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 June 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: 001-40489

 

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.)

 

 

500 Technology Square, Suite 901

Cambridge, Massachusetts

02139

(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 August 9, 2021, the registrant had 47,991,799 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 initiation, timing, progress and results of our research and development programs and preclinical studies and clinical trials; 
the impact of the COVID-19 pandemic and our response to the pandemic; 
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 non-human primates results into 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 or obtain additional funding; and  
our expectations regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act.

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 SEC 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.

 


 

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 very early in our development efforts, and we have not yet completed investigational new drug application, or IND, -enabling studies or initiated clinical development of any product candidate. 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; 
Gene editing, including base editing, is a novel technology in a rapidly evolving field that is not yet clinically validated 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 on gene editing using base editing technology, but other gene editing technologies may be discovered that provide significant advantages over base editing, which could materially harm our business; 
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;
If any of the product candidates we may develop, or the delivery modes we rely on to administer them, cause serious adverse events, undesirable side effects or unexpected characteristics, such events, side effects or characteristics could delay or prevent regulatory approval of the product candidates, limit the commercial potential 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 regulatory approval of, and/or demand for, our potential products; 
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 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. 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 licenses 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, 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 and development efforts; 

 


 

We face substantial competition, which may result in others discovering, developing or commercializing products before us or more successfully than we do; and 
The COVID-19 pandemic may affect our ability to initiate and complete preclinical studies, delay the initiation of future clinical trials, disrupt regulatory activities or have other adverse effects on our business and operations. In addition, this pandemic has adversely impacted economies worldwide, both of which could result in adverse effects on our business, operations and ability to raise capital.

 

 


 

 

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 Convertible Preferred Stock and Stockholders’ Equity (Deficit)

3

Condensed Consolidated Statements of Cash Flows

4

Notes to Unaudited Condensed Consolidated Financial Statements

5

Item 2.

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

15

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

26

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 and Use of Proceeds

85

Item 6.

Exhibits

85

Signatures

87

 

 

 


 

Part I ─ Financial Information

Item 1. Financial Statements

Verve Therapeutics, Inc.

Condensed consolidated balance sheets

 

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

 

June 30,
2021

 

 

December 31,
2020

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

387,446

 

 

$

8,993

 

Marketable securities

 

 

30,178

 

 

 

63,119

 

Prepaid expenses and other current assets

 

 

1,940

 

 

 

1,854

 

Total current assets

 

 

419,564

 

 

 

73,966

 

Property and equipment, net

 

 

6,417

 

 

 

3,984

 

Restricted cash

 

 

463

 

 

 

463

 

Other long term assets

 

 

74

 

 

 

 

Total assets

 

$

426,518

 

 

$

78,413

 

Liabilities, convertible preferred stock, and stockholders’ equity (deficit)

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

1,530

 

 

$

36

 

Accrued expenses

 

 

6,967

 

 

 

7,189

 

Deferred rent, current portion

 

 

152

 

 

 

90

 

Total current liabilities

 

 

8,649

 

 

 

7,315

 

Deferred rent, net of current portion

 

 

13

 

 

 

125

 

Success payment liability (See Notes 5, 8 and 14)

 

 

12,460

 

 

 

2,806

 

Antidilution rights liability (See Notes 5, 8 and 14)

 

 

 

 

 

6,916

 

Total liabilities

 

 

21,122

 

 

 

17,162

 

Commitments and contingencies (See Note 7 and Note 8)

 

 

 

 

 

 

Convertible preferred stock (See Note 10)

 

 

 

 

 

125,160

 

Stockholders’ equity (deficit):

 

 

 

 

 

 

Common stock, $0.001 par value; 200,000,000 and 255,000,000 shares
   authorized, 48,215,812 and 3,123,424 shares issued at June 30, 2021
   and December 31, 2020, respectively; 47,946,996 and 2,585,789 shares
   outstanding at June 30, 2021 and December 31, 2020, respectively

 

 

48

 

 

 

3

 

Additional paid-in capital

 

 

538,109

 

 

 

2,616

 

Accumulated other comprehensive income

 

 

3

 

 

 

8

 

Accumulated deficit

 

 

(132,764

)

 

 

(66,536

)

Total stockholders’ equity (deficit)

 

 

405,396

 

 

 

(63,909

)

Total liabilities, convertible preferred stock, and stockholders’ equity (deficit)

 

$

426,518

 

 

$

78,413

 

 

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 June 30,

 

 

Six months ended June 30,

 

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

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

13,423

 

 

$

5,654

 

 

$

24,768

 

 

$

12,177

 

General and administrative

 

 

3,541

 

 

 

1,032

 

 

 

6,257

 

 

 

1,878

 

Total operating expenses

 

 

16,964

 

 

 

6,686

 

 

 

31,025

 

 

 

14,055

 

Loss from operations

 

 

(16,964

)

 

 

(6,686

)

 

 

(31,025

)

 

 

(14,055

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Change in fair value of preferred stock tranche liability

 

 

-

 

 

 

-

 

 

 

-

 

 

 

2,507

 

Change in fair value of antidilution rights liability

 

 

(25,970

)

 

 

(863

)

 

 

(25,574

)

 

 

(1,745

)

Change in fair value of success payment liability

 

 

(10,036

)

 

 

(81

)

 

 

(9,654

)

 

 

(17

)

Interest income and other income (expense), net

 

 

5

 

 

 

50

 

 

 

25

 

 

 

127

 

Total other (expense) income, net

 

 

(36,001

)

 

 

(894

)

 

 

(35,203

)

 

 

872

 

Net loss

 

$

(52,965

)

 

$

(7,580

)

 

$

(66,228

)

 

$

(13,183

)

Net loss per common share attributable to common
   stockholders, basic and diluted

 

$

(6.66

)

 

$

(3.41

)

 

$

(12.46

)

 

$

(6.36

)

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

 

 

7,948,110

 

 

 

2,225,017

 

 

 

5,316,804

 

 

 

2,071,249

 

Comprehensive Loss:

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(52,965

)

 

$

(7,580

)

 

$

(66,228

)

 

$

(13,183

)

Other comprehensive (loss) income:

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on marketable securities

 

 

(4

)

 

 

(19

)

 

 

(5

)

 

 

(8

)

Comprehensive loss attributable to common stockholders

 

$

(52,969

)

 

$

(7,599

)

 

$

(66,233

)

 

$

(13,191

)

 

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

2


 

Verve Therapeutics, Inc.

Condensed consolidated statements of convertible preferred stock and stockholders’ equity (deficit)

 

 

 

Convertible preferred stock

 

 

Common stock

 

 

 

 

 

 

 

 

 

 

 

 

 

(in thousands, except share amounts)
(unaudited)

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Additional
paid-in
capital

 

 

Accumulated
other
comprehensive
income (loss)

 

 

Accumulated
deficit

 

 

Total
stockholders’
equity (deficit)

 

Balance at December 31, 2019

 

 

51,421,404

 

 

$

25,480

 

 

 

1,854,438

 

 

$

2

 

 

$

1,268

 

 

$

9

 

 

$

(20,832

)

 

$

(19,553

)

Issuance of Series A convertible preferred stock, net
   of issuance costs of $22

 

 

49,749,167

 

 

 

36,792

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock to licensor institutions

 

 

 

 

 

 

 

 

187,867

 

 

 

 

 

 

487

 

 

 

 

 

 

 

 

 

487

 

Vesting of restricted common stock

 

 

 

 

 

 

 

 

134,409

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exercise of stock options

 

 

 

 

 

 

 

 

2,025

 

 

 

 

 

 

3

 

 

 

 

 

 

 

 

 

3

 

Unrealized gain on available-for-sale securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

11

 

 

 

 

 

 

11

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

95

 

 

 

 

 

 

 

 

 

95

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(5,603

)

 

 

(5,603

)

Balance at March 31, 2020

 

 

101,170,571

 

 

$

62,272

 

 

 

2,178,739

 

 

$

2

 

 

$

1,853

 

 

$

20

 

 

$

(26,435

)

 

$

(24,560

)

Issuance of Series A-1 convertible preferred stock,
   net of issuance costs of $112

 

 

78,348,461

 

 

 

62,888

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vesting of restricted common stock

 

 

 

 

 

 

 

 

134,408

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized loss on available-for-sale securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(19

)

 

 

 

 

 

(19

)

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

100

 

 

 

 

 

 

 

 

 

100

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(7,580

)

 

 

(7,580

)

Balance at June 30, 2020

 

 

179,519,032

 

 

$

125,160

 

 

 

2,313,147

 

 

$

2

 

 

$

1,953

 

 

$

1

 

 

$

(34,015

)

 

$

(32,059

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2020

 

 

179,519,032

 

 

$

125,160

 

 

 

2,585,789

 

 

$

3

 

 

$

2,616

 

 

$

8

 

 

$

(66,536

)

 

$

(63,909

)

Issuance of Series B convertible preferred stock,
   net of issuance costs of $241

 

 

77,163,022

 

 

 

93,759

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vesting of restricted common stock

 

 

 

 

 

 

 

 

134,409

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exercise of stock options

 

 

 

 

 

 

 

 

48,745

 

 

 

 

 

 

72

 

 

 

 

 

 

 

 

 

72

 

Unrealized loss on available-for-sale securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1

)

 

 

 

 

 

(1

)

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

670

 

 

 

 

 

 

 

 

 

670

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(13,263

)

 

 

(13,263

)

Balance at March 31, 2021

 

 

256,682,054

 

 

$

218,919

 

 

 

2,768,943

 

 

$

3

 

 

$

3,358

 

 

$

7

 

 

$

(79,799

)

 

$

(76,431

)

Conversion of convertible preferred stock to common stock upon closing of initial public offering

 

 

(256,682,054

)

 

 

(218,919

)

 

 

27,720,923

 

 

 

28

 

 

 

218,891

 

 

 

 

 

 

 

 

 

218,919

 

Issuance of common stock from initial public offering, net of issuance costs of $25,098

 

 

 

 

 

 

 

 

16,141,157

 

 

 

16

 

 

 

281,568

 

 

 

 

 

 

 

 

 

281,584

 

Issuance of common stock to licensor institutions

 

 

 

 

 

 

 

 

878,098

 

 

 

1

 

 

 

32,489

 

 

 

 

 

 

 

 

 

32,490

 

Vesting of restricted common stock

 

 

 

 

 

 

 

 

134,408

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exercise of stock options

 

 

 

 

 

 

 

 

303,467

 

 

 

 

 

 

452

 

 

 

 

 

 

 

 

 

452

 

Unrealized loss on available-for-sale securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(4

)

 

 

 

 

 

(4

)

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,351

 

 

 

 

 

 

 

 

 

1,351

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(52,965

)

 

 

(52,965

)

Balance at June 30, 2021

 

 

 

 

$

 

 

 

47,946,996

 

 

$

48

 

 

$

538,109

 

 

$

3

 

 

$

(132,764

)

 

$

405,396

 

 

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

3


 

Verve Therapeutics, Inc.

Condensed consolidated statements of cash flows

 

 

 

Six months ended June 30,

 

(unaudited, in thousands)

 

2021

 

 

2020

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(66,228

)

 

$

(13,183

)

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

 

 

 

 

 

 

Depreciation

 

 

651

 

 

 

451

 

Amortization of premium on marketable securities

 

 

356

 

 

 

66

 

Stock-based compensation

 

 

2,021

 

 

 

195

 

Change in fair value of preferred stock tranche liabilities

 

 

-

 

 

 

(2,507

)

Change in fair value of antidilution rights

 

 

25,574

 

 

 

1,745

 

Change in fair value of success payments liabilities

 

 

9,654

 

 

 

17

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Prepaid expenses and other assets

 

 

(159

)

 

 

(591

)

Accounts payable

 

 

1,283

 

 

 

(1,044

)

Accrued expenses and other liabilities

 

 

(1,584

)

 

 

914

 

Deferred rent liability

 

 

(50

)

 

 

(29

)

Net cash used in operating activities

 

 

(28,482

)

 

 

(13,966

)

Cash flows from investing activities:

 

 

 

 

 

 

Purchases of property and equipment

 

 

(2,376

)

 

 

(1,449

)

Purchases of marketable securities

 

 

(11,176

)

 

 

(73,128

)

Maturities of marketable securities

 

 

43,755

 

 

 

14,281

 

Net cash provided by (used in) investing activities

 

 

30,203

 

 

 

(60,296

)

Cash flows from financing activities

 

 

 

 

 

 

Proceeds from issuance of Preferred Stock, net

 

 

93,759

 

 

 

92,616

 

Proceeds from initial public offering, net of underwriting discount

 

 

285,214

 

 

 

-

 

Payment of initial public offering costs

 

 

(2,765

)

 

 

-

 

Proceeds from exercise of stock options

 

 

524

 

 

 

3

 

Net cash provided by financing activities

 

 

376,732

 

 

 

92,619

 

Increase in cash, cash equivalents and restricted cash

 

 

378,453

 

 

 

18,357

 

Cash, cash equivalents and restricted cash—beginning of period

 

 

9,456

 

 

 

3,221

 

Cash, cash equivalents and restricted cash—end of period

 

$

387,909

 

 

$

21,578

 

Supplemental disclosure of noncash investing and financing activities:

 

 

 

 

 

 

Property and equipment additions included in accounts payable
   and accrued expenses

 

$

794

 

 

$

98

 

Settlement of tranche right liability

 

$

 

 

$

7,064

 

Initial public offering costs included in accounts payable and accrued liabilities

 

$

865

 

 

$

 

Conversion of convertible preferred stock to common stock upon closing of initial public offering

 

$

218,919

 

 

$

 

Settlement of antidilution rights liability by issuing common stock

 

$

32,490

 

 

$

487

 

 

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 genetic medicines company pioneering a new approach to the care of cardiovascular disease, transforming 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 Cambridge, 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.

On June 21, 2021, the Company completed its initial public offering, or IPO, in which the Company issued and sold 16,141,157 shares of its common stock, including 2,105,368 shares pursuant to the full exercise of the underwriters’ option to purchase additional shares, at a public offering price of $19.00 per share, for aggregate gross proceeds of $306.7 million. The Company received approximately $281.6 million in net proceeds after deducting underwriting discounts and estimated offering expenses payable by the Company. In connection with the IPO, all outstanding shares of convertible preferred stock converted into 27,720,923 shares of the Company’s common stock.

In connection with the Company's IPO, the Company effected a one-for-9.2595 reverse stock split of the Company’s issued and outstanding common stock. Accordingly, all shares of common stock and per share amounts, as well as the conversion ratio of the Company’s outstanding convertible preferred stock, for all periods presented in the accompanying consolidated financial statements and notes thereto have been retroactively adjusted, where applicable, to reflect the reverse stock split, including reclassification of par and additional paid-in capital amounts as a result of the reverse stock split.

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 $417.6 million as of June 30, 2021 will be sufficient to fund its operations and capital expenditure requirements beyond the next 12 months. 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 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

5


 

financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations.

The unaudited interim 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 interim condensed consolidated financial statements contain all adjustments that are necessary to present fairly the Company’s financial position as of June 30, 2021, the results of its operations and other comprehensive loss for the three and six months ended June 30, 2021 and 2020, convertible preferred stock and stockholders’ deficit for the three and six months ended June 30, 2021 and 2020 and cash flows for the six months ended June 30, 2021 and 2020. Such adjustments are of a normal and recurring nature. The results for the three and six months ended June 30, 2021 are not necessarily indicative of the results for the year ending December 31, 2021, 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 December 31, 2020, and the notes thereto, included in the Company’s final prospectus for its initial public offering filed pursuant to Rule 424(b)(4) under the Securities Act with the SEC on June 17, 2021.

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, 2020, and notes thereto, included in the Company’s final prospectus for its IPO filed pursuant to Rule 424(b)(4) under the Securities Act with the SEC on June 17, 2021. Since the date of those financial statements, there have been no changes to its significant accounting policies.

Cash, cash equivalents and restricted cash

Restricted cash represents collateral provided for a letter of credit issued as a security deposit in connection with the Company’s lease of its corporate facilities. A reconciliation of the cash, cash equivalents, and restricted cash reported within the balance sheet that sum to the total of the same amounts shown in the statement of cash flows is as follows:

 

 

 

June 30,

 

 

June 30,

 

(in thousands)

 

2021

 

 

2020

 

Cash and cash equivalents

 

$

387,446

 

 

$

20,931

 

Restricted cash

 

 

463

 

 

 

647

 

Total cash, cash equivalents and restricted cash

 

$

387,909

 

 

$

21,578

 

 

3. Marketable securities

Marketable securities by security type consisted of the following:

 

 

 

June 30, 2021

 

(in thousands)

 

Amortized
cost

 

 

Gross
unrealized
gains

 

 

Gross
unrealized
losses

 

 

Fair
value

 

U.S. treasury bills and notes

 

$

25,173

 

 

$

3

 

 

$

-

 

 

$

25,176

 

U.S. agency securities

 

 

5,002

 

 

 

-

 

 

 

-

 

 

 

5,002

 

Total

 

$

30,175

 

 

$

3

 

 

$

-

 

 

$

30,178

 

 

 

 

December 31, 2020

 

(in thousands)

 

Amortized
cost

 

 

Gross
unrealized
gains

 

 

Gross
unrealized
losses

 

 

Fair
value

 

U.S. treasury bills and notes

 

$

32,221

 

 

$

3

 

 

$

-

 

 

$

32,224

 

U.S. agency securities

 

 

30,890

 

 

 

5

 

 

 

-

 

 

 

30,895

 

Total

 

$

63,111

 

 

$

8

 

 

$

-

 

 

$

63,119

 

 

The remaining contractual maturities of all marketable securities were less than one year as of June 30, 2021 and December 31, 2020.

6


 

4. Property and equipment, net

Property and equipment, net, consist of the following:

 

(in thousands)

 

June 30,
2021

 

 

December 31,
2020

 

Lab equipment

 

$

6,754

 

 

$

3,937

 

Leasehold improvements

 

 

432

 

 

 

259

 

Furniture and fixtures

 

 

535

 

 

 

481

 

Computer equipment

 

 

145

 

 

 

105

 

Total property and equipment

 

 

7,866

 

 

 

4,782

 

Less accumulated depreciation

 

 

(1,449

)

 

 

(798

)

Property and equipment, net

 

$

6,417

 

 

$

3,984

 

 

Depreciation expense for the three and six months ended June 30, 2021 was $0.4 million and $0.7 million, respectively. Depreciation expense for the three and six months ended June 30, 2020 was $0.3 million and $0.5 million, respectively.

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, the preferred stock tranche liability as well as certain derivative liabilities (antidilution right liability and success payment liability) pursuant to the Harvard/Broad License Agreement and the 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 June 30, 2021

 

(in thousands)

 

Fair
value

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

324,973

 

 

$

324,973

 

 

$

-

 

 

$

-

 

Marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. treasury bills and notes

 

 

25,176

 

 

 

-

 

 

 

25,176

 

 

 

-

 

U.S. agency securities

 

 

5,002

 

 

 

-

 

 

 

5,002

 

 

 

-

 

Total assets

 

$

355,151

 

 

$

324,973

 

 

$

30,178

 

 

$

-

 

Liabilities

 

 

 

 

 

 

 

 

 

 

 

 

Success payment liability

 

 

12,460

 

 

 

-

 

 

 

-

 

 

 

12,460

 

Total liabilities

 

$

12,460

 

 

$

-

 

 

$

-

 

 

$

12,460

 

 

 

 

As of December 31, 2020

 

(in thousands)

 

Fair
value

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

6,724

 

 

$

6,724

 

 

$

-

 

 

$

-

 

Marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. treasury bills and notes

 

 

32,224

 

 

 

-

 

 

 

32,224

 

 

 

-

 

U.S. agency securities

 

 

30,895

 

 

 

-

 

 

 

30,895

 

 

 

-

 

Total assets

 

$

69,843

 

 

$

6,724

 

 

$

63,119

 

 

$

 

Liabilities

 

 

 

 

 

 

 

 

 

 

 

 

Success payment liability

 

$

2,806

 

 

$

-

 

 

$

-

 

 

$

2,806

 

Antidilution rights liability

 

 

6,916

 

 

 

-