10-Q 1 pmvp-20220930.htm 10-Q 10-Q
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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, 2022

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 8, 2022, the registrant had 45,665,428 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)

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

22

Item 4.

Controls and Procedures

22

PART II.

OTHER INFORMATION

23

Item 1.

Legal Proceedings

23

Item 1A.

Risk Factors

23

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

23

Item 3.

Defaults Upon Senior Securities

23

Item 4.

Mine Safety Disclosures

23

Item 5.

Other Information

23

Item 6.

Exhibits

24

Signatures

25

 

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 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 coronavirus disease 2019, or COVID-19, pandemic, or other potential global disruptions on our business, such as the recent conflict between Russia and Ukraine and the trade sanctions imposed in response thereto

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, 2021, 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,
2022
(unaudited)

 

 

December 31,
2021

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

99,850

 

 

$

172,467

 

Restricted cash

 

 

822

 

 

 

822

 

Marketable securities, current

 

 

159,007

 

 

 

124,696

 

Prepaid expenses and other current assets

 

 

5,497

 

 

 

3,301

 

Total current assets

 

 

265,176

 

 

 

301,286

 

Property and equipment, net

 

 

9,966

 

 

 

3,090

 

Marketable securities, noncurrent

 

 

 

 

 

16,911

 

Right-of-use assets

 

 

9,535

 

 

 

10,060

 

Other assets

 

 

307

 

 

 

221

 

Total assets

 

$

284,984

 

 

$

331,568

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

4,826

 

 

$

3,189

 

Accrued expenses

 

 

6,436

 

 

 

8,627

 

Operating lease liabilities, current

 

 

394

 

 

 

403

 

Total current liabilities

 

 

11,656

 

 

 

12,219

 

Operating lease liabilities, noncurrent

 

 

12,135

 

 

 

10,790

 

Total liabilities

 

 

23,791

 

 

 

23,009

 

Stockholders’ equity:

 

 

 

 

 

 

Preferred stock, $0.00001 par value, 5,000,000 shares authorized at September 30, 2022 and December 31, 2021. No shares issued or outstanding at September, 2022 and December 31, 2021.

 

 

 

 

 

 

Common stock, $0.00001 par value, 1,000,000,000 shares authorized; 45,624,860 and 45,433,684 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively.

 

 

 

 

 

 

Additional paid-in capital

 

 

483,916

 

 

 

476,363

 

Accumulated deficit

 

 

(221,698

)

 

 

(167,726

)

Accumulated other comprehensive loss

 

 

(1,025

)

 

 

(78

)

Total stockholders’ equity

 

 

261,193

 

 

 

308,559

 

Total liabilities and stockholders’ equity

 

$

284,984

 

 

$

331,568

 

 

 

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,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

13,666

 

 

$

9,162

 

 

$

36,963

 

 

$

24,326

 

General and administrative

 

 

5,709

 

 

 

5,935

 

 

 

18,915

 

 

 

15,495

 

Total operating expenses

 

 

19,375

 

 

 

15,097

 

 

 

55,878

 

 

 

39,821

 

Loss from operations

 

 

(19,375

)

 

 

(15,097

)

 

 

(55,878

)

 

 

(39,821

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Interest income, net

 

 

1,124

 

 

 

102

 

 

 

1,830

 

 

 

343

 

Other income (expense), net

 

 

13

 

 

 

3

 

 

 

67

 

 

 

14

 

Total other income (expense)

 

 

1,137

 

 

 

105

 

 

 

1,897

 

 

 

357

 

Loss before (benefit) provision for income taxes

 

 

(18,238

)

 

 

(14,992

)

 

 

(53,981

)

 

 

(39,464

)

(Benefit) provision for income taxes

 

 

(9

)

 

 

19

 

 

 

(9

)

 

 

23

 

Net loss

 

 

(18,229

)

 

 

(15,011

)

 

 

(53,972

)

 

 

(39,487

)

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

 

 

(2

)

 

 

7

 

 

 

(947

)

 

 

14

 

Comprehensive loss

 

$

(18,231

)

 

$

(15,004

)

 

$

(54,919

)

 

$

(39,473

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share -- basic and diluted

 

$

(0.40

)

 

$

(0.33

)

 

$

(1.18

)

 

$

(0.88

)

Weighted-average common shares outstanding

 

 

45,622,957

 

 

 

45,295,232

 

 

 

45,556,635

 

 

 

45,052,100

 

 

 

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, 2020

 

 

 

44,777,818

 

 

$

 

 

$

469,001

 

 

$

 

 

$

(109,880

)

 

$

359,121

 

Exercise of stock options

 

 

 

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

 

 

 

138,640

 

 

 

 

 

 

309

 

 

 

 

 

 

 

 

 

309

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

1,796

 

 

 

 

 

 

 

 

 

1,796

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(15,011

)

 

 

(15,011

)

Unrealized gain on available for sale investments

 

 

 

 

 

 

 

 

 

 

 

 

7

 

 

 

 

 

 

7

 

Balance at September 30, 2021

 

 

 

45,352,207

 

 

$

 

 

$

474,301

 

 

$

14

 

 

$

(149,367

)

 

$

324,948

 

 

 

 

 

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 and common stock issued under the 2020 ESPP

 

 

 

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

 

 

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,

 

 

 

2022

 

 

2021

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(53,972

)

 

$

(39,487

)

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

 

 

 

 

 

 

Stock-based compensation expense

 

 

7,143

 

 

 

3,573

 

Depreciation

 

 

240

 

 

 

230

 

Amortization (accretion) of premiums on marketable securities

 

 

(102

)

 

 

459

 

Non-cash lease expense

 

 

250

 

 

 

644

 

Other, net

 

 

(86

)

 

 

(17

)

Change in operating assets and liabilities:

 

 

 

 

 

 

Prepaid expenses and other assets

 

 

(2,196

)

 

 

(1,743

)

Operating lease right-of-use assets and liabilities

 

 

1,611

 

 

 

 

Accounts payable

 

 

867

 

 

 

(385

)

Accrued expenses

 

 

(2,191

)

 

 

2,183

 

Net cash used in operating activities

 

 

(48,436

)

 

 

(34,543

)

Cash flows from investing activities:

 

 

 

 

 

 

Purchases of property and equipment

 

 

(6,346

)

 

 

(1,087

)

Purchases of marketable securities

 

 

(194,512

)

 

 

(235,167

)

Maturities of marketable securities

 

 

176,267

 

 

 

85,111

 

Net cash used in investing activities

 

 

(24,591

)