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 second quarter ended June 30,
2023, and provided a business update.
“This quarter, we began to reveal our strategy
to realize one of the great opportunities presented by radioligands
– the use of patient imaging to evaluate how candidate ligands
perform in humans before committing substantial time and resources
required to run an interventional trial,” said Joe McCann, Ph.D.,
CEO of POINT Biopharma. “Imaging can quickly reveal ligand
properties and expression of a molecular target. By pairing ligand
properties with complementary isotope properties, the potential for
therapeutic effect can be efficiently evaluated to optimize
clinical development decisions. We are committed to leveraging
these theranostic principles and making data-driven program
investment decisions in pursuit of accelerated development pathways
for new targeted radioligand therapies.”
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. Six trial sites remain open for recruitment
to complete a separate pharmacokinetic sub-study.
PNT2004: fibroblast activation protein-α
(FAP-α) targeted radioligand therapy
In May 2023, enrollment in cohort 3 of the phase
1 FRONTIER trial (NCT05432193) began, and a total of seven
participants have been dosed with 177Lu-PNT6555 to date. We
continue to anticipate data from the full FRONTIER study to be
available in the first half of 2024.
In June 2023, a Trial-in-Progress poster for
FRONTIER was presented at the 2023 American Society of Clinical
Oncology (ASCO) Annual Meeting, which included trial background
information, study design considerations, and a cohort enrollment
status update.
Later in June 2023, we published and presented
preclinical data at the 2023 Annual Meeting of the Society of
Nuclear Medicine & Molecular Imaging (SNMMI). The auger
electron and beta emitting isotope terbium-161 was paired with
POINT’s FAP-targeted PNT6555 ligand and showed robust anti-tumor
efficacy, similar to 225Ac-PNT6555 and 177Lu-PNT6555. Also,
preclinical proof-of-concept was established for synergistic
interaction of immuno- and radioligand therapies with
177Lu-PNT6555.
PNT2001:
225Ac-labelled next-generation
PSMA-targeted radioligand therapy
At our virtual Investor Day in June 2023, we
unveiled the trial design for the phase 1 portion of ACCEL, the
first-in-human phase 1/2 clinical trial for PNT2001's actinium-225
program. The trial was designed to enable the parallel exploration
of PNT2001 in two patient populations: later-stage mCRPC patients
and earlier-stage BCR or PSMA-positive oligorecurrent patients. We
anticipate a health authority submission in the fourth quarter of
2023, and expect the first patient dosed in this trial to be in the
first quarter of 2024.
Manufacturing & Supply Chain
Updates
In April 2023, we announced an agreement for the
supply of actinium-225 with Eckert & Ziegler. Eckert &
Ziegler will provide predetermined amounts of GMP grade
actinium-225 to POINT for use in the development of POINT’s
pipeline of next generation actinium-225-based radioligands.
In May 2023, we announced a collaboration to
create Ionetix Alpha Corp. (Ionetix-α). Ionetix-α, a new subsidiary
of IONETIX Corp., is focused on near-term, commercial-scale
production of GMP grade therapeutic isotopes, such as actinium-225.
IONETIX has transferred its alpha therapy isotope business assets
into Ionetix-α. POINT will invest $10 million into Ionetix-α.
In June 2023, we announced the intent to
collaborate with AdvanCell, an Australian clinical stage
radiopharmaceutical company, for the development of a global
lead-212 radioisotope and radioligand supply chain and drug
manufacturing network to specifically support the clinical
development and commercialization of lead-212-labeled radioligands
by each company.
Corporate Updates
In June 2023, Bridget Martell, M.A., M.D. was
appointed to our Board of Directors filling a previous vacancy.
In June 2023, we hosted a virtual Investor Day,
and a replay of the presentation can be found at this link
https://hub.pointbiopharma.com/investor-day-june-2023.
Second Quarter 2023 Financial
Results
Cash, Cash Equivalents, and
Investments: As of June 30, 2023, POINT had approximately
$434.8 million in cash, cash equivalents, and investments, which is
anticipated to fund operations into 2026.
Net Loss: Net loss was $25.4
million and $41.9 million, or $0.24 and $0.40 net loss per
share, for the three and six months ended June 30, 2023,
respectively, as compared to a net loss of $24.6 million and
$41.0 million, or $0.27 and $0.45 net loss per share,
respectively, for the same periods in 2022.
Research and Development
Expenses: Research and development expenses were $31.3
million and $58.2 million for the three and six months ended
June 30, 2023, respectively, as compared to $20.8 million and
$33.3 million, respectively, for the same periods in 2022.
General and Administrative
Expenses: General and administrative expenses were $5.1
million and $10.1 million for the three and six months ended
June 30, 2023, respectively, as compared to $4.1 million and
$7.9 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/.
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 and
the format and timing of POINT’s product development activities and
clinical trials. 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, 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. 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 Ended |
|
For the Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Revenue |
|
$ |
4,865,856 |
|
|
$ |
— |
|
|
$ |
14,323,120 |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
31,276,573 |
|
|
|
20,813,882 |
|
|
|
58,187,045 |
|
|
|
33,314,730 |
|
General and administrative |
|
|
5,088,403 |
|
|
|
4,080,401 |
|
|
|
10,098,532 |
|
|
|
7,888,343 |
|
Total operating expenses |
|
|
36,364,976 |
|
|
|
24,894,283 |
|
|
|
68,285,577 |
|
|
|
41,203,073 |
|
Loss from operations |
|
|
(31,499,120 |
) |
|
|
(24,894,283 |
) |
|
|
(53,962,457 |
) |
|
|
(41,203,073 |
) |
Other income (expenses) |
|
|
5,166,983 |
|
|
|
497,441 |
|
|
|
10,861,007 |
|
|
|
513,773 |
|
Loss before income
taxes |
|
|
(26,332,137 |
) |
|
|
(24,396,842 |
) |
|
|
(43,101,450 |
) |
|
|
(40,689,300 |
) |
Income tax benefit
(provision) |
|
|
921,298 |
|
|
|
(183,405 |
) |
|
|
1,159,940 |
|
|
|
(271,521 |
) |
Net loss |
|
$ |
(25,410,839 |
) |
|
$ |
(24,580,247 |
) |
|
$ |
(41,941,510 |
) |
|
$ |
(40,960,821 |
) |
Net loss per basic and
diluted common share: |
|
|
|
|
|
|
|
|
Basic and diluted net loss per
common share |
|
$ |
(0.24 |
) |
|
$ |
(0.27 |
) |
|
$ |
(0.40 |
) |
|
$ |
(0.45 |
) |
Basic and diluted weighted
average common shares outstanding |
|
|
105,724,215 |
|
|
|
90,124,295 |
|
|
|
105,692,615 |
|
|
|
90,123,288 |
|
Interim
Condensed Consolidated Balance Sheets |
(In U.S.
dollars) |
|
|
As at June 30, |
|
As at December 31, |
|
2023 |
|
2022 |
|
(Unaudited) |
|
|
Assets |
|
|
|
Cash, cash equivalents and investments |
$ |
434,796,562 |
|
|
$ |
541,331,271 |
|
Other assets |
|
62,978,210 |
|
|
|
36,991,465 |
|
Total
assets |
$ |
497,774,772 |
|
|
$ |
578,322,736 |
|
Liabilities and
Stockholders' Equity |
|
|
|
Liabilities |
$ |
50,322,854 |
|
|
$ |
91,368,943 |
|
Stockholders' equity |
|
447,451,918 |
|
|
|
486,953,793 |
|
Total liabilities and
stockholders' equity |
$ |
497,774,772 |
|
|
$ |
578,322,736 |
|
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