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PMV Pharmaceuticals, Inc. - Quarter Report: 2023 September (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, 2023

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.)

One Research Way

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 7, 2023, the registrant had 51,157,636 shares of common stock, $0.00001 par value per share, outstanding.

 

 

 


 

Table of Contents

 

Page

PART I.

FINANCIAL INFORMATION

1

Item 1.

Condensed Financial Statements (Unaudited)

1

Condensed Balance Sheets (Unaudited)

1

Condensed Statements of Operations and Comprehensive Loss (Unaudited)

2

Condensed Statements of Stockholders’ Equity (Unaudited)

3

Condensed Statements of Cash Flows (Unaudited)

5

Notes to Unaudited Condensed Financial Statements

6

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

23

PART II.

OTHER INFORMATION

24

Item 1.

Legal Proceedings

24

Item 1A.

Risk Factors

24

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

24

Item 3.

Defaults Upon Senior Securities

24

Item 4.

Mine Safety Disclosures

25

Item 5.

Other Information

25

Item 6.

Exhibits

26

Signatures

27

 

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, development plans, planned preclinical studies and clinical trials, future results of clinical trials, expected research and development costs, regulatory strategy, 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 short-term 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;
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; and
the impact of the ongoing COVID-19 pandemic, geopolitical tensions such as the Ukraine-Russia war, macroeconomic events such as global supply chain challenges, elevated inflation and interest rates and monetary policy changes, or other potential global disruptions on our business.

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, 2022, filed with the United States Securities and Exchange Commission on March 1, 2023, as well as in 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 Financial Statements (Unaudited).

PMV Pharmaceuticals, Inc.

Condensed Balance Sheets

(unaudited)

(in thousands, except share and per share amounts)

 

 

 

September 30,
2023
(unaudited)

 

 

December 31,
2022

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

52,057

 

 

$

108,297

 

Restricted cash

 

 

822

 

 

 

822

 

Marketable securities, current

 

 

149,861

 

 

 

132,757

 

Prepaid expenses and other current assets

 

 

2,556

 

 

 

5,130

 

Total current assets

 

 

205,296

 

 

 

247,006

 

Property and equipment, net

 

 

10,822

 

 

 

10,955

 

Marketable securities, noncurrent

 

 

36,184

 

 

 

2,495

 

Right-of-use assets

 

 

8,545

 

 

 

9,539

 

Other assets

 

 

180

 

 

 

313

 

Total assets

 

$

261,027

 

 

$

270,308

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

1,678

 

 

$

2,996

 

Accrued expenses

 

 

9,038

 

 

 

7,308

 

Operating lease liabilities, current

 

 

 

 

 

528

 

Total current liabilities

 

 

10,716

 

 

 

10,832

 

Operating lease liabilities, noncurrent

 

 

12,699

 

 

 

13,448

 

Total liabilities

 

 

23,415

 

 

 

24,280

 

Stockholders’ equity:

 

 

 

 

 

 

Preferred stock, $0.00001 par value, 5,000,000 shares authorized at September 30, 2023 and December 31, 2022. No shares issued or outstanding at September 30, 2023 and December 31, 2022.

 

 

 

 

 

 

Common stock, $0.00001 par value, 1,000,000,000 shares authorized; 51,157,636 and 45,771,332 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively.

 

 

 

 

 

 

Additional paid-in capital

 

 

532,214

 

 

 

487,516

 

Accumulated deficit

 

 

(294,247

)

 

 

(241,043

)

Accumulated other comprehensive loss

 

 

(355

)

 

 

(445

)

Total stockholders’ equity

 

 

237,612

 

 

 

246,028

 

Total liabilities and stockholders’ equity

 

$

261,027

 

 

$

270,308

 

 

 

The accompanying notes are an integral part of these unaudited condensed financial statements.

1


 

PMV Pharmaceuticals, Inc.

Condensed 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,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

13,586

 

 

$

13,666

 

 

$

42,503

 

 

$

36,963

 

General and administrative

 

 

6,042

 

 

 

5,709

 

 

 

18,727

 

 

 

18,915

 

Total operating expenses

 

 

19,628

 

 

 

19,375

 

 

 

61,230

 

 

 

55,878

 

Loss from operations

 

 

(19,628

)

 

 

(19,375

)

 

 

(61,230

)

 

 

(55,878

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Interest income, net

 

 

2,984

 

 

 

1,124

 

 

 

8,005

 

 

 

1,830

 

Other income (expense), net

 

 

4

 

 

 

13

 

 

 

24

 

 

 

67

 

Total other income (expense)

 

 

2,988

 

 

 

1,137

 

 

 

8,029

 

 

 

1,897

 

Loss before (benefit) provision for income taxes

 

 

(16,640

)

 

 

(18,238

)

 

 

(53,201

)

 

 

(53,981

)

(Benefit) provision for income taxes

 

 

 

 

 

(9

)

 

 

3

 

 

 

(9

)

Net loss

 

 

(16,640

)

 

 

(18,229

)

 

 

(53,204

)

 

 

(53,972

)

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

 

 

(27

)

 

 

(2

)

 

 

90

 

 

 

(947

)

Comprehensive loss

 

$

(16,667

)

 

$

(18,231

)

 

$

(53,114

)

 

$

(54,919

)

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share -- basic and diluted

 

$

(0.34

)

 

$

(0.40

)

 

$

(1.13

)

 

$

(1.18

)

Weighted-average common shares outstanding

 

 

49,047,296

 

 

 

45,622,957

 

 

 

46,889,921

 

 

 

45,556,635

 

 

 

The accompanying notes are an integral part of these unaudited condensed financial statements.

2


 

PMV Pharmaceuticals, Inc.

Condensed Statements of Stockholders’ Equity

(unaudited)

(in thousands, except share amounts)

 

 

 

 

Common Stock

 

 

Additional
Paid-in

 

 

Accumulated
Other
Comprehensive

 

 

Accumulated

 

 

Total
Stockholders'

 

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Equity

 

Balance at December 31, 2021

 

 

 

45,433,684

 

 

$

 

 

$

476,363

 

 

$

(78

)

 

$

(167,726

)

 

$

308,559

 

Exercise of stock options

 

 

 

98,708

 

 

 

 

 

 

128

 

 

 

 

 

 

 

 

 

128

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

2,177

 

 

 

 

 

 

 

 

 

2,177

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(18,433

)

 

 

(18,433

)

Unrealized loss on available for sale investments

 

 

 

 

 

 

 

 

 

 

 

 

(588

)

 

 

 

 

 

(588

)

Balance at March 31, 2022

 

 

 

45,532,392

 

 

$

 

 

$

478,668

 

 

$

(666

)

 

$

(186,159

)

 

$

291,843

 

Exercise of stock options

 

 

 

90,218

 

 

 

 

 

 

276

 

 

 

 

 

 

 

 

 

276

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

2,518

 

 

 

 

 

 

 

 

 

2,518

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(17,310

)

 

 

(17,310

)

Unrealized loss on available for sale investments

 

 

 

 

 

 

 

 

 

 

 

 

(357

)

 

 

 

 

 

(357

)

Balance at June 30, 2022

 

 

 

45,622,610

 

 

$

 

 

$

481,462

 

 

$

(1,023

)

 

$

(203,469

)

 

$

276,970

 

Exercise of stock options

 

 

 

2,250

 

 

 

 

 

 

6

 

 

 

 

 

 

 

 

 

6

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

2,448

 

 

 

 

 

 

 

 

 

2,448

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(18,229

)

 

 

(18,229

)

Unrealized loss on available for sale investments

 

 

 

 

 

 

 

 

 

 

 

 

(2

)

 

 

 

 

 

(2

)

Balance at September 30, 2022

 

 

 

45,624,860

 

 

$

 

 

$

483,916

 

 

$

(1,025

)

 

$

(221,698

)

 

$

261,193

 

 

3


 

 

 

 

 

Common Stock

 

 

Additional
Paid-in

 

 

Accumulated
Other
Comprehensive

 

 

Accumulated

 

 

Total
Stockholders'

 

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

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

 

 

 

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

 

 

 

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

 

 

The accompanying notes are an integral part of these unaudited condensed financial statements.

4


 

PMV Pharmaceuticals, Inc.

Condensed Statements of Cash Flows

(unaudited)

(in thousands)

 

 

 

Nine Months Ended September 30,

 

 

 

2023

 

 

2022

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(53,204

)

 

$

(53,972

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Stock-based compensation expense

 

 

9,409

 

 

 

7,143

 

Depreciation

 

 

898

 

 

 

240

 

(Accretion) of premiums on marketable securities

 

 

(3,511

)

 

 

(102

)

Non-cash lease (income) expense

 

 

(283

)

 

 

250

 

Other, net

 

 

 

 

 

(86

)

Change in operating assets and liabilities:

 

 

 

 

 

 

Prepaid expenses and other assets

 

 

2,707

 

 

 

(2,196

)

Operating lease right-of-use assets and liabilities

 

 

 

 

 

1,611

 

Accounts payable

 

 

(1,318

)

 

 

867

 

Accrued expenses

 

 

1,730

 

 

 

(2,191

)

Net cash used in operating activities

 

 

(43,572

)

 

 

(48,436

)

Cash flows from investing activities:

 

 

 

 

 

 

Purchases of property and equipment

 

 

(765

)

 

 

(6,346

)

Purchases of marketable securities

 

 

(187,147

)

 

 

(194,512

)

Maturities of marketable securities

 

 

139,955

 

 

 

176,267

 

Net cash used in investing activities

 

 

(47,957

)

 

 

(24,591

)

Cash flows from financing activities:

 

 

 

 

 

 

Issuance of common stock, net of issuance costs

 

 

35,121

 

 

 

 

Proceeds from the exercise of stock options

 

 

168

 

 

 

410

 

Net cash provided by financing activities

 

 

35,289

 

 

 

410

 

Net (decrease) increase in cash, cash equivalents and restricted cash

 

 

(56,240

)

 

 

(72,617

)

Cash, cash equivalents, and restricted cash

 

 

 

 

 

 

Cash, cash equivalents, and restricted cash - beginning of period

 

 

109,119

 

 

 

173,289

 

Cash, cash equivalents, and restricted cash - end of period

 

$

52,879

 

 

$

100,672

 

Supplemental disclosures of noncash investing activities

 

 

 

 

 

 

Accrued purchases of property and equipment

 

$

 

 

$

770

 

 

 

The accompanying notes are an integral part of these unaudited condensed financial statements.

5


 

PMV Pharmaceuticals, Inc.

Notes to Condensed 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 One Research Way, Princeton, New Jersey.

The Company is subject to risks and uncertainties common to early-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, 2023, the Company incurred a net loss of $16,640 and $53,204, respectively. For the nine months ended September 30, 2023, the Company used $43,572 of cash for operations. At September 30, 2023, the Company had an accumulated deficit of $294,247. Cash, cash equivalents, and marketable securities were $238,102 as of September 30, 2023. 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 financial statements.

2. Summary of Significant Accounting Policies

The Company’s significant accounting policies are disclosed in the audited financial statements for the year ended December 31, 2022, included in the Company’s Annual Report on Form 10-K filed with the United States Securities and Exchange Commission (the “SEC”) on March 1, 2023. Since the date of those financial statements, there have been no changes to its significant accounting policies.

Basis of Presentation

The accompanying unaudited condensed 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 balance sheet as of September 30, 2023, the condensed statements of operations and comprehensive loss and condensed statements of stockholders’ equity for the three and nine months ended September 30, 2023 and 2022, and the condensed statements of cash flows for the nine months ended September 30, 2023 and 2022, 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, 2023, or for any other subsequent interim period. The condensed balance sheet as of December 31, 2022, has been derived from our audited financial statements.

Use of Estimates

The preparation of 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 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 financial statements include, but

6


PMV Pharmaceuticals, Inc.

Notes to Condensed Financial Statements

(unaudited)

(in thousands, except share and per share amounts)

are not limited to, research and development costs, accrued research and development costs and related prepaid expenses and stock-based compensation. 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 three months ended September 30, 2023 and 2022, the Company recorded $1,840 and $228 of accretion, respectively. For the nine months ended September 30, 2023 and 2022, the Company recorded $3,511 and $102 of accretion, respectively.

Restricted cash as of September 30, 2023 and December 31, 2022 included a $822 deposit 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

The Company presents comprehensive loss in a single statement within its financial statements. Other comprehensive loss consists of unrealized gains and losses on marketable securities, net of tax.

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.

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 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

7


PMV Pharmaceuticals, Inc.

Notes to Condensed Financial Statements

(unaudited)

(in thousands, except share and per share amounts)

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, 2023, and December 31, 2022:

 

 

 

As of September 30, 2023

 

 

 

Carrying
Amount

 

 

Gross Unrealized Gains

 

 

Gross Unrealized Losses

 

 

Fair
Value

 

 

Quoted
priced in
active
markets
(Level 1)

 

 

Significant
other
observable
inputs
(Level 2)

 

 

Significant
unobservable
inputs
(Level 3)

 

Financial assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

51,803

 

 

$

 

 

$

 

 

$

51,803

 

 

$

51,803

 

 

$

 

 

$

 

Corporate securities

 

 

76,176

 

 

 

 

 

 

(107

)

 

 

76,069

 

 

 

2,931

 

 

 

73,138

 

 

 

 

Government securities

 

 

110,223

 

 

 

 

 

 

(247

)

 

 

109,976

 

 

 

89,023

 

 

 

20,953

 

 

 

 

Total financial assets

 

$

238,202

 

 

$

 

 

$

(354

)

 

$

237,848

 

 

$

143,757

 

 

$

94,091

 

 

$

 

 

 

 

 

As of December 31, 2022

 

 

 

Carrying
Amount

 

 

Gross Unrealized Gains

 

 

Gross Unrealized Losses

 

 

Fair
Value

 

 

Quoted
Priced in
Active
Markets
(Level 1)

 

 

Significant
Other
Observable
Inputs
(Level 2)

 

 

Significant
Unobservable
Inputs
(Level 3)

 

Financial assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

106,861

 

 

$

 

 

$

 

 

$

106,861

 

 

$

106,861

 

 

$

 

 

$

 

Corporate securities

 

 

103,755

 

 

 

21

 

 

 

(185

)

 

 

103,591

 

 

 

 

 

 

103,591

 

 

 

 

Government securities

 

 

31,942

 

 

 

 

 

 

(281

)

 

 

31,661

 

 

 

20,981

 

 

 

10,680

 

 

 

 

Total financial assets

 

$

242,558

 

 

$

21

 

 

$

(466

)

 

$

242,113

 

 

$

127,842

 

 

$

114,271

 

 

$

 

 

 

Cash Equivalents — As of September 30, 2023, the Company had cash of $254 and cash equivalents of $ 51,803 in money market funds. As of December 31, 2022, the Company had cash of $1,436 and cash equivalents of $106,861, consisting of money market funds. Money market funds and certificates of deposit are classified within level 1 of the fair value hierarchy because they are valued using quoted market prices in active markets, whereas corporate debt securities are classified within level 2 of the fair value hierarchy because they are valued using inputs other than quoted prices that are observable for the asset or liability either directly or indirectly.

Marketable Securities — Marketable securities of $186,045 as of September 30, 2023, consisted of corporate debt securities of $76,069 and government debt securities of $109,976. There were $149,861 current marketable securities and $36,184 noncurrent marketable securities as of September 30, 2023. Marketable securities of $135,252 as of December 31, 2022, consisted of corporate debt securities of $103,591 and government debt securities of $31,661. There were $132,757 current marketable securities and $2,495 noncurrent marketable securities as of December 31, 2022.

As of September 30, 2023, and December 31, 2022, aggregated gross unrealized losses of available-for-sale investments were not material, and accordingly, no allowance for credit losses was recorded.

 

8


PMV Pharmaceuticals, Inc.

Notes to Condensed Financial Statements

(unaudited)

(in thousands, except share and per share amounts)

4. Property and Equipment, Net

 

 

 

September 30,
2023

 

 

December 31,
2022

 

Machinery & equipment

 

 

2,886

 

 

$

2,448

 

Computers

 

 

13

 

 

 

13

 

Furniture & fixtures

 

 

69

 

 

 

69

 

Leasehold improvements

 

 

10,765

 

 

 

409

 

Assets not placed in service

 

 

 

 

 

10,200

 

Total property and equipment

 

 

13,733

 

 

 

13,139

 

Less: Accumulated depreciation

 

 

(2,911

)

 

 

(2,184

)

Property and equipment, net

 

$

10,822

 

 

$

10,955

 

 

 

 

Depreciation expense for the three months ended September 30, 2023 and 2022 was $358 and $74, respectively. Depreciation expense for the nine months ended September 30, 2023 and 2022 was $898 and $240, respectively.

 

During the nine months ended September 30, 2023, the Company disposed of $171 of fully depreciated fixed assets in conjunction with the move to One Research Way in Princeton, New Jersey (see Note 6). No gain or loss was recorded on these disposals.

5. Accrued Expenses

Accrued expenses consist of the following:

 

 

 

September 30,
2023

 

 

December 31,
2022

 

Accrued compensation

 

$

3,770

 

 

$

2,897

 

Accrued research and development costs

 

 

5,068

 

 

 

4,259

 

Accrued legal and professional services

 

 

200

 

 

 

152

 

Total

 

$

9,038

 

 

$

7,308

 

 

6. Commitments and Contingencies

Operating Leases

In June 2015, the Company executed a noncancelable operating lease for approximately 13,000 square feet of laboratory, research and development, and office space in Cranbury, New Jersey. This location operated as the Company's headquarters until March 2023.

In June 2017, the Company obtained an additional noncancelable operating lease for approximately 6,000 square feet of laboratory space in the same corporate center. As a result of the additional space, both leases were set to expire in June 2022. In January 2022, the Company signed a lease extension for both leases for up to one additional year through June 2023, with the option to terminate upon 120 days of written notice, with an increase in base rent as per the lease extension. The lease was terminated as of June 2023.

In August 2018, the Company executed two noncancelable operating leases. One lease for approximately 6,000 square 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 one additional year through July 2023, with the option to terminate upon 120 days of written notice, with an increase in base rent as per the lease extension. The second lease is for office space in Lexington, Massachusetts, that expired in August 2023.

In January 2021, the Company 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, has a five-year extension option, and replaced the Company’s two existing facilities as the Company’s headquarters in March 2023. Payment under this lease will total $19,889 through May 2032. The Company received a lease incentive of $4,046 from the lessor for a buildout of laboratory, vivarium, and office space, to be reimbursed to the Company in 2022 and 2023. 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

9


PMV Pharmaceuticals, Inc.

Notes to Condensed Financial Statements

(unaudited)

(in thousands, except share and per share amounts)

commencement. Since the inception date of the lease, $2,969 reimbursements were received. For the nine months ended September 30, 2023, no reimbursements were received.

The components of lease cost for the three and nine months ended September 30, 2023, and 2022, are as follows:

 

 

 

Three Months Ended September 30,

Nine Months Ended September 30,

 

(in thousands)

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Operating lease cost

 

$

366

 

 

$

578

 

 

$

1,559

 

 

$

1,619

 

Variable lease cost

 

 

161

 

 

 

247

 

 

 

792

 

 

 

643

 

Total lease cost

 

$

527

 

 

$

825

 

 

$

2,351

 

 

$

2,262

 

 

 

Amounts reported in the balance sheet for leases where the Company is the lessee as of September 30, 2023, and December 31, 2022, are as follows:

 

Operating Leases (in thousands, except lease term and discount rate data):

 

September 30,
2023

 

 

December 31,
2022

 

Right-of-use assets, operating leases

 

$

8,545

 

 

$

9,539

 

 

 

 

 

 

 

Operating lease liabilities, current

 

$

-

 

 

$

528

 

Operating lease liabilities, non-current

 

 

12,699

 

 

 

13,448

 

Total operating lease liabilities

 

$

12,699

 

 

$

13,976

 

 

 

 

 

 

 

Weighted-average remaining lease term (years)

 

 

8.67

 

 

 

9.08

 

Weighted-average discount rate

 

 

5.75

%

 

 

5.75

%

 

 

Other information related to leases for the nine months ended September 30, 2023 and 2022, respectively, as follows:

 

 

 

Nine Months Ended September 30,

 

(in thousands)

 

2023

 

 

2022

 

Net cash paid (received) for amounts included in the measurement of lease liabilities

 

$

1,842

 

 

$

(242

)

Leased assets obtained in exchange for new or modified operating lease liabilities

 

 

11

 

 

 

581

 

 

 

Future minimum lease payments, net of reimbursements, remaining as of September 30, 2023, under operating leases by fiscal year were as follows:

 

Fiscal year

 

(in thousands)

 

2023

 

$

(636

)

2024

 

 

1,814

 

2025

 

 

1,869

 

2026

 

 

1,925

 

2027

 

 

1,983

 

Thereafter

 

 

9,495

 

Total lease payments

 

$

16,450

 

Less: Present Value Adjustment

 

 

(3,751

)

Present value of lease payments

 

$

12,699

 

 

 

Rent expense recorded during the three months ended September 30, 2023 and 2022 was $366 and $578, respectively. Rent expense recorded during the nine months ended September 30, 2023 and 2022 was $1,559 and $1,619, respectively.

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.

10


PMV Pharmaceuticals, Inc.

Notes to Condensed Financial Statements

(unaudited)

(in thousands, except share and per share amounts)

7. Stockholders’ Equity

The Company is authorized to issue up to 1,000,000,000 shares of common stock with a par value of $0.00001 per share and 5,000,000 shares of preferred stock with a par value of $0.00001 per share. At September 30, 2023 and December 31, 2022, there were 51,157,636 and 45,771,332 shares 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, 2023, no dividends 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 $150.0 million from time to time. During the three months ended September 30, 2023, the Company sold 4,805,088 shares of common stock under the ATM Program at a weighted average price of $7.05 per share, for total proceeds of $33.1 million, net of fees. During the nine months ended September 30, 2023, the Company sold 5,149,446 shares of common stock under the ATM Program at a weighted average price of $6.97 per share, for total proceeds of $35.1 million, net of fees. As of September 30, 2023, the Company has approximately $113.8 million 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) 4,406,374 shares 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 2023, the board's compensation committee, as the 2020 Plan administrator, exercised its discretion under clause (iii) to increase the number of shares of common stock reserved for issuance under the 2020 Plan by a lesser amount of 1,830,853 shares, effective as of January 1, 2023. As of September 30, 2023, there were 4,457,004 shares available for issuance under the 2020 Plan.

On September 9, 2022, the Company granted 374,899 Restricted 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 years of 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 400,752 shares 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) 801,504 shares 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 2023, the 2020 ESPP reserved shares were increased under clause (iii) by 457,713 shares, effective as of January 1, 2023. As of September 30, 2023, 116,018 shares are issued or outstanding, and there were 685,446 shares available for issuance, under the 2020 ESPP.

11


PMV Pharmaceuticals, Inc.

Notes to Condensed Financial Statements

(unaudited)

(in thousands, except share and per share amounts)

Stock Options

The following table summarizes option activity for the nine-month period ended September 30, 2023:

 

 

 

 

 

 

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, 2022

 

 

4,618,292

 

 

 

5,278,771

 

 

$

10.40

 

 

 

6.82

 

 

$

17,244

 

Shares reserved for issuance

 

 

1,830,853

 

 

 

 

 

 

 

 

 

 

 

 

 

Options granted

 

 

(2,022,125

)

 

 

2,022,125

 

 

$

5.83

 

 

 

 

 

 

 

Options forfeited / cancelled

 

 

29,984

 

 

 

(29,984

)

 

$

15.22

 

 

 

 

 

 

 

Options exercised

 

 

 

 

 

(96,360

)

 

$

0.73

 

 

 

 

 

 

 

Balances at September 30, 2023

 

 

4,457,004

 

 

 

7,174,552

 

 

$

9.22

 

 

 

7.14

 

 

$

9,944

 

At September 30, 2023

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vested and expected to vest

 

 

 

 

 

7,174,552

 

 

$

9.22

 

 

 

7.14

 

 

$

9,944

 

Exercisable

 

 

 

 

 

4,055,276

 

 

$

8.33

 

 

 

5.72

 

 

$

8,898

 

 

 

At September 30, 2023, the total compensation cost related to nonvested awards not yet recognized was $23,991. The weighted-average period over which the nonvested awards is expected to be recognized was 2.6 years.

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,

 

 

 

2023

 

 

2022

 

Risk-free interest rate

 

 

3.45% - 4.18%

 

 

 

1.48% - 3.42%

 

Expected life (in years)

 

 

5.50 - 6.44

 

 

 

5.50 - 6.44

 

Dividend yield

 

 

0%

 

 

 

0%

 

Expected volatility

 

 

75.2% - 77.7%

 

 

 

77.00%-81.00%

 

 

 

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,

 

 

 

2023

 

 

2022

 

Risk-free interest rate

 

 

5.36%

 

 

 

1.57%

 

Expected life (in years)

 

 

0.49

 

 

 

0.49

 

Dividend yield

 

 

0%

 

 

 

0%

 

Expected volatility

 

 

76.50%

 

 

 

77.00%

 

 

 

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 zero in the valuation model.

Volatility: Volatility is based on the historical volatility of the Company's publicly traded shares for the expected term.

12


PMV Pharmaceuticals, Inc.

Notes to Condensed Financial Statements

(unaudited)

(in thousands, except share and per share amounts)

Restricted Stock Units

The following table presents RSU activity under the 2020 Plan as of September 30, 2023:

 

 

 

Number of
Stock Units

 

 

Weighted-Average
Grant Date Fair Value

 

Unvested shares at December 31, 2022

 

 

374,899

 

 

$

13.60

 

Granted

 

 

 

 

 

 

Vested

 

 

(120,385

)

 

$

13.60

 

Forfeited

 

 

(10,450

)

 

13.60

 

Unvested shares at September 30, 2023

 

 

244,064

 

 

$

13.60

 

 

 

As of September 30, 2023, there was $2,343 of 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 0.9 years.

Stock-based compensation expense recorded under ASC 718 related to stock options and RSU's 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,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Research and development

 

$

1,500

 

 

$

836

 

 

$

4,139

 

 

$

2,293

 

General and administrative

 

 

1,824

 

 

 

1,612

 

 

 

5,270

 

 

 

4,850

 

Total stock-based compensation

 

$

3,324

 

 

$

2,448

 

 

$

9,409

 

 

$

7,143

 

 

 

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,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Stock options

 

$

2,644

 

 

$

2,290

 

 

$

7,414

 

 

$

6,862

 

Restricted stock units

 

 

625

 

 

 

103

 

 

 

1,832

 

 

 

103

 

Employee stock purchase plan

 

 

55

 

 

 

55

 

 

 

163

 

 

 

178

 

Total stock-based compensation

 

$

3,324

 

 

$

2,448

 

 

$

9,409

 

 

$

7,143

 

 

9. Income Taxes

During the three and nine months ended September 30, 2023 and 2022, 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.

10. Net Loss per Share

The Company excluded all outstanding stock options and restricted stock awards at each period end from the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them

13


PMV Pharmaceuticals, Inc.

Notes to Condensed Financial Statements

(unaudited)

(in thousands, except share and per share amounts)

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,

 

 

 

2023

 

 

2022

 

Options to purchase common stock

 

 

7,174,552

 

 

 

5,285,786

 

Unvested RSUs

 

 

244,064

 

 

 

374,899

 

Expected shares to be purchased under 2020 ESPP

 

 

74,100

 

 

 

49,362

 

Total

 

 

7,492,716

 

 

 

5,710,047

 

 

11. Related Parties

The Company has consulting agreements with two members of its board of directors; one of which waived his consulting fees starting as of September 2021. Total consulting fees paid during the three months ended September 30, 2023 and 2022 were $25.0 and $19.7, respectively. Total consulting fees paid during the nine months ended September 30, 2023 and 2022 were $66.7 and $78.0, respectively. There were no amounts owed under the consulting agreements as of September 30, 2023.

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 financial statements and the related notes and other financial information included in this Quarterly Report on Form 10-Q and our audited financial statements and notes thereto as of and for the years ended December 31, 2022 and 2021 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, 2022 filed with the Securities and Exchange Commission, or the SEC, on March 1, 2023. 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, 2022, 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 the top ten most frequent, or hotspot, p53 mutations that are collectively associated with approximately 10-15% of all cancers. In addition, we are expanding the utilization of our platform to target 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. Our net losses were $73.3 million and $57.8 million for the years ended December 31, 2022 and 2021, respectively. During the three and nine months ended September 30, 2023, the Company incurred net losses of $16.6 million and $53.2 million, respectively. As of September 30, 2023, we had an accumulated deficit of $294.2 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 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. We dosed our first patient in this clinical trial in the fourth quarter of 2020. In July 2023, we concluded our End-of-Phase 1 FDA meeting 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 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.

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.

15


 

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.

As we are at a very early stage of development, 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. 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. We dosed our first patient in this clinical trial in the fourth quarter of 2020. 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 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, early 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.

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 have incurred additional expenses as a public company, including expenses related to compliance with the rules and regulations of the SEC, and those of any national securities exchange on which our securities are traded, additional insurance expenses, investor relations activities and other administrative and professional services. We have increased our headcount significantly to support our operations as a public company. 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 short-term marketable securities and interest costs related to amortization of premiums and discounts on short-term marketable securities.

16


 

Results of Operations

Comparison of the Three Months ended September 30, 2023 and 2022.

The following table summarizes our results of operations (in thousands):

 

 

 

Three Months Ended
September 30,

 

 

 

 

Statement of operations data:

 

2023
(Unaudited)

 

 

2022
(Unaudited)

 

 

Change

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

$

13,586

 

 

$

13,666

 

 

$

(80

)

General and administrative

 

 

6,042

 

 

 

5,709

 

 

 

333

 

 

 

 

 

 

 

 

 

 

Total operating expenses

 

 

19,628

 

 

 

19,375

 

 

 

253

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

 

(19,628

)

 

 

(19,375

)

 

 

(253

)

Other income (expense):

 

 

 

 

 

 

 

 

 

Interest income, net

 

 

2,984

 

 

 

1,124

 

 

 

1,860

 

Other income (expense), net

 

 

4

 

 

 

13

 

 

 

(9

)

 

 

 

 

 

 

 

 

 

Total other income (expense)

 

 

2,988

 

 

 

1,137

 

 

 

1,851

 

 

 

 

 

 

 

 

 

 

Loss before provision (benefit) for income taxes

 

 

(16,640

)

 

 

(18,238

)

 

 

1,598

 

Provision (benefit) for income taxes

 

 

 

 

 

(9

)

 

 

9

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(16,640

)

 

$

(18,229

)

 

$

1,589

 

 

Research and Development Expenses

The following table summarizes our research and development expenses incurred during the periods indicated (in thousands):

 

 

 

Three Months Ended
September 30,

 

 

 

 

Statement of operations data:

 

2023
(Unaudited)

 

 

2022
(Unaudited)

 

 

Change

 

Research

 

$

1,920

 

 

$

1,366

 

 

$

554

 

Development

 

 

6,785

 

 

 

9,148

 

 

 

(2,363

)

Personnel related

 

 

3,381

 

 

 

2,316

 

 

 

1,065

 

Stock-based compensation

 

 

1,500

 

 

 

836

 

 

 

664

 

Total

 

$

13,586

 

 

$

13,666

 

 

$

(80

)

 

 

Research and development expenses were $13.6 million for the three months ended September 30, 2023, compared to $13.7 million for the three months ended September 30, 2022. The decrease of $0.1 million, compared to the three months ended September 30, 2022, was primarily due to the following:

$2.3 million decrease in development expenses due to lower clinical and chemistry, manufacturing, and control (CMC) expenses as PC14586, our lead product candidate, was nearing completion of Phase 1; offset by
$1.7 million increase in expenses for personnel related costs and stock-based compensation primarily driven by increased headcount; and
$0.5 million increase in research expenses, largely driven by increased contractual research organization costs and lab facilities costs.

17


 

General and Administrative Expenses

General and administrative expenses were $6.0 million for the three months ended September 30, 2023, compared to $5.7 million for the three months ended September 30, 2022. The increase of $0.3 million, compared to the three months ended September 30, 2022, was primarily due to following:

$0.6 million increase in finance and legal expenses, offset by a $0.3 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 amortization of premiums and discounts on marketable securities. Interest income, net was $3.0 million for the three months ended September 30, 2023. The increase of $1.9 million compared to the three months ended September 30, 2022, is driven by increased interest rates from cash and investments in marketable securities and U.S treasuries during the three months ended September 30, 2023.

Comparison of the Nine Months ended September 30, 2023 and 2022.

The following table summarizes our results of operations (in thousands):

 

 

 

Nine Months Ended
September 30,

 

 

 

 

Statement of operations data:

 

2023
(Unaudited)

 

 

2022
(Unaudited)

 

 

Change

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

$

42,503

 

 

$

36,963

 

 

$

5,540

 

General and administrative

 

 

18,727

 

 

 

18,915

 

 

 

(188

)

 

 

 

 

 

 

 

 

 

Total operating expenses

 

 

61,230

 

 

 

55,878

 

 

 

5,352

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

 

(61,230

)

 

 

(55,878

)

 

 

(5,352

)

Other income (expense):

 

 

 

 

 

 

 

 

 

Interest income, net

 

 

8,005

 

 

 

1,830

 

 

 

6,175

 

Other income (expense), net

 

 

24

 

 

 

67

 

 

 

(43

)

 

 

 

 

 

 

 

 

 

Total other income

 

 

8,029

 

 

 

1,897

 

 

 

6,132

 

 

 

 

 

 

 

 

 

 

Loss before provision (benefit) for income taxes

 

 

(53,201

)

 

 

(53,981

)

 

 

780

 

Provision (benefit) for income taxes

 

 

3

 

 

 

(9

)

 

 

12

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(53,204

)

 

$

(53,972

)

 

$

768

 

Research and Development Expenses

The following table summarizes our research and development expenses incurred during the periods indicated (in thousands):

 

 

 

Nine Months Ended
September 30,

 

 

 

 

Statement of operations data:

 

2023
(Unaudited)

 

 

2022
(Unaudited)

 

 

Change

 

Research

 

$

5,366

 

 

$

5,771

 

 

$

(405

)

Development

 

 

23,074

 

 

 

21,868

 

 

 

1,206

 

Personnel related

 

 

9,924

 

 

 

7,031

 

 

 

2,893

 

Stock-based compensation

 

 

4,139

 

 

 

2,293

 

 

 

1,846

 

Total

 

$

42,503

 

 

$

36,963

 

 

$

5,540

 

 

 

18


 

Research and development expenses were $42.5 million for the nine months ended September 30, 2023, compared to $37.0 million for the nine months ended September 30, 2022. The increase of $5.5 million, compared to the nine months ended September 30, 2022, was primarily due to the following:

$1.2 million increase in development expenses associated with advancing our lead product candidate, PC14586, through the Phase 1/2 clinical trial; and
$4.7 million increase in expenses for personnel related costs and stock-based compensation, primarily driven by increased headcount; offset by
$0.4 million decrease in research expenses, largely driven by decreased contractual research organization costs.

General and Administrative Expenses

General and administrative expenses were $18.7 million for the nine months ended September 30, 2023, compared to $18.9 million for the nine months ended September 30, 2022. The decrease of $0.2 million, compared to the nine months ended September 30, 2022, was primarily due to following:

$0.7 million decrease in director and officer insurance fees and a $0.1 million decrease in facility related costs due to the expiration of three leases; offset by
$0.3 million increase in personnel costs driven by an increase in stock compensation and a $0.3 million increase in general and administrative consulting costs.

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 amortization of premiums and discounts on marketable securities. Interest income, net was $8.0 million for the nine months ended September 30, 2023. The increase of $6.2 million compared to the nine months ended September 30, 2022, is driven by increased interest rates from cash and investments in marketable securities and U.S treasuries during the nine months ended September 30, 2023.

Liquidity and Capital Resources

Our financial condition is summarized as follows:

 

 

 

As of September 30,

 

 

As of December 31,

 

 

 

 

 

 

2023

 

 

2022

 

 

Change

 

Financial assets:

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

52,057

 

 

$

108,297

 

 

$

(56,240

)

Marketable securities - current

 

 

149,861

 

 

 

132,757

 

 

 

17,104

 

Marketable securities - noncurrent

 

 

36,184

 

 

 

2,495

 

 

 

33,689

 

Total financial assets

 

$

238,102

 

 

$

243,549

 

 

$

(5,447

)

 

 

 

 

 

 

 

 

 

Working capital:

 

 

 

 

 

 

 

 

 

Current assets

 

$

205,296

 

 

$

247,006

 

 

$

(41,710

)

Current liabilities

 

 

10,716

 

 

 

10,832

 

 

 

(116

)

Total working capital

 

$

194,580

 

 

$

236,174

 

 

$

(41,594

)

 

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, 2023, we had cash, cash equivalents, and marketable securities of $238.1 million and an accumulated deficit of $294.2 million. In September 2020, we completed an IPO of 13,529,750 shares of our common stock, which includes the exercise in full by the underwriters of their option to purchase 1,764,750 additional shares of common stock, at a public offering price of $18.00 per share for aggregate gross proceeds of $243.5 million. We received $223.2 million in net proceeds after deducting underwriting discounts and commissions and other offering expenses payable by us.

19


 

We have a shelf registration statement on Form S-3 on file with the SEC, which registers 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 our at-the-market equity offering program, dated October 4, 2021, or the ATM Program. During the nine months ended September 30, 2023, we sold 5,149,446 shares of common stock under the ATM Program at a weighted average price of $6.97 per share for $35.1 million in proceeds, net of fees. As of September 30, 2023, 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, has a five-year extension option, and is replaced our two prior facilities. Amounts related to future lease payments as of September 30, 2023, totaled $17.5 million, with $0.7 million, net $1.1 million of cash reimbursements, to be paid within the next 12 months.

Plan of Operation and Future Funding Requirements

We use our capital resources primarily to fund operating expenses, mainly research and development expenditures. We plan to increase our research and development expenses for the foreseeable future as we continue the preclinical and clinical development of our product candidates. At this time, due to the inherently unpredictable nature of preclinical and clinical development and given the early stage of our product candidates, 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 $294.2 million through September 30, 2023. 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, 2023 and 2022, our cash operating expenditures were $43.6 million and $48.4 million, respectively. We expect to increase our investment in operations in the remainder of 2023 and 2024. Based on our research and development plans, we expect that our cash, cash equivalents and marketable securities as of September 30, 2023 will be sufficient to fund our operations at least through 2025.

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; and
our efforts to build out our new office and laboratory headquarters, enhance operational systems and hire additional personnel, including 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

20


 

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.

Cash Flows

The following table summarizes our cash flows for the period indicated (in thousands):

 

 

 

Nine Months Ended
September 30,

 

 

 

2023
(Unaudited)

 

 

2022
(Unaudited)

 

Cash used in operating activities

 

$

(43,572

)

 

$

(48,436

)

Cash used in investing activities

 

 

(47,957

)

 

 

(24,591

)

Cash provided by financing activities

 

 

35,289

 

 

 

410

 

 

 

 

 

 

 

Net (decrease) increase in cash and cash equivalents

 

$

(56,240

)

 

$

(72,617

)

 

Operating Activities

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.

Net cash used in operating activities for the nine months ended September 30, 2022, was $48.4 million, which consisted primarily of net loss of $54.0 million partially offset by non-cash charges of $7.4 million. Changes in our net operating assets decreased operating cash by $1.9 million. The non-cash charges primarily consisted of stock-based compensation of $7.1 million, and non-cash lease expense 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, a decrease in accrued expenses, an increase in outstanding payables, and an increase in operating lease right of use assets and liabilities driven by a cash reimbursement of $1.6 million for the buildout of the new office building in Princeton, New Jersey.

Investing Activities

Our investing activities used $48.0 million of cash during the nine months ended September 30, 2023, which consisted primarily of purchases of marketable securities of $187.1 million, along with purchase of property and equipment of $0.8 million, partially offset by maturities of marketable securities of $140.0 million.

Our investing activities used $24.6 million of cash during the nine months ended September 30, 2022, which consisted primarily of purchases of marketable securities of $194.5 million, along with purchase of property and equipment of $6.4 million partially offset by maturities of marketable securities of $176.3 million.

Financing Activities

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 our 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.

Our financing activities provided $0.4 million of cash during the nine months ended September 30, 2022, which consisted primarily of proceeds from the exercise of stock options and issuance of common stock under the 2020 ESPP.

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Critical Accounting Policies and Significant Judgments and Estimates

The preparation of our 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 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.

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, 2023, there were no material changes to our critical accounting policies from those described in our audited financial statements for the year ended December 31, 2022, included in our Annual Report on Form 10-K filed with the SEC on March 1, 2023, 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 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 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.

Stock-Based Compensation

We measure all stock options and other stock-based awards granted to our employees, directors, consultants, and other non-employee service providers based on the fair value on the date of the grant. Compensation expense related to awards to employees and directors with service-based vesting conditions is recognized on a straight-line basis based on the grant date fair value over the associated service period of the award, which is typically the vesting term.

We classify stock-based compensation expense in our statement of operations in the same way the award recipient’s payroll costs are classified or in which the award recipients’ service payments are classified.

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We use the Black-Scholes option pricing model to estimate the fair value of stock options on the date of grant. Using the Black-Scholes option pricing model requires management to make significant assumptions and judgments. We determined these assumptions for the Black-Scholes option-pricing model.

Expected volatility was derived from the average historical stock volatility of our common stock over a period equivalent to the expected term of the stock-based awards if data was available, and over the longest period for which trading activity is available if data matching the expected term was unavailable.

Recent Accounting Pronouncements

For a description of recent accounting pronouncements, see Note 2 of the notes to our unaudited condensed financial statements for the nine months ended September 30, 2023 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 $238.1 million and restricted cash of $0.8 million as of September 30, 2023. 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 short-term marketable securities.

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. Controls and 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, 2023.

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.

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PART II—OTHER INFORMATION

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, 2022, as filed with the SEC on March 1, 2023, as supplemented by our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023. 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, 2022, as filed with the SEC on March 1, 2023, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, as filed with the SEC on May 10, 2023, and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, as filed with the SEC on August 9, 2023.

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.

We have a shelf registration statement on Form S-3 (File No. 333-260012), which was declared effective by the SEC on April 28, 2022. The shelf registration statement consists 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. During the three months ended September 30, 2023, we sold 4,805,088 shares of common stock under the ATM Program at a weighted average price of $7.05 per share, for total proceeds of $33.1 million, net of fees. During the nine months ended September 30, 2023, we sold 5,149,446 shares of common stock under the ATM Program at a weighted average price of $6.97 per share, for total proceeds of $35.1 million, net of fees. As of September 30, 2023, 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 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 Upon Senior Securities.

None.

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Item 4. Mine Safety Disclosures.

Not applicable.

Item 5. Other Information.

Not applicable.

25


 

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

 

Amended and Restated Bylaws of the Registrant

10-Q

001-39539

3.2

May 10, 2023

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

 

 

 

101.CAL

 

Inline XBRL Taxonomy Extension Calculation Linkbase Document

 

 

 

 

 

 

 

 

 

 

 

101.DEF

 

Inline XBRL Taxonomy Extension Definition Linkbase Document

 

 

 

 

 

 

 

 

 

 

 

101.LAB

 

Inline XBRL Taxonomy Extension Label Linkbase Document

 

 

 

 

 

 

 

 

 

 

 

101.PRE

 

Inline XBRL Taxonomy Extension Presentation Linkbase 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.

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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 9, 2023

By:

/s/ David H. Mack

David H. Mack, Ph.D.

President, Chief Executive Officer, and Director

 

 

 

(Principal Executive Officer)

 

 

 

 

 

 

PMV Pharmaceuticals, Inc.

 

Date: November 9, 2023

By:

/s/ Winston Kung

Winston Kung

Chief Operating Officer and

Chief Financial Officer

 

 

 

(Principal Financial Officer)

 

27