PMV Pharmaceuticals Reports Third Quarter 2022 Financial Results and Corporate Highlights
November 08 2022 - 8:00AM
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 third quarter ended September 30, 2022 and
provided a corporate update.
“PMV continues to advance its ongoing PYNNACLE
study evaluating PC14586, a first-in-class p53 Y220C reactivator,
in patients with advanced solid tumors and plans the next update in
the first half of 2023,” said David Mack, Ph.D., President, and
Chief Executive Officer. “In addition, we look forward to the
initiation of our clinical trial of PC14586 in combination with
KEYTRUDA. This study builds upon the promising, preliminary
tumor-agnostic clinical efficacy observed with PC14586 monotherapy
and allows us to explore the potential synergy between the two
agents to improve patient outcomes.”
Corporate Highlights:
- Continued
enrollment in the ongoing Phase 1/2 PYNNACLE trial of PC14586 in
patients with advanced solid tumors. Initial Phase 1 data presented
at the 2022 ASCO annual meeting demonstrated responses in patients
across multiple solid tumor types with a p53 Y220C mutation.
- On track to
initiate Phase 1b trial evaluating PC14586 in combination with
KEYTRUDA in Q4 2022.
- Appointed Carol
Gallagher, Pharm.D. to the Board of Directors. Dr. Gallagher brings
30 years of biotech leadership and expertise in drug development
and commercialization.
Third Quarter 2022 Financial
Results
- As of September
30, 2022, PMV Pharma had $258.9 million in cash, cash
equivalents, and marketable securities, compared to $314.1
million at December 31, 2021. Net cash used in operations
was $48.4 million for the nine months
ended September 30, 2022, compared to $34.5
million for the nine months ended September 30,
2021.
- Net loss for the
nine months ended September 30, 2022, was $54.0
million compared to $39.5 million for the nine
months ended September 30, 2021.
-
Research and development (R&D) expenses were $37.0
million for the nine months ended September 30,
2022, compared to $24.3 million for the nine months
ended September 30, 2021. The increase in R&D expenses was
primarily due to clinical expenses related to development of
PC14586, the Company’s lead drug candidate.
- General and
administrative (G&A) expenses were $18.9 million for the nine
months ended September 30, 2022, compared to $15.5 million for the
nine months ended September 30, 2021. The increase in G&A
expenses was primarily due to increased headcount expenses
including stock-based compensation.
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 Cranbury, 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
update for the PYNNACLE study and its Phase 1/2 combination trial
of PC14586 and KEYTRUDA, 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, 2022, the Company’s Quarterly Report on Form 10-Q
filed with the SEC on November 8, 2022 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.Condensed Balance
Sheets(unaudited)(in
thousands)
|
September 30,2022
(unaudited) |
|
|
December 31,2021 |
|
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
99,850 |
|
|
$ |
172,467 |
|
Restricted cash |
|
822 |
|
|
|
822 |
|
Marketable securities, current |
|
159,007 |
|
|
|
124,696 |
|
Prepaid expenses and other current assets |
|
5,305 |
|
|
|
3,301 |
|
Total current assets |
|
264,984 |
|
|
|
301,286 |
|
Property and equipment,
net |
|
9,966 |
|
|
|
3,090 |
|
Marketable securities,
noncurrent |
|
— |
|
|
|
16,911 |
|
Right-of-use assets |
|
9,535 |
|
|
|
10,060 |
|
Other assets |
|
307 |
|
|
|
221 |
|
Total assets |
$ |
284,792 |
|
|
$ |
331,568 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
4,826 |
|
|
$ |
3,189 |
|
Accrued expenses |
|
6,440 |
|
|
|
8,627 |
|
Operating lease liabilities, current |
|
394 |
|
|
|
403 |
|
Total current liabilities |
|
11,660 |
|
|
|
12,219 |
|
Operating lease liabilities,
noncurrent |
|
12,135 |
|
|
|
10,790 |
|
Total liabilities |
|
23,795 |
|
|
|
23,009 |
|
Stockholders’ equity: |
|
|
|
|
|
Common stock |
|
— |
|
|
|
— |
|
Additional paid-in capital |
|
483,916 |
|
|
|
476,363 |
|
Accumulated deficit |
|
(221,894 |
) |
|
|
(167,726 |
) |
Accumulated other comprehensive loss |
|
(1,025 |
) |
|
|
(78 |
) |
Total stockholders’ equity |
|
260,997 |
|
|
|
308,559 |
|
Total liabilities and
stockholders’ equity |
$ |
284,792 |
|
|
$ |
331,568 |
|
PMV Pharmaceuticals,
Inc.Condensed Statements of Operations and
Comprehensive Loss(unaudited)(in
thousands, except share and per share amounts)
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
13,666 |
|
|
$ |
9,162 |
|
|
$ |
36,963 |
|
|
$ |
24,326 |
|
General and administrative |
|
5,709 |
|
|
|
5,935 |
|
|
|
18,915 |
|
|
|
15,495 |
|
Total operating expenses |
|
19,375 |
|
|
|
15,097 |
|
|
|
55,878 |
|
|
|
39,821 |
|
Loss from operations |
|
(19,375 |
) |
|
|
(15,097 |
) |
|
|
(55,878 |
) |
|
|
(39,821 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
1,124 |
|
|
|
102 |
|
|
|
1,830 |
|
|
|
343 |
|
Other income (expense), net |
|
13 |
|
|
|
3 |
|
|
|
67 |
|
|
|
14 |
|
Total other income (expense) |
|
1,137 |
|
|
|
105 |
|
|
|
1,897 |
|
|
|
357 |
|
Loss before (benefit) provision for income taxes |
|
(18,238 |
) |
|
|
(14,992 |
) |
|
|
(53,981 |
) |
|
|
(39,464 |
) |
(Benefit) provision for income taxes |
|
(9 |
) |
|
|
19 |
|
|
|
(9 |
) |
|
|
23 |
|
Net loss |
|
(18,229 |
) |
|
|
(15,011 |
) |
|
|
(53,972 |
) |
|
|
(39,487 |
) |
Unrealized (loss) gain on available for sale investments, net of
tax |
|
(2 |
) |
|
|
7 |
|
|
|
(947 |
) |
|
|
14 |
|
Comprehensive loss |
$ |
(18,231 |
) |
|
$ |
(15,004 |
) |
|
$ |
(54,919 |
) |
|
$ |
(39,473 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share -- basic and diluted |
$ |
(0.40 |
) |
|
$ |
(0.33 |
) |
|
$ |
(1.18 |
) |
|
$ |
(0.88 |
) |
Weighted-average common shares outstanding |
|
45,622,957 |
|
|
|
45,295,232 |
|
|
|
45,556,635 |
|
|
|
45,052,100 |
|
Contacts
Investor Contact:
Winston KungPMV Pharmaceuticals,
Inc.investors@pmvpharma.com
Media Contact:
Kathy VincentGreig
Communicationskathy@greigcommunications.com
PMV Pharmaceuticals (NASDAQ:PMVP)
Historical Stock Chart
From Sep 2024 to Oct 2024
PMV Pharmaceuticals (NASDAQ:PMVP)
Historical Stock Chart
From Oct 2023 to Oct 2024