UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 13, 2021
PMV Pharmaceuticals, Inc.
(Exact name of Registrant as Specified in Its Charter)
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Delaware |
001-39539 |
46-3218129 |
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(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
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Clarke Drive, Suite 3, Cranbury, NJ |
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08512 |
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(Address of Principal Executive Offices) |
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(Zip Code) |
Registrant’s Telephone Number, Including Area Code: (609) 642-6670
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
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Common Stock, $0.00001 par value per share |
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PMVP |
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The Nasdaq Global Select Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On August 13, 2021, PMV Pharmaceuticals, Inc. issued a press release announcing its financial results for the first quarter ended June 30, 2021. The full text of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this Item 2.02 of this Form 8-K, including the attached Exhibit 99.1, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits:
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Exhibit Number |
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Description |
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99.1 |
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Press Release issued by PMV Pharmaceuticals, Inc., dated August 13, 2021. |
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1
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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PMV Pharmaceuticals, Inc. |
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Date: August 13, 2021 |
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By: |
/s/ Winston Kung |
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Winston Kung |
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Chief Operating Officer, and Chief Financial Officer (Principal Financial Officer) |
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Exhibit 99.1
PMV Pharmaceuticals Reports Second Quarter 2021 Financial Results and Corporate Highlights
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• |
Continued enrollment in Phase 1/2 trial of first-in-class p53 Y220C reactivator PC14586 |
CRANBURY, NJ, August 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:
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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). |
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Activated twelve clinical trial sites in the United States, consisting of leading oncology centers. |
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Commenced construction of new corporate headquarters and state-of-the-art laboratories in Princeton, New Jersey. |
Second Quarter 2021 Financial Results
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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 $22.1 million for the six months ended June 30, 2021, compared to $15.0 million for the six months ended June 30, 2020. |
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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. |
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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 |
Exhibit 99.1
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and clinical expenses related to development of PC14586, the Company’s lead drug candidate. |
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• |
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
Exhibit 99.1
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.
Exhibit 99.1
PMV Pharmaceuticals, Inc.
(unaudited)
(in thousands, except share and per share amounts)
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June 30, 2021 (unaudited) |
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December 31, 2020 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
189,423 |
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$ |
361,422 |
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Restricted cash |
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822 |
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— |
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Marketable securities, current |
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128,926 |
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— |
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Prepaid expenses and other current assets |
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3,909 |
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3,339 |
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Total current assets |
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323,080 |
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364,761 |
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Property and equipment, net |
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1,253 |
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569 |
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Marketable securities, noncurrent |
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20,613 |
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— |
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Right-of-use assets, operating leases |
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10,763 |
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— |
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Other assets |
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201 |
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201 |
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Total assets |
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$ |
355,910 |
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$ |
365,531 |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
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$ |
2,369 |
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$ |
1,607 |
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Accrued expenses |
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4,458 |
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4,803 |
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Operating lease liability, current |
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677 |
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— |
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Total current liabilities |
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7,504 |
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6,410 |
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Operating lease liability, noncurrent |
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10,559 |
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— |
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Total liabilities |
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18,063 |
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6,410 |
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Stockholders’ equity: |
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Common stock |
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— |
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— |
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Additional paid-in capital |
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472,196 |
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469,001 |
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Accumulated deficit |
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(134,356 |
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(109,880 |
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Accumulated other comprehensive loss |
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7 |
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— |
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Total stockholders’ equity |
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337,847 |
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359,121 |
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Total liabilities and stockholders’ equity |
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$ |
355,910 |
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$ |
365,531 |
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Exhibit 99.1
PMV Pharmaceuticals, Inc.
Condensed Statements of Operations and Comprehensive Loss
(unaudited)
(in thousands, except share and per share amounts)
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Three Months Ended June 30, |
Six Months Ended June 30, |
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2021 |
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2020 |
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2021 |
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2020 |
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Operating expenses: |
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Research and development |
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$ |
7,664 |
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$ |
5,804 |
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$ |
15,163 |
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$ |
11,760 |
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General and administrative |
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5,386 |
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2,281 |
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9,560 |
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3,979 |
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Total operating expenses |
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13,050 |
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8,085 |
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24,723 |
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15,739 |
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Loss from operations |
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(13,050 |
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(8,085 |
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(24,723 |
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(15,739 |
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Other income (expense): |
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Interest income, net |
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113 |
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157 |
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241 |
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563 |
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Other expense |
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63 |
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(39 |
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11 |
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(43 |
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Total other income |
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176 |
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118 |
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252 |
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520 |
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Loss before provision for income taxes |
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(12,874 |
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(7,967 |
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(24,472 |
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(15,219 |
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Provision for income taxes |
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— |
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— |
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4 |
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2 |
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Net loss |
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(12,874 |
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(7,967 |
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(24,476 |
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(15,221 |
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Unrealized losses on marketable securities, net of tax |
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20 |
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88 |
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7 |
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8 |
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Comprehensive loss |
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$ |
(12,854 |
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$ |
(7,879 |
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$ |
(24,469 |
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$ |
(15,213 |
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Net loss per share -- basic and diluted |
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$ |
(0.29 |
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$ |
(2.62 |
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$ |
(0.54 |
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$ |
(5.00 |
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Weighted-average common shares outstanding |
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45,070,104 |
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3,046,200 |
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44,928,518 |
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3,046,200 |
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Contact
For Investors & Media:
Winston Kung
Chief Financial Officer
investors@pmvpharma.com