PMVP PMV Pharmaceuticals Inc

 

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): November 7, 2024

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.)
400 Alexander Park Drive, Suite 301 Princeton, NJ		08540
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s Telephone Number, Including Area Code: (609) 642-6670

One Research Way, Princeton, NJ, 08540

(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 November 7, 2024, PMV Pharmaceuticals, Inc. issued a press release announcing its financial results for the third quarter ended September 30, 2024. 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 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	Form	File No.	Number	Filing Date
99.1		Press Release issued by PMV Pharmaceuticals, Inc., dated November 7, 2024.
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: November 7, 2024		By:	/s/ Michael Carulli
			Michael Carulli
			Chief Financial Officer (Principal Financial and Principal Accounting Officer)

 

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PMV Pharmaceuticals Reports Third Quarter 2024 Financial Results

 

 

 

 

PRINCETON, N.J., November 7, 2024 (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 third quarter ended September 30, 2024, and provided a corporate update.

“The Phase 2 portion of the PYNNACLE trial continues to advance, with site activation and enrollment progressing well,” said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. “We look forward to providing an update on the PYNNACLE clinical trial in the middle of next year.”

PYNNACLE Phase 2 Monotherapy Update

Enrollment is on track in the Phase 2 monotherapy portion of the PYNNACLE clinical trial. The multicenter, single-arm, registrational, tumor-agnostic Phase 2 trial is assessing rezatapopt as monotherapy at a dose of 2000 mg once-daily in patients with TP53 Y220C and KRAS wild-type advanced solid tumors. The primary endpoint is overall response rate per blinded independent central review. The trial is designed to enroll 114 patients across five cohorts at approximately 60 sites.

Site activation is progressing well, with more than 75% of sites activated across the U.S., Europe, and Asia-Pacific. PMV Pharma plans to provide data from the interim analysis of the Phase 2 monotherapy portion of the PYNNACLE trial by mid-2025 and anticipates a New Drug Application filing by the end of 2026.

Third Quarter 2024 and Recent Corporate Highlights:

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Third Quarter 2024 Financial Results

PMV Pharma ended the third quarter with $197.9 million in cash, cash equivalents, and marketable securities, compared to $238.1 million as of September 30, 2023. Net cash used in operations was $34.6 million for the nine months ended September 30, 2024, compared to $43.6 million for the nine months ended September 30, 2023.

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

 

About Rezatapopt

Rezatapopt (PC14586) is a first-in-class, small molecule p53 reactivator designed to selectively bind to the pocket in the p53 Y220C mutant protein, restoring the wild-type tumor-suppressor function. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a TP53 Y220C mutation.

 

About the PYNNACLE Clinical Trial

The ongoing Phase 1/2 PYNNACLE clinical trial is evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation. The primary objective of the Phase 1 portion of the trial was to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D) of rezatapopt when administered orally to patients. Safety, tolerability, pharmacokinetics, and effects on biomarkers were also assessed. In Phase 1, an overall response rate of 38% (6/16 evaluable patients) was achieved at the RP2D of 2000 mg daily reflective of the Phase 2 patient population (TP53 Y220C and KRAS wild-type). The median duration of response was seven months. The Phase 2 monotherapy portion is a registrational, single-arm, expansion basket clinical trial comprising five cohorts (ovarian, lung, breast, endometrial cancers, and other solid tumors) with the primary objective of evaluating the efficacy of rezatapopt at the RP2D in patients with TP53 Y220C and KRAS wild-type advanced solid tumors.

For more information about the Phase 1/2 PYNNACLE clinical trial, refer to www.clinicaltrials.gov (NCT trial 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. TP53 mutations are found in approximately half of all cancers. Our co-founder, Dr. Arnold Levine, established the field of p53 biology when he discovered the p53 protein in 1979. Bringing together leaders in the field to utilize over four decades of p53 biology, PMV

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Pharma combines unique biological understanding with a 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 rezatapopt, including our ability to obtain approval as a treatment option on a tumor-agnostic basis and as a monotherapy or in combination with other agents, including with azacytidine, expectations regarding timing for interim data readouts and success of the Phase 2 portion of the PYNNACLE trial, our expectation and timing of NDA filing(s) with the FDA for the current clinical trial for rezatapopt, the current and future enrollment of patients in our clinical trials, the timing, progress and activation of sites for our clinical trials, collaboration with and plans for MDACC’s and MSK’s investigator initiated study for combination of rezatapopt and azacitidine, and the timing and expectations with respect to our projected cash runway. 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 a clinical stage company, the potential for clinical trials of rezatapopt 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 a global pandemic, other public health emergencies or geopolitical tensions or conflicts may 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 February 29, 2024, our Quarterly Report on Form 10-Q for the three months ended March 31, 2024, filed with the SEC on May 9, 2024, and our 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. We undertake 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.

Condensed Consolidated Balance Sheets

(unaudited)

(in thousands, except share and per share amounts)

		September 30, 2024		December 31, 2023
Assets
Current assets:
Cash and cash equivalents		$ 48,810		$ 37,706
Restricted cash		822		822
Marketable securities, current		134,031		165,351
Prepaid expenses and other current assets		5,957		3,530
Total current assets		189,620		207,409
Property and equipment, net		10,130		10,666
Marketable securities, noncurrent		15,096		25,505
Right-of-use assets		8,407		8,382
Other assets		242		190
Total assets		$ 223,495		$ 252,152
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable		$ 2,063		$ 3,237
Accrued expenses		10,257		9,940
Operating lease liabilities, current		1,243		852
Total current liabilities		13,563		14,029
Operating lease liabilities, noncurrent		12,024		12,434
Total liabilities		25,587		26,463
Stockholders’ equity:
Additional paid-in capital		543,210		535,468
Accumulated deficit		(345,712)		(310,003)
Accumulated other comprehensive income		410		224
Total stockholders’ equity		197,908		225,689
Total liabilities and stockholders’ equity		$ 223,495		$ 252,152

 

 

 

 

 

 

 

 

 

 

 

 

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PMV Pharmaceuticals, Inc.

Condensed Consolidated 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,
		2024		2023		2024		2023
Operating expenses:
Research and development		$ 16,947		$ 13,586		$ 44,760		$ 42,503
General and administrative		4,941		6,042		15,520		18,727
Total operating expenses		21,888		19,628		60,280		61,230
Loss from operations		(21,888)		(19,628)		(60,280)		(61,230)
Other income (expense):
Interest income, net		2,615		2,984		8,368		8,005
Other income, net		121		4		103		24
Total other income		2,736		2,988		8,471		8,029
Loss before provision for income taxes		(19,152)		(16,640)		(51,809)		(53,201)
Provision (benefit) from income taxes		74		-		(16,100)		3
Net loss		(19,226)		(16,640)		(35,709)		(53,204)
Unrealized gain (loss) on available for sale investments, net of tax		591		(27)		211		90
Foreign currency translation gain (loss)		4		-		(25)		-
Total other comprehensive income (loss)		595		(27)		186		90
Total comprehensive loss		$ (18,631)		$ (16,667)		$ (35,523)		$ (53,114)
Net loss per share -- basic and diluted		$ (0.37)		$ (0.34)		$ (0.69)		$ (1.13)
Weighted-average common shares outstanding		51,574,027		49,047,296		51,499,818		46,889,921

 

 

Investors Contact:
Tim Smith
Senior Vice President, Head of Corporate Development and Investor Relations
investors@pmvpharma.com 

 

Media Contact:
Kathy Vincent
Greig Communications
kathy@greigcommunications.com 

 

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v3.24.3

Document and Entity Information	Nov. 07, 2024
Document Information [Line Items]
Amendment Flag	false
Entity Central Index Key	0001699382
Document Type	8-K
Document Period End Date	Nov. 07, 2024
Entity Registrant Name	PMV Pharmaceuticals, Inc.
Entity Incorporation State Country Code	DE
Entity File Number	001-39539
Entity Tax Identification Number	46-3218129
Entity Address, Address Line One	400 Alexander Park Drive
Entity Address, Address Line Two	Suite 301
Entity Address, City or Town	Princeton
Entity Address, State or Province	NJ
Entity Address, Postal Zip Code	08540
City Area Code	(609)
Local Phone Number	642-6670
Written Communications	false
Soliciting Material	false
Pre commencement Tender Offer	false
Pre commencement Issuer Tender Offer	false
Security 12b Title	Common Stock, $0.00001 par value per share
Trading Symbol	PMVP
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false
Former address
Document Information [Line Items]
Entity Address, Address Line One	One Research Way
Entity Address, City or Town	Princeton
Entity Address, State or Province	NJ
Entity Address, Postal Zip Code	08540

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