RK

RK with H.C. Wainwright & Co sought clarification on whether Cohort 2 patients in the Aethlon Medical oncology trial are new participants or carried over from Cohort 1. He also questioned the potential impact of the SLAMB system's smaller tubing and altered blood flow dynamics on the Hemopurifier's EV capture efficacy, and whether this integration would accelerate the current trial. Finally, RK asked about the possibility of resuming clinical trials in India to speed up overall progress.

Answer

Steven LaRosa, CMO of Aethlon Medical, clarified that Cohort 2 consists of entirely new patients. Regarding the SLAMB system, he explained that initial experiments focus on pump compatibility, and subsequent ex vivo tests would be needed to confirm EV capture efficacy with altered flow dynamics, confirming it would not impact the current trial's speed. Jim Frakes, CEO and CFO, along with Dr. LaRosa, stated that Aethlon is highly focused on completing the Australian trial and does not plan to resume safety trials in India due to potential expenses and distractions, though emergency use in India could be considered.

RK asked for a breakdown of the $830 million EscharEx peak sales projection between DFU and VLU opportunities. He also inquired about the status and timing of the BARDA RFP, and the impact of not having a permanent CPT code for NexoBrid on adoption, as well as the benefits a permanent code would bring.

Answer

Barry Wolfenson, EVP of Strategy and Corporate Development, explained that the DFU and VLU opportunities for EscharEx are roughly even, with a slight weighting towards VLU due to the pain associated with venous leg ulcers. Ofer Gonen, CEO, confirmed that the BARDA RFP for a 10-year contract (stockpiling, room-temp stable formulation, trauma/blast injury) is awaiting contract signing, with activities paused due to the government shutdown but expected to resume soon. Barry Wolfenson added that while NexoBrid has a temporary CPT code, a permanent one would enhance national and institutional legitimacy, standardize language, and ease approval pathways, thereby boosting physician and burn center adoption.

The analyst inquired about the timeline for updates and potential milestone payments from the AbbVie collaboration, as well as the market potential and expected revenue flow from the expanded distribution of the Vergenix product.

Answer

The company stated that the timeline for the AbbVie program is determined by AbbVie, and they cannot estimate future milestone payments. Regarding Vergenix, the product targets the tendinopathy market, and the company is establishing distribution networks in Europe and Asia, hoping to see sales in the next year after securing regulatory approvals.

RK from H.C. Wainwright inquired about the expected content of the four upcoming presentations at the AACR conference. He also asked about the development plan and timeline for the HB-700 KRAS program and whether its progress is contingent on milestones from the HB-200 or HB-300 programs.

Answer

Igor Matushansky, CMO & Global Head of R&D, stated the AACR presentations will cover preclinical, translational, and biomarker data, including updates on the prostate cancer (HB-300) and HB-200 programs. He confirmed the HB-700 program is not dependent on further clinical data from other assets and will proceed once manufacturing is ready. CEO Joern Aldag clarified the IND filing for HB-700 is anticipated in 2023 or beyond.