Good morning. And welcome to PDS Biotech's Fourth Quarter and Full Year 2024 Earnings Conference Call. [Operator Instructions] At this time, I would now like to turn the conference over to Tom Johnson of LifeSci Advisors. Please go ahead, sir.

Thank you, operator. Good morning, everyone. And welcome to PDS Biotech's 2024 results and clinical program update call. I am joined on the call today by the following members of the company's management team. Dr. Frank Bedu-Addo, Chief Executive Officer; Dr. Kirk Shepard, Chief Medical Officer; and Lars Boesgaard, Chief Financial Officer. Dr. Bedu-Addo will begin with an overview of the company’s recent progress and it’s clinical development program. Mr. Boesgaard will review the financial results for 2024 fiscal year. And Dr. Shepard will then join the call to help address questions from covering analysts. As a reminder, during this call we will make forward-looking statements, which are subject to various risks and uncertainties that could cause our actual results to differ materially from these statements. Any such statements should be considered in conjunction with the cautionary statements in our press releases and risk factors discussed in our filings with the SEC, including our Quarterly Reports on Form 10-Q and Annual Report on Form 10-K, and these cautionary statements made during this call. We assume no obligation to update any of these forward-looking statements or information. Now I'd like to turn the call over to Dr. Bedu-Addo. Frank?

Thank you, Tom. And good morning, everyone. It's our pleasure to speak with you again and to provide this brief update on our progress in advancing our clinical programs. 2024 and the first weeks of 2025 have been busy and productive led by the initiation of our VERSATILE-003 Phase 3 clinical trial of Versamune HPV + pembrolizumab compared to pembrolizumab as a potential treatment for first line recurrent and/or metastatic HPV16-positive head and neck squamous cell carcinoma HNSCC or head and neck cancer. Patients with HPV16-positive head and neck cancer represents a large fast growing population in need of targeted therapies to treat the underlying cause of the cancer. It is projected that by the mid-2030s HPV-16 positive head and neck cancer could be the most prevalent type of head and neck cancer in the United States and Europe. Considering the strength and durability of the clinical responses observed in our VERSATILE-002 Phase 2 study we are pleased to get this registrational trial underway and are confident in the potential of our innovative combination of Versamune HPV and pembrolizumab to improve patient outcomes and enhance the standard-of-care. In the coming weeks, we expect to continue to activate additional clinical sites and look forward to the continued progression of this trial. As we announced previously, the VERSATILE-003 trial design includes approximately 350 patients. The two-arm registrational trial design has been given the go ahead by the U.S. Food and Drug Administration, FDA. The two-arms of the trial include a treatment arm of the Versamune HPV pembrolizumab combination versus the control arm of pembrolizumab only. Patients are enrolled in a 2:1 randomization. Median overall survival is the primary endpoint. The trial design is informed by the observed durability of the clinical responses in our VERSATILE-002 Phase 2 clinical trial seen over the…

Thank you, Frank and good morning everyone. Net loss for the year ended December 31, 2024 was approximately $37.6 million or $1.03 per basic and diluted share. This compares to a net loss of $42.9 million, or $1.39 per basic and diluted share for the prior year period. The reduced net loss was primarily the result of decreased operating expenses, which were partially offset by increased net interest expense. Research and development expenses for 2024 were $22.6 million compared to $27.8 million in 2023. The decrease of $5.2 million was primarily attributable to decreases in clinical costs of $4.1 million, personnel cost of $1 million, and professional fees of $0.1 million. General and administrative expenses for 2024 were $13.8 million, compared to $15.3 million in 2023. The $1.5 million decrease was primarily attributable to decreases in professional fees of $1.3 million and facilities cost of $0.2 million. Total operating expenses for 2024 were $36.3 million, which compared to $43 million in 2023. Net interest expense was $2.2 million for 2024 compared to $1.3 million in 2023. This change was due to increased debt interest and lower interest income on the company's cash balances. On February 27, 2025, we announced an up to $22 million registered direct offering. The securities purchase agreements with new and existing healthcare for its institutional investors included $11 million upfront gross proceeds with up to an additional $11 million of aggregate gross proceeds upon cash exercise in full of warrants issued to the investors. The company's cash balance as of December 31, 2024 was $41.7 million, and that balance, of course, does not include the aforementioned direct offering, which we concluded in February. With that, I'll just turn the call back to the operator.

Thank you. [Operator Instructions] Thank you. And the first question comes from the line of Joe Pantginis with H.C. Wainwright. Please proceed with your questions.

Hi, guys. Good morning. Thanks for taking the questions. So first I wanted to get a sense of the enrollment trajectory for Versamune-003. And I guess well, projected timelines, number one. And I know that might be hard to project since it's very early, but the sites that you're targeting, what kind of balance are you looking at, with regard to sites that are familiar with Versamune, versus new sites that might require some level of a learning curve?

Thank you, Joe, for the question. Kirk, I'll hand that question over to you.

Yes. So we're happy that as you know, we initiated the first site this month. And we're happy also to say that the sites that were involved, almost all of them from the Phase 2 trial, are re engaged with us now with Phase 3. And as I think you referred to in your question, this helps out a lot as far as their familiarity with the drug, I think their belief in the good results. And so that's really sped us along quite a bit. As far as the patient accrual in the future, I mean, you're right. That'll be determined by how fast we bring these sites on. And so far we're tracking very well. And of course, how well each of the sites do perform.

No, that's helpful, thanks. And I guess, as Lars was describing too, in this day and age, you guys are I guess, in a good position to have a decent cash balance. So I guess, as people look to study completion and pipeline development, how do you view the current funding environment for your current studies?

Lars, I'll hand that over to you.

Sure. Hi Joe, thanks for the question. Yes, you're right. As I mentioned, we did raise $11 million recently. And definitely the current funding environment and market conditions are difficult and challenging. So we're quite pleased that, we were able to raise the funds in a way that enables us, to start the trial. And so we're progressing, as Kirk just mentioned. But of course, I think it should be clear also that we currently don't have enough raised, or on the balance sheet for that matter, to complete the trial. So our plan is to raise necessary capital in a stepwise manner as we make progress with our Phase 3 trial. And our plan is to essentially make use of all options available to us, which includes equity and non-dilutive sources such as debt. And we will continue to balance our funding needs, against dilution of current shareholders.

No, that's totally fair. I appreciate that. And when you said potentially non-dilutive options, I guess maybe I'll throw the potential of business development into the mix, and what do you think that role might play in being able to bring even pipeline programs forward?

So, sorry. So in terms of non-dilutive, right. I think that includes, as I mentioned debt, but it includes all various sources, right. So we don't necessarily want to want to get ahead of ourselves, in terms of talking about specific partnerships, or specific collaborations. Suffice to say, and I think it's also important, as Frank alluded to in his prepared remarks. That most of our pipeline beyond the Phase 3 are essentially IITs, in which our funding is very limited, and the funding needs are very limited, as far as we're concerned. As we're focused solely on VERSATILE-003, with regard to our funding needs.

Totally fair. Appreciate all the comments, guys.

The next question is from the line of Mayank Mamtani with B. Riley Securities. Please proceed with your questions.

Yes, good morning team. Thanks for taking our questions. And pleased to see the Phase 3 VERSATILE-003 trial kicked off. I see you say in press release there are multiple interim readouts built in the study, and your total patient sample size came in a bit lower than perhaps what you had originally thought. We'd love to hear the rationale for that, and also obviously any color you can give on how you've built in these OS interims. And then I have a follow-up?

Hi Mayank, thanks a lot for your question. So yes, you are correct that the trial size was initially over 400. As I alluded to in my remarks, we have seen significant durability of the responses, and also significant improvement of all the clinical outcomes over the last year. And good durability of the Median overall survival, which is going to be our primary readout for this trial. So based upon the durability of the responses, and the increases in those responses, we're able to go back to our statisticians, to tighten the trial design-based on the fact that we had a lot more confidence in those numbers, due to the prolonged follow-up of those patients. And so that took it from over 400 patients down to 350 patients, with the same power, by the way. So we retained the statistical power that, amended IND was then presented to the FDA, who gave us the go ahead with this redesigned trial. And so as you know, Median overall survival as you mentioned, is our primary data readout. And so the goal here, based upon the data we've seen in our VERSATILE-002, which is highly encouraging, was to give us the opportunity. If we are able to replicate these results in the Phase 3 clinical trial, give us that opportunity, to be able to discuss results early on with the FDA. And so, our design built in two interim data readouts. The first interim data readout, will come approximately six months after full enrollment into the trial. And these endpoints are based on specific death events. So they're based on a certain number of death events occurring by that time, and then 12 months after that, we give ourselves another interim data readout. And so really, what this trial design does based on Median overall survival, which has been really durable, is to give us that opportunity, to have early discussions with the FDA regarding potential accelerated approval, pending what the data readouts look like at that specific time. Kirk, is there anything you'd like to add to that?

No Frank, I think you covered it well. I think the important thing is that we do have a good opportunity, at the first interim analysis to go back to the FDA, with a survival data for hopefully, an accelerated review and then an approval. But no, I have nothing to add to what you said before. Thank you.

Yes. So what we see on ClinicalTrials.gov 2029, essentially you're saying that the time frame for first readout could be maybe half of that period. If I had to kind of get to the bottom line here, Frank?

Yes, as Lars said, I don't think we want to get ahead of ourselves. And also as Kirk said, it will take us a few months to understand the enrollment rates, how these sites are enrolling patients, because as really, the timeline for a clinical trial is absolutely dependent, on how the trial recruitment rates, right. So it will take us a few months to get a good handle, on how quickly these patients are coming in. The good thing, as Kirk mentioned, is the fact that most of our VERSATILE-002 sites are interested in participating, and are participating in this Phase 3 clinical trial. So we are hopeful that that familiarity with the trial design, with the process of enrolling patients, will help speed up the process. And also the really promising data, which has been generated in the Phase 2. Which has given a lot of these investigators quite a bit of confidence in both the trial design and the Versamune HPV product itself. So we're hopeful that we'll have a pretty rapid enrollment, but it will take us a few months to get a handle around what the projected timelines could be.

Yes, that was quite evident in your December KOL event. Just switching gears quickly on the initial tumor indications of priority for the MUC1 candidate. And seems like you're doing a PDS01ADC combination strategy here, with at least within CRC and just maybe higher level, is the work on IL-12 ADC in head-and-neck on pause now. And you're letting these ISPs sort of drive data generation activity, including obviously in the prostate setting that, you have with Xtandi? Thanks again, for taking our questions.

Well, thanks a lot Mayank, very good question. So you're right that today our focus is on the VERSATILE-003, and that is where the company is applying our capital. But to the point you made, we have actually been very successful in partnering with the National Cancer Institute, and other top tier academic institutions. So those institutions are able to independently progress some of these Phase 2 trials, including what we're doing with the MUC1 and PDS01ADC. So the combination is based on the preclinical, published preclinical studies that were done by the NCI, where they looked at various combinations with the Versamune-based products, as well as PDS01ADC and also with checkpoint inhibitors. And we saw very, very strong synergy between the Versamune-based product and PDS01ADC. So as PDS01ADC is a tumor targeting IL-12. What IL-12 does is it activates T-cells, but by getting it into the tumor specifically, we're able to really activate those T-cells, within the tumor - microenvironment itself, right. So we believe this is a highly promising combination. So does the National Cancer Institute. And there are a number of tumor types that express highly express MUC1. We've selected colorectal cancer as the first target to demonstrate that proof-of-concept in that Phase 1/2 human clinical trial. But then that then allows us to progress into multiple tumor types, just very similar to what we've done with our Versamune HPV, right. So as Lars mentioned, when we talk about non-dilutive funding, we have done this quite effectively with a number of programs to progress. All these programs in cervical cancer, the triple combination, all types of HPV cancers, and now MUC1 with our collaborators, who are putting their capital to work to progress these programs for us. And then you mentioned, the triple combination. With the triple combination, our current plan is to follow, what we deem to be potentially the simplest regulatory strategy, which will also feed into our product lifecycle management strategy for both Versamune and PDS01ADC. So one scenario, is to get the Versamune HPV + Pembro approved. So once that doublet is approved. We can then add PDS01ADC to that approved combination, to develop a second generation product that may treat patients, who are both checkpoint inhibitor naive in addition to those, who are checkpoint inhibitor resistant. So as you know, in the recent JAMA Oncology Publication that we announced, we see extremely promising survival results both in checkpoint inhibitor naïve, and checkpoint inhibitor resistant patients. And we see this across board, with all types of HPV-related cancers, right. In that publication, they show data from anal cancer, cervical cancer, vaginal vulva, in addition to head-and-neck cancer. So these present us with some real opportunities, as we develop the product, and also potentially get the second generation product out there, after the doublet has been successfully approved. Mayank, I hope this answered your question.

Yes, there were multiple parts. Thank you for taking all of them. And I'll hop back in the queue.

No problem.

Thank you. The next question is from the line of James Molloy with Alliance Global Partners. Please proceed with your questions.

Good morning. Thank you very much for taking my questions. Just to follow-up on that last point, Frank. So the triple, the Phase 3 triple, that wouldn't - would that even start before the Phase 2 double trial wraps up, or is that something that will wait for the Phase 2, double trial data before going into the - starting the Phase 3 triple?

Hi James. As I just said, we're looking for, we're doing this as part of anticipated project product lifecycle management strategy, and also following the simplest regulatory strategy. So the simplest regulatory strategy would be to get the doublet approved. Once that doublet is approved, we can then add the IL-12 on top of that approved doublet. It's simply simplifies the regulatory pathway, of having multiple investigational products involved in the trial, right. And so based upon our discussions, with the FDA and suggestions that have been made, we see this as potentially the simplest regulatory strategy, and also a good product lifecycle management strategy in head-and-neck cancer specifically, right. The initial focus is on checkpoint inhibitor naive patients. But once we add IL-12 on top of that, potentially this could address both ICI naïve, and ICR resistant patients-based upon the data that was recently published in JAMA Oncology.

Perfect. Thank you very much. And then….

You're welcome.

The expectation for the MUC1 sort of kicking off, and sort of the next cut point for potential data and then now the TARP, the Phase 1 TARP, is that still on track for potential IND in 2025?

No. So let's start with the MUC1. So with the MUC1 as I mentioned, that is going to be led by the National Cancer Institute. And so the IND has been successfully filed, and the group we've had the green light from the FDA. And so right now what we would do, would be we will be dependent on the National Cancer Institute's timelines. And so, we will wait to hear from them in terms of their intended start date, right. So again, we don't want to put any start dates out there until they have been confirmed, by the National Cancer Institute. They will be leading the trial, while we focus on the VERSATILE-003 trial design, very similar approach to triple.

Understood. And then is the TARP one or two IND [indiscernible] and TARP expressing cancers? Is that still potentially on for '25, or is that also NTI led?

No, the TARP. Right now we focusing on the MUC1 and the Versamune HPV. We have not presented any timelines yet for the TARP. The TARP as you know is the focus there, is prostate cancer. Approximately 95 and higher percent of prostate cancers express the TARP antigen. But for now, once we get a better handle on how the MUC1 is progressing, and the VERSATILE-003 will then provide some guidance, on how we intend to progress the TARP program. But we have not provided any guidance to-date on progression of the TARP program. Today, our focus is the burst immune HPV. And also now handing the MUC1 over under our crater to the National Cancer Institute, for further development.

Great. Thank you very much for taking the questions.

You're welcome.

Thank you. At this time, I'll turn the floor back to Dr. Bedu-Addo, for closing remarks.

Thank you very much, operator. So in closing, we are very pleased to have initiated the VERSATILE-003 registrational trial this quarter. This study is the first Phase 3 clinical trial, specifically in the growing population of HPV16-positive head-and-neck cancer. We are excited based on the strong VERSATILE-002 results, and our fast track designation about the potential for Versamune HPV, to be the first product of its kind on the market in head-and-neck cancer. We expect to provide final results, from our ongoing Phase 2 VERSATILE-002 study later this year. Our engagement with investors and clinical investigators, has validated our approach and the long-term opportunity that we believe the HPV16 targeted immunotherapy presents, in the HPV16-positive head-and-neck cancer indication. We look forward to keeping you updated on our progress. Thank you very much.

Thank you. This will conclude today's conference. Disconnect your lines at this time. We thank you for your participation.