Longeveron(US:LGVN)2025-11-04 22:30Financial Data and Key Metrics Changes - Revenues for the nine months ended September 30, 2025, were $0.8 million, a decrease of $1.0 million or 53% compared to $1.8 million in 2024, primarily due to decreased participant demand for the Bahamas registry trial and reduced demand for contract manufacturing services [22][24] - Net loss increased to approximately $17.3 million for the nine months ended September 30, 2025, from a net loss of $11.9 million for the same period in 2024, representing an increase of $5.4 million or 45% [26][27] - Cash and cash equivalents as of September 30, 2025, were $9.2 million, with the company anticipating this will fund operating expenses into late Q1 2026 [26][27] Business Line Data and Key Metrics Changes - Clinical trial revenue for the nine months ended September 30, 2025, was $0.7 million, a decrease of $0.3 million or 36% compared to $1.0 million in 2024, driven by decreased participant demand [23] - Contract manufacturing revenue for the same period was $0.2 million, a decrease of $0.6 million or 76% compared to $0.8 million in 2024, also due to reduced demand [24] Company Strategy and Development Direction - The company is focused on three key areas: delivering clinical trial results from ELPASO-2, securing necessary financial resources, and HLHS BLA preparedness [10][12] - The company aims to attract partners for the continued development and potential commercialization of Lomecel-B, particularly in HLHS and other indications [12][30] - The company has made operational decisions to extend its cash runway into late Q1 2026, pushing the potential full BLA filing from late 2026 into 2027 [27][28] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of establishing safety and efficacy through FDA-supported clinical studies as critical for building belief in the potential life-saving qualities of their therapies [7][9] - The company is optimistic about the potential for pivotal clinical data for HLHS and the first BLA submission, viewing this as an exciting time for both the company and its stakeholders [28][30] Other Important Information - The company has received five distinct FDA designations for its development programs, including orphan drug and fast track designations for HLHS [29][30] - The company is exploring opportunities for new contract manufacturing services clients to utilize excess capacity in its Miami cGMP facility [22][24] Q&A Session Summary Question: Business advisability of identifying potential partners for commercialization in rare conditions - Management indicated that they are exploring partnerships outside the US and are prepared to commercialize the product, recognizing the value of being close to pivotal study readouts [34][36] Question: Clarification on the primary endpoint for ELPASO-2 - Management discussed the importance of the composite endpoint, which includes all-cause mortality, transplant-free survival, and overall hospitalization, and emphasized the use of prior positive data to design meaningful endpoints [47][50] Question: Reasons for postponing the BLA submission timeline - Management explained that the full submission by the end of 2026 is unlikely due to operational decisions aimed at optimizing spending, but they remain committed to the database lock and trial conduct [52][55] Question: Impact of early success in similar therapies on Longeveron's value - Management acknowledged the significance of the HLHS program and the potential for high-value outcomes, while also recognizing the success of other cell therapies as a positive case study [65][67] Question: Importance of long-term follow-up data for payer conversations - Management highlighted the value of survival endpoints and long-term data from ELPASO-1 as important for future reimbursement discussions, although they could not predict its exact impact [68][70] Question: Exploration of expedited BLA pathways - Management confirmed ongoing discussions with the FDA regarding potential expedited pathways and emphasized the importance of the priority review voucher system for rare diseases [71][75]