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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): May 10, 2023

PMV Pharmaceuticals, Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware	001-39539	46-3218129
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)
One Research Way Princeton, NJ		08540
(Address of Principal Executive Offices)		(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:

 

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	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:

 

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.00001 par value per share		PMVP		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. ☐

 

 

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Item 2.02 Results of Operations and Financial Condition.

 

On May 10, 2023, PMV Pharmaceuticals, Inc. issued a press release announcing its financial results for the first quarter ended March 31, 2023. 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:

 

Exhibit Number		Description
99.1		Press Release issued by PMV Pharmaceuticals, Inc., dated May 10, 2023.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 

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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.

 

		PMV Pharmaceuticals, Inc.
Date: May 10, 2023		By:	/s/ Winston Kung
			Winston Kung
			Chief Operating Officer, and Chief Financial Officer (Principal Financial Officer)

 

 

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Exhibit 99.1

PMV Pharmaceuticals Reports First Quarter 2023 Financial Results and Corporate Highlights

PRINCETON, N.J., May 10, 2023 (GLOBE NEWSWIRE) - PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, today reported financial results for the first quarter ended March 31, 2023, and provided a corporate update.

 

“We are pleased with the ongoing progress in the PYNNACLE study of PC14586, a first-in-class p53 Y220C reactivator, in patients with advanced solid tumors. We look forward to providing the next clinical and regulatory update in the second half of 2023,” said David Mack, Ph.D., President and Chief Executive Officer. “Additionally, we are actively enrolling patients in the combination arm of PYNNACLE to explore the potential synergistic effects between PC14586 and KEYTRUDA.”

 

Corporate Highlights:

 

First Quarter 2023 Financial Results

KEYTRUDA® (pembrolizumab) is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

 

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. The U.S. Food and Drug Administration granted Fast Track designation to PC14586 for the treatment of patients with locally advanced or metastatic solid tumors that have a p53

 

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Y220C mutation. For more information about the Phase 1/2 PYNNACLE trial (PMV-586-101), refer to 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. 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 Princeton, 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 timing for its Phase 1 and regulatory update for the PYNNACLE study and its Phase 1/2 combination trial of PC14586 and KEYTRUDA, as well as expectations regarding success of its current clinical trial for PC14586 and any future commercialization plans for the product candidate. 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 1, 2023, and the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2023, filed with the SEC on May 10, 2023, 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.

 

 

 

 

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PMV Pharmaceuticals, Inc.

Balance Sheets

(in thousands)

	March 31, 2023 (unaudited)				December 31, 2022
Assets
Current assets:
Cash and cash equivalents	$	142,942			$	108,297
Restricted cash		822				822
Marketable securities, current		86,492				132,757
Prepaid expenses and other current assets		3,022				5,130
Total current assets		233,278				247,006
Property and equipment, net		11,238				10,955
Marketable securities, noncurrent		—				2,495
Right-of-use assets		9,130				9,539
Other assets		314				313
Total assets	$	253,960			$	270,308
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	1,774			$	2,996
Accrued expenses		8,535				7,308
Operating lease liabilities, current		281				528
Total current liabilities		10,590				10,832
Operating lease liabilities, noncurrent		13,197				13,448
Total liabilities		23,787				24,280
Stockholders’ equity:
Additional paid-in capital		490,460				487,516
Accumulated deficit		(260,171	)			(241,043	)
Accumulated other comprehensive loss		(116	)			(445	)
Total stockholders' equity		230,173				246,028
Total liabilities and stockholders’ equity	$	253,960			$	270,308

 

 

 

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PMV Pharmaceuticals, Inc.

Condensed Statements of Operations and Comprehensive Loss

(in thousands, except share and per share amounts)

 

	Three Months Ended March 31,
	2023				2022
Operating expenses:
Research and development	$	15,073			$	11,836
General and administrative		6,407				6,783
Total operating expenses		21,480				18,619
Loss from operations		(21,480	)			(18,619	)
Other income (expense):
Interest income, net		2,325				229
Other income (expense), net		27				(41	)
Total other income (expense)		2,352				188
Loss before provision for income taxes		(19,128	)			(18,431	)
Provision for income taxes		—				2
Net loss		(19,128	)			(18,433	)
Unrealized gain (loss) on available for sale investments, net of tax		329				(588	)
Comprehensive loss	$	(18,799	)		$	(19,021	)
Net loss per share -- basic and diluted	$	(0.42	)		$	(0.41	)
Weighted-average common shares outstanding		45,773,357				45,466,044

 

Investors Contact:

Winston Kung
Chief Financial Officer
investors@pmvpharma.com

 

Media Contact:

Kathy Vincent
Greig Communications
kathy@greigcommunications.com

 

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