POINT Biopharma Global Inc. (NASDAQ: PNT) (the “Company” or
“POINT”), a company accelerating the discovery, development, and
global access to life-changing radiopharmaceuticals, today
announced financial results for the third quarter ended September
30, 2023, and provided a business update.
“The founding mission of our company is to
accelerate the discovery, development and global access to
radiopharmaceuticals,” said Joe McCann, Ph.D., CEO of POINT
Biopharma. “I view Lilly’s agreement to acquire POINT as validation
of the uniqueness of our team, infrastructure and pipeline.
Together, we can become a global radiopharmaceutical leader,
executing on our mission and transforming lives touched by
cancer."
POINT to be Acquired by
Lilly
On October 3, 2023, Eli Lilly and Company (NYSE:
LLY) and POINT Biopharma Global Inc. (NASDAQ: PNT) announced a
definitive agreement for Lilly to acquire POINT for a purchase
price of $12.50 per share in cash (an aggregate of approximately
$1.4 billion) payable at closing. The purchase price payable at
closing represents a premium of approximately 87% to POINT's
closing stock price on Oct. 2, 2023, the last trading day before
the announcement of the transaction, and 68% to the 30-day
volume-weighted average price. The tender offer, which was
previously scheduled to expire at one minute past 11:59 p.m.,
Eastern time, on Nov. 9, 2023, has been extended until 5:00 p.m.,
Eastern time, on Nov. 16, 2023, unless the tender offer is further
extended or earlier terminated, in order for the parties to satisfy
outstanding closing conditions. The proposed acquisition is
expected to close near the end of 2023, subject to customary
closing conditions, including the tender of at least a majority of
the outstanding Shares as of the expiration of the tender
offer.
Business Highlights and Upcoming
Milestones
Pipeline Updates
PNT2002:
177Lu-labelled PSMA-targeted radioligand
therapy
Enrollment in PNT2002's phase 3 SPLASH trial
(NCT04647526) is complete and topline data is expected in the
fourth quarter of 2023.
PNT2004: fibroblast activation protein-α
(FAP-α) targeted radioligand therapy
The PNT2004 program leverages the D-ala-boroPro
FAP targeting warhead, which is a potent and selective FAP
inhibitor. PNT6555 is the current clinical lead in the PNT2004
program.
The phase 1 FRONTIER trial (NCT05432193)
utilizing 68Ga/177Lu-labelled PNT6555 closed enrollment after the
dosing of cohort 3 (12 GBq) in October. There are no plans for
expansion of the third cohort, and there were no dose limiting
toxicities. Analysis of the dosimetry and clinical data from the
FRONTIER trial is underway and includes pancreatic ductal
adenocarcinoma, colorectal cancer, cholangiocarcinoma, and
esophageal cancer subjects.
Presentation of data from the FRONTIER study is
anticipated in the first half of 2024, and based on initial
promising data we expect to advance at least one 2nd-generation
D-ala-boroPro-based lead into the clinic next year.
PNT2001:
225Ac-labelled next-generation
PSMA-targeted radioligand therapy
For the phase 1 portion of ACCEL, the
first-in-human phase 1/2 clinical trial for PNT2001's actinium-225
program, we expect the first patient dosed in this trial to be in
the first quarter of 2024. The trial was designed to enable the
parallel exploration of PNT2001 in two populations: patients with
later-stage mCRPC and patients with earlier-stage BCR or
PSMA-positive oligorecurrent disease.
Manufacturing & Supply Chain
Updates
In July 2023, we announced an expanded agreement
with ITM Isotope Technologies Munich SE (ITM), which broadens the
supply of ITM’s no-carrier-added lutetium-177 (n.c.a. 177Lu) to
POINT to enable its usage in the clinical and potential future
commercial development of the 177Lu-based molecules in POINT’s
development pipeline.
In September 2023, we signed a supply agreement
with Eckert & Ziegler AG for no-carrier-added lutetium-177
(n.c.a. 177Lu).
Discovery Updates
In September 2023, we announced a collaboration
and license agreement to develop and commercialize DARPin-targeted
radioligands (“Radio-DARPins”). The collaboration gives POINT
exclusive access to Athebio’s intellectual property and
capabilities in DARPin development in the radioligand therapy
field. Together, the parties will collaborate in discovery,
candidate selection and preclinical development of Athebody®
DARPins for use as Radio-DARPin drug entities. POINT will be solely
responsible for the clinical development and commercialization of
Radio-DARPins translated from the discovery collaboration.
Third Quarter 2023 Financial
Results
Cash, Cash Equivalents, and
Investments: As of September 30, 2023, POINT had
approximately $399.0 million in cash, cash equivalents, and
investments, which is anticipated to fund operations into 2026.
Net Loss: Net loss was $24.8
million and $66.7 million, or $0.23 and $0.63 net loss per
share, for the three and nine months ended September 30, 2023,
respectively, as compared to a net loss of $24.0 million and
$65.0 million, or $0.26 and $0.71 net loss per share,
respectively, for the same periods in 2022.
Research and Development
Expenses: Research and development expenses were $26.9
million and $85.1 million for the three and nine months ended
September 30, 2023, respectively, as compared to $20.8 million and
$54.1 million, respectively, for the same periods in 2022.
General and Administrative
Expenses: General and administrative expenses were $5.5
million and $15.6 million for the three and nine months ended
September 30, 2023, respectively, as compared to $3.8 million and
$11.7 million for the same periods in 2022.
About POINT Biopharma Global
Inc.
POINT Biopharma Global Inc. is a globally
focused radiopharmaceutical company building a platform for the
clinical development and commercialization of radioligands that
fight cancer. POINT aims to transform precision oncology by
combining a portfolio of targeted radioligand assets, a seasoned
management team, an industry-leading pipeline, in-house
manufacturing capabilities, and secured supply for medical isotopes
including actinium-225 and lutetium-177. POINT’s active clinical
trials include FRONTIER, a phase 1 trial for PNT2004, a pan-cancer
program targeting fibroblast activation protein-α (FAP-α), and
SPLASH, the phase 3 trial for PNT2002 for people with metastatic
castration resistant prostate cancer (mCRPC) after second-line
hormonal treatment. Learn more about POINT Biopharma Global Inc. at
https://www.pointbiopharma.com/.
Additional Information and Where to Find it
In connection with the proposed acquisition of
POINT, Eli Lilly and Company (“Lilly”) caused its acquisition
subsidiary to commence a tender offer for all of the issued and
outstanding shares of common stock of POINT. This communication is
for informational purposes only and is neither an offer to purchase
nor a solicitation of an offer to sell any securities, nor is it a
substitute for the tender offer materials that Lilly and its
acquisition subsidiary filed with the SEC upon commencement of the
tender offer. A solicitation and offer to buy outstanding shares of
POINT is being made only pursuant to the tender offer materials
that Lilly and its acquisition subsidiary have filed with the SEC.
Lilly and its acquisition subsidiary have filed with the SEC a
tender offer statement on Schedule TO, and POINT has filed a
Solicitation/Recommendation Statement on Schedule 14D-9 with the
SEC with respect to the tender offer. THE TENDER OFFER MATERIALS
(INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL
AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE
SOLICITATION/RECOMMENDATION STATEMENT CONTAIN IMPORTANT INFORMATION
ABOUT THE PROPOSED TRANSACTION AND THE PARTIES THERETO. INVESTORS
AND STOCKHOLDERS OF POINT ARE URGED TO READ THESE DOCUMENTS
CAREFULLY (AS EACH MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO
TIME) BECAUSE THEY CONTAIN IMPORTANT INFORMATION THAT INVESTORS AND
STOCKHOLDERS OF POINT SHOULD CONSIDER BEFORE MAKING ANY DECISION
REGARDING TENDERING THEIR SHARES OF COMMON STOCK IN THE TENDER
OFFER. The tender offer materials (including the Offer to Purchase
and the related Letter of Transmittal) are available to all
stockholders of POINT at no expense to them at Lilly’s website at
investor.lilly.com. The information contained in, or that can be
accessed through, Lilly’s website is not a part of, or incorporated
by reference in, this press release. The tender offer materials
(including the Offer to Purchase and the related Letter of
Transmittal), as well as the Solicitation/Recommendation Statement,
are also available for free on the SEC’s website at www.sec.gov. In
addition to the Offer to Purchase, the related Letter of
Transmittal and certain other tender offer documents, as well as
the Solicitation/Recommendation Statement, Lilly and POINT file
annual, quarterly, and current reports, proxy statements and other
information with the SEC. You may read any reports, statements or
other information filed by Lilly and POINT with the SEC for free on
the SEC’s website at www.sec.gov.
Forward Looking Statements
This press release contains forward-looking
statements within the meaning of the “safe harbor” provisions of
the Private Securities Litigation Reform Act of 1995. In some
cases, you can identify forward-looking statements by the following
words: “may,” “will,” “could,” “would,” “should,” “expect,”
“intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,”
“project,” “potential,” “continue,” “ongoing” or the negative of
these terms or other comparable terminology, although not all
forward-looking statements contain these words. These statements
involve risks, uncertainties and other factors that may cause
actual results, levels of activity, performance or achievements to
be materially different from the information expressed or implied
by these forward-looking statements. Although we believe that we
have a reasonable basis for each forward-looking statement
contained in this press release, we caution you that these
statements are based on a combination of facts and factors
currently known by us and our projections of the future, about
which we cannot be certain. Forward-looking statements in this
press release include, but are not limited to, statements about the
potential attributes and benefits of POINT’s product candidates,
the format and timing of POINT’s product development activities and
clinical trials, and timing of the closing of the proposed
acquisition. We cannot assure you that the forward-looking
statements in this press release will prove to be accurate. These
forward-looking statements are subject to a number of significant
risks and uncertainties that could cause actual results to differ
materially from expected results, including, among others, our
ability to grow and manage our growth profitably and retain our key
employees, the impact of COVID-19 on our business, the success,
cost and timing of our product development activities and clinical
trials, our ability to obtain and maintain regulatory approval for
our product candidates, our ability to obtain funding for our
operations, our ability to maintain the listing of our common stock
on NASDAQ, changes in applicable laws or regulations, that there
can be no guarantee that the proposed acquisition will be completed
in the anticipated timeframe or at all, that the conditions
required to complete the proposed acquisition will be met, that any
event, change or other circumstance that could give rise to the
termination of the definitive agreement for the proposed
acquisition will not occur, the possibility that POINT may be
adversely affected by other economic, business, and/or competitive
factors, and other risks and uncertainties, including those
described in our Annual Report on Form 10-K filed with the SEC on
March 27, 2023 and our quarterly report on Form 10-Q filed with the
SEC on November 13, 2023. Many of these factors are outside of
POINT’s control and are difficult to predict. Furthermore, if the
forward-looking statements prove to be inaccurate, the inaccuracy
may be material. In light of the significant uncertainties in these
forward-looking statements, you should not regard these statements
as a representation or warranty by us or any other person that we
will achieve our objectives and plans in any specified time frame,
or at all. The forward-looking statements in this press release
represent our views as of the date of this press release. We
anticipate that subsequent events and developments will cause our
views to change. However, while we may elect to update these
forward-looking statements at some point in the future, we have no
current intention of doing so except to the extent required by
applicable law. You should, therefore, not rely on these
forward-looking statements as representing our views as of any date
subsequent to the date of this press release.
Investor Relations
Contact:Daniel PearlsteinDirector,
Strategyinvestors@pointbiopharma.com
Unaudited Interim Condensed Consolidated Statements of
Operations
(In U.S. dollars, except for share amounts)
|
|
For the Three Months EndedSeptember
30, |
|
For the Nine Months EndedSeptember
30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Revenue |
|
$ |
2,789,993 |
|
|
$ |
— |
|
|
$ |
17,113,113 |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
26,910,286 |
|
|
|
20,797,406 |
|
|
|
85,097,331 |
|
|
|
54,112,136 |
|
General and administrative |
|
|
5,505,869 |
|
|
|
3,839,626 |
|
|
|
15,604,401 |
|
|
|
11,727,969 |
|
Total operating expenses |
|
|
32,416,155 |
|
|
|
24,637,032 |
|
|
|
100,701,732 |
|
|
|
65,840,105 |
|
Loss from operations |
|
|
(29,626,162 |
) |
|
|
(24,637,032 |
) |
|
|
(83,588,619 |
) |
|
|
(65,840,105 |
) |
Other income (expenses) |
|
|
5,723,258 |
|
|
|
804,463 |
|
|
|
16,584,265 |
|
|
|
1,318,236 |
|
Loss before income
taxes |
|
|
(23,902,904 |
) |
|
|
(23,832,569 |
) |
|
|
(67,004,354 |
) |
|
|
(64,521,869 |
) |
Income tax (provision)
benefit |
|
|
(871,449 |
) |
|
|
(180,500 |
) |
|
|
288,491 |
|
|
|
(452,021 |
) |
Net loss |
|
$ |
(24,774,353 |
) |
|
$ |
(24,013,069 |
) |
|
$ |
(66,715,863 |
) |
|
$ |
(64,973,890 |
) |
Net loss per basic and
diluted common share: |
|
|
|
|
|
|
|
|
Basic and diluted net loss per
common share |
|
$ |
(0.23 |
) |
|
$ |
(0.26 |
) |
|
$ |
(0.63 |
) |
|
$ |
(0.71 |
) |
Basic and diluted weighted
average common shares outstanding |
|
|
105,765,954 |
|
|
|
92,401,484 |
|
|
|
105,717,330 |
|
|
|
90,891,031 |
|
Interim Condensed Consolidated Balance
Sheets
(In U.S. dollars)
|
As at September 30,
2023(Unaudited) |
|
As at December 31,2022 |
Assets |
|
|
|
Cash, cash equivalents and investments |
$ |
398,956,509 |
|
|
$ |
541,331,271 |
|
Other assets |
|
78,747,911 |
|
|
|
36,991,465 |
|
Total
assets |
$ |
477,704,420 |
|
|
$ |
578,322,736 |
|
Liabilities and
Stockholders' Equity |
|
|
|
Liabilities |
$ |
53,512,034 |
|
|
$ |
91,368,943 |
|
Stockholders' equity |
|
424,192,386 |
|
|
|
486,953,793 |
|
Total liabilities and
stockholders' equity |
$ |
477,704,420 |
|
|
$ |
578,322,736 |
|
POINT Biopharma Global (NASDAQ:PNT)
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POINT Biopharma Global (NASDAQ:PNT)
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