Core Insights - Lexeo Therapeutics, Inc. is advancing its clinical trial for LX1001, a gene therapy targeting APOE4-associated Alzheimer's disease, with interim data to be presented at the upcoming CTAD conference [1][2] - The Phase 1/2 trial aims to evaluate the safety and efficacy of LX1001 in APOE4 homozygous patients, with enrollment completed in Q4 2023 [2][3] - Approximately 900,000 APOE4 homozygous patients with Alzheimer's disease are estimated to exist in the U.S., highlighting a significant market opportunity for LX1001 [3] Company Overview - Lexeo Therapeutics is a clinical stage genetic medicine company focused on innovative treatments for genetically defined cardiovascular diseases and Alzheimer's disease [4] - The company employs a stepwise development approach, utilizing early proof-of-concept data to advance its pipeline [4] Clinical Trial Details - The ongoing Phase 1/2 trial is an open-label, dose-ranging study involving 15 patients, assessing safety and multiple efficacy measures, including protein expression and tau and amyloid biomarkers [2][3] - The presentation at the CTAD conference will include 12-month data for patients in Cohorts 1-3 and 6-month data for Cohort 4 [2]

Financial Position - As of June 30, 2024, the company had $175.0 million in cash and cash equivalents and raised aggregate net proceeds of $100.3 million from its IPO[82]. - As of June 30, 2024, the company had cash and cash equivalents of $175,000,000, up from $121,500,000 as of December 31, 2023[101]. - The company expects that its existing cash and cash equivalents will be sufficient to fund planned operating expenses and capital expenditures into 2027[102]. - Net cash provided by financing activities in the six months ended June 30, 2024, was $88,945,000, primarily from a Private Placement offering of $88.7 million[105]. - The net increase in cash for the six months ended June 30, 2024, was $53,515,000, compared to a net decrease of $31,797,000 in 2023[104]. Losses and Expenses - The company reported net losses of $42.9 million for the six months ended June 30, 2024, and $66.4 million for the year ended December 31, 2023, with an accumulated deficit of $224.8 million[82]. - Total operating expenses for the three months ended June 30, 2024, were $23,550,000, an increase of $9,575,000 compared to $13,975,000 for the same period in 2023[94]. - For the six months ended June 30, 2024, total operating expenses were $46,841,000, an increase of $13,575,000 from $33,266,000 in 2023[97]. - Research and development expenses are expected to increase significantly as the company advances its clinical trials and expands its product pipeline[83]. - General and administrative expenses are projected to rise due to increased costs associated with operating as a public company[91]. - Research and development expenses increased by $5,324,000 to $16,560,000 for the three months ended June 30, 2024, compared to $11,236,000 in 2023[95]. - General and administrative expenses rose by $4,251,000 to $6,990,000 for the three months ended June 30, 2024, compared to $2,739,000 in 2023[96]. - Research and development expenses for the six months ended June 30, 2024, totaled $32,302,000, up $4,628,000 from $27,674,000 in 2023[98]. - General and administrative expenses for the six months ended June 30, 2024, increased by $8,947,000 to $14,539,000 compared to $5,592,000 in 2023[99]. Clinical Trials and Product Development - The ongoing clinical trial for LX2006 has shown improvements in key cardiac biomarkers, with no treatment-related serious adverse events reported to date[77]. - The company expects to provide interim data readout for LX2020 in the second half of 2024, following its IND clearance from the FDA in July 2023[77]. - The company has completed enrollment for the LX1001 trial and anticipates reporting additional interim data in the second half of 2024[78]. - The company has received multiple designations from the FDA for its product candidates, including Rare Pediatric Disease and Fast Track designations[77]. - The company is actively seeking to expand its operations and product pipeline through collaborations and strategic investments[81]. - The company anticipates significant increases in expenses and capital requirements as it advances product candidates and development programs[106]. - Future operating and capital requirements will depend on various factors, including the progress of clinical trials and regulatory approvals[106]. - The company may face challenges in raising additional funds or entering into collaborations on favorable terms, which could delay or scale back product development[107]. Income and Cash Flow - Interest income for the three months ended June 30, 2024, was $2,348,000, up from $590,000 in the same period of 2023, reflecting increased average invested balance[96]. - Interest income for the six months ended June 30, 2024, was $3,999,000, compared to $1,277,000 in the same period of 2023[100]. - Net cash used in operating activities for the six months ended June 30, 2024, was $35,019,000, compared to $31,566,000 in 2023, indicating an increase of approximately 11.6%[104]. Regulatory and Compliance - There were no significant changes to critical accounting estimates from the previous year, maintaining consistency in financial reporting[109]. - The company qualifies as an "emerging growth company" and has elected to take advantage of reduced disclosure requirements[110]. - No changes in internal control over financial reporting were reported during the fiscal quarter ended June 30, 2024[113]. - Ongoing legal proceedings may impact the company, but it does not expect a material adverse effect on product development timelines[115].

Financial Performance - Lexeo Therapeutics reported cash and cash equivalents of $175.0 million as of June 30, 2024, expected to fund operations into 2027[4] - Research and development (R&D) expenses increased to $16.6 million for Q2 2024, up from $11.2 million in Q2 2023, representing a 48% increase[4] - General and administrative (G&A) expenses rose to $7.0 million in Q2 2024, compared to $2.7 million in Q2 2023, marking a 159% increase[4] - The net loss for Q2 2024 was $21.2 million, or $0.64 per share, compared to a net loss of $13.4 million, or $8.30 per share, in Q2 2023[4] Clinical Development - Interim data from the Phase 1/2 studies of LX2006 showed sustained improvements across multiple cardiac biomarkers in Friedreich ataxia cardiomyopathy[2] - LX2006 was well tolerated with no treatment-related serious adverse events reported to date[3] - Lexeo initiated formal engagements with the FDA regarding surrogate endpoints for a registrational study of LX2006, with an update expected by the end of 2024[3] - The company plans to share additional data from LX2006 at a scientific conference in Fall 2024[4] - Interim data readout for LX2020 (HEROIC-PKP2) is expected in the second half of 2024[4] Leadership Changes - Tim Van Hauwermeiren was appointed to the Board of Directors in July 2024, bringing over 20 years of experience in life sciences[3]

Announced positive interim data from Phase 1/2 studies in Friedreich ataxia (FA) cardiomyopathy, which showed LX2006 was well tolerated with no treatment-related serious adverse events and demonstrated evidence of sustained and consistent treatment effect across multiple cardiac measures Recently initiated formal engagements with FDA on surrogate endpoints for LX2006 registrational study; expects to provide update by end of year Phase 1/2 clinical trial of LX2020 (HEROIC-PKP2) currently recruiting patients; ...

Data from the SUNRISE-FA study showed that treatment with LX2006 achieved a mean reduction in left ventricular mass index (LVMI) of 11.4% at 12 months and 18.3% at 18 months in participants with elevated LVMI at baseline. LVMI is an estimator of cardiac morbidity and mortality. Treatment with the therapy was also well-tolerated across all study participants, with no treatment-related serious adverse events. Shares of Lexeo Therapeutics (LXEO) lost 26% on Monday after it reported positive interim data from t ...

Achieved mean reduction in left ventricular mass index (LVMI) of 11.4% at 12 months and 18.3% at 18 months in participants with elevated LVMI at baseline >10% reduction in LVMI at 12 months in 75% of participants with elevated LVMI at baseline Sustained and consistent improvements in other key measures of cardiac status, including left ventricular wall thickness and troponin I, in majority of participants at 12 months Increased post-treatment frataxin expression above baseline in all participants evaluated ...

"Tim is a highly accomplished life-sciences entrepreneur who has built one of Europe's most successful biotech companies, and I am thrilled to welcome him to our Board of Directors," said R. Nolan Townsend, Chief Executive Officer of Lexeo Therapeutics. "Tim's deep and relevant experience in company building from clinical to commercial stage will be an invaluable asset to Lexeo as we embark on our next phase of growth and progress our pipeline into later stages of clinical and commercial development." "I am ...

Investors might want to bet on Lexeo Therapeutics, Inc. (LXEO) , as it has been recently upgraded to a Zacks Rank #2 (Buy). This upgrade is essentially a reflection of an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices. A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following year ...

Lexeo Therapeutics, Inc. (LXEO) closed the last trading session at $13.56, gaining 12.2% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $21.40 indicates a 57.8% upside potential. The average comprises five short-term price targets ranging from a low of $19 to a high of $24, with a standard deviation of $2.07. While the lowest estimate indicates an increase of 40.1% from the curren ...

Exhibit 99.1 Lexeo Therapeutics Reports First Quarter 2024 Financial Results and Operational Highlights Closed an oversubscribed $95 million equity financing in March with Q1 2024 cash balance of $195.1 million at quarter-end, expected to provide runway into 2027 Completed in-license agreement with Cornell University for intellectual property rights, including current and future clinical data from an ongoing investigator-initiated trial of AAVrh.10hFXN (LX2006) to support regulatory discussions Interim read ...