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PMVP

PMVD
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-08-14
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Investor releaseQuarter not tagged2026-08-14

PMV Pharmaceuticals Reports Second Quarter 2026 Financial Results and Corporate Highlights

GlobeNewswire
Enrollment of platinum-resistant/refractory ovarian cancer patients for the primary analysis in the Phase 2 monotherapy portion of the PYNNACLE clinical trial completed Rezatapopt NDA submission for platinum-resistant/refractory ovarian cancer planned in first quarter of 2027 Cash, cash equivalents, and marketable securities of $79.4 million as of June 30, 2026 providing expected cash runway through second quarter of 2027 PRINCETON, N.J., Aug. 14, 2026 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. (“PMV Pharma” or the “Company”; Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule therapies targeting p53, today reported financial results for the second quarter ended June 30, 2026, and provided a corporate update. “The PYNNACLE clinical trial continues to progress remarkably well, thanks to the dedication and outstanding execution of the clinical investigators, their teams, and ours,” said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. “We anticipate submitting an NDA for accelerated approval of rezatapopt for platinum-resistant/refractory ovarian cancer in the first quarter of 2027.” PYNNACLE Phase 2 Monotherapy Update: Enrollment of platinum-resistant/refractory ovarian cancer patients for the primary analysis in the Phase 2 monotherapy portion of the PYNNACLE clinical trial has been completed. 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 an NDA for accelerated approval of rezatapopt as a treatment for platinum-resistant/refractory ovarian cancer patients with a TP53 Y220C mutation in the first quarter of 2027. Second Quarter 2026 Financial Results PMV Pharma ended the second quarter with $79.4 million in cash, cash equivalents, and marketable securities, compared to $112.9 million as of December 31, 2025. Net cash used in operations was $34.3 million for the six months ended June 30, 2026, compared to $36.6 million for the six months ended June 30, 2025. Net loss for the quarter ended June 30, 2026, was $18.1 million compared to $21.2 million for the quarter ended June 30, 2025. The net loss decrease was primarily due to decreased contract research organization costs and reduced finance support costs. R&D expenses we…Read full document

Enrollment of platinum-resistant/refractory ovarian cancer patients for the primary analysis in the Phase 2 monotherapy portion of the PYNNACLE clinical trial completed Rezatapopt NDA submission for platinum-resistant/refractory ovarian cancer planned in first quarter of 2027 Cash, cash equivalents, and marketable securities of $79.4 million as of June 30, 2026 providing expected cash runway through second quarter of 2027 PRINCETON, N.J., Aug. 14, 2026 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. (“PMV Pharma” or the “Company”; Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule therapies targeting p53, today reported financial results for the second quarter ended June 30, 2026, and provided a corporate update. “The PYNNACLE clinical trial continues to progress remarkably well, thanks to the dedication and outstanding execution of the clinical investigators, their teams, and ours,” said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. “We anticipate submitting an NDA for accelerated approval of rezatapopt for platinum-resistant/refractory ovarian cancer in the first quarter of 2027.” PYNNACLE Phase 2 Monotherapy Update: Enrollment of platinum-resistant/refractory ovarian cancer patients for the primary analysis in the Phase 2 monotherapy portion of the PYNNACLE clinical trial has been completed. 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 an NDA for accelerated approval of rezatapopt as a treatment for platinum-resistant/refractory ovarian cancer patients with a TP53 Y220C mutation in the first quarter of 2027. Second Quarter 2026 Financial Results PMV Pharma ended the second quarter with $79.4 million in cash, cash equivalents, and marketable securities, compared to $112.9 million as of December 31, 2025. Net cash used in operations was $34.3 million for the six months ended June 30, 2026, compared to $36.6 million for the six months ended June 30, 2025. Net loss for the quarter ended June 30, 2026, was $18.1 million compared to $21.2 million for the quarter ended June 30, 2025. The net loss decrease was primarily due to decreased contract research organization costs and reduced finance support costs. R&D expenses were $14.7 million for the quarter ended June 30, 2026, compared to $18.4 million for the quarter ended June 30, 2025. The decrease in R&D expenses was primarily due to decreased contract research organization costs for the advancement of the rezatapopt program. General and administrative (G&A) expenses were $4.2 million for the quarter ended June 30, 2026, compared to $4.5 million for the quarter ended June 30, 2025. The decrease in G&A expenses was primarily due to reduced personnel expenses and a decrease in finance 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 U.S. Food and Drug Administration granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation and Orphan Drug Designation for the treatment of TP53 Y220C positive ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. 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 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. Arnold Levine, established the field of p53 biology when he discovered the p53 protein in 1979. Bringing together leaders in the field to utilize more than four decades of p53 biology, PMV Pharma combines unique biological understanding with a 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 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 March 6, 2026, 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. ContactsInvestors Contact:Tim SmithSenior Vice President, Head of Corporate Development and Investor [email protected] Media Contact:Kathy VincentGreig [email protected]

Investor releaseQuarter not tagged2026-05-12

PMV Pharmaceuticals Reports First Quarter 2026 Financial Results and Corporate Highlights

GlobeNewswire
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 of March 31, 2026 providing expected cash runway to end of second quarter of 2027 PRINCETON, N.J., May 12, 2026 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. (“PMV Pharma” or the “Company”; Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule therapies targeting p53, today reported financial results for the first quarter ended March 31, 2026, and provided a corporate update. “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 David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. “We are also encouraged by the publication of the PYNNACLE Phase 1 results in the New England Journal of Medicine, which underscores the scientific innovation behind rezatapopt and highlights its potential to address a significant unmet medical need. Patients with TP53 Y220C advanced solid tumors, including platinum resistant ovarian cancer, experience poor outcomes despite available therapies.” 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 on April 12, 2026. Confirmed responses were observed in platinum-resistant/refractory ovaria…Read full document

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 of March 31, 2026 providing expected cash runway to end of second quarter of 2027 PRINCETON, N.J., May 12, 2026 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. (“PMV Pharma” or the “Company”; Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule therapies targeting p53, today reported financial results for the first quarter ended March 31, 2026, and provided a corporate update. “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 David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. “We are also encouraged by the publication of the PYNNACLE Phase 1 results in the New England Journal of Medicine, which underscores the scientific innovation behind rezatapopt and highlights its potential to address a significant unmet medical need. Patients with TP53 Y220C advanced solid tumors, including platinum resistant ovarian cancer, experience poor outcomes despite available therapies.” 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 on April 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). 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 the U.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 the U.S. if the treatment is approved. First Quarter 2026 Financial Results PMV Pharma ended the first quarter with $93.5 million in cash, cash equivalents, and marketable securities, compared to $112.9 million as of December 31, 2025. Net cash used in operations was $19.7 million for the three months ended March 31, 2026, compared to $18.3 million for the three months ended March 31, 2025. Net loss for the quarter ended March 31, 2026, was $18 million compared to $17.4 million for the quarter ended March 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 ended March 31, 2026, compared to $17.4 million for the quarter ended March 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 ended March 31, 2026, compared to $4.1 million for the quarter ended March 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 U.S. Food and Drug Administration granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation and Orphan Drug Designation for the treatment of TP53 Y220C positive ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. 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. Arnold Levine, established the field of p53 biology when he discovered the p53 protein in 1979. Bringing together leaders in the field to utilize more than four decades of p53 biology, PMV Pharma combines unique biological understanding with a 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 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 March 6, 2026, 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. Contacts Investors Contact: Tim Smith Senior Vice President, Head of Corporate Development and Investor Relations [email protected] Media Contact: Kathy Vincent Greig Communications [email protected]

Investor releaseQuarter not tagged2026-03-06

PMV Pharmaceuticals Reports Full Year 2025 Financial Results and Corporate Highlights

GlobeNewswire
Enrollment remains on track in Phase 2 pivotal portion of PYNNACLE trial evaluating rezatapopt as monotherapy in platinum-resistant/refractory ovarian cancer patients with a TP53 Y220C mutation 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 $112.9 million as of December 31, 2025 providing expected cash runway to end of second quarter of 2027 PRINCETON, N.J., March 06, 2026 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. (“PMV Pharma” or the “Company”; Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule therapies targeting p53, today reported financial results for the full year ended December 31, 2025, and provided a corporate update. “2025 was an important and productive year for PMV Pharma as we reported positive Phase 2 interim data from the registrational PYNNACLE clinical trial and made significant progress in enrolling the study,” said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. “We look forward to submitting an NDA in the first quarter of 2027 for rezatapopt in platinum-resistant/refractory ovarian cancer.” 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. Full Year 2025 and Recent Corporate Highlights: On March 2, 2026, 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…Read full document

Enrollment remains on track in Phase 2 pivotal portion of PYNNACLE trial evaluating rezatapopt as monotherapy in platinum-resistant/refractory ovarian cancer patients with a TP53 Y220C mutation 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 $112.9 million as of December 31, 2025 providing expected cash runway to end of second quarter of 2027 PRINCETON, N.J., March 06, 2026 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. (“PMV Pharma” or the “Company”; Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule therapies targeting p53, today reported financial results for the full year ended December 31, 2025, and provided a corporate update. “2025 was an important and productive year for PMV Pharma as we reported positive Phase 2 interim data from the registrational PYNNACLE clinical trial and made significant progress in enrolling the study,” said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. “We look forward to submitting an NDA in the first quarter of 2027 for rezatapopt in platinum-resistant/refractory ovarian cancer.” 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. Full Year 2025 and Recent Corporate Highlights: On March 2, 2026, 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 the U.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 the U.S. if the treatment is approved. 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. Updated data from the ongoing PYNNACLE Phase 2 trial were presented as an oral presentation at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics based on a September 4, 2025 data cut-off. 34% overall response rate (ORR) observed among 103 evaluable patients across all cohorts with a median duration of response of 7.6 months. 46% ORR observed among 48 evaluable patients in ovarian cancer cohort with a median duration of response of 8.0 months. Treatment-related adverse events (TRAEs) were mostly Grade 1-2 with the most frequent TRAEs observed (>15%) being nausea, fatigue, blood creatinine increased, and alanine aminotransferase (ALT) increased. Natural history study results were also presented at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics where TP53 Y220C–mutant advanced solid tumors were associated with poor outcomes reinforcing the significant unmet medical need addressed by rezatapopt. New findings from the rezatapopt PYNNACLE Phase 2 trial in ovarian cancer were presented at the 2026 European Society of Gynecologic Oncology Congress, demonstrating robust and consistent ORRs across key ovarian cancer subgroups. The ORR subgroup data included those with platinum-resistant, platinum-refractory disease, prior systemic therapies and folate receptor alpha status, that provide further evidence of the broad efficacy of rezatapopt within ovarian cancer patients. After the September 4, 2025 data cut-off, among the 48 evaluable patients in the ovarian cancer cohort, a 50% ORR was observed with 23 confirmed responses and one unconfirmed partial response. Fiscal Year 2025 Financial Results As of December 31, 2025, PMV Pharma had $112.9 million in cash, cash equivalents, and marketable securities, compared to $183.3 million at December 31, 2024. Net cash used in operations was $73.6 million for the year ended December 31, 2025, compared to $51.3 million for the year ended December 31, 2024. Net loss for the year ended December 31, 2025, was $77.7 million compared to $58.7 million for the year ended December 31, 2024. Research and development (R&D) expenses were $69.9 million for the year ended December 31, 2025, compared to $58.5 million for the year ended December 31, 2024. The increase in R&D expenses was primarily related to clinical expenses for advancing rezatapopt, the Company’s lead product candidate. General and administrative (G&A) expenses were $16.3 million for the year ended December 31, 2025, compared to $26.9 million for the year ended December 31, 2024. The decrease in G&A expenses was primarily due to lower facility-related and personnel costs following the relocation of the Company's lab and office space and staff reductions in the prior year. 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 U.S. Food and Drug Administration granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation and Orphan Drug Designation for the treatment of TP53 Y220C positive ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. 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. Arnold Levine, established the field of p53 biology when he discovered the p53 protein in 1979. Bringing together leaders in the field to utilize more than four decades of p53 biology, PMV Pharma combines unique biological understanding with a 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 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 an 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 March 6, 2026, 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. Contacts Investors Contact: Tim Smith Senior Vice President, Head of Corporate Development and Investor Relations [email protected] Media Contact: Kathy Vincent Greig Communications [email protected]

Investor releaseQuarter not tagged2026-02-03

Alumis Stock Has Rallied 250% This Past Year. One Fund Sold Its $5 Million Stake Last Quarter.

Motley Fool
On February 2, BML Capital Management disclosed in a Securities and Exchange Commission filing that it sold out of Alumis (NASDAQ:ALMS), liquidating 1,210,415 shares in an estimated $4.83 million trade. According to a Securities and Exchange Commission (SEC) filing dated February 2, BML Capital Management reported a complete sale of its 1,210,415-share stake in Alumis (NASDAQ:ALMS). As a result, the fund's quarter-end position value in Alumis decreased by $4.83 million, and it now holds no shares. Top holdings after the filing: NASDAQ: ACRS: $42.89 million (38.0% of AUM) NASDAQ: AVIR: $26.74 million (23.7% of AUM) NASDAQ: ORMP: $9.03 million (8.0% of AUM) NASDAQ: TIL: $7.10 million (6.3% of AUM) NASDAQ: PMVP: $6.62 million (5.9% of AUM) As of February 2, shares of Alumis were priced at $26.42, up a staggering 255.1% over the prior year and well outperforming the S&P 500’s roughly 15% gain in the same period. Alumis develops clinical-stage therapies for autoimmune and neuroinflammatory disorders, including ESK-001 and A-005 targeting TYK2 inhibition. The company operates a biopharmaceutical business model focused on advancing proprietary drug candidates through clinical trials toward regulatory approval and commercialization. It targets patients with autoimmune diseases such as plaque psoriasis, systemic lupus erythematosus, and neurodegenerative conditions. Alumis is a clinical-stage biotechnology company specializing in the development of novel therapies for autoimmune and neuroinflammatory diseases. The company leverages expertise in TYK2 inhibition to advance a pipeline of differentiated drug candidates addressing significant unmet medical needs. With a focus on innovation and clinical rigor, Alumis seeks to establish a competitive position in the biopharmaceutical sector through targeted therapeutic development. BML Capital’s move is a reminder that even disciplined portfolio decisions can collide with fast-moving catalysts. The sale was completed by December 31, as of the filing’s period-end date, before Alumis announced its January upsized public offering and before shares went on to surge roughly 200% in the weeks that followed. At the time, the decision was defensible. Alumis was a clinical-stage biotech with no approved products and heavy R&D spend. As of the third quarter, the company reported $377.7 million in cash and marketable securities, but a…Read full document

On February 2, BML Capital Management disclosed in a Securities and Exchange Commission filing that it sold out of Alumis (NASDAQ:ALMS), liquidating 1,210,415 shares in an estimated $4.83 million trade. According to a Securities and Exchange Commission (SEC) filing dated February 2, BML Capital Management reported a complete sale of its 1,210,415-share stake in Alumis (NASDAQ:ALMS). As a result, the fund's quarter-end position value in Alumis decreased by $4.83 million, and it now holds no shares. Top holdings after the filing: NASDAQ: ACRS: $42.89 million (38.0% of AUM) NASDAQ: AVIR: $26.74 million (23.7% of AUM) NASDAQ: ORMP: $9.03 million (8.0% of AUM) NASDAQ: TIL: $7.10 million (6.3% of AUM) NASDAQ: PMVP: $6.62 million (5.9% of AUM) As of February 2, shares of Alumis were priced at $26.42, up a staggering 255.1% over the prior year and well outperforming the S&P 500’s roughly 15% gain in the same period. Alumis develops clinical-stage therapies for autoimmune and neuroinflammatory disorders, including ESK-001 and A-005 targeting TYK2 inhibition. The company operates a biopharmaceutical business model focused on advancing proprietary drug candidates through clinical trials toward regulatory approval and commercialization. It targets patients with autoimmune diseases such as plaque psoriasis, systemic lupus erythematosus, and neurodegenerative conditions. Alumis is a clinical-stage biotechnology company specializing in the development of novel therapies for autoimmune and neuroinflammatory diseases. The company leverages expertise in TYK2 inhibition to advance a pipeline of differentiated drug candidates addressing significant unmet medical needs. With a focus on innovation and clinical rigor, Alumis seeks to establish a competitive position in the biopharmaceutical sector through targeted therapeutic development. BML Capital’s move is a reminder that even disciplined portfolio decisions can collide with fast-moving catalysts. The sale was completed by December 31, as of the filing’s period-end date, before Alumis announced its January upsized public offering and before shares went on to surge roughly 200% in the weeks that followed. At the time, the decision was defensible. Alumis was a clinical-stage biotech with no approved products and heavy R&D spend. As of the third quarter, the company reported $377.7 million in cash and marketable securities, but advancing its TYK2 inhibitor programs toward late-stage trials requires deep pockets and patience. For a fund concentrated in early-stage biotech, risk management might often mean trimming or exiting ahead of known financing events. What changed was the market’s reaction. The January offering removed balance-sheet uncertainty and flipped the narrative from capital risk to clinical optionality. Momentum followed quickly, repricing the stock well ahead of any new trial data. Ultimately, this portfolio remains heavily skewed toward development-stage names, suggesting the exit was about exposure control rather than a negative read on the science. The lesson isn’t necessarily about regret. After all, in biotech, capital events can reset sentiment faster than fundamentals, and sometimes the biggest moves happen after the risk you were managing disappears. Ever feel like you missed the boat in buying the most successful stocks? Then you’ll want to hear this. On rare occasions, our expert team of analysts issues a “Double Down” stock recommendation for companies that they think are about to pop. If you’re worried you’ve already missed your chance to invest, now is the best time to buy before it’s too late. And the numbers speak for themselves: Nvidia: if you invested $1,000 when we doubled down in 2009, you’d have $481,421!* Apple: if you invested $1,000 when we doubled down in 2008, you’d have $51,367!* Netflix: if you invested $1,000 when we doubled down in 2004, you’d have $446,319!* Right now, we’re issuing “Double Down” alerts for three incredible companies, available when you join Stock Advisor, and there may not be another chance like this anytime soon. See the 3 stocks » *Stock Advisor returns as of February 2, 2026 Jonathan Ponciano has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Atea Pharmaceuticals. The Motley Fool has a disclosure policy. Alumis Stock Has Rallied 250% This Past Year. One Fund Sold Its $5 Million Stake Last Quarter. was originally published by The Motley Fool

Investor releaseQuarter not tagged2025-11-12

PMV Pharmaceuticals Reports Third Quarter 2025 Financial Results and Corporate Highlights

GlobeNewswire
Updated clinical results from Phase 2 pivotal portion of the PYNNACLE study evaluating rezatapopt featured in late-breaking oral presentation at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics 34% overall response rate (ORR) observed among 103 evaluable patients across all cohorts with a median duration of response of 7.6 months 46% ORR observed among 48 evaluable patients in ovarian cancer cohort with a median duration of response of 8.0 months Rezatapopt New Drug Application submission for platinum resistant/refractory ovarian cancer planned in first quarter of 2027 Cash, cash equivalents, and marketable securities of $129.3 million as of September 30, 2025, providing expected cash runway to end of first quarter of 2027 PRINCETON, N.J., Nov. 12, 2025 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. (“PMV Pharma” or the “Company”; Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule therapies targeting p53, today reported financial results for the third quarter ended September 30, 2025, and provided a corporate update. “I am incredibly proud of our team and their commitment to rapidly and efficiently advancing the PYNNACLE study,” said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. “We are excited by the data emerging from this study and look forward to submitting an NDA in the first quarter of 2027 for platinum-resistant/refractory ovarian cancer.” Corporate Highlights Updated clinical results from the Phase 2 pivotal portion of the PYNNACLE study evaluating rezatapopt were featured in late-breaking oral and poster presentations at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics on October 24, 2025. Confirmed responses were observed in patients whose tumors were TP53 Y220C mutated and KRAS wild-type in eight tumor types including ovarian, lung, breast, endometrial, head and neck, colorectal, gallbladder cancers, and ampullary carcinoma. Overall response rate (ORR) of 34% (35/103 patients) per investigator assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, including confirmed and unconfirmed responses. The cohort-specific ORRs were as follows: Ovarian cancer: 46% ORR (22/48 patients, including one confirmed complete response, 18 confirmed partial responses,…Read full document

Updated clinical results from Phase 2 pivotal portion of the PYNNACLE study evaluating rezatapopt featured in late-breaking oral presentation at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics 34% overall response rate (ORR) observed among 103 evaluable patients across all cohorts with a median duration of response of 7.6 months 46% ORR observed among 48 evaluable patients in ovarian cancer cohort with a median duration of response of 8.0 months Rezatapopt New Drug Application submission for platinum resistant/refractory ovarian cancer planned in first quarter of 2027 Cash, cash equivalents, and marketable securities of $129.3 million as of September 30, 2025, providing expected cash runway to end of first quarter of 2027 PRINCETON, N.J., Nov. 12, 2025 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. (“PMV Pharma” or the “Company”; Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule therapies targeting p53, today reported financial results for the third quarter ended September 30, 2025, and provided a corporate update. “I am incredibly proud of our team and their commitment to rapidly and efficiently advancing the PYNNACLE study,” said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. “We are excited by the data emerging from this study and look forward to submitting an NDA in the first quarter of 2027 for platinum-resistant/refractory ovarian cancer.” Corporate Highlights Updated clinical results from the Phase 2 pivotal portion of the PYNNACLE study evaluating rezatapopt were featured in late-breaking oral and poster presentations at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics on October 24, 2025. Confirmed responses were observed in patients whose tumors were TP53 Y220C mutated and KRAS wild-type in eight tumor types including ovarian, lung, breast, endometrial, head and neck, colorectal, gallbladder cancers, and ampullary carcinoma. Overall response rate (ORR) of 34% (35/103 patients) per investigator assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, including confirmed and unconfirmed responses. The cohort-specific ORRs were as follows: Ovarian cancer: 46% ORR (22/48 patients, including one confirmed complete response, 18 confirmed partial responses, and three unconfirmed partial responses [uPR]) Breast cancer: 17% ORR (2/12 patients) Endometrial cancer: 60% ORR (3/5 patients, including one uPR) Lung cancer: 21% ORR (4/19 patients, including one uPR) Other solid tumors: 21% ORR (4/19 patients) Across all cohorts, the median time to response was 1.3 months and the median duration of response was 7.6 months. In the ovarian cancer cohort, the median time to response was 1.3 months and median duration of response was 8.0 months. Post the September 4, 2025 data cutoff date, four uPRs were confirmed and one uPR (ovarian cancer) remains on treatment. A poster entitled, “Natural history and prognostic value of TP53 Y220C mutation in advanced solid tumors: A real-world study,” was also presented at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, which concluded that patients with TP53 Y220C-mutated solid tumors had poor prognoses and reduced overall survival compared to patients without a TP53 Y220C mutation. Third Quarter 2025 Financial Results PMV Pharma ended the third quarter with $129.3 million in cash, cash equivalents, and marketable securities, compared to $148.3 million as of June 30, 2025. Net cash used in operations was $56.4 million for the nine months ended September 30, 2025, compared to $34.6 million for the nine months ended September 30, 2024. Net loss for the quarter ended September 30, 2025, was $21.1 million compared to $19.2 million for the quarter ended September 30, 2024. The net loss increase was primarily due to increased research and development (R&D) costs. R&D expenses were $18.2 million for the quarter ended September 30, 2025, compared to $16.9 million for the quarter ended September 30, 2024. The increase in R&D expenses was primarily due to increased contractual research organization costs for the advancement of the rezatapopt program. General and administrative (G&A) expenses were $4.3 million for the quarter ended September 30, 2025, compared to $4.9 million for the quarter ended September 30, 2024. The decrease in G&A expenses was primarily due to reduced spend for stock-based compensation and facility and operational expenses. 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 U.S. Food and Drug Administration granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation. 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. 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. Arnold Levine, established the field of p53 biology 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 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 rezatapopt, including our ability to obtain approval as a treatment option as a monotherapy, expectations regarding timing, number of patients and treatment durations for our interim data readouts, expectations regarding timing and success of the Phase 2 portion of the current clinical trial for rezatapopt and filing of an NDA for platinum-resistant/refractory ovarian cancer, 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, 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 March 3, 2025, the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2025, filed with the SEC on May 9, 2025, and the Company’s Quarterly Report on Form 10-Q for the three months ended June 30, 2025, filed with the SEC on August 7, 2025, 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: Tim Smith Senior Vice President, Head of Corporate Development and Investor Relations [email protected] Media Contact: Kathy Vincent Greig Communications [email protected]

Investor releaseQuarter not tagged2025-10-14

PMV Pharmaceuticals to Present Rezatapopt Pivotal Phase 2 Initial Analysis and Natural History Study Results at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

GlobeNewswire
Oral presentation to highlight initial data from ongoing pivotal Phase 2 study of rezatapopt, a first-in-class precision oncology investigational therapy, in patients with advanced solid tumors harboring a TP53 Y220C mutation PRINCETON, N.J., Oct. 13, 2025 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. (“PMV Pharma” or the “Company”; Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, today announced that two abstracts have been accepted for oral and poster presentations at the upcoming AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics being held October 22-26, 2025 in Boston, MA. Details for the presentations are as follows: Oral Presentation Title: Rezatapopt for locally advanced or metastatic solid tumors with a TP53 Y220C mutation: Initial analysis of the pivotal PYNNACLE Phase 2 trial Date and Time: Friday, October 24; 10:00 – 11:40 AM ET Session and Location: Clinical Trials Plenary Session; Level 3, Ballroom AB Presenter: Alison M. Schram, M.D., Memorial Sloan Kettering Cancer Center Poster Presentations Title: Rezatapopt for locally advanced or metastatic solid tumors with a TP53 Y220C mutation: Initial analysis of the pivotal PYNNACLE Phase 2 trial Date and Time: Friday, October 24; 12:30 – 4:00 PM ET Session and Location: Poster Session B; Exhibit Hall D Title: Natural history and prognostic value of TP53 Y220C mutation in advanced solid tumors: A real-world study Date and Time: Saturday, October 25; 12:30 – 4:00 PM ET Session and Location: Poster Session C; Exhibit Hall D 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 U.S. Food and Drug Administration granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation. 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 ora…Read full document

Oral presentation to highlight initial data from ongoing pivotal Phase 2 study of rezatapopt, a first-in-class precision oncology investigational therapy, in patients with advanced solid tumors harboring a TP53 Y220C mutation PRINCETON, N.J., Oct. 13, 2025 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. (“PMV Pharma” or the “Company”; Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, today announced that two abstracts have been accepted for oral and poster presentations at the upcoming AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics being held October 22-26, 2025 in Boston, MA. Details for the presentations are as follows: Oral Presentation Title: Rezatapopt for locally advanced or metastatic solid tumors with a TP53 Y220C mutation: Initial analysis of the pivotal PYNNACLE Phase 2 trial Date and Time: Friday, October 24; 10:00 – 11:40 AM ET Session and Location: Clinical Trials Plenary Session; Level 3, Ballroom AB Presenter: Alison M. Schram, M.D., Memorial Sloan Kettering Cancer Center Poster Presentations Title: Rezatapopt for locally advanced or metastatic solid tumors with a TP53 Y220C mutation: Initial analysis of the pivotal PYNNACLE Phase 2 trial Date and Time: Friday, October 24; 12:30 – 4:00 PM ET Session and Location: Poster Session B; Exhibit Hall D Title: Natural history and prognostic value of TP53 Y220C mutation in advanced solid tumors: A real-world study Date and Time: Saturday, October 25; 12:30 – 4:00 PM ET Session and Location: Poster Session C; Exhibit Hall D 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 U.S. Food and Drug Administration granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation. 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. 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, tumor-agnostic therapies targeting p53. TP53 mutations are found in approximately half of all cancers. The Company’s co-founder, Dr. Arnold Levine, established the field of p53 biology when he discovered the p53 protein in 1979. Bringing together leaders in the field to utilize more than four decades of p53 biology, PMV Pharma combines unique biological understanding with a pharmaceutical development focus. PMV Pharma is headquartered in Princeton, New Jersey. For more information, please visit www.pmvpharma.com. Contacts Investors Contact: Tim Smith Senior Vice President, Head of Corporate Development and Investor Relations [email protected] Media Contact: Kathy Vincent Greig Communications [email protected]

Investor releaseQuarter not tagged2025-08-07

PMV Pharmaceuticals Reports Second Quarter 2025 Financial Results and Corporate Highlights

GlobeNewswire
PMV will host an investor webinar on Wednesday, September 10, 2025 at 8:00 AM ET to review Phase 2 PYNNACLE clinical trial interim analysis Interim analysis will include data for approximately 65 patients with at least 18 weeks of follow-up Cash, cash equivalents, and marketable securities of $148.3 million as of June 30, 2025, providing expected cash runway to end of 2026 PRINCETON, N.J., Aug. 07, 2025 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. (“PMV Pharma” or the “Company”; 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, 2025, and provided a corporate update. PMV Pharma will host an investor webinar on Wednesday, September 10, 2025 at 8:00 AM ET to review interim analysis data from the Phase 2 PYNNACLE clinical trial. This interim analysis will include data for approximately 65 patients who have had at least 18 weeks of follow-up, of which approximately 45% are in the ovarian cancer cohort. “Our team has continued to execute at an exceptionally high level as we advance the registrational Phase 2 PYNNACLE clinical trial,” said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. “We look forward to providing data from the interim analysis on September 10.” Second Quarter 2025 Financial Results PMV Pharma ended the second quarter with $148.3 million in cash, cash equivalents, and marketable securities, compared to $165.8 million as of March 31, 2025. Net cash used in operations was $36.5 million for the six months ended June 30, 2025, compared to $17.8 million for the six months ended June 30, 2024. Net loss for the quarter ended June 30, 2025, was $21.2 million compared to $1.2 million for the quarter ended June 30, 2024. The net loss increase was a result of the Company’s sale of its New Jersey accumulated net operating losses in the second quarter of 2024, with a corresponding $16.2 million income tax benefit. Research and development (R&D) expenses were $18.4 million for the quarter ended June 30, 2025, compared to $14.6 million for the quarter ended June 30, 2024. The increase in R&D expenses was primarily due to increased contractual research organization costs for the advancement of the rezatapopt program. General and administrative (G&A) expenses were $4.5 million…Read full document

PMV will host an investor webinar on Wednesday, September 10, 2025 at 8:00 AM ET to review Phase 2 PYNNACLE clinical trial interim analysis Interim analysis will include data for approximately 65 patients with at least 18 weeks of follow-up Cash, cash equivalents, and marketable securities of $148.3 million as of June 30, 2025, providing expected cash runway to end of 2026 PRINCETON, N.J., Aug. 07, 2025 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. (“PMV Pharma” or the “Company”; 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, 2025, and provided a corporate update. PMV Pharma will host an investor webinar on Wednesday, September 10, 2025 at 8:00 AM ET to review interim analysis data from the Phase 2 PYNNACLE clinical trial. This interim analysis will include data for approximately 65 patients who have had at least 18 weeks of follow-up, of which approximately 45% are in the ovarian cancer cohort. “Our team has continued to execute at an exceptionally high level as we advance the registrational Phase 2 PYNNACLE clinical trial,” said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. “We look forward to providing data from the interim analysis on September 10.” Second Quarter 2025 Financial Results PMV Pharma ended the second quarter with $148.3 million in cash, cash equivalents, and marketable securities, compared to $165.8 million as of March 31, 2025. Net cash used in operations was $36.5 million for the six months ended June 30, 2025, compared to $17.8 million for the six months ended June 30, 2024. Net loss for the quarter ended June 30, 2025, was $21.2 million compared to $1.2 million for the quarter ended June 30, 2024. The net loss increase was a result of the Company’s sale of its New Jersey accumulated net operating losses in the second quarter of 2024, with a corresponding $16.2 million income tax benefit. Research and development (R&D) expenses were $18.4 million for the quarter ended June 30, 2025, compared to $14.6 million for the quarter ended June 30, 2024. The increase in R&D expenses was primarily due to increased contractual research organization costs for the advancement of the rezatapopt program. General and administrative (G&A) expenses were $4.5 million for the quarter ended June 30, 2025, compared to $5.5 million for the quarter ended June 30, 2024. The decrease in G&A expenses was primarily due to reduced spend for stock-based compensation and facility and operational expenses. 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 U.S. Food and Drug Administration granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation. 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. 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, tumor-agnostic therapies targeting p53. TP53 mutations are found in approximately half of all cancers. Our co-founder, Dr. Arnold Levine, established the field of p53 biology 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 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 rezatapopt, including our ability to obtain approval as a treatment option on a tumor-agnostic basis and as a monotherapy, expectations regarding timing, number of patients and treatment durations for our interim data readouts, expectations regarding timing and success of the Phase 2 portion of the current clinical trial 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 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, 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 March 3, 2025, the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2025, filed with the SEC on May 9, 2025, and the Company’s Quarterly Report on Form 10-Q for the three months ended June 30, 2025, filed with the SEC on August 7, 2025, 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 Consolidated Balance Sheets (unaudited) (in thousands, except share and per share amounts) Investors Contact: Tim Smith Senior Vice President, Head of Corporate Development and Investor Relations [email protected] Media Contact: Kathy Vincent Greig Communications [email protected]

Investor releaseQuarter not tagged2025-05-09

PMV Pharmaceuticals Reports First Quarter 2025 Financial Results and Corporate Highlights

GlobeNewswire
Enrollment on track in Phase 2 pivotal portion of PYNNACLE clinical trial evaluating rezatapopt as monotherapy in patients with TP53 Y220C and KRAS wild-type advanced solid tumors Interim analysis from Phase 2 PYNNACLE trial expected mid-2025; PMV plans to provide interim analysis data for approximately 50 patients with at least 18 weeks of follow-up Cash, cash equivalents, and marketable securities of $165.8 million as of March 31, 2025, providing expected cash runway to end of 2026 PRINCETON, N.J., May 09, 2025 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. (“PMV Pharma” or the “Company”; 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 first quarter ended March 31, 2025, and provided a corporate update. PMV Pharma plans to provide interim analysis data from the Phase 2 PYNNACLE trial in the middle of 2025. This interim analysis will include data for approximately 50 patients, of which approximately 40% are in the ovarian cancer cohort, who have been followed for at least 18 weeks. “Our registrational PYNNACLE trial continues to progress well and enrollment remains on track,” said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. “I am very appreciative of the efforts of our team and their continued execution. We look forward to providing data from the interim analysis in the middle of this year.” Corporate Highlights Paper published in Cancer Discovery describing the discovery of rezatapopt. The paper entitled, “Restoration of the Tumor Suppressor Function of Y220C-Mutant p53 by Rezatapopt, a Small Molecule Reactivator,” can be accessed here. First Quarter 2025 Financial Results PMV Pharma ended the first quarter with $165.8 million in cash, cash equivalents, and marketable securities, compared to $183.3 million as of December 31, 2024. Net cash used in operations was $18.3 million for the three months ended March 31, 2025, compared to $16.2 million for the three months ended March 31, 2024. Net loss for the quarter ended March 31, 2025, was $17.5 million compared to $15.3 million for the quarter ended March 31, 2024. Research and development (R&D) expenses were $17.4 million for the quarter ended March 31, 2025, compared to $13.2 million for the quarter ended March 31, 2024. The increase in R&D expen…Read full document

Enrollment on track in Phase 2 pivotal portion of PYNNACLE clinical trial evaluating rezatapopt as monotherapy in patients with TP53 Y220C and KRAS wild-type advanced solid tumors Interim analysis from Phase 2 PYNNACLE trial expected mid-2025; PMV plans to provide interim analysis data for approximately 50 patients with at least 18 weeks of follow-up Cash, cash equivalents, and marketable securities of $165.8 million as of March 31, 2025, providing expected cash runway to end of 2026 PRINCETON, N.J., May 09, 2025 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. (“PMV Pharma” or the “Company”; 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 first quarter ended March 31, 2025, and provided a corporate update. PMV Pharma plans to provide interim analysis data from the Phase 2 PYNNACLE trial in the middle of 2025. This interim analysis will include data for approximately 50 patients, of which approximately 40% are in the ovarian cancer cohort, who have been followed for at least 18 weeks. “Our registrational PYNNACLE trial continues to progress well and enrollment remains on track,” said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. “I am very appreciative of the efforts of our team and their continued execution. We look forward to providing data from the interim analysis in the middle of this year.” Corporate Highlights Paper published in Cancer Discovery describing the discovery of rezatapopt. The paper entitled, “Restoration of the Tumor Suppressor Function of Y220C-Mutant p53 by Rezatapopt, a Small Molecule Reactivator,” can be accessed here. First Quarter 2025 Financial Results PMV Pharma ended the first quarter with $165.8 million in cash, cash equivalents, and marketable securities, compared to $183.3 million as of December 31, 2024. Net cash used in operations was $18.3 million for the three months ended March 31, 2025, compared to $16.2 million for the three months ended March 31, 2024. Net loss for the quarter ended March 31, 2025, was $17.5 million compared to $15.3 million for the quarter ended March 31, 2024. Research and development (R&D) expenses were $17.4 million for the quarter ended March 31, 2025, compared to $13.2 million for the quarter ended March 31, 2024. The increase in R&D expenses was primarily due to external expenses related to the advancement of product candidates, offset by decreased personnel related costs and stock-based compensation. General and administrative (G&A) expenses were $4.1 million for the quarter ended March 31, 2025, compared to $5.0 million for the quarter ended March 31, 2024. The decrease in G&A expenses was primarily due to reduced headcount and spend for facility and operational expenses. 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 U.S. Food and Drug Administration (FDA) granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation. 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 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. 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, tumor-agnostic therapies targeting p53. TP53 mutations are found in approximately half of all cancers. Our co-founder, Dr. Arnold Levine, established the field of p53 biology 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 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 rezatapopt, including our ability to obtain approval as a treatment option on a tumor-agnostic basis and as a monotherapy, expectations regarding timing, number of patients and treatment durations for our interim data readouts, expectations regarding timing and success of the Phase 2 portion of the current clinical trial 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 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, 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 March 3, 2025, and the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2025, filed with the SEC on May 9, 2025, 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: Tim Smith Senior Vice President, Head of Corporate Development and Investor Relations [email protected] Media Contact: Kathy Vincent Greig Communications [email protected]

As of 2026-08-15 • Updated weeklySource: Earnings sourceIngestion runbook