NEW YORK - Lexeo Therapeutics, Inc. (NASDAQ:LXEO), a genetic medicine company, announced positive interim results from a Phase 1/2 study of its drug candidate LX1001, intended for the treatment of APOE4-associated Alzheimer's disease (AD). The study showed a dose-dependent increase in neuroprotective APOE2 expression and reductions in tau biomarkers, which are associated with cognitive outcomes in AD.
The treatment has been well tolerated across all dose cohorts with no reports of amyloid-related imaging abnormalities (ARIA), a common side effect in anti-amyloid therapies for Alzheimer's patients, particularly those with the APOE4 allele.
Dr. Kim Johnson, a principal investigator in the study, stated that the results suggest LX1001's potential as a well-tolerated treatment, indicating a possible effect on Alzheimer's disease pathology. The study, which concluded enrollment in Q4 2023, involved fifteen patients with mild cognitive impairment or mild to moderate Alzheimer's disease.
LX1001 is a gene therapy candidate designed to deliver the protective APOE2 allele to patients who have two copies of the toxic APOE4 allele. The interim data includes 12-month follow-ups for the first three dose cohorts and 6-month follow-ups for the fourth, showing consistent biomarker improvements and stabilization of amyloid pathology.
The study's primary objective was to assess safety and tolerability, with secondary outcomes focusing on cerebrospinal fluid APOE2 protein expression and changes in tau and amyloid biomarkers. Four serious adverse events were reported, three of which were deemed unrelated to the treatment. One event of mild-moderate sensorineural hearing loss was possibly related to the treatment.
Lexeo plans to update on regulatory interactions and further development plans for LX1001 in 2025. The company also hosted a webcast today to review the data and discuss the program's next steps. LX1001 has been granted Fast Track designation by the FDA, highlighting its potential as a significant development in the treatment of Alzheimer's disease.
These findings were presented at the Clinical Trials on Alzheimer's Disease conference in Madrid, Spain. The information in this article is based on a press release statement from Lexeo Therapeutics.
"In other recent news, Lexeo Therapeutics has shown promising interim phase 1/2 data from its LX-2006 drug in treating Friedreich's Ataxia cardiomyopathy (FA-CM), as reported by Stifel. The firm maintains a 'Buy' rating on Lexeo, attributing positive signs of efficacy and a clean safety profile to bolstered confidence. Lexeo's proactive engagement with the FDA's CBER division and anticipation of additional regulatory details expected by the end of 2024 further support this outlook.
In financial updates, Lexeo reported a net loss of $0.64 per share for the second quarter of 2024, slightly better than H.C. Wainwright's forecasted loss of $0.65 per share. The company's R&D expenses amounted to $16.6 million, with SG&A expenses reported at $7.0 million. Lexeo concluded the quarter with approximately $175.0 million in cash reserves, expected to sustain operations into 2027.
Despite a recent cut in its price target from $22.00 to $21.00, H.C. Wainwright maintains a 'Buy' rating for Lexeo. The firm also updated its projection for Lexeo's full-year 2024 net loss to $2.75 per share. Other recent developments include Lexeo's election of Mette Kirstine Agger as a Class I Director and the ratification of KPMG LLP as its independent auditor."
InvestingPro Insights
As Lexeo Therapeutics (NASDAQ:LXEO) reports promising interim results for its Alzheimer's disease treatment, investors may be interested in a deeper financial perspective on the company. According to InvestingPro data, Lexeo has a market capitalization of $329.62 million, reflecting its position as a relatively small player in the biotechnology sector.
InvestingPro Tips highlight that Lexeo holds more cash than debt on its balance sheet, which could be crucial for funding ongoing research and development efforts like the LX1001 study. This financial cushion may provide the company with the runway needed to advance its promising Alzheimer's treatment through clinical trials and potential commercialization.
However, it's important to note that Lexeo is currently not profitable, with a negative P/E ratio of -4.29 over the last twelve months as of Q2 2024. This is not uncommon for early-stage biotech companies investing heavily in R&D. The company's gross profit for the same period stands at -$57.76 million, indicating the significant costs associated with developing novel gene therapies.
Despite these financial challenges, Lexeo's stock has shown some positive momentum, with a 10.29% price return over the past month. This could reflect investor optimism about the company's recent clinical results.
For investors seeking a more comprehensive analysis, InvestingPro offers additional tips and insights. There are 7 more InvestingPro Tips available for Lexeo Therapeutics, which could provide valuable context for understanding the company's financial health and market position as it progresses with its innovative Alzheimer's treatment.
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