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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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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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 7, 2023, Verve Therapeutics, Inc. (the “Company”) announced its financial results for the quarter ended September 30, 2023. 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 7, 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: November 7, 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 Highlights Recent Company Progress and Reports Third Quarter 2023 Financial Results
U.S. Food and Drug Administration (FDA) Clears Investigational New Drug Application for VERVE-101 in Patients with Heterozygous Familial Hypercholesterolemia (HeFH)
Collaboration with Eli Lilly and Company (Lilly) Expands Through Lilly’s Acquisition of Product Rights to Verve’s PCSK9 and ANGPTL3 Programs from Beam Therapeutics
Interim Data from the heart-1 Phase 1b Clinical Trial of VERVE-101 in Patients with HeFH to be Presented at the American Heart Association (AHA) Scientific Sessions 2023 on November 12 at 3:30 p.m. ET; Company to Host Investor Event and Webcast on November 12 at 6:30 p.m. ET
Cash, Cash Equivalents and Marketable Securities of $485.2 Million with Cash Runway into 2026
BOSTON — November 7, 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 recent company progress and financial results for the third quarter of 2023.
“Verve was founded in 2018 with a vision to develop single-course gene editing medicines for cardiovascular disease and throughout this year, we have made tremendous strides towards realizing that vision,” said Sekar Kathiresan, M.D., co-founder and chief executive officer of Verve. “We continue to progress the heart-1 Phase 1b trial of VERVE-101 in patients in the United Kingdom and New Zealand, and we are looking forward to presenting interim data from this trial at the upcoming AHA meeting. We have obtained clearance of our first IND application from the FDA, which now enables us to add U.S. sites to the heart-1 trial and begins the regulatory path in the U.S. for VERVE-101. Beyond VERVE-101, we remain focused on advancing our pipeline and are on-track to initiate Phase 1 clinical trials for VERVE-102 in the first half of 2024 and VERVE-201 in the second half of 2024. Finally, we are thrilled to gain Lilly as a collaborator for our PCSK9 and ANGPTL3 programs. Lilly brings development expertise as well as a track record of successful commercialization of cardiometabolic medicines. We believe all of this progress in 2023 moves us closer to being able to deliver a new class of medicines to patients living with atherosclerotic cardiovascular disease (ASCVD).”
VERVE-101 heart-1 Phase 1b Interim Data to be Presented at the American Heart Association’s Scientific Sessions 2023
VERVE-102 On-Track for Clinical Trial Initiation in First Half of 2024
VERVE-201 On-Track for Clinical Trial Initiation in Second Half of 2024
Corporate Update
Other Upcoming Investor Events
Verve plans to participate in fireside chats during the following upcoming investor events:
Third Quarter 2023 Financial Results
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 three 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 cardiovascular disease, in order to durably reduce blood LDL-C levels. 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 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 for homozygous familial hypercholesterolemia (HoFH) and ultimately to treat patients with refractory hypercholesterolemia. 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 ability to enroll patients in its ongoing heart-1 trial and activate clinical trial sites in the United States; the timing and availability of clinical data from its heart-1 trial; the expected timing of initiating clinical trials of VERVE-102 and VERVE-201; its research and development plans; the potential advantages and therapeutic potential of the company’s programs, including VERVE-101, VERVE-102, 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 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 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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2023 |
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2022 |
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2023 |
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2022 |
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Collaboration revenue |
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$ |
3,117 |
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$ |
929 |
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$ |
6,614 |
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$ |
929 |
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Operating expenses: |
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Research and development |
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43,765 |
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35,197 |
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138,135 |
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92,811 |
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General and administrative |
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11,686 |
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9,592 |
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37,655 |
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26,095 |
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Total operating expenses |
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55,451 |
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44,789 |
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175,790 |
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118,906 |
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Loss from operations |
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(52,334 |
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(43,860 |
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(169,176 |
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(117,977 |
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Other income (expense): |
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Change in fair value of success payment liability |
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802 |
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(3,306 |
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878 |
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(691 |
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Interest and other income, net |
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5,841 |
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1,976 |
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16,825 |
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2,366 |
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Total other income (expense), net |
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6,643 |
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(1,330 |
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17,703 |
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1,675 |
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Loss before provision for income taxes |
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(45,691 |
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(45,190 |
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(151,473 |
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(116,302 |
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Provision for income taxes |
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(67 |
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- |
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(243 |
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- |
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Net loss |
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$ |
(45,758 |
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$ |
(45,190 |
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$ |
(151,716 |
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$ |
(116,302 |
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Net loss per common share, basic and diluted |
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$ |
(0.72 |
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$ |
(0.79 |
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$ |
(2.43 |
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$ |
(2.26 |
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Weighted-average common shares used in net loss per share, basic and diluted |
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63,211,849 |
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57,207,125 |
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62,322,965 |
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51,516,037 |
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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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$ |
485,226 |
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$ |
554,808 |
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Total assets |
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$ |
612,407 |
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$ |
679,223 |
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Total liabilities |
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$ |
152,038 |
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$ |
128,291 |
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Total stockholders' equity |
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$ |
460,369 |
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$ |
550,932 |
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