PMV Pharmaceuticals Inc.
11/07/2024 | Press release | Distributed by Public on 11/07/2024 07:01
Quarterly Report for Quarter Ending September 30, 2024 (Form 10-Q)
10-Q
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
|
☒ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2024
OR
|
☐ |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number: 001-39539
PMV PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in its Charter)
|
Delaware |
46-3218129 |
|
(State or other jurisdiction of incorporation or organization) |
(I.R.S. 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
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, par value $0.00001 |
PMVP |
The Nasdaq Global Select Market |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of "large accelerated filer," "accelerated filer," "smaller reporting company," and "emerging growth company" in Rule 12b-2 of the Exchange Act.
|
Large accelerated filer |
☐ |
Accelerated filer |
☐ |
|||
|
Non-accelerated filer |
☒ |
Smaller reporting company |
☒ |
|||
|
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. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes ☒No ☐
As of November 6, 2024, the registrant had 51,747,130shares of common stock, $0.00001 par value per share, outstanding.
Table of Contents
|
Page |
||
|
PART I. |
FINANCIAL INFORMATION |
1 |
|
Item 1. |
Condensed Consolidated Financial Statements (Unaudited) |
1 |
|
Condensed Consolidated Balance Sheets (Unaudited) |
1 |
|
|
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) |
2 |
|
|
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) |
3 |
|
|
Condensed Consolidated Statements of Cash Flows (Unaudited) |
5 |
|
|
Notes to Unaudited Condensed Consolidated Financial Statements |
5 |
|
|
Item 2. |
Management's Discussion and Analysis of Financial Condition and Results of Operations |
15 |
|
Item 3. |
Quantitative and Qualitative Disclosures About Market Risk |
23 |
|
Item 4. |
Controls and Procedures |
24 |
|
PART II. |
OTHER INFORMATION |
25 |
|
Item 1. |
Legal Proceedings |
25 |
|
Item 1A. |
Risk Factors |
25 |
|
Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds |
25 |
|
Item 3. |
Defaults Upon Senior Securities |
25 |
|
Item 4. |
Mine Safety Disclosures |
26 |
|
Item 5. |
Other Information |
26 |
|
Item 6. |
Exhibits |
27 |
|
Signatures |
28 |
i
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements that involve risks and uncertainties. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding our future results of operations and financial position, business strategy, plans for our product candidates, planned preclinical studies and clinical trials, results of clinical trials, future research and development costs, regulatory strategy and approvals, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "would," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. Forward-looking statements contained in this Quarterly Report on Form 10-Q include, but are not limited to, statements about:
•
our financial performance;
•
the sufficiency of our existing cash, cash equivalents and marketable securities to fund our future operating expenses and capital expenditure requirements;
•
our need to raise additional funding before we can expect to generate any revenues from product sales;
•
our ability to obtain additional funding for our operations, when needed, including funding necessary to complete further development and commercialization of our product candidates, if approved;
•
the accuracy of our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
•
our anticipated use of our existing cash, cash equivalents and marketable securities and the proceeds from the ATM Program (as defined below);
•
the implementation of our strategic plans for our business and product candidates;
•
the size of the market opportunity for our product candidates and our ability to maximize those opportunities;
•
the initiation, timing, progress and results of our research and development programs, preclinical studies, clinical trials and investigational new drug applications, or IND, and other regulatory submissions;
•
the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates;
•
our estimates of the number of patients for each of our programs including patients expected to have certain p53 mutations and the number of patients that will enroll in our clinical trials;
•
the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other favorable results;
•
our plans relating to the clinical development of our product candidates, including the disease areas to be evaluated;
•
the timing, progress and focus of our clinical trials, and the reporting of data from those trials;
•
our ability to obtain and maintain regulatory approval of our product candidates;
•
our plans relating to commercializing our product candidates, if approved;
•
the expected benefits of our existing and any potential future strategic collaborations with third parties and our ability to attract collaborators with development, regulatory and commercialization expertise;
•
the success of competing therapies that are or may become available;
•
the timing or likelihood of regulatory filings and approvals, including our expectation to seek accelerated reviews or special designations, such as breakthrough therapy and orphan drug designation, for our product candidates, including our intention to seek accelerated approval for PC14586, our lead product candidate, for a tumor-agnostic indication;
•
our plans relating to the further development and manufacturing of our product candidates, including for additional indications that we may pursue;
•
existing regulations and regulatory developments in the United States and other jurisdictions;
•
our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available;
ii
•
our plans to rely on third parties to conduct and support preclinical and clinical development;
•
our ability to retain the continued service of our key personnel and to identify, hire and then retain additional qualified personnel;
•
our estimates, assumptions, projections and expectations regarding future costs savings and expenses associated with the announced restructuring plan and reduction in force; and
•
the impact of geopolitical tensions, such as the Ukraine-Russia war, the ongoing conflict between Israel and Hamas and the ongoing conflict in the Middle East, the impact of other disruptions resulting from public health epidemics, macroeconomic events such as global supply chain challenges, elevated inflation and interest rates and monetary policy changes, instability in the global banking system, or other related disruptions on our business and the execution of our clinical trials.
We have based these forward-looking statements largely on our current expectations and projections about our business, the industry in which we operate and financial trends that we believe may affect our business, financial condition, results of operations and prospects, and these forward-looking statements are not guarantees of future performance or development. These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q and are subject to a number of risks, uncertainties and assumptions described in the section titled "Item 1A. Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the United States Securities and Exchange Commission on February 29, 2024, as well as in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, as filed with the SEC on May 9, 2024 and this Quarterly Report on Form 10-Q. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events or otherwise.
In addition, statements that "we believe" and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report on Form 10-Q, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and you are cautioned not to unduly rely upon these statements.
iii
PART I-FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements (Unaudited).
PMV Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands, except share and per share amounts)
|
September 30, |
December 31, |
|||||||
|
Assets |
||||||||
|
Current assets: |
||||||||
|
Cash and cash equivalents |
$ |
48,810 |
$ |
37,706 |
||||
|
Restricted cash |
822 |
822 |
||||||
|
Marketable securities, current |
134,031 |
165,351 |
||||||
|
Prepaid expenses and other current assets |
5,957 |
3,530 |
||||||
|
Total current assets |
189,620 |
207,409 |
||||||
|
Property and equipment, net |
10,130 |
10,666 |
||||||
|
Marketable securities, noncurrent |
15,096 |
25,505 |
||||||
|
Right-of-use assets |
8,407 |
8,382 |
||||||
|
Other assets |
242 |
190 |
||||||
|
Total assets |
$ |
223,495 |
$ |
252,152 |
||||
|
Liabilities and Stockholders' Equity |
||||||||
|
Current liabilities: |
||||||||
|
Accounts payable |
$ |
2,063 |
$ |
3,237 |
||||
|
Accrued expenses |
10,257 |
9,940 |
||||||
|
Operating lease liabilities, current |
1,243 |
852 |
||||||
|
Total current liabilities |
13,563 |
14,029 |
||||||
|
Operating lease liabilities, noncurrent |
12,024 |
12,434 |
||||||
|
Total liabilities |
25,587 |
26,463 |
||||||
|
Stockholders' equity: |
||||||||
|
Preferred stock, $0.00001 par value, 5,000,000 shares authorized at September 30, 2024 and December 31, 2023. No shares issued or outstanding at September 30, 2024 and December 31, 2023. |
- |
- |
||||||
|
Common stock, $0.00001 par value, 1,000,000,000 shares authorized; 51,749,504 and 51,445,862 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively. |
- |
- |
||||||
|
Additional paid-in capital |
543,210 |
535,468 |
||||||
|
Accumulated deficit |
(345,712 |
) |
(310,003 |
) |
||||
|
Accumulated other comprehensive income |
410 |
224 |
||||||
|
Total stockholders' equity |
197,908 |
225,689 |
||||||
|
Total liabilities and stockholders' equity |
$ |
223,495 |
$ |
252,152 |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
1
PMV Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(unaudited)
(in thousands, except share and per share amounts)
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
|
2024 |
2023 |
2024 |
2023 |
|||||||||||||
|
Operating expenses: |
||||||||||||||||
|
Research and development |
$ |
16,947 |
$ |
13,586 |
$ |
44,760 |
$ |
42,503 |
||||||||
|
General and administrative |
4,941 |
6,042 |
15,520 |
18,727 |
||||||||||||
|
Total operating expenses |
21,888 |
19,628 |
60,280 |
61,230 |
||||||||||||
|
Loss from operations |
(21,888 |
) |
(19,628 |
) |
(60,280 |
) |
(61,230 |
) |
||||||||
|
Other income (expense): |
||||||||||||||||
|
Interest income, net |
2,615 |
2,984 |
8,368 |
8,005 |
||||||||||||
|
Other income, net |
121 |
4 |
103 |
24 |
||||||||||||
|
Total other income |
2,736 |
2,988 |
8,471 |
8,029 |
||||||||||||
|
Loss before provision for income taxes |
(19,152 |
) |
(16,640 |
) |
(51,809 |
) |
(53,201 |
) |
||||||||
|
Provision (benefit) for income taxes |
74 |
- |
(16,100 |
) |
3 |
|||||||||||
|
Net loss |
(19,226 |
) |
(16,640 |
) |
(35,709 |
) |
(53,204 |
) |
||||||||
|
Unrealized gain (loss) on available for sale investments, net of tax |
591 |
(27 |
) |
211 |
90 |
|||||||||||
|
Foreign currency translation gain (loss) |
4 |
- |
(25 |
) |
- |
|||||||||||
|
Total other comprehensive income (loss) |
595 |
(27 |
) |
186 |
90 |
|||||||||||
|
Total comprehensive loss |
$ |
(18,631 |
) |
$ |
(16,667 |
) |
$ |
(35,523 |
) |
$ |
(53,114 |
) |
||||
|
Net loss per share -- basic and diluted |
$ |
(0.37 |
) |
$ |
(0.34 |
) |
$ |
(0.69 |
) |
$ |
(1.13 |
) |
||||
|
Weighted-average common shares outstanding |
51,574,027 |
49,047,296 |
51,499,818 |
46,889,921 |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
2
PMV Pharmaceuticals, Inc.
Condensed Consolidated Statements of Stockholders' Equity
(unaudited)
(in thousands, except share amounts)
|
Common Stock |
Additional |
Accumulated |
Accumulated |
Total |
|||||||||||||||||||||
|
Shares |
Amount |
Capital |
(Loss) Income |
Deficit |
Equity |
||||||||||||||||||||
|
Balance at December 31, 2022 |
45,771,332 |
$ |
- |
$ |
487,516 |
$ |
(445 |
) |
$ |
(241,043 |
) |
$ |
246,028 |
||||||||||||
|
Exercise of stock options |
3,429 |
- |
12 |
- |
- |
12 |
|||||||||||||||||||
|
Stock-based compensation expense |
- |
- |
2,932 |
- |
- |
2,932 |
|||||||||||||||||||
|
Net loss |
- |
- |
- |
- |
(19,128 |
) |
(19,128 |
) |
|||||||||||||||||
|
Unrealized gain on available for sale investments |
- |
- |
- |
329 |
- |
329 |
|||||||||||||||||||
|
Balance at March 31, 2023 |
45,774,761 |
$ |
- |
$ |
490,460 |
$ |
(116 |
) |
$ |
(260,171 |
) |
$ |
230,173 |
||||||||||||
|
Exercise of stock options and common stock issued under the 2020 ESPP |
24,417 |
- |
105 |
- |
- |
105 |
|||||||||||||||||||
|
Issuance of common stock, net of issuance costs |
344,358 |
- |
2,026 |
- |
- |
2,026 |
|||||||||||||||||||
|
Stock-based compensation expense |
- |
- |
3,153 |
- |
- |
3,153 |
|||||||||||||||||||
|
Net loss |
- |
- |
- |
- |
(17,436 |
) |
(17,436 |
) |
|||||||||||||||||
|
Unrealized loss on available for sale investments |
- |
- |
- |
(212 |
) |
- |
(212 |
) |
|||||||||||||||||
|
Balance at June 30, 2023 |
46,143,536 |
$ |
- |
$ |
495,744 |
$ |
(328 |
) |
$ |
(277,607 |
) |
$ |
217,809 |
||||||||||||
|
Exercise of stock options and release of vested restricted stock units issued under the 2020 EIP |
209,012 |
- |
51 |
- |
- |
51 |
|||||||||||||||||||
|
Issuance of common stock, net of issuance costs |
4,805,088 |
33,095 |
- |
- |
33,095 |
||||||||||||||||||||
|
Stock-based compensation expense |
- |
- |
3,324 |
- |
- |
3,324 |
|||||||||||||||||||
|
Net loss |
- |
- |
- |
- |
(16,640 |
) |
(16,640 |
) |
|||||||||||||||||
|
Unrealized loss on available for sale investments |
- |
- |
- |
(27 |
) |
- |
(27 |
) |
|||||||||||||||||
|
Balance at September 30, 2023 |
51,157,636 |
$ |
- |
$ |
532,214 |
$ |
(355 |
) |
$ |
(294,247 |
) |
$ |
237,612 |
3
PMV Pharmaceuticals, Inc.
Condensed Consolidated Statements of Stockholders' Equity
(unaudited)
(in thousands, except share amounts)
|
Common Stock |
Additional |
Accumulated |
Accumulated |
Total |
|||||||||||||||||||||
|
Shares |
Amount |
Capital |
Income (Loss) |
Deficit |
Equity |
||||||||||||||||||||
|
Balance at December 31, 2023 |
51,445,862 |
$ |
- |
$ |
535,468 |
$ |
224 |
$ |
(310,003 |
) |
$ |
225,689 |
|||||||||||||
|
Exercise of stock options |
- |
- |
- |
- |
- |
- |
|||||||||||||||||||
|
Stock-based compensation expense |
- |
- |
2,610 |
- |
- |
2,610 |
|||||||||||||||||||
|
Net loss |
- |
- |
- |
- |
(15,270 |
) |
(15,270 |
) |
|||||||||||||||||
|
Unrealized loss on available for sale investments |
- |
- |
- |
(319 |
) |
- |
(319 |
) |
|||||||||||||||||
|
Foreign currency translation loss |
- |
- |
- |
(34 |
) |
- |
(34 |
) |
|||||||||||||||||
|
Balance at March 31, 2024 |
51,445,862 |
$ |
- |
$ |
538,078 |
$ |
(129 |
) |
$ |
(325,273 |
) |
$ |
212,676 |
||||||||||||
|
Exercise of stock options and common stock issued under the 2020 ESPP |
76,263 |
- |
141 |
- |
- |
141 |
|||||||||||||||||||
|
Stock-based compensation expense |
- |
- |
2,767 |
- |
- |
2,767 |
|||||||||||||||||||
|
Net loss |
- |
- |
- |
- |
(1,213 |
) |
(1,213 |
) |
|||||||||||||||||
|
Unrealized loss on available for sale investments |
- |
- |
- |
(61 |
) |
- |
(61 |
) |
|||||||||||||||||
|
Foreign currency translation gain |
- |
- |
- |
5 |
- |
5 |
|||||||||||||||||||
|
Balance at June 30, 2024 |
51,522,125 |
$ |
- |
$ |
540,986 |
$ |
(185 |
) |
$ |
(326,486 |
) |
$ |
214,315 |
||||||||||||
|
Release of vested restricted stock units issued under the 2020 EIP |
227,379 |
- |
- |
- |
- |
- |
|||||||||||||||||||
|
Stock-based compensation expense |
- |
- |
2,224 |
- |
- |
2,224 |
|||||||||||||||||||
|
Net loss |
- |
- |
- |
- |
(19,226 |
) |
(19,226 |
) |
|||||||||||||||||
|
Unrealized gain on available for sale investments |
- |
- |
- |
591 |
- |
591 |
|||||||||||||||||||
|
Foreign currency translation gain |
- |
- |
- |
4 |
- |
4 |
|||||||||||||||||||
|
Balance at September 30, 2024 |
51,749,504 |
$ |
- |
$ |
543,210 |
$ |
410 |
$ |
(345,712 |
) |
$ |
197,908 |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
PMV Pharmaceuticals, Inc.
Condensed Consolidated Statements of Cash Flows
(unaudited)
(in thousands)
|
Nine Months Ended September 30, |
||||||||
|
2024 |
2023 |
|||||||
|
Cash flows from operating activities: |
||||||||
|
Net loss |
$ |
(35,709 |
) |
$ |
(53,204 |
) |
||
|
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
|
Stock-based compensation expense |
7,601 |
9,409 |
||||||
|
Depreciation |
1,105 |
898 |
||||||
|
Accretion of discounts on marketable securities |
(4,239 |
) |
(3,511 |
) |
||||
|
Non-cash lease income |
(291 |
) |
(283 |
) |
||||
|
Loss on sale of equipment |
1 |
- |
||||||
|
Other, net |
(52 |
) |
- |
|||||
|
Change in operating assets and liabilities: |
||||||||
|
Prepaid expenses and other assets |
(2,427 |
) |
2,707 |
|||||
|
Operating lease right-of-use assets and liabilities |
247 |
- |
||||||
|
Accounts payable |
(1,174 |
) |
(1,318 |
) |
||||
|
Accrued expenses |
317 |
1,730 |
||||||
|
Net cash used in operating activities |
(34,621 |
) |
(43,572 |
) |
||||
|
Cash flows from investing activities: |
||||||||
|
Purchases of property and equipment |
(599 |
) |
(765 |
) |
||||
|
Purchases of marketable securities |
(110,773 |
) |
(187,147 |
) |
||||
|
Proceeds from sale of equipment |
29 |
- |
||||||
|
Maturities of marketable securities |
156,951 |
139,955 |
||||||
|
Net cash provided (used) by investing activities |
45,608 |
(47,957 |
) |
|||||
|
Cash flows from financing activities: |
||||||||
|
Issuance of common stock, net of issuance costs |
- |
35,121 |
||||||
|
Proceeds from the exercise of stock options and common stock issued under the 2020 EIP |
141 |
168 |
||||||
|
Net cash provided by financing activities |
141 |
35,289 |
||||||
|
Impact of exchange rates on cash, cash equivalents, and restricted cash |
(24 |
) |
- |
|||||
|
Net increase (decrease) in cash and cash equivalents |
11,104 |
(56,240 |
) |
|||||
|
Cash, cash equivalents, and restricted cash |
||||||||
|
Cash, cash equivalents, and restricted cash - beginning of period |
38,528 |
109,119 |
||||||
|
Cash, cash equivalents, and restricted cash - end of period |
$ |
49,632 |
$ |
52,879 |
||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5
PMV Pharmaceuticals, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
(in thousands, except share and per share amounts)
1. Formation and Business of the Company
Organization and Liquidity
PMV Pharmaceuticals, Inc. (the "Company" or "We") was incorporated in the state of Delaware in March 2013. Since inception, the Company has devoted substantially all of its time and efforts to performing research and development activities and raising capital. We are a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53. The Company's headquarters are located at 400 Alexander Park Drive, Suite 301, Princeton, New Jersey.
The Company is subject to risks and uncertainties common to clinical stage companies in the biotechnology industry including, but not limited to, technical risks associated with the successful research, development and manufacturing of product candidates, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. Current and future programs will require significant research and development efforts, including extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel, and infrastructure. Even if the Company's product development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales.
The Company has incurred net losses and negative cash flows from operations since its inception. During the three and nine months ended September 30, 2024, the Company incurred a net loss of $19,226and $35,709, respectively. For the nine months ended September 30, 2024, the Company used $34,621of cash for operations. At September 30, 2024, the Company had an accumulated deficit of $345,712. Cash, cash equivalents, and marketable securities were $197,937as of September 30, 2024. Management expects to incur substantial additional operating losses for the next several years and may need to obtain additional debt or equity financings in order to complete development of its products, obtain regulatory approvals, launch and commercialize its products and continue research and development programs. The Company believes it has adequate cash, cash equivalents, and marketable securities to operate for the next 12 months from the date of issuance of these condensed consolidated financial statements.
2. Summary of Significant Accounting Policies
The Company's significant accounting policies are disclosed in the audited condensed consolidated financial statements for the year ended December 31, 2023, included in the Company's Annual Report on Form 10-K filed with the United States Securities and Exchange Commission (the "SEC") on February 29, 2024. Since the date of those condensed consolidated financial statements, there have been no changes to its significant accounting policies.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States ("GAAP") for interim financial information and with the interim period reporting requirements of Form 10-Q and Article 10 of Regulation S-X. The condensed consolidated balance sheet as of September 30, 2024, the condensed consolidated statements of operations and comprehensive loss, condensed consolidated statements of stockholders' equity and condensed consolidated statements of statements of cash flows for the three and nine months ended September 30, 2024 and 2023 are unaudited, but, in the opinion of management, include all adjustments, consisting only of normal recurring adjustments, which we consider necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The results for any interim period are not necessarily indicative of results for the year ending December 31, 2024, or for any other subsequent interim period. The condensed consolidated balance sheet as of December 31, 2023, has been derived from our audited condensed consolidated financial statements.
The accompanying condensed consolidated financial statements include our accounts and the accounts of our wholly owned subsidiary, PMV Pharma Australia Pvt Ltd. All significant intercompany transactions and balances have been eliminated upon consolidation. These condensed consolidated financial statements are presented in United States ("U.S.") Dollars, which is also the functional currency of the Company.
5
PMV Pharmaceuticals, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
(in thousands, except share and per share amounts)
Use of Estimates
The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and reported amounts of revenues and expenses during the reporting period. The Company bases its estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, research and development costs, accrued research and development costs and related prepaid expenses. Actual results could differ materially from those estimates.
Cash, Cash Equivalents, and Marketable Securities
Management considers all highly liquid investments with original maturities of three months or less to be cash equivalents.
The Company's marketable debt securities have been classified and accounted for as available-for-sale. The Company classifies its marketable debt securities as either short-term or long-term based on each instrument's underlying contractual maturity date. Marketable debt securities with maturities of 12 months or less are classified as short-term and marketable debt securities with maturities greater than 12 months are classified as long-term. The Company's marketable debt securities are carried at fair value, with unrealized gains and losses, net of taxes, reported as a component of accumulated other comprehensive loss in stockholders' equity. Premiums and discounts on marketable debt securities are amortized into earnings over the life of the security and recorded on the interest income, net line of the income statement. For the nine months ended September 30, 2024 and 2023, the Company recorded $4,239and $3,511of accretion, respectively.
Restricted cash as of September 30, 2024 and December 31, 2023included a $822deposit at the Company's commercial bank underlying a stand-by letter of credit issued in favor of a landlord (See Note 6) and is classified in current assets.
Comprehensive Loss and Accumulated Other Comprehensive Income (Loss)
Other comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources, including unrealized gains and losses on investments and foreign currency translation gains and losses.
Leases
At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the circumstances present. The Company accounts for a contract as a lease when it has the right to control the asset for a period of time while obtaining substantially all of the asset's economic benefits. The Company determines the initial classification and measurement of its operating right-of-use ("ROU") assets and operating lease liabilities at the lease commencement date, and thereafter if modified. The lease term includes any renewal options that the Company is reasonably certain to exercise. The Company's policy is to not record leases with a lease term of 12 months or less on its balance sheets. The Company's only existing leases are for office and laboratory space.
The ROU asset represents the right to use the leased asset for the lease term. The lease liability represents the present value of the lease payments under the lease. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its estimated secured incremental borrowing rate for that lease term.
Lease expense for operating leases is recognized on a straight-line basis over the reasonably assured lease term based on the total lease payments and is included in operating expense in the statements of operations.
Payments due under each lease agreement include fixed and variable payments. Variable payments relate to the Company's share of the lessor's operating costs associated with the underlying asset and are recognized when the event on which those payments are assessed occurs. Variable payments have been excluded from the lease liability and associated right-of-use asset. Neither of the Company's leases contain residual value guarantees.
6
PMV Pharmaceuticals, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
(in thousands, except share and per share amounts)
The interest rate implicit in lease agreements is typically not readily determinable, and as such, the Company utilizes the incremental borrowing rate to calculate lease liabilities, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment.
Concentration of Credit Risk and Other Risks and Uncertainties
Financial instruments that potentially subject the Company to significant concentrations of credit risk consist of cash, cash equivalents, and marketable securities. Cash and cash equivalents were held at primarily two financial institutions. At times, such deposits may be in excess of insured limits. The Company has not experienced any losses on its deposits of cash and cash equivalents. The Company's marketable securities are carried at fair value and include any unrealized gains and losses. Any investments with unrealized losses are considered to be temporarily impaired.
The Company's future results of operations involve a number of risks and uncertainties. Factors that could affect the Company's future operating results and cause actual results to vary materially from expectations include, but are not limited to, rapid technological change, uncertainty of market acceptance of the product, competition from substitute products and larger companies, protection of proprietary technology, any future strategic relationships and dependence on key individuals.
Products developed by the Company require clearances from the U.S. Food and Drug Administration or other international regulatory agencies prior to commercial sales. There can be no assurance the Company's product candidates will receive the necessary clearances. If the Company is denied clearance, clearance is delayed or it is unable to maintain clearance, it could have a materially adverse impact on the Company.
3. Fair Value Measurements
The Company's financial assets consist of money market funds, U.S. government debt securities and corporate debt securities. The following tables show the Company's cash equivalents and available-for-sale securities' carrying amounts and fair values as of September 30, 2024, and December 31, 2023:
|
As of September 30, 2024 |
||||||||||||||||||||||||||||
|
Carrying |
Gross Unrealized Gains |
Gross Unrealized Losses |
Fair |
Quoted |
Significant |
Significant |
||||||||||||||||||||||
|
Financial assets |
||||||||||||||||||||||||||||
|
Money market funds |
$ |
48,709 |
$ |
- |
$ |
- |
$ |
48,709 |
$ |
48,709 |
$ |
- |
$ |
- |
||||||||||||||
|
Corporate securities |
36,335 |
64 |
- |
36,399 |
3,130 |
33,269 |
- |
|||||||||||||||||||||
|
Government securities |
112,391 |
337 |
- |
112,728 |
69,172 |
43,556 |
- |
|||||||||||||||||||||
|
Total financial assets |
$ |
197,435 |
$ |
401 |
$ |
- |
$ |
197,836 |
$ |
121,011 |
$ |
76,825 |
$ |
- |
|
As of December 31, 2023 |
||||||||||||||||||||||||||||
|
Carrying |
Gross Unrealized Gains |
Gross Unrealized Losses |
Fair |
Quoted |
Significant |
Significant |
||||||||||||||||||||||
|
Financial assets |
||||||||||||||||||||||||||||
|
Money market funds |
$ |
37,694 |
$ |
- |
$ |
- |
$ |
37,694 |
$ |
37,694 |
$ |
- |
$ |
- |
||||||||||||||
|
Corporate securities |
69,995 |
48 |
- |
70,043 |
5,577 |
64,466 |
- |
|||||||||||||||||||||
|
Government securities |
120,670 |
143 |
- |
120,813 |
92,297 |
28,516 |
- |
|||||||||||||||||||||
|
Total financial assets |
$ |
228,359 |
$ |
191 |
$ |
- |
$ |
228,550 |
$ |
135,568 |
$ |
92,982 |
$ |
- |
Cash Equivalents- As of September 30, 2024, the Company had aggregate cash and cash equivalents of $48,810, including cash equivalents of $48,709, consisting of money market funds. As of December 31, 2023, the Company had aggregate cash and cash equivalents of $37,706, including cash equivalents of $37,694, consisting of money market funds. Money market funds are classified within level 1 of the fair value hierarchy because they are valued using quoted market prices in active markets.
7
PMV Pharmaceuticals, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
(in thousands, except share and per share amounts)
Marketable Securities- Marketable securities of $149,127as of September 30, 2024, consisted of corporate debt securities of $36,399and government debt securities of $112,728. There were $134,031current marketable securities and $15,096noncurrent marketable securities as of September 30, 2024. Marketable securities of $190,856as of December 31, 2023, consisted of corporate debt securities of $70,043and government debt securities of $120,813. There were $165,351current marketable securities and $25,505noncurrent marketable securities as of December 31, 2023.
As of September 30, 2024, and December 31, 2023, aggregated gross unrealized losses of available-for-sale investments were not material, and accordingly, noallowance for credit losses was recorded.
4. Property and Equipment, Net
|
September 30, |
December 31, |
|||||||
|
Machinery & equipment |
2,730 |
$ |
3,089 |
|||||
|
Computers |
13 |
13 |
||||||
|
Furniture & fixtures |
69 |
69 |
||||||
|
Leasehold improvements |
11,364 |
10,765 |
||||||
|
Total property and equipment |
14,176 |
13,936 |
||||||
|
Less: Accumulated depreciation |
(4,046 |
) |
(3,270 |
) |
||||
|
Property and equipment, net |
$ |
10,130 |
$ |
10,666 |
Depreciation expense for the three months ended September 30, 2024 and 2023 was $371and $358, respectively. Depreciation expense for the nine months ended September 30, 2024 and 2023 was $1,105and $898, respectively.
5. Accrued Expenses
Accrued expenses consist of the following:
|
September 30, |
December 31, |
|||||||
|
Accrued compensation |
$ |
3,999 |
$ |
4,498 |
||||
|
Accrued legal and professional services |
343 |
172 |
||||||
|
Accrued research and development costs |
5,915 |
5,270 |
||||||
|
Total |
$ |
10,257 |
$ |
9,940 |
6. Commitments and Contingencies
Operating Leases
In August 2018, the Company executed twononcancelable operating leases. One lease for approximately 6,000square feet for vivarium, laboratory and general office space in South Brunswick, New Jersey. The lease was set to expire in July 2022. In January 2022, the Company signed a lease extension for up to oneadditional year through July 2023, with the option to terminateupon 120 days of written notice, with an increase in base rent as per the lease extension.The lease was terminated as of June 2023. The second lease is for office space in Lexington, Massachusetts, that terminated in August 2023.
In January 2021, the Company signed a lease for 50,581square feet of office and laboratory space at One Research Way in Princeton, New Jersey. That lease term extends through 2032, has a five-yearextension option, and replaced the Company's two existing facilities as the Company's headquarters in March 2023.Payment under this lease will total $19,889through May 2032. The Company received a lease incentive of $4,046from the lessor for a buildout of laboratory, vivarium, and office space. Management estimated the timing and amounts of reimbursements and included them as a reduction of lease payments when initially measuring the lease liability and right-of-use asset upon commencement. Since the inception date of the lease, $4,046reimbursements were received. For the nine months ended September 30, 2024, $242of reimbursements were received.
8
PMV Pharmaceuticals, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
(in thousands, except share and per share amounts)
In August 2024, the Company entered into a Lease Termination Agreement with BMR-One Research Way LLC, a Delaware limited liability company (the "Landlord"), in connection with the termination of the lease for 50,581square feet of office and laboratory space at One Research Way in Princeton, New Jersey (the "Termination Agreement"). Pursuant to the Termination Agreement, the Company and the Landlord agreed to terminate the lease at One Research Way in Princeton, New Jersey, contingent on the sale of the property by the Landlord to a prospective new buyer (the "Contingency"). The Contingency was met on the date of sale on October 1, 2024, and the lease was terminated on such date.
Pursuant to the Termination Agreement, and subject to the Contingency, the Company agreed to surrender the property and paid a total termination fee of approximately $1,420, consisting of (i) a cash payment in the amount of approximately $798and (ii) a release of a security deposit from the Company's existing letter of credit in the amount of approximately $622.
In September 2024, the Company signed a sublease agreement for 3,205square feet of office and laboratory space at 311 Pennington Rocky Hill Road in Hopewell, New Jersey. The Company will utilize the premises as laboratory space for operational research and development activities. The sublease term extends through 2029and provides the Company with the option to extendthe term for an additional three yearperiod. Payment under this sublease will total $768through December 2029.
The components of lease cost for the three and nine months ended September 30, 2024 and 2023, are as follows:
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
|
(in thousands) |
2024 |
2023 |
2024 |
2023 |
||||||||||||
|
Operating lease cost |
$ |
367 |
$ |
366 |
1,105 |
$ |
1,559 |
|||||||||
|
Variable lease cost |
146 |
161 |
507 |
792 |
||||||||||||
|
Total lease cost |
$ |
513 |
$ |
527 |
$ |
1,612 |
$ |
2,351 |
Amounts reported in the balance sheet for leases where the Company is the lessee as of September 30, 2024, and December 31, 2023, are as follows:
|
Operating Leases (in thousands, except lease term and discount rate data): |
September 30, |
December 31, |
||||||
|
Right-of-use assets, operating leases |
$ |
8,407 |
$ |
8,382 |
||||
|
Operating lease liabilities, current |
$ |
1,243 |
$ |
852 |
||||
|
Operating lease liabilities, non-current |
12,024 |
12,434 |
||||||
|
Total operating lease liabilities |
$ |
13,267 |
$ |
13,286 |
||||
|
Weighted-average remaining lease term (years) |
7.57 |
8.42 |
||||||
|
Weighted-average discount rate |
6.08 |
% |
5.75 |
% |
Other information related to leases for the nine months ended September 30, 2024 and 2023, respectively, as follows:
|
Nine Months Ended September 30, |
||||||||
|
(in thousands) |
2024 |
2023 |
||||||
|
Net cash paid for amounts included in the measurement of lease liabilities |
$ |
1,119 |
$ |
1,842 |
||||
|
Leased assets obtained in exchange for new or modified operating lease liabilities |
554 |
11 |
9
PMV Pharmaceuticals, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
(in thousands, except share and per share amounts)
Future minimum lease payments, net of reimbursements, remaining as of September 30, 2024, under operating leases by fiscal year were as follows:
|
Fiscal year |
(in thousands) |
|||
|
2024 |
$ |
479 |
||
|
2025 |
2,012 |
|||
|
2026 |
2,071 |
|||
|
2027 |
2,132 |
|||
|
2028 |
2,194 |
|||
|
Thereafter |
7,608 |
|||
|
Total minimum lease payments |
$ |
16,496 |
||
|
Less: Amounts representing imputed interest |
$ |
(3,229 |
) |
|
|
Present value of lease liabilities |
$ |
13,267 |
Rent expense recorded during the three months ended September 30, 2024 and 2023 was $367and $366, respectively. Rent expense recorded during the nine months ended September 30, 2024 and 2023was $1,076and $1,559respectively.
Contingencies
From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of its business activities. The Company accrues a liability for such matters when future expenditures are probable and such expenditures can be reasonably estimated.
7. Stockholders' Equity
The Company is authorized to issue up to 1,000,000,000shares of common stock with a par value of $0.00001per share and 5,000,000shares of preferred stock with a par value of $0.00001per share. At September 30, 2024 and December 31, 2023, there were 51,749,504and 51,445,862shares of common stock issued and outstanding, respectively.
Common stockholders are entitled to receive dividends if and when declared by the board of directors subject to the rights of any preferred stockholders. As of September 30, 2024, nodividends on common stock had been declared by the Company.
ATM Program
On October 4, 2021, the Company entered into an at-the-market offering program (the "ATM Program") pursuant to which, the Company may offer and sell shares of its common stock having aggregate gross sales proceeds of up to $150.0million from time to time. During the three and nine months ended September 30, 2024, the Company did not sell any shares of its common stock under the ATM Program. As of September 30, 2024, the Company has approximately $113.8million remaining in gross proceeds available for future issuances of common stock under the ATM Program.
8. Stock Plan
2020 Equity Incentive Plan
The 2020 Equity Incentive Plan (the "2020 Plan") was approved by the board of directors on September 24, 2020. The 2020 Plan provides for the grant of incentive stock options, non-qualified stock options, stock appreciation rights, restricted stock units, restricted stock awards, unrestricted stock awards, cash-based awards and dividend equivalent rights to the Company's officers, employees, directors, and consultants. The number of shares of common stock initially reserved for issuance under the 2020 Plan was 4,406,374, which shall be increased, upon approval by the board of directors, on January 1, 2021 and each January 1 thereafter, in an amount equal to the least of (i) 4,406,374shares of common stock, (ii) five percent (5%) of the outstanding common stock on the immediately preceding December 31, or (iii) such number of common stock determined by the board of directors no later than the immediately preceding December 31. For 2024, the board's compensation committee, as the 2020 Plan administrator, exercised its discretion under clause (ii) to increase the number of shares of common stock reserved for issuance under the 2020 Plan by 2,572,174shares, effective as of January 1, 2024. As of September 30, 2024, there were 5,329,431shares available for issuance under the 2020 Plan.
10
PMV Pharmaceuticals, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
(in thousands, except share and per share amounts)
On September 9, 2022, the Company granted 374,899Restricted Stock Units ("RSUs") to employees pursuant to an employee retention program approved by the board's compensation committee. The RSUs have graded vesting on an annual basis for two yearsof continuous service, as per the 2020 Plan. As of September 30, 2024, the RSUs were fully vested and common stock was issued upon the settlement of the RSUs.
On January 18, 2024, the Company granted 952,665RSUs to employees VP-level or higher, pursuant to an employee retention program approved by the compensation committee of the Company's board of directors. The RSUs are scheduled to vest on June 30, 2025, based on approximately one and a half yearsof continuous service, as per the 2020 Plan.
2020 Employee Stock Purchase Plan
The 2020 Employee Stock Purchase Plan (the "2020 ESPP") was approved by the board of directors on September 24, 2020. A total of 400,752shares of common stock were initially reserved for issuance under this plan, which shall be increased, upon approval by the board of directors, on January 1, 2021 and each January 1 thereafter, to the lesser of (i) 801,504shares of common stock, (ii) 1% of the outstanding shares of common stock on the last day of the immediately preceding fiscal year, or (iii) an amount determined by the board of directors or any of its committees no later than the last day of the immediately preceding fiscal year. For 2024, the 2020 ESPP reserved shares were increased under clause (ii) by 514,434shares, effective as of January 1, 2024. As of September 30, 2024, 275,497shares are issued or outstanding, and there were 1,136,410shares available for issuance, under the 2020 ESPP.
Stock Options
On July 16, 2024, the Company filed with the Securities and Exchange Commission a Tender Offer Statement on Schedule TO defining the terms and conditions of a one-time voluntary stock option exchange to its employees of certain options to purchase up to an aggregate of 2,820,491shares of the Company's common stock (the "Option Exchange"). On August 13, 2024, the completion date of the Option Exchange, stock options covering an aggregate of 2,786,691shares of common stock were tendered by eligible employees, and the Company granted new options at an exercise price of $1.48, the Company's closing stock price on August 13, 2024, covering an aggregate of 2,786,691shares of common stock under the 2020 Equity Incentive Plan in exchange for the tendered options. As a result of the Option Exchange, the Company will recognize incremental stock-based compensation expense of $1,370over the requisite service period of the new stock options, which is threeor four years. The Company will recognize the sum of the incremental stock-based compensation expense and the remaining unrecognized compensation expense for the original awards on the modification date, over the requisite service period of the new stock options.
The following table summarizes option activity for the nine-month period ended September 30, 2024:
|
Options Outstanding |
||||||||||||||||||||
|
Weighted- |
||||||||||||||||||||
|
Weighted |
Average |
Aggregate |
||||||||||||||||||
|
Shares |
Average |
Remaining |
Intrinsic |
|||||||||||||||||
|
Available |
Number of |
Exercise |
Contractual Life |
Value |
||||||||||||||||
|
for Grant |
Options |
Price |
(in years) |
(in 000s) |
||||||||||||||||
|
Balances at December 31, 2023 |
4,474,411 |
6,973,464 |
$ |
9.44 |
7.01 |
$ |
990 |
|||||||||||||
|
Shares reserved for issuance |
2,572,174 |
- |
- |
|||||||||||||||||
|
Options granted |
(6,261,885 |
) |
6,261,885 |
$ |
1.64 |
|||||||||||||||
|
Options forfeited / cancelled |
4,544,731 |
(4,544,731 |
) |
$ |
11.25 |
|||||||||||||||
|
Options exercised |
- |
(3,111 |
) |
1.80 |
||||||||||||||||
|
Balances at September 30, 2024 (unaudited) |
5,329,431 |
8,687,507 |
$ |
2.87 |
8.06 |
$ |
190 |
|||||||||||||
|
At September 30, 2024 |
||||||||||||||||||||
|
Vested and expected to vest |
8,687,507 |
$ |
2.87 |
8.06 |
$ |
190 |
||||||||||||||
|
Exercisable |
3,008,229 |
$ |
5.11 |
5.11 |
$ |
162 |
At September 30, 2024, the total compensation cost related to nonvested awards not yet recognized was $14,534. The weighted-average period over which the nonvested awards is expected to be recognized was 3.4years.
11
PMV Pharmaceuticals, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
(in thousands, except share and per share amounts)
The Company estimated the fair value of the options using the Black-Scholes options valuation model. The fair value of the options is being amortized on a straight-line basis over the requisite service period of the awards. The fair value was estimated using the following assumptions:
|
Nine Months Ended |
Nine Months Ended |
|||||||
|
September 30, |
September 30, |
|||||||
|
2024 |
2023 |
|||||||
|
Risk-free interest rate |
3.58% - 4.69% |
3.45% - 4.18% |
||||||
|
Expected life (in years) |
5.50 - 6.25 |
5.50 - 6.44 |
||||||
|
Dividend yield |
0% |
0% |
||||||
|
Expected volatility |
85.55% - 127.07% |
75.2% - 77.7% |
The weighted average assumptions used to estimate the fair value of stock purchase rights under the ESPP are as follows:
|
Nine Months Ended |
Nine Months Ended |
|||||||
|
September 30, |
September 30, |
|||||||
|
2024 |
2023 |
|||||||
|
Risk-free interest rate |
5.43% |
5.36% |
||||||
|
Expected life (in years) |
0.50 |
0.49 |
||||||
|
Dividend yield |
0% |
0% |
||||||
|
Expected volatility |
85.55% |
76.50% |
Risk Free Interest Rate: The risk-free rate is based on the U.S. Treasury yields in effect at the time of grant for periods corresponding with the expected term of the option.
Expected Term: The Company uses the simplified method to calculate expected term described in the SEC's Staff Accounting Bulletin No. 107, which takes into account vesting term and expiration date of the options.
Dividend Yield: The Company has never declared or paid any cash dividends and does not plan to pay cash dividends in the foreseeable future, and therefore, used an expected dividend yield of zeroin the valuation model.
Volatility: Volatility is based on the historical volatility of the Company's publicly traded shares for the expected term.
Restricted Stock Units
The following table presents RSU activity under the 2020 Plan as of September 30, 2024:
|
Number of |
Weighted-Average |
|||||||
|
Unvested shares at December 31, 2023 |
236,296 |
$ |
13.60 |
|||||
|
Granted |
952,665 |
1.80 |
||||||
|
Vested |
(227,379 |
) |
13.62 |
|||||
|
Forfeited |
(53,916 |
) |
3.75 |
|||||
|
Unvested shares at September 30, 2024 |
907,666 |
$ |
1.80 |
As of September 30, 2024, there was $845of unrecognized compensation cost related to RSUs that are expected to vest. These costs are expected to be recognized over a weighted average remaining vesting period of 0.8years.
Stock-based compensation expense recorded under ASC 718 related to stock options granted and common stock issued under the 2020 ESPP were allocated to research and development and general and administrative expense as follows:
|
For the Three Months Ended |
For the Nine Months Ended |
|||||||||||||||
|
September 30, |
September 30, |
September 30, |
September 30, |
|||||||||||||
|
2024 |
2023 |
2024 |
2023 |
|||||||||||||
|
Research and development |
$ |
1,009 |
$ |
1,500 |
$ |
3,245 |
$ |
4,139 |
||||||||
|
General and administrative |
1,215 |
1,824 |
4,356 |
5,270 |
||||||||||||
|
Total stock-based compensation |
$ |
2,224 |
$ |
3,324 |
$ |
7,601 |
$ |
9,409 |
12
PMV Pharmaceuticals, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
(in thousands, except share and per share amounts)
Stock-based compensation expense by award type included within the condensed consolidated statements of operations is as follows:
|
For the Three Months Ended |
For the Nine Months Ended |
|||||||||||||||
|
September 30, |
September 30, |
September 30, |
September 30, |
|||||||||||||
|
2024 |
2023 |
2024 |
2023 |
|||||||||||||
|
Stock options |
$ |
1,447 |
$ |
2,644 |
$ |
5,515 |
$ |
7,414 |
||||||||
|
Restricted stock units |
719 |
625 |
1,918 |
1,832 |
||||||||||||
|
Employee stock purchase plan |
58 |
55 |
168 |
163 |
||||||||||||
|
Total stock-based compensation |
$ |
2,224 |
$ |
3,324 |
$ |
7,601 |
$ |
9,409 |
9. Income Taxes
The Company's effective tax rates were 0.4%and 0% for the three months ended September 30, 2024 and 2023, respectively. The income tax provision and effective tax rate are driven primarily by the proceeds from the sale of the Company's New Jersey tax net operating loss carryforwards and R&D tax credits.
During the three and nine months ended September 30, 2024 and 2023, the Company recorded a full valuation allowance on federal and state net deferred tax assets since management does not forecast the Company to be in a taxable position in the near future.
The State of New Jersey's Technology Business Tax Certificate Program allows certain high technology and biotechnology companies to sell unused net operating loss ("NOL") carryforwards and research and development ("R&D") tax credits to other New Jersey-based corporate taxpayers. As of September 30, 2024, the Company received $16,176of cash for the NOL and R&D tax credit sales related to the tax years ended December 31, 2015 to 2022. The sale of the NOLs and R&D tax credits has been recorded as an income tax benefit within the condensed consolidated statement of operations.
10. Net Loss per Share
The Company excluded all outstanding stock options and restricted stock units at each period end from the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect. The following common stock equivalents were excluded from the calculation of diluted net loss per share:
|
As of September 30, |
||||||||
|
2024 |
2023 |
|||||||
|
Options to purchase common stock |
8,687,507 |
7,174,552 |
||||||
|
Unvested RSUs |
907,666 |
244,064 |
||||||
|
Expected shares to be purchased under 2020 ESPP |
47,242 |
74,100 |
||||||
|
Total |
9,642,415 |
7,492,716 |
11. Related Parties
The Company has consulting agreements with threemembers of its board of directors; one of which waived his consulting feesstarting as of September 2021. Total consulting fees paid during the three months ended September 30, 2024 and 2023were $50 and $25, respectively. Total consulting fees paid during the nine months ended September 30, 2024 and 2023 were$137and$67, respectively. There were noamounts owed under the consulting agreements as of September 30, 2024.
12. Restructuring
On January 18, 2024, the Company announced a restructuring plan involving the reduction of its workforce by approximately 30% of the Company's employees. All of the costs under the restructuring plan were incurred during the nine months ended September 30, 2024. The Company undertook these steps in order to streamline operations, reduce costs and preserve capital as it advances into late-stage development for its lead product candidate, PC14586.
13
PMV Pharmaceuticals, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
(in thousands, except share and per share amounts)
As a result of the reduction in force, the Company incurred an aggregate non-recurring charge of $597, consisting primarily of employee severance and benefit costs associated with the restructuring. The Company has recorded these charges in research and development expenses in the accompanying condensed consolidated statement of operations based on responsibilities of the impacted employees.
The Company accounts for employee termination benefits that represent a one-time benefit in accordance with ASC Topic 420, Exit or Disposal Cost Obligations. It records such costs into expense over the employee's future service period, if any.
The following sets forth information regarding the balances and activity associated with the Company's accrued employee severance and benefits costs (in thousands):
|
Balance as of |
Expenses, net |
Cash |
Balance as of |
||||||||||||
|
Employee severance and benefit costs |
- |
597 |
(597 |
) |
- |
13. Subsequent Event
On August 5, 2024, the Company entered into the Termination Agreement. Pursuant to the Termination Agreement, the Company and the Landlord agreed to terminate the Lease subject to the Contingency. The Contingency was met on the date of sale on October 1, 2024, and the lease at One Research Way was terminated on such date.
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 $1,420consisting of (i) a cash payment in the amount of approximately $798and (ii) a release of a security deposit from the Company's existing letter of credit in the amount of approximately $622. On October 1, 2024, the Company wrote off the $7,864net ROU asset, the $12,714lease liability, and the $9,454of leasehold improvements associated with the lease at One Research Way in Princeton, New Jersey. This, along with associated broker fees, will result in a net loss on the lease termination of $6,768in the condensed consolidated statements of operations for the year ended December 31, 2024.
On September 3, 2024, the Company entered into a new sublease agreement with Hengrui (USA) LTD., for approximately 14,201square feet of office space located at 400 Alexander Park Drive, Suite 301, in Princeton, New Jersey for the Company's new headquarters. The term of the lease is approximately 2 years, commencing on October 1, 2024and expiring on February 28, 2027.
14
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion of our financial condition and results of operations in conjunction with our unaudited condensed consolidated financial statements and the related notes and other financial information included in this Quarterly Report on Form 10-Q and our audited condensed consolidated financial statements and notes thereto as of and for the years ended December 31, 2023 and 2022 and the related "Management's Discussion and Analysis of Financial Condition and Results of Operations," including "Contractual Obligations and Commitments" and "Critical Accounting Policies and Estimates," included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed with the Securities and Exchange Commission, or the SEC, on February 29, 2024. Unless the context requires otherwise, references in this Quarterly Report on Form 10-Q to "we," "us," and "our" refer to PMV Pharmaceuticals, Inc.
In addition to historical information, this Quarterly Report on Form 10-Q contains forward-looking statements that involve risks, uncertainties, and assumptions. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of various factors, including but not limited to those set forth under the captions "Special Note Regarding Forward-Looking Statements," "Item 1A. Risk Factors" and elsewhere in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as updated by our subsequent filings under the Securities Exchange Act of 1934, as amended. Furthermore, past operating results are not necessarily indicative of results that may occur in future periods.
Overview
We are a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53. p53 is a well-defined tumor suppressor protein known as the "guardian of the genome," and normal, or wild-type, p53 has the ability to eliminate cancer cells. However, mutant p53 proteins can be misfolded and lose their wild-type tumor suppressing function. These 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. We have leveraged more than four decades of research experience and developed unique insights into p53 to create a precision oncology platform designed to generate selective, small molecule, tumor-agnostic therapies that structurally correct specific mutant p53 proteins to restore their wild-type function. We are deploying our precision oncology platform to target p53 mutations and other p53-related cancers.
Since our formation in March 2013, we have devoted substantially all of our time and efforts to performing research and development activities and raising capital. We are not profitable and have incurred losses in each year since our inception. During the three and nine months ended September 30, 2024, the Company incurred net losses of $19.2 million and $35.7 million, respectively. As of September 30, 2024, we had an accumulated deficit of $345.7 million. We do not currently have any product candidates approved for sale, and we continue to incur significant research and development and general administrative expenses related to our operations. We initiated a Phase 1/2 clinical trial, PYNNACLE, in October 2020 for our lead product candidate, PC14586 (rezatapopt). In October 2020, we were granted FDA Fast Track Designation of PC14586 for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation. In July 2023, we concluded our End of Phase 1 meeting with the FDA with alignment on the recommended Phase 2 dose and key elements of the single arm, Phase 2 registrational portion of the PYNNACLE study. In October 2023, we presented our updated Phase 1 clinical data for PC14586 at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics Meeting. We are continuing to dose patients in the pivotal Phase 2 monotherapy portion of our PYNNACLE trial, and have activated over 75% of sites globally across the U.S., Europe and Asia-Pacific. In October 2024, we discontinued enrollment in the Phase 1b combination arm of the PYNNACLE trial evaluating rezatapopt in combination with Merck and Co.'s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with advanced solid tumors harboring a TP53 Y220C mutation. Additionally, we announced that we are collaborating with the MD Anderson Cancer Center and the Memorial Sloan Kettering Cancer Center to support an investigator-initiated Phase 1b study, which is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of rezatapopt monotherapy in combination with azacytidine in patients harboring a TP53 Y220C mutation. We expect that enrollment for this Phase 1b study will begin in the first quarter of 2025. We also expect to provide interim data on the Phase 2 monotherapy registrational portion of the PYNNACLE trial by mid-2025.
We expect that our operating expenses will increase significantly as we advance our product candidates through preclinical and clinical development, seek regulatory approval, and prepare for and, if approved, proceed to commercialization; acquire, discover, validate, and develop additional product candidates; obtain, maintain, protect, and enforce our intellectual property portfolio; and hire additional personnel. Furthermore, we have incurred and will continue to incur additional costs associated with operating as a public company that we did not experience as a private company. We expect to continue to incur significant losses for the foreseeable future.
15
Our ability to generate product revenue will depend on the successful development, regulatory approval, and eventual commercialization of one or more of our product candidates. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through private or public equity or debt financings, collaborative, or other arrangements with corporate sources, or through other sources of financing. Adequate funding may not be available to us on acceptable terms, or at all. If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, scale back or discontinue the development and commercialization of our product candidates.
We plan to continue to use third-party service providers, including clinical research organizations, or CROs, and contract manufacturing organization, or CMOs, to carry out our preclinical and clinical development and to manufacture and supply the materials to be used during the development and commercialization of our product candidates. We do not currently have a sales force.
Components of Results of Operations
Revenue
To date, we have not generated any revenue from any sources, including from product sales, and we do not expect to generate any revenue from the sale of products in the foreseeable future. If our development efforts for our product candidates are successful and result in regulatory approval, or license agreements with third parties, we may generate revenue in the future from product sales. However, there can be no assurance as to when we will generate such revenue, if at all.
Operating Expenses
Research and Development Expenses
Our research and development expenses consist primarily of costs incurred to conduct research, such as the discovery and development of our product candidates as well as the development of future product candidates. Research and development expenses include personnel costs, including stock-based compensation expense, third-party contractor services, laboratory materials and supplies, and depreciation and maintenance of research equipment. We expense research and development costs as they are incurred.
We do not allocate our costs by product candidate or development program, as a significant amount of research and development expenses include compensation costs, materials, supplies, depreciation on and maintenance of research equipment, and the cost of services provided by outside contractors, which are not tracked by product candidate or development program. In particular, with respect to internal costs, several of our departments support multiple product candidate research and development programs, and therefore the costs cannot be allocated to a particular product candidate or development program. Substantially all of our research and development costs are associated with our lead product candidate, PC14586 (rezatapopt). We initiated a Phase 1/2 clinical trial in October 2020 for our lead product candidate, PC14586. In October 2020, we were granted FDA Fast Track Designation of PC14586 for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation. In October 2023, we presented our updated Phase 1 clinical data for PC14586 at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics Meeting. We are continuing to dose patients, and have activated over 60% of sites globally across the US, Europe and Asia-Pacific, in the registrational, tumor-agnostic PYNNACLE Phase 2 trial of PC14586 in patients with advanced solid tumors harboring a TP53 Y220C mutation and KRAS wild-type (WT). In October 2024, we discontinued enrollment in the Phase 1b combination arm of the PYNNACLE trial evaluating rezatapopt in combination with Merck and Co.'s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with advanced solid tumors harboring a TP53 Y220C mutation. Additionally, we announced that we are collaborating with the MD Anderson Cancer Center and the Memorial Sloan Kettering Cancer Center to support an investigator-initiated Phase 1b study, which is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of rezatapopt monotherapy in combination with azacytidine in patients harboring a TP53 Y220C mutation. We expect that enrollment for this Phase 1b study will begin in the first quarter of 2025. We also expect to provide interim data on the Phase 2 monotherapy registrational portion of the PYNNACLE trial by mid-2025.
We expect our research and development expenses to increase substantially in absolute dollars in the future as we advance our product candidates into and through clinical trials and pursue regulatory approval of our product candidates. The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming. The actual probability of success for our product candidates may be affected by a variety of factors including: the safety and efficacy of our product candidates, clinical data, investment in our clinical program, the ability of any future collaborators to successfully develop our licensed product candidates, competition, manufacturing capability, and commercial viability. We may never succeed in achieving regulatory approval for any of our product candidates. As a result of the uncertainties discussed above, we are unable to determine the duration and completion costs of our research and development projects.
16
General and Administrative Expenses
General and administrative expenses include personnel costs, expenses for outside professional services and other allocated expenses. Personnel costs consist of salaries, bonuses, benefits, and stock-based compensation. Outside professional services consist of legal, accounting and audit services and other consulting fees. Allocated expenses consist of rent expense related to our office and research and development facilities. We also expect to increase our general and administrative expenses as we advance our product candidates through preclinical research and development, manufacturing, clinical development, and commercialization.
Interest Income, Net
Interest income, net primarily consists of interest income from our interest-bearing cash, cash equivalents and marketable securities and interest costs related to accretion and amortization of discounts and premiums on marketable securities.
Results of Operations
Comparison of the Three Months Ended September 30, 2024 and 2023.
The following table summarizes our results of operations (in thousands):
|
Three Months Ended |
||||||||||||
|
Statement of operations data: |
2024 |
2023 |
Change |
|||||||||
|
Operating expenses: |
||||||||||||
|
Research and development |
$ |
16,947 |
$ |
13,586 |
$ |
3,361 |
||||||
|
General and administrative |
4,941 |
6,042 |
(1,101 |
) |
||||||||
|
Total operating expenses |
21,888 |
19,628 |
2,260 |
|||||||||
|
Loss from operations |
(21,888 |
) |
(19,628 |
) |
(2,260 |
) |
||||||
|
Other income: |
||||||||||||
|
Interest income, net |
2,615 |
2,984 |
(369 |
) |
||||||||
|
Other income, net |
121 |
4 |
117 |
|||||||||
|
Total other income |
2,736 |
2,988 |
(252 |
) |
||||||||
|
Loss before provision for income taxes |
(19,152 |
) |
(16,640 |
) |
(2,512 |
) |
||||||
|
Provision for income taxes |
74 |
- |
74 |
|||||||||
|
Net loss |
$ |
(19,226 |
) |
$ |
(16,640 |
) |
$ |
(2,586 |
) |
Research and Development Expenses
The following table summarizes our research and development expenses incurred during the periods indicated (in thousands):
|
Three Months Ended |
||||||||||||
|
Statement of operations data: |
2024 |
2023 |
Change |
|||||||||
|
Research |
$ |
1,743 |
$ |
1,920 |
$ |
(177 |
) |
|||||
|
Development |
$ |
11,055 |
6,785 |
4,270 |
||||||||
|
Personnel related |
$ |
3,140 |
3,381 |
(241 |
) |
|||||||
|
Stock-based compensation |
$ |
1,009 |
1,500 |
(491 |
) |
|||||||
|
Total |
$ |
16,947 |
$ |
13,586 |
$ |
3,361 |
17
Research and development expenses were $16.9 million for the three months ended September 30, 2024, compared to $13.6 million for the three months ended September 30, 2023. The increase of $3.3 million, compared to the three months ended September 30, 2023, was primarily due to the following:
•
$4.1 million increase in research and development expenses associated with advancing our lead product candidate, PC14586, through the Phase 1/2 clinical trial; and
•
$0.7 million decrease in expenses for personnel related costs and stock-based compensation, primarily driven by decreased headcount from our reduction in force initiated in January 2024.
General and Administrative Expenses
General and administrative expenses were $4.9 million for the three months ended September 30, 2024, compared to $6.0 million for the three months ended September 30, 2023. The decrease of $1.1 million, compared to the three months ended September 30, 2023, was primarily due to following:
•
$0.9 million decrease in personnel expenses driven by a decrease in headcount and $0.2 million decrease in director and officer insurance fees.
Interest Income, Net
Interest income, net primarily consists of interest income from our interest-bearing cash, cash equivalents and marketable securities and interest costs related to accretion and amortization of discounts and premiums on marketable securities. Interest income, net was $2.6 million for the three months ended September 30, 2024. The decrease of $0.4 million compared to the three months ended September 30, 2023, is driven by less cash and investments in marketable securities and U.S treasuries during the three months ended September 30, 2024.
Comparison of the Nine Months Ended September 30, 2024 and 2023.
The following table summarizes our results of operations (in thousands):
|
Nine Months Ended |
||||||||||||
|
Statement of operations data: |
2024 |
2023 |
Change |
|||||||||
|
Operating expenses: |
||||||||||||
|
Research and development |
$ |
44,760 |
$ |
42,503 |
$ |
2,257 |
||||||
|
General and administrative |
15,520 |
18,727 |
(3,207 |
) |
||||||||
|
Total operating expenses |
60,280 |
61,230 |
(950 |
) |
||||||||
|
Loss from operations |
(60,280 |
) |
(61,230 |
) |
950 |
|||||||
|
Other income: |
||||||||||||
|
Interest income, net |
8,368 |
8,005 |
363 |
|||||||||
|
Other income, net |
103 |
24 |
79 |
|||||||||
|
Total other income |
8,471 |
8,029 |
442 |
|||||||||
|
Loss before provision for income taxes |
(51,809 |
) |
(53,201 |
) |
1,392 |
|||||||
|
(Benefit) provision for income taxes |
(16,100 |
) |
3 |
(16,103 |
) |
|||||||
|
Net loss |
$ |
(35,709 |
) |
$ |
(53,204 |
) |
$ |
17,495 |
18
Research and Development Expenses
The following table summarizes our research and development expenses incurred during the periods indicated (in thousands):
|
Nine Months Ended |
||||||||||||
|
Statement of operations data: |
2024 |
2023 |
Change |
|||||||||
|
Research |
$ |
4,370 |
$ |
5,366 |
$ |
(996 |
) |
|||||
|
Development |
26,583 |
23,074 |
3,509 |
|||||||||
|
Personnel related |
10,563 |
9,924 |
639 |
|||||||||
|
Stock-based compensation |
3,244 |
4,139 |
(895 |
) |
||||||||
|
Total |
$ |
44,760 |
$ |
42,503 |
$ |
2,257 |
Research and development expenses were $44.8 million for the nine months ended September 30, 2024, compared to $42.5 million for the nine months ended September 30, 2023. The increase of $2.3 million, compared to the nine months ended September 30, 2023, was primarily due to the following:
•
$2.5 million increase in research and development expenses, largely driven by increased contractual research organization costs; offset by
•
$0.2 million decrease in expenses for personnel related costs and stock-based compensation as a result of reduced headcount from our reduction in force initiated in January 2024.
General and Administrative Expenses
General and administrative expenses were $15.5 million for the nine months ended September 30, 2024, compared to $18.7 million for the nine months ended September 30, 2023. The decrease of $3.2 million, compared to the nine months ended September 30, 2023, was primarily due to following:
•
$1.8 million decrease in personnel expenses driven by a decrease in headcount, $1.1 million decrease in facility and equipment expenses due to expiration of three leases, and $0.5 million decrease in director and officer insurance fees and legal expenses; offset by
•
$0.2 million increase in finance and legal support expenses.
Interest Income, Net
Interest income, net primarily consists of interest income from our interest-bearing cash, cash equivalents and marketable securities and interest costs related to accretion and amortization of discounts and premiums on marketable securities. Interest income, net was $8.4 million for the nine months ended September 30, 2024. The increase of $0.4 million compared to the nine months ended September 30, 2023, is driven by increased interest rates from cash and investments in marketable securities and U.S treasuries during the nine months ended September 30, 2024.
Income Tax Benefit
As of September 30, 2024, the Company received $16.2 million of cash for the NOL and R&D tax credit sales related to the tax years ended December 31, 2015 to 2022. The sale of the NOLs and R&D tax credits have been recorded as an income tax benefit within the condensed consolidated statement of operations.
19
Liquidity and Capital Resources
Our financial condition is summarized as follows (in thousands):
|
As of September 30, |
As of December 31, |
|||||||||||
|
2024 |
2023 |
Change |
||||||||||
|
Financial assets: |
||||||||||||
|
Cash and cash equivalents |
$ |
48,810 |
$ |
37,706 |
$ |
11,104 |
||||||
|
Marketable securities - current |
134,031 |
165,351 |
(31,320 |
) |
||||||||
|
Marketable securities - noncurrent |
15,096 |
25,505 |
(10,409 |
) |
||||||||
|
Total financial assets |
$ |
197,937 |
$ |
228,562 |
$ |
(30,625 |
) |
|||||
|
Working capital: |
||||||||||||
|
Current assets |
$ |
189,620 |
$ |
207,409 |
$ |
(17,789 |
) |
|||||
|
Current liabilities |
(13,563 |
) |
(14,029 |
) |
466 |
|||||||
|
Total working capital |
$ |
176,057 |
$ |
193,380 |
$ |
(17,323 |
) |
Sources of Liquidity
Since our inception, we have not generated any revenue from any product sales or any other sources and have incurred significant operating losses and negative cash flows from our operations. We have not yet commercialized any of our product candidates and we do not expect to generate revenue from sales of any product candidates for several years, if at all. As of September 30, 2024, we had cash, cash equivalents, and marketable securities of $197.9 million and an accumulated deficit of $345.7 million.
On October 4, 2021, we filed a shelf registration statement on Form S-3, as amended, (File No. 333-260012) with the SEC, or the Prior Shelf Registration Statement, which registered the offering, issuance, and sale of up to $200 million of various equity and debt securities and up to $150 million of common stock pursuant to an at-the-market equity offering program with Jefferies LLC, dated October 4, 2021, or the ATM Program. The Prior Shelf Registration Statement expired on October 4, 2024 and no shares of our common stock were able to be sold pursuant to the ATM Program following such date. We expect to file a new shelf registration statement on Form S-3 in order to, amongst other things, issue and sell common stock pursuant to the ATM Program. During the three and nine months ended September 30, 2024, we did not sell any shares of its common stock under the ATM Program. As of September 30, 2024, we have approximately $113.8 million remaining in gross proceeds available for future issuances of common stock under the ATM Program.
Contractual Obligations and Commitments
We enter into contracts in the normal course of business with CROs and other vendors to assist in the performance of our research and development activities and other services and products for operating purposes. These contracts generally provide for termination on notice, and therefore are cancelable contracts and not included in the table of contractual obligations and commitments.
In January 2021, we signed a lease for 50,581 square feet of office and laboratory space at One Research Way in Princeton, New Jersey. That lease term extends through 2032 and has a five-year extension option. Amounts related to future lease payments as of September 30, 2024, totaled $13.9 million, with $1.9 million to be paid within the next 12 months. In August 2024, the Company entered into a Lease Termination Agreement with BMR-One Research Way LLC, in connection with the termination of the lease at One Research Way in Princeton, New Jersey. Pursuant to the Termination Agreement, the Company and the Landlord agreed to terminate the lease, contingent on the sale of the property by the Landlord to a prospective new buyer. The sale to the new buyer was completed on October 1, 2024 and the lease was terminated on such date.
In September 2024, we signed two subleases, one for 14,201 square feet of office space at 400 Alexander Park Drive, Suite 301, in Princeton, New Jersey, to be used as our new headquarters ("400 Alexander Sublease"), and the other for 3,025 square feet of office and laboratory space at 311 Pennington Rocky Hill in Hopewell, New Jersey, to be used for our new laboratory space ("311 Pennington Sublease"). The 400 Alexander Sublease term extends until February 28, 2027, and the 311 Pennington Sublease term extends until December 2029 and has a three-year extension option. Amounts related to future lease payments for 311 Pennington Sublease as of September 30, 2024, totaled $0.8 million with $0.1 million to be paid within the next 12 months. Amounts related to future lease payments for 400 Alexander Sublease as of October 1, 2024 totaled $0.8 million with $0.3 million to be paid within the next 12 months.
20
Plan of Operation and Future Funding Requirements
We use our capital resources primarily to fund operating expenses, mainly research and development expenditures. On January 18, 2024, we announced a restructuring plan involving the reduction of our workforce by approximately 30% of our employees. All of the costs under the restructuring plan were incurred during the nine months ended September 30, 2024. We undertook these steps in order to streamline operations, reduce costs and preserve capital as we advance our lead candidate, PC14586, into late-stage development. At this time, due to the inherently unpredictable nature of preclinical and clinical development, we cannot reasonably estimate the costs we will incur and the timelines that will be required to complete development, obtain marketing approval and commercialize our current product candidates or any future product candidates, if at all. For the same reasons, we are also unable to predict when, if ever, we will generate revenue from product sales or whether, or when, if ever, we may achieve profitability. Clinical and preclinical development timelines, the probability of success, and development costs can differ materially from expectations. In addition, we cannot forecast which product candidates may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.
Due to our significant research and development expenditures, we have generated substantial operating losses in each period since inception. We have incurred an accumulated deficit of $345.7 million through September 30, 2024. We expect to incur substantial additional losses in the future as we expand our research and development activities. For the nine months ended September 30, 2024 and 2023, our cash operating expenditures were $34.6 million and $43.6 million, respectively. Based on our research and development plans, we expect that our cash, cash equivalents and marketable securities as of September 30, 2024 will be sufficient to fund our operations to the end of 2026.
We have based this estimate on assumptions that may prove to be wrong, however, and we could use our capital resources sooner than we expect.
The timing and amount of our operating expenditures will depend largely on:
•
the timing and progress of preclinical and clinical development activities;
•
the number and scope of preclinical and clinical programs we decide to pursue;
•
the timing and amount of milestone payments we may receive under any future collaboration agreements;
•
our ability to maintain future licenses and research and development programs and to establish new collaboration and/or in-licensing arrangements;
•
the costs involved in prosecuting and enforcing patent and other intellectual property claims;
•
the cost and timing of regulatory approvals;
•
the costs involved in finalizing our announced reduction in force and related reorganization; and
•
our efforts to manage our office and laboratory headquarters, enhance operational systems and hire additional personnel to support development of our product candidates and satisfy our obligations as a public company.
Until such time, if ever, as we can generate substantial revenue from product sales, we expect to fund our operations and capital funding needs through equity and/or debt financing. We may also consider entering into collaboration arrangements or selectively partnering for clinical development and commercialization. The sale of additional equity would result in additional dilution to our stockholders. The incurrence of debt financing would result in debt service obligations and the instruments governing such debt could provide for operating and financing covenants that would restrict our operations or our ability to incur additional indebtedness or pay dividends, among other items. If we raise additional funds through governmental funding, collaborations, strategic partnerships and alliances or marketing, distribution, or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are not able to secure adequate additional funding, we may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, and/or suspend or curtail planned programs. Any of these actions could materially and adversely affect our business, financial condition, results of operations and prospects.
21
Cash Flows
The following table summarizes our cash flows for the period indicated (in thousands):
|
Nine Months Ended |
||||||||
|
2024 |
2023 |
|||||||
|
Cash used in operating activities |
$ |
(34,621 |
) |
$ |
(43,572 |
) |
||
|
Cash provided by (used in) investing activities |
45,608 |
(47,957 |
) |
|||||
|
Cash provided by financing activities |
141 |
35,289 |
||||||
|
Impact of exchange rates on cash, cash equivalents, and restricted cash |
(24 |
) |
- |
|||||
|
Net increase (decrease) in cash and cash equivalents |
$ |
11,104 |
$ |
(56,240 |
) |
Operating Activities
Net cash used in operating activities for the nine months ended September 30, 2024, was $34.6 million, which consisted primarily of net loss of $35.7 million partially offset by non-cash charges of $4.1 million. Changes in our net operating assets decreased operating cash by $3.0 million. The non-cash charges primarily consisted of stock-based compensation of $7.6 million, accretion of discounts on marketable securities of $4.2 million, depreciation of $1.1 million, and non-cash lease income of $0.3 million. The change in our net operating assets and liabilities was primarily due to an increase in prepaid expenses and other assets, and a decrease in outstanding payables and accrued expenses.
Net cash used in operating activities for the nine months ended September 30, 2023, was $43.6 million, which consisted primarily of net loss of $53.2 million partially offset by non-cash charges of $6.5 million. Changes in our net operating assets increased operating cash by $3.1 million. The non-cash charges primarily consisted of stock-based compensation of $9.4 million, accretion of premiums on marketable securities of $3.5 million, depreciation of $0.9 million, and non-cash lease income of $0.3 million. The change in our net operating assets and liabilities was primarily due to a decrease in prepaid expenses and other assets, a decrease in outstanding payables and an increase in accrued expenses.
Investing Activities
Our investing activities provided $45.6 million of cash during the nine months ended September 30, 2024, which consisted primarily of maturities of marketable securities of $157.0 million, partially offset by purchases of marketable securities of $110.8 million, along with purchases of property and equipment of $0.6 million.
Our investing activities used $48.0 million of cash during nine months ended September 30, 2023, which consisted primarily of purchases of marketable securities of $187.1 million, along with purchases of property and equipment of $0.8 million, partially offset by maturities of marketable securities of $140.0 million.
Financing Activities
Our financing activities provided $0.1 million of cash during the nine months ended September 30, 2024. This consisted of $0.1 million of proceeds from the exercise of stock options.
Our financing activities provided $35.3 million of cash during the nine months ended September 30, 2023. This consisted of $35.1 million of common stock issued under the ATM Program, net of issuance costs, and $0.2 million of proceeds from the exercise of stock options and issuance of common stock under the 2020 ESPP.
Critical Accounting Policies and Significant Judgments and Estimates
The preparation of our condensed consolidated financial statements in conformity with accounting principles generally accepted in the United States requires us to make estimates and judgments that affect the amounts reported in those condensed consolidated financial statements and accompanying notes. Although we believe that the estimates we use are reasonable, due to the inherent uncertainty involved in making those estimates, actual results reported in future periods could differ from those estimates.
22
We believe that the accounting policies described below involve a high degree of judgment and complexity. Accordingly, these are the policies we believe are the most critical to aid in fully understanding and evaluating our financial condition and results of our operations. During the nine-month period ended September 30, 2024, there were no material changes to our critical accounting policies from those described in our audited condensed consolidated financial statements for the year ended December 31, 2023, included in our Annual Report on Form 10-K filed with the SEC on February 29, 2024, except as noted below.
Research and Development Costs, Accrued Research and Development Costs and Related Prepaid Expenses
Research and development costs are expensed as incurred. Research and development expenses consist principally of personnel costs, including salaries, stock-based compensation and benefits for employees, third-party license fees and other operational costs related to our research and development activities, including sourcing of raw materials and manufacturing of our product candidates, allocated facility-related expenses and external costs of outside vendors, and other direct and indirect costs. Non-refundable research and development advance payments are deferred and capitalized. The capitalized amounts are expensed as the related goods are delivered or services are performed.
As part of the process of preparing our condensed consolidated financial statements, we are required to estimate our accrued research and development expenses. This process involves reviewing open contracts and purchase orders, communicating with our applicable personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual costs. The majority of our service providers invoice us in arrears for services performed, on a pre-determined schedule or when contractual milestones are met; however, some require advance payments. We make estimates of our accrued expenses as of each balance sheet date in the condensed consolidated financial statements based on facts and circumstances known to us at that time. We periodically confirm the accuracy of the estimates with the service providers and make adjustments if necessary. Examples of estimated accrued research and development expenses include fees paid to:
•
vendors, including research laboratories, in connection with preclinical development activities;
•
CROs and investigative sites in connection with preclinical studies and clinical trials; and
•
CMOs in connection with drug substance and drug product formulation of preclinical studies and clinical trial materials.
We base our expenses related to preclinical studies and clinical trials on our estimates of the services received and efforts expended pursuant to quotes and contracts with multiple research institutions and CROs that supply, conduct and manage preclinical studies and clinical trials on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the expense. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones. In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, we adjust the accrual or the prepaid expense accordingly. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low in any particular period. To date, there have not been any material adjustments to our prior estimates of accrued research and development expenses.
Recent Accounting Pronouncements
For a description of recent accounting pronouncements, see Note 2 of the notes to our unaudited condensed consolidated financial statements for the nine months ended September 30, 2024 included elsewhere in this Quarterly Report on Form 10-Q.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
We are exposed to market risks in the ordinary course of our business. These risks primarily relate to interest rate risks.
We had cash, cash equivalents, and marketable securities of $197.9 million and restricted cash of $0.8 million as of September 30, 2024. The Company's cash equivalents consist of interest-bearing U.S. treasury securities, money market funds, and corporate debt securities. Our exposure due to changes in interest rates is not material due to the nature and amount of our money-market funds and marketable securities.
23
We are not currently exposed to significant market risk related to changes in foreign currency exchange rates; however, we may contract with foreign vendors that are located outside the United States in the future. This may subject us to fluctuations in foreign currency exchange rates in the future.
Item 4. Controlsand Procedures.
We maintain disclosure controls and procedures that are designed to provide reasonable assurance that information required to be disclosed in our Securities Exchange Act of 1934, as amended, reports is recorded, processed, summarized and reported within the time periods specified in the SECs rules and forms and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow for timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
We carry out a variety of ongoing procedures, under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, to evaluate the effectiveness of the design and operation of our disclosure controls and procedures. Based on the foregoing, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of September 30, 2024.
There have not been any changes in our internal control over financial reporting during our most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
24
PART II-OTHERINFORMATION
Item 1. Legal Proceedings.
We are not currently involved in any litigation or legal proceedings that, in management's opinion, are likely to have any material adverse effect on the Company.
Item 1A. Risk Factors.
There have been no material changes to the Company's risk factors as set forth in Part I, Item 1A of the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as filed with the SEC on February 29, 2024, as supplemented by our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, as filed with the SEC on May 9, 2024. You should carefully review and consider the information regarding certain factors which could materially affect our business, financial condition or future results set forth under the heading "Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as filed with the SEC on February 29, 2024, and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, as filed with the SEC on May 9, 2024.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
(a) Unregistered Sales of Equity Securities
None.
(b) Use of Proceeds
Our registration statement on Form S-1 (File No. 333-248627) relating to the IPO was declared effective by the SEC. The IPO closed on September 25, 2020 at which time we sold 13,529,750 shares of common stock (including the exercise in full by the underwriters of their option to purchase an additional 1,764,750 shares of common stock) at a public offering price of $18.00 per share. We received net proceeds from the IPO of approximately $223.2 million, after deducting the underwriting discounts and commissions of approximately $17.0 million and estimated offering related expenses of approximately $3.3 million. No offering expenses were paid or payable, directly, or indirectly, to our directors, officers, or persons owning 10% or more of any class of equity securities or to our affiliates. Goldman Sachs & Co. LLC, BofA Securities, Cowen, and Evercore ISI acted as joint book-running managers for the offering.
There has been no material change in the planned use of proceeds from the IPO from that described in the prospectus filed with the SEC pursuant to Rule 424(b)(4) under the Securities Act on September 24, 2020.
On October 4, 2021, we filed a shelf registration statement on Form S-3, as amended (File No. 333-260012), or the Prior Shelf Registration Statement, which was subsequently declared effective by the SEC on April 28, 2022. The Prior Shelf Registration Statement consisted of (i) a base prospectus pursuant to which we may offer and sell, from time to time, up to $200 million of shares of our common stock, shares of our preferred stock, various series of debt securities and warrants to purchase any of such securities in one or more registered offerings, and (ii) a prospectus supplement pursuant to which we may offer and sell, from time to time, up to $150 million of shares of common stock in "at-the-market" offerings. The Prior Shelf Registration Statement expired on October 4, 2024 and no shares of our common stock were able to be sold pursuant to the ATM Program following such date. We expect to file a new shelf registration statement on Form S-3 in order to, among other things, issue and sell common stock pursuant to the ATM Program. During the three and nine months ended September 30, 2024, the Company did not sell any shares of its common stock under the ATM Program. As of September 30, 2024, we have approximately $113.8 million remaining in gross proceeds available for future issuances of common stock under the ATM Program. There has been no material change in the planned use of proceeds as described in the Prior Shelf Registration Statement. None of the offering expenses were paid or payable, directly, or indirectly, to our directors, officers, or persons owning 10% or more of any class of equity securities or to our affiliates.
(c) Issuer Purchases of Equity Securities.
None.
Item 3. Defaults UponSenior Securities.
None.
25
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
Not applicable.
26
Item 6. Exhibits.
|
Exhibit Number |
Description |
Form |
File No. |
Number |
Filing Date |
|
|
3.1 |
Amended and Restated Certificate of Incorporation of the Registrant |
8-K |
001-39539 |
3.1 |
September 29, 2020 |
|
|
3.2 |
10-Q |
001-39539 |
3.2 |
May 10, 2023 |
||
|
10.1 |
8-K |
001-39539 |
10.1 |
August 8, 2024 |
||
|
31.1+ |
Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|||||
|
31.2+ |
Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|||||
|
32.1+ |
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
|||||
|
32.2+ |
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
|||||
|
101.INS |
Inline XBRL Instance Document |
|||||
|
101.SCH |
Inline XBRL Taxonomy Extension Schema Document |
|||||
|
104 |
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
The certifications attached as Exhibit 32.1 and 32.2 that accompany this Quarterly Report on Form 10-Q are deemed furnished and not filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of the Registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Quarterly Report on Form 10-Q, irrespective of any general incorporation language contained in such filing.
+ Filed herewith.
27
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: November 7, 2024 |
By: |
/s/ David H. Mack |
|
|
David H. Mack, Ph.D. |
|||
|
President, Chief Executive Officer, and Director |
|||
|
(Principal Executive Officer) |
|||
|
PMV Pharmaceuticals, Inc. |
|||
|
Date: November 7, 2024 |
By: |
/s/ Michael Carulli |
|
|
Michael Carulli |
|||
|
Chief Financial Officer |
|||
|
(Principal Financial and Principal Accounting Officer) |
28