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Chairman & CEO Tom Lin confirmed a route for accelerated approval existed, but the FDA recommended completing the 24-month study for a potential single-study approval. Regarding data releases, Tom Lin noted the FDA prefers they keep efficacy data confidential until the submission. CFO Hao-Yuan Chuang added that the final 24-month data will be announced once available, prior to the formal filing.

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CFO Hao-Yuan Chuang explained that future stock compensation expense is difficult to predict as it's tied to both time and development milestones, but he does not expect it to remain as high as it was in Q1. Chairman and CEO Dr. Tom Lin addressed manufacturing, stating that Tinlarebant is produced in the U.S. and other geographies, mitigating any potential tariff risks.

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Chairman and CEO Dr. Tom Lin confirmed that the warrants from the February capital raise have not yet been exercised. Regarding the regulatory process, Dr. Lin stated that the company is using multiple CROs for different jurisdictions and that they are 'basically submitting as we speak,' indicating the process is actively underway.

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CEO Laura Niklason provided an update, stating that a paper on the primate results for the CABG program has been accepted for publication. She confirmed that the company is on track to file the Investigational New Drug (IND) application with the FDA later in 2025. Following an anticipated review period, she expects the first human clinical trial to commence sometime in 2026, consistent with prior guidance.

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CEO Dr. Laura Niklason shared an anecdote of a new surgeon having a positive experience, noting adoption typically starts with early adopters. CCO BJ Scheessele added that initial champions are a mix of vascular and trauma surgeons. Regarding the pipeline, Dr. Niklason stated that work on the BioVascular pancreas is continuing, with plans to publish preclinical results later in the year, but had no new explicit updates.

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Executive Laura Niklason reported that ongoing primate studies have successfully demonstrated long-term islet survival and insulin production for months, even in a diabetic primate model. She stated that the company has proven the key technological hurdles of long-term engraftment and function. The current focus is on 'tweaking the design and the dosing' to optimize the therapeutic effect before moving forward.

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Executive Laura Niklason explained that the AV access filing is largely independent of the trauma BLA's trajectory. The timing for a supplemental BLA submission in mid-2025 depends on whether the FDA requires one-year or full two-year follow-up data from the V007 trial. For the CABG program, she stated the FDA requested a third animal model (sheep), and Humacyte has a meeting scheduled to confirm this plan would be sufficient to support a future IND filing.

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CEO Jason Matuszewski explained that their sales footprint is currently strongest west of the Mississippi River. He detailed that their partner, Venture Medical, is actively expanding to the East Coast by hiring 40 direct representatives and has appointed three area sales directors for the East, Central, and West regions to drive adoption where coverage is currently less significant.

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