Full Press Release Details
Verve Therapeutics Announces Pipeline Progress and Reports Fourth Quarter and Full Year 2021 Financial Results
Significant Progress Anticipated in 2022 with Initiation of Clinical Trial for VERVE-101 and
IND-enabling Studies for ANGPTL3 Program
Presentations at Upcoming Scientific Conferences to Highlight Novel Base Editing Approach and
Proprietary Lipid Nanoparticle Delivery System
Cash, Cash Equivalents and Marketable Securities of $360.4 Million with Cash Runway into 2024
CAMBRIDGE, Mass. March 14, 2022 Verve Therapeutics, Inc., (Nasdaq: VERV), a biotechnology company pioneering a
new approach to the care of cardiovascular disease with single-course gene editing medicines, today reported pipeline highlights and fourth quarter and full year 2021 financial results. Verve s programs are designed to mimic natural disease
resistance mutations and turn off specific genes, such as PCSK9 and ANGPTL3, in order to lower blood lipids and treat atherosclerotic cardiovascular disease (ASCVD).
The relationship between the lowering of cumulative LDL-C exposure and reduction in the risk of ASCVD is among
the best understood relationships in medicine, said Sekar Kathiresan, M.D., co-founder and chief executive officer of Verve. Today s chronic care model for lowering LDL-C is sub-optimal as it requires continuous, life-long treatment, and cumulative exposure to LDL-C for many patients with ASCVD
often remains insufficiently controlled. Our lead program, VERVE-101, has demonstrated the ability to meaningfully and durably lower LDL-C with a well-tolerated safety
profile in numerous non-human primate (NHP) studies after one-time dosing. Among many activities and initiatives planned in 2022, we are preparing for our most
meaningful milestone yet treating patients in our first clinical trial of VERVE-101 later this year. We are excited to report progress and execution against our goals.
Upcoming Medical Meeting Presentations
announced that the company will be presenting at multiple upcoming scientific conferences. Details of the presentations are as follows:
Title: Sequential In Vivo Crispr Base Editing of the PCSK9 and ANGPTL3 Genes in
Track: Highlighted Original Research: Ischemic Heart Disease and
Date/Time: Monday, April 4, 2022, 9:06 a.m. 9:16 a.m. ET
Title: In Vivo CRISPR Base Editing to Treat ASCVD
Track: Genome Editing and mRNA
Date/Time: Wednesday, May 11, 2022, 8:30 a.m. 9:00 a.m. ET
Session Title: In Vivo CRISPR Base Editing
of PCSK9 Durably Lowers Cholesterol in Primates
Track: CRISPR/CAS9 Gene Editing - Concepts to In-Vivo Editing
Date/Time: Tuesday, May 17, 2022, 8:00 a.m. 9:45 a.m.
Fourth Quarter and Full Year 2021 Financial Results
About Verve Therapeutics
Verve Therapeutics, Inc.
(Nasdaq: VERV) 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 s initial two programs target
PCSK9 and ANGPTL3, genes that have been extensively validated as targets for lowering blood lipids such as low-density lipoprotein cholesterol (LDL-C), a root cause of
cardiovascular disease. Verve s
lead product candidate, VERVE-101, is designed to permanently turn off the PCSK9 gene in the liver in order to disrupt blood PCSK9 protein production and
thereby durably reduce blood LDL-C levels, with the goal of reducing a patient s risk for cardiovascular disease. VERVE-101, currently in IND-enabling studies, is being developed initially for the treatment of patients with heterozygous familial hypercholesterolemia, a potentially fatal genetic heart disease. 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 initiation, and timing, of the Company s regulatory submissions, future clinical trials, 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 timing of and the Company s ability to submit applications for, its product
candidates; advance its product candidates in clinical trials; initiate and enroll 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 its other product candidates; 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.
Verve Therapeutics, Inc.
Ten Bridge Communications
Verve Therapeutics, Inc.
Selected Condensed Financial Information
(in thousands, except share and per share amounts)
| Three months ended December 31, | Year ended December 31, | |||||||||||||||
| Condensed consolidated statements of operations | 2021 | 2020 | 2021 | 2020 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 25,939 | $ | 15,576 | $ | 68,202 | $ | 35,371 | ||||||||
| General and administrative | 6,601 | 2,024 | 18,865 | 5,256 | ||||||||||||
| Total operating expenses | 32,540 | 17,600 | 87,067 | 40,627 | ||||||||||||
| Loss from operations | (32,540 | ) | (17,600 | ) | (87,067 | ) | (40,627 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Change in fair value of preferred stock tranche liability | 2,507 | |||||||||||||||
| Change in fair value of antidilution rights liability | (3,555 | ) | (25,574 | ) | (5,359 | ) | ||||||||||
| Change in fair value of success payment liability | 1,139 | (2,374 | ) | (7,815 | ) | (2,387 | ) | |||||||||
| Interest income and other income (expense), net | 64 | (2 | ) | 142 | 162 | |||||||||||
| Total other income (expense), net | 1,203 | (5,931 | ) | (33,247 | ) | (5,077 | ) | |||||||||
| Net loss | $ | (31,337 | ) | $ | (23,531 | ) | $ | (120,314 | ) | $ | (45,704 | ) | ||||
| Net loss per common share, attributable to common stockholders, basic and diluted | $ | (0.65 | ) | $ | (9.43 | ) | $ | (4.48 | ) | $ | (20.31 | ) | ||||
| Weighted-average common shares used in net loss per share attributable to common stockholders, basic and diluted | 48,026,078 | 2,495,056 | 26,872,036 | 2,250,093 |
| Condensed consolidated balance sheets | December 31, 2021 | December 31, 2020 | ||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 64,330 | $ | 8,993 | ||||
| Marketable securities | 296,112 | 63,119 | ||||||
| Prepaid expenses and other current assets | 6,686 | 1,854 | ||||||
| Total current assets | 367,128 | 73,966 | ||||||
| Property and equipment, net | 7,224 | 3,984 | ||||||
| Restricted cash | 5,237 | 463 | ||||||
| Operating lease right-of-use assets | 1,839 | |||||||
| Other long term assets | 2,696 | |||||||
| Total assets | $ | 384,124 | $ | 78,413 | ||||
| Liabilities, convertible preferred stock and stockholders equity (deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 20,069 | $ | 7,225 | ||||
| Operating lease obligations, current portion | 1,955 | |||||||
| Deferred rent, current portion | 90 | |||||||
| Total current liabilities | 22,024 | 7,315 | ||||||
| Deferred rent, net of current portion | 125 | |||||||
| Success payment liability, net of current portion | 4,371 | 2,806 | ||||||
| Antidilution rights liability | 6,916 | |||||||
| Other long term liabilities | 377 | |||||||
| Total liabilitites | 26,772 | 17,162 | ||||||
| Convertible preferred stock | 125,160 | |||||||
| Stockholders equity (deficit) | 357,352 | (63,909 | ) | |||||
| Total liabilities, convertible preferred stock and stockholders equity (deficit) | $ | 384,124 | $ | 78,413 |