Lexeo Therapeutics(LXEO) - 2025 Q2 - Quarterly Results

Executive Summary & Highlights Key Operational and Financial Highlights Lexeo Therapeutics reported significant operational progress in Q2 2025, including Breakthrough Therapy designation for LX2006, selection for the FDA's CDRP program, continued dosing in the LX2020 trial, and a new strategic partnership for non-viral RNA therapeutics. Financially, the company secured an $80 million equity financing, extending its operational runway into 2028, and appointed Louis Tamayo as Chief Financial Officer - Breakthrough Therapy designation granted for LX2006 based on interim Phase I/II data demonstrating clinically meaningful improvements in cardiac and neurologic measures of Friedreich ataxia[1][3] - LX2006 selected for FDA Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP program) to facilitate CMC registrational readiness and support faster patient access[1][4] - Eight participants dosed in Phase I/II clinical trial (HEROIC-PKP2) of LX2020 for PKP2-ACM; interim clinical data update on track for second half of 2025[1][4] - Strategic partnership announced with Perceptive Xontogeny Venture Funds and venBio Partners to advance non-viral, RNA-based therapeutics for genetic cardiac diseases[1][6] - $80 million equity financing closed to support development of clinical stage pipeline[1][6] - Cash, cash equivalents and investments in marketable securities of $152.5 million expected to provide operational runway into 2028[1][6] - Louis Tamayo appointed Chief Financial Officer[1][6] Business and Program Updates LX2006 in Friedreich Ataxia (FA) LX2006 received FDA Breakthrough Therapy designation and was selected for the CDRP program, accelerating its path to a registrational study expected to begin in early 2026 with potential efficacy data in 2027. The CLARITY-FA natural history study is enrolling to serve as an external control, and LX2006 continues to demonstrate a generally well-tolerated safety profile - In July 2025, LX2006 received FDA Breakthrough Therapy designation based on interim clinical data demonstrating clinically meaningful improvements in cardiac and neurologic measures of FA[4] - LX2006 selected for FDA Chemistry, Manufacturing, and Controls (CMC) Development Readiness Pilot (CDRP program) to accelerate CMC registrational readiness[4] - Lexeo expects final alignment with FDA on the LX2006 registrational study in late Q3 to early Q4 2025, with initiation planned for early 2026 and potential efficacy readout in 2027[4] - The CLARITY-FA natural history study is currently enrolling and is expected to serve as a concurrent external control arm for the planned registrational study[4] - LX2006 continues to be generally well tolerated with no clinically significant complement activation and no new treatment-related serious adverse events[4] LX2020 in PKP2-ACM Eight participants have been dosed in the HEROIC-PKP2 Phase I/II clinical trial for LX2020, across three cohorts, with the high-dose Cohort 3 still enrolling. The therapy has shown a generally well-tolerated safety profile, and interim clinical data is anticipated in the second half of 2025 - Eight participants have been dosed to date in the HEROIC-PKP2 Phase I/II clinical trial for LX2020, including three in Cohort 1 (low dose), three in Cohort 2 (high dose), and two in dose-expansion Cohort 3 (high dose)[4] - Cohort 3 is still enrolling, and up to two additional participants may be dosed in this cohort[4] - LX2020 has been generally well tolerated with no clinically significant complement activation and no treatment-related serious adverse events to date across all dose cohorts[4] - Lexeo expects to share an interim clinical data update in the second half of 2025[4] Strategic Developments & Corporate Updates Equity Financing Lexeo closed an $80 million equity financing in May 2025, which is expected to fund operations into 2028, covering a potential efficacy readout for the LX2006 registrational study in 2027 - Closed an $80 million equity financing in May 2025 to further advance development of its clinical stage genetic medicine candidates[6] - Lexeo anticipates that current cash, cash equivalents and marketable securities will be sufficient to fund operating and capital expenditures into 2028, through a potential efficacy readout for the registrational study of LX2006 in 2027[6] Research Collaboration In June 2025, Lexeo announced a strategic partnership with Perceptive Xontogeny Venture Funds and venBio Partners to develop non-viral RNA-based therapies for genetic cardiac diseases. The partners will contribute up to $40 million in financing to a new entity, with Lexeo contributing expertise and intellectual property for an equity position, milestone payments, royalties, and opt-in rights - Strategic partnership announced in June 2025 with Perceptive Xontogeny Venture Funds and venBio Partners to develop therapies for genetic cardiac diseases utilizing a novel non-viral RNA platform[6] - PXV Funds and venBio will contribute up to $40 million in private equity financing to a new entity[6] - Lexeo is contributing expertise and know-how in cardiac genetic medicines, preclinical intellectual property and technology to the partnership, with a double-digit percentage equity position in the new entity at transaction close alongside entitlement to future milestone payments, royalties, and opt-in rights[6] New Leadership Appointment Louis Tamayo was appointed Chief Financial Officer, succeeding Kyle Rasbach. Mr. Tamayo brings extensive commercial finance experience from Siemens Healthineers AG, Becton, Dickinson and Company, and Pfizer, and will support Lexeo's late-stage clinical and commercialization plans - Louis Tamayo has been appointed Chief Financial Officer, succeeding Kyle Rasbach[6] - Mr. Tamayo will support Lexeo's late-stage clinical and commercialization plans as LX2006 development accelerates and LX2020 development continues, alongside strategic planning, portfolio management, capital allocation, and other financial operations[6] - Mr. Tamayo brings extensive commercial finance experience, having previously served as Senior Vice President at Siemens Healthineers AG, and held roles at Becton, Dickinson and Company and Pfizer[6] Recent Data Presentations Lexeo presented new data at ASGCT on AAV manufacturing optimization via its Sf9-baculovirus process, demonstrating high purity, potency, improved scalability, and reduced cost. The company also presented data at the Global Cell and Gene Therapy Summit reviewing the favorable complement profile of AAVrh10, with no clinically significant complement activation observed in three gene therapy studies - Lexeo presented new data at the 28th American Society of Gene & Cell Therapy (ASGCT) Annual Meeting on AAV manufacturing optimization via the Company's Sf9-baculovirus process, showing high purity and potency of yields with improved scalability and reduced cost[6] - Lexeo also presented data at the Global Cell and Gene Therapy Summit reviewing the favorable complement profile of AAVrh10 based on clinical monitoring experience across three gene therapy studies in FA and PKP2, with no clinically significant events related to complement activation observed[6] Second Quarter 2025 Financial Results Financial Summary For the three months ended June 30, 2025, Lexeo reported a net loss of $26.1 million, or $0.60 per share, compared to a net loss of $21.2 million, or $0.64 per share, in the prior year period. Research and development expenses decreased slightly, while general and administrative expenses significantly increased. The company's cash position as of June 30, 2025, was $152.5 million, projected to fund operations into 2028 Key Financial Metrics (Three Months Ended June 30) | Financial Metric (in thousands) | 2025 | 2024 | Change (YoY) | | :-------------------------------------------- | :--- | :--- | :----------- | | Research and Development Expenses | $14,721 | $16,560 | -$1,839 | | General and Administrative Expenses | $15,967 | $6,990 | +$8,977 | | Total Operating Expenses | $30,688 | $23,550 | +$7,138 | | Operating Loss | $(30,688) | $(23,550) | -$(7,138) | | Net Loss | $(26,103) | $(21,238) | -$(4,865) | | Net Loss per Common Share (basic and diluted) | $(0.60) | $(0.64) | +$0.04 | - Net loss increased to $26.1 million in Q2 2025 from $21.2 million in Q2 2024[6][9] - General and Administrative expenses significantly increased to $16.0 million in Q2 2025 from $7.0 million in Q2 2024[6][9] - Cash, cash equivalents, and investments in marketable securities were $152.5 million as of June 30, 2025, which Lexeo believes will be sufficient to fund operations into 2028[6][10] Condensed Statements of Operations The condensed statements of operations show a net loss of $26.1 million for Q2 2025 and $58.8 million for the six months ended June 30, 2025. Total operating expenses increased significantly year-over-year for both the quarter and year-to-date periods, primarily driven by general and administrative costs Condensed Statements of Operations (Unaudited, in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $14,721 | $16,560 | $31,892 | $32,302 | | General and administrative | $15,967 | $6,990 | $32,601 | $14,539 | | Total operating expenses | $30,688 | $23,550 | $64,493 | $46,841 | | Operating loss | $(30,688) | $(23,550) | $(64,493) | $(46,841) | | Net loss | $(26,103) | $(21,238) | $(58,759) | $(42,920) | | Net loss per common share, basic and diluted | $(0.60) | $(0.64) | $(1.53) | $(1.41) | | Weighted average number of shares outstanding | 43,573,628 | 33,001,946 | 38,372,704 | 30,490,892 | - Total operating expenses for the three months ended June 30, 2025, were $30.7 million, an increase from $23.6 million in the prior year period[9] - Total operating expenses for the six months ended June 30, 2025, were $64.5 million, up from $46.8 million in the prior year period[9] Condensed Balance Sheet Data As of June 30, 2025, Lexeo's cash, cash equivalents, and investments in U.S. Treasury securities increased to $152.5 million from $128.5 million at December 31, 2024. Total assets also increased, while total liabilities saw a moderate rise Condensed Balance Sheet Data (Unaudited, in thousands) | Metric | June 30, 2025 | December 31, 2024 | Change | | :------------------------------------------------ | :------------ | :---------------- | :----- | | Cash, cash equivalents, and investments in U.S. Treasury securities | $152,506 | $128,530 | +$23,976 | | Total assets | $176,068 | $146,942 | +$29,126 | | Total liabilities | $37,850 | $30,100 | +$7,750 | | Total stockholders' equity | $138,218 | $116,842 | +$21,376 | - Cash, cash equivalents, and investments in U.S. Treasury securities increased by $23.98 million from December 31, 2024, to June 30, 2025[10] About Lexeo Therapeutics Company Overview Lexeo Therapeutics is a New York City-based clinical stage genetic medicine company focused on developing novel treatments for cardiovascular diseases by targeting underlying genetic causes. Its pipeline includes LX2006 for Friedreich ataxia cardiomyopathy and LX2020 for PKP2 arrhythmogenic cardiomyopathy - Lexeo Therapeutics is a New York City-based, clinical stage genetic medicine company dedicated to reshaping heart health by applying pioneering science to fundamentally change how cardiovascular diseases are treated[5] - The Company is advancing a portfolio of therapeutic candidates that take aim at the underlying genetic causes of conditions, including LX2006 in Friedreich ataxia cardiomyopathy (FA) and LX2020 in plakophilin-2 (PKP2) arrhythmogenic cardiomyopathy[5] Legal & Contact Information Cautionary Note Regarding Forward-Looking Statements The report contains forward-looking statements subject to various risks and uncertainties, including those related to clinical trials, regulatory approvals, and financial resources. Lexeo advises against undue reliance on these statements and disclaims any obligation to update them, except as required by law, under the protection of the Private Securities Litigation Reform Act of 1995 - Certain statements in this press release may constitute 'forward-looking statements' regarding Lexeo's product candidates, clinical trials, regulatory developments, and financial condition[7] - These forward-looking statements are subject to various risks and uncertainties, including those set forth in Lexeo's SEC filings, and actual results could be materially different[7] - Lexeo claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements and expressly disclaims any obligation to update or alter any statements, except as required by law[7] Media and Investor Contacts Contact information is provided for media inquiries (Media@lexeotx.com) and investor relations (Carlo Tanzi, Ph.D., ctanzi@kendallir.com) - Media inquiries can be directed to Media@lexeotx.com[8] - Investor inquiries can be directed to Carlo Tanzi, Ph.D., at ctanzi@kendallir.com[8]