Abeona Therapeutics Inc at Jefferies Healthcare Conference Transcript

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

Question: Maury Raycroft - Jefferies - Analyst : Great. And you guys had an update this morning to maybe just briefly recap what that is and talk about the EB-101's timeline for submission and potential approval.

Question: Maury Raycroft - Jefferies - Analyst : Got it. Yeah, I think that's a good overview of the program. Why don't you talk a little bit more about the update with FDA as it's important to the filing for the different assays that FDA wants? Maybe just talk a little bit about that some of the specific say.

Question: Maury Raycroft - Jefferies - Analyst : Got it. And for the pre-BLA meeting, I think you originally planned for July, but now it sounds like that's going to be August. So basically a month difference there and?

Question: Maury Raycroft - Jefferies - Analyst : Got it. And, for the RVV, maybe just talk a little bit about that and sources for it and what the plan is going forward with manufacturing?

Question: Maury Raycroft - Jefferies - Analyst : Got it. And the PPQ runs that you've done, those include the RVV that you're going to move forward?

Question: Maury Raycroft - Jefferies - Analyst : Got it. And just to be clear on the point, is FDA primarily just focused on the RVV assays, are they interested in anything else?

Question: Maury Raycroft - Jefferies - Analyst : Got it. And you have the pre-BLA meeting and then maybe just talk about the next steps after that?

Question: Maury Raycroft - Jefferies - Analyst : Okay. In the past, you talked about timeline for potential approval and then there are some variables that you can't predict. But I think you've said first half '24. Is that kind of the right way to think about it?

Question: Maury Raycroft - Jefferies - Analyst : Got it. And Vish, you highlight some of the key qualities and characteristics of EB-101. Maybe talk a little bit more about some of the data there, the types of wounds that you can treat? And also the types of patients that are out there in the US?

Question: Maury Raycroft - Jefferies - Analyst : Got it. That makes sense and maybe talk a little bit about the market opportunity as well.

Question: Maury Raycroft - Jefferies - Analyst : Got it and with Krystal getting approved, maybe talk a little bit about how they can help prime the market for Abeona? And do you anticipate that both products can be used in combination if a doctor thinks it makes sense or do you think additional data would be needed to inform combination?

Question: Maury Raycroft - Jefferies - Analyst : Got it. And maybe talk about pricing too. For Vyjuvek, I think they've said 6,31,000 for the price or 485,000 after government discounts. And for pricing, you mentioned expectation for an average of two treatments per patient to address all large chronic wounds. Will subsequent applications or retreatments a few years later to repair all graphs or newly formed blisters be included in the max price of the two treatments or will re-treatment

Question: Maury Raycroft - Jefferies - Analyst : Got it. And we've got the Vyjuvek's price. You've talked about Abeona's value proposition with some of the differentiated profile being able to treat these larger wounds. I guess can you contextualize that and how that factors into pricing potential.

Question: Maury Raycroft - Jefferies - Analyst : Got it. And in the past, we've talked about the DEBRA organization, and from my understanding, there's a lot of awareness around this disease setting. Do you have an idea of what the initial demand for EB-101 could look like? And can you talk about what you anticipate bottlenecks will be or how you can alleviate those bottlenecks to treat more patients?

Question: Maury Raycroft - Jefferies - Analyst : Got it. And how do you think about COGS for EB-101?

Question: Maury Raycroft - Jefferies - Analyst : Got it. And you've mentioned that there's a publication in preparation for EB-101. Could this include some of the same data cut that's in the BLA filing? And could you potentially have some additional data updates from this program this year and next year?

Question: Maury Raycroft - Jefferies - Analyst : Got it. And for going to the pre-BLA meeting, you just set the stage there a little bit more. Will you take some of the KOLs like Jean Tang with you for that event? And will you also talk about label discussions with FDA at that meeting, such as the type size of wound in patient age?

Question: Maury Raycroft - Jefferies - Analyst : Got it. And also wanted to check on partnering. You mentioned partnering in the past for this program and also the sites that you plan to use for launching the drug. Maybe talk a little bit more about that as well.

Question: Maury Raycroft - Jefferies - Analyst : Got it. That's helpful and makes sense. I wanted to shift gears and talk about your ophthalmology gene therapy programs where you've shown some preclinical data there and this could potentially turn into a growth pipeline for Abeona. Maybe talk about how you pick these initial indications and programs.

Question: Maury Raycroft - Jefferies - Analyst : Got it. That's helpful. And during the program update call that you guys did last month, you mentioned you were going to have two pre-IND meetings very soon. Just wondering if you've had those meetings and what are some of the key takeaways.

Question: Maury Raycroft - Jefferies - Analyst : Got it. So I think we're pretty much out of time, but maybe talk about key events ahead for Abeona for EB-101 and also for the eye programs as well.

Question: Maury Raycroft - Jefferies - Analyst : Thanks for joining us. And just one quick follow-up for the preclinical data for the eye programs. Could you have some data updates on that this year as well?