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
Date of Report (Date of earliest event reported):
(Exact name of Registrant as Specified in Its Charter)
|
|
|
|
|
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
|
|
|
|
|
|
|
|
|
(Address of Principal Executive Offices) |
|
(Zip Code) |
Registrant’s Telephone Number, Including Area Code:
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 |
|
|
|
|
|
|
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 10, 2022, PMV Pharmaceuticals, Inc. issued a press release announcing its financial results for the first quarter ended June 30, 2021. 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 10, 2022. |
|
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document). |
1
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 10, 2022 |
|
By: |
/s/ Winston Kung |
|
|
|
|
Winston Kung |
|
|
|
|
Chief Operating Officer, and Chief Financial Officer (Principal Financial Officer) |
2
Exhibit 99.1
PMV Pharmaceuticals Reports First Quarter 2022 Financial Results and Corporate Highlights
|
|
• |
Oral presentation at 2022 ASCO annual meeting to highlight initial data from ongoing Phase 1/2 PYNNACLE study of PC14586 in patients with advanced solid tumors |
CRANBURY, N.J., May 10, 2022 (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, 2022, and provided a corporate update.
“Our priority in 2022 is execution of the ongoing Phase 1/2 trial evaluating PC14586, our investigational first-in-class p53 Y220C reactivator, in patients with solid tumors, as well as continued progress on our pipeline” said David Mack, Ph.D., President, and Chief Executive Officer. “We look forward to presenting initial data from the Phase 1 dose escalation trial at the 2022 ASCO annual meeting.”
Corporate Highlights:
|
|
• |
Poster titled “Small Molecule Reactivators of Y220C Mutant p53 Modulate Tumor Infiltrating Leukocytes and Synergize with Immune Checkpoint Inhibitors” presented at the American Association of Cancer Research Annual Meeting 2022. |
|
|
• |
Continued progress on research pipeline with WIP1 (Wild-Type p53-Induced Phosphatase) inhibitor and p53 mutant programs. |
First Quarter 2022 Financial Results
|
|
• |
As of March 31, 2022, PMV Pharma had $294.8 million in cash, cash equivalents, and marketable securities, compared to $314.1 million as of December 31, 2021. Net cash used in operations was $18.0 million for the three months ended March 31, 2022 compared to $12.9 million for the three months ended March 31, 2021. |
|
|
• |
Net loss for the quarter ended March 31, 2022 was $18.4 million compared to $11.6 million for the quarter ended March 31, 2021. |
|
|
• |
Research and development (R&D) expenses were $11.8 million for the quarter ended March 31, 2022 compared to $7.5 million for the quarter ended March 31, 2021. The increase in R&D expenses was primarily related to increased headcount and clinical development expenses to advance PC14586, the Company’s lead drug candidate. |
|
|
• |
General and administrative (G&A) expenses were $6.8 million for the quarter ended March 31, 2022, compared to $4.2 million for the quarter ended March 31, 2021. The increase in G&A expenses was primarily due to expanding the infrastructure necessary for operating as a public company. |
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. PC14586 is being developed for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation. For more information on 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 Cranbury, 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 success of its current clinical trial for PC14586 and any future commercialization plans for the product candidate; and the future plans or expectations for the Company’s discovery platform for its other early-stage and clinical candidates. 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, 2022, the Company’s Quarterly Report on Form 10-Q filed with the SEC on May 10, 2022 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.
(unaudited)
(in thousands, except share and per share amounts)
|
|
|
March 31, 2022 (unaudited) |
|
|
December 31, 2021 |
|
||
|
Assets |
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
115,772 |
|
|
$ |
172,467 |
|
|
Restricted cash |
|
|
822 |
|
|
|
822 |
|
|
Marketable securities, current |
|
|
167,221 |
|
|
|
124,696 |
|
|
Prepaid expenses and other current assets |
|
|
4,225 |
|
|
|
3,301 |
|
|
Total current assets |
|
|
288,040 |
|
|
|
301,286 |
|
|
Property and equipment, net |
|
|
5,238 |
|
|
|
3,090 |
|
|
Marketable securities, noncurrent |
|
|
11,773 |
|
|
|
16,911 |
|
|
Right-of-use assets, operating leases |
|
|
9,736 |
|
|
|
10,060 |
|
|
Other assets |
|
|
221 |
|
|
|
221 |
|
|
Total assets |
|
$ |
315,008 |
|
|
$ |
331,568 |
|
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
4,864 |
|
|
$ |
3,189 |
|
|
Accrued expenses |
|
|
6,563 |
|
|
|
8,627 |
|
|
Operating lease liability, current |
|
|
258 |
|
|
|
403 |
|
|
Total current liabilities |
|
|
11,685 |
|
|
|
12,219 |
|
|
Operating lease liability, noncurrent |
|
|
11,480 |
|
|
|
10,790 |
|
|
Total liabilities |
|
|
23,165 |
|
|
|
23,009 |
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
|
Common stock |
|
|
— |
|
|
|
— |
|
|
Additional paid-in capital |
|
|
478,668 |
|
|
|
476,363 |
|
|
Accumulated deficit |
|
|
(186,159 |
) |
|
|
(167,726 |
) |
|
Accumulated other comprehensive income |
|
|
(666 |
) |
|
|
(78 |
) |
|
Total stockholders’ equity |
|
|
291,843 |
|
|
|
308,559 |
|
|
Total liabilities and stockholders’ equity |
|
$ |
315,008 |
|
|
$ |
331,568 |
|
PMV Pharmaceuticals, Inc.
Condensed Statements of Operations and Comprehensive Loss
(unaudited)
(in thousands, except share and per share amounts)
|
|
|
Three Months Ended March 31, |
|
|||||
|
|
|
2022 |
|
|
2021 |
|
||
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
11,836 |
|
|
$ |
7,500 |
|
|
General and administrative |
|
|
6,783 |
|
|
|
4,174 |
|
|
Total operating expenses |
|
|
18,619 |
|
|
|
11,674 |
|
|
Loss from operations |
|
|
(18,619 |
) |
|
|
(11,674 |
) |
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
Interest income, net |
|
|
229 |
|
|
|
128 |
|
|
Other expense |
|
|
(41 |
) |
|
|
(52 |
) |
|
Total other income (expense) |
|
|
188 |
|
|
|
76 |
|
|
Loss before provision for income taxes |
|
|
(18,431 |
) |
|
|
(11,598 |
) |
|
Provision for income taxes |
|
|
2 |
|
|
|
4 |
|
|
Net loss |
|
|
(18,433 |
) |
|
|
(11,602 |
) |
|
Unrealized loss on marketable securities, net of tax |
|
|
(588 |
) |
|
|
(13 |
) |
|
Comprehensive loss |
|
$ |
(19,021 |
) |
|
$ |
(11,615 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net loss per share -- basic and diluted |
|
$ |
(0.41 |
) |
|
$ |
(0.26 |
) |
|
Weighted-average common shares outstanding |
|
|
45,466,044 |
|
|
|
44,785,226 |
|
|
Investors and Media Contact: |
|
|
|
|
|
Winston Kung |
|
Chief Financial Officer |
|
investors@pmvpharma.com |