1. New Preclinical Base Editing Durability Data and Proprietary GalNAc-targeted Lipid Nanoparticle Delivery Technology Data to be Presented at TIDES in September 2021

    VERVE-101 IND-Enabling Studies Ongoing to Support Planned IND Submission in 2022

    Successful $306.7 Million IPO Completed to Enable Advancement of Gene Editing Programs for Cardiovascular Disease

    CAMBRIDGE, Mass., Aug. 12, 2021 (GLOBE NEWSWIRE) -- 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…

    New Preclinical Base Editing Durability Data and Proprietary GalNAc-targeted Lipid Nanoparticle Delivery Technology Data to be Presented at TIDES in September 2021

    VERVE-101 IND-Enabling Studies Ongoing to Support Planned IND Submission in 2022

    Successful $306.7 Million IPO Completed to Enable Advancement of Gene Editing Programs for Cardiovascular Disease

    CAMBRIDGE, Mass., Aug. 12, 2021 (GLOBE NEWSWIRE) -- 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."

    Pipeline Highlights

    • Updated Data from PCSK9 Gene Editing Program and LNP Delivery Approach to be Presented at TIDES 2021: Verve is scheduled to provide two presentations: (1) updated preclinical durability data from its lead program targeting PCSK9, in non-human primates (NHPs); and (2) new in vivo data highlighting its proprietary, internal lipid nanoparticle (LNP) delivery program (liver-targeting via incorporation of a novel GalNAc-targeting ligand) during oral sessions at the TIDES USA Oligonucleotide & Peptide Therapeutics Conference (TIDES 2021). Details of the presentations are as follows:



      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 Clinic

      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

    • Data Demonstrating Potent and Durable Lowering of PCSK9 in NHPs Published in Nature: In May 2021, Verve published proof-of-concept data highlighting the company's gene editing approach for the treatment of cardiovascular disease in the journal Nature. Data included were from an ongoing preclinical study of the administration of a single gene editing treatment in NHPs. In this study, Verve observed potent and durable lowering of both blood PCSK9 protein and low-density lipoprotein cholesterol (LDL-C) levels of approximately 90% and 60%, respectively, following administration of a single gene editing treatment. These data showed durability out to 10 months at the most recent analysis.

    Business Highlights

    • $306.7 Million Initial Public Offering (IPO) Successfully Completed: In June 2021, Verve sold 16,141,157 shares of its common stock, which included 2,105,368 shares sold pursuant to the exercise in full by the underwriters of their option to purchase additional shares, at a public offering price of $19.00 per share. Including the option exercise, the aggregate gross proceeds to Verve from the offering were $306.7 million, before deducting the underwriting discounts and commissions and offering expenses.



    • Board of Directors Expanded to Support Future Growth: In the second quarter of 2021, Verve announced two appointments to its board of directors:

      • Michael F. MacLean, chief financial officer of Avidity Biosciences, Inc.
      • Sheila Mikhail, J.D., MBA, chief executive officer and co-founder of Asklepios BioPharmaceutical, Inc. (AskBio), a subsidiary of Bayer AG.

    Second Quarter 2021 Financial Results

    • Cash Position: Cash, cash equivalents and marketable securities were $417.6 million as of June 30, 2021, which includes net proceeds from Verve's successful initial public offering, as compared to $72.1 million as of December 31, 2020.
    • Research & Development (R&D) Expenses: R&D expenses were $13.4 million for the second quarter of 2021, as compared to $5.7 million for the second quarter of 2020. The increase of approximately $7.8 million was primarily due to increased costs to support the growth of the company's research and development organization, including expenses associated with developing manufacturing activities and increased headcount.
    • General & Administrative (G&A) Expenses: G&A expenses were $3.5 million for the second quarter of 2021, as compared to $1.0 million for the second quarter of 2020. The increase of $2.5 million was primarily due to expenses stemming from increased headcount to support the company's growth.
    • Net Loss: Net loss attributable to common stockholders was $53.0 million, or $6.66 per share, for the second quarter of 2021, as compared to $7.6 million, or $3.41 per share, for the second quarter of 2020. In addition to the increases in R&D and G&A expenses noted above, the increase in net loss of $45.4 million was partially due to the final settlement of the antidilution rights liability recorded in the second quarter of 2021, which resulted in a charge of $26.0 million recorded to other expense, and an increase to the success payment liability, which resulted in a charge of $10.0 million recorded to other expense.

    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.

    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 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.

    Media Contact

    Gina Nugent

    Ten Bridge Communications

    gina@tenbridgecommunications.com

    Investor Contact

    Monique Allaire

    THRUST Strategic Communications

    monique@thrustsc.com

     

    Verve Therapeutics, Inc.  
    Selected Condensed Financial Information 
    (in thousands, except share and per share amounts) 
    (unaudited) 
                  
    Condensed consolidated statements of operations Three months ended

    June 30,
      Six months ended

    June 30,
     
       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 

     



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  2. CAMBRIDGE, Mass., June 21, 2021 (GLOBE NEWSWIRE) -- Verve Therapeutics (NASDAQ:VERV), a biotech company pioneering a new approach to the care of cardiovascular disease with single-course gene editing medicines, today announced the closing of its previously announced initial public offering of 16,141,157 shares of its common stock, which includes 2,105,368 shares sold pursuant to the exercise in full by the underwriters of their option to purchase additional shares, at a price to the public of $19.00 per share. Including the option exercise, the aggregate gross proceeds to Verve Therapeutics from the offering were approximately $306.7 million, before deducting the underwriting discounts and commissions and offering expenses.

    The shares began…

    CAMBRIDGE, Mass., June 21, 2021 (GLOBE NEWSWIRE) -- Verve Therapeutics (NASDAQ:VERV), a biotech company pioneering a new approach to the care of cardiovascular disease with single-course gene editing medicines, today announced the closing of its previously announced initial public offering of 16,141,157 shares of its common stock, which includes 2,105,368 shares sold pursuant to the exercise in full by the underwriters of their option to purchase additional shares, at a price to the public of $19.00 per share. Including the option exercise, the aggregate gross proceeds to Verve Therapeutics from the offering were approximately $306.7 million, before deducting the underwriting discounts and commissions and offering expenses.

    The shares began trading on the Nasdaq Global Select Market on June 17, 2021 under the ticker symbol "VERV."

    J.P. Morgan, Jefferies, Guggenheim Securities and William Blair acted as joint book-running managers for the offering.

    A registration statement relating to the shares sold in the offering was filed with the Securities and Exchange Commission and was declared effective on June 16, 2021. Copies of the registration statement can be accessed through the SEC's website at www.sec.gov. This offering was made only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by email at prospectus-eq_fi@jpmchase.com; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10012, by telephone at 877-821-7388 or by email at prospectus_department@Jefferies.com; Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, by telephone at (212) 518-5548, or by email at GSEquityProspectusDelivery@guggenheimpartners.com; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by telephone at (800) 621-0687, or by email at prospectus@williamblair.com.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

    About Verve Therapeutics

    Verve Therapeutics (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.

    Media Contact

    Gina Nugent, 617-460-3579

    Ten Bridge Communications

    gina@tenbridgecommunications.com

    Investor Contact

    Monique Allaire

    THRUST Strategic Communications

    monique@thrustsc.com



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  3. Verve Therapeutics, a biotech company pioneering a new approach to the care of cardiovascular disease with single-course gene editing medicines, today announced the pricing of its initial public offering of 14,035,789 shares of its common stock at a price to the public of $19.00 per share. The gross proceeds to Verve from the offering, before deducting the underwriting discounts and commissions and offering expenses, are expected to be $266.7 million. All of the shares are being offered by Verve. In addition, Verve has granted the underwriters a 30-day option to purchase up to an additional 2,105,368 shares of its common stock at the initial public offering price less the underwriting discounts and commissions.

    The shares are expected to begin…

    Verve Therapeutics, a biotech company pioneering a new approach to the care of cardiovascular disease with single-course gene editing medicines, today announced the pricing of its initial public offering of 14,035,789 shares of its common stock at a price to the public of $19.00 per share. The gross proceeds to Verve from the offering, before deducting the underwriting discounts and commissions and offering expenses, are expected to be $266.7 million. All of the shares are being offered by Verve. In addition, Verve has granted the underwriters a 30-day option to purchase up to an additional 2,105,368 shares of its common stock at the initial public offering price less the underwriting discounts and commissions.

    The shares are expected to begin trading on the Nasdaq Global Select Market on June 17, 2021, under the ticker symbol "VERV." The offering is expected to close on June 21, 2021, subject to the satisfaction of customary closing conditions.

    J.P. Morgan, Jefferies, Guggenheim Securities and William Blair are acting as joint book-running managers for the offering.

    A registration statement relating to these securities has been filed with the Securities and Exchange Commission and was declared effective on June 16, 2021. The offering is being made only by means of a prospectus. A copy of the final prospectus, when available, may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by email at prospectus-eq_fi@jpmchase.com; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10012, by telephone at 877-821-7388 or by email at prospectus_department@Jefferies.com; Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, by telephone at (212) 518-5548, or by email at GSEquityProspectusDelivery@guggenheimpartners.com; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by telephone at (800) 621-0687, or by email at prospectus@williamblair.com.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

    About Verve Therapeutics

    Verve Therapeutics 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.

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