- Rezatapopt granted Orphan Drug Designation by the
U.S. Food and Drug Administration for the treatment of TP53 Y220C positive ovarian cancer New England Journal of Medicine published first-in-human rezatapopt data showing selective reactivation of mutant p53 in advanced solid tumors- Rezatapopt New Drug Application submission for platinum-resistant/refractory ovarian cancer planned in first quarter of 2027
- Cash, cash equivalents, and marketable securities of
$93.5 million as ofMarch 31, 2026 providing expected cash runway to end of second quarter of 2027
“The first quarter was one of continued execution as we advance the PYNNACLE study and remain on track to target an NDA submission for rezatapopt for platinum-resistant/refractory ovarian cancer in the first quarter of 2027,” said
PYNNACLE Phase 2 Monotherapy Update:
- Enrollment is on track in the Phase 2 monotherapy portion of the PYNNACLE clinical trial. The multicenter, single-arm, registrational Phase 2 study is assessing rezatapopt as monotherapy at a dose of 2000 mg once-daily in patients with TP53 Y220C advanced solid tumors.
- PMV Pharma anticipates submitting a New Drug Application (NDA) for rezatapopt in platinum-resistant/refractory ovarian cancer patients with a TP53 Y220C mutation in the first quarter of 2027.
Corporate Highlights:
- Updated Phase 2 PYNNACLE clinical results evaluating rezatapopt were featured in an oral presentation at the 2026
Society of Gynecologic Oncology Annual Meeting on Women's Cancer onApril 12, 2026 .- Confirmed responses were observed in platinum-resistant/refractory ovarian cancer patients with a TP53 Y220C mutation
- Overall response rate (ORR) of 44% (32/72 patients) per investigator assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, including one confirmed complete response, 31 confirmed partial responses.
- The median time to response was 1.3 months and the median duration of response was 8.2 months.
- Post the
March 29, 2026 data cutoff, two additional patients achieved unconfirmed partial responses (uPRs), bringing the ORR to 46% (34/74).
- Confirmed responses were observed in platinum-resistant/refractory ovarian cancer patients with a TP53 Y220C mutation
- Phase 1 results from the ongoing Phase 1/2 PYNNACLE study were published in the
New England Journal of Medicine , “Phase 1 Study of Rezatapopt, a p53 Reactivator, in TP53 Y220C-Mutated Tumors.” The manuscript highlighted that rezatapopt demonstrated antitumor activity in heavily pretreated patients across multiple solid tumor types which provided proof-of-concept for p53 reactivation. Clinical activity and biomarker data were consistent with selective binding to the Y220C pocket and restoration of wild-type p53 tumor suppressor function. - The
U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to rezatapopt for the treatment of TP53 Y220C positive ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. The FDA provides ODD status to drugs intended for the safe and effective treatment, diagnosis, or prevention of rare diseases that affect fewer than 200,000 people in theU.S. Benefits of the designation may include exemption from certain FDA fees, financial incentives for qualified clinical development, and seven years of market exclusivity in theU.S. if the treatment is approved.
First Quarter 2026 Financial Results
PMV Pharma ended the first quarter with
- Net loss for the quarter ended
March 31, 2026 , was$18 million compared to$17.4 million for the quarter endedMarch 31, 2025 . The net loss increase was primarily due to the benefit received from the sale of NOL carryforwards in Q1 2025, offset by decreased research and development (R&D) costs. - R&D expenses were
$15.3 million for the quarter endedMarch 31, 2026 , compared to$17.4 million for the quarter endedMarch 31, 2025 . The decrease in R&D expenses was primarily due to decreased contractual research organization costs for the advancement of the rezatapopt program. - General and administrative (G&A) expenses were
$3.7 million for the quarter endedMarch 31, 2026 , compared to$4.1 million for the quarter endedMarch 31, 2025 . The decrease in G&A expenses was primarily due to reduced personnel expenses and a decrease in finance and legal support costs.
About Rezatapopt
Rezatapopt (PC14586) is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the pocket in the p53 Y220C mutant protein, restoring the wild-type tumor-suppressor function. The
About the PYNNACLE Clinical Trial
The ongoing Phase 1/2 PYNNACLE clinical trial is evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation. The primary objective of the Phase 1 portion of the clinical trial was to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D) of rezatapopt when administered orally to patients. Safety, tolerability, pharmacokinetics and effects on biomarkers were also assessed. The Phase 2 portion is a registrational, single arm, expansion basket clinical trial comprising five cohorts (ovarian, lung, breast, and endometrial cancers, and other solid tumors) with the primary objective of evaluating the efficacy of rezatapopt at the RP2D in patients with TP53 Y220C and KRAS wild-type advanced solid tumors, conducted across approximately 70 sites.
For more information about the Phase 1/2 PYNNACLE clinical trial, refer to www.clinicaltrials.gov (NCT trial identifier NCT04585750).
About PMV Pharma
PMV Pharma is a precision oncology company pioneering the discovery and development of small molecule therapies targeting p53. TP53 mutations are found in approximately half of all cancers. 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 rezatapopt, including our ability to obtain approval as a treatment option as a monotherapy, expectations regarding timing, enrollment status and success of the Phase 2 portion of the current clinical trial for rezatapopt and filing of a New Drug Application (NDA) for platinum-resistant/refractory ovarian cancer, the benefits of FDA’s grant of Orphan Drug Designation (ODD) for rezatapopt, and the timing and expectations with respect to our projected 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, including the successful filing of NDAs, and planned clinical trials, the Company’s ability to execute on its strategy and operate as a clinical stage company, the potential for clinical trials of rezatapopt or any future clinical trials of other product candidates to differ from preclinical, preliminary or expected results, maintenance by the Company of ODD status and related benefits for rezatapopt, the Company’s ability to fund operations, and the impact that a global pandemic, other public health emergencies or geopolitical tensions or conflicts may 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
Condensed Consolidated Balance Sheets (unaudited) (in thousands, except share and per share amounts) | ||||||||
2026 | 2025 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 39,130 | $ | 37,983 | ||||
| Marketable securities, current | 54,419 | 74,960 | ||||||
| Prepaid expenses and other current assets | 2,231 | 2,284 | ||||||
| Total current assets | 95,780 | 115,227 | ||||||
| Property and equipment, net | 203 | 237 | ||||||
| Right-of-use assets | 283 | 801 | ||||||
| Other assets | 296 | 297 | ||||||
| Total assets | $ | 96,562 | $ | 116,562 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,631 | $ | 3,155 | ||||
| Accrued expenses | 6,671 | 7,857 | ||||||
| Operating lease liabilities, current | 293 | 403 | ||||||
| Total current liabilities | 8,595 | 11,415 | ||||||
| Operating lease liabilities, noncurrent | — | 435 | ||||||
| Total liabilities | 8,595 | 11,850 | ||||||
| Stockholders’ equity: | ||||||||
| Additional paid-in capital | 552,474 | 551,082 | ||||||
| Accumulated deficit | (464,492 | ) | (446,454 | ) | ||||
| Accumulated other comprehensive income | (15 | ) | 84 | |||||
| Total stockholders’ equity | 87,967 | 104,712 | ||||||
| Total liabilities and stockholders’ equity | $ | 96,562 | $ | 116,562 | ||||
Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) (in thousands, except share and per share amounts) | ||||||||
| Three Months Ended | ||||||||
| 2026 | 2025 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 15,330 | $ | 17,441 | ||||
| General and administrative | 3,689 | 4,123 | ||||||
| Total operating expenses | 19,019 | 21,564 | ||||||
| Loss from operations | (19,019 | ) | (21,564 | ) | ||||
| Other income (expense): | ||||||||
| Interest income, net | 980 | 1,935 | ||||||
| Other income (expense), net | 1 | (4 | ) | |||||
| Total other income | 981 | 1,931 | ||||||
| Loss before (benefit) provision for income taxes | (18,038 | ) | (19,633 | ) | ||||
| (Benefit) provision for income taxes | — | (2,197 | ) | |||||
| Net loss | (18,038 | ) | (17,436 | ) | ||||
| Unrealized loss on available for sale investments, net of tax | (101 | ) | (62 | ) | ||||
| Foreign currency translation gain | 2 | 7 | ||||||
| Total other comprehensive loss | (99 | ) | (55 | ) | ||||
| Total comprehensive loss | $ | (18,137 | ) | $ | (17,491 | ) | ||
| Net loss per share -- basic and diluted | $ | (0.34 | ) | $ | (0.34 | ) | ||
| Weighted-average common shares outstanding | 53,331,766 | 51,952,062 | ||||||
Contacts
Investors Contact:
Senior Vice President, Head of Corporate Development and Investor Relations
investors@pmvpharma.com
Media Contact:
kathy@greigcommunications.com
