PMV Pharmaceuticals Reports Full Year 2022 Financial Results and Corporate Highlights
01 Março 2023 - 10:00AM
PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology
company pioneering the discovery and development of small molecule,
tumor-agnostic therapies targeting p53, today reported financial
results for the full year ended December 31, 2022, and provided a
corporate update.
“Our team successfully delivered on key clinical
development milestones in 2022, highlighted by the preliminary
monotherapy data from the ongoing PYNNACLE study, and the
initiation of a separate combination arm of PC14586 with KEYTRUDA,”
said David Mack, Ph.D., President and Chief Executive Officer. “The
initial PC14586 data have demonstrated clinical proof of concept
for PC14586 as a monotherapy to selectively reactivate p53 across
multiple tumor types. In alignment with FDA draft guidance on
Project Optimus, we continue to enroll additional patients in the
PYNNACLE study and intend to provide a comprehensive clinical and
regulatory update, including our recommended Phase 2 dose, in the
second half of 2023.”
Full Year 2022 and Recent Corporate
Highlights:
- Preliminary results from the ongoing Phase 1/2 PYNNACLE study
of PC14586 in patients with advanced solid tumors harboring a p53
Y220C mutation were featured in an oral presentation at the
American Society of Clinical Oncology (ASCO) 2022 Annual Meeting.
Patient enrollment in PYNNACLE continues on track.
- Enrolled the first patient in a combination arm of the PYNNACLE
study evaluating PC14586 in combination with KEYTRUDA®
(pembrolizumab) in patients with advanced solid tumors harboring a
p53 Y220C mutation. PMV and Merck entered into a collaboration in
2022 under the terms of which Merck will supply KEYTRUDA for this
study.
- Appointed Kirsten Flowers and Carol Gallagher, Pharm.D. to the
Board of Directors. Ms. Flowers and Dr. Gallagher each bring
decades of experience in drug development and
commercialization.
- Promotion of Michael Carulli to Senior Vice President, Finance.
Mr. Carulli joined PMV in 2020 and has made significant
contributions in building the finance function as the company
transitioned to becoming a publicly traded company.
- Primary focus on the clinical development of PC14586 and the
pipeline program R282W. The WIP-1 and R273H programs have been put
on hold which we expect will extend the company’s projected cash
runway to 1H 2025.
- Global headquarters moved to Princeton, NJ.
Fiscal Year 2022 Financial
Results
- As of December 31, 2022, PMV Pharma had $243.5 million in cash,
cash equivalents, and marketable securities, compared to $314.1
million at December 31, 2021. Net cash used in operations was $63.8
million for the year ended December 31, 2022, compared to $46.6
million for the year ended December 31, 2021.
- Net loss for the year ended December 31, 2022, was $73.3
million compared to $57.8 million for the year ended December 31,
2021.
- Research and development (R&D) expenses were $52.0 million
for the year ended December 31, 2022, compared to $36.5 million for
the year ended December 31, 2021. The increase in R&D expenses
was primarily related to increased headcount and clinical expenses
for advancing PC14586, the Company’s lead drug candidate.
- General and administrative (G&A) expenses were $25.1
million for the year ended December 31, 2022, compared to $21.8
million for the year ended December 31, 2021. The increase in
G&A expenses was primarily due to expanding the infrastructure
necessary for operating as a public company.
KEYTRUDA® (pembrolizumab) is a
registered trademark of Merck Sharp & Dohme LLC., a subsidiary
of Merck & Co., Inc., Rahway, NJ, USA.
About PC14586
PC14586 is a first-in-class, small molecule, p53
reactivator designed to selectively bind to the crevice present in
the p53 Y220C mutant protein, hence, restoring the wild-type, or
normal, p53 protein structure and tumor-suppressing function. The
U.S. Food and Drug Administration granted Fast Track designation to
PC14586 for the treatment of patients with locally advanced or
metastatic solid tumors that have a p53 Y220C mutation. For more
information about the Phase 1/2 PYNNACLE trial (PMV-586-101), refer
to www.clinicaltrials.gov (NCT study identifier NCT04585750).
About PMV Pharma
PMV Pharma is a precision oncology company
pioneering the discovery and development of small molecule,
tumor-agnostic therapies targeting p53. 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. Bringing together leaders in the field to
utilize over four decades of p53 biology, PMV Pharma combines
unique biological understanding with pharmaceutical development
focus. PMV Pharma is headquartered in Princeton, New Jersey. For
more information, please visit www.pmvpharma.com.
Forward-Looking Statements
Statements contained in this press release
regarding matters that are not historical facts are
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. Because such statements
are subject to risks and uncertainties, actual results may differ
materially from those expressed or implied by such forward-looking
statements. Such statements include, but are not limited to,
statements regarding the Company’s future plans or expectations for
PC14586, including expectations regarding progress and timing for
its Phase 1 update for the PYNNACLE study and its Phase 1/2
combination trial of PC14586 and KEYTRUDA, as well as expectations
regarding the success of its current clinical trial for PC14586 and
any future commercialization plans for the product candidate, and
its guidance on its expected cash runway. Any forward-looking
statements in this statement are based on management’s current
expectations of future events and are subject to a number of risks
and uncertainties that could cause actual results to differ
materially and adversely from those set forth in or implied by such
forward-looking statements. Risks that contribute to the uncertain
nature of the forward-looking statements include: the success,
cost, and timing of the Company’s product candidate development
activities and clinical trials, the Company’s ability to execute on
its strategy and operate as an early clinical stage company, the
potential for clinical trials of PC14586 or any future clinical
trials of other product candidates to differ from preclinical,
preliminary or expected results, the Company’s ability to fund
operations, and the impact that the current COVID-19 pandemic will
have on the Company’s clinical trials, supply chain, and
operations, as well as those risks and uncertainties set forth in
the section entitled “Risk Factors” in the Company’s Annual Report
on Form 10-K filed with the Securities and Exchange Commission (the
“SEC”) on March 1, 2023, and its other filings filed with the SEC.
All forward-looking statements contained in this press release
speak only as of the date on which they were made. The Company
undertakes no obligation to update such statements to reflect
events that occur or circumstances that exist after the date on
which they were made.
PMV Pharmaceuticals,
Inc.Balance Sheets(in
thousands)
|
|
December 31,2022 |
|
|
December 31,2021 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
108,297 |
|
|
$ |
172,467 |
|
Restricted cash |
|
|
822 |
|
|
|
822 |
|
Marketable securities,
current |
|
|
132,757 |
|
|
|
124,696 |
|
Prepaid expenses and other
current assets |
|
|
5,130 |
|
|
|
3,301 |
|
Total current assets |
|
|
247,006 |
|
|
|
301,286 |
|
Property and equipment, net |
|
|
10,955 |
|
|
|
3,090 |
|
Marketable securities,
noncurrent |
|
|
2,495 |
|
|
|
16,911 |
|
Right-of-use assets |
|
|
9,539 |
|
|
|
10,060 |
|
Other assets |
|
|
313 |
|
|
|
221 |
|
Total assets |
|
$ |
270,308 |
|
|
$ |
331,568 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
2,996 |
|
|
$ |
3,189 |
|
Accrued expenses |
|
|
7,308 |
|
|
|
8,627 |
|
Operating lease liabilities,
current |
|
|
528 |
|
|
|
403 |
|
Total current liabilities |
|
|
10,832 |
|
|
|
12,219 |
|
Operating lease liabilities,
noncurrent |
|
|
13,448 |
|
|
|
10,790 |
|
Total liabilities |
|
|
24,280 |
|
|
|
23,009 |
|
Stockholders’ equity: |
|
|
|
|
|
|
Additional paid-in capital |
|
|
487,516 |
|
|
|
476,363 |
|
Accumulated deficit |
|
|
(241,043 |
) |
|
|
(167,726 |
) |
Accumulated other comprehensive
loss |
|
|
(445 |
) |
|
|
(78 |
) |
Total stockholders' equity |
|
|
246,028 |
|
|
|
308,559 |
|
Total liabilities and
stockholders’ equity |
|
$ |
270,308 |
|
|
$ |
331,568 |
|
|
PMV Pharmaceuticals,
Inc.Condensed Statements of Operations and
Comprehensive Loss(in thousands, except share and
per share amounts)
|
|
Year Ended |
|
|
December 31,2022 |
|
|
December 31,2021 |
|
Operating
expenses: |
|
|
|
|
|
|
Research and development |
|
$ |
51,988 |
|
|
$ |
36,493 |
|
General and administrative |
|
|
25,052 |
|
|
|
21,800 |
|
Total operating expenses |
|
|
77,040 |
|
|
|
58,293 |
|
Loss from operations |
|
|
(77,040 |
) |
|
|
(58,293 |
) |
Other income (expense): |
|
|
|
|
|
|
Interest income, net |
|
|
3,627 |
|
|
|
449 |
|
Other income (expense), net |
|
|
87 |
|
|
|
21 |
|
Total other income (expense) |
|
|
3,714 |
|
|
|
470 |
|
Loss before (benefit) provision
for income taxes |
|
|
(73,326 |
) |
|
|
(57,823 |
) |
(Benefit) provision for income
taxes |
|
|
(9 |
) |
|
|
23 |
|
Net loss |
|
|
(73,317 |
) |
|
|
(57,846 |
) |
Unrealized (loss) gain on
available for sale investments, net of tax |
|
|
(367 |
) |
|
|
(78 |
) |
Comprehensive loss |
|
$ |
(73,684 |
) |
|
$ |
(57,924 |
) |
Net loss per share -- basic and
diluted |
|
$ |
(1.61 |
) |
|
$ |
(1.28 |
) |
Weighted-average common shares
outstanding |
|
|
45,594,824 |
|
|
|
45,137,656 |
|
|
|
|
|
|
|
|
|
|
Contacts
Investor Contact:
Winston KungPMV Pharmaceuticals,
Inc.investors@pmvpharma.com
Media Contact:
Kathy VincentGreig
Communicationskathy@greigcommunications.com
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