PMV Pharmaceuticals Reports Second Quarter 2023 Financial Results and Corporate Highlights
09 Agosto 2023 - 2:00PM
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 second quarter ended June 30, 2023, and
provided a corporate update.
PMV recently concluded an End-of-Phase 1 meeting
with the U.S. Food and Drug Administration (FDA) focused on gaining
alignment with the Agency regarding the clinical and regulatory
pathway for developing PC14586 for the treatment of patients with
locally advanced or metastatic solid tumors that have a p53 Y220C
mutation. Alignment with the FDA was obtained on the recommended
Phase 2 dose as well as key elements of the Phase 2 registrational
portion of the PYNNACLE trial. PMV plans to initiate the single
arm, Phase 2 portion of the PYNNACLE study in early 2024.
“Our ongoing PYNNACLE study of PC14586 in
patients with advanced solid tumors continues to make good
progress,” said David Mack, Ph.D., President and Chief Executive
Officer. “The positive outcome of our recently held End-of-Phase 1
meeting positions us to initiate a registrational trial for PC14586
and is an important milestone in our goal of bringing PC14586 to
advanced cancer patients with a p53 Y220C mutation. Furthermore, we
look forward to sharing updated Phase 1 data in the second half of
the year.”
Dr. Mack added, “We are also very pleased to
welcome Dr. Masha Poyurovsky to PMV as Vice President of Biology.
Her scientific expertise in p53 biology and proven track record in
translational drug development make her the ideal candidate to lead
our biology team. I look forward to Masha’s leadership and
contributions as we continue to leverage the potential of p53
targeted therapies.”
Second Quarter 2023 and Recent Corporate
Highlights:
- Ongoing
enrollment in the combination arm of PYNNACLE evaluating PC14586
with KEYTRUDA® (pembrolizumab). PMV and Merck entered into a
collaboration in 2022 under the terms of which Merck will supply
KEYTRUDA for this study.
- Appointed Masha
Poyurovsky, Ph.D., as Vice President of Biology. Dr. Poyurovsky has
more than a decade of experience leading novel platforms and a
track record of advancing therapies from concept to the clinic.
From 2011 to 2023, she was employed at Kadmon (acquired by Sanofi
in 2021) most recently as Vice President, Discovery Biology. Prior
to working in industry, she was a Research Scientist and a
Postdoctoral Research Fellow at Columbia University where she
conducted studies on p53 in the laboratory of Professor Carol
Prives. She is the author and co-author of numerous publications
and patents in the area of cancer biology and drug discovery. Dr.
Poyurovsky obtained a doctorate in biochemistry from Columbia
University and a bachelor of science in biochemistry and biophysics
from the University of Pittsburgh.
Second Quarter 2023 Financial
Results
- PMV Pharma ended
the second quarter with $218.8 million in cash, cash
equivalents, and marketable securities, compared to $277.4
million as of June 30, 2022. Net cash used in operations
was $27.9 million for the six months ended June 30,
2023, compared to $31.7 million for the six months
ended June 30, 2022.
- Net loss for the
six months ended June 30, 2023, was $36.6
million compared to $35.7 million for the six months
ended June 30, 2022.
- Research and
development (R&D) expenses were $28.9 million for the
six months ended June 30, 2023, compared to $23.3
million for the six months ended June 30, 2022. The
increase in R&D expenses was primarily related to increased
headcount and clinical expenses to advance research on PC14586, the
Company’s lead drug candidate.
- General and
administrative (G&A) expenses were $12.7 million for
the six months ended June 30, 2023, compared to $13.2
million for the six months ended June 30, 2022. The
decrease in G&A expenses was primarily due to facility related
costs now allocated to research as our new laboratory building in
Princeton, New Jersey began operations.
KEYTRUDA® (pembrolizumab) is a registered
trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck
& Co., Inc., Rahway, NJ, USA.
PMV Pharmaceuticals,
Inc.Condensed Balance
Sheets(unaudited)(in thousands,
except share and per share amounts)
|
|
|
|
June 30,2023
(unaudited) |
|
|
December 31,2022 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
68,209 |
|
|
$ |
108,297 |
|
Restricted cash |
|
|
822 |
|
|
|
822 |
|
Marketable securities, current |
|
|
118,878 |
|
|
|
132,757 |
|
Prepaid expenses and other current assets |
|
|
2,504 |
|
|
|
5,130 |
|
Total current assets |
|
|
190,413 |
|
|
|
247,006 |
|
Property and equipment, net |
|
|
11,136 |
|
|
|
10,955 |
|
Marketable securities,
noncurrent |
|
|
31,757 |
|
|
|
2,495 |
|
Right-of-use assets |
|
|
8,729 |
|
|
|
9,539 |
|
Other assets |
|
|
181 |
|
|
|
313 |
|
Total assets |
|
$ |
242,216 |
|
|
$ |
270,308 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
3,489 |
|
|
$ |
2,996 |
|
Accrued expenses |
|
|
7,940 |
|
|
|
7,308 |
|
Operating lease liabilities, current |
|
|
18 |
|
|
|
528 |
|
Total current liabilities |
|
|
11,447 |
|
|
|
10,832 |
|
Operating lease liabilities,
noncurrent |
|
|
12,960 |
|
|
|
13,448 |
|
Total liabilities |
|
|
24,407 |
|
|
|
24,280 |
|
Stockholders’ equity: |
|
|
|
|
|
|
Additional paid-in capital |
|
|
495,744 |
|
|
|
487,516 |
|
Accumulated deficit |
|
|
(277,607 |
) |
|
|
(241,043 |
) |
Accumulated other comprehensive loss |
|
|
(328 |
) |
|
|
(445 |
) |
Total stockholders’ equity |
|
|
217,809 |
|
|
|
246,028 |
|
Total liabilities and
stockholders’ equity |
|
$ |
242,216 |
|
|
$ |
270,308 |
|
PMV Pharmaceuticals, Inc.
Condensed Statements of Operations and
Comprehensive Loss(unaudited)(in
thousands, except share and per share amounts)
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
13,843 |
|
|
$ |
11,462 |
|
|
$ |
28,916 |
|
|
$ |
23,297 |
|
General and administrative |
|
|
6,279 |
|
|
|
6,423 |
|
|
|
12,686 |
|
|
|
13,206 |
|
Total operating expenses |
|
|
20,122 |
|
|
|
17,885 |
|
|
|
41,602 |
|
|
|
36,503 |
|
Loss from operations |
|
|
(20,122 |
) |
|
|
(17,885 |
) |
|
|
(41,602 |
) |
|
|
(36,503 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
|
2,696 |
|
|
|
604 |
|
|
|
5,022 |
|
|
|
832 |
|
Other income (expense), net |
|
|
(6 |
) |
|
|
(31 |
) |
|
|
20 |
|
|
|
(72 |
) |
Total other income (expense) |
|
|
2,690 |
|
|
|
573 |
|
|
|
5,042 |
|
|
|
760 |
|
Loss before (benefit) provision for income taxes |
|
|
(17,432 |
) |
|
|
(17,312 |
) |
|
|
(36,560 |
) |
|
|
(35,743 |
) |
(Benefit) provision for income taxes |
|
|
4 |
|
|
|
(2 |
) |
|
|
4 |
|
|
|
— |
|
Net loss |
|
|
(17,436 |
) |
|
|
(17,310 |
) |
|
|
(36,564 |
) |
|
|
(35,743 |
) |
Unrealized (loss) gain on available for sale investments, net of
tax |
|
|
(212 |
) |
|
|
(357 |
) |
|
|
117 |
|
|
|
(945 |
) |
Comprehensive loss |
|
$ |
(17,648 |
) |
|
$ |
(17,667 |
) |
|
$ |
(36,447 |
) |
|
$ |
(36,688 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share -- basic and diluted |
|
$ |
(0.38 |
) |
|
$ |
(0.38 |
) |
|
$ |
(0.80 |
) |
|
$ |
(0.79 |
) |
Weighted-average common shares outstanding |
|
|
45,813,132 |
|
|
|
45,571,067 |
|
|
|
45,793,355 |
|
|
|
45,518,845 |
|
|
|
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
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 timing for its Phase 1
clinical and regulatory update and the Phase 2 initiation for the
PYNNACLE study, as well as expectations regarding success of its
current clinical trial for PC14586 and any future commercialization
plans for the product candidate. 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 planned 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, the Company’s Quarterly
Report on Form 10-Q for the three months ended March 21, 2023,
filed with the SEC on May 10, 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.
Investors Contact:
Winston KungChief Financial Officerinvestors@pmvpharma.com
Media Contact:
Kathy VincentGreig
Communicationskathy@greigcommunications.com
Grafico Azioni PMV Pharmaceuticals (NASDAQ:PMVP)
Storico
Da Ago 2024 a Set 2024
Grafico Azioni PMV Pharmaceuticals (NASDAQ:PMVP)
Storico
Da Set 2023 a Set 2024