Theriva Biologics, Inc. (NYSE:TOVX) Q3 2023 Earnings Call Transcript

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And in parallel to that, the team has also been working in all these assets related with manufacturing, which is an intrinsic part of the development of products, and it’s very relevant because, as you know, for our products, the application capabilities, it’s a critical feature that allows for a much better clinical behavior. So we have been increasing our capabilities here also in the manufacturing terms for testing the process development for the new candidates that we are developing, and we have acquired new equipments in our labs here in our facilities in Europe. And we are very convinced that with this new capabilities, we are going to just generate very relevant data for just moving ahead the new candidates faster than we have done previously.

James Molloy : Maybe last question on the pipeline, then if I could please. I think you guys touched on most of your early-stage ISTs. Did you touch on the retinoblastoma one with University of Leeds where that IST stands? And then as you look — you’ve been in these trials for a little bit. We stand back and look, do you see 1 or 2 that look more promising than others at this juncture?

Steve Shallcross: Vince, do you want to take the leads question first?

Dr. Vince Wacher: So thanks, Jim. The University of Leeds study, we had to — well, if an investigator sponsored study, the investigators wanted to make an amendment to the protocol, which they did to help with the scheduling of the surgery that’s part of that protocol. As you’re probably well aware, in the U.K., everything runs through the NHS, so scheduling was becoming a bit of a challenge and they submitted that protocol. That protocol has recently been approved by the MHRA and we are now working on the appropriate drug supply for them to move forward with that study. It’s a study that’s really a PK study, I just want to remind everybody, it’s fundamentally to see whether or not intravenous virus can get into the brain. So we have the one patient that’s been treated. We don’t have the final results from them. But that study is moving comparatively slowly just because of this amendment took quite a while to get approved.

Steve Shallcross: So then maybe I’ll just touch briefly on what I think we’re learning from what we’re doing in the clinic and what offers the most promise for unlocking the most value for the shareholders. Obviously, PDAC is the most important program to the company. It’s the one where we’re committing, I would say, 90-plus percent of our financial resources to. The other program that is very exciting that we just recently talked about from ESMO is the data using VCN-01 in combination with durvalumab in head and neck cancer patients. We had an investigator call following the release of the date at ESMO and when we put that press release out, that interview and conference is still available on our website, and I encourage investors to go listen to it because it was quite revealing.

Essentially, this was a group of 20 patients that had failed checkpoint inhibitor therapy. These patients typically die within 7 months after they’ve failed multiple rounds of checkpoint inhibitor therapy. These patients were then given VCN-01 and then started up on checkpoint inhibitor therapy once again. And we had some pretty remarkable results. On average, at the low dose, we had a survival rate of 15.5 months and at the high dose, 17.3 months. So this is an interesting program and potentially a program for partnering, and we have engaged with folks that should be interested in a program like this, and we’ll keep you updated on the progress of those types of discussions.

James Molloy : Well, last question. I know that you touched on it in the prepared remarks, but G&A, pretty remarkable drop in the quarter. Is this the level we should expect going forward? Or is it going to go back to more of that $2 million roughly per quarter that it had been over the last number of quarters?

Steve Shallcross: It will go back to more of the $2 million. That was an anomaly resulted to the accounting for the contingent consideration. We had a payment to the Grifols. And obviously, every quarter, you readjust and revalue the future payments that are all milestone driven. So that was more of an anomaly for the quarter.

Operator: We have no further questions at this time. I would like to turn the floor back over to Steve Shallcross for closing comments.

Steve Shallcross: Thanks, Irene, and thank you to everyone for taking the time to join us today. Again, we remain focused on driving our key programs forward, and we’ll continue to evaluate strategic opportunities that we believe have an opportunity to drive significant shareholder value and long-term success. Once again, thanks for joining us today, and we look forward to keeping you updated in the future. Have a great week.

Operator: This concludes today’s conference. Thank you for joining us. You may now disconnect your lines.

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