PMV Pharmaceuticals Reports First Quarter 2024 Financial Results and Corporate Highlights
PMV Pharmaceuticals, Inc. (Nasdaq: PMVP) reported financial results and corporate highlights for Q1 2024. The company dosed the first patient in the Phase 2 PYNNACLE trial for rezatapopt, a potential treatment for advanced solid tumors. Phase 1 data for rezatapopt in advanced ovarian cancer was presented at the 2024 SGO Annual Meeting. The company ended Q1 with $213.1 million in cash, providing expected cash runway to end of 2026.
PMV Pharmaceuticals successfully dosed the first patient in the Phase 2 PYNNACLE trial, showcasing progress in their development of rezatapopt for advanced solid tumors.
The Phase 1 data for rezatapopt in advanced ovarian cancer at the 2024 SGO Annual Meeting demonstrated promising results with a favorable safety profile.
The company's financial report for Q1 2024 showed cash, cash equivalents, and marketable securities of $213.1 million, ensuring a stable financial position for future operations.
PMV Pharmaceuticals reported a net loss of $15.3 million for Q1 2024, which signifies ongoing financial challenges that need to be addressed for sustainable growth.
Research and development expenses for Q1 2024 were $13.2 million, indicating the need for cost management strategies to optimize operations.
General and administrative expenses decreased in Q1 2024; however, the company should focus on sustained cost-efficiency to enhance overall financial performance.
Insights
The company's reported net loss decreased from
The initiation and ongoing enrollment in both the Phase 2 portion of the PYNNACLE trial and the Phase 1b combination study are clinically significant. If rezatapopt demonstrates efficacy and safety in these trials, there could be considerable implications for the treatment of advanced solid tumors. Also, the reported favorable safety profile and partial responses in the advanced ovarian cancer study are promising for the drug's potential. However, the true measure of value creation will come from successful trial completions and regulatory approvals. Thus, while the data is promising, investors should be aware of the inherent risks associated with drug development.
The oncology market is highly competitive, but PMV Pharmaceuticals is positioning itself in a niche segment targeting TP53 mutations, which are common in many types of cancer. A successful rezatapopt could mean tapping into a broad market with significant unmet needs. Key to investor optimism should be the drug's tumor-agnostic potential, which could lead to widespread applicability if clinical trials are successful. Nonetheless, the market response to these advancements will depend on sustained positive trial results and the strategic positioning of the drug relative to competitors.
- First patient dosed and continued enrollment in Phase 2 portion of the PYNNACLE trial evaluating rezatapopt as monotherapy in patients with TP53 Y220C and KRAS wild-type advanced solid tumors
- Phase 1 data of rezatapopt in advanced ovarian cancer featured in late-breaking oral presentation at 2024 SGO Annual Meeting on Women’s Cancer
- Cash, cash equivalents, and marketable securities of
$213.1 million as of March 31, 2024, providing expected cash runway to end of 2026
PRINCETON, N.J., May 09, 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 first quarter ended March 31, 2024, and provided a corporate update.
“Dosing the first patient in the registrational, tumor-agnostic Phase 2 portion of the PYNNACLE trial was an important milestone for PMV. Our team has worked diligently to initiate this global trial and I would like to thank them for their efforts,” said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. “Rezatapopt, a first-in-class precision oncology investigational therapy, offers the potential to provide a new treatment option for patients with a TP53 Y220C mutation and KRAS wild-type advanced solid tumors.”
Corporate Highlights:
- First patient dosed in Phase 2 portion of the PYNNACLE trial. The multi-center, single-arm, registrational, tumor-agnostic Phase 2 trial will assess 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 of the trial is overall response rate per blinded independent central review. The trial is designed to enroll 114 patients across five cohorts at approximately 60 sites across the U.S., Europe, and Asia-Pacific.
- Phase 1 data of rezatapopt in advanced ovarian cancer were featured in a late-breaking oral presentation at the 2024 SGO Annual Meeting on Women’s Cancer. Results showed that of the 15 heavily pre-treated patients with advanced ovarian cancer harboring a TP53 Y220C mutation, seven patients achieved a confirmed partial response with a seven-month median duration of response and a favorable safety profile.
- Continued enrollment in the Phase 1b combination arm of the PYNNACLE study with rezatapopt and KEYTRUDA® (pembrolizumab).
First Quarter 2024 Financial Results
PMV Pharma ended the first quarter with
- Net loss for the quarter ended March 31, 2024, was
$15.3 million compared to$19.1 million for the quarter ended March 31, 2023. - Research and development (R&D) expenses were
$13.2 million for the quarter ended March 31, 2024, compared to$15.1 million for the quarter ended March 31, 2023. The decrease in R&D expenses was primarily related to decreased contractual research organization costs, offset by increased personnel related costs and stock-based compensation. - General and administrative (G&A) expenses were
$5.0 million for the quarter ended March 31, 2024, compared to$6.4 million for the quarter ended March 31, 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 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 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 February 29, 2024, and the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2024, filed with the SEC on May 9, 2024, 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, 2024 | December 31, 2023 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 47,654 | $ | 37,706 | |||
| Restricted cash | 822 | 822 | |||||
| Marketable securities, current | 150,285 | 165,351 | |||||
| Prepaid expenses and other current assets | 3,699 | 3,530 | |||||
| Total current assets | 202,460 | 207,409 | |||||
| Property and equipment, net | 10,903 | 10,666 | |||||
| Marketable securities, noncurrent | 15,120 | 25,505 | |||||
| Right-of-use assets | 8,211 | 8,382 | |||||
| Other assets | 182 | 190 | |||||
| Total assets | $ | 236,876 | $ | 252,152 | |||
| Liabilities and Stockholders’ Equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 859 | $ | 3,237 | |||
| Accrued expenses | 10,319 | 9,940 | |||||
| Operating lease liabilities, current | 880 | 852 | |||||
| Total current liabilities | 12,058 | 14,029 | |||||
| Operating lease liabilities, noncurrent | 12,142 | 12,434 | |||||
| Total liabilities | 24,200 | 26,463 | |||||
| Stockholders’ equity: | |||||||
| Additional paid-in capital | 538,078 | 545,468 | |||||
| Accumulated deficit | (325,273 | ) | (310,003 | ) | |||
| Accumulated other comprehensive (loss) income | (129 | ) | 224 | ||||
| Total stockholders' equity | 212,676 | 225,689 | |||||
| Total liabilities and stockholders’ equity | $ | 236,876 | $ | 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 March 31, | |||||||
| 2024 | 2023 | ||||||
| Operating expenses: | |||||||
| Research and development | $ | 13,186 | $ | 15,073 | |||
| General and administrative | 5,035 | 6,407 | |||||
| Total operating expenses | 18,221 | 21,480 | |||||
| Loss from operations | (18,221 | ) | (21,480 | ) | |||
| Other income (expense): | |||||||
| Interest income, net | 2,952 | 2,325 | |||||
| Other income (expense), net | (1 | ) | 27 | ||||
| Total other income (expense) | 2,951 | 2,352 | |||||
| Loss before income taxes | (15,270 | ) | (19,128 | ) | |||
| Income taxes | — | — | |||||
| Net loss | (15,270 | ) | (19,128 | ) | |||
| Unrealized (loss) gain on available for sale investments, net of tax | (319 | ) | 329 | ||||
| Foreign currency translation loss | (34 | ) | — | ||||
| Comprehensive loss | $ | (15,623 | ) | $ | (18,799 | ) | |
| Net loss per share -- basic and diluted | $ | (0.30 | ) | $ | (0.42 | ) | |
| Weighted-average common shares outstanding | 51,445,862 | 45,773,357 | |||||
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
<p>What was the cash position of PMV Pharmaceuticals at the end of March 2024?</p>
PMV Pharmaceuticals had $213.1 million in cash, cash equivalents, and marketable securities as of March 31, 2024.
<p>What trial did PMV Pharmaceuticals dose the first patient in during Q1 2024?</p>
PMV Pharmaceuticals dosed the first patient in the registrational Phase 2 portion of the PYNNACLE trial for rezatapopt as monotherapy.
<p>Where was the Phase 1 data for rezatapopt presented in 2024?</p>
The Phase 1 data for rezatapopt was featured in a late-breaking oral presentation at the 2024 SGO Annual Meeting on Women's Cancer.
<p>What were the net cash used in operations for Q1 2024?</p>
PMV Pharmaceuticals used $16.2 million in net cash for operations in Q1 2024.
<p>What were the research and development expenses for Q1 2024?</p>
Research and development expenses were $13.2 million for Q1 2024.
