[SECURITIES PURCHASE AGREEMENT](index=5&type=section&id=SECURITIES%20PURCHASE%20AGREEMENT) Introduces the Securities Purchase Agreement for pre-funded warrants, outlining legal framework and key parties [Introduction and Recitals](index=5&type=section&id=Introduction) This section introduces the Securities Purchase Agreement between Lexeo Therapeutics, Inc. and the Purchasers, outlining the Company's intent to issue and sell pre-funded warrants (Securities) and the Purchasers' intent to buy them, in reliance on a securities registration exemption. It also notes the engagement of Leerink Partners LLC as the placement agent and the contemporaneous execution of a Registration Rights Agreement - The Securities Purchase Agreement is dated **October 16, 2025**, between Lexeo Therapeutics, Inc. and the Purchasers listed in Exhibit A[7](index=7&type=chunk) - The agreement relies on the exemption from securities registration under **Section 4(a)(2)** of the Securities Act of 1933[8](index=8&type=chunk) - The Company will issue and sell pre-funded warrants (Securities) to purchase common stock, and a Registration Rights Agreement will be executed concurrently[8](index=8&type=chunk) [1. Definitions](index=5&type=section&id=1.%20Definitions) Defines key terms for consistent interpretation throughout the Securities Purchase Agreement [1.1 Defined Terms](index=5&type=section&id=1.1%20Defined%20Terms) This section provides a comprehensive list of defined terms used throughout the Securities Purchase Agreement, ensuring clarity and consistent interpretation of the contractual language - Key terms defined include 'Actions,' 'Affiliate,' 'Agreement,' 'Closing,' 'Common Stock,' 'Material Adverse Effect,' 'Purchaser,' 'Securities,' 'Warrants,' and 'Warrant Shares,' among others[9](index=9&type=chunk)[10](index=10&type=chunk)[11](index=11&type=chunk)[16](index=16&type=chunk)[19](index=19&type=chunk)[34](index=34&type=chunk)[39](index=39&type=chunk)[46](index=46&type=chunk)[52](index=52&type=chunk)[53](index=53&type=chunk) [2. Purchase and Sale of Securities](index=8&type=section&id=2.%20Purchase%20and%20Sale%20of%20Securities) Outlines the Company's sale and Purchasers' acquisition of Securities, covering pricing, payment, and closing [2.1 Purchase and Sale](index=8&type=section&id=2.1%20Purchase%20and%20Sale) This subsection details the Company's agreement to sell, and each Purchaser's agreement to buy, a specific number and type of Securities for a set Subscription Amount and purchase price per Warrant on the Closing Date - The Company agrees to sell, and each Purchaser agrees to buy, the Securities for the Subscription Amount specified in Exhibit A[55](index=55&type=chunk) Securities Purchase Details | Item | Detail | | :--- | :--- | | Purchase Price per Warrant | $7.9999 | [2.2 Closing](index=8&type=section&id=2.2%20Closing) This subsection outlines the procedures for the closing of the purchase and sale of Securities, including the Closing Date, payment method, and provisions for returning funds if the closing does not occur as scheduled - The Closing Date is **October 20, 2025**, with the closing occurring remotely via document exchange[17](index=17&type=chunk)[56](index=56&type=chunk) - Securities will be issued against full payment by wire transfer of immediately available funds[56](index=56&type=chunk) - If closing fails within **three business days** after the Closing Date, previously wired amounts will be promptly returned to Purchasers[56](index=56&type=chunk) [3. Representations and Warranties of the Company](index=8&type=section&id=3.%20Representations%20and%20Warranties%20of%20the%20Company) The Company provides assurances on its financial health, legal standing, operations, and regulatory compliance [3.1 Financial Statements](index=9&type=section&id=3.1%20Financial%20Statements) The Company represents that its financial statements in SEC Reports comply with applicable requirements, fairly present its financial position, and are prepared in accordance with GAAP, with no material undisclosed liabilities - Financial statements in SEC Reports comply with Securities Act/Exchange Act, fairly present financial position, and are prepared in conformity with GAAP[58](index=58&type=chunk) - No material liabilities, contingent or otherwise, incurred outside the ordinary course of business since the date of the financial statements, that would have a Material Adverse Effect[58](index=58&type=chunk) [3.2 No Material Adverse Change](index=9&type=section&id=3.2%20No%20Material%20Adverse%20Change) The Company warrants that there has been no material adverse change in its capital stock, debt, or overall business, properties, management, financial position, results of operations, or prospects since the date of its most recent financial statements - No material change in capital stock, short-term debt, or long-term debt (except as disclosed in SEC Reports)[59](index=59&type=chunk) - No material adverse change or development affecting the Company's business, financial position, or prospects[59](index=59&type=chunk) - No material transactions, liabilities, losses, or labor disputes not disclosed in SEC Reports[59](index=59&type=chunk) [3.3 Organization and Good Standing](index=10&type=section&id=3.3%20Organization%20and%20Good%20Standing) The Company affirms its due organization, valid existence, and good standing under Delaware law, possessing all necessary power and authority to conduct its business, and confirms it has no subsidiaries - The Company is duly organized, validly existing, and in good standing under Delaware law[61](index=61&type=chunk) - It possesses all necessary power and authority to own properties and conduct business, and has no subsidiaries[61](index=61&type=chunk) [3.4 Capitalization](index=10&type=section&id=3.4%20Capitalization) The Company represents its authorized capitalization, confirming that all outstanding shares are duly authorized, validly issued, fully paid, and non-assessable, with no outstanding rights or agreements for additional equity issuance beyond what is disclosed - Authorized capitalization consists of **500,000,000 shares** of Common Stock and **10,000,000 shares** of preferred stock[62](index=62&type=chunk) - All outstanding capital stock is duly authorized, validly issued, fully paid, and non-assessable, free from pre-emptive rights[62](index=62&type=chunk) - No other outstanding rights, warrants, or options to acquire capital stock, except as described in SEC Reports and for equity incentive awards[62](index=62&type=chunk) [3.5 Stock Options](index=10&type=section&id=3.5%20Stock%20Options) The Company warrants that all Stock Options granted under its compensation plans were duly authorized, compliant with applicable laws and rules (including Nasdaq Market), and properly accounted for in its financial statements - Each Stock Option intended as an 'incentive stock option' under Section 422 of the Code so qualifies[63](index=63&type=chunk) - Each grant was duly authorized by necessary corporate action and made in accordance with Company Stock Plans, Exchange Act, and Nasdaq Market rules[63](index=63&type=chunk) - Each grant was properly accounted for in accordance with GAAP in the financial statements[63](index=63&type=chunk) [3.6 Due Authorization](index=10&type=section&id=3.6%20Due%20Authorization) The Company represents that it has the full right, power, and authority to execute and deliver the Transaction Agreements and perform its obligations, including the issuance and sale of Securities and Warrant Shares, which are legal, valid, and binding obligations - The Company has full right, power, and authority to execute and deliver the Transaction Agreements and perform its obligations[64](index=64&type=chunk)[65](index=65&type=chunk) - All necessary actions for authorization, execution, and delivery of Transaction Agreements and consummation of transactions have been duly taken[65](index=65&type=chunk) - Each Transaction Agreement is a legal, valid, and binding obligation of the Company, enforceable in accordance with its terms (subject to bankruptcy/insolvency laws)[65](index=65&type=chunk) [3.7 Valid Issuance](index=11&type=section&id=3.7%20Valid%20Issuance) The Company warrants that the Warrant Shares are duly authorized and reserved, and upon exercise of the Warrants, will be validly issued, fully paid, non-assessable, and free of liens, and that the offer and sale of Securities comply with applicable registration exemptions - Warrant Shares are duly and validly authorized and reserved for issuance[66](index=66&type=chunk) - Upon issuance, Warrant Shares will be duly and validly issued, fully paid, non-assessable, and free of liens (except as provided in Transaction Agreements or securities laws)[66](index=66&type=chunk) - The offer and sale of Securities comply with applicable exemptions from registration and qualification requirements of federal and state securities laws[66](index=66&type=chunk) [3.8 No Violation or Default](index=11&type=section&id=3.8%20No%20Violation%20or%20Default) The Company represents that it is not in violation of its organizational documents, in default under any agreements, or in violation of any laws or regulations, except where such default or violation would not reasonably be expected to have a Material Adverse Effect - The Company is not in violation of its charter or bylaws[67](index=67&type=chunk) - The Company is not in default under any agreement or instrument, nor in violation of any law, statute, judgment, order, rule, or regulation, that would reasonably be expected to have a Material Adverse Effect[67](index=67&type=chunk) [3.9 No Conflicts](index=11&type=section&id=3.9%20No%20Conflicts) The Company warrants that the execution, delivery, and performance of the Transaction Agreements and the issuance and sale of Securities will not conflict with its organizational documents, or result in a breach, default, or violation of any other agreements or laws, except for those that would not reasonably be expected to have a Material Adverse Effect - The execution, delivery, and performance of Transaction Agreements and the issuance/sale of Securities will not conflict with or violate the Company's organizational documents[68](index=68&type=chunk) - These actions will not result in a breach, default, termination, or imposition of liens under other agreements,

Core Insights - Lexeo Therapeutics Inc. is making significant progress with its gene therapy candidate LX2006 for Friedreich ataxia/FA cardiomyopathy, having received positive feedback from the US FDA regarding an Accelerated Approval pathway [1][2] - The company is optimistic that the combination of regulatory support and promising interim clinical data will expedite the timeline for submitting a Biologics License Application (BLA) [2][3] - Lexeo plans to initiate a pivotal trial in H1 2026, leveraging a new optimized manufacturing platform while meeting additional FDA requirements [3] Regulatory Support - The FDA has expressed openness to an accelerated approval BLA submission that could pool data from ongoing Phase I/II trials with new data from the planned pivotal study [2][3] - The FDA has agreed to evaluate the co-primary endpoint of left ventricular mass index at an earlier time point than 12 months, which may allow for a smaller and shorter pivotal study [3] Manufacturing and Trial Plans - Lexeo intends to use its optimized, high-yield Sf9-baculovirus manufacturing platform for future commercial supply, moving away from the HEK293 process used in earlier trials [3] - The company is required to submit enhanced manufacturing comparability data and fulfill an additional nonclinical requirement before commencing the pivotal trial [3]

Core Viewpoint - Lexeo Therapeutics, Inc. has announced a public offering and concurrent private placement aimed at raising approximately $135 million to support its clinical stage genetic medicine initiatives for cardiovascular diseases [1][4]. Group 1: Public Offering Details - Lexeo is offering 15,625,000 shares of common stock at a price of $8.00 per share in the public offering [2]. - The underwriters have a 30-day option to purchase an additional 2,343,750 shares at the public offering price [2]. - The public offering is expected to close on or about October 20, 2025, subject to customary closing conditions [4]. Group 2: Private Placement Details - Concurrently, Lexeo is selling pre-funded warrants to purchase 1,250,015 shares of common stock to Balyasny Asset Management at a price of $7.9999 per warrant [3]. - This private placement is exempt from the registration requirements of the Securities Act and is not contingent on the public offering [3][6]. Group 3: Company Overview - Lexeo Therapeutics is focused on pioneering treatments for cardiovascular diseases through genetic medicine [8]. - The company is advancing a portfolio of therapeutic candidates targeting genetic causes of conditions such as Friedreich ataxia cardiomyopathy and plakophilin-2 arrhythmogenic cardiomyopathy [8].

Core Viewpoint - Lexeo Therapeutics, Inc. has initiated an underwritten public offering and a concurrent private placement of its common stock and pre-funded warrants, aiming to raise capital for its clinical stage genetic medicine developments targeting cardiovascular diseases [1][2]. Group 1: Offering Details - The public offering includes a 30-day option for underwriters to purchase additional shares of common stock [1]. - The concurrent private placement involves selling shares and pre-funded warrants to Balyasny Asset Management, exempt from registration under the Securities Act, but is not contingent on the public offering [2][3]. - The offering is subject to market conditions, and there is no guarantee regarding its completion or the final terms [3]. Group 2: Management and Registration - Leerink Partners, Cantor, Stifel, and Oppenheimer & Co. are acting as joint book-running managers, with Baird as the lead manager for the offering [4]. - The offering is made under a previously filed and effective Registration Statement on Form S-3, with details available through the SEC's website [5]. Group 3: Company Overview - Lexeo Therapeutics is focused on innovative treatments for cardiovascular diseases, with a portfolio that includes candidates targeting genetic causes of conditions like Friedreich ataxia cardiomyopathy and plakophilin-2 arrhythmogenic cardiomyopathy [8].

Lexeo Therapeutics Conference Call Summary Company Overview - **Company**: Lexeo Therapeutics (NasdaqGM:LXEO) - **Industry**: Cardiac Genetic Medicines - **Key Programs**: AAV gene therapy for Friedreich's ataxia and arrhythmogenic cardiomyopathy, both in clinical stages [4][18] Key Initiatives and Updates - **Friedreich's Ataxia Program**: - Completed enrollment of Phase 1/2 study - Moving towards a registrational study in 2026 [4][18] - Significant clinical data improvements in cardiovascular and neurologic endpoints [4][19] - Agreement with FDA for expedited path to accelerated approval, including pooling Phase 1/2 data with pivotal study data [5][20] - **Arrhythmogenic Cardiomyopathy Program**: - Enrollment of Phase 1/2 study expected to complete this year - Next steps planned for 2026 and beyond [4][18] Clinical Data Highlights - **Friedreich's Ataxia**: - Clinical data showed improvements exceeding 10% reduction in left ventricular mass index (LVMI), with some patients achieving reductions of 50% [12][26] - All patients with elevated LVMI in Phase 1 studies moved into the normal range [14][28] - FDA's openness to evaluating endpoints earlier than 12 months, potentially shortening study length [7][20] - **Regulatory Developments**: - Breakthrough therapy designation received earlier this year, indicating FDA support for rapid development [7][20] Study Design and Methodology - **Pivotal Study Design**: - Aiming to detect a 10% reduction in LV mass, which correlates with a 20% increased risk of death if not addressed [10][23] - Use of MRI for precise measurement of LV mass [10][23] - Propensity matching to ensure comparability between treatment and natural history study groups [36][38] - **Data Consistency**: - Centralized reading of MRI scans to maintain consistency across different sites [30][30] Neurologic and Cardiac Benefits - **Neurologic Function**: - Improvement in the modified Friedreich's Ataxia Rating Scale (mFARS) observed, with higher doses showing more significant benefits [50][51] - Patients previously treated with standard care (Skyclarys) also showed improvements, indicating the therapy's effectiveness across different patient backgrounds [51][52] Future Outlook - **Market Potential**: - Lexeo aims to position itself as a leader in cardiac precision medicine, similar to the evolution seen in oncology [68][70] - The company believes AAV vectors will be crucial in treating genetically mediated cardiac conditions [69][70] - **Regulatory Engagement**: - Plans to engage with the FDA once sufficient clinical data is available, expected in 2026 [59][60] Conclusion - Lexeo Therapeutics is advancing its clinical programs in cardiac genetic medicines, with promising data in both Friedreich's ataxia and arrhythmogenic cardiomyopathy. The company is positioned for potential accelerated approval and aims to leverage its innovative therapies to address significant unmet medical needs in the cardiac space [68][70]

Group 1 - Chardan Capital sets a price target of $17 for Lexeo Therapeutics, indicating a potential increase of about 94% from its current trading price of $8.25 [1][6] - Lexeo is advancing with the FDA on an Accelerated Approval pathway for its treatment LX2006, which targets Friedreich ataxia cardiomyopathy [2][6] - Interim clinical data shows promising results, with an 18% mean reduction in left ventricular mass index (LVMI) at six months and a 23% mean reduction at twelve months, exceeding the FDA's target threshold of a 10% reduction [3][6] Group 2 - There is a clinically meaningful improvement in the modified Friedreich Ataxia Rating Scale (mFARS), indicating slowed disease progression and improved function, highlighting the potential of LX2006 as a life-changing therapy [4] - Currently, Lexeo's stock is trading at $8.34, reflecting a 28.90% increase, with a market capitalization of approximately $276.86 million and a trading volume of 9.42 million shares [5]

Group 1 - The article discusses Lexeo Therapeutics (NASDAQ: LXEO) and its recent advancements, particularly in relation to the FDA and the LX2006 program [2] - The author highlights the Biotech Analysis Central service, which provides in-depth analysis of pharmaceutical companies and includes a model portfolio of small and mid-cap stocks [2] - The service offers a two-week free trial and a discounted yearly subscription, indicating a focus on providing value to healthcare investors [1] Group 2 - The article does not provide specific financial data or performance metrics related to Lexeo Therapeutics or the broader biotech industry [4]

Core Viewpoint - Lexeo Therapeutics is providing a regulatory update regarding the potential accelerated approval pathway for LX2006, aimed at treating Friedreich's ataxia cardiomyopathy, alongside new interim clinical data from ongoing Phase I/II studies [2]. Group 1: Regulatory Update - The company has engaged in discussions with the FDA about an accelerated approval pathway for LX2006 [2]. - New interim clinical data from two ongoing Phase I/II clinical studies has been released [2]. Group 2: Leadership and Presentation - The presentation includes key executives such as the CEO, Chief Development Officer, Chief Medical Officer, and Chief Technical Officer, who will be available for Q&A [3].

Lexeo Therapeutics Conference Call Summary Company Overview - **Company**: Lexeo Therapeutics (NasdaqGM:LXEO) - **Focus**: Development of LX2006 for the treatment of Friedreich ataxia cardiomyopathy Key Industry Insights - **Regulatory Update**: Discussions with the FDA regarding a potential accelerated approval pathway for LX2006 are ongoing, with the FDA open to a BLA submission that pools clinical data from ongoing Phase 1-2 studies and an upcoming pivotal study [2][4] - **Clinical Data**: New interim clinical data from two ongoing Phase 1-2 studies show promising results in safety and efficacy for LX2006 [2][4] Core Points and Arguments - **FDA Feedback**: The FDA has agreed to evaluate the co-primary endpoint of left ventricular mass index (LVMI) at an earlier time point than 12 months, potentially shortening the pivotal study duration [4][11] - **Clinical Improvements**: - A 23% mean improvement in LVMI observed at 12 months, with an 18% mean improvement at six months, exceeding the FDA's threshold of 10% for the pivotal study [5][21] - Clinically meaningful improvements in the modified Friedreich ataxia rating scale (MFARS) were also reported [5][27] - **Safety Profile**: LX2006 has been generally well tolerated across all dose cohorts, with no significant adverse events reported [5][18] Additional Important Information - **Patient Population**: Friedreich ataxia affects approximately 5,000 people in the U.S. and 15,000 globally, with cardiac complications being the leading cause of death [6][7] - **Mechanism of Action**: LX2006 aims to treat the root cause of the disease by restoring frataxin, a protein that is deficient in individuals with Friedreich ataxia [8][9] - **Manufacturing Changes**: Lexeo has transitioned to an optimized SF9 baculovirus manufacturing platform, which is expected to produce high-yield, high-quality vector with a low empty capsid ratio [10][11] - **Future Plans**: The pivotal study is expected to be initiated in the first half of 2026, pending finalization of the protocol with the FDA [13][44] Summary of Clinical Data - **Participant Data**: - 17 participants treated to date, with 6 having abnormal LVMI at baseline [14][15] - Improvements in cardiac biomarkers observed, with reductions in LVMI and troponin levels [20][21][23] - **Functional Improvement**: Evidence of functional improvement in MFARS scores, indicating better daily living activities for participants [27][29] Conclusion - Lexeo Therapeutics is making significant progress in the development of LX2006 for Friedreich ataxia cardiomyopathy, with promising clinical data and a favorable safety profile. The company is actively engaging with the FDA to expedite the approval process, aiming to address the urgent unmet need for effective treatments in this patient population [35][77]

Clinical Data and Outcomes - Participants with abnormal LVMI at baseline achieved a mean LVMI reduction of 18% at 6 months and 23% at 12 months[5, 47] - In participants with abnormal LVMI at baseline, Cohorts 2 and 3 showed a mean LVMI reduction of 28% at 6 months and 33% at 12 months[25] - 11 out of 16 participants showed improvement or stabilization in mFARS relative to baseline at the latest visit, indicating neurological functional improvement[39, 40] - All participants evaluated showed increases in frataxin expression vs baseline[45] Regulatory and Study Design - The FDA is open to a BLA submission that includes pooled clinical data from ongoing Phase I/II studies of LX2006 with new clinical data from the planned pivotal study[5] - The FDA agreed to evaluate the LVMI co-primary endpoint at a time point earlier than 12 months, potentially reducing the size and length of the pivotal study[5, 17] - Lexeo plans to initiate the pivotal study in the first half of 2026[47] Safety and Tolerability - LX2006 has been generally well-tolerated, with no clinically significant complement activation and minimal, transient LFT elevations[3, 47] - No participants discontinued from either study[20] Disease Context - Cardiac complications account for up to 80% of deaths in individuals with Friedreich Ataxia (FA)[9, 10] - Up to 40% of adults with FA have left ventricular hypertrophy as defined by abnormal LVMI[10]