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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, 2021

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.)

8 Clarke Drive, Suite 3

Cranbury, NJ

08512

(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 10, 2021, the registrant had 45,380,354 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 Convertible Preferred Stock and Stockholders’ (Deficit) Equity (Unaudited)

3

 

Condensed Statements of Cash Flows (Unaudited)

4

 

Notes to Unaudited Condensed Financial Statements

5

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

14

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

21

Item 4.

Controls and Procedures

21

PART II.

OTHER INFORMATION

22

Item 1.

Legal Proceedings

22

Item 1A.

Risk Factors

22

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

24

Item 3.

Defaults Upon Senior Securities

24

Item 4.

Mine Safety Disclosures

24

Item 5.

Other Information

25

Item 6.

Exhibits

25

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 Form10-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 application (“IND”) and other regulatory submissions;

 

the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates;

 

our estimates of the number of patients expected to have certain p53 mutants 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 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;

 

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;

 

our plan 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;

ii


 

the impact of the ongoing COVID-19 pandemic; including the impact from quarantines, shelter-in-place, executive and similar government orders, on the conduct of business operations or the availability or cost of materials; or

 

our expectations regarding the period during which we will qualify as an emerging growth company under the Jumpstart Our Business Startups Act of 2012, as amended.

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, 2020 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,

2021

(unaudited)

 

 

December 31,

2020

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

176,641

 

 

$

361,422

 

Restricted cash

 

 

822

 

 

 

 

Marketable securities, current

 

 

131,010

 

 

 

 

Prepaid expenses and other current assets

 

 

5,082

 

 

 

3,339

 

Total current assets

 

 

313,555

 

 

 

364,761

 

Property and equipment, net

 

 

1,394

 

 

 

569

 

Marketable securities, noncurrent

 

 

18,601

 

 

 

 

Right-of-use assets, operating leases

 

 

10,410

 

 

 

 

Other assets

 

 

218

 

 

 

201

 

Total assets

 

$

344,178

 

 

$

365,531

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

1,278

 

 

$

1,607

 

Accrued expenses

 

 

6,740

 

 

 

4,803

 

Operating lease liability, current

 

 

545

 

 

 

 

Total current liabilities

 

 

8,563

 

 

 

6,410

 

Operating lease liability, noncurrent

 

 

10,667

 

 

 

 

Total liabilities

 

 

19,230

 

 

 

6,410

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Preferred stock, $0.00001 par value, 5,000,000 shares authorized at September 30, 2021 (unaudited) and December 31, 2020.  No shares issued or outstanding at September 30, 2021 (unaudited) and December 31, 2020.

 

 

 

 

 

 

Common stock, $0.00001 par value, 1,000,000,000 shares authorized; 45,352,207 and 44,777,818 shares issued and outstanding at September 30, 2021 (unaudited) and December 31, 2020, respectively.

 

 

 

 

 

 

Additional paid-in capital

 

 

474,301

 

 

 

469,001

 

Accumulated deficit

 

 

(149,367

)

 

 

(109,880

)

Accumulated other comprehensive income

 

 

14

 

 

 

 

Total stockholders’ equity

 

 

324,948

 

 

 

359,121

 

Total liabilities and stockholders’ equity

 

$

344,178

 

 

$

365,531

 

 

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,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

9,162

 

 

$

5,992

 

 

$

24,326

 

 

$

17,752

 

General and administrative

 

 

5,935

 

 

 

2,709

 

 

 

15,495

 

 

 

6,689

 

Total operating expenses

 

 

15,097

 

 

 

8,701

 

 

 

39,821

 

 

 

24,441

 

Loss from operations

 

 

(15,097

)

 

 

(8,701

)

 

 

(39,821

)

 

 

(24,441

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income, net

 

 

102

 

 

 

40

 

 

 

343

 

 

 

603

 

Other income (expense)

 

 

3

 

 

 

(100

)

 

 

14

 

 

 

(143

)

Total other income (expense)

 

 

105

 

 

 

(60

)

 

 

357

 

 

 

460

 

Loss before provision for income taxes

 

 

(14,992

)

 

 

(8,761

)

 

 

(39,464

)

 

 

(23,981

)

Provision for income taxes

 

 

19

 

 

 

3

 

 

 

23

 

 

 

5

 

Net loss

 

 

(15,011

)

 

 

(8,764

)

 

 

(39,487

)

 

 

(23,986

)

Unrealized gains (loss) on marketable securities, net of tax

 

 

7

 

 

 

(5

)

 

 

14

 

 

 

3

 

Comprehensive loss

 

$

(15,004

)

 

$

(8,769

)

 

$

(39,473

)

 

$

(23,983

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share -- basic and diluted

 

$

(0.33

)

 

$

(1.46

)

 

$

(0.88

)

 

$

(5.93

)

Weighted-average common shares outstanding

 

 

45,295,232

 

 

 

6,022,457

 

 

 

45,052,100

 

 

 

4,045,527

 

 

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

 

 

 

2


 

PMV Pharmaceuticals, Inc.

Condensed Statements of Convertible Preferred Stock and Stockholders’ (Deficit) Equity

(unaudited)

(in thousands, except share amounts)

 

 

 

Convertible

Preferred Stock

 

 

 

Common Stock

 

 

Additional

Paid-in

 

 

Accumulated

Other

Comprehensive

 

 

Accumulated

 

 

Total

Stockholders'

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

(Loss) Income

 

 

Deficit

 

 

Equity

 

Balance at December 31, 2019

 

 

22,866,246

 

 

$

168,933

 

 

 

 

3,046,200

 

 

$

 

 

$

4,969

 

 

$

(3

)

 

$

(75,440

)

 

$

(70,474

)

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

296

 

 

 

 

 

 

 

 

 

296

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(7,255

)

 

 

(7,255

)

Unrealized loss on available for sale investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(80

)

 

 

 

 

 

(80

)

Balance at March 31, 2020

 

 

22,866,246

 

 

$

168,933

 

 

 

 

3,046,200

 

 

$

 

 

$

5,265

 

 

$

(83

)

 

$

(82,695

)

 

$

(77,513

)

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

383

 

 

 

 

 

 

 

 

 

383

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(7,967

)

 

 

(7,967

)

Unrealized gain on available for sale investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

88

 

 

 

 

 

 

88

 

Balance at June 30, 2020

 

 

22,866,246

 

 

$

168,933

 

 

 

 

3,046,200

 

 

$

 

 

$

5,648

 

 

$

5

 

 

$

(90,662

)

 

$

(85,009

)

Issuance of Series D convertible preferred stock,

   net of issuance costs of $210

 

 

5,321,864

 

 

 

69,790

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conversion of convertible preferred stock to common stock

 

 

(28,188,110

)

 

 

(238,723

)

 

 

 

28,188,110

 

 

 

 

 

 

238,723

 

 

 

 

 

 

 

 

 

238,723

 

Exercise of warrants

 

 

 

 

 

 

 

 

 

9,688

 

 

 

 

 

 

194

 

 

 

 

 

 

 

 

 

194

 

Issuance of common stock, net of issuance costs of $20,374

 

 

 

 

 

 

 

 

 

13,529,750

 

 

 

 

 

 

223,161

 

 

 

 

 

 

 

 

 

223,161

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

670

 

 

 

 

 

 

 

 

 

670

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(8,764

)

 

 

(8,764

)

Unrealized loss on available for sale investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(5

)

 

 

 

 

 

(5

)

Balance at September 30, 2020

 

 

 

 

$

 

 

 

 

44,773,748

 

 

$

 

 

$

468,396

 

 

$

 

 

$

(99,426

)

 

$

368,970

 

 

 

 

Convertible

Preferred Stock

 

 

 

Common Stock

 

 

Additional

Paid-in

 

 

Accumulated

Other

Comprehensive

 

 

Accumulated

 

 

Total

Stockholders'

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

(Loss) Income

 

 

Deficit

 

 

Equity

 

Balance at December 31, 2020

 

 

 

 

$

 

 

 

 

44,777,818

 

 

$

 

 

$

469,001

 

 

$

 

 

$

(109,880

)

 

$

359,121

 

Exercise of stock options and common stock issued under the

   2020 ESPP

 

 

 

 

 

 

 

 

 

103,351

 

 

 

 

 

 

162

 

 

 

 

 

 

 

 

 

162

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

627

 

 

 

 

 

 

 

 

 

627

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(11,602

)

 

 

(11,602

)

Unrealized loss on available for sale investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(13

)

 

 

 

 

 

(13

)

Balance at March 31, 2021

 

 

 

 

$

 

 

 

 

44,881,169

 

 

$

 

 

$

469,790

 

 

$

(13

)

 

$

(121,482

)

 

$

348,295

 

Exercise of stock options and common stock issued under the

   2020 ESPP

 

 

 

 

 

 

 

 

 

332,398

 

 

 

 

 

 

1,256

 

 

 

 

 

 

 

 

 

1,256

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,150

 

 

 

 

 

 

 

 

 

1,150

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(12,874

)

 

 

(12,874

)

Unrealized gain on available for sale investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

20

 

 

 

 

 

 

20

 

Balance at June 30, 2021

 

 

 

 

$

 

 

 

 

45,213,567

 

 

$

 

 

$

472,196

 

 

$

7

 

 

$

(134,356

)

 

$

337,847

 

Exercise of stock options and common stock issued under the

   2020 ESPP

 

 

 

 

 

 

 

 

 

138,640

 

 

 

 

 

 

309

 

 

 

 

 

 

 

 

 

309

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,796

 

 

 

 

 

 

 

 

 

1,796

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(15,011

)

 

 

(15,011

)

Unrealized loss on available for sale investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

7

 

 

 

 

 

 

7

 

Balance at September 30, 2021

 

 

 

 

$

 

 

 

 

45,352,207

 

 

$

 

 

$

474,301

 

 

$

14

 

 

$

(149,367

)

 

$

324,948

 

 

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

 

3


 

PMV Pharmaceuticals, Inc.

Condensed Statements of Cash Flows

(unaudited)

(in thousands)

 

 

 

Nine Months Ended September 30,

 

 

 

2021

 

 

2020

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(39,487

)

 

$

(23,986

)

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

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

3,573

 

 

 

1,349

 

Depreciation

 

 

230

 

 

 

257

 

Amortization of premiums on marketable securities

 

 

459

 

 

 

152

 

Non-cash lease expense

 

 

644

 

 

 

 

Other

 

 

(17

)

 

 

144

 

Change in operating assets and liabilities:

 

 

 

 

 

 

 

 

Prepaid expenses and other assets

 

 

(1,743

)

 

 

85

 

Accounts payable

 

 

(385

)

 

 

(2,825