SEC Filing | Verve Therapeutics

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10-Q/A

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 10-Q/A

Amendment No. 1

(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


☐	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.

EXPLANATORY NOTE

This Amendment No. 1 to the Quarterly Report on Form 10-Q (the “Amendment”) amends Verve Therapeutics, Inc.’s Quarterly Report on Form 10-Q for the period ended June 30, 2021 (the “Original Form 10-Q”) originally filed with the Securities and Exchange Commission on August 12, 2021. This Amendment is being filed solely to address technical issues with the Interactive Data Files of the Original Form 10-Q filing, which resulted in the omission of Inline eXtensible Business Reporting Language (iXBRL) data from the Original Form 10-Q. The Interactive Data Files are filed as Exhibit 101 to this Amendment.

No other changes have been made to the Original Form 10-Q, but this Amendment restates in its entirety the Original Form 10-Q to include the Interactive Data Files. This Amendment speaks as of the original filing date of the Original Form 10-Q, does not reflect events that may have occurred subsequent to the original filing date and does not modify or update in any way disclosures made in the Original Form 10-Q.

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	86
Signatures		88

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.

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.

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.

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.

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 $