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Lars Boesgaard

Thanks, Frank. And good morning, everyone.
So for the first quarter of 2025, we reported a net loss of approximately $8.5 million or about $0.21 per basic and diluted share for the three months ended March 31. That compares to $10.6 million or $0.30 per basic and diluted share for the three months ended March 31, 2024. This decrease is due to increased benefit from income taxes as well as lower operating expenses.
Research and development expenses were $5.8 million for the first quarter compared to $6.7 million for the prior year quarter. This decrease was primarily due to lower clinical trial expenses. General administrative expenses were $3.3 million for the first quarter compared to $3.4 million for the prior year quarter.
Overall, total operating expenses were $9.1 million for the first quarter compared to approximately $10.1 million for the prior year quarter. Net interest expenses were $0.6 million for the first quarter, which compared to approximately $0.5 million for the prior year period.
Our cash balance as of March 31, 2025, was $40 million compared to $41.7 million as of December 31, 2024. You'll recall that on February 27 this year, we announced that we had entered into a securities purchase agreement with new and existing healthcare focused institutional investors, as well as participation for certain directors of the company. And under that arrangement, we raised approximately $11 million upon the closing. And with an additional $11 million that may be funded upon full cash exercise of the warrants that were included in the agreement.
Also, more recently, at the end of April, we completed a refinancing of our debt with new lenders, resulting in the extension of the term to 36 months, with the first four months being interest only.
With that operator we can open the call to questions.

Question and Answer Session

Operator

(Operator Instructions)
Mayank Mamtani, B. Riley Securities.

Mayank Mamtani

Yes. Good morning team. Thanks for taking your questions and Congrats on getting the versatile 003 phase 3 lamping up. So, first on, the Keytruda head and neck, new achievement data we saw at ACR, could you comment on how such a standard of care, changing data set impacts enrollment expectations of your phase 3, and did we sort of learn anything. If anything, on the HPV positive, tumor set and how maybe checkpoint inhibitors, monotherapy responses, response rate looks like in SPV 16 positive, and then I have a follow up.

Frank Bedu-Addo

Mike you're referring to the KEYNOTE-689 trial.

Mayank Mamtani

That's right.

Frank Bedu-Addo

Okay. Kirk, I'll hand over to you to start if you have any comments on that.

Kirk Shepard

Sure, can you hear me okay.

Frank Bedu-Addo

Yes, we can hear you.

Kirk Shepard

Great. The KEYNOTE-689 trial, should not affect our versatile 003. The reason is 689 was a study of mainly HPV negative patients. That's because the eligibility criteria of the study.
Had to be that the patients were eligible for surgery and most patients who are HPV positive at this stage are not eligible for surgery. So that resulted in only 3% to 4% of the patients of this study being HPV positive. So, the study was focused mainly on HPV negative patients and not positive.

Frank Bedu-Addo

Kirk, thanks a lot. So, that's very important because even if this does become standard of care, there is going to be very little impact on the HPV positive population.
And it may actually speed up the HPV 16 population becoming the predominant recurrent metastatic head and neck cancer population. And this is something that we actually had our steering committee evaluate and give us advice on. And their feedback to PDS was Even if this new adjapan treatment is approved, since very few HPV positive patients are actually eligible for surgery at this stage, there should be negligible impact on the HPV 16 recurrent metastatic head and neck cancer population. And that's exactly what we saw as Kirk mentioned, only about 3% of the patients were actually HPV positive. Mayank that answered your question.

Mayank Mamtani

Yes, it does.
Thank you, both. And then, second on this, ask poster presentation coming up, could you talk to what we should be looking to learn on durability, incremental from what you've shown before, and maybe if you could comment on, just your durability, how might that be tracking relative to, also the emerging data from the next generation EGFR targeted therapies. Thanks again for taking your questions.

Frank Bedu-Addo

Thanks, my I'm not going to speak much about the EGFR inhibitors. I think they will make their presentations at ASCO. We will learn more. At this point, we can't say any more than they have currently presented to the markets. We have no additional information on how their programs are performing. But with regards to PDS Biotech, and our versatile 002 trial, as one of the key characteristics of this technology and the product is the durability.
Right. On our corporate deck, one of the slides that shows how these patients react long term. I think one of the key things with oncology today with the current cytotoxic drugs, including cetuximab, is you get pretty good responses upfront, a good objective response rates. But what we have not seen to date in head and neck cancer, and many other cancers is once you are able to achieve these clinical responses.
Can you maintain these responses long term. That is the challenge, and that is exactly what we see with our adverse immune HPV plus KEYTRUDA formulation, where the patients who have clinical responses, including stable disease, partial responses, and complete responses, the majority of these patients appear to be maintaining those clinical responses long term and that has translated also to survival, which is very important. And so, as our last presentation at ASCO, as you recall, we presented a 30-month median overall survival, right. The standard today is approximately 12 months. So, really just putting that into perspective, right. Today, with the standard of care, if a patient had gone on to the standard of care, which have been KEYTRUDA or KEYTRUDA chemo. The probability of living 12 months was about 50%. You had a 50% probability of living for 12 months. However, if that patient had gone on to our versatile 002 trial, They had a 50% probability of living for 30 months or more. Right, that's the kind of durability we've seen in this HPV 16 population, which by the way, in some studies that have been performed.
In public, have shown that in head and neck cancer, they found that in HPV 16 patients had the worst prognosis for survival once the disease becomes an advanced recurrent metastatic disease, right.
Compared to HPV negative and other types of HPV, the HPV 16 positive patients had by far the worst survival prognosis. So this is for us is an extremely encouraging result. And what we tend to do is to give an additional update on a more recent data cut on that durability and survival of these patients in the versatile 002 trial.

Mayank Mamtani

Thank you, Frank.

Frank Bedu-Addo

You're welcome.

Operator

Joe Pantginis, H. C. Wainwright & Co.

Joe Pantginis

Hi guys, good morning. Thanks for taking the question. So, I want to ask two nuanced questions regarding your two lead programs, and part of it you've already started to discuss. So first with KEYNOTE-689, when you're comparing it again, it's apples and oranges, even though I think from a perception standpoint. There are some, I guess, investor, comparing apples to oranges here, at least from a perception standpoint, so I'm just curious, how do you view the learning curve here and does it apply at all and I don't think it does, to physicians, impact and being able to want to participate in versatile 003 and then I have a follow up.

Frank Bedu-Addo

So, no to date and I'll ask Kirk to give his opinions on that. But to date, we have seen very strong enthusiasm from the investigators and the key opinion leaders in actually participating in the versatile 002 trial. I'll actually hand over to Kirk to give any comments before I get back to continuing my answer. Kirk, any comments on interest in the trial based on KEYNOTE-689.

Kirk Shepard

Yes, no, the response was very brisk and all the same from our steering committee, which are the experts in head and neck cancer, that 689 does not apply to HPV positive patients. And this is even before they saw the data broken down, which we saw at the AACR. And sure enough, when we saw the data, as Frank had mentioned, I mentioned earlier too, only 3% of the patients were HPV positive because it's not appropriate to treat these patients with surgery upfront. So, it's been discussed a lot with our investigators and especially our steering committee that this should not affect our patient accrual at all. And we're very fortunate that we have a number of versatile 002 investigators with us now who have experience with this drug and are very excited for versatile 003 to get started.

Frank Bedu-Addo

Thanks a lot, Kirk.
So, Joe, so along those lines, I think very importantly, I think that the oncologist and the key opinion leaders in the space really understand that this there are very few people who are going to be HPV positive who will be eligible for that new Apan treatment. And one of the things you can see in relation to that is that even at Mayo Clinic, one of the studies that we will be presenting at ASCO has to do with utilizing our Versamune HPV plus KEYTRUDA in that new adjuvan setting for HPV 16 positive patients. And one of the key things that the KOLs mentioned on our last AOL call was that their very strong recommendation for this combination based upon the tolerability that we've seen in the patients today would be to rapidly move it into that earlier stage setting, which would be locally advanced head and neck cancer. Right.
So, we have, we've already seen the experts in the field, based upon the promising results that we've seen in versatile 002, take that. Combination to start evaluating it in this patient population who will not be really impacted, who may not get any benefit from the KEYNOTE-689 since the HPV positive, can we take our combination and apply it now to those patients who may not be eligible for surgery, but can go on this new adjuvant/adjuvant treatment with our combination.So, we see a significant opportunity for this combination there too.

Joe Pantginis

Great, I appreciate that added color, Frank and Kirk. So, my second nuanced question is your newly or IND approved, MUC1 program, so I wanted to do a little bit of historical perspective to where we are today and especially your program. I want to focus on the antigen itself; this has been a key target. I mean, MUC1 for immunotherapy and or cancer vaccines for more than two decades now, and there have been some, pretty high-profile failures with this target. So, I wanted to just get a little more sense again from you guys, why are you differentiated here, and I guess can you describe interest, from sites to participate knowing this history. Thanks a lot.

Frank Bedu-Addo

Really great question, Joe. Well, I'll start by saying that very similarly in HPV 16 positive head and neck cancer, cervical cancer over the last 20 years, there have also been some very high-profile failures. Right. However, with our technology, we now see that for the first time, we have a technology and product that has now has really strong data, very durable responses in moving into a pivotal registrational trial for the first time, right. There have been many failures in HPV 16, positive cancer over the last 20 years. Right.
So, the reason I'm giving you this analogy is it's important to recognize two things, not only the antigen. But the technology that is able to now perform the immunological function that the previous technologies have not been able to perform. That's very important in being able to activate the right immunological signaling pathways and also more effectively present those antigens into the right presentation pathways. So having a strong antigen doesn't get you very far. If it can't be effectively presented. And the right immunological pathways also activated both have to go hand in hand, right.
So now, moving from where we've demonstrated that this technology can do this effectively in head and neck cancer with the HPV antigens, we're now moving on to the Mach one after this proof of con solid proof of concept that we've generated today.
With the Mach one, these are novel antigens, agonist, what we call agonist epitopes that have been designed by the National Cancer Institute. And what they have, what they, these antigens have been designed to do is to be much more immunologically potent than the native MUC1 antigens. Therefore, having a much stronger ability to activate the immune system to recognize MUC1 as a foreign agent. And what we have now done is now taken our verse immune technology.
Combined it with those novel or more potent antigens to facilitate their presentation to the immune system and to facilitate the training of the immune system to recognize them as foreign agents and then also activate those trained T cells to now be a lot more potent in attacking and killing the MUC1 positive cancers.
Right. And so, really, we have to look at it in the entirety of what's really happening here. The antigen alone does not do much to guarantee you or to generate an effective anti-tumor response. And what we're also doing in the study is combining it with our IL-12 anti-used antibody drug conjugate, right. And so, with the IL-12, we have demonstrated also with our HPV programs that by targeting the tumors and really driving the IL-12 away from the circulating blood, but into the tumors, which is the tumors are the required site of T cell activation, right. So, by being able to get both our T cells. And the IL-12 into the patient's tumors. We've also demonstrated significantly enhanced survival and anti-tumor responses. So, the goal is to apply this combination again to MUC1.
Now, this program is being performed as part of our collaboration, collaborative research involvement agreement with the National Cancer Institute. So, this is a program where the first trial is going to be a single-site study and that's going to be done by the NCI. And this collaboration also allows us to focus our resources and efforts on running our versatile 003 program.

Joe Pantginis

Frank, really appreciate that detailed explanation and looking forward to see initial data thanks a lot.

Frank Bedu-Addo

You're welcome.

Operator

James Molloy, Alliance Global Partners.

James Molloy

Hi Frank, good morning.
Thank you for taking my question. Just a quick, follow up on, 003. Has the first patient, have you guys announced the enrollment of the first patient yet. I, did I miss that, or what's the expectation on that. And then any anecdotal comments, from the docs on how they on enrollment and how sort of that's proceeding or how the conversations are going with the potential enrollees.

Frank Bedu-Addo

No, we have not made it public in how enrollment is going. So, as James, once the sites are activated, we act the sites actually have a number of internal processes they will undergo followed by screening of patients. So, the patients have to be screened that's part of the process of getting all these patients into the trial. This process is occurring as we continue to activate more sites, and the goal is to hopefully eventually get to a steady recruitment state.
Also, as the larger sites such as Mayo Clinic take longer to activate and get going. So our goal here is to update the markets when we have a much better idea of how enrollment is going and when we are able to approximately estimate when we're going to get to that interim data readout point. So, we will provide more updates when we have much better insight into when we, how the, what the recruitment rates should be and when we'll get to those data readout points.

James Molloy

That makes sense. Just starting the trial literally to try to guess that yet, I guess, and then maybe, on a mechanistic looking at the print for the OpEx for the quarter. Is this sort of the level we should anticipate going forward or expect that to kind of ramp up going through '25 or '26.

Frank Bedu-Addo

Lars, I'll hand over to you for that.

Lars Boesgaard

Yes, hi Jim. This is Las here. Yes, so we don't currently provide financial guidance, but I think it's fair to say that that we're happy the trial is, has been started well, the way it has, and as you probably are aware, right, we do tend to see a bit of a higher spend in the first couple of quarters, like we get the year up and running. So, I think without giving you any specific numbers, I think we see a relatively stable in terms of the trial spends going forward.

James Molloy

Okay great thank you very much for taking the questions.

Operator

There are no further questions at this time. I would now like to turn the floor back over to Dr. Frank do for closing comments.

Frank Bedu-Addo

Thank you, operator.
In closing, we are very pleased to have initiated the versatile 002 registration trial this quarter. This study is the first phase 3 clinical trial specifically in the growing population of HPV 16 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 in head and neck cancer. We expect to provide updated results from our ongoing phase 2 versatile 002 study at ASCO in a couple of weeks. Our engagement with investors and clinical investigators has validated our approach and the long-term opportunity that we believe the H targeted immunotherapy presents in the HPV 16 positive head and neck cancer indication.
We look forward to keeping you updated on our progress. And thank you very much again for your time and support. Thanks a lot.

Operator

This includes today's teleconference. You may disconnect your lines at this time.
Thank you for your participation.