PMV Pharmaceuticals(PMVP)

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PMV Pharmaceuticals(PMVP) - 2024 Q3 - Quarterly Results
2024-11-07 13:00
Clinical Trials - Enrollment in the Phase 2 portion of the PYNNACLE clinical trial is on track, with over 75% of sites activated across the U.S., Europe, and Asia-Pacific, and interim analysis expected by mid-2025[1][2] - The Phase 1b study in collaboration with MD Anderson and Memorial Sloan Kettering is set to begin enrollment in Q1 2025, evaluating rezatapopt monotherapy and in combination with azacitidine in approximately 25 patients[1][3] - The ongoing Phase 1/2 PYNNACLE trial has achieved an overall response rate of 38% at the recommended Phase 2 dose of 2000 mg daily[1][9] Financial Performance - PMV Pharmaceuticals has $197.9 million in cash, cash equivalents, and marketable securities as of September 30, 2024, down from $238.1 million a year earlier, providing a cash runway expected to last until the end of 2026[1][6] - The net loss for Q3 2024 was $19.2 million, an increase from $16.6 million in Q3 2023, primarily due to increased R&D spending[1][6] - R&D expenses for Q3 2024 were $16.9 million, compared to $13.6 million in Q3 2023, reflecting higher contract research organization costs[1][6] - General and administrative expenses decreased to $4.9 million in Q3 2024 from $6.0 million in Q3 2023, attributed to reduced facility and operational spending[1][6] Drug Development - Rezatapopt showed a 42% increase in exposure levels when taken with food, supporting the recommendation for the 2000 mg once-daily dose to be administered with food[1][4] - The maximum tolerated dose for the combination of rezatapopt and KEYTRUDA was established at 500 mg once-daily, but enrollment in this arm was discontinued due to limited clinical benefit[1][5] - PMV Pharmaceuticals anticipates filing a New Drug Application for rezatapopt by the end of 2026[1][2]
PMV Pharmaceuticals(PMVP) - 2024 Q2 - Quarterly Report
2024-08-08 12:00
Financial Performance - For the three months ended June 30, 2024, the company incurred a net loss of $1.2 million, a significant decrease from a net loss of $17.4 million for the same period in 2023, representing a reduction of $16.2 million [61]. - Net loss for the six months ended June 30, 2024, was $16.5 million, significantly improved from a net loss of $36.6 million in the same period of 2023, an improvement of $20.1 million [65]. - Cash used in operating activities was $17.8 million for the six months ended June 30, 2024, down from $27.9 million in the same period of 2023, a decrease of $10.1 million [76]. Research and Development - Research and development expenses for the three months ended June 30, 2024, were $14.6 million, an increase of $0.8 million compared to $13.8 million for the same period in 2023 [62]. - Research and development expenses decreased to $27.8 million for the six months ended June 30, 2024, from $28.9 million in the same period of 2023, a reduction of $1.1 million [67]. - The company initiated a Phase 1/2 clinical trial for its lead product candidate, PC14586, in October 2020, and expects to provide interim data on the Phase 2 portion by mid-2025 [54]. - The company activated over 60% of clinical trial sites globally for the PYNNACLE trial across the US, Europe, and Asia-Pacific [54]. - The company’s research and development costs primarily consist of personnel costs, third-party license fees, and operational costs related to product candidates [81]. Expenses and Costs - Total operating expenses for the three months ended June 30, 2024, were $20.2 million, slightly higher than $20.1 million for the same period in 2023 [61]. - General and administrative expenses for the three months ended June 30, 2024, were $5.5 million, a decrease of $0.8 million from $6.3 million for the same period in 2023 [63]. - General and administrative expenses were $10.6 million for the six months ended June 30, 2024, down from $12.7 million in 2023, reflecting a decrease of $2.1 million [68]. - The company expects operating expenses to increase significantly as it advances product candidates through clinical development and seeks regulatory approval [54]. Cash and Liquidity - Cash and cash equivalents increased to $48.5 million as of June 30, 2024, from $37.7 million at the end of 2023, an increase of $10.8 million [70]. - Total working capital improved to $207.4 million as of June 30, 2024, compared to $193.4 million at the end of 2023, an increase of $14.0 million [70]. - As of June 30, 2024, the company reported cash, cash equivalents, and marketable securities totaling $212.9 million, with restricted cash of $0.8 million [83]. - The company expects its cash, cash equivalents, and marketable securities as of June 30, 2024, to be sufficient to fund operations until the end of 2026 [74]. Interest Income - Interest income, net for the three months ended June 30, 2024, was $2.8 million, an increase of $0.1 million compared to $2.7 million for the same period in 2023, driven by higher interest rates [63]. - Interest income, net increased to $5.8 million for the six months ended June 30, 2024, compared to $5.0 million in 2023, an increase of $0.7 million [69]. Accumulated Deficit - The company has an accumulated deficit of $326.5 million as of June 30, 2024, and has not generated any revenue from product sales to date [54]. - The company has an accumulated deficit of $326.5 million as of June 30, 2024 [72]. Restructuring and Workforce - The company initiated a restructuring plan in January 2024, reducing its workforce by approximately 30% to streamline operations and reduce costs [74]. Accounting and Estimates - The company has not experienced any material adjustments to prior estimates of accrued research and development expenses to date [81]. - The company estimates accrued research and development expenses based on open contracts and communication with service providers [81]. - The financial terms of agreements with research institutions and CROs vary and may result in uneven payment flows [81]. - The company has deferred and capitalized non-refundable research and development advance payments, expensing them as related goods are delivered [81]. - The company’s accounting policies have not materially changed from those described in the audited financial statements for the year ended December 31, 2023 [80]. Market Risk - The company is not currently exposed to significant market risk related to changes in foreign currency exchange rates, although future contracts with foreign vendors may introduce such risks [83]. - The company’s exposure to interest rate risks is not material due to the nature and amount of its money-market funds and marketable securities [83].
PMV Pharmaceuticals(PMVP) - 2024 Q2 - Quarterly Results
2024-08-08 12:00
Financial Performance - As of June 30, 2024, PMV Pharmaceuticals reported cash, cash equivalents, and marketable securities totaling $212.9 million, providing a cash runway expected to last until the end of 2026[1] - The net loss for the second quarter of 2024 was $1.2 million, a significant reduction from a net loss of $17.4 million in the same quarter of 2023, primarily due to a $16.2 million income tax benefit from the sale of accumulated net operating losses[5] - General and administrative (G&A) expenses decreased to $5.5 million for the quarter ended June 30, 2024, compared to $6.3 million for the same period in 2023, primarily due to reduced facility and operational expenses[5] - Total assets as of June 30, 2024, were reported at $237.5 million, down from $252.2 million as of December 31, 2023[12] Research and Development - Research and development (R&D) expenses increased to $14.6 million for the quarter ended June 30, 2024, compared to $13.8 million for the same period in 2023, driven by higher contractual research organization costs[5] - The Phase 2 monotherapy portion of the PYNNACLE clinical trial is designed to enroll 114 patients across five cohorts, with over 60% of sites activated across the U.S., Europe, and Asia-Pacific[2] - An interim analysis of the Phase 2 monotherapy trial is expected by mid-2025, with a New Drug Application (NDA) filing anticipated by the end of 2026[2] - In the Phase 1b combination arm of the PYNNACLE trial, the safety profile of rezatapopt and pembrolizumab has been consistent with either agent as monotherapy, with no dose-limiting toxicities observed at the 500 mg dose level[3] - The overall response rate in the Phase 1 portion of the PYNNACLE trial was 38% (6 out of 16 evaluable patients) at the recommended Phase 2 dose of 2000 mg daily[8] - PMV Pharmaceuticals has adjusted eligibility criteria in the ongoing Phase 1b trial to exclude patients with a KRAS single-nucleotide variant (SNV) to maximize clinical benefit[4]
Here's Why PMV Pharmaceuticals (PMVP) Could be Great Choice for a Bottom Fisher
ZACKS· 2024-06-03 14:56
Group 1 - PMV Pharmaceuticals, Inc. (PMVP) shares have declined by 10.8% over the past week, but a hammer chart pattern suggests potential support and a trend reversal [1] - The hammer pattern indicates a possible exhaustion of selling pressure, with Wall Street analysts showing rising optimism about PMVP's future earnings [1] - The hammer chart pattern is characterized by a small candle body and a long lower wick, signaling a potential trend reversal when formed at the bottom of a downtrend [1] Group 2 - Recent upward revisions in earnings estimates for PMVP are considered a bullish indicator, correlating strongly with near-term stock price movements [2] - The consensus EPS estimate for the current year has increased by 5.7% over the last 30 days, indicating analysts' agreement on improved earnings potential [2] - PMVP holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which typically outperform the market [2]
Foundation Medicine and PMV Pharma Announce Collaboration to Develop Companion Diagnostic for Rezatapopt, a First-In-Class, Investigational, Selective p53 Y220C Reactivator
Newsfilter· 2024-05-29 11:00
Core Insights - Foundation Medicine and PMV Pharmaceuticals have partnered to develop FoundationOne®CDx as a companion diagnostic for PMV Pharma's investigational therapy rezatapopt, targeting patients with locally advanced or metastatic solid tumors having a TP53 Y220C mutation [1][4]. Company Overview - Foundation Medicine is a pioneer in molecular profiling for cancer, focusing on improving clinical care and research through collaborations across the cancer community [6]. - PMV Pharma specializes in precision oncology, developing small molecule therapies targeting p53 mutations, which are prevalent in approximately 50% of all cancers [9]. Product Details - FoundationOne®CDx is a next-generation sequencing-based diagnostic tool that detects genomic alterations in 324 genes, intended to guide personalized treatment decisions [7]. - Rezatapopt (PC14586) is a first-in-class small molecule designed to reactivate p53 function in patients with the TP53 Y220C mutation, which is thermally unstable and unable to effectively interact with DNA [2][8]. Clinical Development - The FDA has granted Fast Track designation to rezatapopt for treating patients with locally advanced or metastatic solid tumors with a TP53 Y220C mutation, and it is currently undergoing the registrational, tumor-agnostic PYNNACLE Phase 2 clinical trial [3][8].
PMV Pharmaceuticals(PMVP) - 2024 Q1 - Quarterly Report
2024-05-09 12:00
Financial Performance - For the three months ended March 31, 2024, the company incurred a net loss of $15.3 million, compared to a net loss of $19.1 million for the same period in 2023, representing a decrease of $3.9 million[108]. - The accumulated deficit as of March 31, 2024, was $325.3 million, indicating ongoing financial challenges[114]. - The company incurred an accumulated deficit of $325.3 million through March 31, 2024, and expects to incur substantial additional losses as it expands research and development activities[120]. - Cash operating expenditures for the three months ended March 31, 2024, were $16.2 million, compared to $15.0 million for the same period in 2023, reflecting an increase of 8%[120]. - The company reported a net cash used in operating activities of $16.2 million for the three months ended March 31, 2024, primarily due to a net loss of $15.3 million[123]. Research and Development - Research and development expenses for the three months ended March 31, 2024, were $13.2 million, down from $15.1 million in the same period of 2023, a decrease of $1.9 million[109]. - The company initiated a Phase 1/2 clinical trial for its lead product candidate, PC14586, in October 2020, and has advanced to the pivotal Phase 2 trial in early 2024[95]. - The company plans to continue using third-party service providers for clinical development and manufacturing, as it currently lacks a sales force[99]. Cash and Financial Position - As of March 31, 2024, the company had cash and cash equivalents of $47.7 million, an increase of $9.9 million from $37.7 million as of December 31, 2023[113]. - Total financial assets decreased to $213.1 million as of March 31, 2024, from $228.6 million as of December 31, 2023, a decrease of $15.5 million[113]. - The company has cash, cash equivalents, and marketable securities totaling $213.1 million as of March 31, 2024, with restricted cash of $0.8 million[136]. - The company generated a net cash inflow of $26.2 million from investing activities during the three months ended March 31, 2024, primarily from maturities of marketable securities[125]. Future Outlook and Financing - The company anticipates that its cash resources will be sufficient to fund operations until the end of 2026, based on current research and development plans[120]. - The company expects to fund operations and capital needs through equity and/or debt financing until substantial revenue from product sales is generated[121]. - The company has a shelf registration statement with the SEC for offering up to $200 million in various securities and $150 million in common stock under its ATM Program, with approximately $113.8 million remaining for future issuances as of March 31, 2024[115]. - The company did not sell any shares under the ATM Program during the three months ended March 31, 2024[115]. Cost Management and Restructuring - General and administrative expenses decreased to $5.0 million for the three months ended March 31, 2024, from $6.4 million in the same period of 2023, a reduction of $1.4 million[110]. - A restructuring plan was announced on January 18, 2024, involving a workforce reduction of approximately 30%, expected to be completed by the end of Q3 2024[119]. - Interest income, net increased to $3.0 million for the three months ended March 31, 2024, compared to $2.4 million for the same period in 2023, an increase of $0.6 million[111]. - The company has not generated any revenue from product sales and does not expect to do so in the foreseeable future[101].
PMV Pharmaceuticals(PMVP) - 2024 Q1 - Quarterly Results
2024-05-09 12:00
Exhibit 99.1 PMV Pharmaceuticals Reports First Quarter 2024 Financial Results and Corporate Highlights • First patient dosed in Phase 2 portion of the PYNNACLE trial which will assess 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, 20 ...
PMV Pharmaceuticals(PMVP) - 2023 Q4 - Annual Report
2024-02-29 21:05
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM ! 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-39539 PMV PHARMACEUTICALS, INC. (Exact name of Registrant as specified in its Charter) Delaware 46-3218129 (State or other jurisdic ...
PMV Pharmaceuticals(PMVP) - 2023 Q4 - Annual Results
2024-02-29 21:05
PMV Pharmaceuticals Reports Full Year 2023 Financial Results and Corporate Highlights PRINCETON, N.J., February 29, 2024 - 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 fourth quarter and full year ended December 31, 2023, and provided a corporate update. "PMV continues to make significant progress with rezatapopt, a first-in-class precision on ...
PMV Pharmaceuticals(PMVP) - 2023 Q3 - Quarterly Report
2023-11-09 13:00
Financial Performance - The net loss for the three months ended September 30, 2023, was $16.6 million, a decrease of $1.6 million compared to a net loss of $18.2 million for the same period in 2022[101]. - The company incurred a net loss of $53.2 million for the nine months ended September 30, 2023, compared to a net loss of $54.0 million for the same period in 2022, reflecting a decrease of $0.8 million[106]. - The accumulated deficit reached $294.2 million as of September 30, 2023, with cash operating expenditures of $43.6 million for the nine months ended September 30, 2023, compared to $48.4 million in 2022[117]. Research and Development Expenses - Research and development expenses for the three months ended September 30, 2023, were $13.6 million, a slight decrease of $0.1 million from $13.7 million in the same period in 2022[102]. - Research and development expenses for the nine months ended September 30, 2023, totaled $42.5 million, an increase of $5.5 million from $37.0 million in the same period in 2022[107]. - The company expects significant increases in operating expenses as it advances product candidates through clinical development and seeks regulatory approval[90]. Cash and Financial Assets - As of September 30, 2023, total financial assets were $238.1 million, a decrease of $5.4 million from $243.5 million as of December 31, 2022[111]. - The company expects its cash, cash equivalents, and marketable securities as of September 30, 2023, to be sufficient to fund operations at least through 2025[117]. - As of September 30, 2023, the company had cash, cash equivalents, and marketable securities totaling $238.1 million, with restricted cash of $0.8 million[139]. Interest Income - Interest income, net for the three months ended September 30, 2023, was $3.0 million, an increase of $1.9 million compared to $1.1 million for the same period in 2022, driven by higher interest rates[105]. - Interest income, net rose to $8.0 million for the nine months ended September 30, 2023, an increase of $6.2 million compared to the same period in 2022, driven by higher interest rates[109]. Operating Activities - Cash used in operating activities was $43.6 million for the nine months ended September 30, 2023, down from $48.4 million in the same period of 2022[120]. - Total operating expenses for the nine months ended September 30, 2023, were $61.2 million, an increase of $5.4 million compared to $55.9 million for the same period in 2022[106]. Financing Activities - Financing activities generated $35.3 million in cash during the nine months ended September 30, 2023, mainly from the issuance of common stock under the ATM Program[125]. - The company has approximately $113.8 million remaining in gross proceeds available for future issuances of common stock under the ATM Program as of September 30, 2023[113]. Market Risks - The company is exposed to market risks primarily related to interest rate risks in the ordinary course of business[138]. - The company is not currently exposed to significant market risk related to changes in foreign currency exchange rates, but future contracts with foreign vendors may introduce such risks[140]. Stock-Based Compensation - Stock-based compensation expense is recognized on a straight-line basis over the associated service period of the award[132]. - The company uses the Black-Scholes option pricing model to estimate the fair value of stock options on the date of grant[134]. - Expected volatility for stock options is derived from the average historical stock volatility over the expected term of the awards[135]. Other Information - The company has not generated any revenue from product sales to date and does not expect to do so in the foreseeable future[94]. - The company plans to continue using third-party service providers for clinical development and manufacturing, as it does not currently have a sales force[92]. - The company engages vendors, CROs, and CMOs for preclinical development activities and clinical trials[133]. - Recent accounting pronouncements are detailed in Note 2 of the unaudited condensed financial statements for the nine months ended September 30, 2023[137].