UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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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) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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:
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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 1.02 Termination of a Material Definitive Agreement.
On August 5, 2024, PMV Pharmaceuticals, Inc., a Delaware corporation (the “Company”), entered into a Lease Termination Agreement (the “Termination Agreement”) with BMR-One Research Way LLC, a Delaware limited liability company (the “Landlord”), in connection with the termination of that certain Lease, by and between the Landlord and the Company, dated January 8, 2021 (the “Lease”) of One Research Way, Princeton, New Jersey 08540 (the “Property”). The Lease consists of 50,581 square feet of rentable area. Pursuant to the Termination Agreement, the Company and the Landlord agreed to terminate the Lease effective as of September 30, 2024, contingent on the sale of the Property by the Landlord to a prospective new buyer (the “Contingency”).
Pursuant to the Termination Agreement, and subject to the Contingency, the Company agreed to surrender the Property and pay a total termination fee of approximately $1.42 million, consisting of (i) a cash payment in the amount of approximately $798 thousand (the “Cash Payment”); and (ii) a post of a security deposit in the form of a letter of credit in the amount of approximately $622 thousand. The Cash Payment is to be paid by the Company to the Landlord within five (5) business days of written notice from the Landlord of the completion of the prospective buyer’s due diligence review of the Property.
The Lease termination is related to continued efforts by the Company to identify cost reduction opportunities. Concurrently with the termination of the Lease and the effectiveness of the Termination Agreement, the Company intends to relocate its headquarters and labs to an alternative property, with significantly reduced square footage and ongoing operating costs.
The foregoing descriptions of the Termination Agreement is not complete and is qualified in its entirety by reference to the full text of the Termination Agreement, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated by reference herein.
Item 2.02 Results of Operations and Financial Condition.
On August 8, 2024, PMV Pharmaceuticals, Inc. issued a press release announcing its financial results for the second quarter ended June 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 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 |
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Description |
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10.1
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99.1 |
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Press Release issued by PMV Pharmaceuticals, Inc., dated August 8, 2024. |
104 |
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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.
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PMV Pharmaceuticals, Inc. |
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Date: August 8, 2024 |
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By: |
/s/ Michael Carulli |
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Michael Carulli |
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Chief Financial Officer (Principal Financial and Principal Accounting Officer) |
Exhibit 10.1
LEASE TERMINATION AGREEMENT
THIS LEASE TERMINATION AGREEMENT (this “Agreement”) is entered into as of this 5th day of August, 2024 (“Execution Date”), by and between BMR-ONE RESEARCH WAY LLC, a Delaware limited liability company (“Landlord”), and PMV PHARMACEUTICALS, Inc., a Delaware corporation (“Tenant”).
RECITALS
AGREEMENT
NOW, THEREFORE, Landlord and Tenant, in consideration of the mutual promises contained herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound, agree as follows:
Lab Table |
Mott |
Altus, 72” , dual circuit, dual gas connection, 30” deep phenolic top |
(85 total) |
Lab Table |
Mott |
Altus, 60” , dual circuit, dual gas connection, 30” deep phenolic top |
(85 total) |
Mobile Base |
Mott |
Mobile base, 24” , 4 drawer, 24” deep phenolic top |
(65 total) |
Mobile Base |
Mott |
Mobile base, 24” , full door, 24” deep phenolic top |
(50 total) |
Mobile Base |
Mott |
Mobile base, 24” , drawer/door combo, 24” deep phenolic top |
(40 total) |
ACTIVE 699509317v5 |
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ACTIVE 699509317v5 |
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[REMAINDER OF THIS PAGE INTENTIONALLY LEFT BLANK]
ACTIVE 699509317v5 |
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IN WITNESS WHEREOF, the parties have executed this Agreement as of the day hereinabove first written.
LANDLORD: |
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BMR-ONE RESEARCH WAY LLC, |
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a Delaware limited liability company |
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By: |
/s/ Colleen OConnor |
Name: |
Colleen OConnor |
Its: |
EVP, Market Lead, East coast and U.K. Markets |
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TENANT: |
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PMV PHARMACEUTICALS, INC., |
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a Delaware corporation |
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By: |
/s/ David Mack, Ph.D. |
Name: |
David Mack, Ph.D. |
Its: |
President & CEO |
ACTIVE 699509317v5 |
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1RW Lease Termination Agr
Final Audit Report |
2024-08-01 |
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Created: |
2024-08-01 |
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By: |
Robert Ticktin (rticktin@pmvpharma.com) |
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Status: |
Signed |
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Transaction ID: |
CBJCHBCAABAA7uu9RFk5TVdpRl_awWvqfM-slohp8pF2 |
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"1RW Lease Termination Agr" History
Document created by Robert Ticktin (rticktin@pmvpharma.com)
2024-08-01 - 9:20:10 PM GMT
Document emailed to David Mack (dmack@pmvpharma.com) for signature
2024-08-01 - 9:20:47 PM GMT
Email viewed by David Mack (dmack@pmvpharma.com)
2024-08-01 - 9:26:33 PM GMT
Document e-signed by David Mack (dmack@pmvpharma.com}
Signature Date: 2024-08-01 - 9:26:57 PM GMT - Time Source: server
Agreement completed.
2024-08-01 - 9:26:57 PM GMT
Signature:
Email: colleen.oconnor@biomedrealty.com
Exhibit 99.1
PMV Pharmaceuticals Reports Second Quarter 2024 Financial Results and Provides a Progress Update on PYNNACLE Clinical Trial
PRINCETON, N.J., August 8, 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 second quarter ended June 30, 2024, and provided an update on the Phase 2 monotherapy and Phase 1b combination portions of the PYNNACLE clinical trial.
“We are encouraged by the pace of site activation and patient enrollment in the Phase 2 PYNNACLE trial,” said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. “I would like to thank our team for their continued execution, and we look forward to providing an update on the PYNNACLE clinical trial 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 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.
Site activation is progressing well, with more than 60% of sites activated across the U.S., Europe, and Asia-Pacific. PMV 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 (NDA) filing by the end of 2026.
PYNNACLE Phase 1b Rezatapopt/Pembrolizumab Combination Update
Enrollment continues in the Phase 1b combination arm of the PYNNACLE trial evaluating rezatapopt in combination with pembrolizumab (200 mg every 3 weeks) in patients with advanced solid tumors harboring a TP53 Y220C mutation.
Second Quarter 2024 Financial Results
PMV Pharma ended the second quarter with $212.9 million in cash, cash equivalents, and marketable securities, compared to $213.1 million as of March 31, 2024. Net cash used in operations was $17.8 million for the six months ended June 30, 2024, compared to $27.9 million for the six months ended June 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, 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.
In addition, rezatapopt in combination with pembrolizumab is being evaluated in the Phase 1b portion of the Phase 1/2 PYNNACLE trial. The primary objective of the Phase 1b portion of the trial is to determine the maximum tolerated dose and RP2D of rezatapopt when administered with pembrolizumab.
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 and in combination with pembrolizumab, expectations regarding timing for interim data readouts and success of the Phase 1b and Phase 2 portions of the PYNNACLE trial, our expectation and timing of NDA filing(s) with the FDA for the current clinical trial for rezatapopt, expectations regarding eligibility criteria of our clinical trials, the current and future enrollment of patients in our clinical trials, the timing, progress and activation of sites for our clinical trials, the results and preliminary data of our clinical trials 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)
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June 30, |
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December 31, |
Assets |
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Current assets: |
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Cash and cash equivalents |
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$ 48,526 |
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$ 37,706 |
Restricted cash |
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822 |
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822 |
Marketable securities, current |
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164,393 |
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165,351 |
Prepaid expenses and other current assets |
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5,048 |
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3,530 |
Total current assets |
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218,789 |
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207,409 |
Property and equipment, net |
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10,530 |
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10,666 |
Marketable securities, noncurrent |
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— |
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25,505 |
Right-of-use assets |
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8,038 |
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8,382 |
Other assets |
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182 |
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190 |
Total assets |
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$ 237,539 |
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$ 252,152 |
Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
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$ 4,533 |
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$ 3,237 |
Accrued expenses |
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5,701 |
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9,940 |
Operating lease liabilities, current |
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1,151 |
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852 |
Total current liabilities |
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11,385 |
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14,029 |
Operating lease liabilities, noncurrent |
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11,839 |
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12,434 |
Total liabilities |
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23,224 |
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26,463 |
Stockholders’ equity: |
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Additional paid-in capital |
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540,986 |
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535,468 |
Accumulated deficit |
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(326,486) |
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(310,003) |
Accumulated other comprehensive (loss) income |
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(185) |
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224 |
Total stockholders’ equity |
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214,315 |
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225,689 |
Total liabilities and stockholders’ equity |
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$ 237,539 |
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$ 252,152 |
PMV Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(unaudited)
(in thousands, except share and per share amounts)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2024 |
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2023 |
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2024 |
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2023 |
Operating expenses: |
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Research and development |
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$ 14,628 |
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$ 13,843 |
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$ 27,813 |
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$ 28,916 |
General and administrative |
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5,542 |
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6,279 |
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10,578 |
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12,686 |
Total operating expenses |
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20,170 |
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20,122 |
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38,391 |
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41,602 |
Loss from operations |
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(20,170) |
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(20,122) |
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(38,391) |
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(41,602) |
Other income (expense): |
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Interest income, net |
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2,801 |
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2,696 |
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5,753 |
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5,022 |
Other income (expense), net |
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(17) |
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(6) |
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(18) |
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20 |
Total other income |
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2,784 |
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2,690 |
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5,735 |
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5,042 |
Loss before provision for income taxes |
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(17,386) |
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(17,432) |
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(32,656) |
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(36,560) |
Benefit from income taxes |
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(16,173) |
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4 |
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(16,173) |
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4 |
Net loss |
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(1,213) |
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(17,436) |
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(16,483) |
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(36,564) |
Unrealized (loss) gain on available for sale investments, net of tax |
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(61) |
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(212) |
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(380) |
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117 |
Foreign currency translation gain (loss) |
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5 |
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(28) |
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Total other comprehensive (loss) income |
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(56) |
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(212) |
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(408) |
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117 |
Total comprehensive loss |
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$ (1,269) |
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$ (17,648) |
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$ (16,891) |
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$ (36,447) |
Net loss per share -- basic and diluted |
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$ (0.02) |
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$ (0.38) |
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$ (0.32) |
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$ (0.80) |
Weighted-average common shares outstanding |
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51,478,751 |
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45,813,132 |
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51,462,307 |
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45,793,355 |
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