VERV Verve Therapeutics Inc.

42.72
-1.25  -3%
Previous Close 43.97
Open 43.82
52 Week Low 29.5
52 Week High 78
Market Cap $2,050,209,653
Shares 47,991,799
Float 36,449,666
Enterprise Value $1,692,575,402
Volume 175,697
Av. Daily Volume 388,389
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Drug Pipeline

Drug Stage Notes
VERVE-101
Heterozygous familial hypercholesterolemia (HeFH)
Phase 1
Phase 1
IND filing due 2022.

Latest News

  1. CAMBRIDGE, Mass., Oct. 21, 2021 (GLOBE NEWSWIRE) -- Verve Therapeutics, a biotech company pioneering a new approach to the care of cardiovascular disease with single-course gene editing medicines, today announced that Sekar Kathiresan, M.D., co-founder and chief executive officer and Andrew Bellinger, M.D., Ph.D., chief scientific officer and chief medical officer, will participate in a fireside chat during the Jefferies Gene Therapy/Editing Summit on Thursday, October 28, 2021 at 9:00 a.m. ET.

    A live webcast will be available in the investor section of the company's website at www.vervetx.com. The webcast will be archived for 60 days following the presentation.

    About Verve Therapeutics
    Verve Therapeutics, Inc. (NASDAQ:VERV) is a genetic…

    CAMBRIDGE, Mass., Oct. 21, 2021 (GLOBE NEWSWIRE) -- Verve Therapeutics, a biotech company pioneering a new approach to the care of cardiovascular disease with single-course gene editing medicines, today announced that Sekar Kathiresan, M.D., co-founder and chief executive officer and Andrew Bellinger, M.D., Ph.D., chief scientific officer and chief medical officer, will participate in a fireside chat during the Jefferies Gene Therapy/Editing Summit on Thursday, October 28, 2021 at 9:00 a.m. ET.

    A live webcast will be available in the investor section of the company's website at www.vervetx.com. The webcast will be archived for 60 days following the presentation.

    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.

    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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  2. CAMBRIDGE, Mass., Sept. 27, 2021 (GLOBE NEWSWIRE) -- Verve Therapeutics, a biotech company pioneering a new approach to the care of cardiovascular disease with single-course gene editing medicines, today announced that Sekar Kathiresan, M.D., co-founder and chief executive officer and Andrew Bellinger, M.D., Ph.D., chief scientific officer and chief medical officer, will participate in a fireside chat during the Chardan Virtual 5th Annual Genetics Medicines Conference on Monday, October 4, 2021 at 11:00 a.m. ET. Dr. Kathiresan will also participate in a panel titled, "Genetic Medicines: The Ongoing Emergence of the Heart as a Target Tissue Panel" on Monday, October 4, 2021 at 3:00 p.m. ET.

    A live webcast of the fireside chat will be available…

    CAMBRIDGE, Mass., Sept. 27, 2021 (GLOBE NEWSWIRE) -- Verve Therapeutics, a biotech company pioneering a new approach to the care of cardiovascular disease with single-course gene editing medicines, today announced that Sekar Kathiresan, M.D., co-founder and chief executive officer and Andrew Bellinger, M.D., Ph.D., chief scientific officer and chief medical officer, will participate in a fireside chat during the Chardan Virtual 5th Annual Genetics Medicines Conference on Monday, October 4, 2021 at 11:00 a.m. ET. Dr. Kathiresan will also participate in a panel titled, "Genetic Medicines: The Ongoing Emergence of the Heart as a Target Tissue Panel" on Monday, October 4, 2021 at 3:00 p.m. ET.

    A live webcast of the fireside chat will be available in the investor section of the company's website at www.vervetx.com. The webcast will be archived for 60 days following the presentation.

    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.

    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. Treatment of Non-Human Primates with Clinical Candidate, VERVE-101, Led to Durable Reductions of PCSK9 Protein and Low-density Lipoprotein Cholesterol

    Comprehensive Off-Target Editing Analysis Using Industry Leading Methods, ONE-seq and Digenome-seq Showed No Off-Target Editing Across 244 Potential Sites in Human Liver Cells

    Data Support Continued Advancement of VERVE-101 Toward IND Submission in 2022

    CAMBRIDGE, Mass., Sept. 23, 2021 (GLOBE NEWSWIRE) -- Verve Therapeutics, a biotech company pioneering a new approach to the care of cardiovascular disease with single-course gene editing medicines, today reported data from a new preclinical study in 36 non-human primates (NHPs) with its lead clinical candidate, VERVE-101, a potential…

    Treatment of Non-Human Primates with Clinical Candidate, VERVE-101, Led to Durable Reductions of PCSK9 Protein and Low-density Lipoprotein Cholesterol

    Comprehensive Off-Target Editing Analysis Using Industry Leading Methods, ONE-seq and Digenome-seq Showed No Off-Target Editing Across 244 Potential Sites in Human Liver Cells

    Data Support Continued Advancement of VERVE-101 Toward IND Submission in 2022

    CAMBRIDGE, Mass., Sept. 23, 2021 (GLOBE NEWSWIRE) -- Verve Therapeutics, a biotech company pioneering a new approach to the care of cardiovascular disease with single-course gene editing medicines, today reported data from a new preclinical study in 36 non-human primates (NHPs) with its lead clinical candidate, VERVE-101, a potential single-course gene editing treatment for atherosclerotic cardiovascular disease (ASCVD). Findings from that study as well as additional studies in rodents demonstrated potent and durable lowering of blood PCSK9 protein and low-density lipoprotein cholesterol (LDL-C), with no evidence of adverse events or significant off-target editing. The data will be presented today at the TIDES USA Oligonucleotide & Peptide Therapeutics Conference.

    VERVE-101 is being developed initially for the treatment of patients with heterozygous familial hypercholesterolemia (HeFH), a potentially fatal genetic heart disease. In patients with HeFH, a genetic mutation in one copy of the LDL receptor (LDLR) gene down-regulates LDLR expression, which limits the ability of liver cells to remove LDL-C from the bloodstream, resulting in extremely high LDL-C levels in the blood. VERVE-101 is designed to inactivate the PCSK9 gene, resulting in sustained reduction in PCSK9 protein levels and increased LDLR expression, leading to lower LDL-C levels and reduced risk for ASCVD.

    "Building off our earlier pilot study with a precursor formulation, today's data are the first presentation from our clinical candidate, VERVE-101, and demonstrate potent whole liver editing and durable reductions in PCSK9 protein and LDL-C in NHPs, with a well-tolerated safety profile," said Sekar Kathiresan, M.D., co-founder and chief executive officer of Verve. "The precise and predictable nature of base editors combined with the well-established preferential distribution of LNPs to the liver makes for an ideal approach to targeting PCSK9. We believe that studies in NHPs are a powerful predictor of efficacy in humans for LNP delivery to the liver as well as gene editing in the liver. We're very encouraged by these data and look forward to advancing this potentially life-changing treatment to patients with ASCVD around the world."

    The presentation today describes several new studies with the clinical formulation of VERVE-101, including a long-term durability and safety study in NHPs, a durability challenge study consisting of a partial hepatectomy model in mouse, a germline editing assessment in sexually mature male NHPs, and an expanded off-target analysis. Key findings across the studies include:

    • 70% mean editing at the PCSK9 target site in NHPs treated with 1.5 mg/kg VERVE-101 (n=22) as observed in liver biopsies at two weeks, consistent with previously reported data;  
    • Large, durable reductions in PCSK9 and LDL-C levels after a single dose of VERVE-101 at two different dose levels in NHPs when measured at day 14 and day 180:
      • Approximately 86% mean PCSK9 protein reduction and approximately 62% mean LDL-C reduction observed at day 14 and maintained out to 180 days in NHPs treated with 1.5 mg/kg VERVE-101 (n=22);
      • Approximately 54% mean PCSK9 protein reduction and approximately 38% mean LDL-C reduction observed at day 14, which further improved to 71% and 46%, respectively, at day 180 in NHPs treated with 0.75 mg/kg VERVE-101 (n=4);
    • Greater potency with VERVE-101 in primary human hepatocytes than in primary monkey hepatocytes, further supporting the potential for potency in the clinic;
    • No evidence of germline editing in an analysis conducted in sexually mature male NHPs receiving a 1.5 mg/kg dose of VERVE-101 (n=6);
    • Sustained editing of PCSK9 in regenerated liver lobes at 95 days post-treatment, as demonstrated in a partial hepatectomy mouse model to determine durability of PCSK9 base editing in the liver;
    • Demonstration that VERVE-101 introduced a precise A to G edit at the on-target site in PCSK9 with no evidence of any bystander edits;
    • No significant off-target editing observed in human liver cells among 244 candidate sites, as evaluated through a comprehensive off-target analysis in primary human hepatocytes using a highly sensitive hybrid capture assay;
    • No significant off-target editing at the same 244 candidate sites following an extended analysis to primary human splenic cells; and
    • A generally well-tolerated profile with VERVE-101 in NHPs at all doses evaluated, with only reversible, mild transient ALT elevations observed and no impact on glucose levels.

    In addition, Verve provided an update from its pilot study in NHPs initiated in 2020 using a precursor formulation (ABE-PCSK9). At 15 months following a single gene-editing treatment, the company observed persistent lowering of both blood PCSK9 protein and LDL-C levels of approximately 90% and 60%, respectively.

    Andrew Bellinger, M.D., Ph.D., chief scientific officer of Verve added, "Critical to the field of gene editing is minimizing the potential for off-target editing, which we assess using comprehensive, sensitive and state-of-the-art methods, including ONE-seq and Digenome-seq. Analysis of VERVE-101 with these methods continued to demonstrate excellent safety, with no off-target editing at 244 potential sites evaluated in human liver cells. Further, no evidence of germline editing in NHPs has been observed. These findings, combined with the potent and durable reductions in LDL-C, support the continued advancement of VERVE-101 as we prepare to submit our IND and begin human trials in 2022."

    Presentation Details

    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, 9:30 a.m. - 10:00 a.m. ET

    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, 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 planned IND submission and future clinical trials and its research and development plans. 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, 617-460-3579

    Ten Bridge Communications

    gina@tenbridgecommunications.com

    Investor Contact

    Monique Allaire

    THRUST Strategic Communications

    monique@thrustsc.com



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  4. CAMBRIDGE, Mass., Sept. 23, 2021 (GLOBE NEWSWIRE) -- Verve Therapeutics, a biotech company pioneering a new approach to the care of cardiovascular disease with single-course gene editing medicines, today announced new in vivo data from the company's proprietary lipid nanoparticle (LNP) delivery technology leveraging an internally discovered GalNAc-targeting ligand for delivery of base editors to the liver. Findings highlight the ability of Verve's novel GalNAc-LNP to achieve high efficiency liver delivery and base editing in mouse models of homozygous familial hypercholesterolemia (HoFH), a form of atherosclerotic cardiovascular disease (ASCVD). The data will be presented today at the TIDES USA Oligonucleotide & Peptide Therapeutics Conference…

    CAMBRIDGE, Mass., Sept. 23, 2021 (GLOBE NEWSWIRE) -- Verve Therapeutics, a biotech company pioneering a new approach to the care of cardiovascular disease with single-course gene editing medicines, today announced new in vivo data from the company's proprietary lipid nanoparticle (LNP) delivery technology leveraging an internally discovered GalNAc-targeting ligand for delivery of base editors to the liver. Findings highlight the ability of Verve's novel GalNAc-LNP to achieve high efficiency liver delivery and base editing in mouse models of homozygous familial hypercholesterolemia (HoFH), a form of atherosclerotic cardiovascular disease (ASCVD). The data will be presented today at the TIDES USA Oligonucleotide & Peptide Therapeutics Conference.

    Verve is advancing a pipeline of single-course in vivo gene editing programs for the treatment of ASCVD indications, including HoFH. Verve's gene editing programs consist of LNPs that encapsulate mRNA encoding for a gene or base editor, as well as a guide RNA targeting the gene of interest expressed in the liver. For patients with HoFH, LNP-mediated liver delivery is challenging because complete deficiency in the low-density lipoprotein receptor (LDLR) gene in this patient population often drives HoFH pathophysiology, and uptake of LNPs into the liver is generally thought to be through a LDLR-dependent pathway. To overcome this, Verve has developed a novel approach that bypasses the LDLR and delivers LNPs to the liver through a different receptor. Asialoglycoprotein receptors (ASGPRs) are highly expressed in the liver with a high capacity to mediate uptake into the liver, independent of LDLR. As such, by incorporating an internally discovered GalNAc molecule, the targeting ligand for ASGPR, into an LNP, Verve was able to efficiently and safely deliver a base editor to the liver in a mouse model of HoFH.

    "Our goal at Verve is to transform the future treatment of cardiovascular disease by creating single-course gene editing treatments, with lead programs that leverage base editors to turn off disease-driving genes in the liver," said Andrew Bellinger, M.D., Ph.D., chief scientific officer of Verve. "In some patient populations, such as HoFH, using LNPs for delivery of base editors is not possible, requiring the need for an alternative delivery approach to treat these patients. To address this, we have designed and developed a proprietary GalNAc-LNP to enable efficient and potent liver editing regardless of LDLR expression. We are very excited to share findings leveraging this delivery approach, which may allow us to reach patients who lack LDLR and may be applicable in other populations where liver-targeted delivery is advantageous."

    Verve's proprietary GalNAc-LNP was designed using novel chemical ligand compositions and a potent low ligand surface density, which is designed to optimize recognition and binding to ASGPRs. In addition, the formulation has been developed using a scalable process with favorable manufacturing properties similar to standard LNPs. Data presented today demonstrate:

    • High efficiency liver delivery of an adenine base editor targeting ANGPTL3 in both LDLR heterozygous and homozygous deficient mouse models;
    • Low GalNAc-lipid content with 0.05 mol% leading to maximal liver editing in an LDLR knockout model;
    • A scalable process of incorporating the GalNAc ligand into the LNP with near-homogenous distribution of GalNAc ligand; and
    • Potent editing in vivo regardless of the LDLR status of the mouse.

    Verve is advancing a gene editing program that targets ANGPTL3, a gene known to regulate blood LDL-C and triglycerides. Such a program would have potential indications in both HoFH and in heterozygous familial hypercholesterolemia. Verve is designing this program to utilize a GalNAc-modified LNP encapsulating an mRNA encoding a base editor and a gRNA targeting the ANGPTL3 gene. The company's program is currently in the lead optimization stage, and the company expects to name its development candidate and initiate IND-enabling studies in 2022.

    Presentation Details

    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

    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 planned IND submissions and future clinical trials and its research and development plans. 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, 617-460-3579

    Ten Bridge Communications

    gina@tenbridgecommunications.com

    Investor Contact

    Monique Allaire

    THRUST Strategic Communications

    monique@thrustsc.com



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  5. 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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