8-K
0001699382false00016993822023-03-012023-03-01

 

 

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): March 1, 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.)

 

 

 

1 Research Way

Princeton, NJ

 

08536

(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 March 1, 2023, PMV Pharmaceuticals, Inc. issued a press release announcing its financial results for the year ended December 31, 2022. 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 March 1, 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: March 1, 2023

 

By:

/s/ Winston Kung

 

 

 

Winston Kung

 

 

 

Chief Operating Officer, and

Chief Financial Officer

(Principal Financial Officer)

 

 


EX-99

Exhibit 99.1

PMV Pharmaceuticals Reports Full Year 2022 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; PMV expects to provide next clinical update in 2H 2023
Enrolled first patient in combination arm of the PYNNACLE study with PC14586 and KEYTRUDA® (pembrolizumab)
Cash, cash equivalents, and marketable securities of $243.5 million as of December 31, 2022

 

PRINCETON, N.J., March 1, 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 full year ended December 31, 2022, and provided a corporate update.

 

“Our team successfully delivered on key clinical development milestones in 2022, highlighted by the preliminary monotherapy data from the ongoing PYNNACLE study, and the initiation of a separate combination arm of PC14586 with KEYTRUDA,” said David Mack, Ph.D., President and Chief Executive Officer. “The initial PC14586 data have demonstrated clinical proof of concept for PC14586 as a monotherapy to selectively reactivate p53 across multiple tumor types. In alignment with FDA draft guidance on Project Optimus, we continue to enroll additional patients in the PYNNACLE study and intend to provide a comprehensive clinical and regulatory update, including our recommended Phase 2 dose, in the second half of 2023.”

 

Full Year 2022 and Recent Corporate Highlights:

Preliminary results from the ongoing Phase 1/2 PYNNACLE study of PC14586 in patients with advanced solid tumors harboring a p53 Y220C mutation were featured in an oral presentation at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting. Patient enrollment in PYNNACLE continues on track.
Enrolled the first patient in a combination arm of the PYNNACLE study evaluating PC14586 in combination with KEYTRUDA® (pembrolizumab) in patients with advanced solid tumors harboring a p53 Y220C mutation. PMV and Merck entered into a collaboration in 2022 under the terms of which Merck will supply KEYTRUDA for this study.
Appointed Kirsten Flowers and Carol Gallagher, Pharm.D. to the Board of Directors. Ms. Flowers and Dr. Gallagher each bring decades of experience in drug development and commercialization.
Promotion of Michael Carulli to Senior Vice President, Finance. Mr. Carulli joined PMV in 2020 and has made significant contributions in building the finance function as the company transitioned to becoming a publicly traded company.
Primary focus on the clinical development of PC14586 and the pipeline program R282W.

The WIP-1 and R273H programs have been put on hold which we expect will extend the company’s projected cash runway to 1H 2025.

Global headquarters moved to Princeton, NJ.

Fiscal Year 2022 Financial Results

As of December 31, 2022, PMV Pharma had $243.5 million in cash, cash equivalents, and marketable securities, compared to $314.1 million at December 31, 2021. Net cash used in operations was $63.8 million for the year ended December 31, 2022, compared to $46.6 million for the year ended December 31, 2021.

 


 

Net loss for the year ended December 31, 2022, was $73.3 million compared to $57.8 million for the year ended December 31, 2021.
Research and development (R&D) expenses were $52.0 million for the year ended December 31, 2022, compared to $36.5 million for the year ended December 31, 2021. The increase in R&D expenses was primarily related to increased headcount and clinical expenses for advancing PC14586, the Company’s lead drug candidate.
General and administrative (G&A) expenses were $25.1 million for the year ended December 31, 2022, compared to $21.8 million for the year ended December 31, 2021. The increase in G&A expenses was primarily due to expanding the infrastructure necessary for operating as a public company.

 

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 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 progress and timing for its Phase 1 update for the PYNNACLE study and its Phase 1/2 combination trial of PC14586 and KEYTRUDA, as well as expectations regarding the success of its current clinical trial for PC14586 and any future commercialization plans for the product candidate, and its guidance on its expected 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 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 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.

Balance Sheets

(in thousands)

 

December 31,
2022

 

 

December 31,
2021

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

$

108,297

 

 

$

172,467

 

Restricted cash

 

822

 

 

 

822

 

Marketable securities, current

 

132,757

 

 

 

124,696

 

Prepaid expenses and other current assets

 

5,130

 

 

 

3,301

 

Total current assets

 

247,006

 

 

 

301,286

 

Property and equipment, net

 

10,955

 

 

 

3,090

 

Marketable securities, noncurrent

 

2,495

 

 

 

16,911

 

Right-of-use assets

 

9,539

 

 

 

10,060

 

Other assets

 

313

 

 

 

221

 

Total assets

$

270,308

 

 

$

331,568

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

$

2,996

 

 

$

3,189

 

Accrued expenses

 

7,308

 

 

 

8,627

 

Operating lease liabilities, current

 

528

 

 

 

403

 

Total current liabilities

 

10,832

 

 

 

12,219

 

Operating lease liabilities, noncurrent

 

13,448

 

 

 

10,790

 

Total liabilities

 

24,280

 

 

 

23,009

 

Stockholders’ equity:

 

 

 

 

 

Additional paid-in capital

 

487,516

 

 

 

476,363

 

Accumulated deficit

 

(241,043

)

 

 

(167,726

)

Accumulated other comprehensive loss

 

(445

)

 

 

(78

)

Total stockholders' equity

 

246,028

 

 

 

308,559

 

Total liabilities and stockholders’ equity

$

270,308

 

 

$

331,568

 

 

 


 

PMV Pharmaceuticals, Inc.

Condensed Statements of Operations and Comprehensive Loss

(in thousands, except share and per share amounts)

 

 

Year Ended

 

December 31,
2022

 

 

December 31,
2021

 

Operating expenses:

 

 

 

 

 

Research and development

$

51,988

 

 

$

36,493

 

General and administrative

 

25,052

 

 

 

21,800

 

Total operating expenses

 

77,040

 

 

 

58,293

 

Loss from operations

 

(77,040

)

 

 

(58,293

)

Other income (expense):

 

 

 

 

 

Interest income, net

 

3,627

 

 

 

449

 

Other income (expense), net

 

87

 

 

 

21

 

Total other income (expense)

 

3,714

 

 

 

470

 

Loss before (benefit) provision for income taxes

 

(73,326

)

 

 

(57,823

)

(Benefit) provision for income taxes

 

(9

)

 

 

23

 

Net loss

 

(73,317

)

 

 

(57,846

)

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

 

(367

)

 

 

(78

)

Comprehensive loss

$

(73,684

)

 

$

(57,924

)

Net loss per share -- basic and diluted

$

(1.61

)

 

$

(1.28

)

Weighted-average common shares outstanding

 

45,594,824

 

 

 

45,137,656

 

 

Contacts

 

Investor Contact:

 

Winston Kung

PMV Pharmaceuticals, Inc.

investors@pmvpharma.com

 

Media Contact:

 

Kathy Vincent

Greig Communications

kathy@greigcommunications.com