PMVP PMV Pharmaceuticals Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
PC14586
Solid tumors
|
Phase 1/2
Phase 1/2
|
Phase 1/2 dosing of first patient announced November 23, 2020.
|
Latest News
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CRANBURY, N.J., Feb. 23, 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 participate in the Lung Cancer Panel at the Cowen 41st Annual Health Care Conference taking place virtually on March 1-4, 2021. The company will also participate in one-on-one investor meetings at the conference.
Panel details:
Cowen 41st Annual Health Care Conference Lung Cancer Panel Date: Tuesday, March 2, 2021 Time: 11:10am 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 and Media:
Winston Kung
Chief Financial Officer
[email protected]Source: PMV Pharmaceuticals, Inc.
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CRANBURY, N.J., Feb. 16, 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 Guillermina (Gigi) Lozano, Ph.D., to its Scientific Advisory Board (SAB).
"Gigi's work in p53 biology has had a tremendous impact on our fundamental understanding of the p53 pathway and the consequences of p53 mutations in cancer," said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. "We welcome Gigi and look forward to her participation on our SAB."
Dr. Guillermina (Gigi) Lozano is a geneticist recognized for her studies of the p53 tumor suppressor pathway, from characterizing p53 as a transcriptional activator to characterizing the physiological importance of Mdm2 and Mdm4 proteins as inhibitors of p53, and the consequences of p53 mutations on tumor development. She joined The University of Texas MD Anderson Cancer Center in 1987 and rose through the ranks to her current position as professor and chair of the department of Genetics. She was elected a Fellow of the American Association for the Advancement of Science. She received the Minorities in Cancer Research Jane Cooke Wright Lectureship, and Women in Cancer Research Charlotte Friend Lectureship awards both from the American Association for Cancer Research. Dr. Lozano is also the recipient of distinguished alumni awards from both her undergraduate and graduate alma maters. She is a member of the National Academy of Sciences, the National Academy of Medicine, and the Academy of Arts and Sciences.
About p53
p53 plays a pivotal role in preventing abnormal cells from becoming a tumor by preventing proliferation and inducing programmed cell death. p53 is thus altered in the genesis of the majority of cancers. Mutant p53 takes on oncogenic properties that endow cancer cells with a growth advantage and resistance to anti-cancer therapies. The p53 Y220C mutation in particular is associated with many cancers, including but not limited to breast, non-small cell lung, colorectal, pancreatic, and ovarian cancers.
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 is mutated in approximately half of all cancer. 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 exploit over four decades of p53 biology, PMV Pharma combines unique biological understanding with a pharmaceutical development focus. PMV Pharma is headquartered in Cranbury, New Jersey. For more information, please visit www.pmvpharma.com.
Contact
For Investors and Media:
Winston Kung
Chief Financial Officer
[email protected] -
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CRANBURY, N.J., Nov. 24, 2020 (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 and Chief Executive Officer, will present on Wednesday, December 2, 2020 at the Evercore ISI 3rd Annual HealthCONx Conference. The presentation will also be available on PMV's web site. Details on the presentation can be found below.
Evercore ISI 3rd Annual HealthCONx Conference
Date: Wednesday, December 2, 2020 Time: 1:00 PM ET Webcast: https://wsw.com/webcast/evercore11/pmvp/2394615 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 is mutated in approximately half of all cancer. 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.
Contacts
For Investors:
Winston Kung
Chief Financial Officer
[email protected]For Media:
Mariann Caprino
[email protected]
(917) 242-1087
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- PC14586 targets p53 Y220C mutants to selectively reactivate p53, restoring the protein's tumor-suppressing function
- Phase 1/2 study is enrolling patients with advanced solid tumors that have a p53 Y220C mutation
CRANBURY, N.J., Nov. 23, 2020 (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 dosing of the first patient in its Phase 1/2 clinical trial evaluating PC14586, the company's investigational lead compound that targets the Y220C mutant of p53. The trial will enroll up to 130 patients with advanced solid tumors that have the specific p53 Y220C variant.
"This is an important step forward in the battle against the many cancers that are driven by a p53 mutation," said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. "Initiating our Phase 1/2 study represents a significant milestone for PMV, as PC14586 is our first tumor-agnostic therapy to enter the clinic. By selectively binding to the p53 Y220C mutant, PC14586 is designed to reactivate the tumor suppressing function of p53. We look forward to the opportunity to address the significant unmet need for patients whose cancers have a p53 Y220C mutation as we advance PC14586 in the clinic."
The multi-center, single-arm Phase 1/2 study will evaluate PC14586 in patients with advanced solid tumors with a p53 Y220C mutation. Phase 1 will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of PC14586. Phase 2 will determine the overall response rate and duration of response of PC14586 at a dose identified in Phase 1.
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 created by 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 advanced solid tumors that have a p53 Y220C mutation identified by next generation sequencing. PC14586 was granted Fast Track Designation by the U.S. Food and Drug Administration in October 2020.
For information on the Phase 1/2 trial, please visit www.clinicaltrials.gov (NCT study 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 mutants. p53 is mutated in approximately half of all cancer. 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 timing for patient enrollment and success of its current clinical trial for PC14586. 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 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on November 13, 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:
Winston Kung
Chief Financial Officer
[email protected]For Media:
Mariann Caprino
[email protected]
(917) 242-1087 mobile -
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- U.S. Food and Drug Administration (FDA) clearance of PMV Pharmaceutical's investigational new drug application for its lead product candidate PC14586
- PMV Pharma lead product candidate PC14586 granted Fast Track designation by the FDA
- Expanded Board of Directors with appointment of Rich Heyman, Ph.D., and Laurie Stelzer
- Successful completion of initial public offering, raising approximately $243.5 million.
CRANBURY, N.J., Nov. 13, 2020 (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 reported financial results for the third quarter ended September 30, 2020, and provided corporate highlights.
"PMV Pharma has achieved important scientific, clinical, and operational milestones over the past quarter," said David Mack, Ph.D., President and Chief Executive Officer. "The Investigational New Drug (IND) application for our lead product candidate PC14586 was cleared by the U.S. FDA in September. We believe the capital raised to date will enable us to execute on the clinical development of PC14586, while also continuing to invest in our discovery pipeline of small molecule, tumor-agnostic precision medicine products."
Corporate Highlights
- Received IND clearance from the FDA to initiate a Phase 1/2 study of PC14586 in patients with advanced solid tumors that have a p53 Y220C mutation. The Phase 1/2 study will enroll patients with a p53 Y220C mutation as determined by next generation sequencing. Phase 1 will evaluate escalating doses of PC14586 to determine the recommended Phase 2 dose and to assess safety, pharmacokinetics, and preliminary anti-tumor activity. Phase 2 will determine the overall response rate and duration of response. For more information, please visit www.clinicaltrials.gov (NCT study identifier NCT04585750).
- In October, the U.S. FDA granted PMV Pharma Fast Track designation to PC14586 for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation.
- Expanded PMV Pharma's management team and Board of Directors by adding Robert Ticktin as General Counsel, along with Rich Heyman, Ph.D. as Chair of the Board of Directors, and Laurie Stelzer, as Audit Chair of the Board of Directors.
- Advanced its R273H program, targeting a second p53 hot spot mutant, toward lead optimization, and progressed the Company's pipeline derived from its proprietary discovery platform.
- Raised $70.0 million in a Series D financing round in July 2020 with Avoro Capital, RA Capital Management, and Wellington Management Company joining existing investors OrbiMed Advisors, Nextech Invest, Viking Global Investors, and Boxer Capital of Tavistock Group.
- Successfully completed an IPO at a public offering price of $18 per share, with gross proceeds totaling approximately $243.5 million.
Third Quarter 2020 Financial Highlights
- PMV Pharma ended the third quarter with $373.1 million in cash, cash equivalents, and marketable securities compared to $101.5 million as of December 31, 2019. Net cash provided by financing activities for the nine months ended September 30, 2020 was $294.3 million compared to $0.1 million for the nine months ended September 30, 2019. Net cash used in operations was $22.4 million for the nine months ended September 30, 2020 compared to $17.0 million for the nine months ended September 30, 2019.
- Net loss for the quarter ended September 30, 2020 was $8.8 million compared to $6.2 million for the quarter ended September 30, 2019.
- Research and development (R&D) expenses were $6.0 million for the quarter ended September 30, 2020 compared to $4.9 million for the quarter ended September 30, 2019. The increase in R&D expenses was primarily related to increase in personnel, preclinical development, and IND filing of PC14586.
- General and administrative (G&A) expenses were $2.7 million for the quarter ended September 30, 2020, compared to $1.5 million for the quarter ended September 30, 2019. The increase in G&A expenses was primarily due to an increase in personnel and other corporate costs related to building out infrastructure for growth.
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; the future plans or expectations for the Company's discovery platform, including the advancement of our R273H program to lead optimization; 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, regulatory developments in the United States 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 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on November 13, 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 Sheet Data
(Unaudited)
(in thousands)September 30,
2020
(unaudited)December 31,
2019Assets Current assets Cash and cash equivalents $ 373,150 $ 73,278 Short-term marketable securities — 28,208 Prepaid expenses and other current assets 522 607 Total current assets 373,672 102,093 Property and equipment, net 573 739 Other assets 201 201 Total assets $ 374,446 $ 103,033 Liabilities, Convertible Preferred Stock, and Stockholders' Equity (Deficit) Current liabilities Accounts payable $ 548 $ 2,837 Accrued expenses 4,928 1,686 Total current liabilities 5,476 4,523 Other liabilities — 51 Total liabilities 5,476 4,574 Convertible preferred stock — 168,933 Stockholders' equity (deficit): Preferred stock — — Common stock — — Additional paid-in capital 468,396 4,969 Accumulated deficit (99,426 ) (75,440 ) Accumulated other comprehensive loss — (3 ) Total stockholders' equity (deficit) 368,970 (70,474 ) Total liabilities, convertible preferred stock, and stockholders' equity (deficit) $ 374,446 $ 103,033 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, 2020 2019 2020 2019 Operating Expenses: Research and development $ 5,992 $ 4,895 $ 17,752 $ 15,060 General and administrative 2,709 1,545 6,689 4,222 Total operating expenses 8,701 6,440 24,441 19,282 Loss from operations (8,701 ) (6,440 ) (24,441 ) (19,282 ) Other (expense) income Interest income, net 40 272 603 985 Other expense: (100 ) — (143 ) — Total other (expense) income (60 ) 272 460 985 Loss before provision for income taxes (8,761 ) (6,168 ) (23,981 ) (18,297 ) Provision for income taxes 3 7 5 8 Net loss (8,764 ) (6,175 ) (23,986 ) (18,305 ) Unrealized (loss) gains on marketable securities, net of tax (5 ) (2 ) 3 14 Comprehensive loss $ (8,769 ) $ (6,177 ) $ (23,983 ) $ (18,291 ) Net loss per share -- basic and diluted $ (1.46 ) $ (2.03 ) $ (5.93 ) $ (6.04 ) Weighted-average common shares outstanding 6,022,457 3,046,200 4,045,527 3,031,416 Contact
For Investors:
Winston Kung
Chief Financial Officer
[email protected]For Media:
Mariann Caprino
[email protected]
(917) 242-1087 mobile