David Bautz

David Bautz inquired why UMass, a center involved in the Phase 3 study, has not yet been signed on as a ZEVASKYN Qualified Treatment Center (QTC).

Answer

Chief Commercial Officer Madhav Vasanthavada explained that different sites have various reasons for not yet onboarding, which could include financial constraints, incompatibility with trade policies, or other factors. He stated that the company would not discuss specific hurdles for individual sites.

David Bautz (Zacks Small-Cap Research) inquired why UMass, a center involved in the Phase 3 study, has not yet been signed up as a ZEVASKYN Qualified Treatment Center (QTC).

Answer

Madhav Vasanthavada (Chief Commercial Officer, Abeona) explained that different sites have various reasons for not yet onboarding, such as financial constraints, misalignment with trade policies, or other internal factors. He stated that the company would not discuss specific hurdles for individual sites.

David Bautz of Zacks Small-Cap Research asked for details on the billing and reimbursement workflow, including the expected time from patient treatment to payment, and questioned the specific intentions of the 30 patients who have contacted the company.

Answer

Chief Commercial Officer Dr. Madhav Vasanthavada explained that revenue is recognized after treatment, with payment timing on par with other cell and gene therapies, and reimbursement is secured before treatment begins. He clarified that the patient inquiries were general expressions of interest to "get in the queue" before a specific QTC was announced. CEO Dr. Vish Seshadri added this pre-authorization process explains the lead time before the first patient treatment.

David Bautz from Zacks Small-Cap Research asked for details on the planned COVID-19 clinical trial design, whether the ALAN drug candidate would be developed as a monotherapy or combination therapy for AML, and the current development stage and expected timeline for the RAS-F program.

Answer

CEO Michael Poirier explained the COVID-19 trial is planned for approximately 500 patients across multiple arms, including one with remdesivir. For ALAN, he noted that while a monotherapy would be ideal, a combination therapy is more likely given the heterogeneity of AML. Regarding the RAS-F program, he stated the company is working to select a lead candidate from about 160 compounds, with pre-IND studies expected to begin in early 2021, at which point a more detailed update will be provided.