Editas Medicine, Inc. (NASDAQ:EDIT) Q1 2023 Earnings Call Transcript

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Baisong Mei: Yes. Thank you for the question. So we certainly think that with the gene editing approach that we have we will be able to generate a substantial amount of data. And the specifics on the number of patients to be able to use for registration, we need to align with the regulatory agencies. So, we are planning to discuss with FDA.

Rick Bienkowski: And I just have another quick one. I was hoping for a little bit more granularity on the collaborative revenues for the quarter. Were all of the $9.9 million in revenue attributable to the Shoreline transaction, or are there some other revenues attributable to other partnerships in there?

Michelle Robertson: It’s a combination of both the Shoreline and then some other small sublicense revenues.

Operator: Our next question is from Rich Law with Credit Suisse.

Rich Law: I have a couple of questions for you guys. So, with the appeal litigation pending, what does it mean for company such as CRISPR Vertex that already filed a BLA for exa-cel that utilize CRISPR/Cas9 from your IP perspective. They don’t have a license from you or the Broad and could potentially launch the product before we know the outcome of the appeal. So any insight here would be helpful. And then, I have a follow-up question.

Gilmore O’Neill: I think the key thing is that we sort of anticipate the judgment in the early to mid-2024. We are confident that we prevail as we have before, largely because what are — under discussion is the application of the law and not about new facts, and it’s the application of law by PTAB. Now setting aside that interference, I think the important thing is to say that we have a portfolio of IP not subject to any interference that actually covers product in development using Cas9 for the application of human therapeutics. And, looking forward, we are happy to grant licenses to enable delivery of this technology to patients, and believe that we should recognize significant value around that.

Rich Law: So, in terms of granting license, so we’re not going to know the appeal decision likely before the BLA and also potentially the launch? Like, how do you sort of think about that?

Gilmore O’Neill: Well, I think there are a number of important points to make. I think the first, again, is just to remind that the appeal applies to some of our Cas9 in-human therapeutics IP estate, but not all. I think it’s important to emphasize that we have Cas9 or IP around Cas9 use in human therapeutics that is not subject to any interference, and therefore, is not subject to that appeals case. And we actually believe that it actually covers product in development. And so, what I think I want people to really understand is that that appeals case is around interference on some of our IP estate, but not all.

Rich Law: And then, just one more question for me. So you’re seeing some next-gen FCB therapies already in development with new conditioning agents. So, if those exceed, it doesn’t seem like the shelf life for these first gen therapies will last too long. Any thoughts about this?

Gilmore O’Neill: So just to be clear I understand your question. You’re actually questioning if the evolution of new conditioning would actually change the landscape for the products that are either — are close to approval? I think it really very much depends on the nature of the conditioning. As we look out at toxification, obviously, it’s something we’ve looked at closely. One of the important things is to balance both the reduction of toxicities with engraftment efficacy. And I think we all see that it’s a very important path to increasing eligibility for patients because more patients will be able to tolerate a non-genotoxic, less toxic conditioning regime. Many of the regimes or some of the approaches are not actually editing dependent.

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