PMV Pharmaceuticals Reports Second Quarter 2021 Financial Results and Corporate Highlights
- Continued enrollment in Phase 1/2 trial of first-in-class p53 Y220C reactivator PC14586
“We are encouraged by our execution in the clinic, with steady progress in the ongoing Phase 1/2 trial of PC14586,” said
- 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 millionin cash, cash equivalents, and marketable securities, compared to $361.4 millionas of December 31, 2020. Net cash used in operations was $22.0 millionfor the six months ended June 30, 2021, compared to $15.0 millionfor the six months ended June 30, 2020.
- Net loss for the six months ended
June 30, 2021was $24.5 millioncompared to $15.2 millionfor the six months ended June 30, 2020.
- Research and development (R&D) expenses were
$15.2 millionfor the six months ended June 30, 2021compared to $11.8 millionfor 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 millionfor the six months ended June 30, 2021compared to $4.0 millionfor 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.
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.
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
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.
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
Condensed Balance Sheets
(in thousands, except share and per share amounts)
|Cash and cash equivalents||$||189,423||$||361,422|
|Marketable securities, current||128,926||—|
|Prepaid expenses and other current assets||3,909||3,339|
|Total current assets||323,080||364,761|
|Property and equipment, net||1,253||569|
|Marketable securities, noncurrent||20,613||—|
|Right-of-use assets, operating leases||10,763||—|
|Liabilities and Stockholders’ Equity|
|Operating lease liability, current||677||—|
|Total current liabilities||7,504||6,410|
|Operating lease liability, noncurrent||10,559||—|
|Additional paid-in capital||472,218||469,001|
|Accumulated other comprehensive loss||7||—|
|Total stockholders’ equity||337,847||359,121|
|Total liabilities and stockholders’ equity||$||355,910||$||365,531|
Condensed Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
|Three Months Ended June 30,||Six Months Ended June 30,|
|Research and development||$||7,668||$||5,804||$||15,168||$||11,760|
|General and administrative||5,404||2,281||9,578||3,979|
|Total operating expenses||13,072||8,085||24,746||15,739|
|Loss from operations||(13,072||)||(8,085||)||(24,746||)||(15,739||)|
|Other income (expense):|
|Interest income, net||113||157||241||563|
|Total other income||176||118||252||520|
|Loss before provision for income taxes||(12,896||)||(7,967||)||(24,494||)||(15,219||)|
|Provision for income taxes||—||—||4||2|
|Unrealized losses on marketable securities, net of tax||20||88||7||8|
|Net loss per share -- basic and diluted||$||(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|
For Investors & Media:
Chief Financial Officer
Source: PMV Pharmaceuticals, Inc.