UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
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.
Item 2.02 Results of Operations and Financial Condition.
On March 2, 2023, Verve Therapeutics, Inc. (the “Company”) announced its financial results for the quarter and year ended December 31, 2022. The full text of the press release issued by the Company in connection with the announcement is being furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this Item 2.02, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
The following exhibit is furnished herewith:
99.1 Press Release issued by Verve Therapeutics, Inc. on March 2, 2023.
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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VERVE THERAPEUTICS, INC. |
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Date: March 2, 2023 |
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By: |
/s/ Allison Dorval |
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Name: Allison Dorval |
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Title: Chief Financial Officer |
Exhibit 99.1
Verve Therapeutics Provides Pipeline Progress and Reports Fourth Quarter and Full Year 2022 Financial Results
heart-1 Clinical Trial of VERVE-101 Ongoing in New Zealand and UK; Data from Dose Escalation Cohorts Expected in the Second Half of 2023
VERVE-201 Progressing Through Preclinical Development with Clinical Initiation Anticipated in 2024
Well-Capitalized with $554.8 Million Supporting Runway into the Second Half of 2025
BOSTON — March 2, 2023 — Verve Therapeutics, Inc., a clinical-stage biotechnology company pioneering a new approach to the care of cardiovascular disease with single-course gene editing medicines, today reported pipeline updates and financial results for the fourth quarter and year ended December 31, 2022.
“Throughout 2022, we made important progress toward our goal of transforming the treatment of heart disease, as we treated our first patient with VERVE-101 and transitioned to a clinical-stage company, advanced VERVE-201 closer to clinical development, further enhanced our delivery capabilities, and expanded our research pipeline,” said Sekar Kathiresan, M.D., co-founder and chief executive officer of Verve. “As we enter 2023, we are focused on the successful execution of our heart-1 clinical trial with VERVE-101, which we are advancing in high-risk heterozygous familial hypercholesterolemia patients. Beyond VERVE-101 and VERVE-201, we are excited by the opportunities across our portfolio, including an early program targeting the LPA gene, the advancement of our proprietary GalNAc-LNP delivery technology, and our ongoing collaborations with Beam and Vertex. The current chronic care model to treat atherosclerotic cardiovascular disease - daily pills and/or intermittent injections often over decades - is broken, and at Verve, we remain steadfast in our mission to transform the management of this disease through once-and-done therapies.”
VERVE-101
heart-1 Clinical Trial Updates
Regulatory Updates
VERVE-201
Additional Research Pipeline Progress
Corporate Update
Fourth Quarter and Full Year 2022 Financial Results
About heart-1
heart-1 is an open-label Phase1b clinical trial designed to enroll approximately 40 adult patients with heterozygous familial hypercholesterolemia (HeFH) who have established atherosclerotic cardiovascular disease (ASCVD) to evaluate the safety and tolerability of VERVE-101 administration, with additional analyses for pharmacokinetics and reductions in blood PCSK9 protein and low-density lipoprotein cholesterol (LDL-C). Initial clinical data from the dose escalation portion of the heart-1 clinical trial including safety parameters, blood PCSK9 level, and blood LDL-C level are expected in the second half of 2023. For more information, please visit clinicaltrials.gov.
About Verve Therapeutics
Verve Therapeutics, Inc. (Nasdaq: VERV) is a clinical-stage genetic medicines company pioneering a new approach to the care of cardiovascular disease, potentially transforming treatment from chronic management to single-course gene editing medicines. The company’s initial two programs – VERVE-101 and VERVE-201 – target genes that have been extensively validated as targets for lowering low-density lipoprotein cholesterol (LDL-C), a root cause of cardiovascular disease, in order to durably reduce blood LDL-C levels. VERVE-101 is designed to permanently turn off the PCSK9 gene in the liver and is being developed initially for heterozygous familial hypercholesterolemia (HeFH) and ultimately to treat atherosclerotic cardiovascular disease (ASCVD) patients not at goal on oral therapy. VERVE-201 is designed to permanently turn off the ANGPTL3 gene in the liver and is initially being developed in homozygous familial hypercholesterolemia (HoFH) and ultimately to treat patients with refractory hypercholesterolemia. For more information, please visit www.VerveTx.com.
Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding the company’s expectations regarding communications related to the clinical hold on the IND for VERVE-101; the company’s ability to enroll patients in its ongoing heart-1 trial, the timing and availability of clinical data from its heart-1 clinical trial; the expected timing of initiating a clinical trial of VERVE-201; its research and development plans; the potential advantages and therapeutic potential of the company’s programs, including VERVE-101 and VERVE-201; and the period over which the company believes that its existing, cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses. All statements, other than statements of historical facts, contained in this press release, including statements regarding the company’s strategy, future operations, future financial position, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with the company’s limited operating history; the timing of and the company’s ability to submit applications for, its product candidates; advance its product candidates in clinical trials; initiate, enroll and complete its ongoing and future clinical trials on the timeline expected or at all; correctly estimate the potential patient population and/or market for the company’s product candidates; replicate in clinical trials positive results found in preclinical studies and/or earlier-stage clinical trials of VERVE-101 and VERVE-201; advance the development of its product candidates under the timelines it anticipates in current and future clinical trials; obtain, maintain or protect intellectual property rights related to its product candidates; manage expenses; and raise the substantial additional capital needed to achieve its business objectives. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the company’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” section, as
well as discussions of potential risks, uncertainties and other important factors, in the company’s most recent filings with the Securities and Exchange Commission and in other filings that the company makes with the Securities and Exchange Commission in the future. In addition, the forward-looking statements included in this press release represent the company’s views as of the date hereof and should not be relied upon as representing the company’s views as of any date subsequent to the date hereof. The company anticipates that subsequent events and developments will cause the company’s views to change. However, while the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so..
Investor Contact
Jen Robinson
Verve Therapeutics, Inc.
jrobinson@vervetx.com
Media Contact
Ashlea Kosikowski
1AB
ashlea@1abmedia.com
Verve Therapeutics, Inc.
Selected Financial Information
(in thousands, except share and per share amounts)
(unaudited)
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Three months ended December 31, |
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Year ended December 31, |
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Consolidated statements of operations |
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2022 |
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2021 |
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2022 |
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2021 |
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Collaboration revenue |
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$ |
1,012 |
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$ |
— |
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$ |
1,941 |
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$ |
— |
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Operating expenses: |
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Research and development |
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37,283 |
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25,939 |
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130,095 |
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68,202 |
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General and administrative |
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11,438 |
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6,601 |
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37,533 |
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18,865 |
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Total operating expenses |
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48,721 |
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32,540 |
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167,628 |
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87,067 |
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Loss from operations |
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(47,709 |
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(32,540 |
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(165,687 |
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(87,067 |
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Other income (expense): |
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Change in fair value of antidilution rights liability |
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— |
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— |
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— |
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(25,574 |
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Change in fair value of success payment liability |
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2,177 |
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1,139 |
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1,486 |
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(7,815 |
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Interest and other income, net |
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4,501 |
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64 |
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6,867 |
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142 |
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Total other expense, net |
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6,678 |
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1,203 |
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8,353 |
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(33,247 |
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Loss before provision for income taxes |
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(41,031 |
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(31,337 |
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(157,334 |
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(120,314 |
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Provision for income taxes |
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(53 |
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— |
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(53 |
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— |
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Net loss |
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$ |
(41,084 |
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$ |
(31,337 |
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$ |
(157,387 |
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$ |
(120,314 |
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Net loss per common share attributable to common stockholders, basic and diluted |
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$ |
(0.67 |
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$ |
(0.65 |
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$ |
(2.91 |
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$ |
(4.48 |
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Weighted-average common shares used in net loss per share attributable to common stockholders, basic and diluted |
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61,464,731 |
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48,026,078 |
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54,023,653 |
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26,872,036 |
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Condensed consolidated balance sheet data |
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December 31, 2022 |
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December 31, 2021 |
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Cash, cash equivalents and marketable securities |
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$ |
554,808 |
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$ |
360,442 |
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Total assets |
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$ |
679,223 |
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$ |
384,124 |
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Total liabilities |
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$ |
128,291 |
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$ |
26,772 |
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Total stockholders' equity |
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$ |
550,932 |
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$ |
357,352 |
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