive an additional payment of up to $250.0 million upon U.S. regulatory approval. In addition, once certain return on investment financial thresholds have been achieved and other conditions satisfied, POINT will be eligible to receive royalties of 20% on all net sales (prior to which there is a period of sales in which the royalty may be based on only a portion of the gross profit), and contingent upon the satisfaction of certain net sales milestones, additional payments of up to $1.3 billion. POINT received a $10.0 million upfront payment under the PNT2003 Agreement, and will receive up to an additional $30.0 million upon U.S. regulatory approval. The PNT2003 Agreement also provides that POINT will receive royalties of 15% on net sales and, contingent upon the satisfaction of certain net sales milestones, an additional payment of up to $275.0 million.
In connection with the PNT2002 Agreement, the Company is responsible for completing the Company's multi-center, randomized, open label phase 3 Study evaluating metastatic castration-resistant Prostate cancer using 177Lu-PNT2002 PSMA therapy After Second-line Hormonal treatment (“SPLASH") trial and the parties will work together to file the New Drug Application (“NDA”), with the costs incurred in connection with the U.S. Food and Drug Administration ("FDA") submission being borne by Lantheus. Thereafter, Lantheus will be responsible for all additional clinical and regulatory costs in the U.S., as well as all costs for development, clinical trials and regulatory approval in the rest of its territories outside the U.S., except Asia. To determine the appropriate amount of revenue to be recognized under ASC Topic 606, Revenue from Contracts with Customers, the Company performs the following steps: (i) identify the promised goods or services in the contract, (ii) determine whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract, (iii) measure the transaction price, including the constraint on variable consideration, (iv) allocate the transaction price to the performance obligations and (v) recognize revenue when (or as) the Company satisfies each performance obligation. In connection with the PNT2002 Agreement, the Company identified the following performance conditions: (i) the license it conveyed to Lantheus with respect to certain intellectual property, (ii) service provided to complete the SPLASH trial, support the NDA submission and participate in joint steering activities and (iii) manufacturing activities. The Company determined the transaction price under ASC Topic 606 at the inception of the PNT2002 Agreement to be the $250.0 million upfront payment and has allocated this to the first two performance obligations based on a relative standalone selling price basis. The standalone selling prices for the first two performance obligations were determined using the adjusted market assessment approach and the expected cost plus a margin assessment approach, respectively. The Company concluded that variable consideration associated with the product manufacturing relates solely to the manufacturing activities performance obligation on the basis that it believes that the expected margin associated with this consideration is in line with market standards and specifically relates to the Company's efforts to satisfy its manufacturing obligations. In connection with the PNT2003 Agreement, the Company identified the following performance conditions: (i) the license it conveyed to Lantheus with respect to certain intellectual property, (ii) service provided to complete the necessary submissions for regulatory approval and participate in joint steering activities and (iii) manufacturing activities. The Company determined the transaction price under ASC Topic 606 at the inception of the PNT2003 Agreement to be the $10.0 million upfront payment and has allocated this to the first two performance obligations based on a relative standalone selling price basis. The standalone selling prices for the first two performance obligations were determined using the adjusted market assessment approach and the expected cost plus a margin assessment approach, respectively. The Company concluded that variable consideration associated with the product manufacturing relates solely to the manufacturing activities performance obligation on the basis that it believes that the expected margin associated with this consideration is in line with market standards and specifically relates to the Company's efforts to satisfy its manufacturing obligations. The Company does not include variable consideration to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will occur. Variable consideration in the PNT2002 Agreement and PNT2003 Agreement consists of: •Potential future regulatory milestone payments. The Company concluded that this variable consideration is constrained considering that achievement of the milestones is outside its control and contingent upon the future success of clinical trials and regulatory approval by the FDA and in respect of other territories outside the U.S. •Potential future milestone payments in connection with certain sales targets as well as any future royalties. The Company concluded that these payments qualify for the royalty exception. Under the royalty exception, sales-based royalties are recognized at the later of when (1) the subsequent sale or usage occurs or (2) the performance obligation to which some or all of the sales- or usage-based royalty has been allocated is satisfied (in whole or in part). That is, an entity does not estimate the amount of a sales-based royalty at contract inception; rather, revenue would be recognized when the subsequent sales occur (under the assumption that the associated performance obligation has been satisfied or partially satisfied). •Potential payments for the manufacturing and supply of commercial product. The Company concluded that this variable consideration is constrained as it is contingent upon future regulatory approvals and the execution of a manufacturing and supply agreement. The estimate of the Company’s variable consideration to be included in the transaction price is updated at each reporting date as a change in estimate. For the potential future regulatory milestone payments, the Company utilizes the most likely amount approach to determine the amounts recognized and timing of recognition. For the potential payments for manufacturing and supply of commercial product, the Company utilizes the expected value approach to determine the amounts recognized and timing of recognition. Once the constraint is removed, the milestone payments will be accounted for and allocated to the performance obligations. For the licenses conveyed to Lantheus, the Company recognized revenue upon execution and regulatory approval of the Lantheus License Agreements. The Company concluded that the licenses represent that of functional intellectual property as each has significant standalone functionality and derives a substantial portion of their utility from that standalone functionality. For the obligations to complete the SPLASH trial, support the NDA submission and participate in joint steering activities in connection with the PNT2002 Agreement as well as the obligations to complete the necessary submissions for regulatory approval and participate in joint steering activities for the PNT2003 Agreement, the Company recognizes revenue using the cost-to-cost method, which it concluded best depicts the transfer of control to the customer. Under the cost-to-cost method, the extent of progress towards completion is measured based on the ratio of actual costs incurred to the total estimated costs expected upon satisfying the identified performance obligation. Under this method, revenue is recorded as a percentage of the estimated transaction price based on the extent of progress towards completion. The following table presents the Company’s contract liabilities as of June 30, 2023 and December 31, 2022: | | | | | | | | | | | | | June 30, 2023 | | December 31, 2022 | Deferred revenue | | | | Deferred revenue, current | $ | 15,899,770 | | | $ | 23,242,290 | | Deferred revenue, net of current portion | 3,197,547 | | | 10,178,147 | | Total | $ | 19,097,317 | | | $ | 33,420,437 | |
At inception of the Lantheus License Agreements, deferred revenue of $34.8 million was recognized in connection with future performance. During the three and six months ended June 30, 2023, the Company recognized $4.9 million and $14.3 million in revenue for services performed (three and six months ended June 30, 2022 — $nil and $nil, respectively). The current portion of deferred revenue reflects the Company’s estimate of the revenue it expects to recognize within the next 12 months. The Company expects to recognize the remainder of the deferred revenue in subsequent periods through the year ending December 31, 2028. No contract assets were recognized in connection with the Lantheus License Agreements, including costs incurred in obtaining the agreements.
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- DefinitionThe entire disclosure of revenue from contract with customer to transfer good or service and to transfer nonfinancial asset. Includes, but is not limited to, disaggregation of revenue, credit loss recognized from contract with customer, judgment and change in judgment related to contract with customer, and asset recognized from cost incurred to obtain or fulfill contract with customer. Excludes insurance and lease contracts.
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v3.23.2
Cash, cash equivalents and investments
|
6 Months Ended |
Jun. 30, 2023 |
Cash and Cash Equivalents [Abstract] |
|
Cash, cash equivalents and investments |
Cash, cash equivalents and investments Cash, cash equivalents and investments consisted of the following: | | | | | | | | | | | | | As of June 30, 2023 | | As of December 31, 2022 | Cash | $ | 5,540,926 | | | $ | 12,429,627 | | Cash equivalents: | | | | Money market funds | 47,656,269 | | | 273,998,744 | | Commercial paper | 4,096,143 | | | — | | Total cash and cash equivalents | 57,293,338 | | | 286,428,371 | | Short-term investments | | | | Commercial paper | 131,797,284 | | | 115,156,455 | | Corporate bonds | 102,294,737 | | | 45,219,042 | | U.S. Government agency debt securities | 56,130,624 | | | 42,577,762 | | Asset backed securities | 75,709,878 | | | 35,830,211 | | Total short-term investments | 365,932,523 | | | 238,783,470 | | Long-term investments | | | | Asset backed securities | 750,129 | | | 16,119,430 | | Corporate bonds | 10,820,572 | | | — | | Total long-term investments | 11,570,701 | | | 16,119,430 | | Total cash, cash equivalents and investments | $ | 434,796,562 | | | $ | 541,331,271 | |
Available-for-sale investments The amortized cost, gross unrealized gains, gross unrealized losses and fair value of available-for-sale investments by type of security as of June 30, 2023 were as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Amortized Cost | | Unrealized Gains | | Unrealized Losses | | Fair Value | | Current | | Non-current | Commercial paper | $ | 131,908,748 | | | $ | 15 | | | $ | (111,479) | | | $ | 131,797,284 | | | $ | 131,797,284 | | | $ | — | | Corporate bonds | 113,657,153 | | 705 | | $ | (542,549) | | | 113,115,309 | | 102,294,737 | | 10,820,572 | | Asset backed securities | 76,699,026 | | — | | | (239,019) | | | 76,460,007 | | 75,709,878 | | 750,129 | | U.S. Government agency debt securities | 56,306,438 | | — | | | (175,814) | | | 56,130,624 | | 56,130,624 | | — | | Total available-for-sale securities | $ | 378,571,365 | | | $ | 720 | | | $ | (1,068,861) | | | $ | 377,503,224 | | | $ | 365,932,523 | | | $ | 11,570,701 | |
The following table summarizes the fair value of available-for-sale investments based on stated contractual maturities as of June 30, 2023: | | | | | | | | | | | | | Amortized Cost | | Fair Value | Due within one year | $ | 366,912,175 | | | $ | 365,932,523 | | Due between one and five years | 11,659,190 | | | 11,570,701 | | Total | $ | 378,571,365 | | | $ | 377,503,224 | |
The primary objective of our investment portfolio is to maintain safety of principal balances, provide sufficient levels of liquidity and enhance overall returns in an efficient manner with acceptable levels of risk. Our investment policy limits interest-bearing security investments to certain types of debt and money market instruments issued by institutions with primarily investment-grade credit ratings, and it places restrictions on maturities and concentration by asset class and issuer. During the three and six months ended June 30, 2023, we had no realized gains or losses on available-for-sale investments.
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- DefinitionThe entire disclosure for cash and cash equivalent footnotes, which may include the types of deposits and money market instruments, applicable carrying amounts, restricted amounts and compensating balance arrangements. Cash and equivalents include: (1) currency on hand (2) demand deposits with banks or financial institutions (3) other kinds of accounts that have the general characteristics of demand deposits (4) short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Generally, only investments maturing within three months from the date of acquisition qualify.
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v3.23.2
Fair value measurements
|
6 Months Ended |
Jun. 30, 2023 |
Fair Value Disclosures [Abstract] |
|
Fair value measurements |
Fair value measurements We measure fair value based on the prices that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value measurements are based on a three-tier hierarchy that prioritizes the inputs used to measure fair value. These tiers include the following: Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities that are accessible at the measurement date. The fair value hierarchy gives the highest priority to Level 1 inputs.
Level 2: Observable prices that are based on inputs not quoted on active markets, but corroborated by market data. These inputs include quoted prices for similar assets or liabilities; quoted market prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs.
The following table presents information about the Company’s financial assets and liabilities as of June 30, 2023 that are measured at fair value on a recurring basis and indicates the level of the fair value hierarchy used to determine such fair values: | | | | | | | | | | | | | | | | | | | | | | | | | Level 1 | | Level 2 | | Level 3 | | Total | June 30, 2023 | | | | | | | | Cash equivalents: | | | | | | | | Money market mutual fund | $ | 47,656,269 | | | $ | — | | | $ | — | | | $ | 47,656,269 | | Commercial paper | — | | | 4,096,143 | | | — | | | 4,096,143 | | Available-for-sale debt securities: | | | | | | | | Commercial paper | — | | | 131,797,284 | | | — | | | 131,797,284 | | Corporate bonds | — | | | 113,115,309 | | | — | | | 113,115,309 | | Asset backed securities | — | | | 76,460,007 | | | — | | | 76,460,007 | | U.S. Government agency debt securities | 56,130,624 | | | — | | | — | | | 56,130,624 | | Total | $ | 103,786,893 | | | $ | 325,468,743 | | | $ | — | | | $ | 429,255,636 | |
Certain of our available-for-sale debt securities, including U.S. Government agency debt securities, are valued using inputs observable in active markets for identical securities and are therefore classified as Level 1 within the fair value hierarchy.
On May 7, 2023, POINT Biopharma Inc. entered into a Convertible Note Purchase Agreement (the "Convertible Note Agreement") with Ionetix Alpha Corporation ("Ionetix-α"), a subsidiary of IONETIX Corporation. On June 1, 2023, the Company purchased $5.0 million in unsecured promissory notes (the "Note Receivable") convertible into common stock of Ionetix-α at a conversion price that is subject to certain conditions as defined in the Convertible Note Agreement. Pursuant to the Convertible Note Agreement, the Company will purchase an additional $5.0 million of the Note Receivable six months following the initial purchase. Management assessed all features in the Convertible Note Agreement to determine embedded derivatives requiring bifurcation. In accordance with the Convertible Note Agreement, Ionetix-α has a voluntary redemption option, subject to certain terms and conditions, and may provide notice to the Company upon which the Company can elect to either redeem the Note Receivable at 150% of principal and interest outstanding or convert it into common stock of Ionetix-α. Management concluded that this put option meets the definition of a derivative and it is not clearly and closely related to the Note Receivable, thus requiring bifurcation from the host instrument and recognition at fair value. Further, management concluded the Note Receivable host instrument is to be classified as a loan receivable and therefore is measured at amortized cost but disclosure of fair value is required. Management determined the fair values of both the Note Receivable and embedded derivative under Level 3 in the fair value hierarchy. Management concluded that the fair value of the Note Receivable as at June 30, 2023 was equal to its amortized cost and that the fair value of the embedded derivative was nil both at inception of the arrangement and at June 30, 2023.
We did not have any financial liabilities measured at fair value on a recurring basis as of June 30, 2023.
There have been no transfers of assets or liabilities between the fair value measurement levels as of June 30, 2023.
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- DefinitionThe entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.
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v3.23.2
Prepaid expenses and other current assets
|
6 Months Ended |
Jun. 30, 2023 |
Prepaid Expense and Other Assets, Current [Abstract] |
|
Prepaid expenses and other current assets |
Prepaid expenses and other current assets Prepaid expenses and other current assets consisted of the following: | | | | | | | | | | | | | As of June 30, 2023 | | As of December 31, 2022 | | $ | | $ | Prepaid clinical trial expenses | 3,418,491 | | | 4,011,419 | | Prepaid insurance | 1,781,969 | | | 1,310,314 | | Canadian harmonized sales tax receivable | 332,654 | | | 60,222 | | Other | 217,319 | | | 228,934 | | Total | 5,750,433 | | | 5,610,889 | |
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v3.23.2
Property, plant and equipment, net
|
6 Months Ended |
Jun. 30, 2023 |
Property, Plant and Equipment [Abstract] |
|
Property, plant and equipment, net |
Property, plant and equipment, net Property, plant and equipment, net consisted of the following: | | | | | | | | | | | | | As of June 30, 2023 | | As of December 31, 2022 | | $ | | $ | Land and building | 18,976,410 | | | 18,163,962 | | Machinery and equipment | 10,415,742 | | | 5,328,639 | | Property, plant and equipment, in development | 15,459,230 | | | 8,434,384 | | Facility lease | 5,384,707 | | | — | | Furniture and fixtures | 721,595 | | | 698,728 | | Computer equipment | 153,891 | | | 149,892 | | | 51,111,575 | | | 32,775,605 | | Less: Accumulated depreciation | (2,717,358) | | | (1,395,029) | | Total | 48,394,217 | | | 31,380,576 | |
In July 2020, the Company purchased land and a building in Indianapolis, Indiana (which has been expanded to approximately 81,000 square feet) for the purpose of retrofitting the existing building into a state-of-the-art, Good Manufacturing Practices ("GMP") compliant facility that will support the Company’s drug manufacturing operations. The Company commenced the manufacture of clinical supply in the Indianapolis manufacturing facility in January 2022. Construction continues on the facility to expand capacity.
On February 2, 2023, POINT Biopharma Corp., entered into a Facility Agreement (the "UHN Agreement") with University Health Network (“UHN”), a not-for-profit corporation incorporated under the laws of Canada. Pursuant to the UHN Agreement, the Company was provided access to utilize a 7,700 square foot, licensed research and development space with cGMP manufacturing suites (the “Facility”) under a lease effective April 1, 2023, which the Company will use to develop and expand its pipeline of next-generation radioligands. The lease is accounted for as a finance lease in accordance with ASC 842 and the right-of-use asset has been included within property, plant and equipment. See Note 9 for additional details.
Property, plant and equipment that have finite lives are recorded at cost less accumulated depreciation and impairment losses. Depreciation is expensed from the month the particular asset is available for its intended use, using the straight-line method over the estimated useful life of such asset at the following rates, which in each case are intended to reduce the carrying value of the asset to the estimated residual value: | | | | | | Asset Category | Estimated Useful Life | Computer equipment | 5 years | Machinery and equipment | 7 years | Furniture and fixtures | 7 years | Facility lease | 7 years | Building | 20 years |
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v3.23.2
Accrued liabilities
|
6 Months Ended |
Jun. 30, 2023 |
Accrued Liabilities, Current [Abstract] |
|
Accrued liabilities |
Accrued liabilities Accrued liabilities consisted of the following: | | | | | | | | | | | | | As of June 30, 2023 | | As of December 31, 2022 | | $ | | $ | Accrued personnel costs | 3,772,849 | | | 7,116,382 | | Accrued research and development costs | 5,233,075 | | | 9,645,594 | | Accrued corporate legal fees and other professional services | 666,995 | | | 2,068,793 | | Accrued costs for purchases of property, plant and equipment | 289,244 | | | 105,741 | | Other accrued costs | 136,889 | | | 157,944 | | Total | 10,099,052 | | | 19,094,454 | |
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v3.23.2
Leases
|
6 Months Ended |
Jun. 30, 2023 |
Leases [Abstract] |
|
Leases |
Leases Right-of-use assets and lease liabilities are recognized at the commencement date based on the present value of lease payments over the lease term. ASC 842 requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its incremental borrowing rate. As an implicit interest rate was not readily determinable in the Company’s current portfolio of leases, the incremental borrowing rate was used based on the information available at the commencement date in determining the present value of lease payments. On February 2, 2023, POINT Biopharma Corp. entered into the UHN Agreement. The lease commencement date was determined to be April 1, 2023, the date upon which the Company was provided access to the Facility. The lease is accounted for as a finance lease in accordance with ASC 842 and the right-of-use asset has been included within property, plant and equipment. Management concluded that the lease represents a finance lease on the basis that management believes that the lease term covers a substantial portion of the economic life of the primary lease component. See Note 7 for additional details. The initial term of the UHN Agreement will run for five years from the lease commencement date, with an option to renew for additional two-year terms thereafter, subject to certain conditions described in the UHN Agreement. Management included the first option to renew for two years as part of the lease term in determining the right-of-use asset and lease liability. The agreement does not transfer any title in the Facility to the Company. During the term, the Company shall be responsible for day-to-day management, activities and decision-making regarding the Facility. General governance of the Facility will be exercised by the Company and UHN through a joint committee. The joint committee, which will meet quarterly, will have a minimum of six people and will be comprised of an equal number of members from each of the Company and UHN. On April 12, 2023, the Company entered into an operating lease for laboratory space with a lease term of two years. The lease is recorded separately on the interim condensed consolidated balance sheet as an operating lease right-of-use asset with a related operating lease liability as of June 30, 2023. The agreement does not transfer any title in the laboratory space to the Company.
The components of lease expense are as follows:
| | | | | | | | | | | | | For the six months ended June 30, 2023 | | For the six months ended June 30, 2022 | Operating lease expense | $ | 50,499 | | | $ | — | | | | | | Finance lease cost | | | | Amortization of right-of-use asset | 192,311 | | | — | | Interest on lease liability | 99,199 | | | — | | Total finance lease cost | $ | 291,510 | | | $ | — | |
Supplemental cash flow information related to leases are as follows: | | | | | | | | | | | | | For the six months ended June 30, 2023 | | For the six months ended June 30, 2022 | Cash flow information: | | | | Cash paid for amounts included in the measurement of lease liabilities: | | | | Operating cash flow use from operating leases | $ | 49,321 | | | $ | — | | Operating cash flow use from finance leases | $ | 99,199 | | | $ | — | | Financing cash flow use from finance leases | $ | 133,641 | | | $ | — | | | | | | Non-cash activity: | | | | Right-of-use assets obtained in exchange for lease obligations: | | | | Operating lease | $ | 453,490 | | | $ | — | | Finance lease | $ | 5,384,707 | | | $ | — | |
The following table summarizes the weighted average remaining lease terms for the Company’s leases:
| | | | | | | As of June 30, 2023 | Weighted-average remaining lease term (in years): | | Operating lease | 1.8 | Finance lease | 6.8 |
As the interest rate implicit in the leases was not readily determinable at the time that the leases were evaluated, the Company used its incremental borrowing rate based on the information available in determining the present value of lease payments. The Company’s incremental borrowing rate was based on the term of the lease, the economic environment of the lease and reflect the rate the Company would have had to pay to borrow on a secured basis. Below is information on the weighted average discount rates used at the time that the leases were evaluated:
| | | | | | | As of June 30, 2023 | Weighted-average discount rates: | | Operating lease | 7.6 | % | Finance lease | 7.7 | % |
The following table summarizes the future maturities of the Company's lease liabilities as of June 30, 2023:
| | | | | | | | | | | | | Operating Lease | | Finance Lease | 2023 | $ | 121,091 | | | $ | 505,608 | | 2024 | 249,446 | | | 1,011,217 | | 2025 | 74,938 | | | 1,011,217 | | 2026 | — | | | 1,011,217 | | 2027 | — | | | 1,011,217 | | Thereafter | — | | | 2,275,237 | | Total lease payments | $ | 445,475 | | | $ | 6,825,713 | | Less: imputed interest | (30,616) | | | (1,466,384) | | Present value of lease liabilities | $ | 414,859 | | | $ | 5,359,329 | |
|
Leases |
Leases Right-of-use assets and lease liabilities are recognized at the commencement date based on the present value of lease payments over the lease term. ASC 842 requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its incremental borrowing rate. As an implicit interest rate was not readily determinable in the Company’s current portfolio of leases, the incremental borrowing rate was used based on the information available at the commencement date in determining the present value of lease payments. On February 2, 2023, POINT Biopharma Corp. entered into the UHN Agreement. The lease commencement date was determined to be April 1, 2023, the date upon which the Company was provided access to the Facility. The lease is accounted for as a finance lease in accordance with ASC 842 and the right-of-use asset has been included within property, plant and equipment. Management concluded that the lease represents a finance lease on the basis that management believes that the lease term covers a substantial portion of the economic life of the primary lease component. See Note 7 for additional details. The initial term of the UHN Agreement will run for five years from the lease commencement date, with an option to renew for additional two-year terms thereafter, subject to certain conditions described in the UHN Agreement. Management included the first option to renew for two years as part of the lease term in determining the right-of-use asset and lease liability. The agreement does not transfer any title in the Facility to the Company. During the term, the Company shall be responsible for day-to-day management, activities and decision-making regarding the Facility. General governance of the Facility will be exercised by the Company and UHN through a joint committee. The joint committee, which will meet quarterly, will have a minimum of six people and will be comprised of an equal number of members from each of the Company and UHN. On April 12, 2023, the Company entered into an operating lease for laboratory space with a lease term of two years. The lease is recorded separately on the interim condensed consolidated balance sheet as an operating lease right-of-use asset with a related operating lease liability as of June 30, 2023. The agreement does not transfer any title in the laboratory space to the Company.
The components of lease expense are as follows:
| | | | | | | | | | | | | For the six months ended June 30, 2023 | | For the six months ended June 30, 2022 | Operating lease expense | $ | 50,499 | | | $ | — | | | | | | Finance lease cost | | | | Amortization of right-of-use asset | 192,311 | | | — | | Interest on lease liability | 99,199 | | | — | | Total finance lease cost | $ | 291,510 | | | $ | — | |
Supplemental cash flow information related to leases are as follows: | | | | | | | | | | | | | For the six months ended June 30, 2023 | | For the six months ended June 30, 2022 | Cash flow information: | | | | Cash paid for amounts included in the measurement of lease liabilities: | | | | Operating cash flow use from operating leases | $ | 49,321 | | | $ | — | | Operating cash flow use from finance leases | $ | 99,199 | | | $ | — | | Financing cash flow use from finance leases | $ | 133,641 | | | $ | — | | | | | | Non-cash activity: | | | | Right-of-use assets obtained in exchange for lease obligations: | | | | Operating lease | $ | 453,490 | | | $ | — | | Finance lease | $ | 5,384,707 | | | $ | — | |
The following table summarizes the weighted average remaining lease terms for the Company’s leases:
| | | | | | | As of June 30, 2023 | Weighted-average remaining lease term (in years): | | Operating lease | 1.8 | Finance lease | 6.8 |
As the interest rate implicit in the leases was not readily determinable at the time that the leases were evaluated, the Company used its incremental borrowing rate based on the information available in determining the present value of lease payments. The Company’s incremental borrowing rate was based on the term of the lease, the economic environment of the lease and reflect the rate the Company would have had to pay to borrow on a secured basis. Below is information on the weighted average discount rates used at the time that the leases were evaluated:
| | | | | | | As of June 30, 2023 | Weighted-average discount rates: | | Operating lease | 7.6 | % | Finance lease | 7.7 | % |
The following table summarizes the future maturities of the Company's lease liabilities as of June 30, 2023:
| | | | | | | | | | | | | Operating Lease | | Finance Lease | 2023 | $ | 121,091 | | | $ | 505,608 | | 2024 | 249,446 | | | 1,011,217 | | 2025 | 74,938 | | | 1,011,217 | | 2026 | — | | | 1,011,217 | | 2027 | — | | | 1,011,217 | | Thereafter | — | | | 2,275,237 | | Total lease payments | $ | 445,475 | | | $ | 6,825,713 | | Less: imputed interest | (30,616) | | | (1,466,384) | | Present value of lease liabilities | $ | 414,859 | | | $ | 5,359,329 | |
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v3.23.2
Stockholders' equity
|
6 Months Ended |
Jun. 30, 2023 |
Stockholders' Equity Note [Abstract] |
|
Stockholders' equity |
Stockholders’ equity The Company is authorized to issue 430,000,000 shares of common stock, with a par value of $0.0001 per share ("Common Stock"), as well as 20,000,000 of shares of preferred stock, with a par value of $0.0001 per share (“Preferred Stock”). During the three months ended June 30, 2023, the Company issued (a) 71,585 shares of Common Stock in connection with the exercise of stock options granted to non-employee consultants, resulting in total cash proceeds of $99,503 and (b) 11,692 shares of Common Stock in connection with the exercise of stock options granted to employees, resulting in total cash proceeds of $86,555. During the six months ended June 30, 2023, the Company issued (i) 86,585 shares of Common Stock in connection with the exercise of stock options granted to non-employee consultants, resulting in total cash proceeds of $120,353 and (ii) 29,628 shares of Common Stock in connection with the exercise of stock options granted to employees and directors, resulting in total cash proceeds of $211,569.
During the three months ended June 30, 2022, the Company issued 2,490 shares of Common Stock in connection with the exercise of stock options issued to non-employee consultants, resulting in total cash proceeds of $3,461. During the six months ended June 30, 2022, the Company issued 3,168 shares of Common Stock in connection with the exercise of stock options issued to non-employee consultants, resulting in total cash proceeds of $4,403. As of June 30, 2023, the total number of issued and outstanding shares of Common Stock was 105,765,954 (December 31, 2022 — 105,649,741). As of June 30, 2023, there were no issued and outstanding shares of Preferred Stock (December 31, 2022 — nil). Each share of Common Stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. Holders of Common Stock are entitled to receive dividends, if any, as may be declared by the Company’s board of directors (the “Board”). During the three and six months ended June 30, 2023, no cash dividends were declared or paid by the Company (June 30, 2022 — $nil). The Board has the authority to issue shares of Preferred Stock from time to time on terms it may determine, to divide shares of Preferred Stock into one or more series and to fix the designations, preferences, privileges, and restrictions of Preferred Stock, including dividend rights, conversion rights, voting rights, terms of redemption, liquidation preference, sinking fund terms, and the number of shares constituting any series or the designation of any series to the fullest extent permitted by the Delaware General Corporation Law ("DGCL"). During the six months ended June 30, 2023, no shares of Preferred Stock were issued by the Company.
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v3.23.2
Stock-based compensation
|
6 Months Ended |
Jun. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
Stock-based compensation |
Stock-based compensation In March 2020, the board of directors of POINT Biopharma Inc. approved the 2020 Equity Incentive Plan (the “2020 EIP”). The 2020 EIP provided for the granting of incentive and non-qualified stock options, stock appreciation rights, restricted stock units, performance awards and other stock-based awards to employees, directors, and consultants of POINT Biopharma Inc. Effective as of June 30, 2021, the Board adopted the POINT Biopharma Global Inc. 2021 Equity Incentive Plan (the “2021 EIP”) to replace the 2020 EIP and allow the Company to grant equity and equity-based incentive awards to officers, employees, non-employee directors and consultants of the Company. The Company assumed the outstanding equity awards under the 2020 EIP, but no further grants may be made under the 2020 EIP. The 2021 EIP provides that the number of shares reserved and available for issuance under the 2021 EIP will automatically increase each January 1, beginning on January 1, 2022, by 4% of the number of outstanding shares of Common Stock on the immediately preceding December 31, or such lesser amount as determined by the Board. As of January 1, 2023, the number of shares of Common Stock available under the 2021 EIP increased by 4,225,990 for a total of 9,129,858 shares of Common Stock authorized for issuance under the 2021 EIP as of June 30, 2023. Stock options The Company recorded $685,263 and $1,131,391 to research and development expenses and $1,025,086 and $1,588,454 to general and administrative expenses for stock-based compensation for the three and six months ended June 30, 2023, respectively (June 30, 2022 — $458,634 and $743,945 to research and development expenses and $568,929 and $724,068 to general and administrative expenses for the three and six months ended, respectively). The Company did not recognize a tax benefit related to stock-based compensation expense during the three and six months ended June 30, 2023 as well as during the three and six months ended June 30, 2022, as the Company had net operating loss carryforwards and recorded a valuation allowance against the deferred tax asset. The following table summarizes the activity relating to the Company’s stock options. | | | | | | | | | | | | | | | | | | | Number of Shares | | Weighted Average Exercise Price Per Share ($) | | Weighted- Average Remaining Contractual Term (in years) | Outstanding as of December 31, 2022 | 5,592,173 | | 5.85 | | | Granted | 3,144,071 | | 7.03 | | | Exercised | (116,213) | | 2.86 | | | Forfeited | (122,887) | | 7.37 | | | Expired | (13,551) | | 8.47 | | | Outstanding as of June 30, 2023 | 8,483,593 | | 6.30 | | 4.7 | Vested and expected to vest as of June 30, 2023 | 8,483,593 | | 6.30 | | 4.7 | Options exercisable as of June 30, 2023 | 2,705,429 | | 4.89 | | 4.0 |
During the three months ended June 30, 2023, 304,248 stock options were granted to directors of the Company, with a weighted average grant date fair value of $4.75 per share. The vesting terms of these options are such that they vest on the one-year anniversary of the date of grant. During the six months ended June 30, 2023, 3,144,071 stock options were granted, including the 304,248 stock options discussed above as well as 2,839,823 stock options granted to employees of the Company, with a weighted average grant date fair value of $3.76 per share. The vesting terms of the options granted to employees of the Company are such that 25% of the options vest on the one-year anniversary of the date of grant and the remaining 75% of such stock options vest in three equal annual installments thereafter.
During the three months ended June 30, 2022, 243,417 stock options were granted to employees and directors of the Company, with a weighted average grant date fair value of $4.66 per share. During the six months ended June 30, 2022, 1,948,614 stock options were granted to employees and directors of the Company, with a weighted average grant date fair value of $4.59 per share. Except as provided below with respect to options granted to directors, the vesting terms of these options are such that 25% of the options vest on the one-year anniversary of the date of grant and the remaining 75% of such stock options vest in three equal annual installments thereafter. On June 6, 2022, the terms of 128,070 stock options granted to directors of the Company during the quarter were amended to reduce the vesting period to one year. This amendment was accounted for as a modification and there was no material impact to stock-based compensation recorded.
The following table presents the assumptions used in the Black-Scholes-Merton option-pricing model to determine the grant date fair value of stock options granted: | | | | | | | | | | | | | | | | | | | | | | | | | Three months ended June 30, 2023 | | Three months ended June 30, 2022 | | Six months ended June 30, 2023 | | Six months ended June 30, 2022 | Risk-free interest rate | 3.91% - 4.23% | | 2.57% - 3.13% | | 3.71% - 4.23% | | 1.24% - 3.13% | Expected term (in years) | 3.50 | | 4.25 | | 3.50 - 4.25 | | 4.25 - 5.38 | Expected volatility | 67% | | 74% - 75% | | 67% - 68% | | 72% - 75% | Expected dividend yield | —% | | —% | | —% | | —% |
During the three months ended June 30, 2023, non-employee consultants of the Company exercised 71,585 stock options with an intrinsic value of $604,767 and employees of the Company exercised 11,692 stock options with an intrinsic value of $32,740, for total cash proceeds to the Company of $186,058. During the six months ended June 30, 2023, non-employee consultants of the Company exercised 86,585 stock options with an intrinsic value of $700,217, and employees and directors of the Company exercised 29,628 stock options with an intrinsic value of $38,300, for total cash proceeds to the Company of $331,922. During the three and six months ended June 30, 2022, non-employee consultants of the Company exercised 2,490 and 3,168 stock options with intrinsic values of $16,060 and $19,301, respectively. The exercises resulted in cash proceeds to the Company of $3,461 and $4,403, respectively. As of June 30, 2023, the unrecognized stock-based compensation expense related to unvested stock options was $19,343,654 and the estimated weighted average remaining vesting period was 2.3 years. Performance Share Units During the year ended December 31, 2022, 146,044 performance share units ("PSUs") were granted to employees of the Company, with a grant date fair value of $6.61 per unit based on the closing share price of the Company's Common Stock on the date of grant. The vesting terms of these PSUs are such that 100% vest upon the regulatory approval of PNT2002 by the FDA. During the three and six months ended June 30, 2023, the Company did not record any stock-based compensation expense related to these PSUs on the basis that they cannot be considered probable to vest as the regulatory approval requirement is outside the control of the Company and the clinical trial remains ongoing.
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- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.23.2
Commitments and contingencies
|
6 Months Ended |
Jun. 30, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and contingencies |
Commitments and contingencies Indianapolis facility commitments The Company is party to certain agreements for the continuing expansion of the manufacturing capabilities of the Indianapolis facility. Effective in the second quarter of 2022, the Company entered into an agreement for the design and build of a commercial manufacturing line. As of June 30, 2023, the Company is committed to aggregate future payments of approximately $20.0 million in connection with these agreements. During the three and six months ended June 30, 2023, approximately $7.4 million and $10.3 million, respectively, has been recorded within property, plant and equipment in connection with these agreements (three and six months ended June 30, 2022 — approximately $3.4 million and $4.0 million, respectively). Clinical trial and commercial commitments The Company in the normal course of business enters into various services and supply agreements in connection with its clinical trials to ensure the supply of certain products and product lines during the Company’s clinical phase. These agreements often have minimum purchase commitments and generally terminate upon the termination of the clinical trial. Minimum purchase commitments under these agreements include individual commitments up to $1.7 million. Aggregate remaining minimum commitments amount to approximately $6.2 million with payments ranging from three to eight years or upon completion of the clinical trial, if earlier. The Company recorded research and development expenses in connection with these agreements of approximately $4.8 million and $11.3 million during the three and six months ended June 30, 2023, respectively (three and six months ended June 30, 2022 — $2.6 million and $4.3 million, respectively). The Company also has supply agreements with third parties to purchase certain products for use in the Company’s full scale production process. The Company is committed to purchase a minimum quantity of product in the amount of approximately $111.9 million ($148.3 million CAD) over the contract term. The purchase commitments are contingent upon the completion of certain milestones by the third-party suppliers. The Company recorded $nil and $nil in connection with these agreements during the three and six months ended June 30, 2023, respectively (three and six months ended June 30, 2022 — $nil and $nil, respectively). On May 10, 2023, the Company entered into an Irradiation Services Agreement (the "Irradiation Agreement") which expands the Company's reactor network. Pursuant to the Irradiation Agreement, the Company will receive irradiation services to irradiate ytterbium-176 (“176Yb”) and has minimum purchase commitments of approximately $32.4 million over the ten year contract term. During the three and six months ended June 30, 2023, the Company did not record any research and development expenses in connection with this agreement. The Company also has an agreement with a third party to provide certain services in connection with the Company’s SPLASH clinical phase study. The agreement expires on the date of the completion or termination of the clinical trial. The remaining minimum purchase commitment under this agreement is approximately $24.0 million with payments that range from one to five years. The Company recorded research and development expenses in connection with this agreement of approximately $6.2 million and $11.1 million during the three and six months ended June 30, 2023, respectively (three and six months ended June 30, 2022 — $2.5 million and $5.6 million, respectively). License agreements The Company in the normal course of business enters into license and sublicense agreements in connection with its clinical trials and product development. For additional details of the Company’s license agreements, see Note 15 to the 2022 Financial Statements. On April 17, 2023, POINT Biopharma Inc. entered into first and second amendments (the "Amendments") to that certain Sublicense Agreement, dated November 14, 2019, between POINT Biopharma Inc. and Scintomics GmbH ("Scintomics"). Pursuant to the Amendments, the exclusive, sublicensable, license is expanded to include all geographies worldwide and the Company will have increased flexibility in connection with sublicense arrangements. The Company recorded research and development expenses in connection to its license agreements of approximately $3.0 million and $3.5 million during the three and six months ended June 30, 2023, respectively (three and six months ended June 30, 2022 — $3.8 million and $4.6 million, respectively).
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- DefinitionThe entire disclosure for commitments and contingencies.
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v3.23.2
Net loss per share
|
6 Months Ended |
Jun. 30, 2023 |
Earnings Per Share [Abstract] |
|
Net loss per share |
Net loss per share Basic loss per share is computed by dividing the loss available to common stockholders by the weighted-average number of shares of Common Stock outstanding during the period. Diluted loss per share is computed by dividing loss available to common stockholders by the weighted-average number of shares of Common Stock outstanding during the period increased to include the number of additional shares of Common Stock that would have been outstanding if the potentially dilutive securities had been issued, using the treasury stock method. | | | | | | | | | | | | | | | | | | | | | | | | | Three months ended June 30, 2023 | | Three months ended June 30, 2022 | | Six months ended June 30, 2023 | | Six months ended June 30, 2022 | Net loss attributable to common stockholders | $ | 25,410,839 | | | $ | 24,580,247 | | | $ | 41,941,510 | | | $ | 40,960,821 | | Weighted-average common shares outstanding-basic and diluted | 105,724,215 | | | 90,124,295 | | | 105,692,615 | | | 90,123,288 | | Net loss per share attributable to common stockholders-basic and diluted | $ | 0.24 | | | $ | 0.27 | | | $ | 0.40 | | | $ | 0.45 | |
The Company’s potentially dilutive securities, which include stock options, have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. The Company's PSU's are considered contingently issuable shares for the purpose of the computation of loss per share and have been excluded on the basis that as of June 30, 2023, the performance condition for vesting had not been achieved. Therefore, the weighted-average number of shares of Common Stock outstanding used to calculate both basic and diluted net loss per share attributable to the holders of Common Stock is the same.
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- DefinitionThe entire disclosure for earnings per share.
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v3.23.2
Income Taxes
|
6 Months Ended |
Jun. 30, 2023 |
Income Tax Disclosure [Abstract] |
|
Income Taxes |
Income Taxes The Company calculates its interim tax provision at the end of each interim period and estimates the annual effective tax rate which is applied to its ordinary quarterly earnings. The computation of the annual estimated effective tax rate at each interim period requires certain estimates and significant judgment including, but not limited to, the expected operating income for the year, projections of the proportion of income earned and taxed in foreign jurisdictions, permanent and temporary differences between book and tax amounts, and the likelihood of recovering deferred tax assets generated in the current year. The accounting estimates used to compute the provision for income taxes may change as new events occur, additional information is obtained or as the tax environment changes. The Company has operations in both the United States and Canada, and as such it is subject to tax in both countries. The income tax benefit and expense for the three months ended June 30, 2023 and June 30, 2022 was $921,298 and $183,405, respectively and the income tax benefit and expense for the six months ended June 30, 2023 and June 30, 2022 was $1,159,940 and $271,521, respectively. The income tax benefit for the three and six months ended June 30, 2023, consists primarily of tax benefits related to research and development tax credits partially offset by current taxes in Canada. The income tax expense for the three and six months ended June 30, 2022, consists of current taxes in Canada. The Company files income tax returns in the U.S. federal, certain states, and Canada with varying statutes of limitations. The Company is not currently subject to tax examinations by any taxing jurisdiction. However, in the event of any such examination, there may or may not be an impact on the Company’s net operating loss carryforwards and credits. The Company does not anticipate that any potential tax adjustments resulting from such examinations would have a significant impact on its financial position or results of operations. As of June 30, 2023, the Company believes no significant changes in the unrecognized tax benefits will occur within the next 12 months.
|
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- DefinitionThe entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.
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v3.23.2
Related party transactions
|
6 Months Ended |
Jun. 30, 2023 |
Related Party Transactions [Abstract] |
|
Related party transactions |
Related party transactionsThe Company recognized expenses in connection with related party transactions in the unaudited interim condensed consolidated statements of operations as follows: | | | | | | | | | | | | | | | | | | | | | | | | | Three months ended June 30, 2023 | | Three months ended June 30, 2022 | | Six months ended June 30, 2023 | | Six months ended June 30, 2022 | Consulting fees on business activities to Board member | $ | 31,496 | | | $ | 102,396 | | | $ | 205,911 | | | $ | 169,092 | | Reimbursement to Board member for occupancy costs | 17,894 | | | 17,898 | | | 35,313 | | | 35,676 | | Total | $ | 49,390 | | | $ | 120,294 | | | $ | 241,224 | | | $ | 204,768 | |
Transactions with related parties are in the normal course of operations and have been measured at their agreed upon exchange amount. During the three and six-month periods ended June 30, 2023 and 2022, the Company received consulting services for research and development from a Board member. As of June 30, 2023, $33,471 is recorded within accrued liabilities in relation to this consulting arrangement. The Company currently has a lease arrangement in place with a Board member for the use of office space. The arrangement does not have a defined contractual lease term and is payable monthly. The Company has applied the short-term lease exemption under ASC 842 to this arrangement and is recording the lease payments of approximately $6,000 monthly as rent expense.
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- DefinitionThe entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.
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v3.23.2
Pay vs Performance Disclosure - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Mar. 31, 2023 |
Jun. 30, 2022 |
Mar. 31, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Pay vs Performance Disclosure |
|
|
|
|
|
|
Net loss |
$ (25,410,839)
|
$ (16,530,671)
|
$ (24,580,247)
|
$ (16,380,574)
|
$ (41,941,510)
|
$ (40,960,821)
|
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v3.23.2
Summary of significant accounting policies (Policies)
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Basis of presentation |
Basis of presentation The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 270, Interim Reporting and include the accounts of the Company and the Subsidiaries, for financial information and pursuant to the rules and regulations of the Securities and Exchange Commission ("SEC"). Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America (“GAAP”). All intercompany accounts and transactions have been eliminated in consolidation. In the opinion of management, the unaudited interim condensed consolidated financial statements reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the balances and results for the periods presented. Except as described below, the accounting policies and methods of computation applied in the unaudited interim condensed consolidated financial statements and related notes contained therein are consistent with those applied by the Company in its audited consolidated financial statements as of and for the year ended December 31, 2022 contained in our Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the SEC on March 27, 2023 (the “2022 Financial Statements”). These unaudited interim condensed consolidated financial statements should be read in conjunction with the 2022 Financial Statements.
|
Going concern |
These unaudited interim condensed consolidated financial statements and accompanying notes have been prepared in accordance with the provisions of ASC Topic 205-40, Presentation of Financial Statements—Going Concern on the basis that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business.
|
Risks and uncertainties |
Risks and uncertainties Except for the upfront payment received pursuant to the Lantheus License Agreements (as defined in Note 3 below), the Company has incurred significant net losses and has funded operations primarily through equity financings. Operating losses and negative cash flows were incurred in the three and six months ended June 30, 2023 and are expected to continue to be incurred in future periods. The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, successful discovery and development of its product candidates, regulatory approval of its product candidates, development by competitors of new technological innovations, dependence on key personnel, the ability to attract and retain qualified employees, protection of proprietary technology, compliance with governmental regulations, the impact of macroeconomic disruptions, such as those arising from public health crisis or military conflicts and adverse developments affecting the financial services industry, the ability to secure additional capital to fund operations and commercial success of its product candidates. Product candidates currently under development will require extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of capital, adequate personnel, and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s drug development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales.
|
Use of estimates |
Use of estimates The preparation of the unaudited interim condensed consolidated financial statements in conformity with GAAP requires management to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, related disclosure of contingent assets and liabilities at the date of the unaudited interim condensed consolidated financial statements, and the reported amounts of expenses for the periods presented. Significant estimates and assumptions reflected in these unaudited interim condensed consolidated financial statements include, but are not limited to, the allocation of consideration and the recognition of revenues in respect of the performance obligations under the Lantheus License Agreements, the accrual of research and development expenses, incremental borrowing rates determined in connection with finance and operating lease obligations and the valuations of stock options. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates when there are changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results may differ from those estimates or assumptions.
|
Leases |
Leases The Company accounts for leases in accordance with ASC Topic 842, Leases ("ASC 842"). At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present. The Company has elected not to recognize leases with an original term of one year or less in the unaudited interim condensed consolidated balance sheets. The Company has also elected to account for the lease and non-lease components as a combined lease component for its current lease portfolio. Right-of-use assets and lease liabilities are recognized at the commencement date based on the present value of lease payments over the lease term. Options to renew or early terminate a lease are included in the initial lease term of a lease when there is reasonable certainty that the option will be applied.
ASC 842 requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its incremental borrowing rate. The Company's incremental borrowing rate is determined using a secured borrowing rate for the same currency and term as the associated lease in a similar economic environment.
Lease expense for operating leases is recognized on a straight-line basis over the lease term and included in operating expenses in the unaudited interim condensed consolidated statements of operations and comprehensive loss.
|
Recent accounting pronouncements |
Recent accounting pronouncements The Company has evaluated accounting pronouncements recently issued but not yet adopted and believes that the current accounting pronouncements currently do not apply to the Company’s operations and are not expected to have a material impact on the Company’s unaudited interim condensed consolidated financial statements or disclosures.
|
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v3.23.2
Revenue (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Revenue from Contract with Customer [Abstract] |
|
Schedule of Contract Liabilities |
The following table presents the Company’s contract liabilities as of June 30, 2023 and December 31, 2022: | | | | | | | | | | | | | June 30, 2023 | | December 31, 2022 | Deferred revenue | | | | Deferred revenue, current | $ | 15,899,770 | | | $ | 23,242,290 | | Deferred revenue, net of current portion | 3,197,547 | | | 10,178,147 | | Total | $ | 19,097,317 | | | $ | 33,420,437 | |
|
X |
- DefinitionTabular disclosure of receivable, contract asset, and contract liability from contract with customer. Includes, but is not limited to, change in contract asset and contract liability.
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v3.23.2
Cash, cash equivalents and investments (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Cash and Cash Equivalents [Abstract] |
|
Schedule of Cash, Cash Equivalents and Investments |
Cash, cash equivalents and investments consisted of the following: | | | | | | | | | | | | | As of June 30, 2023 | | As of December 31, 2022 | Cash | $ | 5,540,926 | | | $ | 12,429,627 | | Cash equivalents: | | | | Money market funds | 47,656,269 | | | 273,998,744 | | Commercial paper | 4,096,143 | | | — | | Total cash and cash equivalents | 57,293,338 | | | 286,428,371 | | Short-term investments | | | | Commercial paper | 131,797,284 | | | 115,156,455 | | Corporate bonds | 102,294,737 | | | 45,219,042 | | U.S. Government agency debt securities | 56,130,624 | | | 42,577,762 | | Asset backed securities | 75,709,878 | | | 35,830,211 | | Total short-term investments | 365,932,523 | | | 238,783,470 | | Long-term investments | | | | Asset backed securities | 750,129 | | | 16,119,430 | | Corporate bonds | 10,820,572 | | | — | | Total long-term investments | 11,570,701 | | | 16,119,430 | | Total cash, cash equivalents and investments | $ | 434,796,562 | | | $ | 541,331,271 | |
|
Schedule of Available-For-Sale Investments |
The amortized cost, gross unrealized gains, gross unrealized losses and fair value of available-for-sale investments by type of security as of June 30, 2023 were as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Amortized Cost | | Unrealized Gains | | Unrealized Losses | | Fair Value | | Current | | Non-current | Commercial paper | $ | 131,908,748 | | | $ | 15 | | | $ | (111,479) | | | $ | 131,797,284 | | | $ | 131,797,284 | | | $ | — | | Corporate bonds | 113,657,153 | | 705 | | $ | (542,549) | | | 113,115,309 | | 102,294,737 | | 10,820,572 | | Asset backed securities | 76,699,026 | | — | | | (239,019) | | | 76,460,007 | | 75,709,878 | | 750,129 | | U.S. Government agency debt securities | 56,306,438 | | — | | | (175,814) | | | 56,130,624 | | 56,130,624 | | — | | Total available-for-sale securities | $ | 378,571,365 | | | $ | 720 | | | $ | (1,068,861) | | | $ | 377,503,224 | | | $ | 365,932,523 | | | $ | 11,570,701 | |
The following table summarizes the fair value of available-for-sale investments based on stated contractual maturities as of June 30, 2023: | | | | | | | | | | | | | Amortized Cost | | Fair Value | Due within one year | $ | 366,912,175 | | | $ | 365,932,523 | | Due between one and five years | 11,659,190 | | | 11,570,701 | | Total | $ | 378,571,365 | | | $ | 377,503,224 | |
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v3.23.2
Fair value measurements (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Fair Value Disclosures [Abstract] |
|
Schedule of Financial Assets and Liabilities Measured at Fair Value |
The following table presents information about the Company’s financial assets and liabilities as of June 30, 2023 that are measured at fair value on a recurring basis and indicates the level of the fair value hierarchy used to determine such fair values: | | | | | | | | | | | | | | | | | | | | | | | | | Level 1 | | Level 2 | | Level 3 | | Total | June 30, 2023 | | | | | | | | Cash equivalents: | | | | | | | | Money market mutual fund | $ | 47,656,269 | | | $ | — | | | $ | — | | | $ | 47,656,269 | | Commercial paper | — | | | 4,096,143 | | | — | | | 4,096,143 | | Available-for-sale debt securities: | | | | | | | | Commercial paper | — | | | 131,797,284 | | | — | | | 131,797,284 | | Corporate bonds | — | | | 113,115,309 | | | — | | | 113,115,309 | | Asset backed securities | — | | | 76,460,007 | | | — | | | 76,460,007 | | U.S. Government agency debt securities | 56,130,624 | | | — | | | — | | | 56,130,624 | | Total | $ | 103,786,893 | | | $ | 325,468,743 | | | $ | — | | | $ | 429,255,636 | |
|
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v3.23.2
Prepaid expenses and other current assets (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Prepaid Expense and Other Assets, Current [Abstract] |
|
Summary of Prepaid Expenses and Other Current Assets |
Prepaid expenses and other current assets consisted of the following: | | | | | | | | | | | | | As of June 30, 2023 | | As of December 31, 2022 | | $ | | $ | Prepaid clinical trial expenses | 3,418,491 | | | 4,011,419 | | Prepaid insurance | 1,781,969 | | | 1,310,314 | | Canadian harmonized sales tax receivable | 332,654 | | | 60,222 | | Other | 217,319 | | | 228,934 | | Total | 5,750,433 | | | 5,610,889 | |
|
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v3.23.2
Property, plant and equipment, net (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Property, Plant and Equipment [Abstract] |
|
Summary of Property, Plant and Equipment, Net |
Property, plant and equipment, net consisted of the following: | | | | | | | | | | | | | As of June 30, 2023 | | As of December 31, 2022 | | $ | | $ | Land and building | 18,976,410 | | | 18,163,962 | | Machinery and equipment | 10,415,742 | | | 5,328,639 | | Property, plant and equipment, in development | 15,459,230 | | | 8,434,384 | | Facility lease | 5,384,707 | | | — | | Furniture and fixtures | 721,595 | | | 698,728 | | Computer equipment | 153,891 | | | 149,892 | | | 51,111,575 | | | 32,775,605 | | Less: Accumulated depreciation | (2,717,358) | | | (1,395,029) | | Total | 48,394,217 | | | 31,380,576 | |
Depreciation is expensed from the month the particular asset is available for its intended use, using the straight-line method over the estimated useful life of such asset at the following rates, which in each case are intended to reduce the carrying value of the asset to the estimated residual value: | | | | | | Asset Category | Estimated Useful Life | Computer equipment | 5 years | Machinery and equipment | 7 years | Furniture and fixtures | 7 years | Facility lease | 7 years | Building | 20 years |
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v3.23.2
Accrued liabilities (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Accrued Liabilities, Current [Abstract] |
|
Summary of Accrued Liabilities |
Accrued liabilities consisted of the following: | | | | | | | | | | | | | As of June 30, 2023 | | As of December 31, 2022 | | $ | | $ | Accrued personnel costs | 3,772,849 | | | 7,116,382 | | Accrued research and development costs | 5,233,075 | | | 9,645,594 | | Accrued corporate legal fees and other professional services | 666,995 | | | 2,068,793 | | Accrued costs for purchases of property, plant and equipment | 289,244 | | | 105,741 | | Other accrued costs | 136,889 | | | 157,944 | | Total | 10,099,052 | | | 19,094,454 | |
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v3.23.2
Leases (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Leases [Abstract] |
|
Schedule of Lease Expense and Supplemental Cash Flow |
The components of lease expense are as follows:
| | | | | | | | | | | | | For the six months ended June 30, 2023 | | For the six months ended June 30, 2022 | Operating lease expense | $ | 50,499 | | | $ | — | | | | | | Finance lease cost | | | | Amortization of right-of-use asset | 192,311 | | | — | | Interest on lease liability | 99,199 | | | — | | Total finance lease cost | $ | 291,510 | | | $ | — | |
Supplemental cash flow information related to leases are as follows: | | | | | | | | | | | | | For the six months ended June 30, 2023 | | For the six months ended June 30, 2022 | Cash flow information: | | | | Cash paid for amounts included in the measurement of lease liabilities: | | | | Operating cash flow use from operating leases | $ | 49,321 | | | $ | — | | Operating cash flow use from finance leases | $ | 99,199 | | | $ | — | | Financing cash flow use from finance leases | $ | 133,641 | | | $ | — | | | | | | Non-cash activity: | | | | Right-of-use assets obtained in exchange for lease obligations: | | | | Operating lease | $ | 453,490 | | | $ | — | | Finance lease | $ | 5,384,707 | | | $ | — | |
The following table summarizes the weighted average remaining lease terms for the Company’s leases:
| | | | | | | As of June 30, 2023 | Weighted-average remaining lease term (in years): | | Operating lease | 1.8 | Finance lease | 6.8 |
Below is information on the weighted average discount rates used at the time that the leases were evaluated: | | | | | | | As of June 30, 2023 | Weighted-average discount rates: | | Operating lease | 7.6 | % | Finance lease | 7.7 | % |
|
Operating Lease Maturity |
The following table summarizes the future maturities of the Company's lease liabilities as of June 30, 2023:
| | | | | | | | | | | | | Operating Lease | | Finance Lease | 2023 | $ | 121,091 | | | $ | 505,608 | | 2024 | 249,446 | | | 1,011,217 | | 2025 | 74,938 | | | 1,011,217 | | 2026 | — | | | 1,011,217 | | 2027 | — | | | 1,011,217 | | Thereafter | — | | | 2,275,237 | | Total lease payments | $ | 445,475 | | | $ | 6,825,713 | | Less: imputed interest | (30,616) | | | (1,466,384) | | Present value of lease liabilities | $ | 414,859 | | | $ | 5,359,329 | |
|
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v3.23.2
Stock-based compensation (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
Summary of Stock Option Activity |
The following table summarizes the activity relating to the Company’s stock options. | | | | | | | | | | | | | | | | | | | Number of Shares | | Weighted Average Exercise Price Per Share ($) | | Weighted- Average Remaining Contractual Term (in years) | Outstanding as of December 31, 2022 | 5,592,173 | | 5.85 | | | Granted | 3,144,071 | | 7.03 | | | Exercised | (116,213) | | 2.86 | | | Forfeited | (122,887) | | 7.37 | | | Expired | (13,551) | | 8.47 | | | Outstanding as of June 30, 2023 | 8,483,593 | | 6.30 | | 4.7 | Vested and expected to vest as of June 30, 2023 | 8,483,593 | | 6.30 | | 4.7 | Options exercisable as of June 30, 2023 | 2,705,429 | | 4.89 | | 4.0 |
|
Summary of Assumptions Used to Determine the Grant Date Fair Value of Stock Options Granted |
The following table presents the assumptions used in the Black-Scholes-Merton option-pricing model to determine the grant date fair value of stock options granted: | | | | | | | | | | | | | | | | | | | | | | | | | Three months ended June 30, 2023 | | Three months ended June 30, 2022 | | Six months ended June 30, 2023 | | Six months ended June 30, 2022 | Risk-free interest rate | 3.91% - 4.23% | | 2.57% - 3.13% | | 3.71% - 4.23% | | 1.24% - 3.13% | Expected term (in years) | 3.50 | | 4.25 | | 3.50 - 4.25 | | 4.25 - 5.38 | Expected volatility | 67% | | 74% - 75% | | 67% - 68% | | 72% - 75% | Expected dividend yield | —% | | —% | | —% | | —% |
|
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v3.23.2
Net loss per share (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Earnings Per Share [Abstract] |
|
Summary of Basic and Diluted Net Loss per Share |
| | | | | | | | | | | | | | | | | | | | | | | | | Three months ended June 30, 2023 | | Three months ended June 30, 2022 | | Six months ended June 30, 2023 | | Six months ended June 30, 2022 | Net loss attributable to common stockholders | $ | 25,410,839 | | | $ | 24,580,247 | | | $ | 41,941,510 | | | $ | 40,960,821 | | Weighted-average common shares outstanding-basic and diluted | 105,724,215 | | | 90,124,295 | | | 105,692,615 | | | 90,123,288 | | Net loss per share attributable to common stockholders-basic and diluted | $ | 0.24 | | | $ | 0.27 | | | $ | 0.40 | | | $ | 0.45 | |
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v3.23.2
Related party transaction (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Related Party Transactions [Abstract] |
|
Schedule of Related Party Transactions |
The Company recognized expenses in connection with related party transactions in the unaudited interim condensed consolidated statements of operations as follows: | | | | | | | | | | | | | | | | | | | | | | | | | Three months ended June 30, 2023 | | Three months ended June 30, 2022 | | Six months ended June 30, 2023 | | Six months ended June 30, 2022 | Consulting fees on business activities to Board member | $ | 31,496 | | | $ | 102,396 | | | $ | 205,911 | | | $ | 169,092 | | Reimbursement to Board member for occupancy costs | 17,894 | | | 17,898 | | | 35,313 | | | 35,676 | | Total | $ | 49,390 | | | $ | 120,294 | | | $ | 241,224 | | | $ | 204,768 | |
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v3.23.2
Revenue - Narrative (Details) - USD ($) $ in Millions |
1 Months Ended |
3 Months Ended |
6 Months Ended |
Dec. 31, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Revenue Recognition, Milestone Method [Line Items] |
|
|
|
|
|
Revenue recognized for future performance |
$ 34.8
|
|
|
|
|
Revenue recognized |
|
$ 4.9
|
$ 0.0
|
$ 14.3
|
$ 0.0
|
Lantheus Holdings, Inc. | License Agreements, PNT2002 Agreement |
|
|
|
|
|
Revenue Recognition, Milestone Method [Line Items] |
|
|
|
|
|
Upfront payment |
250.0
|
|
|
|
|
Milestone payment |
$ 250.0
|
|
|
|
|
Royalty rate |
20.00%
|
|
|
|
|
Annual net sales milestone payment |
$ 1,300.0
|
|
|
|
|
Lantheus Holdings, Inc. | License Agreements, PNT2003 Agreement |
|
|
|
|
|
Revenue Recognition, Milestone Method [Line Items] |
|
|
|
|
|
Upfront payment |
10.0
|
|
|
|
|
Milestone payment |
$ 30.0
|
|
|
|
|
Royalty rate |
15.00%
|
|
|
|
|
Annual net sales milestone payment |
$ 275.0
|
|
|
|
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Revenue - Contract Liabilities (Details) - USD ($)
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Revenue from Contract with Customer [Abstract] |
|
|
Deferred revenue, current |
$ 15,899,770
|
$ 23,242,290
|
Long-term income taxes payable |
3,197,547
|
10,178,147
|
Total |
$ 19,097,317
|
$ 33,420,437
|
X |
- DefinitionAmount of obligation to transfer good or service to customer for which consideration has been received or is receivable.
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v3.23.2
Cash, cash equivalents and investments - Schedule of cash, cash equivalents, and investments (Details) - USD ($)
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Cash and Cash Equivalents [Line Items] |
|
|
Cash |
$ 5,540,926
|
$ 12,429,627
|
Money market funds |
47,656,269
|
273,998,744
|
Commercial paper |
4,096,143
|
0
|
Total cash and cash equivalents |
57,293,338
|
286,428,371
|
Short-term investments |
365,932,523
|
238,783,470
|
Long-term investments |
11,570,701
|
16,119,430
|
Total cash, cash equivalents and investments |
434,796,562
|
541,331,271
|
Commercial paper |
|
|
Cash and Cash Equivalents [Line Items] |
|
|
Short-term investments |
131,797,284
|
115,156,455
|
Corporate bonds |
|
|
Cash and Cash Equivalents [Line Items] |
|
|
Short-term investments |
102,294,737
|
45,219,042
|
Long-term investments |
10,820,572
|
0
|
U.S. Government agency debt securities |
|
|
Cash and Cash Equivalents [Line Items] |
|
|
Short-term investments |
56,130,624
|
42,577,762
|
Asset backed securities |
|
|
Cash and Cash Equivalents [Line Items] |
|
|
Short-term investments |
75,709,878
|
35,830,211
|
Long-term investments |
$ 750,129
|
$ 16,119,430
|
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v3.23.2
Cash, cash equivalents and investments - Schedule of available-for-sale investments (Details)
|
Jun. 30, 2023
USD ($)
|
Debt Securities, Available-for-sale [Line Items] |
|
Amortized Cost |
$ 378,571,365
|
Unrealized Gains |
720
|
Unrealized Losses |
(1,068,861)
|
Fair Value |
377,503,224
|
Current |
365,932,523
|
Non-current |
11,570,701
|
Commercial paper |
|
Debt Securities, Available-for-sale [Line Items] |
|
Amortized Cost |
131,908,748
|
Unrealized Gains |
15
|
Unrealized Losses |
(111,479)
|
Fair Value |
131,797,284
|
Current |
131,797,284
|
Non-current |
0
|
Corporate bonds |
|
Debt Securities, Available-for-sale [Line Items] |
|
Amortized Cost |
113,657,153
|
Unrealized Gains |
705
|
Unrealized Losses |
(542,549)
|
Fair Value |
113,115,309
|
Current |
102,294,737
|
Non-current |
10,820,572
|
Asset backed securities |
|
Debt Securities, Available-for-sale [Line Items] |
|
Amortized Cost |
76,699,026
|
Unrealized Gains |
0
|
Unrealized Losses |
(239,019)
|
Fair Value |
76,460,007
|
Current |
75,709,878
|
Non-current |
750,129
|
U.S. Government agency debt securities |
|
Debt Securities, Available-for-sale [Line Items] |
|
Amortized Cost |
56,306,438
|
Unrealized Gains |
0
|
Unrealized Losses |
(175,814)
|
Fair Value |
56,130,624
|
Current |
56,130,624
|
Non-current |
$ 0
|
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v3.23.2
Cash, cash equivalents and investments - Schedule of available-for-sale investments by maturity (Details)
|
Jun. 30, 2023
USD ($)
|
Amortized Cost |
|
Due within one year |
$ 366,912,175
|
Due between one and five years |
11,659,190
|
Amortized Cost |
378,571,365
|
Fair Value |
|
Due within one year |
365,932,523
|
Due between one and five years |
11,570,701
|
Fair Value |
$ 377,503,224
|
X |
- DefinitionAmortized cost of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale).
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v3.23.2
Fair value measurements - Schedule of financial assets and liabilities measured at fair value on a recurring basis (Details) - USD ($)
|
|
|
6 Months Ended |
Dec. 01, 2023 |
Jun. 01, 2023 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Available-for-sale debt securities: |
|
|
$ 377,503,224
|
|
Purchase of note receivable |
|
$ 5,000,000
|
5,000,000
|
$ 0
|
Forecast |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Purchase of note receivable |
$ 5,000,000
|
|
|
|
Fair Value, Recurring |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Total |
|
|
429,255,636
|
|
Fair Value, Recurring | Level 1 |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Total |
|
|
103,786,893
|
|
Fair Value, Recurring | Level 2 |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Total |
|
|
325,468,743
|
|
Fair Value, Recurring | Level 3 |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Total |
|
|
0
|
|
Commercial paper |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Available-for-sale debt securities: |
|
|
131,797,284
|
|
Commercial paper | Fair Value, Recurring |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Available-for-sale debt securities: |
|
|
131,797,284
|
|
Commercial paper | Fair Value, Recurring | Level 1 |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Available-for-sale debt securities: |
|
|
0
|
|
Commercial paper | Fair Value, Recurring | Level 2 |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Available-for-sale debt securities: |
|
|
131,797,284
|
|
Commercial paper | Fair Value, Recurring | Level 3 |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Available-for-sale debt securities: |
|
|
0
|
|
Corporate bonds |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Available-for-sale debt securities: |
|
|
113,115,309
|
|
Corporate bonds | Fair Value, Recurring |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Available-for-sale debt securities: |
|
|
113,115,309
|
|
Corporate bonds | Fair Value, Recurring | Level 1 |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Available-for-sale debt securities: |
|
|
0
|
|
Corporate bonds | Fair Value, Recurring | Level 2 |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Available-for-sale debt securities: |
|
|
113,115,309
|
|
Corporate bonds | Fair Value, Recurring | Level 3 |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Available-for-sale debt securities: |
|
|
0
|
|
Asset backed securities |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Available-for-sale debt securities: |
|
|
76,460,007
|
|
Asset backed securities | Fair Value, Recurring |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Available-for-sale debt securities: |
|
|
76,460,007
|
|
Asset backed securities | Fair Value, Recurring | Level 1 |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Available-for-sale debt securities: |
|
|
0
|
|
Asset backed securities | Fair Value, Recurring | Level 2 |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Available-for-sale debt securities: |
|
|
76,460,007
|
|
Asset backed securities | Fair Value, Recurring | Level 3 |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Available-for-sale debt securities: |
|
|
0
|
|
U.S. Government agency debt securities |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Available-for-sale debt securities: |
|
|
56,130,624
|
|
U.S. Government agency debt securities | Fair Value, Recurring |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Available-for-sale debt securities: |
|
|
56,130,624
|
|
U.S. Government agency debt securities | Fair Value, Recurring | Level 1 |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Available-for-sale debt securities: |
|
|
56,130,624
|
|
U.S. Government agency debt securities | Fair Value, Recurring | Level 2 |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Available-for-sale debt securities: |
|
|
0
|
|
U.S. Government agency debt securities | Fair Value, Recurring | Level 3 |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Available-for-sale debt securities: |
|
|
0
|
|
Money market mutual fund | Fair Value, Recurring |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Cash equivalents: |
|
|
47,656,269
|
|
Money market mutual fund | Fair Value, Recurring | Level 1 |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Cash equivalents: |
|
|
47,656,269
|
|
Money market mutual fund | Fair Value, Recurring | Level 2 |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Cash equivalents: |
|
|
0
|
|
Money market mutual fund | Fair Value, Recurring | Level 3 |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Cash equivalents: |
|
|
0
|
|
Commercial paper | Fair Value, Recurring |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Cash equivalents: |
|
|
4,096,143
|
|
Commercial paper | Fair Value, Recurring | Level 1 |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Cash equivalents: |
|
|
0
|
|
Commercial paper | Fair Value, Recurring | Level 2 |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Cash equivalents: |
|
|
4,096,143
|
|
Commercial paper | Fair Value, Recurring | Level 3 |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Cash equivalents: |
|
|
$ 0
|
|
X |
- DefinitionFair value portion of probable future economic benefits obtained or controlled by an entity as a result of past transactions or events.
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v3.23.2
Prepaid expenses and other current assets (Details) - USD ($)
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Prepaid Expense and Other Assets, Current [Abstract] |
|
|
Prepaid clinical trial expenses |
$ 3,418,491
|
$ 4,011,419
|
Prepaid insurance |
1,781,969
|
1,310,314
|
Canadian harmonized sales tax receivable |
332,654
|
60,222
|
Other |
217,319
|
228,934
|
Total |
$ 5,750,433
|
$ 5,610,889
|
X |
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v3.23.2
Property, plant and equipment, net (Details)
|
Jun. 30, 2023
USD ($)
|
Feb. 02, 2023
ft²
|
Dec. 31, 2022
USD ($)
|
Jul. 31, 2020
ft²
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
Facility lease |
$ 5,384,707
|
|
$ 0
|
|
Total property, plant and equipment, gross |
51,111,575
|
|
32,775,605
|
|
Less: Accumulated depreciation |
(2,717,358)
|
|
(1,395,029)
|
|
Total |
48,394,217
|
|
31,380,576
|
|
Good Manufacturing Practices |
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
Square-foot of building | ft² |
|
|
|
81,000
|
UHN |
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
Square-foot of building | ft² |
|
7,700
|
|
|
Land and building |
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
Property, plant and equipment, gross |
18,976,410
|
|
18,163,962
|
|
Machinery and equipment |
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
Property, plant and equipment, gross |
10,415,742
|
|
5,328,639
|
|
Property, plant and equipment, in development |
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
Property, plant and equipment, gross |
15,459,230
|
|
8,434,384
|
|
Furniture and fixtures |
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
Property, plant and equipment, gross |
721,595
|
|
698,728
|
|
Computer equipment |
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
Property, plant and equipment, gross |
$ 153,891
|
|
$ 149,892
|
|
X |
- DefinitionAmount, before accumulated amortization, of right-of-use asset from finance lease.
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v3.23.2
Accrued liabilities (Details) - USD ($)
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Accrued Liabilities, Current [Abstract] |
|
|
Accrued personnel costs |
$ 3,772,849
|
$ 7,116,382
|
Accrued research and development costs |
5,233,075
|
9,645,594
|
Accrued corporate legal fees and other professional services |
666,995
|
2,068,793
|
Accrued costs for purchases of property, plant and equipment |
289,244
|
105,741
|
Other accrued costs |
136,889
|
157,944
|
Total |
$ 10,099,052
|
$ 19,094,454
|
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v3.23.2
Leases - Operating Lease Maturity (Details)
|
Jun. 30, 2023
USD ($)
|
Operating Lease |
|
2023 |
$ 121,091
|
2024 |
249,446
|
2025 |
74,938
|
2026 |
0
|
2027 |
0
|
Thereafter |
0
|
Total lease payments |
445,475
|
Less: imputed interest |
(30,616)
|
Present value of lease liabilities |
414,859
|
Finance Lease |
|
2023 |
505,608
|
2024 |
1,011,217
|
2025 |
1,011,217
|
2026 |
1,011,217
|
2027 |
1,011,217
|
Thereafter |
2,275,237
|
Total lease payments |
6,825,713
|
Less: imputed interest |
(1,466,384)
|
Present value of lease liabilities |
$ 5,359,329
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v3.23.2
Stockholders' equity (Details)
|
3 Months Ended |
6 Months Ended |
|
|
Jun. 30, 2023
USD ($)
$ / shares
shares
|
Mar. 31, 2023
shares
|
Jun. 30, 2022
USD ($)
shares
|
Mar. 31, 2022
shares
|
Jun. 30, 2023
USD ($)
vote
$ / shares
shares
|
Jun. 30, 2022
USD ($)
shares
|
Dec. 31, 2022
$ / shares
shares
|
Dec. 31, 2021
shares
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
Common stock, authorized (in shares) |
430,000,000
|
|
|
|
430,000,000
|
|
430,000,000
|
|
Common shares, par value (in dollars per share) | $ / shares |
$ 0.0001
|
|
|
|
$ 0.0001
|
|
$ 0.0001
|
|
Common stock, shares issued (in shares) |
105,765,954
|
|
|
|
105,765,954
|
|
105,649,741
|
|
Common stock, shares outstanding (in shares) |
105,765,954
|
|
|
|
105,765,954
|
|
105,649,741
|
|
Preferred stock, shares outstanding (in shares) |
0
|
|
|
|
0
|
|
0
|
|
Preferred stock, shares issued (in shares) |
0
|
|
|
|
0
|
|
0
|
|
Number of votes per share | vote |
|
|
|
|
1
|
|
|
|
Cash dividend declared | $ |
$ 0
|
|
|
|
$ 0
|
$ 0
|
|
|
Cash dividend paid | $ |
$ 0
|
|
|
|
$ 0
|
$ 0
|
|
|
Preferred shares |
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
Preferred shares, shares authorized (in shares) |
20,000,000
|
|
|
|
20,000,000
|
|
|
|
Preferred stock, par value (in dollars per share) | $ / shares |
$ 0.0001
|
|
|
|
$ 0.0001
|
|
|
|
Issuance of shares of preferred stock (in shares) |
|
|
|
|
0
|
|
|
|
Common Stock |
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
Issuance of shares of common stock in connection with stock option exercises (in shares) |
83,277
|
32,936
|
2,490
|
678
|
|
|
|
|
Common stock, shares outstanding (in shares) |
105,765,954
|
105,682,677
|
90,124,962
|
90,122,472
|
105,765,954
|
90,124,962
|
105,649,741
|
90,121,794
|
Common Stock | Non-employee consultant |
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
Issuance of shares of common stock in connection with stock option exercises (in shares) |
71,585
|
|
|
|
86,585
|
|
|
|
Proceeds from issuance of shares of common stock | $ |
$ 99,503
|
|
$ 3,461
|
|
$ 120,353
|
$ 4,403
|
|
|
Issuance of shares of common stock, net of direct and incremental costs in connection with the business combination (in shares) |
|
|
2,490
|
|
|
3,168
|
|
|
Common Stock | Board member |
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
Issuance of shares of common stock in connection with stock option exercises (in shares) |
11,692
|
|
|
|
29,628
|
|
|
|
Proceeds from issuance of shares of common stock | $ |
$ 86,555
|
|
|
|
$ 211,569
|
|
|
|
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v3.23.2
Stock-based compensation - Narrative (Details) - USD ($)
|
|
|
3 Months Ended |
6 Months Ended |
12 Months Ended |
Jan. 01, 2023 |
Jun. 06, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Annual increase in shares authorized, percentage |
|
|
|
|
4.00%
|
|
|
Number of additional shares available (in shares) |
4,225,990
|
|
|
|
|
|
|
Number of shares authorized for issuance under plan (in shares) |
|
|
9,129,858
|
|
9,129,858
|
|
|
Unrecognized stock-based compensation |
|
|
$ 19,343,654
|
|
$ 19,343,654
|
|
|
Period for recognition |
|
|
|
|
2 years 3 months 18 days
|
|
|
Non-employee consultant |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Proceeds from issuance of shares of common stock |
|
|
$ 186,058
|
$ 3,461
|
$ 331,922
|
$ 4,403
|
|
Vesting on 1st year anniversary | Employees and Directors |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Vesting percentage |
|
|
|
|
|
25.00%
|
|
Vesting on 1st year anniversary | Employee |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Vesting percentage |
|
|
|
|
25.00%
|
|
|
Vesting ratably over the remaining three years | Employees and Directors |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Vesting percentage |
|
|
|
|
|
75.00%
|
|
Vesting ratably over the remaining three years | Employee |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Vesting percentage |
|
|
|
|
75.00%
|
|
|
Stock options |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Number of options granted (in shares) |
|
|
|
|
3,144,071
|
|
|
Stock options exercised (in shares) |
|
|
|
|
116,213
|
|
|
Stock options | Director |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Number of options granted (in shares) |
|
128,070
|
304,248
|
|
|
|
|
Options granted in period, weighted average grant date fair value (in dollars per share) |
|
|
$ 4.75
|
|
|
|
|
Stock options | Employees and Directors |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Number of options granted (in shares) |
|
|
|
243,417
|
|
1,948,614
|
|
Options granted in period, weighted average grant date fair value (in dollars per share) |
|
|
|
$ 4.66
|
|
$ 4.59
|
|
Stock options exercised (in shares) |
|
|
|
|
29,628
|
|
|
Intrinsic value |
|
|
|
|
$ 38,300
|
|
|
Stock options | Non-employee consultant |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Stock options exercised (in shares) |
|
|
71,585
|
2,490
|
86,585
|
3,168
|
|
Intrinsic value |
|
|
$ 604,767
|
$ 16,060
|
$ 700,217
|
$ 19,301
|
|
Stock options | Employee |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Number of options granted (in shares) |
|
|
|
|
2,839,823
|
|
|
Options granted in period, weighted average grant date fair value (in dollars per share) |
|
|
|
|
$ 3.76
|
|
|
Stock options exercised (in shares) |
|
|
11,692
|
|
|
|
|
Intrinsic value |
|
|
$ 32,740
|
|
|
|
|
Stock options | Vesting on 1st year anniversary | Director |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Vesting period |
|
|
1 year
|
|
|
|
|
Stock options | Vesting on 1st year anniversary | Employees and Directors |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Vesting period |
|
|
|
|
|
1 year
|
|
Stock options | Vesting on 1st year anniversary | Employee |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Vesting period |
|
|
|
|
1 year
|
|
|
Stock options | Vesting ratably over the remaining three years | Employees and Directors |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Vesting period |
|
|
|
|
|
3 years
|
|
Stock options | Vesting ratably over the remaining three years | Employee |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Vesting period |
|
|
|
|
3 years
|
|
|
Performance Shares |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Vesting percentage |
|
|
|
|
|
|
100.00%
|
Grants in period (in shares) |
|
|
|
|
|
|
146,044
|
Grant date fair value (in dollars per share) |
|
|
|
|
|
|
$ 6.61
|
Research and development |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Share-based compensation expense |
|
|
$ 685,263
|
458,634
|
$ 1,131,391
|
$ 743,945
|
|
General and administrative |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Share-based compensation expense |
|
|
$ 1,025,086
|
$ 568,929
|
$ 1,588,454
|
$ 724,068
|
|
X |
- DefinitionAmount of expense for award under share-based payment arrangement. Excludes amount capitalized.
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v3.23.2
Stock-based compensation - Summarizes activity relating to options to purchase stock (Details) - Stock options - $ / shares
|
6 Months Ended |
Jun. 30, 2023 |
Number of Shares |
|
Beginning balance (in shares) |
5,592,173
|
Granted (in shares) |
3,144,071
|
Exercised (in shares) |
(116,213)
|
Forfeited (in shares) |
(122,887)
|
Expired (in shares) |
(13,551)
|
Ending balance (in shares) |
8,483,593
|
Vested and expected to vest (in shares) |
8,483,593
|
Options exercisable (in shares) |
2,705,429
|
Weighted Average Exercise Price Per Share ($) |
|
Beginning balance (in dollars per share) |
$ 5.85
|
Granted (in dollars per share) |
7.03
|
Exercised (in dollars per share) |
2.86
|
Forfeited (in dollars per share) |
7.37
|
Expired (in dollars per share) |
8.47
|
Ending balance (in dollars per share) |
6.30
|
Vested and expected to vest (in dollars per share) |
6.30
|
Options exercisable (in dollars per share) |
$ 4.89
|
Weighted- Average Remaining Contractual Term (in years) |
|
Outstanding (in years) |
4 years 8 months 12 days
|
Vested and expected to vest (in years) |
4 years 8 months 12 days
|
Options exercisable (in years) |
4 years
|
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v3.23.2
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Commitments and contingencies - Clinical trial and commercial commitments & License agreements (Details) $ in Millions |
|
3 Months Ended |
6 Months Ended |
May 10, 2023
USD ($)
|
Jun. 30, 2023
USD ($)
|
Jun. 30, 2022
USD ($)
|
Jun. 30, 2023
USD ($)
|
Jun. 30, 2023
CAD ($)
|
Jun. 30, 2022
USD ($)
|
Research and development | License Agreement |
|
|
|
|
|
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Long-term Purchase Commitment [Line Items] |
|
|
|
|
|
|
Total aggregate remaining minimum commitment |
|
$ 3,000,000
|
$ 3,800,000
|
$ 3,500,000
|
|
$ 4,600,000
|
Supply agreements in connection with clinical trials |
|
|
|
|
|
|
Long-term Purchase Commitment [Line Items] |
|
|
|
|
|
|
Total aggregate remaining minimum commitment |
|
|
|
6,200,000
|
|
|
Supply agreements in connection | Research and development |
|
|
|
|
|
|
Long-term Purchase Commitment [Line Items] |
|
|
|
|
|
|
Total aggregate remaining minimum commitment |
|
4,800,000
|
2,600,000
|
11,300,000
|
|
4,300,000
|
Supply agreement to purchase certain products |
|
|
|
|
|
|
Long-term Purchase Commitment [Line Items] |
|
|
|
|
|
|
Minimum purchase commitments |
$ 32,400,000
|
|
|
111,900,000
|
$ 148.3
|
|
Term for total aggregate remaining minimum commitment |
10 years
|
|
|
|
|
|
Supply agreement to purchase certain products | Research and development |
|
|
|
|
|
|
Long-term Purchase Commitment [Line Items] |
|
|
|
|
|
|
Total aggregate remaining minimum commitment |
|
0
|
|
0
|
|
|
Agreement in connection |
|
|
|
|
|
|
Long-term Purchase Commitment [Line Items] |
|
|
|
|
|
|
Total aggregate remaining minimum commitment |
|
0
|
0
|
0
|
|
|
Agreement in connection with the SPLASH clinical phase study |
|
|
|
|
|
|
Long-term Purchase Commitment [Line Items] |
|
|
|
|
|
|
Total aggregate remaining minimum commitment |
|
|
|
24,000,000
|
|
|
Agreement in connection with the SPLASH clinical phase study | Research and development |
|
|
|
|
|
|
Long-term Purchase Commitment [Line Items] |
|
|
|
|
|
|
Total aggregate remaining minimum commitment |
|
$ 6,200,000
|
$ 2,500,000
|
11,100,000
|
|
$ 5,600,000
|
Maximum | Supply agreements in connection with clinical trials |
|
|
|
|
|
|
Long-term Purchase Commitment [Line Items] |
|
|
|
|
|
|
Minimum purchase commitments |
|
|
|
$ 1,700,000
|
|
|
Term for total aggregate remaining minimum commitment |
|
|
|
8 years
|
8 years
|
|
Maximum | Agreement in connection with the SPLASH clinical phase study |
|
|
|
|
|
|
Long-term Purchase Commitment [Line Items] |
|
|
|
|
|
|
Term for total aggregate remaining minimum commitment |
|
|
|
5 years
|
5 years
|
|
Minimum | Supply agreements in connection with clinical trials |
|
|
|
|
|
|
Long-term Purchase Commitment [Line Items] |
|
|
|
|
|
|
Term for total aggregate remaining minimum commitment |
|
|
|
3 years
|
3 years
|
|
Minimum | Agreement in connection with the SPLASH clinical phase study |
|
|
|
|
|
|
Long-term Purchase Commitment [Line Items] |
|
|
|
|
|
|
Term for total aggregate remaining minimum commitment |
|
|
|
1 year
|
1 year
|
|
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v3.23.2
Net loss per share - Summary of basic and diluted net loss per share (Details) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Mar. 31, 2023 |
Jun. 30, 2022 |
Mar. 31, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Earnings Per Share [Abstract] |
|
|
|
|
|
|
Net loss attributable to common stockholders |
$ 25,410,839
|
$ 16,530,671
|
$ 24,580,247
|
$ 16,380,574
|
$ 41,941,510
|
$ 40,960,821
|
Weighted-average common shares outstanding - basic (in shares) |
105,724,215
|
|
90,124,295
|
|
105,692,615
|
90,123,288
|
Weighted-average common shares outstanding - diluted (in shares) |
105,724,215
|
|
90,124,295
|
|
105,692,615
|
90,123,288
|
Net loss per share attributable to common stockholders - basic (in dollars per share) |
$ 0.24
|
|
$ 0.27
|
|
$ 0.40
|
$ 0.45
|
Net loss per share attributable to common stockholders - diluted (in dollars per share) |
$ 0.24
|
|
$ 0.27
|
|
$ 0.40
|
$ 0.45
|
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v3.23.2
v3.23.2
Related party transactions - Schedule of Related Party Transactions (Details) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Related Party Transaction [Line Items] |
|
|
|
|
Related party expenses |
$ 49,390
|
$ 120,294
|
$ 241,224
|
$ 204,768
|
Consulting fees on business activities to Board member |
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
Related party expenses |
31,496
|
102,396
|
205,911
|
169,092
|
Reimbursement to Board member for occupancy costs |
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
Related party expenses |
$ 17,894
|
$ 17,898
|
$ 35,313
|
$ 35,676
|
v3.23.2
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POINT Biopharma Global (NASDAQ:PNT)
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