0000950170-23-040151.txt : 20230809 0000950170-23-040151.hdr.sgml : 20230809 20230809080021 ACCESSION NUMBER: 0000950170-23-040151 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 13 CONFORMED PERIOD OF REPORT: 20230809 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20230809 DATE AS OF CHANGE: 20230809 FILER: COMPANY DATA: COMPANY CONFORMED NAME: PMV Pharmaceuticals, Inc. CENTRAL INDEX KEY: 0001699382 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] 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: 231153423 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-20230809.htm 8-K 8-K
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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): August 9, 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. ☐

 

 

 

 

Item 2.02 Results of Operations and Financial Condition.

 

On August 9, 2023, PMV Pharmaceuticals, Inc. issued a press release announcing its financial results for the first quarter ended June 30, 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 August 9, 2023.

 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: August 9, 2023

By:

/s/ Winston Kung

Winston Kung

Chief Operating Officer, and

Chief Financial Officer

(Principal Financial Officer)

 

 

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

Ex 99.1

PMV Pharmaceuticals Reports Second Quarter 2023 Financial Results and Corporate Highlights

•
Continued progress in ongoing Phase 1/2 PYNNACLE study of PC14586, a first-in-class precision oncology investigational therapy in patients with advanced solid tumors with a p53 Y220C mutation; updated Phase 1 data expected in 2H 2023
•
Concluded successful End-of-Phase 1 FDA meeting with alignment on recommended Phase 2 dose and key elements of single arm, Phase 2 registrational portion of PYNNACLE study
•
Ongoing enrollment in combination arm of PYNNACLE study with PC14586 and KEYTRUDA® (pembrolizumab)
•
Appointed Dr. Masha Poyurovsky as Vice President of Biology

 

PRINCETON, N.J., August 9, 2023 - 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 second quarter ended June 30, 2023, and provided a corporate update.

PMV recently concluded an End-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA) focused on gaining alignment with the Agency regarding the clinical and regulatory pathway for developing PC14586 for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation. Alignment with the FDA was obtained on the recommended Phase 2 dose as well as key elements of the Phase 2 registrational portion of the PYNNACLE trial. PMV plans to initiate the single arm, Phase 2 portion of the PYNNACLE study in early 2024.

“Our ongoing PYNNACLE study of PC14586 in patients with advanced solid tumors continues to make good progress,” said David Mack, Ph.D., President and Chief Executive Officer. “The positive outcome of our recently held End-of-Phase 1 meeting positions us to initiate a registrational trial for PC14586 and is an important milestone in our goal of bringing PC14586 to advanced cancer patients with a p53 Y220C mutation. Furthermore, we look forward to sharing updated Phase 1 data in the second half of the year.”

Dr. Mack added, “We are also very pleased to welcome Dr. Masha Poyurovsky to PMV as Vice President of Biology. Her scientific expertise in p53 biology and proven track record in translational drug development make her the ideal candidate to lead our biology team. I look forward to Masha’s leadership and contributions as we continue to leverage the potential of p53 targeted therapies.”

Second Quarter 2023 and Recent Corporate Highlights:

•
Ongoing enrollment in the combination arm of PYNNACLE evaluating PC14586 with KEYTRUDA® (pembrolizumab). PMV and Merck entered into a collaboration in 2022 under the terms of which Merck will supply KEYTRUDA for this study.

 

•
Appointed Masha Poyurovsky, Ph.D., as Vice President of Biology. Dr. Poyurovsky has more than a decade of experience leading novel platforms and a track record of advancing therapies from concept to the clinic. From 2011 to 2023, she was employed at Kadmon (acquired by Sanofi in 2021) most recently as Vice President, Discovery Biology. Prior to working in industry, she was a Research Scientist and a Postdoctoral Research Fellow at Columbia University where she conducted studies on p53 in the laboratory of Professor Carol Prives. She is the author and co-author of numerous publications and patents in the area of cancer biology and drug discovery. Dr. Poyurovsky obtained a

 

 

doctorate in biochemistry from Columbia University and a bachelor of science in biochemistry and biophysics from the University of Pittsburgh.

 

Second Quarter 2023 Financial Results

•
PMV Pharma ended the second quarter with $218.8 million in cash, cash equivalents, and marketable securities, compared to $277.4 million as of June 30, 2022. Net cash used in operations was $27.9 million for the six months ended June 30, 2023, compared to $31.7 million for the six months ended June 30, 2022.
•
Net loss for the six months ended June 30, 2023, was $36.6 million compared to $35.7 million for the six months ended June 30, 2022.
•
Research and development (R&D) expenses were $28.9 million for the six months ended June 30, 2023, compared to $23.3 million for the six months ended June 30, 2022. The increase in R&D expenses was primarily related to increased headcount and clinical expenses to advance research on PC14586, the Company’s lead drug candidate.
•
General and administrative (G&A) expenses were $12.7 million for the six months ended June 30, 2023, compared to $13.2 million for the six months ended June 30, 2022. The decrease in G&A expenses was primarily due to facility related costs now allocated to research as our new laboratory building in Princeton, New Jersey began operations.

 

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

 

 

 

PMV Pharmaceuticals, Inc.

Condensed Balance Sheets

(unaudited)

(in thousands, except share and per share amounts)

 

 

 

June 30,
2023
(unaudited)

 

 

December 31,
2022

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

68,209

 

 

$

108,297

 

Restricted cash

 

 

822

 

 

 

822

 

Marketable securities, current

 

 

118,878

 

 

 

132,757

 

Prepaid expenses and other current assets

 

 

2,504

 

 

 

5,130

 

Total current assets

 

 

190,413

 

 

 

247,006

 

Property and equipment, net

 

 

11,136

 

 

 

10,955

 

Marketable securities, noncurrent

 

 

31,757

 

 

 

2,495

 

Right-of-use assets

 

 

8,729

 

 

 

9,539

 

Other assets

 

 

181

 

 

 

313

 

Total assets

 

$

242,216

 

 

$

270,308

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

3,489

 

 

$

2,996

 

Accrued expenses

 

 

7,940

 

 

 

7,308

 

Operating lease liabilities, current

 

 

18

 

 

 

528

 

Total current liabilities

 

 

11,447

 

 

 

10,832

 

Operating lease liabilities, noncurrent

 

 

12,960

 

 

 

13,448

 

Total liabilities

 

 

24,407

 

 

 

24,280

 

Stockholders’ equity:

 

 

 

 

 

 

Additional paid-in capital

 

 

495,744

 

 

 

487,516

 

Accumulated deficit

 

 

(277,607

)

 

 

(241,043

)

Accumulated other comprehensive loss

 

 

(328

)

 

 

(445

)

Total stockholders’ equity

 

 

217,809

 

 

 

246,028

 

Total liabilities and stockholders’ equity

 

$

242,216

 

 

$

270,308

 

 

 

 

 

PMV Pharmaceuticals, Inc.

Condensed Statements of Operations and Comprehensive Loss

(unaudited)

(in thousands, except share and per share amounts)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

13,843

 

 

$

11,462

 

 

$

28,916

 

 

$

23,297

 

General and administrative

 

 

6,279

 

 

 

6,423

 

 

 

12,686

 

 

 

13,206

 

Total operating expenses

 

 

20,122

 

 

 

17,885

 

 

 

41,602

 

 

 

36,503

 

Loss from operations

 

 

(20,122

)

 

 

(17,885

)

 

 

(41,602

)

 

 

(36,503

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Interest income, net

 

 

2,696

 

 

 

604

 

 

 

5,022

 

 

 

832

 

Other income (expense), net

 

 

(6

)

 

 

(31

)

 

 

20

 

 

 

(72

)

Total other income (expense)

 

 

2,690

 

 

 

573

 

 

 

5,042

 

 

 

760

 

Loss before (benefit) provision for income taxes

 

 

(17,432

)

 

 

(17,312

)

 

 

(36,560

)

 

 

(35,743

)

(Benefit) provision for income taxes

 

 

4

 

 

 

(2

)

 

 

4

 

 

 

—

 

Net loss

 

 

(17,436

)

 

 

(17,310

)

 

 

(36,564

)

 

 

(35,743

)

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

 

 

(212

)

 

 

(357

)

 

 

117

 

 

 

(945

)

Comprehensive loss

 

$

(17,648

)

 

$

(17,667

)

 

$

(36,447

)

 

$

(36,688

)

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share -- basic and diluted

 

$

(0.38

)

 

$

(0.38

)

 

$

(0.80

)

 

$

(0.79

)

Weighted-average common shares outstanding

 

 

45,813,132

 

 

 

45,571,067

 

 

 

45,793,355

 

 

 

45,518,845

 

 

 

 

 

 

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 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

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 clinical and regulatory update and the Phase 2 initiation for the PYNNACLE study, 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, the Company’s Quarterly Report on Form 10-Q for the three months ended March 21, 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.

Investors Contact:

Winston Kung
Chief Financial Officer
investors@pmvpharma.com 

 

 

Media Contact:

Kathy Vincent
Greig Communications
kathy@greigcommunications.com 

 

 

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