10-Q 1 verv-20240930.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, 2024

OR

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ____________ to ____________

Commission File Number: 001-40489

 

VERVE THERAPEUTICS, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

82-4800132

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer
Identification No.)

 

 

201 Brookline Avenue, Suite 601

Boston, Massachusetts

02215

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (617) 603-0070

 

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 $0.001 per share

 

VERV

 

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, a 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

As of October 29, 2024, the registrant had 84,663,840 shares of common stock, par value $0.001 per share, outstanding.

 

 

 


 

FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q includes forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this Quarterly Report on Form 10-Q, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” or the negative of these words or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

The forward-looking statements in this Quarterly Report on Form 10-Q include, among other things, statements about:

the timing, progress, design and conduct of our Heart-2 clinical trial, a Phase 1b clinical trial of VERVE-102, and our Pulse-1 clinical trial, a Phase 1b clinical trial of VERVE-201, including statements regarding the timing of enrollment and the period during which data from such clinical trials is expected to become available, and our Heart-1 clinical trial, a Phase 1b clinical trial of VERVE-101, including statements regarding next steps for such trial;
our estimates regarding expenses, future revenue, capital requirements, need for additional financing and the period over which we believe our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements;
the timing of and our ability to submit applications for and obtain and maintain regulatory approvals for our current and future product candidates;
the potential therapeutic attributes and advantages of our current and future product candidates;
our expectations about the translatability of results from studies in animals into clinical trials in humans;
our plans to develop and, if approved, subsequently commercialize any product candidates we may develop;
the rate and degree of market acceptance and clinical utility of our products, if approved;
our estimates regarding the addressable patient population and potential market opportunity for our current and future product candidates;
our commercialization, marketing and manufacturing capabilities and strategy;
our expectations regarding our ability to obtain and maintain intellectual property protection;
our ability to identify additional products, product candidates or technologies with significant commercial potential that are consistent with our commercial objectives;
the impact of government laws and regulations;
our competitive position and expectations regarding developments and projections relating to our competitors and any competing therapies that are or become available;
developments relating to our competitors and our industry;
our ability to establish and maintain collaborations, including our collaborations with Eli Lilly and Company and Vertex Pharmaceuticals Incorporated; and
the potential impact of public health epidemics or pandemics and of global economic developments, including fluctuations in inflation and interest rates, on our business, operations, strategy and goals.

We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in this Quarterly Report on Form 10-Q, particularly in the “Risk Factors” section, that we believe could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, collaborations, joint ventures or investments we may make or enter into.

You should read this Quarterly Report on Form 10-Q and the documents that we reference in this Quarterly Report on Form 10-Q and have filed as exhibits to our other filings with the Securities and Exchange Commission completely and with the understanding that our actual future results may be materially different from what we expect. The forward-looking statements contained in this Quarterly Report on Form 10-Q are made as of the date of this Quarterly Report on Form 10-Q, and we do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

 


 

Except where the context otherwise requires or where otherwise indicated, the terms “we,” “us,” “our,” “our company,” “the company,” and “our business” in this Quarterly Report on Form 10-Q refer to Verve Therapeutics, Inc. and its consolidated subsidiary.

 


 

 

RISK FACTOR SUMMARY

 

Our business is subject to a number of risks of which you should be aware before making an investment decision. Below we summarize what we believe to be the principal risks facing our business, in addition to the risks described more fully in Item 1A, “Risk Factors” of Part II of this Quarterly Report on Form 10-Q and other information included in this report. The risks and uncertainties described below are not the only risks and uncertainties we face. Additional risks and uncertainties not presently known to us or that we presently deem less significant may also impair our business operations.

If any of the following risks occurs, our business, financial condition and results of operations and future growth prospects could be materially and adversely affected, and the actual outcomes of matters as to which forward-looking statements are made in this report could be materially different from those anticipated in such forward-looking statements:

We will need substantial additional funding. If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts;
Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability;
We are early in our development efforts and have not yet completed a clinical trial. As a result, we expect it will be many years before we commercialize any product candidate, if ever. If we are unable to advance our current or future product candidates into and through clinical trials, obtain marketing approval and ultimately commercialize our product candidates or experience significant delays in doing so, our business will be materially harmed;
In vivo gene editing, including base editing, is a novel technology in a rapidly evolving field that is not yet clinically validated as being safe and efficacious for human therapeutic use. The approaches we are taking to discover and develop novel therapeutics are unproven and may never lead to marketable products. We are focusing our research and development efforts for our lead product candidates on gene editing using base editing technology, but other gene editing technologies may be discovered that provide significant advantages over base editing and we may not be able to access or use those technologies, which could materially harm our business;
We are also seeking to discover and develop new gene editing technologies and may not be successful in doing so;
The outcome of preclinical studies and earlier-stage clinical trials may not be predictive of future results or the success of later preclinical studies and clinical trials and interim, preliminary or top-line data from our clinical trials may materially change as participant enrollment continues, more participant data become available and audit and verification procedures are conducted. As a result, interim, preliminary or top-line data from a clinical trial should be viewed with caution until the final data are available;
If we experience delays or difficulties in the enrollment of patients in our clinical trials, our clinical trials could experience significant delays and our receipt of necessary regulatory approvals could be delayed or prevented;
If any of the product candidates we develop, or the delivery modes we rely on to administer them, including lipid nanoparticles, cause serious adverse events, undesirable side effects or unexpected characteristics, such adverse events, side effects or characteristics could require us to abandon or limit development of the product candidates, delay or prevent regulatory approval of the product candidates, limit the commercial potential of our product candidates or result in significant negative consequences following any potential marketing approval;
Adverse public perception of genetic medicines, and gene editing and base editing in particular, may negatively impact demand for our potential products and increased regulatory scrutiny of genetic medicines may adversely affect our ability to obtain regulatory approvals for our product candidates;
Genetic medicines are complex and difficult to manufacture. We could experience delays in satisfying regulatory authorities or production problems that result in delays in our development programs, limit the supply of our product candidates we may develop, or otherwise harm our business;
We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success;
We rely, and expect to continue to rely, on third parties to conduct some or all aspects of our product manufacturing, research and preclinical and clinical testing, and these third parties may not perform satisfactorily;
We have entered into collaborations, and may enter into additional collaborations, with third parties for the research, development, manufacture and commercialization of programs or product candidates. Collaboration agreements may not lead to development or commercialization of product candidates in the most efficient manner, or at all. If these collaborations are not successful, our business could be adversely affected;
If we or our licensors are unable to obtain, maintain, defend and enforce patent rights that cover our gene editing technology and product candidates or if the scope of the patent protection obtained is not sufficiently broad, our

 


 

competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully develop and commercialize our technology and product candidates may be adversely affected;
If we fail to comply with our obligations in our intellectual property licensing arrangements with third parties, or otherwise experience disruptions to our business relationships with our licensors, we could lose intellectual property rights that are important to our business;
The intellectual property landscape around genome editing technology, including base editing and delivery, is highly dynamic, and third parties may initiate legal proceedings alleging that we are infringing, misappropriating, or otherwise violating their intellectual property rights, the outcome of which would be uncertain and may prevent, delay or otherwise interfere with our product discovery, development and commercialization efforts; and
We face substantial competition, which may result in others discovering, developing or commercializing products before us or more successfully than we do. The market with respect to new products for the treatment of cardiovascular disease, for which the standard of care is well established, is particularly competitive.

 


 

 

Table of Contents

 

 

Page

PART I.

FINANCIAL INFORMATION

1

Item 1.

Financial Statements (Unaudited)

1

Condensed Consolidated Balance Sheets

1

Condensed Consolidated Statements of Operations and Comprehensive Loss

2

Condensed Consolidated Statements of Stockholders’ Equity

3

Condensed Consolidated Statements of Cash Flows

4

Notes to Condensed Consolidated Financial Statements (Unaudited)

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

25

Item 4.

Controls and Procedures

26

 

 

 

PART II.

OTHER INFORMATION

27

Item 1.

Legal Proceedings

27

Item 1A.

Risk Factors

27

Item 2.

Unregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of Equity Securities

91

Item 5.

Other Information

91

Item 6.

Exhibits

92

Signatures

93

 

 

 


 

Part I ─ Financial Information

Item 1. Financial Statements

Verve Therapeutics, Inc.

Condensed consolidated balance sheets

 

(in thousands, except share and per share amounts)
(unaudited)

 

September 30,
2024

 

 

December 31,
2023

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

158,709

 

 

$

206,180

 

Marketable securities

 

 

381,211

 

 

 

417,770

 

Collaboration receivable

 

 

2,628

 

 

 

5,897

 

Prepaid expenses and other current assets

 

 

13,911

 

 

 

8,102

 

Total current assets

 

 

556,459

 

 

 

637,949

 

Property and equipment, net

 

 

19,625

 

 

 

22,505

 

Restricted cash

 

 

4,774

 

 

 

4,774

 

Operating lease right-of-use assets

 

 

79,921

 

 

 

85,295

 

Other long term assets

 

 

3,127

 

 

 

2,165

 

Total assets

 

$

663,906

 

 

$

752,688

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

4,637

 

 

$

6,636

 

Accrued expenses

 

 

21,918

 

 

 

20,178

 

Deferred revenue, current

 

 

5,719

 

 

 

 

Lease liability, current

 

 

10,368

 

 

 

10,192

 

Total current liabilities

 

 

42,642

 

 

 

37,006

 

Long term lease liability

 

 

60,887

 

 

 

64,715

 

Success payment liability

 

 

977

 

 

 

2,720

 

Deferred revenue, non-current

 

 

50,731

 

 

 

48,556

 

Other long term liabilities

 

 

118

 

 

 

189

 

Total liabilities

 

 

155,355

 

 

 

153,186

 

Commitments and contingencies (See Note 7, Note 8 and Note 9)

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares issued and outstanding

 

 

 

 

 

 

Common stock, $0.001 par value; 200,000,000 shares authorized, 84,638,814 and 81,969,693 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively

 

 

85

 

 

 

82

 

Additional paid-in capital

 

 

1,200,302

 

 

 

1,143,453

 

Accumulated other comprehensive income

 

 

1,143

 

 

 

272

 

Accumulated deficit

 

 

(692,979

)

 

 

(544,305

)

Total stockholders’ equity

 

 

508,551

 

 

 

599,502

 

Total liabilities and stockholders’ equity

 

$

663,906

 

 

$

752,688

 

 

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

1


 

Verve Therapeutics, Inc.

Condensed consolidated statements of operations and comprehensive loss

 

 

 

Three months ended September 30,

 

 

Nine months ended September 30,

 

(in thousands, except share and per share amounts) (unaudited)

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Collaboration revenue

 

$

6,865

 

 

$

3,117

 

 

$

19,252

 

 

$

6,614

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

49,938

 

 

 

43,765

 

 

 

149,299

 

 

 

138,135

 

General and administrative

 

 

13,837

 

 

 

11,686

 

 

 

42,546

 

 

 

37,655

 

Total operating expenses

 

 

63,775

 

 

 

55,451

 

 

 

191,845

 

 

 

175,790

 

Loss from operations

 

 

(56,910

)

 

 

(52,334

)

 

 

(172,593

)

 

 

(169,176

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Change in fair value of success payment liability

 

 

(6

)

 

 

802

 

 

 

1,743

 

 

 

878

 

Interest and other income, net

 

 

6,887

 

 

 

5,841

 

 

 

22,452

 

 

 

16,825

 

Total other income, net

 

 

6,881

 

 

 

6,643

 

 

 

24,195

 

 

 

17,703

 

Loss before provision for income taxes

 

 

(50,029

)

 

 

(45,691

)

 

 

(148,398

)

 

 

(151,473

)

Provision for income taxes

 

 

(104

)

 

 

(67

)

 

 

(276

)

 

 

(243

)

Net loss

 

$

(50,133

)

 

$

(45,758

)

 

$

(148,674

)

 

$

(151,716

)

Net loss per common share, basic and diluted

 

$

(0.59

)

 

$

(0.72

)

 

$

(1.77

)

 

$

(2.43

)

Weighted-average common shares used in net loss per share, basic and diluted

 

 

84,632,952

 

 

 

63,211,849

 

 

 

83,999,797

 

 

 

62,322,965

 

Comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(50,133

)

 

$

(45,758

)

 

$

(148,674

)

 

$

(151,716

)

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain on marketable securities

 

 

1,758

 

 

 

157

 

 

 

871

 

 

 

97

 

Comprehensive loss

 

$

(48,375

)

 

$

(45,601

)

 

$

(147,803

)

 

$

(151,619

)

 

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

2


 

Verve Therapeutics, Inc.

Condensed consolidated statements of stockholders’ equity

 

 

 

Common stock

 

 

 

 

 

 

 

 

 

 

 

 

 

(in thousands, except share amounts)
(unaudited)

 

Shares

 

 

Amount

 

 

Additional
paid-in
capital

 

 

Accumulated
other
comprehensive loss

 

 

Accumulated
deficit

 

 

Total
stockholders’
equity

 

Balance at December 31, 2022

 

 

61,730,816

 

 

$

62

 

 

$

895,801

 

 

$

(694

)

 

$

(344,237

)

 

$

550,932

 

Exercise of stock options

 

 

29,010

 

 

 

-

 

 

 

116

 

 

 

-

 

 

 

-

 

 

 

116

 

Issuance of common stock from At-the-Market offering, net of issuance costs of $126

 

 

103,184

 

 

 

-

 

 

 

1,922

 

 

 

-

 

 

 

-

 

 

 

1,922

 

Unrealized gain on marketable securities

 

 

-

 

 

 

-

 

 

 

-

 

 

 

457

 

 

 

-

 

 

 

457

 

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

8,024

 

 

 

-

 

 

 

-

 

 

 

8,024

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(51,975

)

 

 

(51,975

)

Balance at March 31, 2023

 

 

61,863,010

 

 

 

62

 

 

 

905,863

 

 

 

(237

)

 

 

(396,212

)

 

 

509,476

 

Exercise of stock options

 

 

98,598

 

 

 

-

 

 

 

548

 

 

 

-

 

 

 

-

 

 

 

548

 

Vesting of restricted stock units

 

 

50,537

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Issuance of common stock under employee stock purchase plan

 

 

52,134

 

 

 

-

 

 

 

685

 

 

 

-

 

 

 

-

 

 

 

685

 

Unrealized loss on marketable securities

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(517

)

 

 

-

 

 

 

(517

)

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

9,013

 

 

 

-

 

 

 

-

 

 

 

9,013

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(53,983

)

 

 

(53,983

)

Balance at June 30, 2023

 

 

62,064,279

 

 

 

62

 

 

 

916,109

 

 

 

(754

)

 

 

(450,195

)

 

 

465,222

 

Exercise of stock options

 

 

43,429

 

 

 

-

 

 

 

213

 

 

 

-

 

 

 

-

 

 

 

213

 

Vesting of restricted stock units

 

 

76,586

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Issuance of common stock in connection with the Lilly Agreement

 

 

1,552,795

 

 

 

2

 

 

 

31,708

 

 

 

-

 

 

 

-

 

 

 

31,710

 

Unrealized gain on marketable securities

 

 

-

 

 

 

-

 

 

 

-

 

 

 

157

 

 

 

-

 

 

 

157

 

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

8,825

 

 

 

-

 

 

 

-

 

 

 

8,825

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(45,758

)

 

 

(45,758

)

Balance at September 30, 2023

 

 

63,737,089

 

 

$

64

 

 

$

956,855

 

 

$

(597

)

 

$

(495,953

)

 

$

460,369

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2023

 

 

81,969,693

 

 

$

82

 

 

$

1,143,453

 

 

$

272

 

 

$

(544,305

)

 

$

599,502

 

Exercise of stock options

 

 

76,044

 

 

 

-

 

 

 

301

 

 

 

-

 

 

 

-

 

 

 

301

 

Vesting of restricted stock units

 

 

7,290

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Issuance of common stock from At-the-Market offering, net of issuance costs of $747

 

 

1,766,835

 

 

 

2

 

 

 

22,431

 

 

 

-

 

 

 

-

 

 

 

22,433

 

Unrealized loss on marketable securities

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(772

)

 

 

-

 

 

 

(772

)

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

10,341

 

 

 

-

 

 

 

-

 

 

 

10,341

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(48,736

)

 

 

(48,736

)

Balance at March 31, 2024

 

 

83,819,862

 

 

 

84

 

 

 

1,176,526

 

 

 

(500

)

 

 

(593,041

)

 

 

583,069

 

Exercise of stock options

 

 

520,995

 

 

 

1

 

 

 

825

 

 

 

-

 

 

 

-

 

 

 

826

 

Vesting of restricted stock units

 

 

104,426

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Issuance of common stock under employee stock purchase plan

 

 

106,986

 

 

 

-

 

 

 

472

 

 

 

-

 

 

 

-

 

 

 

472

 

Unrealized loss on marketable securities

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(115

)

 

 

-

 

 

 

(115

)

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

11,647

 

 

 

-

 

 

 

-

 

 

 

11,647

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(49,805

)

 

 

(49,805

)

Balance at June 30, 2024

 

 

84,552,269

 

 

 

85

 

 

 

1,189,470

 

 

 

(615

)

 

 

(642,846

)

 

 

546,094

 

Exercise of stock options

 

 

5,075

 

 

 

-

 

 

 

14

 

 

 

-

 

 

 

-

 

 

 

14

 

Vesting of restricted stock units

 

 

81,470

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Unrealized gain on marketable securities

 

 

-

 

 

 

-

 

 

 

-

 

 

 

1,758

 

 

 

-

 

 

 

1,758

 

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

10,818

 

 

 

-

 

 

 

-

 

 

 

10,818

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(50,133

)

 

 

(50,133

)

Balance at September 30, 2024

 

 

84,638,814

 

 

$

85

 

 

$

1,200,302

 

 

$

1,143

 

 

$

(692,979

)

 

$

508,551

 

 

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

3


 

Verve Therapeutics, Inc.

Condensed consolidated statements of cash flows

 

 

 

Nine months ended September 30,

 

(unaudited, in thousands)

 

2024

 

 

2023

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(148,674

)

 

$

(151,716

)

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

 

 

 

 

 

 

Depreciation

 

 

5,053

 

 

 

3,938

 

Non-cash lease expense

 

 

5,374

 

 

 

5,046

 

Net accretion of discount on marketable securities

 

 

(10,250

)

 

 

(11,044

)

Stock-based compensation

 

 

32,806

 

 

 

25,862

 

Change in fair value of success payments liabilities

 

 

(1,743

)

 

 

(878

)

Changes in operating assets and liabilities:

 

 

 

 

 

 

Collaboration receivable

 

 

3,264

 

 

 

(3,117

)

Prepaid expenses and other assets

 

 

(6,765

)

 

 

(2,587

)

Accounts payable

 

 

(2,321

)

 

 

(589

)

Accrued expenses and other liabilities

 

 

2,167

 

 

 

2,996

 

Operating lease liabilities

 

 

(3,653

)

 

 

(5,320

)

Deferred revenue

 

 

7,895

 

 

 

28,540

 

Net cash used in operating activities

 

 

(116,847

)

 

 

(108,869

)

Cash flows from investing activities:

 

 

 

 

 

 

Purchases of property and equipment

 

 

(2,349

)

 

 

(7,098

)

Purchases of marketable securities

 

 

(350,928

)

 

 

(394,817

)

Maturities of marketable securities

 

 

398,607

 

 

 

438,498

 

Net cash provided by investing activities

 

 

45,330

 

 

 

36,583

 

Cash flows from financing activities:

 

 

 

 

 

 

Proceeds from the issuance of common stock in connection with collaboration agreements

 

 

 

 

 

31,710

 

Proceeds from exercise of stock options

 

 

1,141

 

 

 

877

 

Proceeds from issuance of common stock, net of issuance costs

 

 

22,433

 

 

 

1,922

 

Issuance of common stock under employee stock purchase plan

 

 

472

 

 

 

685

 

Net cash provided by financing activities

 

 

24,046

 

 

 

35,194

 

Decrease in cash, cash equivalents and restricted cash

 

 

(47,471

)

 

 

(37,092

)

Cash, cash equivalents and restricted cash—beginning of period

 

 

210,954

 

 

 

120,236

 

Cash, cash equivalents and restricted cash—end of period

 

$

163,483

 

 

$

83,144

 

Supplemental disclosure of noncash investing and financing activities:

 

 

 

 

 

 

Property and equipment additions included in accounts payable and accrued expenses

 

$

757

 

 

$

495

 

 

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

4


 

Verve Therapeutics, Inc.

Notes to condensed consolidated financial statements (unaudited)

1. Nature of the business and basis of presentation

Organization

Verve Therapeutics, Inc. (the “Company” or “Verve”) is a clinical-stage company developing a new class of genetic medicines for cardiovascular disease with the potential to transform treatment from chronic management to single-course gene editing medicines. The Company was incorporated on March 9, 2018 as Endcadia, Inc., a Delaware corporation, and began operations shortly thereafter. In January 2019, the Company amended its certificate of incorporation to change its name to Verve Therapeutics, Inc. The Company’s principal offices are located in Boston, Massachusetts.

Liquidity and capital resources

Since its inception, the Company has devoted its efforts principally to research and development and raising capital. 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 and extensive compliance-reporting capabilities. Even if the Company’s development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales.

The accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business. The Company expects that its cash, cash equivalents and marketable securities of $539.9 million as of September 30, 2024 will be sufficient to fund its operations and capital expenditure requirements beyond the next 12 months from the date of issuance of these financial statements. The Company will need additional financing to support its continuing operations and pursue its growth strategy. Until such time as the Company can generate significant revenue from product sales, if ever, it expects to finance its operations through a combination of equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. The Company may be unable to raise additional funds or enter into such other agreements when needed on favorable terms or at all. The inability to raise capital as and when needed could have a negative impact on the Company’s financial condition and its ability to pursue its business strategy. The Company will need to generate significant revenue to achieve profitability, and it may never do so.

Basis of presentation

The accompanying condensed consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles (“GAAP”) and pursuant to the rules and regulations of the Securities and Exchange Commission ("SEC"). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations.

The unaudited condensed consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements. In the opinion of the Company’s management, the accompanying unaudited condensed consolidated financial statements contain all adjustments that are necessary to present fairly the Company’s financial position as of September 30, 2024, the results of its operations and other comprehensive loss for the three and nine months ended September 30, 2024 and 2023, stockholders’ equity for the three and nine months ended September 30, 2024 and 2023 and cash flows for the nine months ended September 30, 2024 and 2023. Such adjustments are of a normal and recurring nature. The results for the three and nine months ended September 30, 2024 are not necessarily indicative of the results for the year ending December 31, 2024, or for any future period. These interim financial statements should be read in conjunction with the audited consolidated financial statements as of and for the year ended

5


 

December 31, 2023, and the notes thereto, included in the Company’s Annual Report on Form 10-K filed with the SEC on February 27, 2024.

2. Summary of significant accounting policies

The Company's significant accounting policies are disclosed in Note 2, "Summary of significant accounting policies," in the audited consolidated financial statements for the year ended December 31, 2023, and notes thereto, included in the Company’s Annual Report on Form 10-K filed with the SEC on February 27, 2024. Since the date of those financial statements, there have been no changes to the Company's significant accounting policies.

Cash, cash equivalents and restricted cash

Restricted cash represents collateral provided for letters of credit issued as security deposits in connection with the Company’s leases of its corporate facilities. A reconciliation of the cash, cash equivalents, and restricted cash reported within the condensed consolidated balance sheet that sum to the total of the same amounts shown in the condensed consolidated statements of cash flows is as follows:

 

 

 

September 30,

 

 

September 30,

 

(in thousands)

 

2024

 

 

2023

 

Cash and cash equivalents

 

$

158,709

 

 

$

78,370

 

Restricted cash

 

 

4,774

 

 

 

4,774

 

Total cash, cash equivalents and restricted cash

 

$

163,483

 

 

$

83,144

 

 

3. Marketable securities

Marketable securities by security type consisted of the following:

 

 

September 30, 2024

 

(in thousands)

 

Amortized
cost

 

 

Gross
unrealized
gains

 

 

Gross
unrealized
losses

 

 

Fair
value

 

U.S. treasury bills and notes

 

$

179,012

 

 

$

673

 

 

$

(1

)

 

$

179,684

 

U.S. agency securities

 

 

201,056

 

 

 

486

 

 

 

(15

)

 

 

201,527

 

Total

 

$

380,068

 

 

$

1,159

 

 

$

(16

)

 

$

381,211

 

 

 

December 31, 2023

 

(in thousands)

 

Amortized
cost

 

 

Gross
unrealized
gains

 

 

Gross
unrealized
losses

 

 

Fair
value

 

U.S. treasury bills and notes

 

$

147,978

 

 

$

144

 

 

$

(15

)

 

$

148,107

 

U.S. agency securities

 

 

269,520

 

 

 

277

 

 

 

(134

)

 

 

269,663

 

Total

 

$

417,498

 

 

$

421

 

 

$

(149

)

 

$

417,770

 

The remaining contractual maturities of all marketable securities were less than 18 months as of September 30, 2024 and 24 months as of December 31, 2023. The gross unrealized losses on the Company’s marketable securities were de minimis as of September 30, 2024. The gross unrealized losses on the Company's marketable securities of $0.1 million as of December 31, 2023 was caused by interest rate increases which resulted in the decrease in market value of these securities. Because the decline in fair value is attributable to changes in interest rates and not credit quality, and because the Company does not intend to sell the investments and it is not more likely than not that the Company will be required to sell the investments before recovery of their amortized cost bases, which may be maturity, the Company did not consider such marketable securities to be impaired at September 30, 2024 or December 31, 2023. None of the Company’s marketable securities have been in a continuous unrealized loss position for 12 months or greater as of September 30, 2024 or December 31, 2023.

6


 

4. Property and equipment, net

Property and equipment, net, consisted of the following:

 

(in thousands)

 

September 30, 2024

 

 

December 31, 2023

 

Lab equipment

 

$

30,937

 

 

$

28,851

 

Leasehold improvements

 

 

776

 

 

 

726

 

Furniture and fixtures

 

 

2,323

 

 

 

2,323

 

Computer equipment

 

 

997

 

 

 

997

 

Total property and equipment

 

 

35,033

 

 

 

32,897

 

Less accumulated depreciation

 

 

(15,408

)

 

 

(10,392

)

Property and equipment, net

 

$

19,625

 

 

$

22,505

 

 

The following table summarizes depreciation expense incurred:

 

 

Three months ended September 30,

 

 

Nine months ended September 30,

 

(in thousands)

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Depreciation expense

 

$

1,754

 

 

$

1,474

 

 

$

5,053

 

 

$

3,938

 

 

5. fair value of financial instruments

The Company’s financial instruments that are measured at fair value on a recurring basis consist of money market funds, marketable securities, and a derivative liability (success payment liability) pursuant to the Company's license agreement with the President and Fellows of Harvard College ("Harvard") and The Broad Institute, Inc. (“Broad”), which license agreement is referred to herein as the Harvard/Broad License Agreement.

The following tables set forth the fair value of the Company’s financial instruments by level within the fair value hierarchy:

 

 

 

As of September 30, 2024

 

(in thousands)

 

Fair
value

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

72,489

 

 

$

72,489

 

 

$

 

 

$

 

Marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. treasury bills and notes

 

 

179,684

 

 

 

 

 

 

179,684

 

 

 

 

U.S. agency securities

 

 

201,527

 

 

 

 

 

 

201,527

 

 

 

 

Total assets

 

$

453,700

 

 

$

72,489

 

 

$

381,211

 

 

$

 

Liabilities

 

 

 

 

 

 

 

 

 

 

 

 

Success payment liability

 

$

977

 

 

$

 

 

$

 

 

$

977

 

Total liabilities

 

$

977

 

 

$

 

 

$

 

 

$

977

 

 

 

 

 

As of December 31, 2023

 

(in thousands)

 

Fair
value