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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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 November 5, 2024, Verve Therapeutics, Inc. (the “Company”) announced its financial results for the quarter ended September 30, 2024. 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 November 5, 2024.
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: November 5, 2024 |
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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 Announces Pipeline Progress and Reports Third Quarter 2024 Financial Results
Seven participants across two cohorts dosed in the Heart-2 Phase 1b clinical trial of VERVE-102 targeting PCSK9; Initial data planned for the first half of 2025
First participant dosed in the Pulse-1 Phase 1b clinical trial of VERVE-201 targeting ANGPTL3; Regulatory clearances in Australia, Canada, and the U.K.
Cash, cash equivalents, and marketable securities of $539.9 million; cash runway through 2026
BOSTON — November 5, 2024 — Verve Therapeutics, a clinical-stage company developing a new class of genetic medicines for cardiovascular disease, today reported pipeline updates and financial results for the quarter ended September 30, 2024.
“In the third quarter, we made considerable progress towards our mission to develop a new class of genetic medicines where a one-time treatment leads to lifelong lowering of blood cholesterol,” said Sekar Kathiresan, M.D., co-founder and chief executive officer of Verve Therapeutics. “We continue to execute on the Heart-2 clinical trial and are pleased to share that as of October 29, 2024, seven participants have been dosed. VERVE-102 has been well-tolerated, with no serious adverse events and no clinically significant laboratory abnormalities observed. We look forward to providing initial data from the Heart-2 clinical trial and an update on the PCSK9 program in the first half of 2025.”
Dr. Kathiresan continued, “In addition, we are excited to announce that the first participant in the Pulse-1 Phase 1b clinical trial for our ANGPTL3 product candidate, VERVE-201, was recently dosed. With cash runway through 2026, we are well-positioned to execute additional important milestones across our pipeline and advance our early-stage programs, including our program targeting LPA. With two product candidates being tested in the clinic, we expect 2025 to be an eventful year for Verve as we develop a new approach for the treatment of cardiovascular disease.”
PCSK9 Program
Enrollment Ongoing in Heart-2 Phase 1b Clinical Trial Evaluating VERVE-102
Analyses of Heart-1 Phase 1b Clinical Trial of VERVE-101
ANGPTL3 Program
First Participant Dosed with VERVE-201 in the Pulse-1 Phase 1b Clinical Trial
The Pulse-1 clinical trial is designed to evaluate the safety and tolerability of VERVE-201 administration in adult patients with RH who require additional lowering of LDL-C despite treatment with maximally tolerated standard of care therapies, potentially including PCSK9 inhibitors. Endpoints also include pharmacokinetics and changes in blood ANGPTL3 protein and LDL-C levels. The Pulse-1 clinical trial is a single-ascending dose study that has an adaptive design. The Pulse-1 clinical trial is expected to include four dose cohorts each comprised of three to nine patients with RH.
Upcoming Investor Events
Verve plans to participate in fireside chats during the following upcoming investor events:
Upcoming Medical Meeting Presentations
Verve plans to present a moderated digital poster at the American Heart Association (AHA) Scientific Sessions in Chicago, IL. Details of the poster session are as follows:
Title: Design of Heart-2: a phase 1b clinical trial of VERVE-102, an in vivo base editing medicine delivered by a GalNAc-LNP and targeting PCSK9 to durably lower LDL cholesterol
Session:Genomic Therapies for Cardiovascular Disease
Date and Time: November 16 at 10:35 AM CT
Third Quarter 2024 Financial Results
Cash Position: Verve ended the third quarter of 2024 with $539.9 million in cash, cash equivalents, and marketable securities. Verve expects its capital position to be sufficient to fund its operations through 2026.
Collaboration Revenue: Collaboration revenue was $6.9 million for the third quarter of 2024, compared to $3.1 million for the third quarter of 2023. The increase was primarily due to an increase in research services performed under the company’s collaboration agreements.
Research & Development (R&D) Expenses: R&D expenses were $49.9 million for the third quarter of 2024, compared to $43.8 million for the third quarter of 2023. Stock-based compensation expense included in R&D expenses was $5.4 million and $4.9 million for the third quarter of 2024 and 2023, respectively.
General & Administrative (G&A) Expenses: G&A expenses were $13.8 million for the third quarter of 2024, compared to $11.7 million for the third quarter of 2023. Stock-based compensation expense included in G&A expenses was $5.4 million and $3.9 million for the third quarter of 2024 and 2023, respectively.
Net Loss: Net loss was $50.1 million, or $0.59 basic and diluted net loss per share, for the third quarter of 2024, compared to $45.8 million, or $0.72 basic and diluted net loss per share, for the third quarter of 2023.
About Verve Therapeutics
Verve Therapeutics, Inc. (Nasdaq: VERV) 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’s lead programs – VERVE-101, VERVE-102, and VERVE-201 – target genes that have been extensively validated as targets for lowering low-density lipoprotein cholesterol (LDL-C), a root cause of
atherosclerotic cardiovascular disease (ASCVD). VERVE-101 and VERVE-102 are designed to permanently turn off the PCSK9 gene in the liver and are being developed initially for heterozygous familial hypercholesterolemia (HeFH) and ultimately to treat patients with established ASCVD who continue to be impacted by high LDL-C levels. VERVE-201 is designed to permanently turn off the ANGPTL3 gene in the liver and is initially being developed for refractory hypercholesterolemia, where patients still have high LDL-C despite treatment with maximally tolerated standard of care therapies, and homozygous familial hypercholesterolemia (HoFH). For more information, please visit www.VerveTx.com.
Cautionary Note Regarding 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 ongoing Heart-2 clinical trial and Pulse-1 clinical trial; the timing and availability of data for the Heart-2 trial, PCSK9 program and Pulse-1 trial; expectations for the company’s Heart-1 clinical trial; its research and development plans; the potential advantages and therapeutic potential of the company’s programs; 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 company’s ability to timely submit and receive approvals of regulatory 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, VERVE-102, 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 Condensed Consolidated Financial Information
(in thousands, except share and per share amounts)
(unaudited)
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Three months ended September 30, |
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Nine months ended September 30, |
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Condensed consolidated statements of operations |
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2024 |
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2023 |
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2024 |
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2023 |
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Collaboration revenue |
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$ |
6,865 |
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$ |
3,117 |
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$ |
19,252 |
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$ |
6,614 |
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Operating expenses: |
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Research and development |
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49,938 |
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43,765 |
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149,299 |
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138,135 |
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General and administrative |
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13,837 |
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11,686 |
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42,546 |
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37,655 |
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Total operating expenses |
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63,775 |
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55,451 |
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191,845 |
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175,790 |
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Loss from operations |
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(56,910 |
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(52,334 |
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(172,593 |
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(169,176 |
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Other income (expense): |
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Change in fair value of success payment liability |
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(6 |
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802 |
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1,743 |
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878 |
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Interest and other income, net |
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6,887 |
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5,841 |
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22,452 |
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16,825 |
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Total other income, net |
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6,881 |
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6,643 |
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24,195 |
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17,703 |
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Loss before provision for income taxes |
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(50,029 |
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(45,691 |
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(148,398 |
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(151,473 |
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Provision for income taxes |
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(104 |
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(67 |
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(276 |
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(243 |
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Net loss |
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$ |
(50,133 |
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$ |
(45,758 |
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$ |
(148,674 |
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$ |
(151,716 |
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Net loss per common share, basic and diluted |
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$ |
(0.59 |
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$ |
(0.72 |
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$ |
(1.77 |
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$ |
(2.43 |
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Weighted-average common shares used in net loss per share, basic and diluted |
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84,632,952 |
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63,211,849 |
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83,999,797 |
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62,322,965 |
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Condensed consolidated balance sheet data |
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September 30, |
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December 31, |
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Cash, cash equivalents and marketable securities |
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$ |
539,920 |
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$ |
623,950 |
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Total assets |
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$ |
663,906 |
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$ |
752,688 |
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Total liabilities |
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$ |
155,355 |
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$ |
153,186 |
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Total stockholders' equity |
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$ |
508,551 |
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$ |
599,502 |
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