Abeona Therapeutics Inc Q4 2024 Earnings and Business Update Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Kristen Kluska - Cantor Fitzgerald - Analyst : Hi, good morning, everyone. Thanks for taking my question and just want to say, very much appreciate how transparent you've been with us during this review process, including the last year. So considering where are in discussions right now with the agency, do you feel that the FDA is satisfied with the work you've done on the CMC side that resulted in the CRL last year. Have you fielded more questions specific on that? Do you have a sense of any work that you'll need to do on that side?

Question: Kristen Kluska - Cantor Fitzgerald - Analyst : Yes, it does. Thank you. And then of the five centers that you referenced, have you had conversations with them specifically just to get an early sense of maybe the percent of their patients that may be eligible for this therapy over time.

Question: Kristen Kluska - Cantor Fitzgerald - Analyst : Okay. Thanks. And last question for me. I've seen a lot of new investor faces on the story over the last few weeks and months in particular. So can you just remind us what's really going to be the top reason for patients wanting to seek this therapy? Is it just the wound profile itself and having to deal with the advantages is it in particular because these wounds make patients more susceptible to things like squamous cell carcinoma and infections, which are leading causes of mortality here? Just what is like really drilling down the key reason? Thank you so much, again.

Question: Kristen Kluska - Cantor Fitzgerald - Analyst : Thanks again, and wishing you all the best in the next six weeks.

Question: Francois Brisebois - Oppenheimer & Co. Inc. - Analyst : Hi. Thanks for taking the question. And thanks for the updates on the developments here. I was just wondering, you mentioned your conferences recently, can you help us understand maybe the physician education that's necessary? The trials have been going on for a while. So I'm just wondering if this is a situation where the doctors are just waiting for it? Or is there still based on the fact that it's not approved yet, is there still a lot of physician education and training that's necessary at launch? Then I'll have a follow-up. Thank you.

Question: Francois Brisebois - Oppenheimer & Co. Inc. - Analyst : Yes. No, no, absolutely. And I think the competitor having a product out there is probably helped as well for awareness. But I guess so on the physician side and then on the patient angle, is this an RDEB community, this is so severe that I'm just wondering how tightly knit -- is the patient community? And I'm not talking a full-blown DTC, but is there an angle on the digital side? Is there an online community that makes these patients very aware quickly of the opportunity? Or how do you market to that? Thank you.

Question: Francois Brisebois - Oppenheimer & Co. Inc. - Analyst : Thank you.

Question: Ram Selvaraju - H.C. Wainwright & Co LLC - Analyst : Hi. Thanks for taking my question. Firstly, on the PRV, I was just wondering if you could enumerate any potential factors that might preclude the PRV from being granted or if at this juncture, you fully expect it to be awarded? And also if you could comment on the recent environment for PRV resales.

Question: Ram Selvaraju - H.C. Wainwright & Co LLC - Analyst : Okay. Very helpful. And then the only other follow-up was with respect to potential positioning and deployment of pz-cel in markets outside of the US. In particular, I wanted to see if you had any other comments regarding logistical potential deployment of this for treatment of European

Question: Ram Selvaraju - H.C. Wainwright & Co LLC - Analyst : Thank you.

Question: David Bautz - Zacks Small-Cap Research - Analyst : Hey, good morning, everyone. Thanks for the overview this morning. You had mentioned that you want to get five treatment centers online with launch when you launch but what is the ultimate goal for the total number of treatment centers you'd like to see one day? Is it to get it up to 10, 15? What do you see in terms of that?

Question: David Bautz - Zacks Small-Cap Research - Analyst : Okay. Great. Thanks for that. And in terms of treatment, you mentioned that most patients are probably going to require two treatments. And I'm just curious, what is the maximum service area that a patient can be treated with at one time? And then what kind of dictates that number?

Question: David Bautz - Zacks Small-Cap Research - Analyst : Okay. Great. I appreciate the information there. Thanks for taking my question. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 20, 2025 / 12:30PM, ABEO.OQ - Q4 2024 Abeona Therapeutics Inc Earnings and Business Update Call