Core Insights - Verve Therapeutics has received FDA clearance for its Investigational New Drug (IND) application for VERVE-102, aimed at treating patients with heterozygous familial hypercholesterolemia (HeFH) and/or premature coronary artery disease (CAD) [1][2] - VERVE-102 is designed as a single-course treatment that inactivates the PCSK9 gene in the liver to durably lower low-density lipoprotein cholesterol (LDL-C) levels [1][2] - The company aims to provide lifelong cholesterol lowering with its gene editing medicines, addressing the limitations of existing cholesterol-lowering therapies [2] Clinical Trial Progress - The ongoing Heart-2 Phase 1b clinical trial for VERVE-102 is evaluating safety and tolerability, with interim clinical data submitted to the FDA as of January 10, 2025 [2][3] - Initial safety and efficacy data from the Heart-2 trial is expected to be announced in the second quarter of 2025, with participants having at least 28 days of follow-up [3] - The final data for the dose escalation portion of the Heart-2 trial is anticipated in the second half of 2025, along with the initiation of the Phase 2 clinical trial for the PCSK9 program [4] Company Overview - Verve Therapeutics is a clinical-stage company focused on developing genetic medicines for cardiovascular disease, transitioning treatment from chronic therapies to single-course gene editing [5] - The company's lead programs include VERVE-102, VERVE-201, and VERVE-301, targeting key cholesterol drivers of atherosclerosis [5] - VERVE-201 aims to turn off the ANGPTL3 gene for refractory hypercholesterolemia, while VERVE-301 targets the LPA gene to reduce Lp(a) levels, an independent risk factor for cardiovascular diseases [5]

Core Viewpoint - Verve Therapeutics reported a quarterly loss of $0.58 per share, which was better than the Zacks Consensus Estimate of a loss of $0.72, indicating a positive earnings surprise of 19.44% [1] Financial Performance - The company achieved revenues of $13.08 million for the quarter ended December 2024, surpassing the Zacks Consensus Estimate by 90.39%, compared to $5.14 million in the same quarter last year [2] - Over the last four quarters, Verve Therapeutics has exceeded consensus EPS estimates four times and topped consensus revenue estimates three times [2] Stock Performance - Verve Therapeutics shares have increased by approximately 11.9% since the beginning of the year, outperforming the S&P 500, which gained 1.3% [3] Future Outlook - The company's earnings outlook will be crucial for determining future stock performance, with current consensus EPS estimates at -$0.71 for the coming quarter and -$2.83 for the current fiscal year [4][7] - The estimate revisions trend for Verve Therapeutics is currently mixed, resulting in a Zacks Rank 3 (Hold), suggesting the stock is expected to perform in line with the market in the near future [6] Industry Context - The Medical - Drugs industry, to which Verve Therapeutics belongs, is currently in the top 50% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8]

Genetic Medicines Development - The company is developing a new class of genetic medicines for cardiovascular disease (CVD), targeting three lipoprotein pathways that drive atherosclerotic cardiovascular disease (ASCVD) [19] - The company aims to disrupt the chronic care model for CVD by providing single-course gene editing treatments, potentially reducing the burden on patients and healthcare systems [37] - The company is developing a pipeline of single-course gene editing treatments targeting genes associated with ASCVD, leveraging advancements in human genetic analysis and gene editing technologies [38] - The company aims to address additional cardiovascular disease indications beyond ASCVD, expanding its pipeline of gene editing treatments [39] Clinical Trials and Programs - The lead clinical-stage programs, VERVE-102 and VERVE-101, target the PCSK9 gene, aiming to lower LDL cholesterol (LDL-C) levels durably throughout patients' lifetimes [21] - VERVE-102 is currently in the Heart-2 trial, with dosing completed or ongoing in three cohorts (0.3 mg/kg, 0.45 mg/kg, and 0.6 mg/kg) [22] - The company plans to announce initial safety and efficacy data from the Heart-2 trial in Q2 2025 and expects to report final data in the second half of 2025 [22][24] - VERVE-201, targeting ANGPTL3, is designed to treat ASCVD patients with refractory hypercholesterolemia and is currently in the Pulse-1 trial [25][26] - The Heart-1 clinical trial is evaluating VERVE-101 in patients with HeFH and established ASCVD, with 13 participants dosed in New Zealand and the UK [79] Safety and Efficacy - In the Heart-2 clinical trial, dosing has been completed or is ongoing in participants across three dose cohorts: 0.3 mg/kg, 0.45 mg/kg, and 0.6 mg/kg, with no treatment-related serious adverse events reported as of February 13, 2025 [77] - The company expects to report initial safety and efficacy data from the Heart-2 trial in Q2 2025, with final data for the dose escalation portion expected in the second half of 2025 [78] - The safety profile of VERVE-101 was generally well-tolerated, with no treatment-related adverse events in lower dose cohorts, while higher doses experienced mild to moderate infusion reactions [80] Gene Editing Technologies - The gene editing approach aims for a potent and durable lowering of blood lipids, potentially reducing ASCVD risk throughout a patient's lifetime [38] - The gene editing technologies include base editing and CRISPR nucleases, allowing for precise modifications at the single base pair level [42] - The company is optimizing its internal LNP discovery platform to improve delivery technology for current and future therapeutic programs [53] Manufacturing and Collaboration - The company is focused on scalable manufacturing capabilities for its gene editing treatments, utilizing Good Manufacturing Practice (GMP) vendors to produce high-quality mRNA, gRNA, and LNP [40] - The company has entered into a collaboration with Lilly, acquiring rights to jointly commercialize PCSK9 and ANGPTL3 programs in the U.S., enhancing its strategic partnerships [39] - The company currently relies on third-party contract manufacturing organizations (CMOs) and suppliers for critical starting materials and drug products, with plans to expand its network of CMOs as manufacturing scales [103] Financial and Competitive Landscape - The competitive landscape includes major pharmaceutical and biotechnology companies with significantly greater financial resources and expertise, posing challenges for the company's product candidates [108] - Key competitive factors for the company's product candidates include efficacy, safety, convenience, price, and the level of generic competition [109] - The company holds a patent estate covering various aspects of its programs, including gene editing programs for PCSK9 and ANGPTL3, with patents set to expire between 2041 and 2044 [118] Regulatory Compliance - The company must comply with extensive government regulations regarding the research, development, and marketing of pharmaceutical products, which require substantial time and financial resources [171] - The FDA must approve any product candidate before it can be marketed in the United States, requiring a series of preclinical and clinical testing steps [173] - Clinical trials must comply with GCP and undergo independent ethics committee review to ensure data integrity and participant safety [191]

Financial Performance - Cash, cash equivalents, and marketable securities totaled $524.3 million as of December 31, 2024, down from $624.0 million as of December 31, 2023, providing a cash runway into mid-2027[9] - Collaboration revenue increased to $13.1 million for Q4 2024 and $32.3 million for the full year 2024, compared to $5.1 million and $11.8 million for the same periods in 2023, respectively[10] - R&D expenses were $55.0 million for Q4 2024 and $204.3 million for the full year 2024, compared to $46.8 million and $184.9 million for the same periods in 2023[12] - General and administrative expenses were $14.1 million for Q4 2024 and $56.6 million for the full year 2024, compared to $12.3 million and $49.9 million for the same periods in 2023[13] - Total operating expenses for Q4 2024 were $69.15 million, up from $59.09 million in Q4 2023, with annual operating expenses totaling $260.99 million compared to $234.88 million in 2023[20] - The net loss for Q4 2024 was $50.0 million, or $0.58 per share, and for the full year 2024 was $198.7 million, or $2.35 per share, compared to a net loss of $48.4 million, or $0.69 per share, for Q4 2023[14] - The net loss for Q4 2024 was $50.04 million, slightly higher than the net loss of $48.35 million in Q4 2023, with an annual net loss of $198.71 million compared to $200.07 million in 2023[20] - Basic and diluted net loss per share improved to $0.58 in Q4 2024 from $0.69 in Q4 2023, with annual net loss per share at $2.35 compared to $3.12 in 2023[20] - Total assets declined to $647.39 million in Q4 2024 from $752.69 million in Q4 2023[20] - Total stockholders' equity decreased to $493.40 million in Q4 2024 from $599.50 million in Q4 2023[20] - Total liabilities remained relatively stable at $153.99 million in Q4 2024 compared to $153.19 million in Q4 2023[20] Clinical Trials and Developments - Initial data from the Heart-2 Phase 1b clinical trial of VERVE-102 targeting PCSK9 is expected in the second quarter of 2025, with final dose escalation data anticipated in the second half of 2025[1] - VERVE-102 has been well-tolerated with no treatment-related serious adverse events reported as of February 13, 2025[3] - Enrollment is ongoing in the Pulse-1 Phase 1b clinical trial of VERVE-201 targeting ANGPTL3, with initial data expected in the second half of 2025[1] - The company plans to deliver the opt-in data package for the PCSK9 program to Eli Lilly and receive a decision in the second half of 2025[6] - VERVE-301 has been nominated as the development candidate targeting the LPA gene, with a milestone payment received from Lilly[11]

Core Insights - Verve Therapeutics is making significant progress in its clinical trials for cardiovascular disease treatments, with key data expected in 2025 [1][2][3] Pipeline Updates - Initial data from the Heart-2 Phase 1b clinical trial of VERVE-102, targeting PCSK9, is anticipated in the second quarter of 2025, with final dose escalation data expected in the second half of 2025 [1][3] - VERVE-102 has shown good tolerability, with no serious adverse events or significant laboratory abnormalities reported [1][3] - Enrollment is ongoing for the Pulse-1 Phase 1b clinical trial of VERVE-201, which targets ANGPTL3 [1][4] Financial Position - As of December 31, 2024, the company reported cash, cash equivalents, and marketable securities totaling $524.3 million, providing a cash runway into mid-2027 [1][8] - Collaboration revenue for the fourth quarter of 2024 was $13.1 million, up from $5.1 million in the same quarter of 2023, indicating growth in research services [9] - Research and development expenses for the fourth quarter of 2024 were $55.0 million, compared to $46.8 million in the fourth quarter of 2023 [10] Leadership Changes - Dr. Frederick T. Fiedorek, Chief Medical Officer, will retire effective February 28, 2025, but will continue in an advisory role [2][7] Upcoming Events - Verve Therapeutics will present at the European Atherosclerosis Society Congress from May 4-7, 2025, in Glasgow, UK [5]

NEW YORK, Jan. 31, 2025 /PRNewswire/ -- Kuehn Law, PLLC, a shareholder litigation law firm, is investigating whether certain officers and directors of Verve Therapeutics, Inc. (NASDAQ: VERV) breached their fiduciary duties to shareholders.  The investigation concerns potential self-dealing. Shareholders may be entitled to damages and corporate governance reforms.If you are a long-term VERV stockholder please contact Justin Kuehn, Esq. here, by email at [email protected], or  call (833) 672-0814.  The consul ...

Company Overview - Verve Therapeutics is a clinical-stage company focused on developing a new class of genetic medicines aimed at treating cardiovascular disease, transitioning from chronic therapies to single-course gene editing medicines [3] - The company is publicly traded on Nasdaq under the ticker symbol VERV [3] Lead Programs - The lead programs include VERVE-102, VERVE-201, and VERVE-301, which target key cholesterol drivers of atherosclerosis: LDL-C, remnant cholesterol, and Lp(a) [3] - VERVE-102 aims to permanently turn off the PCSK9 gene in the liver, initially targeting heterozygous familial hypercholesterolemia (HeFH) and eventually patients with established atherosclerotic cardiovascular disease (ASCVD) [3] - VERVE-201 is designed to permanently turn off the ANGPTL3 gene in the liver, focusing on refractory hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH) [3] - VERVE-301 targets the LPA gene to reduce Lp(a) levels, which is an independent risk factor for ASCVD, ischemic stroke, thrombosis, and aortic stenosis [3] Upcoming Events - Sekar Kathiresan, M.D., co-founder and CEO of Verve Therapeutics, will participate in a fireside chat at the Guggenheim Securities SMID Cap Biotech Conference on February 5, 2025, at 9 a.m. ET in New York [1] - A live webcast of the event will be available on the company's investor section of the website and will be archived for 90 days [2]

Company Overview - Verve Therapeutics (VERV) shares increased by 18.7% to close at $7.80, with notable trading volume compared to typical sessions, and a 13.9% gain over the past four weeks [1][2] Clinical Pipeline - Investor optimism is high regarding Verve's clinical-stage pipeline, particularly for VERVE-102, which is in early-stage studies for heterozygous familial hypercholesterolemia and premature coronary artery disease, with initial data expected in Q2 2025 [2] - Verve is also developing two other early-stage candidates: VERVE-201 for refractory hypercholesterolemia and VERVE-301 for various cardiovascular diseases [2] Financial Expectations - The company is projected to report a quarterly loss of $0.72 per share, reflecting a year-over-year change of -4.4%, while revenues are expected to reach $6.87 million, a 33.7% increase from the previous year [3] - The consensus EPS estimate for the quarter has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4] Industry Context - Verve Therapeutics is part of the Zacks Medical - Drugs industry, where Karyopharm Therapeutics (KPTI) closed 3% lower at $0.67, despite a 15.4% return over the past month [4] - Karyopharm's consensus EPS estimate has decreased by 27.5% over the past month to -$0.26, showing a year-over-year change of +27.8%, and it currently holds a Zacks Rank of 4 (Sell) [5]

Core Insights - Verve Therapeutics is advancing a new class of genetic medicines targeting cardiovascular diseases, with significant milestones expected in 2025 [2][3][4] Pipeline Updates - Initial data for the Heart-2 Phase 1b clinical trial of VERVE-102, targeting PCSK9, is anticipated in the second quarter of 2025 [4][5] - The Heart-2 trial includes patients with heterozygous familial hypercholesterolemia (HeFH) and premature coronary artery disease (CAD), with dosing having progressed to the 0.6 mg/kg cohort [4][5] - VERVE-301 has been nominated as a development candidate targeting the LPA gene, with a milestone payment expected from Eli Lilly [2][6] - The company plans to initiate a Phase 2 clinical trial for the PCSK9 program in the second half of 2025 [5] Financial Position - Verve Therapeutics is well-capitalized, with a cash runway extending into mid-2027, supported by existing cash and a milestone payment from Eli Lilly [2][6] Upcoming Events - The company will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 15, 2025 [2][7] Company Overview - Verve Therapeutics is focused on developing genetic medicines that aim to provide lifelong cholesterol lowering after a single treatment, targeting key drivers of high cholesterol [3][8] - The lead programs include VERVE-102, VERVE-201, and VERVE-301, which address LDL-C, remnant cholesterol, and Lp(a) respectively [8][9]

Core Insights - Verve Therapeutics is advancing a new class of genetic medicines targeting cardiovascular disease, with significant milestones expected in 2025 [1][2][3] Pipeline Updates - Initial data for the Heart-2 Phase 1b clinical trial of VERVE-102, targeting PCSK9, is expected in the second quarter of 2025 [1][3] - Dosing in the Heart-2 trial has progressed to the 0.6 mg/kg cohort, with previous cohorts showing no serious adverse events [3][4] - The Heart-2 trial includes patients with heterozygous familial hypercholesterolemia (HeFH) and premature coronary artery disease (CAD) [3][8] - VERVE-301 has been nominated as a development candidate targeting the LPA gene, with a milestone payment from Eli Lilly expected [1][5][7] Financial Position - Verve is well-capitalized, with cash runway extending into mid-2027, supported by existing cash and expected milestone payments [1][5] Upcoming Events - The company will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 15, 2025 [1][6]