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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
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☒ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2024
OR
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☐ |
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: 001-39539
PMV PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in its Charter)
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Delaware |
46-3218129 |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
One Research Way Princeton, NJ |
08540 |
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: (609) 642-6670
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
Common stock, par value $0.00001 |
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PMVP |
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The Nasdaq Global Select 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, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Large accelerated filer |
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☐ |
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Accelerated filer |
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☐ |
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Non-accelerated filer |
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☒ |
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Smaller reporting company |
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☒ |
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Emerging growth company |
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☐ |
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 by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes ☒ No ☐
As of May 9, 2024, the registrant had 51,443,488 shares of common stock, $0.00001 par value per share, outstanding.
Table of Contents
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements that involve risks and uncertainties. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding our future results of operations and financial position, business strategy, development plans, planned preclinical studies and clinical trials, future results of clinical trials, expected research and development costs, regulatory strategy, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. Forward-looking statements contained in this Quarterly Report on Form 10-Q include, but are not limited to, statements about:
•our financial performance;
•the sufficiency of our existing cash, cash equivalents and marketable securities to fund our future operating expenses and capital expenditure requirements;
•our need to raise additional funding before we can expect to generate any revenues from product sales;
•our ability to obtain additional funding for our operations, when needed, including funding necessary to complete further development and commercialization of our product candidates, if approved;
•the accuracy of our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
•the implementation of our strategic plans for our business and product candidates;
•the size of the market opportunity for our product candidates and our ability to maximize those opportunities;
•the initiation, timing, progress and results of our research and development programs, preclinical studies, clinical trials and investigational new drug applications, or IND, and other regulatory submissions;
•the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates;
•our estimates of the number of patients for each of our programs including patients expected to have certain p53 mutations and the number of patients that will enroll in our clinical trials;
•the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other favorable results;
•our plans relating to the clinical development of our product candidates, including the disease areas to be evaluated;
•the timing, progress and focus of our clinical trials, and the reporting of data from those trials;
•our ability to obtain and maintain regulatory approval of our product candidates;
•our plans relating to commercializing our product candidates, if approved;
•the expected benefits of our existing and any potential future strategic collaborations with third parties and our ability to attract collaborators with development, regulatory and commercialization expertise;
•the success of competing therapies that are or may become available;
•the timing or likelihood of regulatory filings and approvals, including our expectation to seek accelerated reviews or special designations, such as breakthrough therapy and orphan drug designation, for our product candidates, including our intention to seek accelerated approval for PC14586, our lead product candidate, for a tumor-agnostic indication;
•our plans relating to the further development and manufacturing of our product candidates, including for additional indications that we may pursue;
•existing regulations and regulatory developments in the United States and other jurisdictions;
•our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available;
•our plans to rely on third parties to conduct and support preclinical and clinical development;
•our ability to retain the continued service of our key personnel and to identify, hire and then retain additional qualified personnel;
•our estimates, assumptions, projections and expectations regarding future cost savings and expenses associated with the announced restructuring plan and reduction in force; and
•our expectations regarding the impact of the macroeconomic and geopolitical environment, including inflation, rising interest rates, increased volatility in the debt and equity markets, instability in the global banking system, global pandemics and other public health emergencies, and geopolitical conflicts, and their potentially material adverse impact on our business and the execution of our clinical trials.
We have based these forward-looking statements largely on our current expectations and projections about our business, the industry in which we operate and financial trends that we believe may affect our business, financial condition, results of operations and prospects, and these forward-looking statements are not guarantees of future performance or development. These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q and are subject to a number of risks, uncertainties and assumptions described in the section titled “Item 1A. Risk Factors” and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the United States Securities and Exchange Commission on February 29, 2024, as well as in this Quarterly Report on Form 10-Q. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events or otherwise.
In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report on Form 10-Q, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and you are cautioned not to unduly rely upon these statements.
PART I—FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements (Unaudited).
PMV Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands, except share and per share amounts)
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March 31, 2024 (unaudited) |
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December 31, 2023 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
47,654 |
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$ |
37,706 |
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Restricted cash |
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822 |
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822 |
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Marketable securities, current |
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150,285 |
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165,351 |
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Prepaid expenses and other current assets |
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3,699 |
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3,530 |
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Total current assets |
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202,460 |
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207,409 |
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Property and equipment, net |
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10,903 |
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10,666 |
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Marketable securities, noncurrent |
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15,120 |
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25,505 |
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Right-of-use assets |
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8,211 |
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8,382 |
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Other assets |
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182 |
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190 |
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Total assets |
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$ |
236,876 |
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$ |
252,152 |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
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$ |
859 |
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$ |
3,237 |
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Accrued expenses |
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10,319 |
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9,940 |
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Operating lease liabilities, current |
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880 |
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852 |
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Total current liabilities |
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12,058 |
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14,029 |
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Operating lease liabilities, noncurrent |
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12,142 |
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12,434 |
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Total liabilities |
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24,200 |
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26,463 |
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Stockholders’ equity: |
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Preferred stock, $0.00001 par value, 5,000,000 shares authorized at March 31, 2024 and December 31, 2023. No shares issued or outstanding at March 31, 2024 and December 31, 2023. |
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— |
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— |
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Common stock, $0.00001 par value, 1,000,000,000 shares authorized; 51,445,862 and 51,445,862 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively. |
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— |
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— |
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Additional paid-in capital |
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538,078 |
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535,468 |
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Accumulated deficit |
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(325,273 |
) |
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(310,003 |
) |
Accumulated other comprehensive (loss) income |
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(129 |
) |
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224 |
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Total stockholders’ equity |
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212,676 |
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225,689 |
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Total liabilities and stockholders’ equity |
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$ |
236,876 |
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$ |
252,152 |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
PMV Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(unaudited)
(in thousands, except share and per share amounts)
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Three Months Ended March 31, |
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2024 |
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2023 |
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Operating expenses: |
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Research and development |
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$ |
13,186 |
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$ |
15,073 |
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General and administrative |
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5,035 |
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6,407 |
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Total operating expenses |
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18,221 |
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21,480 |
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Loss from operations |
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(18,221 |
) |
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(21,480 |
) |
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Other income (expense): |
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Interest income, net |
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2,952 |
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2,325 |
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Other income (expense), net |
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(1 |
) |
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27 |
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Total other income (expense) |
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2,951 |
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2,352 |
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Loss before provision for income taxes |
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(15,270 |
) |
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(19,128 |
) |
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Income taxes |
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— |
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— |
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Net loss |
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(15,270 |
) |
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(19,128 |
) |
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Unrealized (loss) gain on available for sale investments, net of tax |
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(319 |
) |
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329 |
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Foreign currency translation loss |
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(34 |
) |
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— |
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Total other comprehensive (loss) income |
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(353 |
) |
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329 |
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Total comprehensive loss |
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$ |
(15,623 |
) |
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$ |
(18,799 |
) |
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Net loss per share -- basic and diluted |
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$ |
(0.30 |
) |
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$ |
(0.42 |
) |
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Weighted-average common shares outstanding |
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51,445,862 |
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45,773,357 |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
PMV Pharmaceuticals, Inc.
Condensed Consolidated Statements of Stockholders’ Equity
(unaudited)
(in thousands, except share amounts)
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Common Stock |
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Additional Paid-in |
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Accumulated Other Comprehensive |
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Accumulated |
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Total Stockholders' |
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Shares |
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Amount |
|
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Capital |
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(Loss) Income |
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Deficit |
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Equity |
|
Balance at December 31, 2022 |
|
|
|
45,771,332 |
|
|
$ |
— |
|
|
$ |
487,516 |
|
|
$ |
(445 |
) |
|
$ |
(241,043 |
) |
|
$ |
246,028 |
|
Exercise of stock options |
|
|
|
3,429 |
|
|
|
— |
|
|
|
12 |
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|
|
— |
|
|
|
— |
|
|
|
12 |
|
Stock-based compensation expense |
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|
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— |
|
|
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— |
|
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2,932 |
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|
|
— |
|
|
|
— |
|
|
|
2,932 |
|
Net loss |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(19,128 |
) |
|
|
(19,128 |
) |
Unrealized gain on available for sale investments |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
329 |
|
|
|
— |
|
|
|
329 |
|
Balance at March 31, 2023 |
|
|
|
45,774,761 |
|
|
$ |
— |
|
|
$ |
490,460 |
|
|
$ |
(116 |
) |
|
$ |
(260,171 |
) |
|
$ |
230,173 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock |
|
|
Additional Paid-in |
|
|
Accumulated Other Comprehensive |
|
|
Accumulated |
|
|
Total Stockholders' |
|
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
(Loss) Income |
|
|
Deficit |
|
|
Equity |
|
Balance at December 31, 2023 |
|
|
|
51,445,862 |
|
|
$ |
— |
|
|
$ |
535,468 |
|
|
$ |
224 |
|
|
$ |
(310,003 |
) |
|
$ |
225,689 |
|
Exercise of stock options |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Stock-based compensation expense |
|
|
|
— |
|
|
|
— |
|
|
|
2,610 |
|
|
|
— |
|
|
|
— |
|
|
|
2,610 |
|
Net loss |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(15,270 |
) |
|
|
(15,270 |
) |
Unrealized loss on available for sale investments |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(319 |
) |
|
|
— |
|
|
|
(319 |
) |
Foreign currency translation loss |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(34 |
) |
|
|
— |
|
|
|
(34 |
) |
Balance at March 31, 2024 |
|
|
|
51,445,862 |
|
|
$ |
— |
|
|
$ |
538,078 |
|
|
$ |
(129 |
) |
|
$ |
(325,273 |
) |
|
$ |
212,676 |
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
PMV Pharmaceuticals, Inc.
Condensed Consolidated Statements of Cash Flows
(unaudited)
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2024 |
|
|
2023 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
Net loss |
|
$ |
(15,270 |
) |
|
$ |
(19,128 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
Stock-based compensation expense |
|
|
2,610 |
|
|
|
2,932 |
|
Depreciation |
|
|
362 |
|
|
|
171 |
|
Accretion of discounts on marketable securities |
|
|
(1,628 |
) |
|
|
(712 |
) |
Non-cash lease income |
|
|
(92 |
) |
|
|
(89 |
) |
Other, net |
|
|
8 |
|
|
|
(1 |
) |
Change in operating assets and liabilities: |
|
|
|
|
|
|
Prepaid expenses and other assets |
|
|
(169 |
) |
|
|
2,108 |
|
Operating lease right-of-use assets and liabilities |
|
|
— |
|
|
|
— |
|
Accounts payable |
|
|
(2,384 |
) |
|
|
(1,520 |
) |
Accrued expenses |
|
|
379 |
|
|
|
1,227 |
|
Net cash used in operating activities |
|
|
(16,184 |
) |
|
|
(15,012 |
) |
Cash flows from investing activities: |
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(594 |
) |
|
|
(156 |
) |
Purchases of marketable securities |
|
|
(30,489 |
) |
|
|
(23,502 |
) |
Maturities of marketable securities |
|
|
57,249 |
|
|
|
73,303 |
|
Net cash provided by investing activities |
|
|
26,166 |
|
|
|
49,645 |
|
Cash flows from financing activities: |
|
|
|
|
|
|
Proceeds from the exercise of stock options and common stock issued under the 2020 EIP |
|
|
— |
|
|
|
12 |
|
Net cash provided by financing activities |
|
|
— |
|
|
|
12 |
|
Impact of exchange rates on cash, cash equivalents, and restricted cash |
|
|
(34 |
) |
|
|
|
Net increase in cash and cash equivalents |
|
|
9,948 |
|
|
|
34,645 |
|
Cash, cash equivalents, and restricted cash |
|
|
|
|
|
|
Cash, cash equivalents, and restricted cash - beginning of period |
|
|
38,528 |
|
|
|
109,119 |
|
Cash, cash equivalents, and restricted cash - end of period |
|
$ |
48,476 |
|
|
$ |
143,764 |
|
Supplemental disclosures of noncash investing activities |
|
|
|
|
|
|
Accrued purchases of property and equipment |
|
$ |
6 |
|
|
$ |
298 |
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
PMV Pharmaceuticals, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
(in thousands, except share and per share amounts)
1. Formation and Business of the Company
Organization and Liquidity
PMV Pharmaceuticals, Inc. (the “Company” or “We”) was incorporated in the state of Delaware in March 2013. Since inception, the Company has devoted substantially all of its time and efforts to performing research and development activities and raising capital. We are a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53. The Company’s headquarters are located at One Research Way, Princeton, New Jersey.
The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry including, but not limited to, technical risks associated with the successful research, development and manufacturing of product candidates, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. Current and future programs will require significant research and development efforts, including extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel, and infrastructure. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales.
The Company has incurred net losses and negative cash flows from operations since its inception. During the three months ended March 31, 2024, the Company incurred a net loss of $15,270. For the three months ended March 31, 2024, the Company used $16,184 of cash for operations. At March 31, 2024, the Company had an accumulated deficit of $325,273. Cash, cash equivalents, and marketable securities were $213,059 as of March 31, 2024. Management expects to incur substantial additional operating losses for the next several years and may need to obtain additional debt or equity financings in order to complete development of its products, obtain regulatory approvals, launch and commercialize its products and continue research and development programs. The Company believes it has adequate cash, cash equivalents, and marketable securities to operate for the next 12 months from the date of issuance of these condensed consolidated financial statements.
2. Summary of Significant Accounting Policies
The Company’s significant accounting policies are disclosed in the audited condensed consolidated financial statements for the year ended December 31, 2023, included in the Company’s Annual Report on Form 10-K filed with the United States Securities and Exchange Commission (the “SEC”) on February 29, 2024. Since the date of those condensed consolidated financial statements, there have been no changes to its significant accounting policies.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information and with the interim period reporting requirements of Form 10-Q and Article 10 of Regulation S-X. The condensed consolidated balance sheet as of March 31, 2024, the condensed consolidated statements of operations and comprehensive loss, stockholders’ equity, and statements of cash flows for the three months ended March 31, 2024 and 2023, are unaudited, but, in the opinion of management, include all adjustments, consisting only of normal recurring adjustments, which we consider necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The results for any interim period are not necessarily indicative of results for the year ending December 31, 2024, or for any other subsequent interim period. The condensed consolidated balance sheet as of December 31, 2023, has been derived from our audited condensed consolidated financial statements.
The accompanying condensed consolidated financial statements include our accounts and the accounts of our wholly owned subsidiary, PMV Pharma Australia Pvt Ltd. All significant intercompany transactions and balances have been eliminated upon consolidation. These condensed consolidated financial statements are presented in United States ("U.S.") Dollars, which is also the functional currency of the Company.
PMV Pharmaceuticals, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
(in thousands, except share and per share amounts)
Use of Estimates
The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and reported amounts of revenues and expenses during the reporting period. The Company bases its estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, research and development costs, accrued research and development costs and related prepaid expenses. Actual results could differ materially from those estimates.
Cash, Cash Equivalents and Marketable Securities
Management considers all highly liquid investments with original maturities of three months or less to be cash equivalents.
The Company’s marketable debt securities have been classified and accounted for as available-for-sale. The Company classifies its marketable debt securities as either short-term or long-term based on each instrument’s underlying contractual maturity date. Marketable debt securities with maturities of 12 months or less are classified as short-term and marketable debt securities with maturities greater than 12 months are classified as long-term. The Company’s marketable debt securities are carried at fair value, with unrealized gains and losses, net of taxes, reported as a component of accumulated other comprehensive loss in stockholders’ equity. Premiums and discounts on marketable debt securities are amortized into earnings over the life of the security and recorded on the interest income, net line of the income statement. For the three months ended March 31, 2024 and 2023, the Company recorded $1,628 and $712 of accretion, respectively.
Restricted cash as of March 31, 2024 and December 31, 2023 included a $822 deposit at the Company’s commercial bank underlying a stand-by letter of credit issued in favor of a landlord (See Note 6) and is classified in current assets.
Comprehensive Loss and Accumulated Other Comprehensive Income (Loss)
Other comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources, including unrealized gains and losses on investments and foreign currency translation gains and losses.
Leases
At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the circumstances present. The Company accounts for a contract as a lease when it has the right to control the asset for a period of time while obtaining substantially all of the asset’s economic benefits. The Company determines the initial classification and measurement of its operating right-of-use (“ROU”) assets and operating lease liabilities at the lease commencement date, and thereafter if modified. The lease term includes any renewal options that the Company is reasonably certain to exercise. The Company’s policy is to not record leases with a lease term of 12 months or less on its balance sheets. The Company’s only existing leases are for office and laboratory space.
The ROU asset represents the right to use the leased asset for the lease term. The lease liability represents the present value of the lease payments under the lease. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its estimated secured incremental borrowing rate for that lease term.
Lease expense for operating leases is recognized on a straight-line basis over the reasonably assured lease term based on the total lease payments and is included in operating expense in the statements of operations.
Payments due under each lease agreement include fixed and variable payments. Variable payments relate to the Company’s share of the lessor’s operating costs associated with the underlying asset and are recognized when the event on which those payments are assessed occurs. Variable payments have been excluded from the lease liability and associated right-of-use asset. Neither of the Company’s leases contain residual value guarantees.
PMV Pharmaceuticals, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
(in thousands, except share and per share amounts)
The interest rate implicit in lease agreements is typically not readily determinable, and as such, the Company utilizes the incremental borrowing rate to calculate lease liabilities, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment.
Concentration of Credit Risk and Other Risks and Uncertainties
Financial instruments that potentially subject the Company to significant concentrations of credit risk consist of cash, cash equivalents and marketable securities. Cash and cash equivalents were held at two financial institutions. At times, such deposits may be in excess of insured limits. The Company has not experienced any losses on its deposits of cash and cash equivalents. The Company’s marketable securities are carried at fair value and include any unrealized gains and losses. Any investments with unrealized losses are considered to be temporarily impaired.
The Company’s future results of operations involve a number of risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, rapid technological change, uncertainty of market acceptance of the product, competition from substitute products and larger companies, protection of proprietary technology, any future strategic relationships and dependence on key individuals.
Products developed by the Company require clearances from the U.S. Food and Drug Administration or other international regulatory agencies prior to commercial sales. There can be no assurance the Company’s product candidates will receive the necessary clearances. If the Company is denied clearance, clearance is delayed or it is unable to maintain clearance, it could have a materially adverse impact on the Company.
3. Fair Value Measurements
The Company’s financial assets consist of money market funds, U.S. government debt securities and corporate debt securities. The following tables show the Company’s cash equivalents and available-for-sale securities’ carrying amounts and fair values as of March 31, 2024, and December 31, 2023:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of March 31, 2024 |
|
|
|
Carrying Amount |
|
|
Gross Unrealized Gains |
|
|
Gross Unrealized Losses |
|
|
Fair Value |
|
|
Quoted priced in active markets (Level 1) |
|
|
Significant other observable inputs (Level 2) |
|
|
Significant unobservable inputs (Level 3) |
|
Financial assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
39,666 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
39,666 |
|
|
$ |
39,666 |
|
|
$ |
— |
|
|
$ |
— |
|
Corporate securities |
|
|
52,020 |
|
|
|
8 |
|
|
|
(16 |
) |
|
|
52,012 |
|
|
|
5,572 |
|
|
|
46,440 |
|
|
|
— |
|
Government securities |
|
|
121,494 |
|
|
|
— |
|
|
|
(120 |
) |
|
|
121,374 |
|
|
|
95,418 |
|
|
|
25,956 |
|
|
|
— |
|
Total financial assets |
|
$ |
213,180 |
|
|
$ |
8 |
|
|
$ |
(136 |
) |
|
$ |
213,052 |
|
|
$ |
140,656 |
|
|
$ |
72,396 |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2023 |
|
|
|
Carrying Amount |
|
|
Gross Unrealized Gains |
|
|
Gross Unrealized Losses |
|
|
Fair Value |
|
|
Quoted Priced in Active Markets (Level 1) |
|
|
Significant Other Observable Inputs (Level 2) |
|
|
Significant Unobservable Inputs (Level 3) |
|
Financial assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
37,694 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
37,694 |
|
|
$ |
37,694 |
|
|
$ |
— |
|
|
$ |
— |
|
Corporate securities |
|
|
69,995 |
|
|
|
48 |
|
|
|
— |
|
|
|
70,043 |
|
|
|
5,577 |
|
|
|
64,466 |
|
|
|
— |
|
Government securities |
|
|
120,670 |
|
|
|
143 |
|
|
|
— |
|
|
|
120,813 |
|
|
|
92,297 |
|
|
|
28,516 |
|
|
|
— |
|
Total financial assets |
|
$ |
228,359 |
|
|
$ |
191 |
|
|
$ |
— |
|
|
$ |
228,550 |
|
|
$ |
135,568 |
|
|
$ |
92,982 |
|
|
$ |
— |
|
PMV Pharmaceuticals, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
(in thousands, except share and per share amounts)
Cash Equivalents — As of March 31, 2024, the Company had aggregate cash and cash equivalents of $47,654, including cash equivalents of $47,647, consisting of money market funds and corporate securities. As of December 31, 2023, the Company had aggregate cash and cash equivalents of $37,706, including cash equivalents of $37,694, consisting of money market funds. Money market funds and certificates of deposit are classified within level 1 of the fair value hierarchy because they are valued using quoted market prices in active markets, whereas corporate debt securities are classified within level 2 of the fair value hierarchy because they are valued using inputs other than quoted prices that are observable for the asset or liability either directly or indirectly.
Marketable Securities — Marketable securities of $165,405 as of March 31, 2024, consisted of corporate debt securities of $44,031 and government debt securities of $121,374. There were $150,285 current marketable securities and $15,120 noncurrent marketable securities as of March 31, 2024. Marketable securities of $190,856 as of December 31, 2023, consisted of corporate debt securities of $70,043 and government debt securities of $120,813. There were $165,351 current marketable securities and $25,505 noncurrent marketable securities as of December 31, 2023.
As of March 31, 2024, and December 31, 2023, aggregated gross unrealized losses of available-for-sale investments were not material, and accordingly, no allowance for credit losses was recorded.
4. Property and Equipment, Net
|
|
|
|
|
|
|
|
|
|
|
March 31, 2024 |
|
|
December 31, 2023 |
|
Machinery & equipment |
|
|
3,089 |
|
|
$ |
3,089 |
|
Computers |
|
|
13 |
|
|
|
13 |
|
Furniture & fixtures |
|
|
69 |
|
|
|
69 |
|
Leasehold improvements |
|
|
11,364 |
|
|
|
10,765 |
|
Total property and equipment |
|
|
14,535 |
|
|
|
13,936 |
|
Less: Accumulated depreciation |
|
|
(3,632 |
) |
|
|
(3,270 |
) |
Property and equipment, net |
|
$ |
10,903 |
|
|
$ |
10,666 |
|
Depreciation expense for the three months ended March 31, 2024 and 2023 was $362 and $171, respectively.
5. Accrued Expenses
Accrued expenses consist of the following:
|
|
|
|
|
|
|
|
|
|
|
March 31, 2024 |
|
|
December 31, 2023 |
|
Accrued compensation |
|
$ |
2,220 |
|
|
$ |
4,498 |
|
Accrued legal and professional services |
|
|
248 |
|
|
|
172 |
|
Accrued research and development costs |
|
|
7,851 |
|
|
|
5,270 |
|
Total |
|
$ |
10,319 |
|
|
$ |
9,940 |
|
6. Commitments and Contingencies
Operating Leases
In June 2015, the Company executed a noncancelable operating lease for approximately 13,000 square feet of laboratory, research and development, and office space in Cranbury, New Jersey. This location operated as the Company's headquarters until March 2023.
In June 2017, the Company obtained an additional noncancelable operating lease for approximately 6,000 square feet of laboratory space in the same corporate center. Both leases were set to expire in June 2022. In January 2022, the Company signed a lease extension for both leases for up to one additional year through June 2023, with the option to terminate upon 120 days of written notice, with an increase in base rent as per the lease extension. The lease was terminated as of June 2023.
PMV Pharmaceuticals, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
(in thousands, except share and per share amounts)
In August 2018, the Company executed two noncancelable operating leases. One lease for approximately 6,000 square feet for vivarium, laboratory and general office space in South Brunswick, New Jersey. The lease was set to expire in July 2022. In January 2022, the Company signed a lease extension for up to one additional year through July 2023, with the option to terminate upon 120 days of written notice, with an increase in base rent as per the lease extension. The lease was terminated as of June 2023. The second lease is for office space in Lexington, Massachusetts, that expired in August 2023.
In January 2021, the Company signed a lease for 50,581 square feet of office and laboratory space at One Research Way in Princeton, New Jersey. That lease term extends through 2032, has a five-year extension option, and replaced the Company’s two existing facilities as the Company’s headquarters in March 2023. Payment under this lease will total $19,889 through May 2032. The Company received a lease incentive of $4,046 from the lessor for a buildout of laboratory, vivarium, and office space, to be reimbursed to the Company in 2022 and 2023. Management estimated the timing and amounts of reimbursements and included them as a reduction of lease payments when initially measuring the lease liability and right-of-use asset upon commencement. Since the inception date of the lease, $3,806 reimbursements were received. For the three months ended March 31, 2024, no reimbursements were received.
The components of lease cost for the three months ended March 31, 2024 and 2023, are as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
(in thousands) |
|
2024 |
|
|
2023 |
|
Operating lease cost |
|
$ |
355 |
|
|
$ |
597 |
|
Variable lease cost |
|
|
133 |
|
|
|
319 |
|
Total lease cost |
|
$ |
488 |
|
|
$ |
916 |
|
Amounts reported in the balance sheet for leases where the Company is the lessee as of March 31, 2024, and December 31, 2023, are as follows:
|
|
|
|
|
|
|
|
|
Operating Leases (in thousands, except lease term and discount rate data): |
|
March 31, 2024 |
|
|
December 31, 2023 |
|
Right-of-use assets, operating leases |
|
$ |
8,211 |
|
|
$ |
8,382 |
|
|
|
|
|
|
|
|
Operating lease liabilities, current |
|
$ |
880 |
|
|
$ |
852 |
|
Operating lease liabilities, non-current |
|
|
12,142 |
|
|
|
12,434 |
|
Total operating lease liabilities |
|
$ |
13,022 |
|
|
$ |
13,286 |
|
|
|
|
|
|
|
|
Weighted-average remaining lease term (years) |
|
|
8.17 |
|
|
|
8.42 |
|
Weighted-average discount rate |
|
|
5.75 |
% |
|
|
5.75 |
% |
Other information related to leases for the three months ended March 31, 2024 and 2023, respectively, as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
(in thousands) |
|
2024 |
|
|
2023 |
|
Net cash paid for amounts included in the measurement of lease liabilities |
|
$ |
447 |
|
|
$ |
686 |
|
Future minimum lease payments, net of reimbursements, remaining as of March 31, 2024, under operating leases by fiscal year were as follows:
|
|
|
|
|
Fiscal year |
|
(in thousands) |
|
2024 |
|
$ |
1,127 |
|
2025 |
|
|
1,869 |
|
2026 |
|
|
1,925 |
|
2027 |
|
|
1,983 |
|
2028 |
|
|
2,042 |
|
Thereafter |
|
|
7,453 |
|
Total minimum lease payments |
|
$ |
16,399 |
|
Less: Amounts representing imputed interest |
|
|
(3,377 |
) |
Present value of lease liabilities |
|
$ |
13,022 |
|
PMV Pharmaceuticals, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
(in thousands, except share and per share amounts)
Rent expense recorded during the three months ended March 31, 2024 and 2023 was $355 and $597, respectively.
Contingencies
From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of its business activities. The Company accrues a liability for such matters when future expenditures are probable and such expenditures can be reasonably estimated.
7. Stockholders’ Equity
The Company is authorized to issue up to 1,000,000,000 shares of common stock with a par value of $0.00001 per share and 5,000,000 shares of preferred stock with a par value of $0.00001 per share. At March 31, 2024 and December 31, 2023, there were 51,445,862 and 51,445,862 shares of common stock issued and outstanding, respectively.
Common stockholders are entitled to receive dividends if and when declared by the board of directors subject to the rights of any preferred stockholders. As of March 31, 2024, no dividends on common stock had been declared by the Company.
ATM Program
On October 4, 2021, the Company entered into an at-the-market offering program (the “ATM Program”) pursuant to which, the Company may offer and sell shares of its common stock having aggregate gross sales proceeds of up to $150.0 million from time to time. During the three months ended March 31, 2024, the Company did not sell any shares of its common stock under the ATM Program. As of March 31, 2024, the Company has approximately $113.8 million remaining in gross proceeds available for future issuances of common stock under the ATM Program.
8. Stock Plan
2020 Equity Incentive Plan
The 2020 Equity Incentive Plan (the “2020 Plan”) was approved by the Company's board of directors on September 24, 2020. The 2020 Plan provides for the grant of incentive stock options, non-qualified stock options, stock appreciation rights, restricted stock units, restricted stock awards, unrestricted stock awards, cash-based awards and dividend equivalent rights to the Company’s officers, employees, directors, and consultants. The number of shares of common stock initially reserved for issuance under the 2020 Plan was 4,406,374, which shall be increased, upon approval by the Company's board of directors, on January 1, 2021 and each January 1 thereafter, in an amount equal to the least of (i) 4,406,374 shares of common stock, (ii) five percent (5%) of the outstanding common stock on the immediately preceding December 31, or (iii) such number of common stock determined by the board of directors no later than the immediately preceding December 31. For 2024, the compensation committee of the Company's board of directors, as the 2020 Plan administrator, exercised its discretion under clause (ii) to increase the number of shares of common stock reserved for issuance under the 2020 Plan by 2,572,174 shares, effective as of January 1, 2024. As of March 31, 2024, there were 4,954,570 shares available for issuance under the 2020 Plan.
On September 9, 2022, the Company granted 374,899 Restricted Stock Units (“RSUs”) to employees pursuant to an employee retention program approved by the compensation committee of the Company's board of directors. The RSUs have graded vesting on an annual basis for two years of continuous service, as per the 2020 Plan.
On January 18, 2024, the Company granted 952,665 RSUs to employees VP-level or higher, pursuant to an employee retention program approved by the compensation committee of the Company's board of directors. The RSUs are scheduled to vest on June 30, 2025, based on approximately one and a half years of continuous service, as per the 2020 Plan.
2020 Employee Stock Purchase Plan
The 2020 Employee Stock Purchase Plan (the “2020 ESPP”) was approved by the Company's board of directors on September 24, 2020. A total of 400,752 shares of common stock were initially reserved for issuance under this plan, which shall be increased, upon approval by the Company's board of directors, on January 1, 2021 and each January 1 thereafter, to the lesser of (i) 801,504 shares of common stock, (ii) 1% of the outstanding shares of common stock on the last day of the
PMV Pharmaceuticals, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
(in thousands, except share and per share amounts)
immediately preceding fiscal year, or (iii) an amount determined by the board of directors or any of its committees no later than the last day of the immediately preceding fiscal year. For 2024, the 2020 ESPP reserved shares were increased under clause (ii) by 514,434 shares, effective as of January 1, 2024. As of March 31, 2024, 202,345 shares are issued or outstanding, and there were 1,571,266 shares available for issuance, under the 2020 ESPP.
Stock Options
The following table summarizes option activity for the three-month period ended March 31, 2024:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Average |
|
|
Aggregate |
|
|
|
Shares |
|
|
|
|
|
Average |
|
|
Remaining |
|
|
Intrinsic |
|
|
|
Available |
|
|
Number of |
|
|
Exercise |
|
|
Contractual Life |
|
|
Value |
|
|
|
for Grant |
|
|
Options |
|
|
Price |
|
|
(in years) |
|
|
(in 000s) |
|
Balances at December 31, 2023 |
|
|
4,474,411 |
|
|
|
6,973,464 |
|
|
$ |
9.44 |
|
|
|
7.01 |
|
|
$ |
990 |
|
Shares reserved for issuance |
|
|
2,572,174 |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
Options granted |
|
|
(2,776,030 |
) |
|
|
2,776,030 |
|
|
$ |
1.79 |
|
|
|
|
|
|
|
Options forfeited / cancelled |
|
|
684,015 |
|
|
|
(684,015 |
) |
|
$ |
9.41 |
|
|
|
|
|
|
|
Options exercised |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
Balances at March 31, 2024 (unaudited) |
|
|
4,954,570 |
|
|
|
9,065,479 |
|
|
$ |
7.10 |
|
|
|
6.91 |
|
|
$ |
273 |
|
At March 31, 2024 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and expected to vest |
|
|
|
|
|
9,065,479 |
|
|
$ |
7.10 |
|
|
|
6.91 |
|
|
$ |
273 |
|
Exercisable |
|
|
|
|
|
4,506,573 |
|
|
$ |
8.87 |
|
|
|
4.54 |
|
|
$ |
259 |
|
At March 31, 2024, the total compensation cost related to nonvested awards not yet recognized was $16,250. The weighted-average period over which the nonvested awards is expected to be recognized was 2.8 years.
The Company estimated the fair value of the options using the Black-Scholes options valuation model. The fair value of the options is being amortized on a straight-line basis over the requisite service period of the awards. The fair value was estimated using the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
March 31, |
|
|
|
2024 |
|
|
2023 |
|
Risk-free interest rate |
|
|
3.82% - 4.26% |
|
|
|
3.58% |
|
Expected life (in years) |
|
|
6.02 - 6.25 |
|
|
|
6.25 |
|
Dividend yield |
|
|
0% |
|
|
|
0% |
|
Expected volatility |
|
|
86.76% |
|
|
|
79.90% |
|
The weighted average assumptions used to estimate the fair value of stock purchase rights under the ESPP are as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
March 31, |
|
|
|
2024 |
|
|
2023 |
|
Risk-free interest rate |
|
|
5.43% |
|
|
|
4.65% |
|
Expected life (in years) |
|
|
0.49 |
|
|
|
0.49 |
|
Dividend yield |
|
|
0% |
|
|
|
0% |
|
Expected volatility |
|
|
76.22% |
|
|
|
76.33% |
|
Risk Free Interest Rate: The risk-free rate is based on the U.S. Treasury yields in effect at the time of grant for periods corresponding with the expected term of the option.
Expected Term: The Company uses the simplified method to calculate expected term described in the SEC’s Staff Accounting Bulletin No. 107, which takes into account vesting term and expiration date of the options.
Dividend Yield: The Company has never declared or paid any cash dividends and does not plan to pay cash dividends in the foreseeable future, and therefore, used an expected dividend yield of zero in the valuation model.
PMV Pharmaceuticals, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
(in thousands, except share and per share amounts)
Volatility: Volatility is based on the historical volatility of the Company's publicly traded shares for the expected term.
Restricted Stock Units
The following table presents RSU activity under the 2020 Plan as of March 31, 2024:
|
|
|
|
|
|
|
|
|
|
|
Number of Stock Units |
|
|
Weighted-Average Grant Date Fair Value |
|
Unvested shares at December 31, 2023 |
|
|
236,296 |
|
|
$ |
13.60 |
|
Granted |
|
|
952,665 |
|
|
|
1.80 |
|
Forfeited |
|
|
(52,550 |
) |
|
|
3.50 |
|
Unvested shares at March 31, 2024 |
|
|
1,136,411 |
|
|
$ |
4.18 |
|
As of March 31, 2024, there was $2,196 of unrecognized compensation cost related to RSUs that are expected to vest. These costs are expected to be recognized over a weighted average remaining vesting period of 1.1 years.
Stock-based compensation expense recorded under ASC 718 related to stock options and RSUs granted and common stock issued under the 2020 ESPP were allocated to research and development and general and administrative expense as follows:
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended |
|
|
|
March 31, |
|
|
March 31, |
|
|
|
2024 |
|
|
2023 |
|
Research and development |
|
$ |
975 |
|
|
$ |
1,263 |
|
General and administrative |
|
|
1,635 |
|
|
|
1,669 |
|
Total stock-based compensation |
|
$ |
2,610 |
|
|
$ |
2,932 |
|
Stock-based compensation expense by award type included within the condensed consolidated statements of operations is as follows:
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended |
|
|
|
March 31, |
|
|
March 31, |
|
|
|
2024 |
|
|
2023 |
|
Stock options |
|
$ |
2,214 |
|
|
$ |
2,281 |
|
Restricted stock units |
|
|
342 |
|
|
|
597 |
|
Employee stock purchase plan |
|
|
54 |
|
|
|
54 |
|
Total stock-based compensation |
|
$ |
2,610 |
|
|
$ |
2,932 |
|
9. Income Taxes
During the three months ended March 31, 2024 and 2023, the Company recorded a full valuation allowance on federal and state net deferred tax assets since management does not forecast the Company to be in a taxable position in the near future.
10. Net Loss per Share
The Company excluded all outstanding stock options and restricted stock awards at each period end from the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them
PMV Pharmaceuticals, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
(in thousands, except share and per share amounts)
would have had an anti-dilutive effect. The following common stock equivalents were excluded from the calculation of diluted net loss per share:
|
|
|
|
|
|
|
|
|
|
|
As of March 31, |
|
|
|
2024 |
|
|
2023 |
|
Options to purchase common stock |
|
|
9,065,479 |
|
|
|
5,310,011 |
|
Unvested RSUs |
|
|
1,136,411 |
|
|
|
374,899 |
|
Expected shares to be purchased under 2020 ESPP |
|
|
11,405 |
|
|
|
47,974 |
|
Total |
|
|
10,213,295 |
|
|
|
5,732,884 |
|
11. Related Parties
The Company has consulting agreements with three members of its board of directors; one of which waived his consulting fees starting as of September 2021. Total consulting fees paid during the three months ended March 31, 2024 and 2023 were $37 and $8, respectively. There were no amounts owed under the consulting agreements as of March 31, 2024.
12. Restructuring
On January 18, 2024, the Company announced a restructuring plan involving the reduction of its workforce by approximately 30% of the Company's employees. Substantially all of the costs under the restructuring plan were incurred during the three months ended March 31, 2024. The remaining expected costs are not expected to be material and will be complete by September 30, 2024. The Company is taking these steps in order to streamline operations, reduce costs and preserve capital as it advances into late-stage development for its lead product candidate, PC14586.
As a result of the reduction in force, the Company incurred an aggregate non-recurring charge of $675, consisting primarily of employee severance and benefit costs associated with the restructuring. The Company has recorded these charges in research and development expenses in the accompanying condensed consolidated statement of operations based on responsibilities of the impacted employees. The restructuring expenditure of $675 was recognized in March 2024.
The following sets forth information regarding the balances and activity associated with the Company's accrued employee severance and benefits costs (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2023 |
|
|
Expenses, net |
|
|
Cash |
|
|
Balance as of March 31, 2024 |
|
Employee severance and benefit costs |
|
— |
|
|
|
675 |
|
|
|
(392 |
) |
|
|
283 |
|
13. Subsequent Event
The State of New Jersey’s Technology Business Tax Certificate Program allows certain high technology and biotechnology companies to sell unused net operating loss (“NOL”) carryforwards and R&D tax credits to other New Jersey-based corporate taxpayers. We have applied for and received preliminary confirmation for our sale of NOLs and R&D tax credits related to the tax years ended December 31, 2015 to 2020 in the amount of approximately $16,176, which we expect to recognize in the second quarter of 2024, upon receipt of the certificates for the refund. Subsequent to March 31, 2024, the Company received the entire $16,176 of expected cash for the NOL and R&D tax credit sales.
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion of our financial condition and results of operations in conjunction with our unaudited condensed consolidated financial statements and the related notes and other financial information included in this Quarterly Report on Form 10-Q and our audited condensed consolidated financial statements and notes thereto as of and for the years ended December 31, 2023 and 2022 and the related “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” including “Contractual Obligations and Commitments” and “Critical Accounting Policies and Estimates,” included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed with the Securities and Exchange Commission, or the SEC, on February 29, 2024. Unless the context requires otherwise, references in this Quarterly Report on Form 10-Q to “we,” “us,” and “our” refer to PMV Pharmaceuticals, Inc.
In addition to historical information, this Quarterly Report on Form 10-Q contains forward-looking statements that involve risks, uncertainties, and assumptions. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of various factors, including but not limited to those set forth under the captions “Special Note Regarding Forward-Looking Statements,” “Item 1A. Risk Factors” and elsewhere in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as updated by our subsequent filings under the Securities Exchange Act of 1934, as amended. Furthermore, past operating results are not necessarily indicative of results that may occur in future periods.
Overview
We are a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53. p53 is a well-defined tumor suppressor protein known as the “guardian of the genome,” and normal, or wild-type, p53 has the ability to eliminate cancer cells. However, mutant p53 proteins can be misfolded and lose their wild-type tumor suppressing function. These p53 mutations are found in approximately half of all cancers. The field of p53 biology was established by our co-founder Dr. Arnold Levine when he discovered the p53 protein in 1979. We have leveraged more than four decades of research experience and developed unique insights into p53 to create a precision oncology platform designed to generate selective, small molecule, tumor-agnostic therapies that structurally correct specific mutant p53 proteins to restore their wild-type function. We are deploying our precision oncology platform to target p53 mutations and other p53-related cancers.
Since our formation in March 2013, we have devoted substantially all of our time and efforts to performing research and development activities and raising capital. We are not profitable and have incurred losses in each year since our inception. During the three months ended March 31, 2024, the Company incurred net losses of $15.3 million. As of March 31, 2024, we had an accumulated deficit of $325.3 million. We do not currently have any product candidates approved for sale, and we continue to incur significant research and development and general administrative expenses related to our operations. We initiated a Phase 1/2 clinical trial, PYNNACLE, in October 2020 for our lead product candidate, PC14586 (rezatapopt). In October 2020, we were granted FDA Fast Track Designation of PC14586 for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation. In July 2023, we concluded our End of Phase 1 meeting with the FDA with alignment on the recommended Phase 2 dose and key elements of the single arm, Phase 2 registrational portion of the PYNNACLE study. In October 2023, we presented our updated Phase 1 clinical data for PC14586 at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics Meeting. We dosed our first patient in the pivotal Phase 2 monotherapy portion of our PYNNACLE trial in the first quarter of 2024. In addition, in December 2022, we opened a separate Phase 1b arm within the existing Phase 1/2 PYNNACLE trial combining PC14586 with KEYTRUDA® (pembrolizumab) in collaboration with Merck and Co. In March 2024, Phase 1 data from the PYNNACLE clinical trial for PC14586 was presented at the 2024 SGO Annual Meeting on Women's Cancer.
We expect that our operating expenses will increase significantly as we advance our product candidates through preclinical and clinical development, seek regulatory approval, and prepare for and, if approved, proceed to commercialization; acquire, discover, validate, and develop additional product candidates; obtain, maintain, protect, and enforce our intellectual property portfolio; and hire additional personnel. Furthermore, we have incurred and will continue to incur additional costs associated with operating as a public company that we did not experience as a private company. We expect to continue to incur significant losses for the foreseeable future.
Our ability to generate product revenue will depend on the successful development, regulatory approval, and eventual commercialization of one or more of our product candidates. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through private or public equity or debt financings, collaborative, or other arrangements with corporate sources, or through other sources of financing. Adequate funding may not be available to us on acceptable terms, or at all. If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, scale back or discontinue the development and commercialization of our product candidates.
We plan to continue to use third-party service providers, including clinical research organizations, or CROs, and contract manufacturing organization, or CMOs, to carry out our preclinical and clinical development and to manufacture and supply the
materials to be used during the development and commercialization of our product candidates. We do not currently have a sales force.
Components of Results of Operations
Revenue
To date, we have not generated any revenue from any sources, including from product sales, and we do not expect to generate any revenue from the sale of products in the foreseeable future. If our development efforts for our product candidates are successful and result in regulatory approval, or license agreements with third parties, we may generate revenue in the future from product sales. However, there can be no assurance as to when we will generate such revenue, if at all.
Operating Expenses
Research and Development Expenses
Our research and development expenses consist primarily of costs incurred to conduct research, such as the discovery and development of our product candidates as well as the development of future product candidates. Research and development expenses include personnel costs, including stock-based compensation expense, third-party contractor services, laboratory materials and supplies, and depreciation and maintenance of research equipment. We expense research and development costs as they are incurred.
We do not allocate our costs by product candidate or development program, as a significant amount of research and development expenses include compensation costs, materials, supplies, depreciation on and maintenance of research equipment, and the cost of services provided by outside contractors, which are not tracked by product candidate or development program. In particular, with respect to internal costs, several of our departments support multiple product candidate research and development programs, and therefore the costs cannot be allocated to a particular product candidate or development program. Substantially all of our research and development costs are associated with our lead product candidate, PC14586 (rezatapopt). We initiated a Phase 1/2 clinical trial in October 2020 for our lead product candidate, PC14586. In October 2020, we were granted FDA Fast Track Designation of PC14586 for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation. In October 2023, we presented our updated Phase 1 clinical data for PC14586 at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics Meeting. We dosed our first patient in the first quarter of 2024 in the registrational, tumor-agnostic PYNNACLE Phase 2 trial of PC14586 in patients with advanced solid tumors harboring a TP53 Y220C mutation and KRAS wild-type (WT). In December 2022, we opened a separate Phase 1b arm within the existing Phase 1/2 PYNNACLE trial combining PC14586 with KEYTRUDA® (pembrolizumab) in collaboration with Merck and Co. In March 2024, Phase 1 data from the PYNNACLE clinical trial for PC14586 was presented at the 2024 SGO Annual Meeting on Women's Cancer.
We expect our research and development expenses to increase substantially in absolute dollars in the future as we advance our product candidates into and through clinical trials and pursue regulatory approval of our product candidates. The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming. The actual probability of success for our product candidates may be affected by a variety of factors including: the safety and efficacy of our product candidates, clinical data, investment in our clinical program, the ability of any future collaborators to successfully develop our licensed product candidates, competition, manufacturing capability, and commercial viability. We may never succeed in achieving regulatory approval for any of our product candidates. As a result of the uncertainties discussed above, we are unable to determine the duration and completion costs of our research and development projects.
General and Administrative Expenses
General and administrative expenses include personnel costs, expenses for outside professional services and other allocated expenses. Personnel costs consist of salaries, bonuses, benefits, and stock-based compensation. Outside professional services consist of legal, accounting and audit services and other consulting fees. Allocated expenses consist of rent expense related to our office and research and development facilities. We also expect to increase our general and administrative expenses as we advance our product candidates through preclinical research and development, manufacturing, clinical development, and commercialization.
Interest Income, Net
Interest income, net primarily consists of interest income from our interest-bearing cash, cash equivalents and marketable securities and interest costs related to accretion and amortization of discounts and premiums on marketable securities.
Results of Operations
Comparison of the Three Months ended March 31, 2024 and 2023.
The following table summarizes our results of operations (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
Statement of operations data: |
|
2024 (Unaudited) |
|
|
2023 (Unaudited) |
|
|
Change |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
13,186 |
|
|
$ |
15,073 |
|
|
$ |
(1,887 |
) |
General and administrative |
|
|
5,035 |
|
|
|
6,407 |
|
|
|
(1,372 |
) |
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
18,221 |
|
|
|
21,480 |
|
|
|
(3,259 |
) |
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(18,221 |
) |
|
|
(21,480 |
) |
|
|
3,259 |
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
Interest income, net |
|
|
2,952 |
|
|
|
2,325 |
|
|
|
627 |
|
Other income (expense), net |
|
|
(1 |
) |
|
|
27 |
|
|
|
(28 |
) |
|
|
|
|
|
|
|
|
|
|
Total other income (expense) |
|
|
2,951 |
|
|
|
2,352 |
|
|
|
599 |
|
|
|
|
|
|
|
|
|
|
|
Loss before (benefit) provision for income taxes |
|
|
(15,270 |
) |
|
|
(19,128 |
) |
|
|
3,858 |
|
(Benefit) provision for income taxes |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(15,270 |
) |
|
$ |
(19,128 |
) |
|
$ |
3,858 |
|
Research and Development Expenses
The following table summarizes our research and development expenses incurred during the periods indicated (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
Statement of operations data: |
|
2024 (Unaudited) |
|
|
2023 (Unaudited) |
|
|
Change |
|
Research |
|
$ |
1,078 |
|
|
$ |
1,538 |
|
|
$ |
(460 |
) |
Development |
|
|
6,788 |
|
|
|
8,838 |
|
|
|
(2,050 |
) |
Personnel related |
|
|
4,345 |
|
|
|
3,434 |
|
|
|
911 |
|
Stock-based compensation |
|
|
975 |
|
|
|
1,263 |
|
|
|
(288 |
) |
Total |
|
$ |
13,186 |
|
|
$ |
15,073 |
|
|
$ |
(1,887 |
) |
Research and development expenses were $13.2 million for the three months ended March 31, 2024, compared to $15.1 million for the three months ended March 31, 2023. The decrease of $1.9 million, compared to the three months ended March 31, 2023, was primarily due to the following:
•$2.5 million decrease in research and development expenses largely driven by decreased contractual research organization costs, offset by
•$0.6 million increase in personnel related costs and stock-based compensation as a result of the non-recurring charges from our reduction in force initiated in January 2024.
General and Administrative Expenses
General and administrative expenses were $5.0 million for the three months ended March 31, 2024, compared to $6.4 million for the three months ended March 31, 2023. The decrease of $1.4 million, compared to the three months ended March 31, 2023, was primarily due to following:
•$0.7 million decrease in facility and equipment expenses due to expiration of three leases, $0.3 million decrease in director and officer insurance fees and legal expenses, and $0.4 million decrease in personnel expenses driven by decrease in headcount.
Interest Income, Net
Interest income, net primarily consists of interest income from our interest-bearing cash, cash equivalents and marketable securities and interest costs related to accretion and amortization of discounts and premiums on marketable securities. Interest income, net was $3.0 million for the three months ended March 31, 2024, compared to $2.4 million for the three months March 31, 2023. The increase of $0.6 million compared to the three months ended March 31, 2023, is driven by increased interest rates from cash and investments in marketable securities and U.S treasuries during the three months ended March 31, 2024.
Liquidity and Capital Resources
Our financial condition is summarized as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of March 31, |
|
|
As of December 31, |
|
|
|
|
|
|
2024 |
|
|
2023 |
|
|
Change |
|
Financial assets: |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
47,654 |
|
|
$ |
37,706 |
|
|
$ |
9,948 |
|
Marketable securities – current |
|
|
150,285 |
|
|
|
165,351 |
|
|
|
(15,066 |
) |
Marketable securities – noncurrent |
|
|
15,120 |
|
|
|
25,505 |
|
|
|
(10,385 |
) |
Total financial assets |
|
$ |
213,059 |
|
|
$ |
228,562 |
|
|
$ |
(15,503 |
) |
|
|
|
|
|
|
|
|
|
|
Working capital: |
|
|
|
|
|
|
|
|
|
Current assets |
|
$ |
202,460 |
|
|
$ |
207,409 |
|
|
$ |
(4,949 |
) |
Current liabilities |
|
|
(12,058 |
) |
|
|
(14,029 |
) |
|
|
1,971 |
|
Total working capital |
|
$ |
190,402 |
|
|
$ |
193,380 |
|
|
$ |
(2,978 |
) |
Sources of Liquidity
Since our inception, we have not generated any revenue from any product sales or any other sources and have incurred significant operating losses and negative cash flows from our operations. We have not yet commercialized any of our product candidates and we do not expect to generate revenue from sales of any product candidates for several years, if at all. As of March 31, 2024, we had cash, cash equivalents and marketable securities of $213.1 million and an accumulated deficit of $325.3 million.
We have a shelf registration statement on Form S-3 on file with the SEC, which registers the offering, issuance, and sale of up to $200 million of various equity and debt securities and up to $150 million of common stock pursuant to our at-the-market equity offering program, dated October 4, 2021, or the ATM Program. During the three months ended March 31, 2024, the Company did not sell any shares of its common stock under the ATM Program. As of March 31, 2024, we have approximately $113.8 million remaining in gross proceeds available for future issuances of common stock under the ATM Program.
Contractual Obligations and Commitments
We enter into contracts in the normal course of business with CROs and other vendors to assist in the performance of our research and development activities and other services and products for operating purposes. These contracts generally provide for termination on notice, and therefore are cancelable contracts and not included in the table of contractual obligations and commitments.
In January 2021, we signed a lease for 50,581 square feet of office and laboratory space at One Research Way in Princeton, New Jersey. That lease term extends through 2032 and has a five-year extension option. Amounts related to future
lease payments as of March 31, 2024, totaled $14.8 million, with $1.4 million, net $0.2 million of cash reimbursements, to be paid within the next 12 months.
Plan of Operation and Future Funding Requirements
We use our capital resources primarily to fund operating expenses, mainly research and development expenditures. On January 18, 2024, we announced a restructuring plan involving the reduction of our workforce by approximately 30% of our employees. We expect the reduction in workforce to be substantially completed by June 30, 2024, and fully completed by the end of the third quarter of 2024. As announced, we are taking these steps in order to streamline operations, reduce costs and preserve capital as we advance our lead candidate, PC14586, into late-stage development. At this time, due to the inherently unpredictable nature of preclinical and clinical development, we cannot reasonably estimate the costs we will incur and the timelines that will be required to complete development, obtain marketing approval and commercialize our current product candidates or any future product candidates, if at all. For the same reasons, we are also unable to predict when, if ever, we will generate revenue from product sales or whether, or when, if ever, we may achieve profitability. Clinical and preclinical development timelines, the probability of success, and development costs can differ materially from expectations. In addition, we cannot forecast which product candidates may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.
Due to our significant research and development expenditures, we have generated substantial operating losses in each period since inception. We have incurred an accumulated deficit of $325.3 million through March 31, 2024. We expect to incur substantial additional losses in the future as we expand our research and development activities. For the three months ended March 31, 2024 and 2023, our cash operating expenditures were $16.2 million and $15.0 million, respectively. Based on our research and development plans, we expect that our cash, cash equivalents and marketable securities as of March 31, 2024 will be sufficient to fund our operations to the end of 2026.
We have based this estimate on assumptions that may prove to be wrong, however, and we could use our capital resources sooner than we expect.
The timing and amount of our operating expenditures will depend largely on:
•the timing and progress of preclinical and clinical development activities;
•the number and scope of preclinical and clinical programs we decide to pursue;
•the timing and amount of milestone payments we may receive under any future collaboration agreements;
•our ability to maintain future licenses and research and development programs and to establish new collaboration and/or in-licensing arrangements;
•the costs involved in prosecuting and enforcing patent and other intellectual property claims;
•the cost and timing of regulatory approvals;
•the costs involved in implementing our announced reduction in force and related reorganization; and
•our efforts to manage our office and laboratory headquarters, enhance operational systems and hire additional personnel to support development of our product candidates and satisfy our obligations as a public company.
Until such time, if ever, as we can generate substantial revenue from product sales, we expect to fund our operations and capital funding needs through equity and/or debt financing. We may also consider entering into collaboration arrangements or selectively partnering for clinical development and commercialization. The sale of additional equity would result in additional dilution to our stockholders. The incurrence of debt financing would result in debt service obligations and the instruments governing such debt could provide for operating and financing covenants that would restrict our operations or our ability to incur additional indebtedness or pay dividends, among other items. If we raise additional funds through governmental funding, collaborations, strategic partnerships and 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 product candidates or grant licenses on terms that may not be favorable to us. If we are not able to secure adequate additional funding, we may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, and/or suspend or curtail planned programs. Any of these actions could materially and adversely affect our business, financial condition, results of operations and prospects.
Cash Flows
The following table summarizes our cash flows for the period indicated (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2024 (Unaudited) |
|
|
2023 (Unaudited) |
|
Cash used in operating activities |
|
$ |
(16,184 |
) |
|
$ |
(15,012 |
) |
Cash provided by (used in) investing activities |
|
|
26,166 |
|
|
|
49,645 |
|
Cash provided by financing activities |
|
|
— |
|
|
|
12 |
|
Impact of exchange rates on cash, cash equivalents, and restricted cash |
|
|
(34 |
) |
|
|
— |
|
Net increase (decrease) in cash and cash equivalents |
|
$ |
9,948 |
|
|
$ |
34,645 |
|
Operating Activities
Net cash used in operating activities for the three months ended March 31, 2024, was $16.2 million, which consisted primarily of net loss of $15.3 million partially offset by non-cash charges of $1.3 million. Changes in our net operating assets decreased operating cash by $2.2 million. The non-cash charges primarily consisted of stock-based compensation of $2.6 million, accretion of discounts on marketable securities of $1.6 million, depreciation of $0.4 million, and non-cash lease income of $0.1 million. The change in our net operating assets and liabilities was primarily due to an increase in prepaid expenses and other assets, a decrease in outstanding payables and an increase in accrued expenses.
Net cash used in operating activities for the three months ended March 31, 2023, was $15.0 million, which consisted primarily of net loss of $19.1 million partially offset by non-cash charges of $2.3 million. Changes in our net operating assets increased operating cash by $1.8 million. The non-cash charges primarily consisted of stock-based compensation of $2.9 million, accretion of discounts on marketable securities of $0.7 million, depreciation of $0.2 million, and non-cash lease expense of $0.1 million. The change in our net operating assets and liabilities was primarily due to a decrease in prepaid expenses and other assets, an increase in accrued expenses, offset by a decrease in outstanding payables.
Investing Activities
Our investing activities provided $26.2 million of cash during the three months ended March 31, 2024, which consisted primarily of maturities of marketable securities of $57.2 million, partially offset by purchases of marketable securities of $30.5 million, along with purchase of property and equipment of $0.6 million.
Our investing activities provided $49.6 million of cash during the three months ended March 31, 2023, which consisted primarily of maturities of marketable securities of $73.3 million, purchases of marketable securities of $23.5 million, along with purchase of property and equipment of $0.2 million.
Financing Activities
For the three months ended March 31, 2024 and 2023, net cash provided by financing activities was zero.
Critical Accounting Policies and Estimates
The preparation of our condensed consolidated financial statements in conformity with accounting principles generally accepted in the United States requires us to make estimates and judgments that affect the amounts reported in those condensed consolidated financial statements and accompanying notes. Although we believe that the estimates we use are reasonable, due to the inherent uncertainty involved in making those estimates, actual results reported in future periods could differ from those estimates.
We believe that the accounting policies described below involve a high degree of judgment and complexity. Accordingly, these are the policies we believe are the most critical to aid in fully understanding and evaluating our financial condition and results of our operations. During the three-month period ended March 31, 2024, there were no material changes to our critical accounting policies from those described in our audited condensed consolidated financial statements for the year ended December 31, 2023, included in our Annual Report on Form 10-K filed with the SEC on February 29, 2024, except as noted below.
Research and Development Costs, Accrued Research and Development Costs and Related Prepaid Expenses
Research and development costs are expensed as incurred. Research and development expenses consist principally of personnel costs, including salaries, stock-based compensation and benefits for employees, third-party license fees and other operational costs related to our research and development activities, including sourcing of raw materials and manufacturing of our product candidates, allocated facility-related expenses and external costs of outside vendors, and other direct and indirect costs. Non-refundable research and development advance payments are deferred and capitalized. The capitalized amounts are expensed as the related goods are delivered or services are performed.
As part of the process of preparing our condensed consolidated financial statements, we are required to estimate our accrued research and development expenses. This process involves reviewing open contracts and purchase orders, communicating with our applicable personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual costs. The majority of our service providers invoice us in arrears for services performed, on a pre-determined schedule or when contractual milestones are met; however, some require advance payments. We make estimates of our accrued expenses as of each balance sheet date in the condensed consolidated financial statements based on facts and circumstances known to us at that time. We periodically confirm the accuracy of the estimates with the service providers and make adjustments if necessary. Examples of estimated accrued research and development expenses include fees paid to:
•vendors, including research laboratories, in connection with preclinical development activities;
•CROs and investigative sites in connection with preclinical studies and clinical trials; and
•CMOs in connection with drug substance and drug product formulation of preclinical studies and clinical trial materials.
We base our expenses related to preclinical studies and clinical trials on our estimates of the services received and efforts expended pursuant to quotes and contracts with multiple research institutions and CROs that supply, conduct and manage preclinical studies and clinical trials on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the expense. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones. In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, we adjust the accrual or the prepaid expense accordingly. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low in any particular period. To date, there have not been any material adjustments to our prior estimates of accrued research and development expenses.
Recent Accounting Pronouncements
For a description of recent accounting pronouncements, see Note 2 of the notes to our unaudited condensed consolidated financial statements for the three months ended March 31, 2024 included elsewhere in this Quarterly Report on Form 10-Q.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
We are exposed to market risks in the ordinary course of our business. These risks primarily relate to interest rate risks.
We had cash, cash equivalents, and marketable securities of $213.1 million and restricted cash of $0.8 million as of March 31, 2024. The Company’s cash equivalents consist of interest-bearing U.S. treasury securities, money market funds, and corporate debt securities. Our exposure due to changes in interest rates is not material due to the nature and amount of our money-market funds and marketable securities.
We are not currently exposed to significant market risk related to changes in foreign currency exchange rates; however, we may contract with foreign vendors that are located outside the United States in the future. This may subject us to fluctuations in foreign currency exchange rates in the future.
Item 4. Controls and Procedures.
We maintain disclosure controls and procedures that are designed to provide reasonable assurance that information required to be disclosed in our Securities Exchange Act of 1934, as amended reports is recorded, processed, summarized and reported within the time periods specified in the SECs rules and forms and that such information is accumulated and
communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow for timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
We carry out a variety of ongoing procedures, under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, to evaluate the effectiveness of the design and operation of our disclosure controls and procedures. Based on the foregoing, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of March 31, 2024.
There have not been any changes in our internal control over financial reporting during our most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
We are not currently involved in any litigation or legal proceedings that, in management’s opinion, are likely to have any material adverse effect on the Company.
Item 1A. Risk Factors.
Other than as described below, there have been no additional material changes to the Company’s risk factors as set forth in Part I, Item 1A of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as filed with the SEC on February 29, 2024. You should carefully review and consider the information regarding certain factors which could materially affect our business, financial condition or future results set forth under the heading “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as filed with the SEC on February 29, 2024.
A portion of our chemistry-based product development and sourcing of certain manufacturing raw materials for our product candidates takes place in China through third-party manufacturers. A significant disruption in the operation of those manufacturers, a trade war or political unrest in China could materially adversely affect our business, financial condition and results of operations.
We currently contract certain product development and manufacturing operations to third parties outside the United States, including in China, and we expect to continue to use such third-party manufacturers for such product candidates. Any disruption in production or inability of our manufacturers in China to produce adequate quantities to meet our needs, whether as a result of a natural disaster or other causes could impair our ability to operate our business on a day-to-day basis and to continue our development of our product candidates. Furthermore, since these manufacturers are located in China, we are exposed to the possibility of product supply disruption and increased costs in the event of changes in the policies of the United States or Chinese governments, political unrest or unstable economic conditions in China. For example, a trade war could lead to tariffs on the chemical intermediates we use that are manufactured in China. Any of these matters could materially adversely affect our business, financial condition and results of operations. Any recall of the manufacturing lots or similar action regarding our product candidates used in clinical trials could delay the trials or detract from the integrity of the trial data and its potential use in future regulatory filings. In addition, manufacturing interruptions or failure to comply with regulatory requirements by any of these manufacturers could significantly delay clinical development of potential products and reduce third-party or clinical researcher interest and support of proposed trials. These interruptions or failures could also impede commercialization of our product candidates and impair our competitive position. Further, we may be exposed to fluctuations in the value of the local currency in China. Future appreciation of the local currency could increase our costs. In addition, our labor costs could continue to rise as wage rates increase due to increased demand for skilled laborers and the availability of skilled labor declines in China.
In addition to the use of tariffs and other traditional trade tools, the U.S. government has made and continues to make significant additional changes in U.S. trade policy and may continue to take future actions that could negatively impact U.S. trade. In particular, the U.S. has made or considered making a broad set of trade-related or security-related policy changes with respect to specific counterparty countries, most significantly China, to create various limitations on cross-border operations. For example, legislation has been introduced in Congress to limit certain U.S. biotechnology companies from using equipment or services produced or provided by select Chinese biotechnology companies, and others in Congress have advocated for the use of existing executive branch authorities to limit those Chinese service providers’ ability to engage in business in the U.S. We cannot predict what actions may ultimately be taken with respect to trade relations between the United States and China or other countries, what products and services may be subject to such actions or what actions may be taken by the other countries in retaliation. If we are unable to obtain or use services from existing service providers or become unable to export or sell our products to any of our customers or service providers, our business, financial condition, and results of operations would be materially adversely affected.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
(a) Unregistered Sales of Equity Securities
None.
(b) Use of Proceeds
Our registration statement on Form S-1 (File No. 333-248627) relating to the IPO was declared effective by the SEC. The IPO closed on September 25, 2020 at which time we sold 13,529,750 shares of common stock (including the exercise in full by the underwriters of their option to purchase an additional 1,764,750 shares of common stock) at a public offering price
of $18.00 per share. We received net proceeds from the IPO of approximately $223.2 million, after deducting the underwriting discounts and commissions of approximately $17.0 million and estimated offering related expenses of approximately $3.3 million. No offering expenses were paid or payable, directly, or indirectly, to our directors, officers, or persons owning 10% or more of any class of equity securities or to our affiliates. Goldman Sachs & Co. LLC, BofA Securities, Cowen, and Evercore ISI acted as joint book-running managers for the offering.
There has been no material change in the planned use of proceeds from the IPO from that described in the prospectus filed with the SEC pursuant to Rule 424(b)(4) under the Securities Act on September 24, 2020.
We have a shelf registration statement on Form S-3 (File No. 333-260012), which was declared effective by the SEC on April 28, 2022. The shelf registration statement consists of (i) a base prospectus pursuant to which we may offer and sell, from time to time, up to $200 million of shares of our common stock, shares of our preferred stock, various series of debt securities and warrants to purchase any of such securities in one or more registered offerings, and (ii) a prospectus supplement pursuant to which we may offer and sell, from time to time, up to $150 million of shares of common stock in "at-the-market" offerings. During the three months ended March 31, 2024, the Company did not sell any shares of its common stock under the ATM Program. As of March 31, 2024, we have approximately $113.8 million remaining in gross proceeds available for future issuances of common stock under the ATM Program. There has been no material change in the planned use of proceeds as described in the shelf registration statement. None of the offering expenses were paid or payable, directly, or indirectly, to our directors, officers, or persons owning 10% or more of any class of equity securities or to our affiliates.
(c) Issuer Purchases of Equity Securities.
None.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
Not applicable.
Item 6. Exhibits.
The certifications attached as Exhibit 32.1 and 32.2 that accompany this Quarterly Report on Form 10-Q are deemed furnished and not filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of the Registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Quarterly Report on Form 10-Q, irrespective of any general incorporation language contained in such filing.
+ Filed herewith.
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.
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PMV Pharmaceuticals, Inc. |
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Date: May 9, 2024 |
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By: |
/s/ David H. Mack |
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David H. Mack, Ph.D. |
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|
President, Chief Executive Officer, and Director |
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(Principal Executive Officer) |
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PMV Pharmaceuticals, Inc. |
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Date: May 9, 2024 |
|
By: |
/s/ Michael Carulli |
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Michael Carulli |
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Chief Financial Officer |
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|
(Principal Financial and Principal Accounting Officer) |
Exhibit 10.4
Updated as of: May 2024
PMV PHARMACEUTICALS, INC.
2020 EMPLOYEE STOCK PURCHASE PLAN
1.Purpose. The purpose of the Plan is to provide employees of the Company and its Designated Companies with an opportunity to purchase Common Stock through accumulated Contributions. The Company intends for the Plan to have two components: a component that is intended to qualify as an “employee stock purchase plan” under Section 423 of the Code (the “423 Component”) and a component that is not intended to qualify as an “employee stock purchase plan” under Section 423 of the Code (the “Non-423 Component”). The provisions of the 423 Component, accordingly, will be construed so as to extend and limit Plan participation in a uniform and nondiscriminatory basis consistent with the requirements of Section 423 of the Code. An option to purchase shares of Common Stock under the Non-423 Component will be granted pursuant to rules, procedures, or sub-plans adopted by the Administrator designed to achieve tax, securities laws, or other objectives for Eligible Employees and the Company. Except as otherwise provided herein or by the Administrator, the Non-423 Component will operate and be administered in the same manner as the 423 Component.
(a)“Administrator” means the Board or any Committee designated by the Board to administer the Plan pursuant to Section 14.
(b)“Affiliate” means any entity, other than a Subsidiary, in which the Company has an equity or other ownership interest.
(c)“Applicable Laws” means the legal and regulatory requirements relating to the administration of equity-based awards, including but not limited to the related issuance of shares of Common Stock, including but not limited to, under U.S. federal and state corporate laws, U.S. federal and state securities laws, the Code, any stock exchange or quotation system on which the Common Stock is listed or quoted and the applicable laws of any non-U.S. country or jurisdiction where options are, or will be, granted under the Plan.
(d)“Board” means the Board of Directors of the Company.
(e)“Change in Control” means the occurrence of any of the following events:
(i)A change in the ownership of the Company which occurs on the date that any one person, or more than one person acting as a group (“Person”), acquires ownership of the stock of the Company that, together with the stock held by such Person, constitutes more than fifty percent (50%) of the total voting power of the stock of the Company; provided, however, that for purposes of this subsection, the acquisition of additional stock by any one Person, who is considered to own more than fifty percent (50%) of the total voting power of the stock of the Company will not be considered a Change in Control. Further, if the stockholders of the Company immediately before such change in ownership continue to retain immediately after the change in ownership, in substantially the same proportions as their ownership of shares of the Company’s voting stock
immediately prior to the change in ownership, direct or indirect beneficial ownership of fifty percent (50%) or more of the total voting power of the stock of the Company or of the ultimate parent entity of the Company, such event shall not be considered a Change in Control under this subsection (i). For this purpose, indirect beneficial ownership shall include, without limitation, an interest resulting from ownership of the voting securities of one or more corporations or other business entities which own the Company, as the case may be, either directly or through one or more subsidiary corporations or other business entities; or
(i)A change in the effective control of the Company which occurs on the date that a majority of members of the Board is replaced during any twelve (12)month period by Directors whose appointment or election is not endorsed by a majority of the members of the Board prior to the date of the appointment or election. For purposes of this subsection (ii), if any Person is considered to be in effective control of the Company, the acquisition of additional control of the Company by the same Person will not be considered a Change in Control; or
(ii)A change in the ownership of a substantial portion of the Company’s assets which occurs on the date that any Person acquires (or has acquired during the twelve (12)-month period ending on the date of the most recent acquisition by such Person) assets from the Company that have a total gross fair market value equal to or more than fifty percent (50%) of the total gross fair market value of all of the assets of the Company immediately prior to such acquisition or acquisitions; provided, however, that for purposes of this subsection (iii), the following will not constitute a change in the ownership of a substantial portion of the Company’s assets: (A) a transfer to an entity that is controlled by the Company’s stockholders immediately after the transfer, or (B) a transfer of assets by the Company to: (1) a stockholder of the Company (immediately before the asset transfer) in exchange for or with respect to the Company’s stock, (2) an entity, fifty percent (50%) or more of the total value or voting power of which is owned, directly or indirectly, by the Company, (3) a Person, that owns, directly or indirectly, fifty percent (50%) or more of the total value or voting power of all the outstanding stock of the Company, or (4) an entity, at least fifty percent (50%) of the total value or voting power of which is owned, directly or indirectly, by a Person described in this subsection (iii)(B)(3). For purposes of this subsection (iii), gross fair market value means the value of the assets of the Company, or the value of the assets being disposed of, determined without regard to any liabilities associated with such assets.
For purposes of this definition, persons will be considered to be acting as a group if they are owners of a corporation that enters into a merger, consolidation, purchase, or acquisition of stock, or similar business transaction with the Company.
Notwithstanding the foregoing, a transaction will not be deemed a Change in Control unless the transaction qualifies as a change in control event within the meaning of Section 409A.
Further and for the avoidance of doubt, a transaction will not constitute a Change in Control if: (i) its sole purpose is to change the jurisdiction of the Company’s incorporation, or (ii) its sole purpose is to create a holding company that will be owned in substantially the same proportions by the persons who held the Company’s securities immediately before such transaction.
(b)“Code” means the U.S. Internal Revenue Code of 1986, as amended. Reference to a specific section of the Code or U.S. Treasury Regulation thereunder will include such section or regulation, any valid regulation or other official applicable guidance promulgated under such section, and any comparable provision of any future legislation or regulation amending, supplementing or superseding such section or regulation.
(c)“Committee” means a committee of the Board appointed in accordance with Section 14 hereof.
(d)“Common Stock” means the common stock of the Company.
(e)“Company” means PMV Pharmaceuticals, Inc., a Delaware corporation, or any successor thereto.
(f)“Compensation” includes an Eligible Employee’s base straight time gross earnings but excludes payments for commissions, incentive compensation, bonuses, payments for overtime and shift premium, equity compensation income and other similar compensation. The Administrator, in its discretion, may, on a uniform and nondiscriminatory basis, establish a different definition of Compensation for a subsequent Offering Period. Further, the Administrator shall have discretion to determine the application of this definition to Participants outside the United States.
(g)“Contributions” means the payroll deductions and other additional payments that the Company may permit to be made by a Participant to fund the exercise of options granted pursuant to the Plan.
(h)“Designated Company” means any Subsidiary or Affiliate that has been designated by the Administrator from time to time in its sole discretion as eligible to participate in the Plan. For purposes of the 423 Component, only the Company and its Subsidiaries may be Designated Companies, provided, however that at any given time, a Subsidiary that is a Designated Company under the 423 Component will not be a Designated Company under the Non-423 Component.
(i)“Director” means a member of the Board.
(j)“Eligible Employee” means any individual who is a common law employee providing services to the Company or a Designated Company and is customarily employed for at least twenty (20) hours per week and more than five (5) months in any calendar year by the Employer, or any lesser number of hours per week and/or number of months in any calendar year established by the Administrator (if required under Applicable Laws) for purposes of any separate Offering or for Participants in the Non-423 Component. For purposes of the Plan, the employment relationship will be treated as continuing intact while the individual is on sick leave or other leave of absence that the Employer approves or is legally protected under Applicable Laws with respect to the Participant’s participation in the Plan. Where the period of leave exceeds three (3) months and the individual’s right to reemployment is not guaranteed either by statute or by contract, the employment relationship will be deemed to have terminated three (3) months and one (1) day following the commencement of such leave. The Administrator, in its discretion, from time to time
may, prior to an Enrollment Date for all options to be granted on such Enrollment Date in an Offering, determine (for each Offering under the 423 Component, on a uniform and nondiscriminatory basis or as otherwise permitted by U.S. Treasury Regulation Section 1.423-2) that the definition of Eligible Employee will or will not include an individual if he or she: (i) has not completed at least two (2) years of service since his or her last hire date (or such lesser period of time as may be determined by the Administrator in its discretion), (ii) customarily works not more than twenty (20) hours per week (or such lesser period of time as may be determined by the Administrator in its discretion), (iii) customarily works not more than five (5) months per calendar year (or such lesser period of time as may be determined by the Administrator in its discretion),
(iv) is a highly compensated employee within the meaning of Section 414(q) of the Code, or (v) is a highly compensated employee within the meaning of Section 414(q) of the Code with compensation above a certain level or is an officer or subject to the disclosure requirements of Section 16(a) of the Exchange Act, provided the exclusion is applied with respect to each Offering under the 423 Component in an identical manner to all highly compensated individuals of the Employer whose employees are participating in that Offering. Each exclusion will be applied with respect to an Offering under the 423 Component in a manner complying with U.S. Treasury Regulation Section 1.423-2(e)(2)(ii). Such exclusions may be applied with respect to an Offering under the Non- 423 Component without regard to the limitations of U.S. Treasury Regulation Section 1.423-2.
(k)“Employer” means the employer of the applicable Eligible Employee(s).
(l)“Enrollment Date” means the first Trading Day of each Offering Period.
(m)“Exchange Act” means the U.S. Securities Exchange Act of 1934, as amended, including the rules and regulations promulgated thereunder.
(n)“Exercise Date” means the first Trading Day on or after May 20 and November 20 of each Purchase Period. Notwithstanding the foregoing, the first Exercise Date under the Plan will be the first Trading Day on or after May 20, 2021. Notwithstanding the foregoing, in the event that an Offering Period is terminated prior to its expiration pursuant to Section 19, the Administrator, in its sole discretion, may determine that such Offering Period will terminate without options being exercised on the Exercise Date that otherwise would have occurred on the last Trading Day of such Purchase Period.
(o)“Fair Market Value” means, as of any date and unless the Administrator determines otherwise, the value of a share of Common Stock determined as follows:
(i)For purposes of the Enrollment Date of the first Offering Period under the Plan, the Fair Market Value will be the initial price to the public as set forth in the final prospectus included within the Registration Statement.
(ii)For all other purposes, the Fair Market Value will be the closing sales price for Common Stock as quoted on any established stock exchange or national market system (including without limitation the New York Stock Exchange, Nasdaq Global Select Market, the Nasdaq Global Market or the Nasdaq Capital Market of The Nasdaq Stock Market) on which the Common Stock is listed on the date of determination (or the closing bid, if no sales were reported),
as reported in The Wall Street Journal or such other source as the Administrator deems reliable. If the determination date for the Fair Market Value occurs on a non-trading day (i.e., a weekend or holiday), the Fair Market Value will be such price on the immediately preceding trading day, unless otherwise determined by the Administrator. In the absence of an established market for the Common Stock, the Fair Market Value thereof will be determined in good faith by the Administrator; or
(iii)In the absence of an established market for the Common Stock, the Fair Market Value thereof will be determined in good faith by the Administrator.
The determination of fair market value for purposes of tax withholding may be made in the Administrator’s discretion subject to Applicable Laws and is not required to be consistent with the determination of Fair Market Value for other purposes.
(p)“Fiscal Year” means the fiscal year of the Company.
(q)“New Exercise Date” means a new Exercise Date if the Administrator shortens any Offering Period then in progress.
(r)“Offering” means an offer under the Plan of an option that may be exercised during an Offering Period as further described in Section 4. For purposes of the Plan, the Administrator may designate separate Offerings under the Plan (the terms of which need not be identical) in which Eligible Employees of one or more Employers will participate, even if the dates of the applicable Offering Periods of each such Offering are identical and the provisions of the Plan will separately apply to each Offering. To the extent permitted by U.S. Treasury Regulation Section 1.423-2(a)(1), the terms of each Offering need not be identical provided that the terms of the Plan and an Offering together satisfy U.S. Treasury Regulation Section 1.423-2(a)(2) and (a)(3).
(s)“Offering Periods” means the consecutive periods of approximately six (6) months during which an option granted pursuant to the Plan may be exercised, commencing on the first Trading Day on or after May 20 and November 20 of each year and terminating on the first Trading Day on or after November 20 and May 20, approximately six (6) months later; provided, however, that the first Offering Period under the Plan will commence with the first Trading Day on or after the date on which the Securities and Exchange Commission declares the Company’s Registration Statement effective and will end on the first Trading Day on or after May 20, 2021, and provided, further, that the second Offering Period under the Plan will commence on the first Trading Day on or after May 20, 2021. The duration and timing of Offering Periods may be changed pursuant to Sections 4, 20 and 30.
(t)“Parent” means a “parent corporation,” whether now or hereafter existing, as defined in Section 424(e) of the Code.
(u)“Participant” means an Eligible Employee who participates in the Plan.
(v)“Plan” means this PMV Pharmaceuticals, Inc. 2020 Employee Stock Purchase
Plan.
(aa) “Purchase Period” means the period during an Offering Period during which shares of Common Stock may be purchased on a Participant’s behalf in accordance with the terms of the Plan. For the first Offering Period, the Purchase Period will commence on the first Trading Day on or after the Registration Date and terminate on the first Trading Day on or after May 20, 2021. Unless the Administrator provides otherwise, Purchase Periods for all other Offering Periods will commence on the first Trading Day of the Offering Period and terminate on the last Trading Day of the Offering Period.
(bb) “Purchase Price” means an amount equal to eighty-five percent (85%) of the Fair Market Value of a share of Common Stock on the Enrollment Date or on the Exercise Date, whichever is lower; provided however, that the Purchase Price may be determined for subsequent Offering Periods by the Administrator subject to compliance with Section 423 of the Code (or any successor rule or provision or any other Applicable Law, regulation or stock exchange rule) or pursuant to Section 20.
(cc) “Registration Date” means the effective date of the first registration statement that is filed by the Company and declared effective pursuant to Section 12(b) of the Exchange Act, with respect to any class of the Company’s securities (the “Registration Statement”).
(dd) “Section 409A” means Section 409A of the Code and the regulations and guidance thereunder, and formal, effective guidance of either general applicability or direct applicability thereunder, and any applicable state law equivalent, as each may be promulgated, amended or modified from time to time.
(ee) “Subsidiary” means a “subsidiary corporation,” whether now or hereafter existing, as defined in Section 424(f) of the Code.
(ff) “Trading Day” means a day that the primary stock exchange (or national market system, or other trading platform, as applicable) upon which the Common Stock is listed is open for trading.
(gg) “U.S. Treasury Regulations” means the Treasury Regulations of the Code. Reference to a specific Treasury Regulation or Section of the Code shall include such Treasury Regulation or Section, any valid regulation promulgated under such Section, and any comparable provision of any future legislation or regulation amending, supplementing or superseding such Section or regulation.
(a)First Offering Period. Any individual who is an Eligible Employee immediately prior to the first Offering Period automatically will be enrolled in the first Offering Period, subject to the requirements of Section 5.
(b)Subsequent Offering Periods. Any Eligible Employee on a given Enrollment Date subsequent to the first Offering Period will be eligible to participate in the Plan, subject to the requirements of Section 5.
(c)Non-U.S. Employees. Eligible Employees who are citizens or residents of a non-U.S. jurisdiction (without regard to whether they also are citizens or residents of the United States or
resident aliens (within the meaning of Section 7701(b)(1)(A) of the Code)) may be excluded from participation in the Plan or an Offering if the participation of such Eligible Employees is prohibited under the laws of the applicable jurisdiction or if complying with the laws of the applicable jurisdiction would cause the Plan or an Offering to violate Section 423 of the Code. In the case of the Non-423 Component, an Eligible Employee may be excluded from participation in the Plan or an Offering if the Administrator has determined that participation of such Eligible Employee is not advisable or practicable.
(d)Limitations. Any provisions of the Plan to the contrary notwithstanding, no Eligible Employee will be granted an option under the Plan (i) to the extent that, immediately after the grant, such Eligible Employee (or any other person whose stock would be attributed to such Eligible Employee pursuant to Section 424(d) of the Code) would own capital stock of the Company or any Parent or Subsidiary of the Company and/or hold outstanding options to purchase such stock possessing five percent (5%) or more of the total combined voting power or value of all classes of the capital stock of the Company or of any Parent or Subsidiary of the Company, or (ii) to the extent that his or her rights to purchase stock under all employee stock purchase plans (as defined in Section 423 of the Code) of the Company or any Parent or Subsidiary of the Company accrues at a rate, which exceeds twenty-five thousand dollars ($25,000) worth of stock (determined at the Fair Market Value of the stock at the time such option is granted) for each calendar year in which such option is outstanding at any time, as determined in accordance with Section 423 of the Code and the regulations thereunder.
3.Offering Periods. The Plan will be implemented by consecutive Offering Periods with a new Offering Period commencing on the first Trading Day on or after May 20 and November 20 each year, or on such other date(s) as the Administrator will determine; provided, however, that the first Offering Period under the Plan will commence with the first Trading Day on or after the Registration Date and end on the first Trading Day on or after May 20, 2021. The Administrator will have the power to change the duration of Offering Periods (including the commencement dates thereof) with respect to future Offerings without stockholder approval if such change is announced prior to the scheduled beginning of the first Offering Period to be affected thereafter; provided, however, that no Offering Period may last more than twenty-seven (27) months.
(a)First Offering Period. An Eligible Employee will be entitled to continue to participate in the first Offering Period pursuant to Section 3(a) only if such individual submits a subscription agreement authorizing Contributions in a form determined by the Administrator (which may be similar to the form attached hereto as Exhibit A) to the Company’s designated plan administrator (i) no earlier than the effective date of the Form S-8 registration statement with respect to the issuance of Common Stock under this Plan and (ii) with respect to the first Offering Period, no later than ten (10) business days following the effective date of such Form S-8 registration statement or such other date as the Administrator may determine (the “Enrollment Window”). An Eligible
Employee’s failure to submit the subscription agreement during the Enrollment Window will result in the automatic termination of such individual’s participation in the first Offering Period.
(b)Subsequent Offering Periods. An Eligible Employee may participate in the Plan pursuant to Section 3(b) by (i) submitting to the Company’s stock administration office (or its designee) a properly completed subscription agreement authorizing Contributions in the form provided by the Administrator for such purpose, or (ii) following an electronic or other enrollment procedure determined by the Administrator, in either case, on or before a date determined by the Administrator prior to an applicable Enrollment Date.
(a)At the time a Participant enrolls in the Plan pursuant to Section 5, he or she will elect to have Contributions (in the form of payroll deductions or otherwise, to the extent permitted by the Administrator) made on each pay day during the Offering Period in an amount not exceeding fifteen percent (15%) of the Compensation, which he or she receives on each pay day during the Offering Period; provided, however, that should a pay day occur on an Exercise Date, a Participant will have any Contributions made on such day applied to his or her account under the then-current Purchase Period or Offering Period with respect to which that Exercise Date relates. The Administrator, in its sole discretion, may permit all Participants in a specified Offering to contribute amounts to the Plan through payment by cash, check or other means set forth in the subscription agreement prior to each Exercise Date of each Purchase Period. A Participant’s subscription agreement will remain in effect for successive Offering Periods unless terminated as provided in Section 10 hereof.
(b)In the event Contributions are made in the form of payroll deductions, such payroll deductions for a Participant will commence on the first pay day following the Enrollment Date and will end on the last pay day on or prior to the last Exercise Date of such Offering Period to which such authorization is applicable, unless sooner terminated by the Participant as provided in Section 10 hereof; provided, however, that for the first Offering Period, payroll deductions will commence on the first pay day on or following the end of the Enrollment Window.
(c)All Contributions made for a Participant will be credited to his or her account under the Plan and Contributions will be made in whole percentages of his or her Compensation only. A Participant may not make any additional payments into such account.
(d)A Participant may discontinue his or her participation in the Plan as provided under Section 10. Until and unless determined otherwise by the Administrator, in its sole discretion, during any Purchase Period, a Participant may not increase the rate of his or her Contributions and may only decrease the rate of his or her Contributions one (1) time. A Participant may make a Contribution rate adjustment pursuant to this subsection (d) by (i) properly completing and submitting to the Company’s stock administration office (or its designee), a new subscription agreement authorizing the change in Contribution rate in the form provided by the Administrator for such purpose, or (ii) following an electronic or other procedure prescribed by the Administrator, in either case, on or before a date determined by the Administrator prior to (x) the scheduled beginning of the first Offering Period to be affected or (y) an applicable Exercise Date, as applicable. If a
Participant has not followed such procedures to change the rate of Contributions, the rate of his or her Contributions will continue at the originally elected rate throughout the Purchase Period and future Offering Periods and Purchase Periods (unless the Participant’s participation is terminated as provided in Sections 10 or 11). The Administrator may, in its sole discretion, limit or amend the nature and/or number of Contribution rate changes (including to permit, prohibit and/or limit increases and/or decreases to rate changes) that may be made by Participants during any Offering Period or Purchase Period, and may establish such other conditions or limitations as it deems appropriate for Plan administration. Any change in the rate of Contributions made pursuant to this Section 6(d) will be effective as of the first full payroll period following five (5) business days after the date on which the change is made by the Participant (unless the Administrator, in its sole discretion, elects to process a given change in payroll deduction rate more quickly).
(e)Notwithstanding the foregoing, to the extent necessary to comply with Section 423(b)(8) of the Code and Section 3(d), a Participant’s Contributions may be decreased to zero percent (0%) by the Administrator at any time during a Purchase Period. Subject to Section 423(b)(8) of the Code and Section 3(d) hereof, Contributions will recommence at the rate originally elected by the Participant effective as of the beginning of the first Purchase Period scheduled to end in the following calendar year, unless terminated by the Participant as provided in Section 10.
(f)Notwithstanding any provisions to the contrary in the Plan, the Administrator may allow Participants to participate in the Plan via cash contributions instead of payroll deductions if (i) payroll deductions are not permitted or advisable under Applicable Laws, (ii) the Administrator determines that cash contributions are permissible under Section 423 of the Code; or (iii) the Participants are participating in the Non-423 Component.
(g)At the time the option is exercised, in whole or in part, or at the time some or all of the Common Stock issued under the Plan is disposed of (or any other time that a taxable event related to the Plan occurs), the Participant must make adequate provision for the Company’s or Employer’s federal, state, local or any other tax liability payable to any authority including taxes imposed by jurisdictions outside of the U.S., national insurance, social security or other tax withholding or payment on account obligations, if any, which arise upon the exercise of the option or the disposition of the Common Stock (or any other time that a taxable event related to the Plan occurs). At any time, the Company or the Employer may, but will not be obligated to, withhold from the Participant’s compensation the amount necessary for the Company or the Employer to meet applicable withholding obligations, including any withholding required to make available to the Company or the Employer any tax deductions or benefits attributable to sale or early disposition of Common Stock by the Eligible Employee. In addition, the Company or the Employer may, but will not be obligated to, withhold from the proceeds of the sale of Common Stock or any other method of withholding the Company or the Employer deems appropriate to the extent permitted by U.S. Treasury Regulation Section 1.423-2(f).
6.Grant of Option. On the Enrollment Date of each Offering Period, each Eligible Employee participating in such Offering Period will be granted an option to purchase on each Exercise Date during such Offering Period (at the applicable Purchase Price) up to a number of shares of Common Stock determined by dividing such Eligible Employee’s Contributions accumulated prior to such Exercise Date and retained in the Eligible Employee’s account as of the
Exercise Date by the applicable Purchase Price; provided that in no event will an Eligible Employee be permitted to purchase during each Purchase Period more than 25,000 shares of Common Stock (subject to any adjustment pursuant to Section 18, but only with respect to adjustments occurring after the Registration Date) and provided further that such purchase will be subject to the limitations set forth in Sections 3(d) and 13 and in the subscription agreement. The Eligible Employee may accept the grant of such option (i) with respect to the first Offering Period by submitting a properly completed subscription agreement in accordance with the requirements of Section 5 on or before the last day of the Enrollment Window, and (ii) with respect to any subsequent Offering Period under the Plan, by electing to participate in the Plan in accordance with the requirements of Section 5. The Administrator may, for future Offering Periods, increase or decrease, in its absolute discretion, the maximum number of shares of Common Stock that an Eligible Employee may purchase during each Purchase Period and/or Offering Period, as applicable. Exercise of the option will occur as provided in Section 8, unless the Participant has withdrawn pursuant to Section 10 (or Participant’s participation is terminated as provided in Section 11). The option will expire on the last day of the Offering Period.
(a)Unless a Participant withdraws from the Plan as provided in Section 9 (or Participant’s participation is terminated as provided in Section 11), his or her option for the purchase of shares of Common Stock will be exercised automatically on each Exercise Date, and the maximum number of full shares of Common Stock subject to the option will be purchased for such Participant at the applicable Purchase Price with the accumulated Contributions from his or her account. No fractional shares of Common Stock will be purchased; any Contributions accumulated in a Participant’s account, which are not sufficient to purchase a full share will be retained in the Participant’s account for the subsequent Purchase Period or Offering Period, as applicable, subject to earlier withdrawal by the Participant as provided in Section 9 (or the earlier termination of Participant’s participation as provided in Section 11). Any other funds left over in a Participant’s account after the Exercise Date will be returned to the Participant. During a Participant’s lifetime, a Participant’s option to purchase shares of Common Stock hereunder is exercisable only by him or her.
(b)If the Administrator determines that, on a given Exercise Date, the number of shares of Common Stock with respect to which options are to be exercised may exceed (i) the number of shares of Common Stock that were available for sale under the Plan on the Enrollment Date of the applicable Offering Period, or (ii) the number of shares of Common Stock available for sale under the Plan on such Exercise Date, the Administrator may in its sole discretion (x) provide that the Company will make a pro rata allocation of the shares of Common Stock available for purchase on such Enrollment Date or Exercise Date, as applicable, in as uniform a manner as will be practicable and as it will determine in its sole discretion to be equitable among all Participants exercising options to purchase Common Stock on such Exercise Date, and continue all Offering Periods then in effect or (y) provide that the Company will make a pro rata allocation of the shares of Common Stock available for purchase on such Enrollment Date or Exercise Date, as applicable, in as uniform a manner as will be practicable and as it will determine in its sole discretion to be equitable among all participants exercising options to purchase Common Stock on such Exercise Date, and terminate any or all Offering Periods then in effect pursuant to Section 20. The Company
may make a pro rata allocation of the shares of Common Stock available on the Enrollment Date of any applicable Offering Period pursuant to the preceding sentence, notwithstanding any authorization of additional shares of Common Stock for issuance under the Plan by the Company’s stockholders subsequent to such Enrollment Date.
8.Delivery. As soon as reasonably practicable after each Exercise Date on which a purchase of shares of Common Stock occurs, the Company will arrange the delivery to each Participant of the shares purchased upon exercise of his or her option in a form determined by the Administrator (in its sole discretion) and pursuant to rules established by the Administrator. The Company may permit or require that shares be deposited directly with a broker designated by the Company or with a trustee or designated agent of the Company, and the Company may utilize electronic or automated methods of share transfer. The Company may require that shares be retained with such broker, trustee or agent for a designated period of time and/or may establish other procedures to permit tracking of disqualifying dispositions or other dispositions of such shares. No Participant will have any voting, dividend, or other stockholder rights with respect to shares of Common Stock subject to any option granted under the Plan until such shares have been purchased and delivered to the Participant as provided in this Section 9.
(a)A Participant may withdraw all but not less than all the Contributions credited to his or her account and not yet used to exercise his or her option under the Plan at any time by
(i) submitting to the Company’s stock administration office (or its designee) a written notice of withdrawal in the form determined by the Administrator for such purpose (which may be similar to the form attached hereto as Exhibit B), or (ii) following an electronic or other withdrawal procedure determined by the Administrator. The Administrator may set forth a deadline of when a withdrawal must occur to be effective prior to a given Exercise Date in accordance with policies it may approve from time to time. All of the Participant’s Contributions credited to his or her account will be paid to such Participant as soon as administratively practicable after receipt of notice of withdrawal and such Participant’s option for the Offering Period will be automatically terminated, and no further Contributions for the purchase of shares will be made for such Offering Period. If a Participant withdraws from an Offering Period, Contributions will not resume at the beginning of the succeeding Offering Period, unless the Participant re-enrolls in the Plan in accordance with the provisions of Section 5.
(b)A Participant’s withdrawal from an Offering Period will not have any effect upon his or her eligibility to participate in any similar plan that may hereafter be adopted by the Company or in succeeding Offering Periods that commence after the termination of the Offering Period from which the Participant withdraws.
10.Termination of Employment. Upon a Participant’s ceasing to be an Eligible Employee, for any reason, he or she will be deemed to have elected to withdraw from the Plan and the Contributions credited to such Participant’s account during the Offering Period but not yet used to purchase shares of Common Stock under the Plan will be returned to such Participant, or, in the case of his or her death, to the person or persons entitled thereto, and such Participant’s option will be automatically terminated. Unless otherwise provided by the Administrator, a Participant whose
employment transfers between entities through a termination with an immediate rehire (with no break in service) by the Company or a Designated Company will not be treated as terminated under the Plan. The Administrator may establish rules to govern transfers of employment among the Company and any Designated Company, consistent with any applicable requirements of Section 423 of the Code and the terms of the Plan. In addition, the Administrator may establish rules to govern transfers of employment among the Company and any Designated Company where such companies are participating in separate Offerings under the Plan. However, if a Participant transfers from an Offering under the 423 Component to the Non-423 Component, the exercise of the option will be qualified under the 423 Component only to the extent it complies with Section 423 of the Code, unless otherwise provided by the Administrator.
11.Interest. No interest will accrue on the Contributions of a participant in the Plan, except as may be required by Applicable Law, as determined by the Company, and if so required by the laws of a particular jurisdiction, will apply to all Participants in the relevant Offering under the
423 Component, except to the extent otherwise permitted by U.S. Treasury Regulation Section 1.423-2(f).
(a)Subject to adjustment upon changes in capitalization of the Company as provided in Section 18 hereof, the maximum number of shares of Common Stock that will be made available for sale under the Plan will be 2,110,000 shares of Common Stock. The number of shares of Common Stock available for issuance under the Plan will be increased on the first day of each Fiscal Year beginning with the 2021 Fiscal Year equal to the least of (i) 4,220,000 shares of Common Stock, (ii) one percent (1%) of the outstanding shares of Common Stock on the last day of the immediately preceding Fiscal Year, or (iii) an amount determined by the Administrator no later than the last day of the immediately preceding Fiscal Year. The shares of Common Stock may be authorized, but unissued, or reacquired Common Stock.
(b)Until the shares of Common Stock are issued (as evidenced by the appropriate entry on the books of the Company or of a duly authorized transfer agent of the Company), a Participant will have only the rights of an unsecured creditor with respect to such shares, and no right to vote or receive dividends or any other rights as a stockholder will exist with respect to such shares.
(c)Shares of Common Stock to be delivered to a Participant under the Plan will be registered in the name of the Participant or, if so required under Applicable Laws, in the name of the Participant and his or her spouse.
13.Administration. The Plan will be administered by the Board or a Committee appointed by the Board, which Committee will be constituted to comply with Applicable Laws. The Administrator will have full and exclusive discretionary authority to construe, interpret and apply the terms of the Plan, to delegate ministerial duties to any of the Company’s employees, to designate separate Offerings under the Plan, to designate Subsidiaries and Affiliates as participating in the 423 Component or Non-423 Component, to determine eligibility, to adjudicate all disputed claims filed under the Plan and to establish such procedures that it deems necessary or advisable for the
administration of the Plan (including, without limitation, to adopt such procedures, sub-plans, and appendices to the enrollment agreement as are necessary or appropriate to permit the participation in the Plan by employees who are foreign nationals or employed outside the U.S., the terms of which rules, procedures, sub-plans and appendices may take precedence over other provisions of this Plan, with the exception of Section 13(a) hereof, but unless otherwise superseded by the terms of such rules, procedures, sub-plan or appendix, the provisions of this Plan will govern the operation of such rules, procedure, sub-plan or appendix). Unless otherwise determined by the Administrator, the Eligible Employees eligible to participate in each sub-plan will participate in a separate Offering under the 423 Component, or if the terms would not qualify under the 423 Component, in the Non- 423 Component, in either case unless such designation would cause the 423 Component to violate the requirements of Section 423 of the Code. Without limiting the generality of the foregoing, the Administrator is specifically authorized to adopt rules and procedures regarding eligibility to participate, the definition of Compensation, handling of Contributions, making of Contributions to the Plan (including, without limitation, in forms other than payroll deductions), establishment of bank or trust accounts to hold Contributions, payment of interest, conversion of local currency, obligations to pay payroll tax, determination of beneficiary designation requirements, withholding procedures and handling of stock certificates that vary with applicable local requirements. The Administrator also is authorized to determine that, to the extent permitted by U.S. Treasury Regulation Section 1.423-2(f), the terms of an option granted under the Plan or an Offering to citizens or residents of a non-U.S. jurisdiction will be less favorable than the terms of options granted under the Plan or the same Offering to employees resident solely in the U.S. Every finding, decision, and determination made by the Administrator will, to the full extent permitted by law, be final and binding upon all parties.
14. Transferability. Neither Contributions credited to a Participant’s account nor any rights with regard to the exercise of an option or to receive shares of Common Stock under the Plan may be assigned, transferred, pledged or otherwise disposed of in any way (other than by will or the laws of descent and distribution) by the Participant. Any such attempt at assignment, transfer, pledge or other disposition will be without effect, except that the Company may treat such act as an election to withdraw funds from an Offering Period in accordance with Section 10 hereof.
15.Use of Funds. The Company may use all Contributions received or held by it under the Plan for any corporate purpose, and the Company will not be obligated to segregate such Contributions except under Offerings or for Participants in the Non-423 Component for which Applicable Laws require that Contributions to the Plan by Participants be segregated from the Company’s general corporate funds and/or deposited with an independent third party, provided that, if such segregation or deposit with an independent third party is required by Applicable Laws, it will apply to all Participants in the relevant Offering under the 423 Component, except to the extent otherwise permitted by U.S. Treasury Regulation Section 1.423-2(f). Until shares of Common Stock are issued, Participants will only have the rights of an unsecured creditor with respect to such shares.
16.Reports. Individual accounts will be maintained for each Participant in the Plan. Statements of account will be given to participating Eligible Employees at least annually, which statements will set forth the amounts of Contributions, the Purchase Price, the number of shares of Common Stock purchased and the remaining cash balance, if any.
17.Adjustments, Dissolution, Liquidation, Merger or Change in Control.
(a)Adjustments. In the event that any dividend or other distribution (whether in the
form of cash, Common Stock, other securities, or other property), recapitalization, stock split, reverse stock split, reorganization, merger, consolidation, split-up, spin-off, combination, reclassification, repurchase, or exchange of Common Stock or other securities of the Company, or other change in the corporate structure of the Company affecting the Common Stock occurs (other than any ordinary dividends or other ordinary distributions), the Administrator, in order to prevent diminution or enlargement of the benefits or potential benefits intended to be made available under the Plan, will, in such manner as it may deem equitable, adjust the number and class of Common Stock that may be delivered under the Plan, the Purchase Price per share, the class and the number of shares of Common Stock covered by each option under the Plan that has not yet been exercised, and the numerical limits of Sections 7 and 13.
(b)Dissolution or Liquidation. In the event of the proposed dissolution or liquidation of the Company, any Offering Period then in progress will be shortened by setting a New Exercise Date, and will terminate immediately prior to the consummation of such proposed dissolution or liquidation, unless provided otherwise by the Administrator. The New Exercise Date will be before the date of the Company’s proposed dissolution or liquidation. The Administrator will notify each Participant in writing or electronically, prior to the New Exercise Date, that the Exercise Date for the Participant’s option has been changed to the New Exercise Date and that the Participant’s option will be exercised automatically on the New Exercise Date, unless prior to such date the Participant has withdrawn from the Offering Period as provided in Section 10 hereof.
(c)Merger or Change in Control. In the event of a merger or Change in Control, each outstanding option will be assumed or an equivalent option substituted by the successor corporation or a Parent or Subsidiary of the successor corporation. In the event that the successor corporation refuses to assume or substitute for the option, the Offering Period with respect to which such option relates will be shortened by setting a New Exercise Date on which such Offering Period shall end. The New Exercise Date will occur before the date of the Company’s proposed merger or Change in Control. The Administrator will notify each Participant in writing or electronically prior to the New Exercise Date, that the Exercise Date for the Participant’s option has been changed to the New Exercise Date and that the Participant’s option will be exercised automatically on the New Exercise Date, unless prior to such date the Participant has withdrawn from the Offering Period as provided in Section 10 hereof.
18.Amendment or Termination.
(a)The Administrator, in its sole discretion, may amend, suspend, or terminate the Plan, or any part thereof, at any time and for any reason. If the Plan is terminated, the Administrator, in its discretion, may elect to terminate all outstanding Offering Periods either immediately or upon completion of the purchase of shares of Common Stock on the next Exercise Date (which may be sooner than originally scheduled, if determined by the Administrator in its discretion), or may elect to permit Offering Periods to expire in accordance with their terms (and subject to any adjustment pursuant to Section 18). If the Offering Periods are terminated prior to expiration, all amounts then credited to Participants’ accounts that have not been used to purchase
shares of Common Stock will be returned to the Participants (without interest thereon, except as otherwise required under Applicable Laws, as further set forth in Section 12 hereof) as soon as administratively practicable.
(b)Without stockholder consent and without limiting Section 19(a), the Administrator will be entitled to change the Offering Periods or Purchase Periods, designate separate Offerings, limit the frequency and/or number of changes in the amount withheld during an Offering Period, establish the exchange rate applicable to amounts withheld in a currency other than U.S. dollars, permit Contributions in excess of the amount designated by a Participant in order to adjust for delays or mistakes in the Company’s processing of properly completed Contribution elections, establish reasonable waiting and adjustment periods and/or accounting and crediting procedures to ensure that amounts applied toward the purchase of Common Stock for each Participant properly correspond with Contribution amounts, and establish such other limitations or procedures as the Administrator determines in its sole discretion advisable that are consistent with the Plan.
(c)In the event the Administrator determines that the ongoing operation of the Plan may result in unfavorable financial accounting consequences, the Administrator may, in its discretion and, to the extent necessary or desirable, modify, amend or terminate the Plan to reduce or eliminate such accounting consequence including, but not limited to:
(i)amending the Plan to conform with the safe harbor definition under the Financial Accounting Standards Board Accounting Standards Codification Topic 718 (or any successor thereto), including with respect to an Offering Period underway at the time;
(ii)altering the Purchase Price for any Offering Period or Purchase Period including an Offering Period or Purchase Period underway at the time of the change in Purchase Price;
(iii)shortening any Offering Period or Purchase Period by setting a New Exercise Date, including an Offering Period or Purchase Period underway at the time of the Administrator action;
(iv)reducing the maximum percentage of Compensation a Participant may elect to set aside as Contributions; and
(v)reducing the maximum number of shares of Common Stock a Participant may purchase during any Offering Period or Purchase Period.
Such modifications or amendments will not require stockholder approval or the consent of any Participants.
19.Notices. All notices or other communications by a Participant to the Company under or in connection with the Plan will be deemed to have been duly given when received in the form and manner specified by the Company at the location, or by the person, designated by the Company for the receipt thereof.
20.Conditions Upon Issuance of Shares. Shares of Common Stock will not be issued with respect to an option unless the exercise of such option and the issuance and delivery of such shares pursuant thereto will comply with all applicable provisions of law, domestic or foreign, including, without limitation, the U.S. Securities Act of 1933, as amended, the Exchange Act, the rules and
regulations promulgated thereunder, and the requirements of any stock exchange upon which the shares may then be listed, and will be further subject to the approval of counsel for the Company with respect to such compliance.
As a condition to the exercise of an option, the Company may require the person exercising such option to represent and warrant at the time of any such exercise that the shares are being purchased only for investment and without any present intention to sell or distribute such shares if, in the opinion of counsel for the Company, such a representation is required by any of the aforementioned applicable provisions of law.
21. Section 409A. The 423 Component of the Plan is intended to be exempt from the application of Section 409A, and, to the extent not exempt, is intended to comply with Section 409A and any ambiguities herein will be interpreted to so be exempt from, or comply with, Section 409A. In furtherance of the foregoing and notwithstanding any provision in the Plan to the contrary, if the Administrator determines that an option granted under the Plan may be subject to Section 409A or that any provision in the Plan would cause an option under the Plan to be subject to Section 409A, the Administrator may amend the terms of the Plan and/or of an outstanding option granted under the Plan, or take such other action the Administrator determines is necessary or appropriate, in each case, without the Participant’s consent, to exempt any outstanding option or future option that may be granted under the Plan from or to allow any such options to comply with Section 409A, but only to the extent any such amendments or action by the Administrator would not violate Section 409A. Notwithstanding the foregoing, the Company and any of its Parent or Subsidiaries shall have no obligation to reimburse, indemnify, or hold harmless a Participant or any other party if the option to purchase Common Stock under the Plan that is intended to be exempt from or compliant with Section 409A is not so exempt or compliant or for any action taken by the Administrator with respect thereto. The Company makes no representation that the option to purchase Common Stock under the Plan is compliant with Section 409A.
22.Term of Plan. The Plan will become effective upon the later to occur of (a) its adoption by the Board or (b) the business day immediately prior to the Registration Date. It will continue in effect for a term of twenty (20) years, unless sooner terminated under Section 19.
23.Stockholder Approval. The Plan will be subject to approval by the stockholders of the Company within twelve (12) months after the date the Plan is adopted by the Board. Such stockholder approval will be obtained in the manner and to the degree required under Applicable Laws.
24.Governing Law. The Plan will be governed by, and construed in accordance with, the laws of the State of New Jersey (except its choice-of-law provisions).
25.No Right to Employment. Participation in the Plan by a Participant will not be construed as giving a Participant the right to be retained as an employee of the Company or a
Subsidiary or Affiliate, as applicable. Furthermore, the Company or a Subsidiary or Affiliate may dismiss a Participant from employment at any time, free from any liability or any claim under the Plan.
26.Severability. If any provision of the Plan is or becomes or is deemed to be invalid, illegal, or unenforceable for any reason in any jurisdiction or as to any Participant, such invalidity, illegality or unenforceability will not affect the remaining parts of the Plan, and the Plan will be construed and enforced as to such jurisdiction or Participant as if the invalid, illegal or unenforceable provision had not been included.
27.Compliance with Applicable Laws. The terms of this Plan are intended to comply with all Applicable Laws and will be construed accordingly.
Updated as of: May 2024
EXHIBIT A
PMV PHARMACEUTICALS, INC.
2020 EMPLOYEE STOCK PURCHASE PLAN SUBSCRIPTION AGREEMENT
Original Application Offering Date:
Change in Payroll Deduction Rate
3. hereby elects to participate in the PMV Pharmaceuticals, Inc. 2020 Employee Stock Purchase Plan (the “Plan”) and subscribes to purchase shares of the Company’s Common Stock in accordance with this Subscription Agreement and the Plan. Unless otherwise defined herein, the terms defined in the 2020 Employee Stock Purchase Plan (the “Plan”) shall have the same defined meanings in this Subscription Agreement.
4.I hereby authorize and consent to payroll deductions from each paycheck in the amount of % (from 0 to fifteen percent (15%)) of my Compensation on each payday during the Offering Period in accordance with the Plan. (Please note that no fractional percentages are permitted.) I understand that only my first, one election to decrease the rate of my payroll deductions may be applied with respect to an ongoing Offering Period in accordance with the terms of the Plan, and any subsequent election to decrease the rate of my payroll deductions during the same Offering Period, and any election to increase the rate of my payroll deductions during any Offering Period, will not be applied to the ongoing Offering Period.
5.I understand that said payroll deductions will be accumulated for the purchase of shares of Common Stock at the applicable Purchase Price determined in accordance with the Plan. I understand that if I do not withdraw from an Offering Period, any accumulated payroll deductions will be used to automatically exercise my option and purchase Common Stock under the Plan. I further understand that if I am outside of the U.S., my payroll deductions will be converted to U.S. dollars at an exchange rate selected by the Company on the purchase date.
6.I have received a copy of the complete Plan and its accompanying prospectus. I understand that my participation in the Plan is in all respects subject to the terms of the Plan.
7.Shares of Common Stock purchased for me under the Plan should be issued in the name(s) of (Eligible Employee or Eligible Employee and spouse only).
8.If I am a U.S. taxpayer, I understand that if I dispose of any shares received by me pursuant to the Plan within two (2) years after the Enrollment Date (the first day of the Offering Period during which I purchased such shares) or one (1) year after the applicable Exercise Date, I will be treated for federal income tax purposes as having received ordinary income at the time of such disposition in an amount equal to the excess of the fair market value of the shares at the time such shares were purchased by me over the price that I paid for the shares. I hereby agree to notify
the Company in writing within thirty (30) days after the date of any disposition of my shares and I will make adequate provision for federal, state or other tax withholding obligations, if any, which arise upon the disposition of such shares. The Company may, but will not be obligated to, withhold from my compensation the amount necessary to meet any applicable withholding obligation including any withholding necessary to make available to the Company any tax deductions or benefits attributable to sale or early disposition of Common Stock by me. If I dispose of such shares at any time after the expiration of the two (2)-year and one (1)-year holding periods, I understand that I will be treated for federal income tax purposes as having received income only at the time of such disposition, and that such income will be taxed as ordinary income only to the extent of an amount equal to the lesser of (a) the excess of the fair market value of the shares at the time of such disposition over the purchase price which I paid for the shares, or (b) 15% of the fair market value of the shares on the first day of the Offering Period. The remainder of the gain, if any, recognized on such disposition will be taxed as capital gain.
9.I hereby agree to be bound by the terms of the Plan. The effectiveness of this Subscription Agreement is dependent upon my eligibility to participate in the Plan.
Employee’s ID Number:
Employee’s Address:
I UNDERSTAND THAT THIS SUBSCRIPTION AGREEMENT WILL REMAIN IN EFFECT THROUGHOUT SUCCESSIVE OFFERING PERIODS UNLESS TERMINATED BY ME.
Dated:
Signature of Employee
-2-
EXHIBIT B
PMV PHARMACEUTICALS, INC.
2020 EMPLOYEE STOCK PURCHASE PLAN NOTICE OF WITHDRAWAL
Unless otherwise defined herein, the terms defined in the 2020 Employee Stock Purchase Plan (the “Plan”) shall have the same defined meanings in this Notice of Withdrawal.
The undersigned Participant in the Offering Period of the PMV Pharmaceuticals, Inc. 2020 Employee Stock Purchase Plan that began on , (the “Enrollment Date”) hereby notifies the Company that he or she hereby withdraws from the Offering Period. He or she hereby directs the Company to pay to the undersigned as promptly as practicable all the payroll deductions credited to his or her account with respect to such Offering Period. The undersigned understands and agrees that his or her option for such Offering Period will be terminated automatically. The undersigned understands further that no further payroll deductions will be made for the purchase of shares in the current Offering Period and the undersigned will be eligible to participate in succeeding Offering Periods only by delivering to the Company a new Subscription Agreement.
Name and Address of Participant:
Signature:
Date:
Exhibit 31.1
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, David H. Mack, certify that:
1.I have reviewed this Quarterly Report on Form 10-Q for the period ended March 31, 2024, of PMV Pharmaceuticals, 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(s) 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(s) 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.
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Date: May 9, 2024 |
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By: |
/s/ David H. Mack |
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|
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David H. Mack, Ph.D. |
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|
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Chief Executive Officer (Principal Executive Officer) |
Exhibit 31.2
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, Michael Carulli, certify that:
1.I have reviewed this Quarterly Report on Form 10-Q for the period ended March 31, 2024, of PMV Pharmaceuticals, 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(s) 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(s) 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.
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Date: May 9, 2024 |
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By: |
/s/ Michael Carulli |
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|
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Michael Carulli |
|
|
|
Chief Financial Officer (Principal Financial and Principal Accounting Officer) |
Exhibit 32.1
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 on Form 10-Q for the period ended March 31, 2024, of PMV Pharmaceuticals, Inc. (the “Company”) as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:
(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 result of operations of the Company.
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|
Date: May 9, 2024 |
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By: |
/s/ David H. Mack |
|
|
|
David H. Mack, Ph.D. |
|
|
|
Chief Executive Officer (Principal Executive Officer) |
Exhibit 32.2
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 on Form 10-Q for the period ended March 31, 2024, of PMV Pharmaceuticals, Inc. (the “Company”) as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:
(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 result of operations of the Company.
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Date: May 9, 2024 |
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By: |
/s/ Michael Carulli |
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Michael Carulli |
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Chief Financial Officer (Principal Financial and Principal Accounting Officer) |
v3.24.1.u1
Document and Entity Information - shares
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3 Months Ended |
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Mar. 31, 2024 |
May 08, 2024 |
Cover [Abstract] |
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10-Q
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Document Quarterly Report |
true
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Document Transition Report |
false
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Document Period End Date |
Mar. 31, 2024
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Entity File Number |
001-39539
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Entity Registrant Name |
PMV PHARMACEUTICALS, INC.
|
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Entity Incorporation, State or Country Code |
DE
|
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Entity Tax Identification Number |
46-3218129
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Entity Address, Address Line One |
One Research Way
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Entity Address, City or Town |
Princeton
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Entity Address, State or Province |
NJ
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Entity Address, Postal Zip Code |
08540
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City Area Code |
609
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Local Phone Number |
642-6670
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Title of 12(b) Security |
Common stock, par value $0.00001
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Trading Symbol |
PMVP
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Security Exchange Name |
NASDAQ
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v3.24.1.u1
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
Current assets: |
|
|
Cash and cash equivalents |
$ 47,654
|
$ 37,706
|
Restricted cash |
822
|
822
|
Marketable securities, current |
150,285
|
165,351
|
Prepaid expenses and other current assets |
3,699
|
3,530
|
Total current assets |
202,460
|
207,409
|
Property and equipment, net |
10,903
|
10,666
|
Marketable securities, noncurrent |
15,120
|
25,505
|
Right-of-use assets |
8,211
|
8,382
|
Other assets |
182
|
190
|
Total assets |
236,876
|
252,152
|
Current liabilities: |
|
|
Accounts payable |
859
|
3,237
|
Accrued expenses |
10,319
|
9,940
|
Operating lease liabilities, current |
880
|
852
|
Total current liabilities |
12,058
|
14,029
|
Operating lease liabilities, noncurrent |
12,142
|
12,434
|
Total liabilities |
24,200
|
26,463
|
Stockholders’ equity: |
|
|
Preferred stock, $0.00001 par value, 5,000,000 shares authorized at March 31, 2024 and December 31, 2023. No shares issued or outstanding at March 31, 2024 and December 31, 2023. |
|
|
Common stock, $0.00001 par value, 1,000,000,000 shares authorized; 51,445,862 and 51,445,862 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively. |
|
|
Additional paid-in capital |
538,078
|
535,468
|
Accumulated deficit |
(325,273)
|
(310,003)
|
Accumulated other comprehensive (loss) income |
(129)
|
224
|
Total stockholders’ equity |
212,676
|
225,689
|
Total liabilities and stockholders’ equity |
$ 236,876
|
$ 252,152
|
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v3.24.1.u1
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares
|
Mar. 31, 2024 |
Dec. 31, 2023 |
Statement of Financial Position [Abstract] |
|
|
Preferred stock, par value |
$ 0.00001
|
$ 0.00001
|
Preferred stock, shares authorized |
5,000,000
|
5,000,000
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
Common stock, par value |
$ 0.00001
|
$ 0.00001
|
Common stock, shares authorized |
1,000,000,000
|
1,000,000,000
|
Common stock, shares issued |
51,445,862
|
51,445,862
|
Common stock, shares outstanding |
51,445,862
|
51,445,862
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.24.1.u1
Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) - USD ($) $ in Thousands |
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Operating expenses: |
|
|
Research and development |
$ 13,186
|
$ 15,073
|
General and administrative |
5,035
|
6,407
|
Total operating expenses |
18,221
|
21,480
|
Loss from operations |
(18,221)
|
(21,480)
|
Other income (expense): |
|
|
Interest income, net |
2,952
|
2,325
|
Other income (expense), net |
(1)
|
27
|
Total other income (expense) |
2,951
|
2,352
|
Loss before provision for income taxes |
(15,270)
|
(19,128)
|
Net loss |
(15,270)
|
(19,128)
|
Unrealized (loss) gain on available for sale investments, net of tax |
(319)
|
329
|
Foreign currency translation loss |
(34)
|
|
Total other comprehensive (loss) income |
(353)
|
329
|
Total comprehensive loss |
$ (15,623)
|
$ (18,799)
|
Net loss per share - basic |
$ (0.3)
|
$ (0.42)
|
Net loss per share - diluted |
$ (0.3)
|
$ (0.42)
|
Weighted-average common shares outstanding - basic |
51,445,862
|
45,773,357
|
Weighted-average common shares outstanding - diluted |
51,445,862
|
45,773,357
|
X |
- DefinitionOther nonoperating income (expense), other.
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v3.24.1.u1
Condensed Consolidated Statements of Stockholders' Equity (unaudited) - USD ($) $ in Thousands |
Total |
Common Stock |
Additional Paid-in Capital |
Accumulated Other Comprehensive (Loss) Income |
Accumulated Deficit |
Balance at Dec. 31, 2022 |
$ 246,028
|
|
$ 487,516
|
$ (445)
|
$ (241,043)
|
Balance, Shares at Dec. 31, 2022 |
|
45,771,332
|
|
|
|
Exercise of stock options |
12
|
|
12
|
|
|
Exercise of stock options, Shares |
|
3,429
|
|
|
|
Stock-based compensation expense |
2,932
|
|
2,932
|
|
|
Net loss |
(19,128)
|
|
|
|
(19,128)
|
Unrealized gain (loss) on available for sale investments |
329
|
|
|
329
|
|
Balance at Mar. 31, 2023 |
230,173
|
|
490,460
|
(116)
|
(260,171)
|
Balance, Shares at Mar. 31, 2023 |
|
45,774,761
|
|
|
|
Balance at Dec. 31, 2023 |
225,689
|
|
535,468
|
224
|
(310,003)
|
Balance, Shares at Dec. 31, 2023 |
|
51,445,862
|
|
|
|
Stock-based compensation expense |
2,610
|
|
2,610
|
|
|
Net loss |
(15,270)
|
|
|
|
(15,270)
|
Unrealized gain (loss) on available for sale investments |
(319)
|
|
|
(319)
|
|
Foreign currency translation loss |
(34)
|
|
|
(34)
|
|
Balance at Mar. 31, 2024 |
$ 212,676
|
|
$ 538,078
|
$ (129)
|
$ (325,273)
|
Balance, Shares at Mar. 31, 2024 |
|
51,445,862
|
|
|
|
X |
- DefinitionAmount of increase to additional paid-in capital (APIC) for recognition of cost for award under share-based payment arrangement.
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v3.24.1.u1
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Cash flows from operating activities: |
|
|
Net loss |
$ (15,270)
|
$ (19,128)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Stock-based compensation expense |
2,610
|
2,932
|
Depreciation |
362
|
171
|
Accretion of discounts on marketable securities |
(1,628)
|
(712)
|
Non-cash lease income |
(92)
|
(89)
|
Other, net |
8
|
(1)
|
Change in operating assets and liabilities: |
|
|
Prepaid expenses and other assets |
(169)
|
2,108
|
Accounts payable |
(2,384)
|
(1,520)
|
Accrued expenses |
379
|
1,227
|
Net cash used in operating activities |
(16,184)
|
(15,012)
|
Cash flows from investing activities: |
|
|
Purchases of property and equipment |
(594)
|
(156)
|
Purchases of marketable securities |
(30,489)
|
(23,502)
|
Maturities of marketable securities |
57,249
|
73,303
|
Net cash provided by investing activities |
26,166
|
49,645
|
Cash flows from financing activities: |
|
|
Proceeds from the exercise of stock options and common stock issued under the 2020 EIP |
|
12
|
Net cash provided by financing activities |
|
12
|
Impact of exchange rates on cash, cash equivalents, and restricted cash |
(34)
|
|
Net increase in cash and cash equivalents |
9,948
|
34,645
|
Cash, cash equivalents, and restricted cash |
|
|
Cash, cash equivalents, and restricted cash - beginning of period |
38,528
|
109,119
|
Cash, cash equivalents, and restricted cash - end of period |
48,476
|
143,764
|
Supplemental disclosures of noncash investing activities |
|
|
Accrued purchases of property and equipment |
$ 6
|
$ 298
|
X |
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v3.24.1.u1
Formation and Business of the Company
|
3 Months Ended |
Mar. 31, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Formation and Business of the Company |
1. Formation and Business of the Company Organization and Liquidity PMV Pharmaceuticals, Inc. (the “Company” or “We”) was incorporated in the state of Delaware in March 2013. Since inception, the Company has devoted substantially all of its time and efforts to performing research and development activities and raising capital. We are a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53. The Company’s headquarters are located at One Research Way, Princeton, New Jersey. The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry including, but not limited to, technical risks associated with the successful research, development and manufacturing of product candidates, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. Current and future programs will require significant research and development efforts, including extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel, and infrastructure. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales. The Company has incurred net losses and negative cash flows from operations since its inception. During the three months ended March 31, 2024, the Company incurred a net loss of $15,270. For the three months ended March 31, 2024, the Company used $16,184 of cash for operations. At March 31, 2024, the Company had an accumulated deficit of $325,273. Cash, cash equivalents, and marketable securities were $213,059 as of March 31, 2024. Management expects to incur substantial additional operating losses for the next several years and may need to obtain additional debt or equity financings in order to complete development of its products, obtain regulatory approvals, launch and commercialize its products and continue research and development programs. The Company believes it has adequate cash, cash equivalents, and marketable securities to operate for the next 12 months from the date of issuance of these condensed consolidated financial statements.
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v3.24.1.u1
Summary of Significant Accounting Policies
|
3 Months Ended |
Mar. 31, 2024 |
Accounting Policies [Abstract] |
|
Summary of Significant Accounting Policies |
2. Summary of Significant Accounting Policies The Company’s significant accounting policies are disclosed in the audited condensed consolidated financial statements for the year ended December 31, 2023, included in the Company’s Annual Report on Form 10-K filed with the United States Securities and Exchange Commission (the “SEC”) on February 29, 2024. Since the date of those condensed consolidated financial statements, there have been no changes to its significant accounting policies. Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information and with the interim period reporting requirements of Form 10-Q and Article 10 of Regulation S-X. The condensed consolidated balance sheet as of March 31, 2024, the condensed consolidated statements of operations and comprehensive loss, stockholders’ equity, and statements of cash flows for the three months ended March 31, 2024 and 2023, are unaudited, but, in the opinion of management, include all adjustments, consisting only of normal recurring adjustments, which we consider necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The results for any interim period are not necessarily indicative of results for the year ending December 31, 2024, or for any other subsequent interim period. The condensed consolidated balance sheet as of December 31, 2023, has been derived from our audited condensed consolidated financial statements. The accompanying condensed consolidated financial statements include our accounts and the accounts of our wholly owned subsidiary, PMV Pharma Australia Pvt Ltd. All significant intercompany transactions and balances have been eliminated upon consolidation. These condensed consolidated financial statements are presented in United States ("U.S.") Dollars, which is also the functional currency of the Company. Use of Estimates The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and reported amounts of revenues and expenses during the reporting period. The Company bases its estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, research and development costs, accrued research and development costs and related prepaid expenses. Actual results could differ materially from those estimates. Cash, Cash Equivalents and Marketable Securities Management considers all highly liquid investments with original maturities of three months or less to be cash equivalents. The Company’s marketable debt securities have been classified and accounted for as available-for-sale. The Company classifies its marketable debt securities as either short-term or long-term based on each instrument’s underlying contractual maturity date. Marketable debt securities with maturities of 12 months or less are classified as short-term and marketable debt securities with maturities greater than 12 months are classified as long-term. The Company’s marketable debt securities are carried at fair value, with unrealized gains and losses, net of taxes, reported as a component of accumulated other comprehensive loss in stockholders’ equity. Premiums and discounts on marketable debt securities are amortized into earnings over the life of the security and recorded on the interest income, net line of the income statement. For the three months ended March 31, 2024 and 2023, the Company recorded $1,628 and $712 of accretion, respectively. Restricted cash as of March 31, 2024 and December 31, 2023 included a $822 deposit at the Company’s commercial bank underlying a stand-by letter of credit issued in favor of a landlord (See Note 6) and is classified in current assets. Comprehensive Loss and Accumulated Other Comprehensive Income (Loss) Other comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources, including unrealized gains and losses on investments and foreign currency translation gains and losses. Leases At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the circumstances present. The Company accounts for a contract as a lease when it has the right to control the asset for a period of time while obtaining substantially all of the asset’s economic benefits. The Company determines the initial classification and measurement of its operating right-of-use (“ROU”) assets and operating lease liabilities at the lease commencement date, and thereafter if modified. The lease term includes any renewal options that the Company is reasonably certain to exercise. The Company’s policy is to not record leases with a lease term of 12 months or less on its balance sheets. The Company’s only existing leases are for office and laboratory space. The ROU asset represents the right to use the leased asset for the lease term. The lease liability represents the present value of the lease payments under the lease. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its estimated secured incremental borrowing rate for that lease term. Lease expense for operating leases is recognized on a straight-line basis over the reasonably assured lease term based on the total lease payments and is included in operating expense in the statements of operations. Payments due under each lease agreement include fixed and variable payments. Variable payments relate to the Company’s share of the lessor’s operating costs associated with the underlying asset and are recognized when the event on which those payments are assessed occurs. Variable payments have been excluded from the lease liability and associated right-of-use asset. Neither of the Company’s leases contain residual value guarantees. The interest rate implicit in lease agreements is typically not readily determinable, and as such, the Company utilizes the incremental borrowing rate to calculate lease liabilities, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. Concentration of Credit Risk and Other Risks and Uncertainties Financial instruments that potentially subject the Company to significant concentrations of credit risk consist of cash, cash equivalents and marketable securities. Cash and cash equivalents were held at two financial institutions. At times, such deposits may be in excess of insured limits. The Company has not experienced any losses on its deposits of cash and cash equivalents. The Company’s marketable securities are carried at fair value and include any unrealized gains and losses. Any investments with unrealized losses are considered to be temporarily impaired. The Company’s future results of operations involve a number of risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, rapid technological change, uncertainty of market acceptance of the product, competition from substitute products and larger companies, protection of proprietary technology, any future strategic relationships and dependence on key individuals. Products developed by the Company require clearances from the U.S. Food and Drug Administration or other international regulatory agencies prior to commercial sales. There can be no assurance the Company’s product candidates will receive the necessary clearances. If the Company is denied clearance, clearance is delayed or it is unable to maintain clearance, it could have a materially adverse impact on the Company.
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v3.24.1.u1
Fair Value Measurements
|
3 Months Ended |
Mar. 31, 2024 |
Fair Value Disclosures [Abstract] |
|
Financial Instruments and Fair Value Measurements |
3. Fair Value Measurements The Company’s financial assets consist of money market funds, U.S. government debt securities and corporate debt securities. The following tables show the Company’s cash equivalents and available-for-sale securities’ carrying amounts and fair values as of March 31, 2024, and December 31, 2023:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of March 31, 2024 |
|
|
|
Carrying Amount |
|
|
Gross Unrealized Gains |
|
|
Gross Unrealized Losses |
|
|
Fair Value |
|
|
Quoted priced in active markets (Level 1) |
|
|
Significant other observable inputs (Level 2) |
|
|
Significant unobservable inputs (Level 3) |
|
Financial assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
39,666 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
39,666 |
|
|
$ |
39,666 |
|
|
$ |
— |
|
|
$ |
— |
|
Corporate securities |
|
|
52,020 |
|
|
|
8 |
|
|
|
(16 |
) |
|
|
52,012 |
|
|
|
5,572 |
|
|
|
46,440 |
|
|
|
— |
|
Government securities |
|
|
121,494 |
|
|
|
— |
|
|
|
(120 |
) |
|
|
121,374 |
|
|
|
95,418 |
|
|
|
25,956 |
|
|
|
— |
|
Total financial assets |
|
$ |
213,180 |
|
|
$ |
8 |
|
|
$ |
(136 |
) |
|
$ |
213,052 |
|
|
$ |
140,656 |
|
|
$ |
72,396 |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2023 |
|
|
|
Carrying Amount |
|
|
Gross Unrealized Gains |
|
|
Gross Unrealized Losses |
|
|
Fair Value |
|
|
Quoted Priced in Active Markets (Level 1) |
|
|
Significant Other Observable Inputs (Level 2) |
|
|
Significant Unobservable Inputs (Level 3) |
|
Financial assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
37,694 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
37,694 |
|
|
$ |
37,694 |
|
|
$ |
— |
|
|
$ |
— |
|
Corporate securities |
|
|
69,995 |
|
|
|
48 |
|
|
|
— |
|
|
|
70,043 |
|
|
|
5,577 |
|
|
|
64,466 |
|
|
|
— |
|
Government securities |
|
|
120,670 |
|
|
|
143 |
|
|
|
— |
|
|
|
120,813 |
|
|
|
92,297 |
|
|
|
28,516 |
|
|
|
— |
|
Total financial assets |
|
$ |
228,359 |
|
|
$ |
191 |
|
|
$ |
— |
|
|
$ |
228,550 |
|
|
$ |
135,568 |
|
|
$ |
92,982 |
|
|
$ |
— |
|
Cash Equivalents — As of March 31, 2024, the Company had aggregate cash and cash equivalents of $47,654, including cash equivalents of $47,647, consisting of money market funds and corporate securities. As of December 31, 2023, the Company had aggregate cash and cash equivalents of $37,706, including cash equivalents of $37,694, consisting of money market funds. Money market funds and certificates of deposit are classified within level 1 of the fair value hierarchy because they are valued using quoted market prices in active markets, whereas corporate debt securities are classified within level 2 of the fair value hierarchy because they are valued using inputs other than quoted prices that are observable for the asset or liability either directly or indirectly. Marketable Securities — Marketable securities of $165,405 as of March 31, 2024, consisted of corporate debt securities of $44,031 and government debt securities of $121,374. There were $150,285 current marketable securities and $15,120 noncurrent marketable securities as of March 31, 2024. Marketable securities of $190,856 as of December 31, 2023, consisted of corporate debt securities of $70,043 and government debt securities of $120,813. There were $165,351 current marketable securities and $25,505 noncurrent marketable securities as of December 31, 2023. As of March 31, 2024, and December 31, 2023, aggregated gross unrealized losses of available-for-sale investments were not material, and accordingly, no allowance for credit losses was recorded.
|
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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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v3.24.1.u1
Property and Equipment, Net
|
3 Months Ended |
Mar. 31, 2024 |
Property, Plant and Equipment [Abstract] |
|
Property and Equipment, Net |
4. Property and Equipment, Net
|
|
|
|
|
|
|
|
|
|
|
March 31, 2024 |
|
|
December 31, 2023 |
|
Machinery & equipment |
|
|
3,089 |
|
|
$ |
3,089 |
|
Computers |
|
|
13 |
|
|
|
13 |
|
Furniture & fixtures |
|
|
69 |
|
|
|
69 |
|
Leasehold improvements |
|
|
11,364 |
|
|
|
10,765 |
|
Total property and equipment |
|
|
14,535 |
|
|
|
13,936 |
|
Less: Accumulated depreciation |
|
|
(3,632 |
) |
|
|
(3,270 |
) |
Property and equipment, net |
|
$ |
10,903 |
|
|
$ |
10,666 |
|
Depreciation expense for the three months ended March 31, 2024 and 2023 was $362 and $171, respectively.
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- DefinitionThe entire disclosure for long-lived, physical asset used in normal conduct of business and not intended for resale. Includes, but is not limited to, work of art, historical treasure, and similar asset classified as collections.
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v3.24.1.u1
Accrued Expenses
|
3 Months Ended |
Mar. 31, 2024 |
Payables and Accruals [Abstract] |
|
Accrued Expenses |
5. Accrued Expenses Accrued expenses consist of the following:
|
|
|
|
|
|
|
|
|
|
|
March 31, 2024 |
|
|
December 31, 2023 |
|
Accrued compensation |
|
$ |
2,220 |
|
|
$ |
4,498 |
|
Accrued legal and professional services |
|
|
248 |
|
|
|
172 |
|
Accrued research and development costs |
|
|
7,851 |
|
|
|
5,270 |
|
Total |
|
$ |
10,319 |
|
|
$ |
9,940 |
|
|
X |
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v3.24.1.u1
Commitments and Contingencies
|
3 Months Ended |
Mar. 31, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
6. Commitments and Contingencies Operating Leases In June 2015, the Company executed a noncancelable operating lease for approximately 13,000 square feet of laboratory, research and development, and office space in Cranbury, New Jersey. This location operated as the Company's headquarters until March 2023. In June 2017, the Company obtained an additional noncancelable operating lease for approximately 6,000 square feet of laboratory space in the same corporate center. Both leases were set to expire in June 2022. In January 2022, the Company signed a lease extension for both leases for up to one additional year through June 2023, with the option to terminate upon 120 days of written notice, with an increase in base rent as per the lease extension. The lease was terminated as of June 2023. In August 2018, the Company executed two noncancelable operating leases. One lease for approximately 6,000 square feet for vivarium, laboratory and general office space in South Brunswick, New Jersey. The lease was set to expire in July 2022. In January 2022, the Company signed a lease extension for up to one additional year through July 2023, with the option to terminate upon 120 days of written notice, with an increase in base rent as per the lease extension. The lease was terminated as of June 2023. The second lease is for office space in Lexington, Massachusetts, that expired in August 2023. In January 2021, the Company signed a lease for 50,581 square feet of office and laboratory space at One Research Way in Princeton, New Jersey. That lease term extends through 2032, has a five-year extension option, and replaced the Company’s two existing facilities as the Company’s headquarters in March 2023. Payment under this lease will total $19,889 through May 2032. The Company received a lease incentive of $4,046 from the lessor for a buildout of laboratory, vivarium, and office space, to be reimbursed to the Company in 2022 and 2023. Management estimated the timing and amounts of reimbursements and included them as a reduction of lease payments when initially measuring the lease liability and right-of-use asset upon commencement. Since the inception date of the lease, $3,806 reimbursements were received. For the three months ended March 31, 2024, no reimbursements were received. The components of lease cost for the three months ended March 31, 2024 and 2023, are as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
(in thousands) |
|
2024 |
|
|
2023 |
|
Operating lease cost |
|
$ |
355 |
|
|
$ |
597 |
|
Variable lease cost |
|
|
133 |
|
|
|
319 |
|
Total lease cost |
|
$ |
488 |
|
|
$ |
916 |
|
Amounts reported in the balance sheet for leases where the Company is the lessee as of March 31, 2024, and December 31, 2023, are as follows:
|
|
|
|
|
|
|
|
|
Operating Leases (in thousands, except lease term and discount rate data): |
|
March 31, 2024 |
|
|
December 31, 2023 |
|
Right-of-use assets, operating leases |
|
$ |
8,211 |
|
|
$ |
8,382 |
|
|
|
|
|
|
|
|
Operating lease liabilities, current |
|
$ |
880 |
|
|
$ |
852 |
|
Operating lease liabilities, non-current |
|
|
12,142 |
|
|
|
12,434 |
|
Total operating lease liabilities |
|
$ |
13,022 |
|
|
$ |
13,286 |
|
|
|
|
|
|
|
|
Weighted-average remaining lease term (years) |
|
|
8.17 |
|
|
|
8.42 |
|
Weighted-average discount rate |
|
|
5.75 |
% |
|
|
5.75 |
% |
Other information related to leases for the three months ended March 31, 2024 and 2023, respectively, as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
(in thousands) |
|
2024 |
|
|
2023 |
|
Net cash paid for amounts included in the measurement of lease liabilities |
|
$ |
447 |
|
|
$ |
686 |
|
Future minimum lease payments, net of reimbursements, remaining as of March 31, 2024, under operating leases by fiscal year were as follows:
|
|
|
|
|
Fiscal year |
|
(in thousands) |
|
2024 |
|
$ |
1,127 |
|
2025 |
|
|
1,869 |
|
2026 |
|
|
1,925 |
|
2027 |
|
|
1,983 |
|
2028 |
|
|
2,042 |
|
Thereafter |
|
|
7,453 |
|
Total minimum lease payments |
|
$ |
16,399 |
|
Less: Amounts representing imputed interest |
|
|
(3,377 |
) |
Present value of lease liabilities |
|
$ |
13,022 |
|
Rent expense recorded during the three months ended March 31, 2024 and 2023 was $355 and $597, respectively. Contingencies From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of its business activities. The Company accrues a liability for such matters when future expenditures are probable and such expenditures can be reasonably estimated.
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v3.24.1.u1
Stockholders' Equity
|
3 Months Ended |
Mar. 31, 2024 |
Equity [Abstract] |
|
Stockholders' Equity |
7. Stockholders’ Equity The Company is authorized to issue up to 1,000,000,000 shares of common stock with a par value of $0.00001 per share and 5,000,000 shares of preferred stock with a par value of $0.00001 per share. At March 31, 2024 and December 31, 2023, there were 51,445,862 and 51,445,862 shares of common stock issued and outstanding, respectively. Common stockholders are entitled to receive dividends if and when declared by the board of directors subject to the rights of any preferred stockholders. As of March 31, 2024, no dividends on common stock had been declared by the Company. ATM Program On October 4, 2021, the Company entered into an at-the-market offering program (the “ATM Program”) pursuant to which, the Company may offer and sell shares of its common stock having aggregate gross sales proceeds of up to $150.0 million from time to time. During the three months ended March 31, 2024, the Company did not sell any shares of its common stock under the ATM Program. As of March 31, 2024, the Company has approximately $113.8 million remaining in gross proceeds available for future issuances of common stock under the ATM Program.
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v3.24.1.u1
Stock Plan
|
3 Months Ended |
Mar. 31, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
Stock Plan |
8. Stock Plan 2020 Equity Incentive Plan The 2020 Equity Incentive Plan (the “2020 Plan”) was approved by the Company's board of directors on September 24, 2020. The 2020 Plan provides for the grant of incentive stock options, non-qualified stock options, stock appreciation rights, restricted stock units, restricted stock awards, unrestricted stock awards, cash-based awards and dividend equivalent rights to the Company’s officers, employees, directors, and consultants. The number of shares of common stock initially reserved for issuance under the 2020 Plan was 4,406,374, which shall be increased, upon approval by the Company's board of directors, on January 1, 2021 and each January 1 thereafter, in an amount equal to the least of (i) 4,406,374 shares of common stock, (ii) five percent (5%) of the outstanding common stock on the immediately preceding December 31, or (iii) such number of common stock determined by the board of directors no later than the immediately preceding December 31. For 2024, the compensation committee of the Company's board of directors, as the 2020 Plan administrator, exercised its discretion under clause (ii) to increase the number of shares of common stock reserved for issuance under the 2020 Plan by 2,572,174 shares, effective as of January 1, 2024. As of March 31, 2024, there were 4,954,570 shares available for issuance under the 2020 Plan. On September 9, 2022, the Company granted 374,899 Restricted Stock Units (“RSUs”) to employees pursuant to an employee retention program approved by the compensation committee of the Company's board of directors. The RSUs have graded vesting on an annual basis for two years of continuous service, as per the 2020 Plan. On January 18, 2024, the Company granted 952,665 RSUs to employees VP-level or higher, pursuant to an employee retention program approved by the compensation committee of the Company's board of directors. The RSUs are scheduled to vest on June 30, 2025, based on approximately one and a half years of continuous service, as per the 2020 Plan. 2020 Employee Stock Purchase Plan The 2020 Employee Stock Purchase Plan (the “2020 ESPP”) was approved by the Company's board of directors on September 24, 2020. A total of 400,752 shares of common stock were initially reserved for issuance under this plan, which shall be increased, upon approval by the Company's board of directors, on January 1, 2021 and each January 1 thereafter, to the lesser of (i) 801,504 shares of common stock, (ii) 1% of the outstanding shares of common stock on the last day of the immediately preceding fiscal year, or (iii) an amount determined by the board of directors or any of its committees no later than the last day of the immediately preceding fiscal year. For 2024, the 2020 ESPP reserved shares were increased under clause (ii) by 514,434 shares, effective as of January 1, 2024. As of March 31, 2024, 202,345 shares are issued or outstanding, and there were 1,571,266 shares available for issuance, under the 2020 ESPP. Stock Options The following table summarizes option activity for the three-month period ended March 31, 2024:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Average |
|
|
Aggregate |
|
|
|
Shares |
|
|
|
|
|
Average |
|
|
Remaining |
|
|
Intrinsic |
|
|
|
Available |
|
|
Number of |
|
|
Exercise |
|
|
Contractual Life |
|
|
Value |
|
|
|
for Grant |
|
|
Options |
|
|
Price |
|
|
(in years) |
|
|
(in 000s) |
|
Balances at December 31, 2023 |
|
|
4,474,411 |
|
|
|
6,973,464 |
|
|
$ |
9.44 |
|
|
|
7.01 |
|
|
$ |
990 |
|
Shares reserved for issuance |
|
|
2,572,174 |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
Options granted |
|
|
(2,776,030 |
) |
|
|
2,776,030 |
|
|
$ |
1.79 |
|
|
|
|
|
|
|
Options forfeited / cancelled |
|
|
684,015 |
|
|
|
(684,015 |
) |
|
$ |
9.41 |
|
|
|
|
|
|
|
Options exercised |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
Balances at March 31, 2024 (unaudited) |
|
|
4,954,570 |
|
|
|
9,065,479 |
|
|
$ |
7.10 |
|
|
|
6.91 |
|
|
$ |
273 |
|
At March 31, 2024 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and expected to vest |
|
|
|
|
|
9,065,479 |
|
|
$ |
7.10 |
|
|
|
6.91 |
|
|
$ |
273 |
|
Exercisable |
|
|
|
|
|
4,506,573 |
|
|
$ |
8.87 |
|
|
|
4.54 |
|
|
$ |
259 |
|
At March 31, 2024, the total compensation cost related to nonvested awards not yet recognized was $16,250. The weighted-average period over which the nonvested awards is expected to be recognized was 2.8 years. The Company estimated the fair value of the options using the Black-Scholes options valuation model. The fair value of the options is being amortized on a straight-line basis over the requisite service period of the awards. The fair value was estimated using the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
March 31, |
|
|
|
2024 |
|
|
2023 |
|
Risk-free interest rate |
|
|
3.82% - 4.26% |
|
|
|
3.58% |
|
Expected life (in years) |
|
|
6.02 - 6.25 |
|
|
|
6.25 |
|
Dividend yield |
|
|
0% |
|
|
|
0% |
|
Expected volatility |
|
|
86.76% |
|
|
|
79.90% |
|
The weighted average assumptions used to estimate the fair value of stock purchase rights under the ESPP are as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
March 31, |
|
|
|
2024 |
|
|
2023 |
|
Risk-free interest rate |
|
|
5.43% |
|
|
|
4.65% |
|
Expected life (in years) |
|
|
0.49 |
|
|
|
0.49 |
|
Dividend yield |
|
|
0% |
|
|
|
0% |
|
Expected volatility |
|
|
76.22% |
|
|
|
76.33% |
|
Risk Free Interest Rate: The risk-free rate is based on the U.S. Treasury yields in effect at the time of grant for periods corresponding with the expected term of the option. Expected Term: The Company uses the simplified method to calculate expected term described in the SEC’s Staff Accounting Bulletin No. 107, which takes into account vesting term and expiration date of the options. Dividend Yield: The Company has never declared or paid any cash dividends and does not plan to pay cash dividends in the foreseeable future, and therefore, used an expected dividend yield of zero in the valuation model. Volatility: Volatility is based on the historical volatility of the Company's publicly traded shares for the expected term. Restricted Stock Units The following table presents RSU activity under the 2020 Plan as of March 31, 2024:
|
|
|
|
|
|
|
|
|
|
|
Number of Stock Units |
|
|
Weighted-Average Grant Date Fair Value |
|
Unvested shares at December 31, 2023 |
|
|
236,296 |
|
|
$ |
13.60 |
|
Granted |
|
|
952,665 |
|
|
|
1.80 |
|
Forfeited |
|
|
(52,550 |
) |
|
|
3.50 |
|
Unvested shares at March 31, 2024 |
|
|
1,136,411 |
|
|
$ |
4.18 |
|
As of March 31, 2024, there was $2,196 of unrecognized compensation cost related to RSUs that are expected to vest. These costs are expected to be recognized over a weighted average remaining vesting period of 1.1 years. Stock-based compensation expense recorded under ASC 718 related to stock options and RSUs granted and common stock issued under the 2020 ESPP were allocated to research and development and general and administrative expense as follows:
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended |
|
|
|
March 31, |
|
|
March 31, |
|
|
|
2024 |
|
|
2023 |
|
Research and development |
|
$ |
975 |
|
|
$ |
1,263 |
|
General and administrative |
|
|
1,635 |
|
|
|
1,669 |
|
Total stock-based compensation |
|
$ |
2,610 |
|
|
$ |
2,932 |
|
Stock-based compensation expense by award type included within the condensed consolidated statements of operations is as follows:
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended |
|
|
|
March 31, |
|
|
March 31, |
|
|
|
2024 |
|
|
2023 |
|
Stock options |
|
$ |
2,214 |
|
|
$ |
2,281 |
|
Restricted stock units |
|
|
342 |
|
|
|
597 |
|
Employee stock purchase plan |
|
|
54 |
|
|
|
54 |
|
Total stock-based compensation |
|
$ |
2,610 |
|
|
$ |
2,932 |
|
|
X |
- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.24.1.u1
Income Taxes
|
3 Months Ended |
Mar. 31, 2024 |
Income Tax Disclosure [Abstract] |
|
Income Taxes |
9. Income Taxes During the three months ended March 31, 2024 and 2023, the Company recorded a full valuation allowance on federal and state net deferred tax assets since management does not forecast the Company to be in a taxable position in the near future.
|
X |
- 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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v3.24.1.u1
Net Loss per Share
|
3 Months Ended |
Mar. 31, 2024 |
Earnings Per Share [Abstract] |
|
Net Loss per Share |
10. Net Loss per Share The Company excluded all outstanding stock options and restricted stock awards at each period end from the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect. The following common stock equivalents were excluded from the calculation of diluted net loss per share:
|
|
|
|
|
|
|
|
|
|
|
As of March 31, |
|
|
|
2024 |
|
|
2023 |
|
Options to purchase common stock |
|
|
9,065,479 |
|
|
|
5,310,011 |
|
Unvested RSUs |
|
|
1,136,411 |
|
|
|
374,899 |
|
Expected shares to be purchased under 2020 ESPP |
|
|
11,405 |
|
|
|
47,974 |
|
Total |
|
|
10,213,295 |
|
|
|
5,732,884 |
|
|
X |
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- DefinitionThe entire disclosure for earnings per share.
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v3.24.1.u1
Related Parties
|
3 Months Ended |
Mar. 31, 2024 |
Related Party Transactions [Abstract] |
|
Related Parties |
11. Related Parties The Company has consulting agreements with three members of its board of directors; one of which waived his consulting fees starting as of September 2021. Total consulting fees paid during the three months ended March 31, 2024 and 2023 were $37 and $8, respectively. There were no amounts owed under the consulting agreements as of March 31, 2024.
|
X |
- 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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v3.24.1.u1
Restructuring
|
3 Months Ended |
Mar. 31, 2024 |
Restructuring and Related Activities [Abstract] |
|
Restructuring |
12. Restructuring On January 18, 2024, the Company announced a restructuring plan involving the reduction of its workforce by approximately 30% of the Company's employees. Substantially all of the costs under the restructuring plan were incurred during the three months ended March 31, 2024. The remaining expected costs are not expected to be material and will be complete by September 30, 2024. The Company is taking these steps in order to streamline operations, reduce costs and preserve capital as it advances into late-stage development for its lead product candidate, PC14586. As a result of the reduction in force, the Company incurred an aggregate non-recurring charge of $675, consisting primarily of employee severance and benefit costs associated with the restructuring. The Company has recorded these charges in research and development expenses in the accompanying condensed consolidated statement of operations based on responsibilities of the impacted employees. The restructuring expenditure of $675 was recognized in March 2024. The following sets forth information regarding the balances and activity associated with the Company's accrued employee severance and benefits costs (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2023 |
|
|
Expenses, net |
|
|
Cash |
|
|
Balance as of March 31, 2024 |
|
Employee severance and benefit costs |
|
— |
|
|
|
675 |
|
|
|
(392 |
) |
|
|
283 |
|
|
X |
- DefinitionThe entire disclosure for restructuring and related activities. Description of restructuring activities such as exit and disposal activities, include facts and circumstances leading to the plan, the expected plan completion date, the major types of costs associated with the plan activities, total expected costs, the accrual balance at the end of the period, and the periods over which the remaining accrual will be settled.
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v3.24.1.u1
Subsequent Event
|
3 Months Ended |
Mar. 31, 2024 |
Subsequent Events [Abstract] |
|
Subsequent Event |
13. Subsequent Event The State of New Jersey’s Technology Business Tax Certificate Program allows certain high technology and biotechnology companies to sell unused net operating loss (“NOL”) carryforwards and R&D tax credits to other New Jersey-based corporate taxpayers. We have applied for and received preliminary confirmation for our sale of NOLs and R&D tax credits related to the tax years ended December 31, 2015 to 2020 in the amount of approximately $16,176, which we expect to recognize in the second quarter of 2024, upon receipt of the certificates for the refund. Subsequent to March 31, 2024, the Company received the entire $16,176 of expected cash for the NOL and R&D tax credit sales.
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- DefinitionThe entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business.
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v3.24.1.u1
Summary of Significant Accounting Policies (Policies)
|
3 Months Ended |
Mar. 31, 2024 |
Accounting Policies [Abstract] |
|
Basis of Presentation |
Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information and with the interim period reporting requirements of Form 10-Q and Article 10 of Regulation S-X. The condensed consolidated balance sheet as of March 31, 2024, the condensed consolidated statements of operations and comprehensive loss, stockholders’ equity, and statements of cash flows for the three months ended March 31, 2024 and 2023, are unaudited, but, in the opinion of management, include all adjustments, consisting only of normal recurring adjustments, which we consider necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The results for any interim period are not necessarily indicative of results for the year ending December 31, 2024, or for any other subsequent interim period. The condensed consolidated balance sheet as of December 31, 2023, has been derived from our audited condensed consolidated financial statements. The accompanying condensed consolidated financial statements include our accounts and the accounts of our wholly owned subsidiary, PMV Pharma Australia Pvt Ltd. All significant intercompany transactions and balances have been eliminated upon consolidation. These condensed consolidated financial statements are presented in United States ("U.S.") Dollars, which is also the functional currency of the Company.
|
Use of Estimates |
Use of Estimates The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and reported amounts of revenues and expenses during the reporting period. The Company bases its estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, research and development costs, accrued research and development costs and related prepaid expenses. Actual results could differ materially from those estimates.
|
Cash, Cash Equivalents and Marketable Securities |
Cash, Cash Equivalents and Marketable Securities Management considers all highly liquid investments with original maturities of three months or less to be cash equivalents. The Company’s marketable debt securities have been classified and accounted for as available-for-sale. The Company classifies its marketable debt securities as either short-term or long-term based on each instrument’s underlying contractual maturity date. Marketable debt securities with maturities of 12 months or less are classified as short-term and marketable debt securities with maturities greater than 12 months are classified as long-term. The Company’s marketable debt securities are carried at fair value, with unrealized gains and losses, net of taxes, reported as a component of accumulated other comprehensive loss in stockholders’ equity. Premiums and discounts on marketable debt securities are amortized into earnings over the life of the security and recorded on the interest income, net line of the income statement. For the three months ended March 31, 2024 and 2023, the Company recorded $1,628 and $712 of accretion, respectively. Restricted cash as of March 31, 2024 and December 31, 2023 included a $822 deposit at the Company’s commercial bank underlying a stand-by letter of credit issued in favor of a landlord (See Note 6) and is classified in current assets.
|
Comprehensive Loss and Accumulated Other Comprehensive Income (Loss) |
Comprehensive Loss and Accumulated Other Comprehensive Income (Loss) Other comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources, including unrealized gains and losses on investments and foreign currency translation gains and losses.
|
Leases |
Leases At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the circumstances present. The Company accounts for a contract as a lease when it has the right to control the asset for a period of time while obtaining substantially all of the asset’s economic benefits. The Company determines the initial classification and measurement of its operating right-of-use (“ROU”) assets and operating lease liabilities at the lease commencement date, and thereafter if modified. The lease term includes any renewal options that the Company is reasonably certain to exercise. The Company’s policy is to not record leases with a lease term of 12 months or less on its balance sheets. The Company’s only existing leases are for office and laboratory space. The ROU asset represents the right to use the leased asset for the lease term. The lease liability represents the present value of the lease payments under the lease. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its estimated secured incremental borrowing rate for that lease term. Lease expense for operating leases is recognized on a straight-line basis over the reasonably assured lease term based on the total lease payments and is included in operating expense in the statements of operations. Payments due under each lease agreement include fixed and variable payments. Variable payments relate to the Company’s share of the lessor’s operating costs associated with the underlying asset and are recognized when the event on which those payments are assessed occurs. Variable payments have been excluded from the lease liability and associated right-of-use asset. Neither of the Company’s leases contain residual value guarantees. The interest rate implicit in lease agreements is typically not readily determinable, and as such, the Company utilizes the incremental borrowing rate to calculate lease liabilities, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment.
|
Concentration of Credit Risk and Other Risks and Uncertainties |
Concentration of Credit Risk and Other Risks and Uncertainties Financial instruments that potentially subject the Company to significant concentrations of credit risk consist of cash, cash equivalents and marketable securities. Cash and cash equivalents were held at two financial institutions. At times, such deposits may be in excess of insured limits. The Company has not experienced any losses on its deposits of cash and cash equivalents. The Company’s marketable securities are carried at fair value and include any unrealized gains and losses. Any investments with unrealized losses are considered to be temporarily impaired. The Company’s future results of operations involve a number of risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, rapid technological change, uncertainty of market acceptance of the product, competition from substitute products and larger companies, protection of proprietary technology, any future strategic relationships and dependence on key individuals. Products developed by the Company require clearances from the U.S. Food and Drug Administration or other international regulatory agencies prior to commercial sales. There can be no assurance the Company’s product candidates will receive the necessary clearances. If the Company is denied clearance, clearance is delayed or it is unable to maintain clearance, it could have a materially adverse impact on the Company.
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v3.24.1.u1
Fair Value Measurements (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Fair Value Disclosures [Abstract] |
|
Summary of Cash Equivalents and Available-for-sale Securities Carrying Amounts and Fair Values |
The Company’s financial assets consist of money market funds, U.S. government debt securities and corporate debt securities. The following tables show the Company’s cash equivalents and available-for-sale securities’ carrying amounts and fair values as of March 31, 2024, and December 31, 2023:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of March 31, 2024 |
|
|
|
Carrying Amount |
|
|
Gross Unrealized Gains |
|
|
Gross Unrealized Losses |
|
|
Fair Value |
|
|
Quoted priced in active markets (Level 1) |
|
|
Significant other observable inputs (Level 2) |
|
|
Significant unobservable inputs (Level 3) |
|
Financial assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
39,666 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
39,666 |
|
|
$ |
39,666 |
|
|
$ |
— |
|
|
$ |
— |
|
Corporate securities |
|
|
52,020 |
|
|
|
8 |
|
|
|
(16 |
) |
|
|
52,012 |
|
|
|
5,572 |
|
|
|
46,440 |
|
|
|
— |
|
Government securities |
|
|
121,494 |
|
|
|
— |
|
|
|
(120 |
) |
|
|
121,374 |
|
|
|
95,418 |
|
|
|
25,956 |
|
|
|
— |
|
Total financial assets |
|
$ |
213,180 |
|
|
$ |
8 |
|
|
$ |
(136 |
) |
|
$ |
213,052 |
|
|
$ |
140,656 |
|
|
$ |
72,396 |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2023 |
|
|
|
Carrying Amount |
|
|
Gross Unrealized Gains |
|
|
Gross Unrealized Losses |
|
|
Fair Value |
|
|
Quoted Priced in Active Markets (Level 1) |
|
|
Significant Other Observable Inputs (Level 2) |
|
|
Significant Unobservable Inputs (Level 3) |
|
Financial assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
37,694 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
37,694 |
|
|
$ |
37,694 |
|
|
$ |
— |
|
|
$ |
— |
|
Corporate securities |
|
|
69,995 |
|
|
|
48 |
|
|
|
— |
|
|
|
70,043 |
|
|
|
5,577 |
|
|
|
64,466 |
|
|
|
— |
|
Government securities |
|
|
120,670 |
|
|
|
143 |
|
|
|
— |
|
|
|
120,813 |
|
|
|
92,297 |
|
|
|
28,516 |
|
|
|
— |
|
Total financial assets |
|
$ |
228,359 |
|
|
$ |
191 |
|
|
$ |
— |
|
|
$ |
228,550 |
|
|
$ |
135,568 |
|
|
$ |
92,982 |
|
|
$ |
— |
|
|
X |
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v3.24.1.u1
Property and Equipment, Net (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Property, Plant and Equipment [Abstract] |
|
Summary of Property and Equipment, Net |
|
|
|
|
|
|
|
|
|
|
|
March 31, 2024 |
|
|
December 31, 2023 |
|
Machinery & equipment |
|
|
3,089 |
|
|
$ |
3,089 |
|
Computers |
|
|
13 |
|
|
|
13 |
|
Furniture & fixtures |
|
|
69 |
|
|
|
69 |
|
Leasehold improvements |
|
|
11,364 |
|
|
|
10,765 |
|
Total property and equipment |
|
|
14,535 |
|
|
|
13,936 |
|
Less: Accumulated depreciation |
|
|
(3,632 |
) |
|
|
(3,270 |
) |
Property and equipment, net |
|
$ |
10,903 |
|
|
$ |
10,666 |
|
|
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v3.24.1.u1
Accrued Expenses (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Payables and Accruals [Abstract] |
|
Summary of Accrued Expenses |
Accrued expenses consist of the following:
|
|
|
|
|
|
|
|
|
|
|
March 31, 2024 |
|
|
December 31, 2023 |
|
Accrued compensation |
|
$ |
2,220 |
|
|
$ |
4,498 |
|
Accrued legal and professional services |
|
|
248 |
|
|
|
172 |
|
Accrued research and development costs |
|
|
7,851 |
|
|
|
5,270 |
|
Total |
|
$ |
10,319 |
|
|
$ |
9,940 |
|
|
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v3.24.1.u1
Commitments and Contingencies (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
Summary of Components of Lease Cost |
The components of lease cost for the three months ended March 31, 2024 and 2023, are as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
(in thousands) |
|
2024 |
|
|
2023 |
|
Operating lease cost |
|
$ |
355 |
|
|
$ |
597 |
|
Variable lease cost |
|
|
133 |
|
|
|
319 |
|
Total lease cost |
|
$ |
488 |
|
|
$ |
916 |
|
|
Schedule of Amounts Reported in Consolidated Balance Sheets for Leases |
Amounts reported in the balance sheet for leases where the Company is the lessee as of March 31, 2024, and December 31, 2023, are as follows:
|
|
|
|
|
|
|
|
|
Operating Leases (in thousands, except lease term and discount rate data): |
|
March 31, 2024 |
|
|
December 31, 2023 |
|
Right-of-use assets, operating leases |
|
$ |
8,211 |
|
|
$ |
8,382 |
|
|
|
|
|
|
|
|
Operating lease liabilities, current |
|
$ |
880 |
|
|
$ |
852 |
|
Operating lease liabilities, non-current |
|
|
12,142 |
|
|
|
12,434 |
|
Total operating lease liabilities |
|
$ |
13,022 |
|
|
$ |
13,286 |
|
|
|
|
|
|
|
|
Weighted-average remaining lease term (years) |
|
|
8.17 |
|
|
|
8.42 |
|
Weighted-average discount rate |
|
|
5.75 |
% |
|
|
5.75 |
% |
|
Summary of Other Information Related to Leases |
Other information related to leases for the three months ended March 31, 2024 and 2023, respectively, as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
(in thousands) |
|
2024 |
|
|
2023 |
|
Net cash paid for amounts included in the measurement of lease liabilities |
|
$ |
447 |
|
|
$ |
686 |
|
|
Schedule of Minimum Lease Payments, Net of Reimbursements, under Operating Leases |
Future minimum lease payments, net of reimbursements, remaining as of March 31, 2024, under operating leases by fiscal year were as follows:
|
|
|
|
|
Fiscal year |
|
(in thousands) |
|
2024 |
|
$ |
1,127 |
|
2025 |
|
|
1,869 |
|
2026 |
|
|
1,925 |
|
2027 |
|
|
1,983 |
|
2028 |
|
|
2,042 |
|
Thereafter |
|
|
7,453 |
|
Total minimum lease payments |
|
$ |
16,399 |
|
Less: Amounts representing imputed interest |
|
|
(3,377 |
) |
Present value of lease liabilities |
|
$ |
13,022 |
|
|
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- DefinitionTabular disclosure of lessee's lease cost. Includes, but is not limited to, interest expense for finance lease, amortization of right-of-use asset for finance lease, operating lease cost, short-term lease cost, variable lease cost and sublease income.
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v3.24.1.u1
Stock Plan (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Schedule of Stock Options Activity |
The following table summarizes option activity for the three-month period ended March 31, 2024:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Average |
|
|
Aggregate |
|
|
|
Shares |
|
|
|
|
|
Average |
|
|
Remaining |
|
|
Intrinsic |
|
|
|
Available |
|
|
Number of |
|
|
Exercise |
|
|
Contractual Life |
|
|
Value |
|
|
|
for Grant |
|
|
Options |
|
|
Price |
|
|
(in years) |
|
|
(in 000s) |
|
Balances at December 31, 2023 |
|
|
4,474,411 |
|
|
|
6,973,464 |
|
|
$ |
9.44 |
|
|
|
7.01 |
|
|
$ |
990 |
|
Shares reserved for issuance |
|
|
2,572,174 |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
Options granted |
|
|
(2,776,030 |
) |
|
|
2,776,030 |
|
|
$ |
1.79 |
|
|
|
|
|
|
|
Options forfeited / cancelled |
|
|
684,015 |
|
|
|
(684,015 |
) |
|
$ |
9.41 |
|
|
|
|
|
|
|
Options exercised |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
Balances at March 31, 2024 (unaudited) |
|
|
4,954,570 |
|
|
|
9,065,479 |
|
|
$ |
7.10 |
|
|
|
6.91 |
|
|
$ |
273 |
|
At March 31, 2024 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and expected to vest |
|
|
|
|
|
9,065,479 |
|
|
$ |
7.10 |
|
|
|
6.91 |
|
|
$ |
273 |
|
Exercisable |
|
|
|
|
|
4,506,573 |
|
|
$ |
8.87 |
|
|
|
4.54 |
|
|
$ |
259 |
|
|
Schedule of Estimated Fair Value of Stock Options |
The Company estimated the fair value of the options using the Black-Scholes options valuation model. The fair value of the options is being amortized on a straight-line basis over the requisite service period of the awards. The fair value was estimated using the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
March 31, |
|
|
|
2024 |
|
|
2023 |
|
Risk-free interest rate |
|
|
3.82% - 4.26% |
|
|
|
3.58% |
|
Expected life (in years) |
|
|
6.02 - 6.25 |
|
|
|
6.25 |
|
Dividend yield |
|
|
0% |
|
|
|
0% |
|
Expected volatility |
|
|
86.76% |
|
|
|
79.90% |
|
|
Schedule of RSU Activity Under the 2020 Plan |
The following table presents RSU activity under the 2020 Plan as of March 31, 2024:
|
|
|
|
|
|
|
|
|
|
|
Number of Stock Units |
|
|
Weighted-Average Grant Date Fair Value |
|
Unvested shares at December 31, 2023 |
|
|
236,296 |
|
|
$ |
13.60 |
|
Granted |
|
|
952,665 |
|
|
|
1.80 |
|
Forfeited |
|
|
(52,550 |
) |
|
|
3.50 |
|
Unvested shares at March 31, 2024 |
|
|
1,136,411 |
|
|
$ |
4.18 |
|
|
Stock-based Compensation Expense Related to Stock Options and RSU's Granted and Common Stock Issued under 2020 ESPP Recorded and Allocated |
Stock-based compensation expense recorded under ASC 718 related to stock options and RSUs granted and common stock issued under the 2020 ESPP were allocated to research and development and general and administrative expense as follows:
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended |
|
|
|
March 31, |
|
|
March 31, |
|
|
|
2024 |
|
|
2023 |
|
Research and development |
|
$ |
975 |
|
|
$ |
1,263 |
|
General and administrative |
|
|
1,635 |
|
|
|
1,669 |
|
Total stock-based compensation |
|
$ |
2,610 |
|
|
$ |
2,932 |
|
|
Schedule of Stock-based Compensation Expense by Award Type |
Stock-based compensation expense by award type included within the condensed consolidated statements of operations is as follows:
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended |
|
|
|
March 31, |
|
|
March 31, |
|
|
|
2024 |
|
|
2023 |
|
Stock options |
|
$ |
2,214 |
|
|
$ |
2,281 |
|
Restricted stock units |
|
|
342 |
|
|
|
597 |
|
Employee stock purchase plan |
|
|
54 |
|
|
|
54 |
|
Total stock-based compensation |
|
$ |
2,610 |
|
|
$ |
2,932 |
|
|
ESPP |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Schedule of Estimated Fair Value of Stock Options |
The weighted average assumptions used to estimate the fair value of stock purchase rights under the ESPP are as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
March 31, |
|
|
|
2024 |
|
|
2023 |
|
Risk-free interest rate |
|
|
5.43% |
|
|
|
4.65% |
|
Expected life (in years) |
|
|
0.49 |
|
|
|
0.49 |
|
Dividend yield |
|
|
0% |
|
|
|
0% |
|
Expected volatility |
|
|
76.22% |
|
|
|
76.33% |
|
|
X |
- DefinitionTabular disclosure of the changes in outstanding nonvested restricted stock shares.
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v3.24.1.u1
Net Loss per Share (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Earnings Per Share [Abstract] |
|
Schedule of Common Stock Equivalents Excluded from Calculation of Diluted Net Loss per Share |
The following common stock equivalents were excluded from the calculation of diluted net loss per share:
|
|
|
|
|
|
|
|
|
|
|
As of March 31, |
|
|
|
2024 |
|
|
2023 |
|
Options to purchase common stock |
|
|
9,065,479 |
|
|
|
5,310,011 |
|
Unvested RSUs |
|
|
1,136,411 |
|
|
|
374,899 |
|
Expected shares to be purchased under 2020 ESPP |
|
|
11,405 |
|
|
|
47,974 |
|
Total |
|
|
10,213,295 |
|
|
|
5,732,884 |
|
|
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v3.24.1.u1
Formation and Business of the Company - Additional Information (Details) - USD ($) $ in Thousands |
3 Months Ended |
|
Mar. 31, 2024 |
Mar. 31, 2023 |
Dec. 31, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
|
|
Net loss |
$ 15,270
|
$ 19,128
|
|
Cash used in operating activities |
16,184
|
$ 15,012
|
|
Accumulated deficit |
325,273
|
|
$ 310,003
|
Cash, cash equivalents, and marketable securities |
$ 213,059
|
|
|
X |
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Fair Value Measurements - Summary of Cash Equivalents and Available-for-sale Securities Carrying Amounts and Fair Values (Details) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] |
|
|
Carrying Amount |
$ 213,180
|
$ 228,359
|
Gross Unrealized Gains |
8
|
191
|
Gross Unrealized Losses |
(136)
|
|
Fair Value |
213,052
|
228,550
|
Quoted Priced in Active Markets (Level 1) |
|
|
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] |
|
|
Total financial assets |
140,656
|
135,568
|
Significant Other Observable Inputs (Level 2) |
|
|
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] |
|
|
Total financial assets |
72,396
|
92,982
|
Money Market Funds |
|
|
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] |
|
|
Carrying Amount |
39,666
|
37,694
|
Fair Value |
39,666
|
37,694
|
Money Market Funds | Quoted Priced in Active Markets (Level 1) |
|
|
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] |
|
|
Total financial assets |
39,666
|
37,694
|
Corporate Securities |
|
|
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] |
|
|
Carrying Amount |
52,020
|
69,995
|
Gross Unrealized Gains |
8
|
48
|
Gross Unrealized Losses |
(16)
|
|
Fair Value |
52,012
|
70,043
|
Corporate Securities | Quoted Priced in Active Markets (Level 1) |
|
|
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] |
|
|
Total financial assets |
5,572
|
5,577
|
Corporate Securities | Significant Other Observable Inputs (Level 2) |
|
|
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] |
|
|
Total financial assets |
46,440
|
64,466
|
Government Securities |
|
|
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] |
|
|
Carrying Amount |
121,494
|
120,670
|
Gross Unrealized Gains |
|
143
|
Gross Unrealized Losses |
(120)
|
|
Fair Value |
121,374
|
120,813
|
Government Securities | Quoted Priced in Active Markets (Level 1) |
|
|
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] |
|
|
Total financial assets |
95,418
|
92,297
|
Government Securities | Significant Other Observable Inputs (Level 2) |
|
|
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] |
|
|
Total financial assets |
$ 25,956
|
$ 28,516
|
X |
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Fair Value Measurements - Additional Information (Details) - USD ($)
|
Mar. 31, 2024 |
Dec. 31, 2023 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] |
|
|
Aggregate cash and cash equivalents |
$ 47,654,000
|
$ 37,706,000
|
Cash equivalents |
47,654,000
|
37,694,000
|
Marketable Securities |
165,405,000
|
190,856,000
|
Marketable securities, noncurrent |
15,120,000
|
25,505,000
|
Marketable securities, current |
150,285,000
|
165,351,000
|
Allowance for credit losses |
0
|
0
|
Corporate Debt Securities |
|
|
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] |
|
|
Marketable Securities |
44,031,000
|
70,043,000
|
Government Debt Securities |
|
|
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] |
|
|
Marketable Securities |
121,374,000
|
$ 120,813,000
|
Money Market Funds and Corporate Securities |
|
|
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] |
|
|
Cash equivalents |
$ 47,647,000
|
|
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v3.24.1.u1
Property and Equipment, Net - Summary of Property and Equipment, Net (Details) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
Property Plant And Equipment [Line Items] |
|
|
Total property and equipment |
$ 14,535
|
$ 13,936
|
Less: Accumulated depreciation |
(3,632)
|
(3,270)
|
Property and equipment, net |
10,903
|
10,666
|
Machinery & Equipment |
|
|
Property Plant And Equipment [Line Items] |
|
|
Total property and equipment |
3,089
|
3,089
|
Computers |
|
|
Property Plant And Equipment [Line Items] |
|
|
Total property and equipment |
13
|
13
|
Furniture & Fixtures |
|
|
Property Plant And Equipment [Line Items] |
|
|
Total property and equipment |
69
|
69
|
Leasehold Improvements |
|
|
Property Plant And Equipment [Line Items] |
|
|
Total property and equipment |
$ 11,364
|
$ 10,765
|
X |
- DefinitionAmount of accumulated depreciation, depletion and amortization for physical assets used in the normal conduct of business to produce goods and services.
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Commitments and Contingencies - Additional Information (Details)
|
1 Months Ended |
3 Months Ended |
39 Months Ended |
|
|
Jan. 31, 2022 |
Jan. 31, 2021
USD ($)
ft²
|
Aug. 31, 2018
ft²
Lease
|
Mar. 31, 2024
USD ($)
|
Mar. 31, 2023
USD ($)
|
Mar. 31, 2024
USD ($)
|
Jun. 30, 2017
ft²
|
Jun. 30, 2015
ft²
|
Commitments And Contingencies Disclosure [Line Items] |
|
|
|
|
|
|
|
|
Number of noncancelable operating leases | Lease |
|
|
2
|
|
|
|
|
|
Rent expense |
|
|
|
$ 355,000
|
$ 597,000
|
|
|
|
Cranbury, New Jersey |
|
|
|
|
|
|
|
|
Commitments And Contingencies Disclosure [Line Items] |
|
|
|
|
|
|
|
|
Area of operating lease property | ft² |
|
|
|
|
|
|
6,000
|
13,000
|
Operating lease expiration period |
2023-06
|
|
|
2022-06
|
|
|
|
|
Operating lease, existence of option to terminate [true false] |
true
|
|
|
|
|
|
|
|
Operating lease, option to terminate |
In January 2022, the Company signed a lease extension for both leases for up to one additional year through June 2023, with the option to terminate upon 120 days of written notice, with an increase in base rent as per the lease extension
|
|
|
|
|
|
|
|
Cranbury, New Jersey | Maximum |
|
|
|
|
|
|
|
|
Commitments And Contingencies Disclosure [Line Items] |
|
|
|
|
|
|
|
|
Operating lease, renewal term |
1 year
|
|
|
|
|
|
|
|
South Brunswick, New Jersey |
|
|
|
|
|
|
|
|
Commitments And Contingencies Disclosure [Line Items] |
|
|
|
|
|
|
|
|
Area of operating lease property | ft² |
|
|
6,000
|
|
|
|
|
|
Operating lease expiration period |
|
|
2022-07
|
|
|
|
|
|
Operating lease, existence of option to terminate [true false] |
true
|
|
|
|
|
|
|
|
Operating lease, option to terminate |
In January 2022, the Company signed a lease extension for up to one additional year through July 2023, with the option to terminate upon 120 days of written notice, with an increase in base rent as per the lease extension.
|
|
|
|
|
|
|
|
South Brunswick, New Jersey | Maximum |
|
|
|
|
|
|
|
|
Commitments And Contingencies Disclosure [Line Items] |
|
|
|
|
|
|
|
|
Operating lease, renewal term |
1 year
|
|
|
|
|
|
|
|
Lexington, Massachusetts |
|
|
|
|
|
|
|
|
Commitments And Contingencies Disclosure [Line Items] |
|
|
|
|
|
|
|
|
Operating lease expiration period |
|
|
2023-08
|
|
|
|
|
|
Terminated period |
|
|
|
2023-06
|
|
|
|
|
Princeton, New Jersey |
|
|
|
|
|
|
|
|
Commitments And Contingencies Disclosure [Line Items] |
|
|
|
|
|
|
|
|
Operating lease, description |
|
|
|
That lease term extends through 2032, has a five-year extension option, and replaced the Company’s two existing facilities as the Company’s headquarters in March 2023.
|
|
|
|
|
Lease area of square feet | ft² |
|
50,581
|
|
|
|
|
|
|
Operating Leases, extended year |
|
2032
|
|
|
|
|
|
|
Operating leases, extension period |
|
5 years
|
|
|
|
|
|
|
Operating lease, payments |
|
$ 19,889,000
|
|
|
|
|
|
|
Operating leases extended month and year |
|
2032-05
|
|
|
|
|
|
|
Tenant improvement allowance |
|
$ 4,046,000
|
|
|
|
|
|
|
Reimbursements received |
|
|
|
$ 0
|
|
$ 3,806,000
|
|
|
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v3.24.1.u1
Commitments and Contingencies - Schedule of Amounts Reported in Consolidated Balance Sheets for Leases (Details) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
Operating Leases: |
|
|
Right-of-use assets, operating leases |
$ 8,211
|
$ 8,382
|
Operating lease liabilities, current |
880
|
852
|
Operating lease liabilities, non-current |
12,142
|
12,434
|
Total operating lease liabilities |
$ 13,022
|
$ 13,286
|
Weighted-average remaining lease term (years) |
8 years 2 months 1 day
|
8 years 5 months 1 day
|
Weighted-average discount rate |
5.75%
|
5.75%
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v3.24.1.u1
Commitments and Contingencies - Schedule of Minimum Lease Payments, Net of Reimbursements, under Operating Leases (Details) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
|
2024 |
$ 1,127
|
|
2025 |
1,869
|
|
2026 |
1,925
|
|
2027 |
1,983
|
|
2028 |
2,042
|
|
Thereafter |
7,453
|
|
Total lease payments |
16,399
|
|
Less: Present Value Adjustment |
(3,377)
|
|
Present value of lease payments |
$ 13,022
|
$ 13,286
|
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v3.24.1.u1
Stockholders' Equity - Additional Information (Details) - USD ($)
|
|
3 Months Ended |
|
Oct. 04, 2021 |
Mar. 31, 2024 |
Dec. 31, 2023 |
Subsidiary, Sale of Stock [Line Items] |
|
|
|
Common stock, shares authorized |
|
1,000,000,000
|
1,000,000,000
|
Common stock, par value |
|
$ 0.00001
|
$ 0.00001
|
Common stock, shares issued |
|
51,445,862
|
51,445,862
|
Common stock, shares outstanding |
|
51,445,862
|
51,445,862
|
Preferred stock, shares authorized |
|
5,000,000
|
5,000,000
|
Preferred stock, par value |
|
$ 0.00001
|
$ 0.00001
|
Dividends, common stock declared |
|
$ 0
|
|
ATM Program |
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
Aggregate gross sales proceeds |
$ 150,000,000
|
|
|
Common stock shares sold |
|
0
|
|
Gross proceeds available for future issuances of common stock |
|
$ 113,800,000
|
|
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v3.24.1.u1
Stock Plan - Additional Information (Details) - USD ($) $ in Thousands |
|
|
3 Months Ended |
|
|
Jan. 18, 2024 |
Sep. 09, 2022 |
Mar. 31, 2024 |
Mar. 31, 2023 |
Jan. 01, 2024 |
Sep. 24, 2020 |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] |
|
|
|
|
|
|
Number of shares reserved for issuance |
|
|
|
|
514,434
|
|
Restricted stock units granted to employees |
|
|
952,665
|
|
|
|
Total compensation cost related to nonvested awards not yet recognized |
|
|
$ 16,250
|
|
|
|
Unrecognized compensation cost, weighted average period of recognition |
|
|
2 years 9 months 18 days
|
|
|
|
Dividend yield |
|
|
0.00%
|
0.00%
|
|
|
Restricted stock units |
|
|
|
|
|
|
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] |
|
|
|
|
|
|
Restricted stock units granted to employees |
952,665
|
374,899
|
|
|
|
|
Unrecognized compensation cost, weighted average period of recognition |
|
|
1 year 1 month 6 days
|
|
|
|
Unrecognized compensation cost |
|
|
$ 2,196
|
|
|
|
2020 Plan |
|
|
|
|
|
|
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] |
|
|
|
|
|
|
Number of shares reserved for issuance |
|
|
|
|
|
4,406,374
|
Number of additional shares reserved for issuance, minimum |
|
|
|
|
|
4,406,374
|
Percentage of number of shares of common stock outstanding increase |
|
|
|
|
|
5.00%
|
Number of additional shares reserved for issuance, maximum |
|
|
|
|
2,572,174
|
|
Shares issued |
|
|
4,954,570
|
|
|
|
2020 Plan | Restricted stock units |
|
|
|
|
|
|
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] |
|
|
|
|
|
|
Vesting period on an annual basis |
1 year 6 months
|
2 years
|
|
|
|
|
2020 ESPP |
|
|
|
|
|
|
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] |
|
|
|
|
|
|
Number of shares reserved for issuance |
|
|
1,571,266
|
|
|
400,752
|
Percentage of number of shares of common stock outstanding increase |
|
|
|
|
|
1.00%
|
Number of additional shares reserved for issuance, maximum |
|
|
|
|
|
801,504
|
Shares issued |
|
|
202,345
|
|
|
|
Shares outstanding |
|
|
202,345
|
|
|
|
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v3.24.1.u1
Stock Plan - Schedule of Stock Options Activity (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended |
12 Months Ended |
Mar. 31, 2024 |
Dec. 31, 2023 |
Shares Available For Grant |
|
|
Shares Available for Grant, Balance |
4,474,411
|
|
Shares Available for Grant, Shares reserved for issuance |
2,572,174
|
|
Shares Available for Grant, Options granted |
(2,776,030)
|
|
Shares Available for Grant, Options forfeited / cancelled |
684,015
|
|
Shares Available for Grant, Balance |
4,954,570
|
4,474,411
|
Number of Options |
|
|
Options Outstanding, Number of Options |
6,973,464
|
|
Options granted, Number of Options |
2,776,030
|
|
Options forfeited / cancelled, Number of Options |
(684,015)
|
|
Options Outstanding, Number of Options |
9,065,479
|
6,973,464
|
Vested and expected to vest, Number of Options |
9,065,479
|
|
Exercisable, Number of Options |
4,506,573
|
|
Weighted Average Exercise Price |
|
|
Options Outstanding, Weighted Average Exercise Price |
$ 9.44
|
|
Options granted, Weighted Average Exercise Price |
1.79
|
|
Options forfeited / cancelled, Weighted Average Exercise Price |
9.41
|
|
Options Outstanding, Weighted Average Exercise Price |
7.10
|
$ 9.44
|
Vested and expected to vest, Weighted Average Exercise Price |
7.1
|
|
Exercisable, Weighted Average Exercise Price |
$ 8.87
|
|
Weighted-Average Remaining Contractual Life |
|
|
Options Outstanding, Weighted-Average Remaining Contractual Life |
6 years 10 months 28 days
|
7 years 3 days
|
Vested and expected to vest, Weighted-Average Remaining Contractual Life |
6 years 10 months 28 days
|
|
Exercisable, Weighted-Average Remaining Contractual Life |
4 years 6 months 14 days
|
|
Aggregate Intrinsic Value |
|
|
Options Outstanding, Aggregate Intrinsic Value |
$ 273
|
$ 990
|
Vested and expected to vest, Aggregate Intrinsic Value |
273
|
|
Exercisable, Aggregate Intrinsic Value |
$ 259
|
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Stock Plan - Schedule of RSU Activity Under the 2020 Plan (Details)
|
3 Months Ended |
Mar. 31, 2024
$ / shares
shares
|
Share-Based Payment Arrangement [Abstract] |
|
Number of Stock Units, Beginning balance | shares |
236,296
|
Number of Stock Units, Granted | shares |
952,665
|
Number of Stock Units, Forfeited | shares |
(52,550)
|
Number of Stock Units, Ending balance | shares |
1,136,411
|
Weighted-Average Grant Date Fair Value, Beginning balance | $ / shares |
$ 13.6
|
Weighted-Average Grant Date Fair Value, Granted | $ / shares |
1.8
|
Weighted-Average Grant Date Fair Value, Forfeited | $ / shares |
3.5
|
Weighted-Average Grant Date Fair Value, Ending balance | $ / shares |
$ 4.18
|
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PMV Pharmaceuticals (NASDAQ:PMVP)
Gráfica de Acción Histórica
De Dic 2024 a Ene 2025
PMV Pharmaceuticals (NASDAQ:PMVP)
Gráfica de Acción Histórica
De Ene 2024 a Ene 2025