- Continued progress in ongoing Phase 1/2 PYNNACLE study of PC14586, a first-in-class precision oncology investigational therapy in patients with advanced solid tumors with a p53 Y220C mutation; PMV expects to provide next clinical update in 2H 2023
- Enrolled first patient in combination arm of the PYNNACLE study with PC14586 and KEYTRUDA® (pembrolizumab)
- Cash, cash equivalents, and marketable securities of
$243.5 million as ofDecember 31, 2022
“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
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 andCarol Gallagher , Pharm.D. to the Board of Directors.Ms. Flowers andDr. 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 atDecember 31, 2021 . Net cash used in operations was$63.8 million for the year endedDecember 31, 2022 , compared to$46.6 million for the year endedDecember 31, 2021 . - Net loss for the year ended
December 31, 2022 , was$73.3 million compared to$57.8 million for the year endedDecember 31, 2021 . - Research and development (R&D) expenses were
$52.0 million for the year endedDecember 31, 2022 , compared to$36.5 million for the year endedDecember 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 endedDecember 31, 2022 , compared to$21.8 million for the year endedDecember 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
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
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.
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
Balance Sheets
(in thousands)
2022 | 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 | ||||
Condensed Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
Year Ended | ||||||||
2022 | 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:
investors@pmvpharma.com
Media Contact:
kathy@greigcommunications.com
Source:
2023 GlobeNewswire, Inc., source