PMV Pharmaceuticals Reports Fourth Quarter and Full Year 2020 Financial Results and Corporate Highlights
2021年3月4日 - 6:01AM
PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology
company pioneering the discovery and development of small molecule,
tumor-agnostic therapies targeting p53 mutants, today reported
financial results for the fourth quarter and full year ended
December 31, 2020 and provided corporate highlights.
“2020 was a transformative year for PMV Pharma,
marked by our entry into the clinic, a strengthened management team
and successful completion of our Nasdaq initial public offering,”
said David Mack, Ph.D., President and Chief Executive Officer. “The
treatment of the first patient with PC14586, our tumor agnostic
small molecule targeting the p53 Y220C mutant, was an important
step forward in precision oncology. Our strong leadership and
balance sheet position us to further advance our discovery pipeline
of small molecule, tumor-agnostic precision medicine products that
specifically target p53 mutants.”
Corporate Highlights:
- Initiated Phase 1/2 study of
PC14586 in patients with advanced solid tumors that have a p53
Y220C mutation. The Phase 1/2 study will enroll up to 130 patients
with a p53 Y220C mutation as determined by next generation
sequencing. Phase 1 dose escalation will assess the safety,
tolerability, pharmacokinetics, and preliminary anti-tumor activity
of PC14586. Phase 2 will assess the overall response rate and
duration of response at the PC14586 dose identified in Phase 1.For
information on the Phase 1/2 trial, please visit
www.clinicaltrials.gov (NCT study identifier NCT04585750).
- In October, the FDA granted PMV
Pharma Fast Track designation to PC14586 for the treatment of
patients with locally advanced or metastatic solid tumors that have
a p53 Y220C mutation.
- Appointment of Deepika Jalota,
Pharm. D. to Chief Regulatory and Quality Officer, who joined PMV
Pharma in June 2019 as Senior Vice President, Head of Regulatory
Affairs and Quality Assurance. Dr. Jalota will continue to lead
global regulatory strategy and execution as well as the quality
assurance function. Dr. Jalota is a strategic regulatory leader
with more than 20 years of regulatory affairs and drug development
experience in oncology and other therapeutic areas. Prior to
joining PMV Pharma, she served as Vice President, Global Regulatory
Strategy, Oncology at Bayer HealthCare Pharmaceuticals where she
was responsible for driving the development of global regulatory
strategies for multiple early and late-stage oncology projects,
including Xofigo®, Vitrakvii® and Nubeqa®.
- Expanded Scientific Advisory Board
with the appointment of p53 pioneer Dr. Guillermina (Gigi) Lozano,
Professor and Chair, Department of Genetics, MD Anderson Cancer
Center.
Fourth Quarter 2020 Financial
Results
- PMV Pharma ended the fourth quarter
with $361.4 million in cash, cash equivalents, and marketable
securities, compared to $101.5 million as of December 31, 2019. Net
cash used in operations was $32.7 million for the twelve months
ended December 31, 2020 compared to $22.1 million for the twelve
months ended December 31, 2019.
- Net loss for the year ended
December 31, 2020 was $34.4 million compared to $25.4 million for
the year ended December 31, 2019.
- Research and development (R&D)
expenses were $23.9 million for the year ended December 31, 2020
compared to $20.8 million for the year ended December 31, 2019. The
increase in R&D expenses was primarily related to increased
headcount and clinical expenses related to advancing research on
PC14586, the Company’s lead drug candidate.
- General and administrative
(G&A) expenses were $11.0 million for the year ended December
31, 2020, compared to $5.9 million for the year ended December 31,
2019. The increase in G&A expenses was primarily due to
expanding the infrastructure necessary for operating as a public
company.
About p53
p53 plays a pivotal role in preventing abnormal
cells from becoming a tumor by inducing programmed cell death.
Mutant p53 takes on oncogenic properties that endow cancer cells
with a growth advantage and resistance to anti-cancer therapy. The
p53 Y220C mutation is associated with many cancers, including but
not limited to breast, non-small cell lung cancer, colorectal,
pancreatic, and ovarian cancers.
About PC14586
PC14586 is a first-in-class, small molecule, p53
reactivator designed to selectively bind to the crevice created by
the p53 Y220C mutant protein, hence, restoring the wild-type, or
normal, p53 protein structure and tumor suppressing function.
PC14586 is being developed for the treatment of patients with
locally advanced or metastatic solid tumors that have a p53 Y220C
mutation.
About PMV Pharma
PMV Pharma is a precision oncology company
pioneering the discovery and development of small molecule,
tumor-agnostic therapies targeting p53 mutants. 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 a 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 the success of its
current clinical trial for PC14586; the future plans or
expectations for the Company’s discovery platform; and the period
over which the Company estimates its existing cash and cash
equivalents will be sufficient to fund its current operating plan.
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 3,
2021, 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.Consolidated Balance Sheet
Data(unaudited, in thousands)
|
|
|
|
|
December 31,2020 |
|
December 31,2019 |
Assets |
|
|
|
|
|
Current assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
361,422 |
|
|
$ |
73,278 |
|
Short-term marketable securities |
|
— |
|
|
|
28,208 |
|
Prepaid expenses and other current assets |
|
3,339 |
|
|
|
607 |
|
Total current assets |
|
364,761 |
|
|
|
102,093 |
|
Property and equipment, net |
|
569 |
|
|
|
739 |
|
Other assets |
|
201 |
|
|
|
201 |
|
Total assets |
$ |
365,531 |
|
|
$ |
103,033 |
|
Liabilities, Convertible
Preferred Stock, and Stockholders’ Equity (Deficit) |
|
|
|
|
|
Current liabilities |
|
|
|
|
|
Accounts payable |
$ |
1,607 |
|
|
$ |
2,837 |
|
Accrued expenses |
|
4,803 |
|
|
|
1,686 |
|
Total current liabilities |
|
6,410 |
|
|
|
4,523 |
|
Other liabilities |
|
— |
|
|
|
51 |
|
Total liabilities |
|
6,410 |
|
|
|
4,574 |
|
Convertible preferred stock |
|
— |
|
|
|
168,933 |
|
Stockholders’ deficit: |
|
|
|
|
|
Preferred stock |
|
— |
|
|
|
— |
|
Common stock |
|
— |
|
|
|
— |
|
Additional paid-in capital |
|
469,001 |
|
|
|
4,969 |
|
Accumulated deficit |
|
(109,880 |
) |
|
|
(75,440 |
) |
Accumulated other comprehensive loss |
|
— |
|
|
|
(3 |
) |
Total stockholders’ equity (deficit) |
|
359,121 |
|
|
|
(70,474 |
) |
Total liabilities, convertible
preferred stock, and stockholders’ equity (deficit) |
$ |
365,531 |
|
|
$ |
103,033 |
|
|
|
|
|
|
|
|
|
PMV Pharmaceuticals,
Inc.Statements of Operations and Comprehensive
Loss(unaudited, in thousands, except share and per
share amounts)
|
|
|
|
|
Year EndedDecember
31,2020 |
|
Year EndedDecember
31,2019 |
Operating
Expenses: |
|
|
|
|
|
Research and development |
$ |
23,933 |
|
|
$ |
20,759 |
|
General and administrative |
|
11,009 |
|
|
|
5,878 |
|
Total operating expenses |
|
34,942 |
|
|
|
26,637 |
|
Loss from operations |
|
(34,942 |
) |
|
|
(26,637 |
) |
Other income (expense): |
|
|
|
|
|
Interest income, net |
|
651 |
|
|
|
1,301 |
|
Other expense |
|
(143 |
) |
|
|
(8 |
) |
Total other income (expense) |
|
508 |
|
|
|
1,293 |
|
Loss before provision for income taxes |
|
(34,434 |
) |
|
|
(25,344 |
) |
Provision for income taxes |
|
6 |
|
|
|
8 |
|
Net loss |
|
(34,440 |
) |
|
|
(25,352 |
) |
Unrealized gains on marketable securities, net of tax |
|
3 |
|
|
|
10 |
|
Comprehensive loss |
$ |
(34,437 |
) |
|
$ |
(25,342 |
) |
Net loss per share—basic and diluted |
$ |
(2.40 |
) |
|
$ |
(8.35 |
) |
Weighted-average common shares outstanding |
|
14,364,475 |
|
|
|
3,035,142 |
|
|
|
|
|
|
|
|
|
Contact
For Investors & Media:
Winston KungChief Financial Officerinvestors@pmvpharma.com
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