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PMV Pharmaceuticals Reports Third Quarter 2024 Financial Results

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PMV Pharmaceuticals reported Q3 2024 financial results and provided updates on its PYNNACLE clinical trial. The Phase 2 portion evaluating rezatapopt as monotherapy is progressing with over 75% of sites activated globally. The company ended Q3 with $197.9 million in cash, providing runway through 2026. Net loss increased to $19.2 million from $16.6 million year-over-year. R&D expenses rose to $16.9 million, while G&A expenses decreased to $4.9 million. The company plans an interim analysis by mid-2025 and anticipates a New Drug Application filing by end of 2026.

PMV Pharmaceuticals ha riportato i risultati finanziari del terzo trimestre del 2024 e fornito aggiornamenti sul suo trial clinico PYNNACLE. La fase 2 che valuta rezatapopt come monoterapia sta procedendo con oltre il 75% dei siti attivati a livello globale. L'azienda ha chiuso il terzo trimestre con 197,9 milioni di dollari in contante, garantendo così un margine operativo fino al 2026. La perdita netta è aumentata a 19,2 milioni di dollari rispetto ai 16,6 milioni dello stesso periodo dell'anno precedente. Le spese per Ricerca e Sviluppo sono aumentate a 16,9 milioni di dollari, mentre le spese generali e amministrative sono diminuite a 4,9 milioni di dollari. L'azienda prevede un'analisi intermedia entro la metà del 2025 e anticipa una richiesta di nuova applicazione per farmaci entro la fine del 2026.

PMV Pharmaceuticals reportó resultados financieros del tercer trimestre de 2024 y proporcionó actualizaciones sobre su ensayo clínico PYNNACLE. La fase 2 que evalúa rezatapopt como monoterapia está avanzando con más del 75% de los sitios activados a nivel mundial. La compañía finalizó el tercer trimestre con 197,9 millones de dólares en efectivo, lo que proporciona un margen operativo hasta 2026. La pérdida neta aumentó a 19,2 millones de dólares desde 16,6 millones en el año anterior. Los gastos en I+D crecieron a 16,9 millones de dólares, mientras que los gastos generales y administrativos disminuyeron a 4,9 millones de dólares. La compañía planea un análisis intermedio para mediados de 2025 y anticipa una presentación de solicitud de nuevo fármaco para finales de 2026.

PMV Pharmaceuticals는 2024년 3분기 재무 결과를 발표하고 PYNNACLE 임상 시험에 대한 업데이트를 제공했습니다. rezatapopt을 단독 치료제로 평가하는 2상 부분은 전 세계적으로 75% 이상의 사이트가 활성화되면서 진행되고 있습니다. 회사는 3분기를 1억 9790만 달러의 현금으로 마감하여 2026년까지 운영 자금을 확보했습니다. 순손실은 전년 대비 1660만 달러에서 1920만 달러로 증가했습니다. 연구 및 개발 비용은 1690만 달러로 증가했고, 일반 관리 비용은 490만 달러로 감소했습니다. 회사는 2025년 중반까지 중간 분석을 계획하고 있으며, 2026년 말까지 신규 약물 신청서를 제출할 것으로 예상하고 있습니다.

PMV Pharmaceuticals a annoncé les résultats financiers du troisième trimestre 2024 et a fourni des mises à jour sur son essai clinique PYNNACLE. La phase 2 évaluant rezatapopt en tant que monothérapie progresse avec plus de 75 % des sites activés dans le monde entier. L'entreprise a terminé le troisième trimestre avec 197,9 millions de dollars en liquidités, assurant un fonds de roulement jusqu'en 2026. La perte nette a augmenté à 19,2 millions de dollars, contre 16,6 millions de dollars l'année précédente. Les dépenses de R&D ont augmenté à 16,9 millions de dollars, tandis que les dépenses générales et administratives ont diminué à 4,9 millions de dollars. L'entreprise prévoit une analyse intermédiaire d'ici la mi-2025 et anticipe une demande de nouvel médicament d'ici la fin de 2026.

PMV Pharmaceuticals hat die finanziellen Ergebnisse des dritten Quartals 2024 veröffentlicht und Updates zu seiner PYNNACLE-Studie bereitgestellt. Der Phase-2-Teil zur Bewertung von rezatapopt als Monotherapie schreitet voran, mit über 75 % aktivierter Standorte weltweit. Das Unternehmen schloss das dritte Quartal mit 197,9 Millionen Dollar an baren Mitteln ab, was eine finanzielle Basis bis 2026 bietet. Der Nettoverlust stieg von 16,6 Millionen Dollar im Vorjahr auf 19,2 Millionen Dollar. Die Aufwendungen für Forschung und Entwicklung erhöhten sich auf 16,9 Millionen Dollar, während die allgemeinen und Verwaltungskosten auf 4,9 Millionen Dollar sanken. Das Unternehmen plant eine Zwischenanalyse bis Mitte 2025 und erwartet, bis Ende 2026 einen Antrag auf Zulassung eines neuen Arzneimittels einzureichen.

Positive
  • Strong cash position of $197.9M providing runway through 2026
  • Over 75% of clinical trial sites activated across U.S., Europe, and Asia-Pacific
  • Reduced G&A expenses from $6.0M to $4.9M year-over-year
Negative
  • Net loss increased to $19.2M from $16.6M year-over-year
  • R&D expenses increased to $16.9M from $13.6M year-over-year
  • Discontinued Phase 1b combination arm with KEYTRUDA due to clinical benefit
  • Cash position decreased from $238.1M to $197.9M year-over-year

Insights

The Q3 financial results reveal a mixed picture for PMV Pharmaceuticals. The company maintains a strong cash position of $197.9 million, providing runway through 2026, though this represents a decline from $238.1 million year-over-year. The net loss widened to $19.2 million from $16.6 million, primarily due to increased R&D expenses.

Notably, operational efficiency has improved with net cash burn reducing to $34.6 million for the nine months, down from $43.6 million in the previous year. The 42% increase in drug exposure levels when taken with food could potentially lead to better cost-effectiveness in drug administration.

The PYNNACLE trial progress shows promising operational execution with 75% of sites activated globally. However, the discontinuation of the combination arm with KEYTRUDA® due to dose-limiting toxicities and clinical benefit at 500mg represents a setback in the combination therapy strategy. The upcoming investigator-initiated Phase 1b study in AML/MDS patients and the interim analysis expected by mid-2025 are critical milestones that could validate rezatapopt's potential in treating TP53 Y220C mutations across multiple cancer types.

  • Enrollment on track in Phase 2 portion of PYNNACLE clinical trial evaluating rezatapopt as monotherapy in patients with TP53 Y220C and KRAS wild-type advanced solid tumors; more than 75% of sites activated across the U.S., Europe, and Asia-Pacific; interim analysis expected by mid-2025

  • PMV Pharmaceuticals is collaborating with MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center to support an investigator-initiated Phase 1b study evaluating rezatapopt monotherapy and in combination with azacitidine in patients with relapsed or refractory AML/MDS harboring a TP53 Y220C mutation; enrollment planned to begin in the first quarter of 2025

  • Cash, cash equivalents, and marketable securities of $197.9 million as of September 30, 2024, providing expected cash runway to end of 2026

PRINCETON, N.J., Nov. 07, 2024 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, today reported financial results for the third quarter ended September 30, 2024, and provided a corporate update.

“The Phase 2 portion of the PYNNACLE trial continues to advance, with site activation and enrollment progressing well,” said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. “We look forward to providing an update on the PYNNACLE clinical trial in the middle of next year.”

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, tumor-agnostic Phase 2 trial is assessing rezatapopt as monotherapy at a dose of 2000 mg once-daily in patients with TP53 Y220C and KRAS wild-type advanced solid tumors. The primary endpoint is overall response rate per blinded independent central review. The trial is designed to enroll 114 patients across five cohorts at approximately 60 sites.

Site activation is progressing well, with more than 75% of sites activated across the U.S., Europe, and Asia-Pacific. PMV Pharma plans to provide data from the interim analysis of the Phase 2 monotherapy portion of the PYNNACLE trial by mid-2025 and anticipates a New Drug Application filing by the end of 2026.

Third Quarter 2024 and Recent Corporate Highlights:

  • PMV Pharma is collaborating with MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center to support an investigator-initiated Phase 1b study. The study is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of rezatapopt monotherapy and in combination with azacitidine in approximately 25 patients with relapsed or refractory acute myeloid leukemia (AML)/myelodysplastic syndrome (MDS) harboring a TP53 Y220C mutation. Enrollment is planned to begin in the first quarter of 2025.
  • Rezatapopt food effect data were presented on September 8, 2024 during a poster session at the American College of Clinical Pharmacology Annual Conference. Key data are summarized below:
    • In the Phase 1 portion of the PYNNACLE study, 13 patients received rezatapopt in a fasted state, while 12 patients received rezatapopt after eating. When taken with food, exposure levels at steady state as measured by AUC0-24 and Cmax increased by 42% and 40%, respectively. Additionally, variability in exposure decreased significantly with food.
    • Overall, rezatapopt was well-tolerated and associated with fewer gastrointestinal (GI) treatment-related adverse events (TRAEs) when administered with food. In addition, the frequency and severity of GI TRAEs were lowest in the 2000 mg once-daily (QD) fed cohort versus higher dose cohorts. These data supported the 2000 mg QD dose being recommended to be taken with food within the ongoing PYNNACLE Phase 2 study.
  • Dose-limiting toxicities were observed in the combination arm of the Phase 1b PYNNACLE trial evaluating rezatapopt and Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab). As a result, rezatapopt 500 mg once-daily in combination with pembrolizumab 200 mg every three weeks was established as the maximum tolerated dose. Due to limited clinical benefit at this dose, PMV Pharma discontinued enrollment in the Phase 1b combination arm.

Third Quarter 2024 Financial Results

PMV Pharma ended the third quarter with $197.9 million in cash, cash equivalents, and marketable securities, compared to $238.1 million as of September 30, 2023. Net cash used in operations was $34.6 million for the nine months ended September 30, 2024, compared to $43.6 million for the nine months ended September 30, 2023.

  • Net loss for the quarter ended September 30, 2024, was $19.2 million compared to $16.6 million for the quarter ended September 30, 2023. The net loss increase was a result of increased research and development (R&D) spending associated with advancing our lead product candidate through the PYNNACLE Phase 1/2 clinical trial.
  • R&D expenses were $16.9 million for the quarter ended September 30, 2024, compared to $13.6 million for the quarter ended September 30, 2023. The increase in R&D expenses was primarily related to increased contract research organization costs.
  • General and administrative (G&A) expenses were $4.9 million for the quarter ended September 30, 2024, compared to $6.0 million for the quarter ended September 30, 2023. The decrease in G&A expenses was primarily due to reduced spend for facility and operational expenses.

KEYTRUDA® (pembrolizumab) is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

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 TP53 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. In Phase 1, an overall response rate of 38% (6/16 evaluable patients) was achieved at the RP2D of 2000 mg daily reflective of the Phase 2 patient population (TP53 Y220C and KRAS wild-type). The median duration of response was seven months. The Phase 2 monotherapy portion is a registrational, single-arm, expansion basket clinical trial comprising five cohorts (ovarian, lung, breast, 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 or in combination with other agents, including with azacytidine, expectations regarding timing for interim data readouts and success of the Phase 2 portion of the PYNNACLE trial, our expectation and timing of New Drug Application filing(s) with the U.S. Food and Drug Administration for the current clinical trial for rezatapopt, the current and future enrollment of patients in our clinical trials, the timing, progress and activation of sites for our clinical trials, collaboration with and plans for the MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center investigator-initiated study for the combination of rezatapopt and azacitidine, 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 February 29, 2024, our Quarterly Report on Form 10-Q for the three months ended March 31, 2024, filed with the SEC on May 9, 2024, and our 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. We undertake 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)
 September 30,
2024
 December 31,
2023
Assets   
Current assets:   
Cash and cash equivalents$48,810  $37,706 
Restricted cash 822   822 
Marketable securities, current 134,031   165,351 
Prepaid expenses and other current assets 5,957   3,530 
Total current assets 189,620   207,409 
Property and equipment, net 10,130   10,666 
Marketable securities, noncurrent 15,096   25,505 
Right-of-use assets 8,407   8,382 
Other assets 242   190 
Total assets$223,495  $252,152 
Liabilities and Stockholders’ Equity   
Current liabilities:   
Accounts payable$2,063  $3,237 
Accrued expenses 10,257   9,940 
        
Operating lease liabilities, current 1,243   852 
Total current liabilities 13,563   14,029 
Operating lease liabilities, noncurrent 12,024   12,434 
Total liabilities 25,587   26,463 
Stockholders’ equity:   
Additional paid-in capital 543,210   535,468 
Accumulated deficit (345,712)  (310,003)
Accumulated other comprehensive income 410   224 
Total stockholders’ equity 197,908   225,689 
Total liabilities and stockholders’ equity$223,495  $252,152 


PMV Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(unaudited)
(in thousands, except share and per share amounts)
 Three Months Ended
September 30,
 Nine Months Ended
September 30,
  2024   2023   2024   2023 
Operating expenses:       
Research and development$16,947  $13,586  $44,760  $42,503 
General and administrative 4,941   6,042   15,520   18,727 

Total operating expenses
 21,888   19,628   60,280   61,230 
Loss from operations (21,888)  (19,628)  (60,280)  (61,230)
Other income (expense):       
Interest income, net 2,615   2,984   8,368   8,005 
Other income, net 121   4   103   24 

Total other income
 2,736   2,988   8,471   8,029 
Loss before provision for income
taxes
 (19,152)  (16,640)  (51,809)  (53,201)
Provision (benefit) from income taxes 74   -   (16,100)  3 
Net loss (19,226)  (16,640)  (35,709)  (53,204)
Unrealized gain (loss) on available for
sale investments, net of tax
 591   (27)  211   90 
Foreign currency translation gain
(loss)
 4   -   (25)  - 
Total other comprehensive income
(loss)
 595   (27)  186   90 

Total comprehensive loss
$(18,631) $(16,667) $(35,523) $(53,114)

Net loss per share -- basic and diluted
$(0.37) $(0.34) $(0.69) $(1.13)
Weighted-average common shares
outstanding
 51,574,027   49,047,296   51,499,818   46,889,921 

Investors Contact:
Tim Smith
Senior Vice President, Head of Corporate Development and Investor Relations
investors@pmvpharma.com

Media Contact:
Kathy Vincent
Greig Communications
kathy@greigcommunications.com


FAQ

What was PMV Pharmaceuticals (PMVP) net loss in Q3 2024?

PMV Pharmaceuticals reported a net loss of $19.2 million for Q3 2024, compared to $16.6 million in Q3 2023.

When does PMVP expect to provide interim analysis of the PYNNACLE Phase 2 trial?

PMV Pharmaceuticals plans to provide data from the interim analysis of the Phase 2 monotherapy portion of the PYNNACLE trial by mid-2025.

What is PMVP's current cash runway?

With $197.9 million in cash, cash equivalents, and marketable securities as of September 30, 2024, PMV Pharmaceuticals expects its cash runway to extend to the end of 2026.

PMV Pharmaceuticals, Inc

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