0000950170-24-056294.txt : 20240509 0000950170-24-056294.hdr.sgml : 20240509 20240509080014 ACCESSION NUMBER: 0000950170-24-056294 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 12 CONFORMED PERIOD OF REPORT: 20240509 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240509 DATE AS OF CHANGE: 20240509 FILER: COMPANY DATA: COMPANY CONFORMED NAME: PMV Pharmaceuticals, Inc. CENTRAL INDEX KEY: 0001699382 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] ORGANIZATION NAME: 03 Life Sciences IRS NUMBER: 463218129 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-39539 FILM NUMBER: 24928662 BUSINESS ADDRESS: STREET 1: ONE RESEARCH WAY CITY: PRINCETON STATE: NJ ZIP: 08540 BUSINESS PHONE: (609) 642-6664 MAIL ADDRESS: STREET 1: ONE RESEARCH WAY CITY: PRINCETON STATE: NJ ZIP: 08540 8-K 1 pmvp-20240509.htm 8-K 8-K
0001699382false00016993822024-05-092024-05-09

 

 

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 9, 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.)

 

 

 

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. ☐

 

 

 

 

Item 2.02 Results of Operations and Financial Condition.

 

On May 9, 2024, PMV Pharmaceuticals, Inc. issued a press release announcing its financial results for the first quarter ended March 31, 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 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 9, 2024.

 104

Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 

 

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 9, 2024

By:

/s/ Michael Carulli

Michael Carulli

Chief Financial Officer

(Principal Financial and Principal Accounting Officer)

 

 

 EX-99.1 2 pmvp-ex99_1.htm EX-99.1 EX-99.1

Exhibit 99.1

PMV Pharmaceuticals Reports First Quarter 2024 Financial Results and Corporate Highlights

•
First patient dosed in Phase 2 portion of the PYNNACLE trial which will assess rezatapopt as monotherapy in patients with TP53 Y220C and KRAS wild-type advanced solid tumors

•
Phase 1 data of rezatapopt in advanced ovarian cancer featured in late-breaking oral presentation at 2024 SGO Annual Meeting on Women’s Cancer

•
Cash, cash equivalents, and marketable securities of $213.1 million as of March 31, 2024, providing expected cash runway to end of 2026

PRINCETON, N.J.,May 9, 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 first quarter ended March 31, 2024, and provided a corporate update.

“Dosing the first patient in the registrational, tumor-agnostic Phase 2 portion of the PYNNACLE trial is an important milestone for PMV. Our team has worked diligently to initiate this global trial and I would like to thank them for their efforts,” said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. “Rezatapopt offers the potential to provide a new treatment option for patients with a TP53 Y220C mutation and KRAS wild-type advanced solid tumors.”

Corporate Highlights:

•
First patient dosed in Phase 2 portion of the PYNNACLE trial. The multi-center, single-arm, registrational, tumor-agnostic Phase 2 trial will assess 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 of the trial is overall response rate per blinded independent central review. The trial is designed to enroll 114 patients across five cohorts at approximately 60 sites across the U.S., Europe, and Asia-Pacific.
•
Phase 1 data of rezatapopt in advanced ovarian cancer was featured in a late-breaking oral presentation at the 2024 SGO Annual Meeting on Women’s Cancer. Of the 15 heavily pre-treated patients with advanced ovarian cancer harboring a TP53 Y220C mutation, seven patients achieved a confirmed partial response with a seven-month median duration of response and a favorable safety profile.

First Quarter 2024 Financial Results

•
PMV Pharma ended the first quarter with $213.1 million in cash, cash equivalents, and marketable securities, compared to $228.6 million as of December 31, 2023. Net cash used in operations was $16.2 million for the three months ended March 31, 2024, compared to $15.0 million for the three months ended March 31, 2023.
•
Net loss for the quarter ended March 31, 2024, was $15.3 million compared to $19.1 million for the quarter ended March 31, 2023.
•
Research and development (R&D) expenses were $13.2 million for the quarter ended March 31, 2024, compared to $15.1 million for the quarter ended March 31, 2023. The decrease in R&D expenses was primarily related to decreased contractual research organization costs, offset by increased personnel related costs and stock-based compensation.
•
General and administrative (G&A) expenses were $5.0 million for the quarter ended March 31, 2024, compared to $6.4 million for the quarter ended March 31, 2023. The decrease in G&A expenses was primarily due to reduced spend for facility and operational expenses.

 

 

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 p53 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. The Phase 2 portion is a registrational, single arm, expansion basket clinical trial comprising five cohorts (ovarian, lung, breast, and 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 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, expectations regarding timing and success of the Phase 2 portion of the current clinical trial for rezatapopt, 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, and the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2024, filed with the SEC on May 9, 2024, 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 Sheets

(unaudited)

(in thousands, except share and per share amounts)

March 31,
2024

December 31,
2023

Assets

Current assets:

Cash and cash equivalents

$

47,654

$

37,706

Restricted cash

822

822

Marketable securities, current

150,285

165,351

Prepaid expenses and other current assets

3,699

3,530

Total current assets

202,460

207,409

Property and equipment, net

10,903

10,666

Marketable securities, noncurrent

15,120

25,505

Right-of-use assets

8,211

8,382

Other assets

182

190

Total assets

$

236,876

$

252,152

Liabilities and Stockholders’ Equity

Current liabilities:

Accounts payable

$

859

$

3,237

Accrued expenses

10,319

9,940

Operating lease liabilities, current

880

852

Total current liabilities

12,058

14,029

Operating lease liabilities, noncurrent

12,142

12,434

Total liabilities

24,200

26,463

Stockholders’ equity:

Additional paid-in capital

538,078

545,468

Accumulated deficit

(325,273

)

(310,003

)

Accumulated other comprehensive (loss) income

(129

)

224

Total stockholders' equity

212,676

225,689

Total liabilities and stockholders’ equity

$

236,876

$

252,152

 

 

PMV Pharmaceuticals, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(unaudited)

(in thousands, except share and per share amounts)

Three Months Ended March 31,

2024

2023

Operating expenses:

Research and development

$

13,186

$

15,073

General and administrative

5,035

6,407

Total operating expenses

18,221

21,480

Loss from operations

(18,221

)

(21,480

)

Other income (expense):

Interest income, net

2,952

2,325

Other income (expense), net

(1

)

27

Total other income (expense)

2,951

2,352

Loss before income taxes

(15,270

)

(19,128

)

Income taxes

—

—

Net loss

(15,270

)

(19,128

)

Unrealized (loss) gain on available for sale investments, net of tax

(319

)

329

Foreign currency translation loss

(34

)

—

Total comprehensive (loss) income

(353

)

329

Total comprehensive loss

$

(15,623

)

$

(18,799

)

Net loss per share -- basic and diluted

$

(0.30

)

$

(0.42

)

Weighted-average common shares outstanding

51,445,862

45,773,357

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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