PMVP PMV Pharmaceuticals Inc.
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| Drug | Stage | Catalyst Date |
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PC14586
Solid tumors
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Phase 1/2
Phase 1/2
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CRANBURY, N.J., Nov. 22, 2021 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. (NASDAQ:PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutants, today announced that David H. Mack, Ph.D., President & Chief Executive Officer, will represent PMV Pharma in a "Fireside Chat" at the Evercore ISI 4th Annual HealthCONx Conference taking place November 30 – December 2, 2021. The company will also participate in one-on-one investor meetings at the conference.
Details on the presentation can be found below.
Evercore ISI 4th Annual HealthCONx Conference Date: Thursday, December 2, 2021 Time: 11:20 am ET Format: Fireside Chat About PMV Pharma
PMV Pharma is a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutants. p53 mutations are found in approximately half of all cancers. The field of p53 biology was established by our co-founder Dr. Arnold Levine 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 pharmaceutical development focus. PMV Pharma is headquartered in Cranbury, New Jersey. For more information, please visit www.pmvpharma.com.
Contact
For Investors:
Winston Kung
Chief Financial Officer
[email protected]
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CRANBURY, N.J., Nov. 12, 2021 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. (NASDAQ:PMVP), a clinical-stage oncology company pioneering the discovery and development of small molecule therapies designed to activate p53 function, today reported financial results for the third quarter ended September 30, 2021 and provided corporate highlights.
"We made important progress in the third quarter of 2021 as we advanced the clinical development of our lead candidate, PC14586, an investigational small molecule p53 Y220C reactivator, and strengthened our corporate foundation to ensure that we have the talent and resources in place to support our future success," said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. "Our ongoing Phase 1/2 trial of PC14586 is progressing well, with twelve sites at leading oncology centers, and we expect to present data from the study in the first half of next year."
Corporate Highlights and Guidance
- Data from the Phase 1 portion of the ongoing Phase 1/2 clinical trial of PC14586, the Company's first-in-class, tumor-agnostic, investigational small molecule p53 Y220C reactivator, in patients with advanced solid tumors that harbor a p53 Y220C mutation (NCT04585750) are expected in the first half of 2022
- Appointed Tim Smith as Senior Vice President, Head of Corporate Development. Prior to joining PMV Pharma, Mr. Smith was Chief Business Officer of Verseau Therapeutics. He has held senior business development leadership roles at IDEAYA Biosciences, Cleave Biosciences, and Celgene Corporation. He spent his early career in equity research covering the biotechnology sector at RBC Capital Markets, Lazard Capital Markets, and Citi Research. Mr. Smith holds a B.S. in biology from the University of Texas at Arlington, an MBA in finance from Fordham University and an M.A. in biotechnology from Columbia University.
- Strong cash, cash equivalents and marketable securities position of $326.3 million as of September 30, 2021 sufficient to support execution of clinical, research and operational goals through the end of 2023.
Third Quarter 2021 Financial Results
- PMV Pharma ended the third quarter with $326.3 million in cash, cash equivalents, and marketable securities, compared to $361.4 million as of December 31, 2020. Net cash used in operations was $34.5 million for the nine months ended September 30, 2021, compared to $22.4 million for the nine months ended September 30, 2020.
- Net loss for the nine months ended September 30, 2021 was $39.5 million compared to $24.0 million for the nine months ended September 30, 2020.
- Research and development (R&D) expenses were $24.3 million for the nine months ended September 30, 2021 compared to $17.8 million for the nine months ended September 30, 2020. The increase in R&D expenses was primarily due to increased headcount and clinical expenses related to development of PC14586, the Company's lead drug candidate.
- General and administrative (G&A) expenses were $15.5 million for the nine months ended September 30, 2021 compared to $6.7 million for the nine months ended September 30, 2020. The increase in G&A expenses was primarily due to costs relating to building the infrastructure necessary to operate as a public company.
About p53
p53 plays a pivotal role in preventing abnormal cells from becoming a tumor by inducing programmed cell death. Mutant p53 takes on oncogenic properties that endow cancer cells with a growth advantage and resistance to anti-cancer therapy. The p53 Y220C mutation is associated with many cancers, including but not limited to breast, non-small cell lung cancer, colorectal, pancreatic, and ovarian cancers.
About PC14586
PC14586 is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the crevice present in the p53 Y220C mutant protein, hence, restoring the wild-type, or normal, p53 protein structure and tumor suppressing function. PC14586 is being developed for the treatment of patients with locally advanced or metastatic solid tumors that have the p53 Y220C mutation and has been granted Fast Track designation by the U.S. FDA.
About PMV Pharma
PMV Pharma is a clinical-stage oncology company pioneering the discovery and development of small molecule therapies designed to activate p53 function. Experts in p53 biology, cancer genetics, and medicinal chemistry, PMV Pharma is focused on delivering precision therapeutics that improve the lives of patients living with cancer. Along with the expertise of co-founder Dr. Arnold Levine, who discovered p53, PMV brings together leaders in the field to utilize over four decades of p53 biology to develop tumor-agnostic, targeted, pharmaceutical products. PMV Pharma is headquartered in Cranbury, 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 PC14586, including expectations regarding the timing for release of preliminary Phase 1 data and success of its current clinical trial for PC14586; the future plans or expectations for the Company's discovery platform; and the period over which the Company estimates its existing cash and cash equivalents will be sufficient to fund its current operating plan. 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 an early clinical stage company, the potential for clinical trials of PC14586 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 the current COVID-19 pandemic will 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, 2021, the Company's Quarterly Report on Form 10-Q filed with the SEC on November 12, 2021 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 Balance Sheets
(unaudited)
(in thousands, except share and per share amounts)September 30, 2021 December 31, (unaudited) 2020 Assets Current assets: Cash and cash equivalents $ 176,641 $ 361,422 Restricted Cash 822 — Short-term marketable securities 131,010 — Prepaid expenses and other current assets 5,082 3,339 Total current assets 313,555 364,761 Property and equipment, net 1,394 569 Long-term marketable securities 18,601 — Lease asset 10,410 — Other assets 218 201 Total assets $ 344,178 $ 365,531 Liabilities, Convertible Preferred Stock, and Stockholders' Equity Current liabilities: Accounts payable $ 1,278 $ 1,607 Accrued expenses 6,740 4,803 Current lease liability 545 — Total current liabilities 8,563 6,410 Noncurrent lease liability 10,667 — Total liabilities 19,230 6,410 Stockholders' equity: Common stock — — Additional paid-in capital 474,301 469,001 Accumulated deficit (149,367 ) (109,880 ) Accumulated other comprehensive loss 14 — Total stockholders' equity 324,948 359,121 Total liabilities, convertible preferred stock, and stockholders' equity $ 344,178 $ 365,531 PMV Pharmaceuticals, Inc.
Condensed 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, 2021 2020 2021 2020 Operating expenses: Research and development $ 9,162 $ 5,992 $ 24,326 $ 17,752 General and administrative 5,935 2,709 15,495 6,689 Total operating expenses 15,097 8,701 39,821 24,441 Loss from operations (15,097 ) (8,701 ) (39,821 ) (24,441 ) Other income (expense): Interest income, net 102 40 343 603 Other income (expense) 3 (100 ) 14 (143 ) Total other income (expense) 105 (60 ) 357 460 Loss before provision for income taxes (14,992 ) (8,761 ) (39,464 ) (23,981 ) Provision for income taxes 19 3 23 5 Net loss (15,011 ) (8,764 ) (39,487 ) (23,986 ) Unrealized gains (losses) on marketable securities, net of tax 7 (5 ) 14 3 Comprehensive loss $ (15,004 ) $ (8,769 ) $ (39,473 ) $ (23,983 ) Net loss per share -- basic and diluted $ (0.33 ) $ (1.46 ) $ (0.88 ) $ (5.93 ) Weighted-average common shares outstanding 45,295,232 6,022,457 45,052,100 4,045,527 Contact
For Investors & Media:
Winston Kung
Chief Financial Officer
[email protected]
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CRANBURY, N.J., Sept. 09, 2021 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. (NASDAQ:PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutants, today announced the appointment of Tim Smith as Senior Vice President, Head of Corporate Development.
"Tim's extensive experience and proven leadership in business and corporate development in both small and large biotechnology companies will be a key asset for PMV Pharma as we continue to maximize the full potential of our pipeline of tumor-agnostic p53 targeted therapies," said David Mack, Ph.D., President and Chief Executive Officer of PMV. "We are delighted to have Tim join us and we look forward to his leadership for our business and corporate development initiatives."
"It truly is an honor to join a team that is pioneering the field of p53 biology with a mission to deliver precision oncology therapeutics to patients," said Mr. Smith. "I look forward to contributing to the company's growth to realize the potential of activating p53 function in precision oncology."
Prior to joining PMV Pharma, Mr. Smith was Chief Business Officer of Verseau Therapeutics. He has held senior business development leadership roles at IDEAYA Biosciences, Cleave Biosciences, and Celgene Corporation. He spent his early career in equity research covering the biotechnology sector at RBC Capital Markets, Lazard Capital Markets, and Citi Research. Mr. Smith holds a B.S. in biology from the University of Texas at Arlington, an MBA in finance from Fordham University and an M.A. in biotechnology from Columbia University.
About p53p53 plays a pivotal role in preventing abnormal cells from becoming a tumor by inducing programmed cell death. Mutant p53 takes on oncogenic properties that endow cancer cells with a growth advantage and resistance to anti-cancer therapy. The p53 Y220C mutation is associated with many cancers, including but not limited to breast, non-small cell lung cancer, colorectal, pancreatic, and ovarian cancers.
About PC14586
PC14586 is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the crevice present in the p53 Y220C mutant protein, hence, restoring the wild-type, or normal, p53 protein structure and tumor suppressing function. PC14586 is being developed for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation.
About PMV Pharma
PMV Pharma is a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutants. p53 mutations are found in approximately half of all cancers. The field of p53 biology was established by our co-founder Dr. Arnold Levine 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 pharmaceutical development focus. PMV Pharma is headquartered in Cranbury, 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 PC14586, including expectations regarding the success of its current clinical trial for PC14586; and the future plans or expectations for the Company's discovery platform. 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 an early clinical stage company, the potential for clinical trials of PC14586 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 the current COVID-19 pandemic will 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, 2021, 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.
Contact
For Investors & Media:
Winston Kung
Chief Financial Officer
[email protected]
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CRANBURY, N.J., Sept. 02, 2021 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. (NASDAQ:PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutants, today announced that David H. Mack, Ph.D., President & Chief Executive Officer, will present at the Morgan Stanley 19th Annual Global Healthcare Conference taking place September 9-10 and 13-15, 2021. The company will also participate in one-on-one investor meetings at the conference.
Details on the presentation can be found below.
Morgan Stanley 19th Annual Global Healthcare Conference Date: Thursday, September 9th, 2021 Time: 4:15pm ET About PMV Pharma
PMV Pharma is a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutants. p53 mutations are found in approximately half of all cancers. The field of p53 biology was established by our co-founder Dr. Arnold Levine 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 pharmaceutical development focus. PMV Pharma is headquartered in Cranbury, New Jersey. For more information, please visit www.pmvpharma.com.
Contact
For Investors:
Winston Kung
Chief Financial Officer
[email protected]
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- Continued enrollment in Phase 1/2 trial of first-in-class p53 Y220C reactivator PC14586
CRANBURY, N.J., Aug. 13, 2021 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. (NASDAQ:PMVP), a clinical-stage oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies designed to target p53 mutants, today reported financial results for the second quarter ended June 30, 2021 and provided corporate highlights.
"We are encouraged by our execution in the clinic, with steady progress in the ongoing Phase 1/2 trial of PC14586," said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. "We believe PC14586, our first-in-class, tumor agnostic, p53 Y220C reactivator has the potential to transform outcomes for cancer patients. Furthermore, our strong balance sheet leaves us well positioned to continue to translate our deep scientific expertise to deliver benefits to patients."
Corporate Highlights:
- Continued enrollment in the Phase 1 portion of a Phase 1/2 clinical trial of PC14586, the Company's first-in-class, tumor-agnostic, investigational small molecule p53 Y220C reactivator, in patients with advanced solid tumors that have a p53 Y220C mutation (NCT04585750).
- Activated twelve clinical trial sites in the United States, consisting of leading oncology centers.
- Commenced construction of new corporate headquarters and state-of-the-art laboratories in Princeton, New Jersey.
Second Quarter 2021 Financial Results
- PMV Pharma ended the second quarter with $339.0 million in cash, cash equivalents, and marketable securities, compared to $361.4 million as of December 31, 2020. Net cash used in operations was $22.0 million for the six months ended June 30, 2021, compared to $15.0 million for the six months ended June 30, 2020.
- Net loss for the six months ended June 30, 2021 was $24.5 million compared to $15.2 million for the six months ended June 30, 2020.
- Research and development (R&D) expenses were $15.2 million for the six months ended June 30, 2021 compared to $11.8 million for the six months ended June 30, 2020. The increase in R&D expenses was primarily due to increased headcount and clinical expenses related to development of PC14586, the Company's lead drug candidate.
- General and administrative (G&A) expenses were $9.6 million for the six months ended June 30, 2021 compared to $4.0 million for the six months ended June 30, 2020. The increase in G&A expenses was primarily due to costs relating to building the infrastructure necessary to operate as a public company.
About p53
p53 plays a pivotal role in preventing abnormal cells from becoming a tumor by inducing programmed cell death. Mutant p53 takes on oncogenic properties that endow cancer cells with a growth advantage and resistance to anti-cancer therapy. The p53 Y220C mutation is associated with many cancers, including but not limited to breast, non-small cell lung cancer, colorectal, pancreatic, and ovarian cancers.
About PC14586
PC14586 is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the crevice present in the p53 Y220C mutant protein, hence, restoring the wild-type, or normal, p53 protein structure and tumor suppressing function. PC14586 is being developed for the treatment of patients with locally advanced or metastatic solid tumors that have the p53 Y220C mutation and has been granted Fast Track designation by the U.S. FDA.
About PMV Pharma
PMV Pharma is a clinical-stage oncology company pioneering the discovery and development of small molecule therapies designed to activate p53 function. Experts in p53 biology, cancer genetics, and medicinal chemistry, PMV Pharma is focused on delivering precision therapeutics that improve the lives of patients living with cancer. Along with the expertise of co-founder Dr. Arnold Levine, who discovered p53, PMV brings together leaders in the field to utilize over four decades of p53 biology to develop tumor-agnostic, targeted, pharmaceutical products. PMV Pharma is headquartered in Cranbury, 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 PC14586, including expectations regarding the timing for patient enrollment and success of its current clinical trial for PC14586; the future plans or expectations for the Company's discovery platform; and the period over which the Company estimates its existing cash and cash equivalents will be sufficient to fund its current operating plan. 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 an early clinical stage company, the potential for clinical trials of PC14586 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 the current COVID-19 pandemic will 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, 2021, the Company's Quarterly Report on Form 10-Q filed with the SEC on May 14, 2021 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 Balance Sheets
(unaudited)
(in thousands, except share and per share amounts)June 30,
2021
(unaudited)December 31,
2020Assets Current assets: Cash and cash equivalents $ 189,423 $ 361,422 Restricted cash 822 — Marketable securities, current 128,926 — Prepaid expenses and other current assets 3,909 3,339 Total current assets 323,080 364,761 Property and equipment, net 1,253 569 Marketable securities, noncurrent 20,613 — Right-of-use assets, operating leases 10,763 — Other assets 201 201 Total assets $ 355,910 $ 365,531 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $ 2,369 $ 1,607 Accrued expenses 4,458 4,803 Operating lease liability, current 677 — Total current liabilities 7,504 6,410 Operating lease liability, noncurrent 10,559 — Total liabilities 18,063 6,410 Stockholders' equity: Common stock — — Additional paid-in capital 472,218 469,001 Accumulated deficit (134,378 ) (109,880 ) Accumulated other comprehensive loss 7 — Total stockholders' equity 337,847 359,121 Total liabilities and stockholders' equity $ 355,910 $ 365,531 PMV Pharmaceuticals, Inc.
Condensed Statements of Operations and Comprehensive Loss
(unaudited)
(in thousands, except share and per share amounts)Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Operating expenses: Research and development $ 7,668 $ 5,804 $ 15,168 $ 11,760 General and administrative 5,404 2,281 9,578 3,979 Total operating expenses 13,072 8,085 24,746 15,739 Loss from operations (13,072 ) (8,085 ) (24,746 ) (15,739 ) Other income (expense): Interest income, net 113 157 241 563 Other expense 63 (39 ) 11 (43 ) Total other income 176 118 252 520 Loss before provision for income taxes (12,896 ) (7,967 ) (24,494 ) (15,219 ) Provision for income taxes — — 4 2 Net loss (12,896 ) (7,967 ) (24,498 ) (15,221 ) Unrealized losses on marketable securities, net of tax 20 88 7 8 Comprehensive loss $ (12,875 ) $ (7,880 ) $ (24,491 ) $ (15,213 ) Net loss per share -- basic and diluted $ (0.29 ) $ (2.62 ) $ (0.55 ) $ (5.00 ) Weighted-average common shares outstanding 45,070,104 3,046,200 44,928,518 3,046,200 Contact
For Investors & Media:
Winston Kung
Chief Financial Officer
[email protected]
- Continued enrollment in Phase 1/2 trial of first-in-class p53 Y220C reactivator PC14586