Full Press Release Details
Verve Therapeutics Announces Business and Program Highlights and Reports Second Quarter 2021 Financial
New Preclinical Base Editing Durability Data and Proprietary GalNAc-targeted Lipid Nanoparticle Delivery Technology Data to
be Presented at TIDES in September 2021
IND-Enabling Studies Ongoing to Support Planned IND Submission in 2022
Million IPO Completed to Enable Advancement of Gene Editing Programs for Cardiovascular Disease
August 12, 2021 Verve Therapeutics, Inc., (Nasdaq: VERV), a biotech company pioneering a new approach to the care of cardiovascular disease with single-course gene editing medicines, today reported pipeline and
business highlights and second quarter 2021 financial results.
Verve is committed to advancing medicines that can fundamentally change treatment
for patients with cardiovascular disease and ultimately, prevent it altogether, said Sekar Kathiresan, M.D., co-founder and chief executive officer of Verve. We have spent the last few years making
progress on our mission, and in non-human primate studies, have shown that with just a single treatment of our base editor targeting PCSK9, we can safely and durably lower disease-causing high LDL cholesterol,
a key driver of cardiovascular disease today. I am proud of what we have achieved to date and look forward to the milestones ahead for our programs and the potential impact our therapies could make for millions of patients around the world.
Andrew Ashe, J.D., president and chief operating officer of Verve added, Following the completion of our successful IPO in June, we are well
capitalized today, with resources to support the advancement of our two lead programs into clinical development, potential expansion of our pipeline and optimization of our technologies. The combination of a compelling pipeline, strong balance sheet
and dedicated team, positions Verve to advance gene editing therapies that could transform cardiovascular disease treatment.
Title: In vivo CRISPR Base Editing of PCSK9 Durably Lowers
Cholesterol in Primates
Track: mRNA and Genome Editing TRACK: Genome Editing Advances from Preclinical to the
Date/Time: Thursday, September 23, 2021, 8:30 a.m. 9:00 a.m. ET
Title: Targeted Delivery of Base Editors to Hepatocytes In Vivo
Track: Oligonucleotide CMC and Targeted Delivery TRACK: Targeted Delivery of Therapeutic Oligonucleotides
Date/Time: Thursday, September 23, 2021, 8:30 a.m. 9:00 a.m. ET
Second Quarter 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 turn off the PCSK9 gene in the liver in order to disrupt blood PCSK9 protein production and thereby 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.
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 future clinical trials and its research and development. 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, and obtain and
maintain regulatory approvals for, its product candidates; continue to 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.
Ten Bridge Communications
THRUST Strategic Communications
Verve Therapeutics, Inc.
Selected Condensed Financial Information
(in thousands, except share and per share amounts)
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| Condensed consolidated statements of operations | 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 | ||||||||||||
| Condensed consolidated balance sheets | 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 and accrued liabilities | $ | 8,497 | $ | 7,225 | ||||||||||||
| Deferred rent, current portion | 152 | 90 | ||||||||||||||
| Total current liabilities | 8,649 | 7,315 | ||||||||||||||
| Deferred rent, net of current portion | 13 | 125 | ||||||||||||||
| Success payment and antidilution rights liabilities | 12,460 | 9,722 | ||||||||||||||
| Total liabilities | 21,122 | 17,162 | ||||||||||||||
| Convertible preferred stock | 125,160 | |||||||||||||||
| Stockholders equity (deficit) | 405,396 | (63,909 | ) | |||||||||||||
| Total liabilities, convertible preferred stock and stockholders equity (deficit) | $ | 426,518 | $ | 78,413 |