Greetings and welcome to the PDS Biotechnology Third Quarter 2023 Earnings Call and Webcast. At this time, all participants are in a listen-only mode. [Operator Instructions]. As a reminder, this conference is being recorded. I’d now like to turn the conference over to your host, Nicole Jones, Investor Relations for PDS Biotechnology. Thank you. You may begin.

Good morning and welcome to PDS Biotechnology’s third quarter 2023 earnings conference call and webcast. On the call from the company are Dr. Frank Bedu-Addo, Chief Executive Officer; Matt Hill, Chief Financial Officer, and Dr. Lauren V. Wood, Chief Medical Officer. Earlier this morning, PDS Biotech issued a press release announcing financial results for the quarter ended September 30, 2023. We encourage everyone to read the press release as well as PDS Biotech’s report on Form 10-Q, which will be filed with the SEC shortly. The company’s press release is available on the PDS website at pdsbiotech.com. In addition, this conference call is being webcast and will be archived on the company website for future reference. Before we begin, we need to remind everyone that on today’s call, the company will be making forward-looking statements regarding regulatory and clinical candidate development plans, as well as research activities. Certain information in this presentation may include forward-looking statements, including within the meaning of Section 21(e) of the United States Securities Exchange Act of 1934, as amended, and Section 27(a) of the United States Securities Act of 1933, as amended, concerning PDS Biotechnology Corporation and other matters. These statements may discuss goals, intentions, and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise based on the current beliefs of the company’s management, as well as assumptions made by and information currently available to management. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. A description of these risks can be found in PDS Biotech’s most recent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this conference call. Except to the extent required by applicable law or regulation, PDS Biotech undertakes no obligation to update the forward-looking statements included today to reflect subsequent events or circumstances. I'll now hand the call over to Dr. Frank Bedu-Addo. Frank?

Thank you, Nicole, and welcome to everyone to our third quarter 2023 conference call. We are excited about the strides we are making, fueled by our commitment to developing groundbreaking therapies that revolutionized cancer treatments based on our proprietary reverse immune platform. And IL 12 fused antibody-drug conjugate PDS01ADC, formerly known as PDS0301 or M9241. The clinical data stemming from the PDS01ADC asset, which we acquired nearly a year ago from Merck KGaA Darmstadt, Germany, continues to advance and mature, reinforcing our belief that this innovative ADC could potentially address the safety and efficacy limitations that have been observed with cytokine therapy to date. The combination of adverse immune-based approaches and our IL 12 ADC has demonstrated the potential to overcome the limitations of effectively treating advanced cancer and extending patients’ lives with immunotherapy. Currently, we have safety data for over 250 patients who have been treated with PDS01ADC, supporting the early data, suggesting that this innovative ADC effectively directs the IL 12 into the tumor, therefore reducing its presence in the circulating blood and subsequently limiting the adverse events that have been reported with other Cytokines. In addition, the increased and sustained presence of IL 12 in the tumor has been shown in our ongoing trials to enhance the clinical activity. This novel modification of IL 12 therefore presents us with a unique opportunity to address a broad range of cancers. We continue to move this ADC forward with various promising approaches. It is being developed as a monotherapy. It's also being developed in combination with Versamune-based approaches and also in combination with other standards of care. I will talk more about these updates on PDS01ADC later on the call. We are pleased with our current progress driven by our mission to develop groundbreaking therapies that transform cancer treatment.…

Now turning to our financial results for the three months ended September 30th, 2023. Net loss for the period was approximately $10.8 million or $0.35 per basic and deleted share compared to a net loss of approximately $7.4 million or $0.26 per basic and diluted share for the three months ended September 30th, 2022. The higher net loss this quarter was primarily due to cost incurred in connection with our research and development and clinical programs. Research and development costs, which includes clinical and manufacturing expenses for the quarter ended September 30th, 2023 increased to approximately $6.4 million compared to $4.3 million for the same period of 2022. The increase of $2 million is primarily attributable to an increase of $1.3 million in clinical trial costs and $0.7 million in personnel costs, which includes $0.3 million in non-cash stock-based compensation. General and administrative expenses for the second quarter of 2023 increased to approximately $4.1 million compared to $2.9 million for the same period of 2022. The increase of $1.2 million is primarily attributable to an increase of $0.7 million in personal costs, including $0.5 million in non-cash stock base compensation and $0.5 million investor relations costs. Our cash and cash equivalent as of September 30th, 2023 totaled approximately $54.3 million. We continue to be prudent with our cash expenditures and we believe that with initiating the VERSATILE-003 Phase III clinical trial in the first quarter of 2024. Our available cash resources will sustain our operational and research and development endeavors into the third quarter of 2024. We expect to execute our current operational and research and development endeavors by obtaining additional capital, principally through running into collaborations, strategic alliances or license agreements with third parties and or public or private debt and or equity financing. We've had and continue to provide what we believe to be favorable development milestones to the market and have upcoming development milestones we believe may provide additional Catalysts to investors. At this time, this completes my financial discussion. I would like to hand the call back over to the operator for the Q&A session. Operator?

[Operator Instructions]. Our first question comes from the line of Louise Chen with Cantor Fitzgerald. Please proceed with your question.

Hi, congratulations on all the progress this quarter, and thank you for taking my questions. So, I had a few questions for you. As you think about 2024, and we table set for next year, what are the key milestones, catalyst readouts that you think we should have on our radar? Secondly, how do you think about OPEX for fourth quarter ‘23 and 2024 in light of the fact that you're going to start this VERSATILE-003 Phase III? And the last question is, when do you think we'll see data on VERSATILE-003? Thank you.

Thank you, Louis. Thank you very much for your questions. I'll answer two, and I'll hand over the OPEX to Matt. But in terms of the key milestones and Catalysts, as we move into 2024, as I mentioned, key will be getting VERSATILE-003 up and running. We also have announced and stated that we do anticipate and expect the final data readouts from VERSATILE-002 sometime in the second quarter of 2024. As I also just mentioned, we do expect to initiate the PDS0103 clinical trial in Mach 1-related cancers early in 2024, at least in the first half of 2024. We also are hopeful that we will have the preliminary data from our neoadjuvant trial ongoing at the Mayo Clinic in early-stage oral cancer HPV positive oral cancer, where we are looking at PDS0101 both as a monotherapy and also in combination with KEYTRUDA. We have not had any readouts from that study yet, and we are hopeful that we will get that in some time the first half of 2024 based upon what we've been informed by the PI and their goal of presenting at an upcoming conference. And also, we do expect to have additional data readouts on the immunotherapy cervical cancer trial. And so, we do have a number of potential milestones coming up as well as readouts for, and as you know, we don't talk too much about the trials going on. Also, at the National Cancer Institute, we had the readout from the docetaxel as well as the PDS01ADC. We also have those studies ongoing in earlier stage prostate cancer locally advanced prostate cancer. We'd hopeful that we'll see some data from that trial in 2024. We have the monotherapy trial going to Kaposi Sarcoma. Hopefully, we'll see some data from that trial in 2024.…

Thank you, Frank. I want to let you know that it's a good question. I would say, we've been extremely prudent with the use of the company's cash and capital. When you look over the last probably seven quarters or so, we burned about little north at $6 million per quarter. And with the significant number of studies that we have ongoing, not only the VERSATILE-002 trial, but also the trials with the NCI, the Its, with MD Anderson as well as Mayo. We've been extremely frugal in our opinion, in how we manage these costs. But as we prepare to move forward into Phase III clinical trial, obviously those costs are going to increase. Now, from the perspective of OpEx, the administrative costs will grow slightly, but we could expect that the company will incur costs in R&D of somewhere around overall costs -- I'm sorry, will be somewhere around between $12 million to $15 million once the study starts up with some of that being front-loaded for the normal deposits that are need to be made to get the consultant CROs and the likes set up, which is why we -- under the current circumstances of us looking at a trial beginning in Q1, we've got cash into Q3 of ‘24, which also gives us additional time to go out and look for the business development deals. We had the -- data come out, we've had the versus the NCI triple data come out. We've had the docetaxel data come out, we've had the KOL meeting, so there has been a significant number of data readouts and we're hopeful that will be a catalyst for potential business development deals as well.

Thank you. Can I just ask you one follow-up question? So, for fourth quarter ‘23, then you would expect OPEX to be similar to third quarter, or would there be some ramp-up for the start?

There will be some ramp-up in Q4 of this year. So, we spent about $10.5 million in total in Q3. So, my expectation would be around there or a little higher.

Okay. Thank you.

Thank you. Our next question comes from the line of Mayank Mamtani with B. Riley Securities. Please proceed with your question.

Appreciate the comprehensive pipeline update. So maybe a high-level question quickly for you guys. So, given 0101 prolonged survival and the higher ORR, you seem to have the driven by 01ADC investor, one investor generally wonders if perhaps it makes sense to also evaluate triplet in first line or should we think of triplet to be more in the ICI resistance patients or maybe even being HTV agnostic? Could you just clarify how you're thinking, relative positioning of these two programs? And then I have a couple of follow-ups.

Frank, if you're speaking, you may be on mute.

Thank you very much. Yes. So Mayank, I think, you are absolutely right. We have seen highly encouraging survival data with PDS0101, as well as PDS01ADC, as well as extremely encouraging ORR with the PDS01ADC. Now, we have certainly considered the application of the PDS01ADC in the earlier line ICI naive. However, after talking to key opinion leaders in the field, as well as the regulatory experts, it's evident that the survival and safety data generated with a doublet, presents the most straightforward regulatory pathway, as well as the robust uptake if and when it becomes standard of care, right? With the doublet will also enable a more rapid potential approval path for early, even early use. Now, when we look at the triple in the ICI resistant population, it also presents the quickest path to approval and potentially application in multiple HPV cancer indications, as you mentioned, essentially tumor agnostic. This triple combination may then also subsequently find its way to an approval for use in ICI naive patients. So, this is something we have actually seriously considered, but after talking to the experts in the field, the two options we are taking now appear to provide the quickest paths to rapid approvals and uptake.

I understood. Thank you for that clarification. And then maybe drilling down on the doublet trial protocol, are there any details on the SAP that you're able to share in terms of the target OSS [ph], differential, you're going for against standard of care? I recognize you are talking about sites, but not specific patient numbers, but just sort of it would be helpful to understand what sort of hazard ratio, what sort of delta on OSS you're aiming for. And this is related question, your ESMO translational biomarker data was actually quite novel in context of demonstrating CD8 T-cell responses specific to tumor cells. So, I was wondering if there are any implications of that in terms of patient enrichment or response assessment strategies that you could deploy in your late state development.

Mayan a lot of really good questions. So, let me start with the biomarker data. So, with the biomarker data, as you did mention, we are looking at a number of novel approaches to really understanding and documenting how PDS0101 is working and really documenting and clarifying the differentiation of our assets. So, if you look at the data presented at ESMO, for example, looking at the poly functional CDA T-cells, confirming increase in poly functionality was very important. But also understanding the kind of immunological profile that PDS0101 is promoting, for example, going from a TH2 bias to a TH1. TH1 being well documented to be better associated with strong CD8 T-cell responses, right? And also showing that we have potential exit of the CDA T-cells from the blood to the tumor sites, right? Showing the decline in circulating peripheral blood, um, containing CDA T-cells. So, we have that approach in that study in the PDS0101 KEYTRUDA. Now, when you also look at what's been done in terms of biomarkers in the Immunotherapies study, right? Very complimentary to what we've seen with the PDS0101 KEYTRUDA study. In the IMMUNOCERV study, what MD Anderson was looking at is circulating tumor DNA. Circulating tumor DNA is extremely important for a number of reasons, right? If you look at cancer today, most patients don't die from the initial tumor or the initial cancer. They often die from micrometastatic cancer that remains after the initial treatment, right? And so being able to essentially eliminate the tumors from the patient's body becomes extremely important. And how do you know that your technology or product is actually achieving that? What we have seen now with our circulating tumor, DNA in that study is the strong potential for PDS0101 to actually dramatically eliminate and reduce and…

Yes, no, very comprehensive, very helpful. Lastly for Matt, just quickly on the strategic collaboration discussions, are you able to describe qualitatively interest from strategic on doublet versus triplet and how maybe recent Triplett data may have informed those discussions, and also, there's a full data set from your double-edged expected in second quarter. Would they want to see that mature analysis before transacting or like kind of just lay out what sort of the variables are there that impact discussion like that? Thanks for digging the question.

So, Mayank, I'm not going to be able to go -- I'm not going to be able to go into specific….

Do you want to take that one Frank?

Yes, I'll take that one. Yes. So Mayank, I won't be able to go into very specific details as to what we are discussing. However, the data that we have today has been very helpful in clarifying certain things. So, one of the key things that I mentioned over the last couple of earnings calls has been the fact that we are waiting to see the data from the VERSATILE-002 refractory arm. That data was very important because it was key in giving us insight into the specific role of PDS0101 or the contribution of PDS101 in extending life in head and neck cancer patients. And so, looking at that combination of PDS0101 in KEYTRUDA, in patients who have failed checkpoint inhibitors, the majority of which we know were on KEYTRUDA, and still being able to extend those patients' lives significantly was very important for us to demonstrate and to get potential partners also comfortable that, okay, PDS0101 is actually biologically active in this population and even seeing this extension in even a much more difficult to treat population. So that was key. It was also important for us in the triple combination trial, as I mentioned previously, for us to have that understanding of what PDS0101 is doing in that combination. Because a lot of the questions we receive, both from investors and prospective partners is well in the triple, how do we know which of these components is working and what is contributing to what, right? So now the role of PDS0101 becomes very clear, but with the data we have today, right? We also now see the critical role of PDS01 ADC. And so now both components, both drugs have very clearly shown their biological activity. And what was also very important is you look at VERSATILE-002…

It does. Thank you for taking your questions and look forward to future updates. No problem. Thanks a lot.

Our next question comes from the line of Joe Pantginis with HC Wainwright. Please proceed with your question.

Hi, good morning, everybody. Thanks to taking my question. Two questions please. So, first for 0101, wanted to ask about currently what you have ready to go followed by your intermediate near term needs and intermediate needs with regard to manufacturing? And then the second question is a little bit of the off the beaten path here. Because it's been nice to hear such the encouraging data updates from a 0101, but I wanted to ask about 0202 and the universal flu vaccine. You are sitting on what we consider to be a very strong asset profile and the data that you've accumulated to date. So other than the rhetorical answer of financial resources, what could you envision being a development plan for that asset? Thanks.

Hey, thanks a lot Joe. I'll start with the first question in terms of what we have ready to go with PDS0101. So, with PDS0101, we have done all the tech transfer. The material has been scaled up to our commercial process, and the Phase III clinical product has already been successfully manufactured and released. So, in terms of clinical product that has been scaled up to the final process and has been successfully manufactured, we are there today. So, the material is ready to go. We don't have any additional needs from the perspective of PDS0101 materials in order to run the phase -- to run the Phase III clinical trial with either program VERSATILE-002 or the triple combination. With PDS0202, as you mentioned, this is a program that we are quite excited about. Today, our resources, financial resources are really focused on the oncology programs. However, we have made significant progress also with this program. As you know, the data was presented in September at the European influenza Conference. The data from ferrets, right? Ferrets being the gold standard for preclinical studies. So, it was very important to be able to demonstrate that we can replicate the data that was generated in the mouse models in the ferrets, which are closest to humans in influenza. And again, all that was done has been done successfully. We've shown very similar levels or identical levels of broadly reactive neutralizing antibodies against multiple strains of the flu that was shown successfully in Ferrets. We also showed successful prevention of viral replication in the lungs when the animals were given lethal doses of the H1 N1 virus, as well as protection against infection in the ferrets also. So, we have shown very good translation. Now, from PDS perspective, for us, this is…

[Operator Instructions]. Our next question comes from the line of Jim Molloy with Alliance Resource Partners. Please proceed with your question.

Hello, this is Laura on for Jim. Thank you for taking the questions and congrats on all your progress. So, you mentioned an upcoming trial for your preclinical PDS0103 candidate for the first half of next year. What are any other updates that you have for your preclinical PDS0102 and 0104 candidates?

Hi, Laura. Thanks for the question. So, with PDS0103, as I mentioned, the goal is to start in the third quarter -- in the first half of next year, and so that is going to be done under our collaboration with the NIH. Right now, we are finalizing the CMC section. We are finalizing the animal studies and looking at the new triple combination, which is potentially going to be very likely the path we go down. That's been evaluated now in specific tumor models that we would want to include in the IND filing. So, we are working towards an IND filing hopefully in Q1 of next year to get this into the clinic, hopefully by the second quarter of next year. With PDS0102, we are also working now on the tech transfer, and the formulation development has been completed. Preclinical work has been completed with PDS0102. And just to remind, just to remind the audience who may still be on PDS0102 specifically addressing prostate cancer. So, I'm sure you can see how that potentially lines up with what we are doing with docetaxel. There is the potential that we could include that to make a new triple combination. But the goal here with that program is to get that dual combination as rapidly as possible to commercialization, but there's potential for expansion in terms of even more difficult or latest treat cancer patients and decline of circulating tumor DNA using that PDS0102 asset in which the target is top, TARP. TARP has been found in about 90% of prostate cancers at all stages of the disease and about 50% of breast cancers. So that's an asset that we do anticipate hopefully getting into manufacturing sometime next year in 2024 to allow us to start to evaluate that asset. Also, probably later in the year, but we'll provide updates regarding what the what we're doing with that process program, what the potential partnerships, how we're going to move that forward. We'll provide some of, some more of those details later as the year, the year goes by in 2024 PDS0104, we have not yet made any additional progress with PDS0104. We've really concentrated on PDS0101, 0102, and 0103 at this point, as well as PDS01ADC.

And also, just one more question alongside the data presented for IMMUNOCERV, for your other investigator-initiated trial of PDS0101, this with the Mayo Clinics. Do you have any estimates as to when you might get data announced here?

No. So with the Mayo Clinic, starting with the Mayo Clinic, as you mentioned that's another investigate-initiated trial, it's evaluating the early stage HPV16 positive oral cancer in neoadjuvant setting. We have been informed, as I mentioned, by the PI, that they hope to present preliminary data at the scientific meeting in the first half of 2024. And so, we'll keep you updated as we learn more as to what conference that would be and what the exact timing would be. But we are hopeful that we'll see some data -- we'll see the first preliminary data from that trial, hopefully in the first half of 2024. And with IMMUNOCERV, the investigators are extremely encouraged with the data that they've seen today. Based on what we've been told by Dr. Klopp of MD Anderson who leads this trial, she's actually planning on submitting interim results of the study for scientific publication, and particularly the recent circulating tumor HPV DNA outcomes reported at ASCO. The previously reported tracking, and accumulation of multifunctional CDA T-cells in the tumors, and she also intends to update clinical response and survival data. So, we are hopeful that we'll get an additional update on that trial in the near future.

Thank you. There are no other questions at this time. I'll turn the floor back to Dr. Bedu-Addo for any final comments.

Thank you very much. So, thank you to all for participating in our third quarter earnings conference call today. The progress made this quarter has been truly exciting. We remain enthusiastic about what lies ahead for the rest of this quarter and into 2024. We have made significant strides towards our objective of developing groundbreaking therapies that transform cancer treatments. We are confident that our efforts will positively impact these patients with critical unmet medical needs leading to longer lives and improved quality of life. We appreciate your continued support and eagerly anticipate updating you on our accomplishments. Thank you very much again, and have a wonderful day.

Thank you. This concludes today's conference call. You may disconnect your lines at this time. Thank you for your participation.