Form 8-K

8-K — PMV Pharmaceuticals, Inc.

Accession: 0001193125-26-218225

Filed: 2026-05-12

Period: 2026-05-12

CIK: 0001699382

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — pmvp-20260512.htm (Primary)

EX-99.1 (pmvp-ex99_1.htm)

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8-K

8-K (Primary)

Filename: pmvp-20260512.htm · Sequence: 1

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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 12, 2026

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

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 12, 2026, PMV Pharmaceuticals, Inc. issued a press release announcing its financial results for the first quarter ended March 31, 2026. 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 12, 2026.

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 12, 2026

By:

/s/ Michael Carulli

Michael Carulli

Chief Financial Officer

(Principal Financial and Accounting Officer)

EX-99.1

Filename: pmvp-ex99_1.htm · Sequence: 2

EX-99.1

Exhibit 99.1

PMV Pharmaceuticals Reports First Quarter 2026 Financial Results and Corporate Highlights

•

Rezatapopt granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of TP53 Y220C positive ovarian cancer

•

New England Journal of Medicine published first-in-human rezatapopt data showing selective reactivation of mutant p53 in advanced solid tumors

•

Rezatapopt New Drug Application submission for platinum-resistant/refractory ovarian cancer planned in first quarter of 2027

•

Cash, cash equivalents, and marketable securities of $93.5 million as of March 31, 2026 providing expected cash runway to end of second quarter of 2027

PRINCETON, N.J., May 12, 2026 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. (“PMV Pharma” or the “Company”; Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule therapies targeting p53, today reported financial results for the first quarter ended March 31, 2026, and provided a corporate update.

“The first quarter was one of continued execution as we advance the PYNNACLE study and remain on track to target an NDA submission for rezatapopt for platinum‑resistant/refractory ovarian cancer in the first quarter of 2027,” said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. “We are also encouraged by the publication of the PYNNACLE Phase 1 results in the New England Journal of Medicine, which underscores the scientific innovation behind rezatapopt and highlights its potential to address a significant unmet medical need. Patients with TP53 Y220C advanced solid tumors, including platinum resistant ovarian cancer, experience poor outcomes despite available therapies.”

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 Phase 2 study is assessing rezatapopt as monotherapy at a dose of 2000 mg once-daily in patients with TP53 Y220C advanced solid tumors.

•

PMV Pharma anticipates submitting a New Drug Application (NDA) for rezatapopt in platinum-resistant/refractory ovarian cancer patients with a TP53 Y220C mutation in the first quarter of 2027.

Corporate Highlights:

•

Updated Phase 2 PYNNACLE clinical results evaluating rezatapopt were featured in an oral presentation at the 2026 Society of Gynecologic Oncology Annual Meeting on Women's Cancer on April 12, 2026.

Confirmed responses were observed in platinum-resistant/refractory ovarian cancer patients with a TP53 Y220C mutation

▪

Overall response rate (ORR) of 44% (32/72 patients) per investigator assessment according to Response Evaluation Criteria in Solid Tumors

Exhibit 99.1

(RECIST) version 1.1, including one confirmed complete response, 31 confirmed partial responses.

▪

The median time to response was 1.3 months and the median duration of response was 8.2 months.

▪

Post the March 29, 2026 data cutoff, two additional patients achieved unconfirmed partial responses (uPRs), bringing the ORR to 46% (34/74).

•

Phase 1 results from the ongoing Phase 1/2 PYNNACLE study were published in the New England Journal of Medicine, “Phase 1 Study of Rezatapopt, a p53 Reactivator, in TP53 Y220C-Mutated Tumors.” The manuscript highlighted that rezatapopt demonstrated antitumor activity in heavily pretreated patients across multiple solid tumor types which provided proof-of-concept for p53 reactivation. Clinical activity and biomarker data were consistent with selective binding to the Y220C pocket and restoration of wild-type p53 tumor suppressor function.

•

The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to rezatapopt for the treatment of TP53 Y220C positive ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. The FDA provides ODD status to drugs intended for the safe and effective treatment, diagnosis, or prevention of rare diseases that affect fewer than 200,000 people in the U.S. Benefits of the designation may include exemption from certain FDA fees, financial incentives for qualified clinical development, and seven years of market exclusivity in the U.S. if the treatment is approved.

First Quarter 2026 Financial Results

PMV Pharma ended the first quarter with $93.5 million in cash, cash equivalents, and marketable securities, compared to $112.9 million as of December 31, 2025. Net cash used in operations was $19.7 million for the three months ended March 31, 2026, compared to $18.3 million for the three months ended March 31, 2025.

•

Net loss for the quarter ended March 31, 2026, was $18 million compared to $17.4 million for the quarter ended March 31, 2025. The net loss increase was primarily due to the benefit received from the sale of NOL carryforwards in Q1 2025, offset by decreased research and development (R&D) costs.

•

R&D expenses were $15.3 million for the quarter ended March 31, 2026, compared to $17.4 million for the quarter ended March 31, 2025. The decrease in R&D expenses was primarily due to decreased contractual research organization costs for the advancement of the rezatapopt program.

•

General and administrative (G&A) expenses were $3.7 million for the quarter ended March 31, 2026, compared to $4.1 million for the quarter ended March 31, 2025. The decrease in G&A expenses was primarily due to reduced personnel expenses and a decrease in finance and legal support costs.

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 granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a p53 Y220C

Exhibit 99.1

mutation and Orphan Drug Designation for the treatment of TP53 Y220C positive ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.

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 clinical 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, conducted across approximately 70 sites.

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 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 more than 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 as a monotherapy, expectations regarding timing, enrollment status and success of the Phase 2 portion of the current clinical trial for rezatapopt and filing of a New Drug Application (NDA) for platinum-resistant/refractory ovarian cancer, the benefits of FDA’s grant of Orphan Drug Designation (ODD) 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, including the successful filing of NDAs, 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, maintenance by the Company of ODD status and related benefits for rezatapopt, 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

Exhibit 99.1

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 6, 2026, 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.

Condensed Consolidated Balance Sheets

(unaudited)

(in thousands, except share and per share amounts)

March 31,

2026

December 31,

2025

Assets

Current assets:

Cash and cash equivalents

$ 39,130

$ 37,983

Marketable securities, current

54,419

74,960

Prepaid expenses and other current assets

2,231

2,284

Total current assets

95,780

115,227

Property and equipment, net

203

237

Right-of-use assets

283

801

Other assets

296

297

Total assets

$ 96,562

$ 116,562

Liabilities and Stockholders’ Equity

Current liabilities:

Accounts payable

$ 1,631

$ 3,155

Accrued expenses

6,671

7,857

Operating lease liabilities, current

293

403

Total current liabilities

8,595

11,415

Operating lease liabilities, noncurrent

—

435

Total liabilities

8,595

11,850

Stockholders’ equity:

Additional paid-in capital

552,474

551,082

Accumulated deficit

(464,492)

(446,454)

Accumulated other comprehensive income

(15)

Total stockholders’ equity

87,967

104,712

Total liabilities and stockholders’ equity

$ 96,562

$ 116,562

Exhibit 99.1

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,

2026

2025

Operating expenses:

Research and development

$ 15,330

$ 17,441

General and administrative

3,689

4,123

Total operating expenses

19,019

21,564

Loss from operations

(19,019)

(21,564)

Other income (expense):

Interest income, net

980

1,935

Other income (expense), net

(4)

Total other income

981

1,931

Loss before (benefit) provision for income taxes

(18,038)

(19,633)

(Benefit) provision for income taxes

—

(2,197)

Net loss

(18,038)

(17,436)

Unrealized loss on available for sale investments, net of tax

(101)

(62)

Foreign currency translation gain

Total other comprehensive loss

(99)

(55)

Total comprehensive loss

$ (18,137)

$ (17,491)

Net loss per share -- basic and diluted

$ (0.34)

Weighted-average common shares outstanding

53,331,766

51,952,062

Contacts

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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