PMV Pharmaceuticals Reports First Quarter 2025 Financial Results and Corporate Highlights

Rhea-AI Summary

PMV Pharmaceuticals (PMVP) has reported its Q1 2025 financial results and provided updates on its PYNNACLE clinical trial for rezatapopt. The company plans to release interim analysis data from approximately 50 patients in mid-2025, with 40% from the ovarian cancer cohort. Financially, PMV ended Q1 with $165.8 million in cash and equivalents, expecting runway through 2026.

The company reported a net loss of $17.5 million for Q1 2025, compared to $15.3 million in Q1 2024. R&D expenses increased to $17.4 million from $13.2 million year-over-year, while G&A expenses decreased to $4.1 million from $5.0 million. Net cash used in operations was $18.3 million for Q1 2025.

Positive

• Strong cash position of $165.8M providing runway through 2026
• PYNNACLE trial enrollment progressing on track
• Reduction in G&A expenses from $5.0M to $4.1M year-over-year

Negative

• Increased net loss to $17.5M from $15.3M year-over-year
• Higher R&D expenses at $17.4M vs $13.2M in Q1 2024
• Increased cash burn with $18.3M used in operations vs $16.2M year-over-year

Insights

Oncology Clinical Trials Expert

PMV Pharma shows solid progress in p53-targeting trial with strong cash position, but next catalyst needed for stock movement.

The PYNNACLE trial for rezatapopt continues to track according to the company's timeline, with an important interim analysis expected mid-2025. This analysis will include data from approximately 50 patients with at least 18 weeks of follow-up, with about 40% in the ovarian cancer cohort.

What's particularly interesting about rezatapopt is its tumor-agnostic approach targeting the Y220C mutation of p53, often called the "guardian of the genome" for its role in preventing cancer. Mutations in p53 occur in roughly 50% of all cancers, with Y220C representing about 1-2% of these mutations across various tumor types.

The recent publication in Cancer Discovery describing rezatapopt's mechanism is significant as it provides peer-reviewed validation of the compound's ability to restore normal function to mutated p53. This represents a potential breakthrough in precision oncology, as successful p53 reactivation has been an elusive goal for decades.

The PYNNACLE trial's focus on TP53 Y220C and KRAS wild-type advanced solid tumors follows a rational precision medicine approach. The enrichment of ovarian cancer patients (40% of the interim analysis population) makes strategic sense, as these patients often have limited treatment options after progression on first-line therapies.

The upcoming interim analysis will be a critical inflection point to validate whether rezatapopt's promising mechanism translates to meaningful clinical benefit. Investors should look for objective response rate, duration of response, and safety signals from this readout.

Biotech Financial Analyst

PMV maintains solid $165.8M cash position with 18-month runway, though increased R&D spend reflects advancing clinical programs.

PMV Pharmaceuticals' financial position remains relatively stable with $165.8 million in cash, cash equivalents, and marketable securities, down from $183.3 million at year-end 2024. The current cash position provides runway through the end of 2026, approximately 18 months from now, giving the company sufficient resources to advance through several key clinical milestones.

The quarterly cash burn increased to $18.3 million compared to $16.2 million in Q1 2024, a 13% year-over-year increase. This accelerated burn rate reflects the company's progression into more advanced and costly clinical development stages. The net loss widened to $17.5 million from $15.3 million in the year-ago period.

R&D expenses showed the most significant change, increasing to $17.4 million from $13.2 million year-over-year, a 31.8% increase that reflects the costs of advancing the pivotal portion of the PYNNACLE trial. This investment is appropriate given the stage of development and potential market opportunity.

On a positive note, G&A expenses decreased to $4.1 million from $5.0 million, indicating prudent cost management in non-research areas. This 18% reduction in administrative expenses shows management's focus on allocating capital to value-creating R&D activities while controlling overhead.

The financial strategy appears sound for a clinical-stage biotech, with sufficient runway to reach the next major value inflection point - the interim data readout expected mid-2025. This upcoming catalyst will be crucial for potential partnerships, financing opportunities, or capital market activities that could extend the runway further if the data is positive.

• 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.

PMV Pharmaceuticals, Inc. Condensed Consolidated Balance Sheets (unaudited) (in thousands, except share and per share amounts)
	March 31, 2025				December 31, 2024
Assets
Current assets:
Cash and cash equivalents	$	51,341			$	40,876
Marketable securities, current		109,047				128,578
Prepaid expenses and other current assets		3,111				6,204
Total current assets		163,499				175,658
Property and equipment, net		376				409
Marketable securities, noncurrent		5,435				13,843
Right-of-use assets		1,061				1,143
Other assets		237				235
Total assets	$	170,608			$	191,288
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	3,593			$	6,579
Accrued expenses		5,802				7,439
Operating lease liabilities, current		364				352
Total current liabilities		9,759				14,370
Operating lease liabilities, noncurrent		742				838
Total liabilities		10,501				15,208
Stockholders’ equity:
Additional paid-in capital		546,171				544,653
Accumulated deficit		(386,148)				(368,712)
Accumulated other comprehensive (loss) income		84				139
Total stockholders' equity		160,107				176,080
Total liabilities and stockholders’ equity	$	170,608			$	191,288

PMV Pharmaceuticals, Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) (in thousands, except share and per share amounts)
	Three Months Ended March 31,
	2025				2024
Operating expenses:
Research and development	$	17,441			$	13,186
General and administrative		4,123				5,035
Total operating expenses		21,564				18,221
Loss from operations		(21,564)				(18,221)
Other income (expense):
Interest income, net		1,935				2,952
Other income (expense), net		(4)				(1)
Total other income (expense)		1,931				2,951
Loss before income taxes		(19,633)				(15,270)
Income taxes		(2,197)				—
Net loss		(17,436)				(15,270)
Unrealized (loss) gain on available for sale investments, net of tax		(62)				(319)
Foreign currency translation gain (loss)		7				(34)
Total comprehensive (loss) income		(55)				(353)
Total comprehensive loss	$	(17,491)			$	(15,623)
Net loss per share -- basic and diluted	$	(0.34)			$	(0.30)
Weighted-average common shares outstanding		51,952,062				51,445,862

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 is PMV Pharmaceuticals' (PMVP) cash position as of Q1 2025?

PMV Pharmaceuticals had $165.8 million in cash, cash equivalents, and marketable securities as of March 31, 2025, with an expected cash runway through the end of 2026.

When will PMVP release interim data for the PYNNACLE trial?

PMV Pharmaceuticals plans to release interim analysis data from the Phase 2 PYNNACLE trial in mid-2025, including data from approximately 50 patients with at least 18 weeks of follow-up.

What was PMV Pharmaceuticals' net loss in Q1 2025?

PMV Pharmaceuticals reported a net loss of $17.5 million for Q1 2025, compared to $15.3 million in Q1 2024.

What is rezatapopt being developed for by PMVP?

Rezatapopt is being evaluated as a monotherapy in patients with TP53 Y220C and KRAS wild-type advanced solid tumors in the PYNNACLE clinical trial.

How much did PMVP spend on R&D in Q1 2025?

PMV Pharmaceuticals' R&D expenses were $17.4 million in Q1 2025, up from $13.2 million in Q1 2024, primarily due to external expenses related to product candidate advancement.