Greetings. Welcome to Theriva Biologics 2022 full year operational highlights and financial results conference call. [Operator Instructions] Please note, this conference is being recorded. I will now turn the conference over to Chris Calabrese with LifeSci Advisors. Thank you. You may begin.

Thank you, operator, and good morning, everyone. Welcome to the Theriva Biologics Full Year 2022 Investor Conference Call. Leading the call today will be Steven Shallcross, Chief Executive and Chief Financial Officer of Theriva Biologics. Dr. Manel Cascalló, General Director of Theriva Biologics, European subsidiary; Dr. Frank Tufaro, Chief Operating Officer; and Dr. Vince Wacher, Head of Corporate and Product Development of Theriva Biologics are also on the call and will be available to answer questions during the Q&A session. Theriva Biologics issued a press release this morning, which provided operational highlights and included the financial results for the full year ending December 31, 2022. The press release can be found in the Investors section of the company website at www.therivabio.com together with the annual report on Form 10-K for year ended December 31, 2022, which we plan to file today with the Securities and Exchange Commission, or SEC. In addition to the phone line, this call is being streamed live via webcast, which will be archived on the company website, www.therivabio.com for 90 days. During this call, certain forward-looking statements regarding Theriva Biologics and VCN Biosciences, current expectations and projections of our future events will be made. Generally, the forward-looking statements can be identified by terminologies such as may, should, expects, anticipates, intends, plans, believes, estimates and similar expressions. These statements are based upon current beliefs, expectations and assumptions and are subject to a number of risks and uncertainties, including those set forth in Theriva Biologics filings with the SEC, many of which are difficult to predict. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. The information on this call is provided only as of the date of this call, and Theriva Biologics undertakes no obligation to update any forward-looking statements contained on this conference call on account of new information, future events or otherwise, except as required by law. With that, I'd like to turn the call over to Steve. Steve?

Thank you, Chris. Good morning, and I appreciate everyone for taking the time to join us today. During the full year of 2022 and the first few months of 2023, we continue to make significant progress across our oncology-focused portfolio. With a cash runway into the third quarter of 2024, we believe we're well positioned to execute on our corporate objectives and reach multiple value-enhancing milestones throughout this year. Our lead clinical candidate, VCN-01, is a systemically administered oncolytic adenovirus, designed to selectively replicate within the tumor, remodel the tumor matrix and increase tumor immunogenicity. We've dedicated our primary resources to VCN-01 and have successfully initiated 2 clinical trials, VIRAGE, our Phase IIb trial for patients with newly diagnosed metastatic pancreatic ductal adenocarcinoma, or PDAC, as well as the investigator-sponsored Phase I trial for patients with brain tumors. We have dosed the first patients and enrollment is ongoing for both of these newly initiated clinical trials. With these studies, we look forward to building on the growing data that underscore VCN-01's differentiated mechanism of action, biological activity and synergistic clinical benefit observed in combination with standard of care chemotherapy. As part of our oncology-focused portfolio, we've also initiated the second cohort of the Phase Ib/IIa clinical trial SYN-004, which is designed to prevent potentially fatal adverse outcomes in patients who undergo allogeneic hematopoietic cell transplant, HCT, to treat hematologic cancers. In addition, our OV discovery team continues to identify new development candidates to leverage our novel albumin shield technology. This proprietary technology is designed to protect systemically administered oncolytic viruses from the host immune system. We believe the albumin shield technology may facilitate repeated administration of oncolytic virus therapies increasing their efficacy and potentially allowing our pipeline programs to be used in standardized treatment cycles that are well established in…

[Operator Instructions] Our first question is from James Molloy with Alliance Global.

I had a question on the head and neck squamous cell, where you anticipating data second half 2023 and look at that Phase I investigator-sponsored trial. Could you walk through sort of expectations of what we should be looking for [Audio Gap] and any thoughts on what the number of patients that might be treated at that point?

Sure. I'll let Manel take that question. There are 20 patients in that study. Manel, you want to give an overview of the design and what we could expect to see when there is efficacy and survival data come out? Manel Cascalló: Exactly. Yes. The was started in 2018, okay? And the sign included 2 different cohorts where we combined our product with durvalumab, which is anti-PDL1 antibody after failure of the patients have head and neck carcinoma to previous lines of anti-PD-1 therapy. Basically, the main goal of the trial, obviously, is to evaluate the certain tolerability of the combination, but also to evaluate if the treatment with been was able to [antibiotic] overcome resistance to PD-1 antibody. We published last year in ESMO meeting in Paris, all the data related to the safety of the trial, which has demonstrated to be very mild, and we can also dose at the highest dose when combining sequentially our product with anti-PD-L1. And at ESMO, we also disclosed all the biological data obtained from these trial, where we have demonstrated the replication capability of the virus, but also the capability of the virus to shift the immunological environment of these tumors to express more immunologically sustainable markers that warrant eventual better prognosis. We are collecting right now the survival data. That's going to be interesting data because we have seen interesting things. And we expect to present this data probably at ESMO in 2023 that is going to be in the last part of September of '23. It's an international meeting is going to be held in Madrid in Spain. So we expect to do a release at that point of all the survivability data that we have at that point. That is -- I promise it's going to be interesting.

I think you mentioned [KEYTRUDA] as well. Any updates on beyond on Imfinzi? Manel Cascalló: Sorry, could you repeat, please? Yes.

Yes, I'm sorry. I believe in the past, you had spoken about trying a combination with KEYTRUDA as well in this patient population. Is that something that?

Well, that definitely is something that we could evaluate. We have already data with anti-PD-L1 KEYTRUDA and anti-PD-1 antibody. And obviously, we are evaluating based on the results that we obtained from this when we have a better understanding of the final conclusions, we're evaluating different possibilities to move this program ahead. And obviously, the combination with anti-PD-1 antibodies could be an option. Yes.

Great. And then maybe a last question. On the PDAC trial, can you walk through how you -- I believe, Steven, you said you anticipate enrollment completing first half of '24. And what should we anticipate there in that interim look in late '23?

So maybe I'll start this one off. So based on our projections, we expect to have the trial enrolled by early 2024. But as you recall, the study design is quite creative. Although it's a controlled study, it's also open label. And as we all know, from the eyes of the regulators, overall survivability is absolutely the most important endpoint. However, we're going to have the ability to look at response rates real time for this -- the patients enrolled in this trial. And the expectation is that sometime by the end of this year, we hope to have enough patients enrolled and have collected enough data for us to get a good indication of whether or not we're observing the same types of response rates that we saw in our Phase I study. If the data look very compelling, then we'll have options to go back and talk to the regulatory authorities to figure out how we could advance this trial much more rapidly, and there are a lot of options on the table, which could possibly include converts to a pivotal or possibly even making it a registration trial with additional data monitoring on the back end. I mean all those are on the table. It's ultimately going to come down to the data.

Got it. Last question. On VCN-11, the next gen optimized for IV administration. Can you walk through the [Audio Gap] and expectations for VCN-11, please?

Yes. Maybe, Manel, you could take that as well and discuss? We're kind of not only evaluating VCN-11 but sort of our other product candidate, VCN-12 and 13 as we not only advance that program, but look for opportunities to further enhance the payloads of the viruses for additional therapeutic benefit. Manel Cascalló: Yes. So basically, as probably you remember, we discussed the [indiscernible] technology. It's in fact, a platform technology that we can apply to different products. And that's what we are doing right now. So our scientists are very actively right now working in different payloads evaluating what's the best combination of genetic modification that the product can, let's say, incorporate to have additional properties. We know very well that the VCN-11 can be perfectly redosed after systemic administration after our data in different systemic administration models in animals, and that's really, really encouraging data because that's something that has not been described never before for other adenovirus. But we are seeing if that probably we can even incorporate additional properties to the virus to really be much more active in the antitumoral [ameliorate], okay? So that's why we have not only the VCN-11 as indicated by Steve, but different candidates that we are evaluating in parallel, and that's why our recommendation right now is that we probably are going to have a final decision on what's it going to be if we're going to move into the clinic during this year.

We have reached the end of our question-and-answer session. I would like to turn the conference back over to Steve for closing comments.

Thank you, Sherry, and thank you to everyone for taking the time to join us today. We remain very deeply committed to improving patient outcomes for these very hard-to-treat cancers, and we look forward to providing updates on our progress as we continue forward. Once again, I'd like to thank our shareholders, the entire team and the many people who have supported us along the way, including our patients, their families. Once again, thank you for joining us today, and we look forward to future updates.

Thank you. This will conclude today's conference. You may disconnect your lines at this time, and thank you for your participation.