PMV Pharmaceuticals(PMVP)
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PMV Pharmaceuticals (NASDAQ:PMVP) versus Aurinia Pharmaceuticals (NASDAQ:AUPH) Financial Comparison
Defense World· 2025-11-23 07:38
Core Insights - Aurinia Pharmaceuticals is generally favored over PMV Pharmaceuticals based on a comparison of various financial and operational metrics, outperforming PMV in 10 out of 13 factors analyzed [10]. Analyst Ratings - Aurinia Pharmaceuticals has a consensus target price of $17.67, suggesting a potential upside of 12.67%, while PMV Pharmaceuticals has a target price of $5.00, indicating a potential upside of 278.79% [2]. Risk & Volatility - Aurinia Pharmaceuticals has a beta of 1.3, indicating its share price is 30% more volatile than the S&P 500, whereas PMV Pharmaceuticals has a beta of 1.54, meaning its share price is 54% more volatile than the S&P 500 [3][4]. Institutional and Insider Ownership - 36.8% of Aurinia Pharmaceuticals shares are held by institutional investors, compared to 90.2% for PMV Pharmaceuticals. Insider ownership stands at 12.2% for Aurinia and 7.6% for PMV [5]. Profitability - Aurinia Pharmaceuticals has a net margin of 23.31%, return on equity of 20.06%, and return on assets of 13.81%. PMV Pharmaceuticals does not have net margin data available, with a return on equity of -55.34% and return on assets of -51.01% [7]. Earnings and Valuation - Aurinia Pharmaceuticals reported gross revenue of $265.81 million, a net income of $5.75 million, and earnings per share of $0.56, with a price-to-earnings ratio of 28.00. PMV Pharmaceuticals has no revenue reported, a net loss of $58.71 million, earnings per share of -$1.60, and a price-to-earnings ratio of -0.83 [9].
PMV Pharmaceuticals(PMVP) - 2025 Q3 - Quarterly Report
2025-11-12 13:00
Financial Performance - For the three months ended September 30, 2025, the company incurred a net loss of $21.1 million, compared to a net loss of $19.2 million for the same period in 2024, representing an increase of $1.8 million [124]. - The company reported a net loss of $59.7 million for the nine months ended September 30, 2025, compared to a net loss of $35.7 million for the same period in 2024, an increase of $24.0 million [128]. - As of September 30, 2025, the company has an accumulated deficit of $428.4 million [112]. - The accumulated deficit reached $428.4 million as of September 30, 2025, reflecting ongoing significant operating losses [136]. Operating Expenses - Research and development expenses for the three months ended September 30, 2025, were $18.2 million, an increase of $1.3 million from $16.9 million in the same period of 2024 [126]. - For the nine months ended September 30, 2025, total operating expenses were $66.9 million, an increase of $6.7 million compared to $60.3 million for the same period in 2024 [128]. - Research and development expenses for the nine months ended September 30, 2025, were $54.1 million, compared to $44.8 million for the same period in 2024, an increase of $9.3 million [128]. - General and administrative expenses decreased to $4.3 million for the three months ended September 30, 2025, down from $4.9 million in 2024, a reduction of $0.6 million [126]. - General and administrative expenses decreased to $12.9 million for the nine months ended September 30, 2025, down from $15.5 million in 2024, a reduction of $2.6 million [131]. Cash Flow and Financial Position - As of September 30, 2025, total financial assets were $129.3 million, down from $183.3 million as of December 31, 2024, a decrease of $54.0 million [135]. - Cash used in operating activities was $56.4 million for the nine months ended September 30, 2025, compared to $34.6 million in 2024, an increase of $21.8 million [145]. - Cash provided by investing activities was $51.7 million for the nine months ended September 30, 2025, compared to $45.6 million in 2024, an increase of $6.1 million [148]. - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $129.3 million [157]. - The company expects its cash, cash equivalents, and marketable securities as of September 30, 2025, to be sufficient to fund operations until the end of the first quarter of 2027 [142]. - 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, 2025 [137]. Interest Income - Interest income, net for the three months ended September 30, 2025, was $1.5 million, a decrease of $1.1 million from $2.6 million in the same period of 2024 [127]. - Interest income, net decreased to $5.1 million for the nine months ended September 30, 2025, compared to $8.4 million in 2024, a decline of $3.3 million due to lower interest rates [131]. Research and Development - The company initiated a Phase 1/2 clinical trial, PYNNACLE, for its lead product candidate, rezatapopt, in October 2020, and expects to submit a New Drug Application (NDA) for platinum-resistant/refractory ovarian cancer in the first quarter of 2027 [112]. - The company plans to complete enrollment in the ovarian cohort for the primary analysis of the Phase 2 portion of the PYNNACLE study by the first quarter of 2026 [112]. - Research and development costs primarily consist of personnel costs, third-party license fees, and operational costs related to product candidates [153]. - Payments under research and development contracts may depend on successful patient enrollment and completion of clinical trial milestones [154]. - The company capitalizes non-refundable research and development advance payments, expensing them as related goods are delivered or services performed [153]. - The financial terms of agreements with research institutions and CROs vary and may result in uneven payment flows [154]. - The company estimates accrued research and development expenses based on open contracts and purchase orders, adjusting as necessary [154]. - The company has not experienced any material adjustments to prior estimates of accrued research and development expenses to date [154]. Market Risk - The company does not expect material exposure to interest rate risks due to the nature and amount of its money-market funds and marketable securities [157]. - The company is currently not exposed to significant market risk related to foreign currency exchange rates, but future contracts with foreign vendors may introduce such risks [159].
PMV Pharmaceuticals(PMVP) - 2025 Q3 - Quarterly Results
2025-11-12 13:00
Financial Performance - PMV Pharmaceuticals reported a net loss of $21.1 million for Q3 2025, compared to a net loss of $19.2 million in Q3 2024, primarily due to increased R&D costs[10] - Total operating expenses for Q3 2025 were $22.5 million, compared to $21.9 million in Q3 2024[17] - The company reported total comprehensive loss of $20.99 million for Q3 2025[17] - PMV Pharma's accumulated deficit increased to $428.4 million as of September 30, 2025, from $368.7 million at the end of 2024[15] Research and Development - R&D expenses for Q3 2025 were $18.2 million, up from $16.9 million in Q3 2024, driven by higher contractual research organization costs for the rezatapopt program[10] - The overall response rate (ORR) for the rezatapopt study was 34% among 103 evaluable patients, with a median duration of response of 7.6 months[4] - In the ovarian cancer cohort, the ORR was 46% among 48 evaluable patients, with a median duration of response of 8.0 months[4] - The median time to response across all cohorts in the rezatapopt study was 1.3 months[5] Future Plans - PMV Pharma plans to submit a New Drug Application (NDA) for rezatapopt in the first quarter of 2027 for the treatment of platinum-resistant/refractory ovarian cancer[4] Cash Position - The company ended Q3 2025 with $129.3 million in cash, cash equivalents, and marketable securities, down from $148.3 million as of June 30, 2025[7]
PMV Pharmaceuticals Reports Third Quarter 2025 Financial Results and Corporate Highlights
Globenewswire· 2025-11-12 13:00
Core Insights - PMV Pharmaceuticals reported financial results for Q3 2025, highlighting advancements in their clinical study and financial position [1][2] Financial Performance - As of September 30, 2025, PMV Pharma had $129.3 million in cash, cash equivalents, and marketable securities, down from $148.3 million as of June 30, 2025 [3][4] - The net loss for Q3 2025 was $21.1 million, an increase from $19.2 million in Q3 2024, primarily due to higher research and development costs [10][14] - Research and development expenses for Q3 2025 were $18.2 million, compared to $16.9 million in Q3 2024 [10][14] - General and administrative expenses decreased to $4.3 million in Q3 2025 from $4.9 million in Q3 2024 [10] Clinical Developments - The PYNNACLE study, evaluating rezatapopt, showed a 34% overall response rate among 103 evaluable patients, with a median duration of response of 7.6 months [4][5] - In the ovarian cancer cohort, the overall response rate was 46% among 48 evaluable patients, with a median duration of response of 8.0 months [4][5] - The company plans to submit a New Drug Application (NDA) for rezatapopt in the first quarter of 2027 for the treatment of platinum-resistant/refractory ovarian cancer [2][4] Company Overview - PMV Pharmaceuticals focuses on precision oncology, specifically targeting p53 mutations, which are present in approximately half of all cancers [8] - The company was co-founded by Dr. Arnold Levine, a pioneer in p53 biology [8]
PMV Pharmaceuticals, Inc. (PMVP) Presents at AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics - Slideshow (NASDAQ:PMVP) 2025-10-25
Seeking Alpha· 2025-10-25 09:30
Group 1 - The article does not provide any specific content or key points related to a company or industry [1]
PMV Pharmaceuticals Announces Updated Rezatapopt Monotherapy Interim Data From Ongoing PYNNACLE Phase 2 Trial Across Multiple Solid Tumors With a TP53 Y220C Mutation
Globenewswire· 2025-10-24 15:39
Core Insights - PMV Pharmaceuticals announced updated data from the Phase 2 pivotal portion of the ongoing PYNNACLE clinical trial, focusing on rezatapopt for patients with advanced solid tumors harboring a TP53 Y220C mutation [1][4][6] Efficacy Data - The Phase 2 clinical trial data showed a 34% overall response rate (ORR) among 103 evaluable patients, with a median duration of response of 7.6 months [4][5] - In the ovarian cancer cohort, the ORR was 46% among 48 evaluable patients, with a median duration of response of 8.0 months [4][5] - Confirmed responses were observed across eight tumor types, including ovarian, lung, breast, endometrial, head and neck, colorectal, gallbladder, and ampullary carcinoma [4][5] Safety Profile - The safety population included 112 patients treated with rezatapopt at a dose of 2000mg daily, with a median of three prior lines of systemic therapy [5][11] - Treatment-related adverse events (TRAEs) were mostly Grade 1-2, with the most frequent being nausea, fatigue, and increased blood creatinine [11] - The rate of drug discontinuations due to TRAEs was 3.6%, indicating manageable safety [11] Regulatory Plans - The company plans to submit a New Drug Application (NDA) for rezatapopt in the first quarter of 2027 for the treatment of platinum-resistant/refractory ovarian cancer [4][6] About Rezatapopt - Rezatapopt is a first-in-class small molecule designed to reactivate p53 by selectively binding to the p53 Y220C mutant protein, restoring its tumor-suppressor function [7][9] About the PYNNACLE Clinical Trial - The PYNNACLE trial is a Phase 1/2 study evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation, with a focus on safety, tolerability, and efficacy [8][9]
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· 2025-10-13 20:01
Core Insights - PMV Pharmaceuticals is presenting initial data from the pivotal Phase 2 study of rezatapopt, a first-in-class precision oncology therapy targeting the TP53 Y220C mutation in advanced solid tumors [1][3] Presentation Details - An oral presentation titled "Rezatapopt for locally advanced or metastatic solid tumors with a TP53 Y220C mutation: Initial analysis of the pivotal PYNNACLE Phase 2 trial" is scheduled for October 24, 2025, from 10:00 to 11:40 AM ET [2] - Poster presentations will include the same title for a session on October 24, 2025, from 12:30 to 4:00 PM ET, and another titled "Natural history and prognostic value of TP53 Y220C mutation in advanced solid tumors: A real-world study" on October 25, 2025, from 12:30 to 4:00 PM ET [2] About Rezatapopt - Rezatapopt (PC14586) is designed to selectively bind to the p53 Y220C mutant protein, restoring its tumor-suppressor function, and has received Fast Track designation from the FDA for treating patients with locally advanced or metastatic solid tumors with this mutation [3] About the PYNNACLE Clinical Trial - The ongoing Phase 1/2 PYNNACLE clinical trial is assessing the safety and efficacy of rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation, with a focus on determining the maximum tolerated dose and evaluating efficacy in various cancer types [4] About PMV Pharma - PMV Pharma specializes in the development of small molecule, tumor-agnostic therapies targeting p53, with a significant focus on TP53 mutations, which are present in approximately half of all cancers [5]
PMV Pharmaceuticals, Inc. (PMVP) Special Call - Slideshow (NASDAQ:PMVP)
Seeking Alpha· 2025-09-11 23:19
Core Insights - The company is focused on the development of transcript-related projects, indicating a commitment to enhancing their offerings in this area [1] Group 1 - The company publishes thousands of quarterly earnings calls each quarter, showcasing significant growth and expansion in their coverage [1]
Small-Cap PMV Pharmaceuticals Cancer Drug Shows Confirmed Responses In 8 Tumor Types
Benzinga· 2025-09-10 19:10
Core Insights - PMV Pharmaceuticals, Inc. released interim data from the Phase 2 pivotal portion of the PYNNACLE clinical trial evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation [1] Efficacy - Confirmed responses were observed in patients with TP53 Y220C mutated and KRAS wild-type tumors across eight tumor types, with an overall response rate (ORR) of 33% [2] - Specific ORRs included: - Ovarian cancer: 43% ORR (19/44 patients, including one confirmed complete response and 17 confirmed partial responses) [3] - Breast cancer: 18% ORR (2/11 patients) [3] - Endometrial cancer: 60% ORR (3/5 patients, including one unconfirmed partial response) [3] - Lung cancer: 22% ORR (4/18 patients, including three unconfirmed partial responses) [3] - Other solid tumors: 21% ORR (4/19 patients) [3] - The median time to response across all cohorts was 1.4 months, with a median duration of response of 6.2 months [3] - In the ovarian cancer cohort, the median time to response was 1.3 months, and the median duration of response was 7.6 months [3] Safety - Treatment-related adverse events (TRAEs) were primarily grade 1-2, with the most frequent TRAEs (>15%) being nausea, fatigue, increased blood creatinine, and increased alanine aminotransferase [4] Regulatory Update - PMV Pharma received feedback from the U.S. Food and Drug Administration (FDA) regarding the initial New Drug Application (NDA) submission strategy for platinum-resistant/refractory ovarian cancer [5] - The company plans to enroll an additional 20-25 platinum-resistant/refractory ovarian cancer patients by the end of Q1 2026 [5] - An NDA submission for platinum-resistant/refractory ovarian cancer is planned by the end of Q1 2027 [6] Price Action - PMVP stock is down 23.30% at $1.23 as of the last check on Wednesday [6]
PMV Pharmaceuticals Announces Promising Rezatapopt Monotherapy Interim Data From PYNNACLE Phase 2 Trial Across Multiple Solid Tumors With a TP53 Y220C Mutation
Globenewswire· 2025-09-10 11:00
Core Insights - PMV Pharmaceuticals announced interim data from the Phase 2 pivotal portion of the PYNNACLE clinical trial evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation [1][5][10] Efficacy - The Phase 2 clinical trial data as of August 4, 2025, showed an overall response rate (ORR) of 33% among 97 evaluable patients across all cohorts, with a median duration of response of 6.2 months [5][6] - In the ovarian cancer cohort, the ORR was 43% among 44 evaluable patients, with a median duration of response of 7.6 months [5][6] - Confirmed responses were observed in eight tumor types, including ovarian, lung, breast, endometrial, head and neck, colorectal, gallbladder, and ampullary carcinoma [5][6] Safety - The safety population consisted of 109 patients treated with rezatapopt 2000 mg daily as monotherapy, with a median of three prior lines of systemic therapy [6] - Treatment-related adverse events (TRAEs) were mostly Grade 1-2, with the most frequent being nausea, fatigue, increased blood creatinine, and increased alanine aminotransferase [6] - The rate of drug discontinuations due to TRAEs was 3.7%, and all Grade 3 TRAEs resolved on treatment [6] Regulatory Update - PMV Pharma plans to submit a New Drug Application (NDA) for rezatapopt in platinum-resistant/refractory ovarian cancer by the end of the first quarter of 2027 [5][7] - The company aims to enroll an additional 20-25 patients with platinum-resistant/refractory ovarian cancer by the end of the first quarter of 2026 [7] About Rezatapopt - Rezatapopt (PC14586) is a first-in-class small molecule designed to selectively bind to the p53 Y220C mutant protein, restoring its tumor-suppressor function [9] - The FDA has granted Fast Track designation to rezatapopt for treating patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation [9] About the PYNNACLE Clinical Trial - The ongoing Phase 1/2 PYNNACLE clinical trial evaluates rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation, with the primary objective of assessing efficacy at the recommended Phase 2 dose [10]