Good day, and welcome to the Synthetic Biologics' Second Quarter 2022 Earnings Call. Today's conference is being recorded. And at this time, I'd like to turn the conference over to Chris Calabrese. Please go ahead sir.

Thank you, operator and good morning, everyone. Welcome to the Synthetic Biologics 2022 second quarter investor conference call. Leading the call today will be Steven Shallcross, Chief Executive and Chief Financial Officer of Synthetic Biologics; Dr. Manel Cascallo, General Director of Synthetic Biologics European Subsidiary; Dr. Frank Tufaro, Chief Operating Officer; and Dr. Vince Wacher, Head of Corporate and Product Development of Synthetic Biologics are also on the call and will be available to answer questions during the Q&A session. Synthetic Biologics issued a press release this morning, which provided operational highlights and included the financial results for the second quarter ending June 30, 2022. The press release can be found in the investors section of the company website at syntheticbiologics.com, together with the quarterly report on Form 10-Q for the quarter ended June 30, 2022, 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.syntheticbiologics.com for 90 days. During this call, certain forward-looking statements regarding Synthetic Biologics and VCN Biosciences current expectations and projections about future events will be made. Generally, the forward-looking statements can be identified by terminology 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 Synthetic 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 Synthetic 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 taking the time to join us on this call today. In the second quarter of 2022, we continue to execute on our plan to advance our exciting portfolio of clinical assets and to address a number of structural and administrative items that we believe are critical to our long-term success. Today, I will present an update on our progress as well as outline our priorities and path forward. Our team continues to advance our highly differentiated oncolytic adenovirus programs and we believe we are well positioned to lead the clinical path forward for oncolytic virus therapies. First, our VCN-01 product has been administered to 76 patients to date and we believe that there are very few, if any competing programs that have dosed as many patients by systemic administration as we have. Secondly, we've generated promising clinical data that gives us the confidence to advance our products into important planned clinical trials. Thirdly, our programs are led and advised by a world-class team of renowned scientists as evidenced by ongoing clinical collaborations and the formation of our SAB earlier this year to advance our oncology pipeline. Finally, our strong cash position of approximately $53.5 million is expected to comfortably take us into the first quarter of 2024. This should enable us to deliver on a number of value-enhancing milestones before we need to raise additional capital. I am very proud of how we positioned our company for future growth as we continue to work diligently to advance the development of our pipeline. Our oncolytic adenovirus platform currently comprises our lead clinical stage drug candidate VCN-01, a systemically administered oncolytic adenovirus designed to break down the tumor stroma; and preclinical stage drug candidates VCN-11 the first candidate from the truly novel of…

[Operator Instructions] We will now take our first question from Laura Suriel from Alliance Global Partners. Please go ahead.

Hi. This is Laura calling in for Jim Molloy from AGP. Thank you for taking our questions and congratulations on all your progress this quarter. So for the -- for VCN-11 so with the current plans for IND-enabling studies for this candidate what is the overall current status on the IND filing? And more questions regarding your infant candidates. How are potential partnership discussions going on for them? Thank you.

Okay. So first I'll take the SYN-004 and SYN-020 question. And then I'll have Manel give you an update on our plans continue to advance VCN-11. So as I stated last quarter the SYN-020 program has interest from outside parties. We've had diligence discussions on that asset and they continue. And as I've previously stated, once we have something that is definitive and more clear cut, we'll certainly get that information out there. For the SYN-004 asset or ribaxamase, there is a nice fit within an oncology platform and that is a preventative for acute graft versus host disease in bone marrow transplant patients. We just completed the first cohort of that study and we announced we'll have that data released here in the second half. We're very encouraged about that program and we're getting it teed up once we clear the safety data monitoring board at Wash U to advance that into the next cohort. I think there will be a real opportunity and an inflection point for us to make a decision around that asset once we complete this Phase 1 study and demonstrate the safety of this program in this more fragile patient population. And the decision point once we complete the study will be whether to partner that were to continue to advance that on our own. So that one I think the decision is a little bit further down the line. The discussions on SYN-020 continue and we'll have some information on that is we have something that's a little bit more concrete. Manel why don't you take the status on the VCN-11 program?

Okay. Perfect Steve. So with VCN-11, we have been conducting several preclinical activities and we have definitively said towards the candidate definition. We have a very clear idea about the safety, the pharmacokinetic and the toxicity profile of the product. And also we have been conducting several activities related to establishing the different mechanism action of the product and the effectiveness of the antitumor activity in several preclinical models. And in parallel to all these activities, we have also been working under the final definition of the manufacturing process for VCN-11, which is very similar to VCN-01 but with some specificities, not major but obviously we need to test that. And that's what we are doing right now in our internal CMO department, and we are planning to start manufacturing as soon as we have all these internal activities finished with respect to be not in the not very far in the next months probably. As soon as we have this done and we can translate the refactoring process to the CMO, we are going to have the material to conduct the IND-enabling studies. So we are progressing quite smoothly with this candidate and we are pretty convinced that in the next months we are going to have major advantages with them.

Thank you. We will now take our next question from Michael Okunewitch from Maxim Group. Please go ahead.

Hey guys, thank you for taking the question, and congratulations on the process over the quarter -- or progress in the quarter. I guess, my first question I'd like to ask a bit more just about the rationale for targeting retinoblastoma. Is this largely based on the relatively short path to market, or are there any particular mechanistic rationale that make this indication particularly attractive?

I'll take the first part and then I'll hand it over to Manel to talk about the scientific rationale. For me this is really exciting because there's no approved treatment for this serious, serious type of cancer that affects these pediatric patients. And if you would see the outcome opportunities, they're not very pleasant. If present treatments, whether it's cryotherapy or different forms of chemotherapy don't work, these eyes get a nucleate to prevent the cancer to spread to the brain and ultimately cause death. So we're very excited not only to be able to utilize our technology, but to hopefully prevent the serious destruction of the eyes of these types of patients and prevent their deaths with orphan drug designation. I think that gives us a real opportunity, assuming the data that we continue to generate from our Phase 1 study and ultimately, the data we hope to generate from a Phase 3 study to separate us from anybody else who's tried to advance a serious treatment for these patients. I'll turn it over to Manel and let him talk about the scientific rationale and maybe some of the observations we've had as we've used VCN to treat these patients, VCN-01 to treat the vitreous seeds.

Okay. Thank you, Steve. Yes, there's some -- a list of different scientific reasons for selecting writing of some as a target indication for VCN-01. First of all, it's basically the genetic reasons for retinoblastoma -- as I mentioned tumor that it's characterized by the mutation of retinoblastoma protein that's the reason for the name of this tumor. And our bio selectivity is just based on the retinoblastoma pathway. Not only is related to the mutation of retinoblastoma but any mutation in the retinoblastoma pathway, but also the mutation of retinoblastoma. So the only thing that mechanism of action is extremely well fitted, because we are basically confirming selectivity to be seen VCN-01 based on the pathway that is mutated in this specific tumor indications, okay? That's an initial indication. The other very impressing thing for this indication is that one of the major problems with chemotherapies in retinoblastoma of toxicity of the chemotherapy that patients are receiving the patients are receiving for controlling the growth of the retinoblastoma tumor cells okay? Majority of the tumors -- the majority of therapies that patients are receiving are damaging the retina of the patient and that makes that this patient maybe can live without tumor, but also without a major view, mature capacity of view of site. So that's also one of the reasons because VCN-01 has demonstrated in our Phase 1 trial that is extremely selective for retinoblastoma cell. We have collected biopsies from patients. And we can observe the replication capability in tumor cell compared to standard retina and we know that the virus is not affecting at all the normal routine of patients. So the visible capacity of patients is not impacted at all. And that's a major thing in the field of retinoblastoma because that's really a real need for this type of really selective therapies that maintain not only the viability of the eye, but also the visual accuracy of patients, okay? So in addition to that, obviously, there are other reasons. The convenience of admission VCN-01 in the detailed disease as in Virotherapy, it's also very combining retinoblastoma because they are quite used to this type of administrations and probably with a single or let's say a reduced number of doses of our product, we can allow maintaining the response of patients for long periods. And in fact we have observed even a complete response in a patient that is still free of disease more than 3.5 years after administration of our product. So there's several candidate reasons that makes the retinoblastoma a perfect target for VCN-01.

Thank you very much. I appreciate the additional color. As a follow-up, at least talk a bit about the Albumin Shield program in VCN-11. And specifically, how you're viewing that program strategically? Is this more of a follow-up to VCN-01 where it can excel in the same indications, but you have the option for multiple dosing, or does it open up new indications where a single dose may not be ideal?

So…

Okay. Go ahead.

Let me take the first part and then and I'll hand it off to Manel again. We see this as a strategic asset to build on the data that we're generating in VCN-01 and we believe this has a really nice opportunity to treat more difficult cancers out there. And one of the keys has always been neutralizing antibodies. And I think the design of this allows us to address that. And as you suggested to allow us to use multiple dosings with these more difficult-to-treat cancers. Manel, do you want to comment further on the technology?

Yes. Obviously, as said by Steve that's the first goal of this program is to expand the range of tumors that can be treated with a product like VCN-01. However, we are also working very intensively in improving and putting albumin binding technology with other payloads that are obviously maintaining the [indiscernible] because we think that it's critical for the therapeutic effect that we are observing in our patient with VCN-01, but we are exploring to add additional payloads. And eventually, these additional payloads with the albumin shield technology can bring these products to a new stage. And I think that we can be -- that's obviously that's something that we are still in very preclinical average stage, let's say, but that can open additional venues to what we have right now with VCN-01. But that's something more speculating at this point. So VCN-11 is probably more direct continuation of VCN-01. But eventually, that opens the door to new technologies and new products that can be more -- even more differential.

All right. Thank you very much for the answers.

Thank you. [Operator Instructions] There are no further questions. Pardon me we do have a question one moment. Sorry the caller has stepped away. There are no further questions. I will turn the call back to your host.

Thank you, Emma, and thank you to everyone for taking the time to join our call today. Looking ahead, we are well positioned to deliver on our focused clinical development strategy as well as our key objectives that we believe will drive significant value for our shareholders in the months and years ahead. We remain deeply committed to improving patient outcomes for hard-to-treat cancers and we look forward to providing updates on our progress. Once again, I would like to thank our shareholders, the entire team and the many people who have been supportive along the way including our patients and their families. Once again, thank you for joining us today and have a great weekend.

Ladies and gentlemen, that will conclude today's conference. You may now all disconnect.