PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents Verve Therapeutics' unaudited condensed consolidated financial statements, including balance sheets, statements of operations, and cash flows, along with notes detailing key accounting policies and recent financial activities [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $277,019 | $64,330 | | Marketable securities | $273,691 | $296,112 | | Total current assets | $561,630 | $367,128 | | Total assets | $673,355 | $384,124 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $29,018 | $22,024 | | Total liabilities | $125,412 | $26,772 | | Total stockholders' equity | $547,943 | $357,352 | | Total liabilities and stockholders' equity | $673,355 | $384,124 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Statement of Operations Highlights (in thousands) | Metric | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :--- | :--- | :--- | | Collaboration revenue | $929 | $0 | | Research and development | $92,811 | $42,263 | | General and administrative | $26,095 | $12,264 | | Loss from operations | ($117,977) | ($54,527) | | Net loss | ($116,302) | ($88,977) | | Net loss per common share | ($2.26) | ($4.52) | [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary for Nine Months Ended September 30 (in thousands) | Cash Flow Activity | 2022 | 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($89,440) | ($49,837) | | Net cash provided by (used in) investing activities | $12,358 | ($182,113) | | Net cash provided by financing activities | $289,358 | $375,865 | | **Increase in cash, cash equivalents and restricted cash** | **$212,276** | **$143,915** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes detail the company's accounting policies and financial activities, including the Vertex collaboration, recent financing through a follow-on offering and ATM program, and ongoing license and lease obligations - In July 2022, Verve entered into a strategic collaboration with Vertex Pharmaceuticals, receiving a **$25.0 million** upfront payment and a **$35.0 million** equity investment through a private placement[31](index=31&type=chunk)[32](index=32&type=chunk)[102](index=102&type=chunk) - The company completed a follow-on public offering in July 2022, raising net proceeds of approximately **$242.9 million**[33](index=33&type=chunk)[118](index=118&type=chunk) - An Open Market Sale Agreement (ATM offering) was established in July 2022, and as of September 30, 2022, the company had sold shares for aggregate net proceeds of **$7.3 million**[34](index=34&type=chunk)[35](index=35&type=chunk) - As of September 30, 2022, the company's cash, cash equivalents, and marketable securities of **$550.7 million** are expected to be sufficient to fund operations beyond the next 12 months[36](index=36&type=chunk) - The company recognized its first-ever revenue of **$0.9 million** during the three and nine months ended September 30, 2022, related to research services performed under the Vertex Agreement[111](index=111&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The MD&A section provides management's perspective on the company's financial condition and results of operations, detailing business developments, including the heart-1 clinical trial and FDA clinical hold, analyzing increased R&D and G&A expenses, and reviewing liquidity and capital resources [Recent Developments](index=30&type=section&id=Recent%20Developments) This section outlines key recent developments, including the initiation of the heart-1 clinical trial for VERVE-101, the subsequent FDA clinical hold in the U.S., and progress on the VERVE-201 program - The first patient was dosed with VERVE-101 in the heart-1 clinical trial in July 2022, with enrollment ongoing in New Zealand and the United Kingdom[154](index=154&type=chunk) - On November 4, 2022, the FDA placed the company's Investigational New Drug (IND) application for VERVE-101 on a clinical hold in the United States[155](index=155&type=chunk) - The company plans to report initial safety and pharmacodynamic data for the dose-escalation portion of the heart-1 study in the second half of 2023[157](index=157&type=chunk) - VERVE-201, targeting the ANGPTL3 gene, has initiated IND-enabling studies and will utilize a proprietary GalNAc-LNP delivery technology to enable uptake in the liver of HoFH patients[158](index=158&type=chunk)[159](index=159&type=chunk)[160](index=160&type=chunk) [Results of Operations](index=34&type=section&id=Results%20of%20Operations) Comparison of Operating Expenses (in thousands) | Expense Category | Three Months Ended Sep 30, 2022 | Three Months Ended Sep 30, 2021 | Change | | :--- | :--- | :--- | :--- | | Research and development | $35,197 | $17,495 | $17,702 | | General and administrative | $9,592 | $6,007 | $3,585 | | **Total operating expenses** | **$44,789** | **$23,502** | **$21,287** | - The **$17.7 million** increase in R&D expenses for Q3 2022 compared to Q3 2021 was primarily driven by a **$6.8 million** increase in personnel-related costs due to higher headcount, a **$2.8 million** increase in preclinical study costs, and a **$0.9 million** increase in clinical trial costs for the heart-1 trial[189](index=189&type=chunk)[191](index=191&type=chunk) Comparison of Nine-Month Operating Results (in thousands) | Metric | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | Change | | :--- | :--- | :--- | :--- | | Collaboration revenue | $929 | $0 | $929 | | Research and development | $92,811 | $42,263 | $50,548 | | General and administrative | $26,095 | $12,264 | $13,831 | | **Net loss** | **($116,302)** | **($88,977)** | **($27,325)** | [Liquidity and Capital Resources](index=38&type=section&id=Liquidity%20and%20Capital%20Resources) - As of September 30, 2022, the company had **$550.7 million** in cash, cash equivalents, and marketable securities[203](index=203&type=chunk) - Management believes that existing cash, cash equivalents, and marketable securities will be sufficient to fund operating expenses and capital expenditure requirements into the second half of 2025[217](index=217&type=chunk) - For the nine months ended September 30, 2022, net cash used in operating activities was **$89.4 million**, while net cash provided by financing activities was **$289.4 million**, primarily from stock offerings and the Vertex private placement[209](index=209&type=chunk)[210](index=210&type=chunk)[214](index=214&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=43&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section discusses the company's exposure to market risks, primarily interest rate risk on its cash and marketable securities, and notes no significant foreign currency or inflation risk - The company's primary market risk is related to changes in interest rates on its cash, cash equivalents (**$277.0 million**), and marketable securities (**$273.7 million**)[240](index=240&type=chunk) - Due to the short-term maturities and low-risk profile of its investments, management believes a 10% change in interest rates would not materially affect their fair market value[240](index=240&type=chunk) - The company is not currently exposed to significant foreign currency exchange risk or inflation risk[241](index=241&type=chunk)[242](index=242&type=chunk) [Item 4. Controls and Procedures](index=43&type=section&id=Item%204.%20Controls%20and%20Procedures) This section addresses the company's disclosure controls and internal control over financial reporting, concluding their effectiveness and noting no material changes during the quarter - Based on an evaluation as of September 30, 2022, the principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective[244](index=244&type=chunk) - There were no changes in internal control over financial reporting during the quarter ended September 30, 2022, that have materially affected, or are reasonably likely to materially affect, internal controls[246](index=246&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=45&type=section&id=Item%201.%20Legal%20Proceedings) The company states that it is not currently a party to any material legal proceedings - As of the filing date, Verve Therapeutics is not a party to any material legal proceedings[248](index=248&type=chunk) [Item 1A. Risk Factors](index=45&type=section&id=Item%201A.%20Risk%20Factors) This section comprehensively outlines the company's risks, including a history of losses, the early stage of development, the FDA clinical hold on VERVE-101, the unproven nature of gene editing technology, reliance on third parties, and intense competition - The company has a history of significant losses, with a net loss of **$116.3 million** for the nine months ended September 30, 2022, and expects to incur losses for the foreseeable future, requiring substantial additional funding[250](index=250&type=chunk)[257](index=257&type=chunk) - A significant risk is the FDA's clinical hold on the IND application for VERVE-101 in the United States, which could delay or prevent the initiation of the U.S. clinical trial and impair the ability to obtain FDA approval[293](index=293&type=chunk) - The company's approach using gene editing, particularly base editing, is a novel and largely unproven technology that is not yet clinically validated as safe and efficacious for human therapeutic use[277](index=277&type=chunk) - The company relies on third parties for manufacturing, research, and clinical testing, which reduces control and introduces risks of delays, non-performance, and supply chain disruptions[335](index=335&type=chunk)[340](index=340&type=chunk) - Verve faces substantial competition from major pharmaceutical and biotech companies with approved products or candidates in development for cardiovascular disease, including those targeting PCSK9 and ANGPTL3[442](index=442&type=chunk)[444](index=444&type=chunk)[445](index=445&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=106&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section reports no unregistered equity sales during the period and confirms that the net proceeds from the June 2021 IPO remain unused and invested in short-term instruments - The company received net proceeds of **$281.6 million** from its Initial Public Offering (IPO) in June 2021[586](index=586&type=chunk) - As of September 30, 2022, the company had not used any of the net proceeds from the IPO, which are invested in money market funds and short-term investments[586](index=586&type=chunk) [Item 6. Exhibits](index=107&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate governance documents, material agreements like the Amended Beam Agreement and Vertex Agreement, and CEO/CFO certifications - Key agreements filed as exhibits include the Amended and Restated Collaboration and License Agreement with Beam Therapeutics, Inc. and the Strategic Collaboration and License Agreement with Vertex Pharmaceuticals Incorporated[588](index=588&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO 2SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ Commission File Number: 001-40489 VERVE THERAPEUTICS , INC. (Exact Name of Registrant as Specified in its Charter) Delaware 82-4800 ...

1 | --- | --- | --- | --- | |-------|-------|------------------------|-------------------------------------------------| | | | | | | | | | | | | | to Treat ASCVD | Verve Therapeutics: In Vivo CRISPR Base Editing | | | | TIDES USA Annual Event | Andrew Bellinger, MD PhD | | | | May 11, 2022 | | Disclosure I am an employee of Verve Therapeutics. This presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ Commission File Number: 001-40489 VERVE THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 82-48001 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-40489 VERVE THERAPEUTICS, INC. (Exact name of Registrant as specified in its Charter) Delaware 82-4800132 (State or other jurisdictio ...

1 Verve Therapeutics Disrupting the Care of Cardiovascular Disease through Single-course Gene Editing Medicines January 2022 Forward looking statements This presentation 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 regulatory submissions, future clinical trials, its research and development plans and the pote ...

FORM 10-Q (Mark One) UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of incorporation or organization) Delaware 82-4800132 (I.R.S. Employer Identification No.) ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ Commission File Number: 001-40489 ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SEC ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 (Address of principal executive offices) (Zip Code) OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ Commission File Number: 001-40489 VERVE THERAPEUTICS, INC. (Exact Name of Regist ...