PDS Biotechnology Q1 2025 Earnings Report

PDS Biotechnology EPS Results

• Actual EPS: -$0.21
• Consensus EPS: -$0.25
• Beat/Miss: Beat by +$0.04
• One Year Ago EPS: N/A

PDS Biotechnology Revenue Results

• Actual Revenue: N/A
• Expected Revenue: N/A
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

PDS Biotechnology Announcement Details

• Quarter: Q1 2025
• Date: 5/14/2025
• Time: Before Market Opens
• Conference Call Date: Wednesday, May 14, 2025
• Conference Call Time: 8:00AM ET

PDS Biotechnology (NASDAQ:PDSB), a clinical-stage biopharmaceutical company, developing a pipeline of targeted cancer immunotherapies in the United States. The company's lead product candidate is PDS0101 (HPV16), which is in Phase II clinical trial provides a first line treatment for the recurrent/metastatic head and neck cancer, and human papillomavirus associated malignancies. It also develops various product candidates, which are in preclinical trials, including PDS0102, an investigational immunotherapy utilizing tumor-associated and immunologically active T cell receptor gamma alternate reading framed protein (TARP) for treating prostate and breast cancers; and PDS0103 for ovarian, colorectal, lung, and breast cancers. In addition, the company is developing PDS01ADC, a novel investigational Interleukin 12 fused antibody-drug conjugate that enhances the proliferation, potency, and longevity of T cells in the tumor microenvironment; and PDS0104, a novel investigational Tyrosinase-related Protein 2 targeted immunotherapy that stimulates a potent targeted T cell attack against melanoma. Further, the company provides PDS0202, a novel investigational influenza vaccine that generates broad and robust antibody and T cell responses that provide protection against continually evolving strains of seasonal flu and potentially emerging pandemic flu. It has a license and collaboration agreements with National Institutes of Health, Merck Eprova AG, The U.S. Department of Health and Human Services, and MSD International GmbH. The company was founded in 2005 and is based in Princeton, New Jersey.

PDS Biotechnology Q1 2025 Earnings Call Transcript

Key Takeaways

• PDS Biotech has initiated its VERSAL-three Phase III trial combining Versamune HPV and pembrolizumab in first-line recurrent/metastatic HPV16-positive head and neck cancer, with a 2:1 randomization and median overall survival as the primary endpoint.
• Data from the prior VERSAL-two Phase II study showed durable clinical responses and a median overall survival of 30 months versus ~12 months with standard pembrolizumab therapy in HPV16-positive patients.
• The company will present updated durability and survival data at the 2025 ASCO Annual Meeting, including Phase II results, the registrational trial design, and neoadjuvant MC20-710 data from Mayo Clinic.
• For Q1 2025, PDS Biotech reported a net loss of $8.5 million (vs $10.6 million prior year), reduced R&D and G&A expenses, $40 million in cash, and raised $11 million in equity with potential for $11 million more.
• PDS Biotech’s broader pipeline includes preclinical universal flu vaccine data with NIAID and an NCI-collaborative Phase I/II IL-12 ADC (PDS01) program targeting MUC1-positive solid tumors.

Presentation

[Operator]

Greetings, and welcome to the PBS Biotech First Quarter and twenty twenty five Earnings Conference Call. At this time, all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mike Moyer, LifeSci Advisors.

[Operator]

Thank you, sir. You may begin.

[Mike Moyer, Managing Director at LifeSci Advisors, LLC]

Thank you, operator. Good morning, everyone, and welcome to PDS Biotech's first quarter twenty twenty five results and clinical programs update call. I am joined on the call today by the following members of the company's management team. Doctor. Frank Baduodeau, Chief Executive Officer doctor Kirk Shepherd, chief medical officer, and Lars Boesgaard, chief financial officer.

[Mike Moyer, Managing Director at LifeSci Advisors, LLC]

Doctor Baduodeau will begin with an overview of the company's recent progress in its clinical development program. Mr. Boesgaard will review the financial results for the quarter ended 03/31/2025, and Doctor. Shepherd will then join the call to help address questions from our covering analysts. As a reminder, during this call, we will be making forward looking statements, which are subject to various risks and uncertainties that could cause our actual results to differ materially from these statements.

[Mike Moyer, Managing Director at LifeSci Advisors, LLC]

Any such statements should be considered in conjunction with 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 ks and 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 Doctor. Padua Doh. Frank?

[Frank Bedu-Addo, Chief Executive Officer at PDS Biotechnology]

Thank you, Mike, 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. The first quarter of twenty twenty five and recent weeks have been a productive period for PDS Biotech, led by the initiation of our Versamune HPV plus pembrolizumab. Versamune HPV plus pembrolizumab is a potential treatment for first line recurrence and or metastatic HPV16 positive head and neck squamous cell carcinoma or head and neck cancer. Patients with recurrent or metastatic HPV16 positive head and neck cancer are difficult to treat and represent a large fast growing population in need of targeted therapies to treat the underlying cause of the cancer.

[Frank Bedu-Addo, Chief Executive Officer at PDS Biotechnology]

It is projected that by the mid-2030s, HPV16 positive head and neck cancer will become 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 VERSAL-two Phase two study, we are excited to get the VERSAL-three registrational trial underway and are confident in the potential of the combination of Versamune HPV and pembrolizumab to significantly improve outcomes for patients with recurrent and or metastatic HPV sixteen positive head and neck cancer. We are pleased to announce that new sites, including Mayo Clinic sites, were recently added to the trial, and we continue the process of activating additional clinical sites. We look forward to the continued progression of this trial. As we announced previously, the BERSAL-three trial design includes approximately three fifty patients.

[Frank Bedu-Addo, Chief Executive Officer at PDS Biotechnology]

The two arm registrational trial design has been given the go ahead by the U. S. Food and Drug Administration, or FDA. The two arms of the trial include a treatment arm of the Versamines HPV and pembrolizumab combination versus the control arm of pembrolizumab only. Patients are enrolled in a two:one randomization.

[Frank Bedu-Addo, Chief Executive Officer at PDS Biotechnology]

Median overall survival is the primary endpoint. The trial design is informed by the observed durability of the clinical responses in our VERSAL-two clinical trial seen over the last year and a half, with the most recent data presented at the European Society for Medical Oncology, ESMO Congress, in September. The encouraging patient survival and clinical responses, coupled with promising tolerability as seen in the BERTAL-two clinical trial, will be the subject of the poster presentation at the twenty twenty five American Society of Clinical Oncology Annual Meeting, or ASCO. These data underscore our belief in the potential of the combination to be the first HPV16 targeted therapy for head and neck cancer, and a significant advancement in the treatment of the growing population of patients with HPV16 positive head and neck cancer. The VERSAL-three trial in progress is the first phase three trial in the high risk HPV16 population and has also been accepted for presentation at the twenty twenty five ASCO Annual Meeting.

[Frank Bedu-Addo, Chief Executive Officer at PDS Biotechnology]

Thirdly, Mayo Clinic will present the results of the MC20-seven 10 study investigating Versamune HPV alone or with pembrolizumab prior to surgery or radiation therapy for locally advanced HPV sixteen positive oropharyngeal cancer. All three presentations will be held on Monday, June 2025, from nine a. M. To twelve p. M.

[Frank Bedu-Addo, Chief Executive Officer at PDS Biotechnology]

Central Daylight Time during the head and neck cancer poster session. Elsewhere in our pipeline, last week, we announced that at the American Association of Immunologists, Immunology twenty twenty five Annual Meeting, preclinical efficacy and immune response data in mice and ferrets with a novel infect immune based universal flu vaccine were featured in two presentations on universal influenza vaccines, including an oral symposium. These studies were funded by and performed by investigators at the National Institute of Allergy and Infectious Diseases, NIAID, Center for Influenza Vaccine Research for High Risk Populations. The collaborative approach between NIAID and PDS Biotech allows PDS Biotech to focus our resources on our Versal three clinical trial. And our IL-twelve fused antibody drug conjugate PDS0-one ADC to treat metastatic colorectal cancer.

[Frank Bedu-Addo, Chief Executive Officer at PDS Biotechnology]

Several highly prevalent solid tumors are MUC1 positive, including non small cell lung cancer, ovarian cancer, breast cancer, liver cancer, and others. We are pleased to continue our strong relationship with the National Cancer Institute, NCI, and this phase onetwo clinical trial is scheduled to be run under our collaborative research and development agreement with the NCI. PDS Biotech will continue to focus our efforts on progressing the BERTHDAL003 phase three clinical trial. Now I will turn it over to Lars for a review of our results for 2020. Lars?

[Lars Boesgaard, Chief Financial Officer at PDS Biotechnology]

Thanks Frank and good morning everyone. So for the first quarter of twenty twenty five, we reported a net loss of approximately $8,500,000 or about $0.21 per basic and diluted share for the three months ended March 31. That compares to $10,600,000 or $0.30 per basic and diluted share for the three months ended 03/31/2024. This decrease was due to increased benefit from income taxes as well as lower operating expenses. Research and development expenses were $5,800,000 for the first quarter compared to $6,700,000 for the prior year quarter.

[Lars Boesgaard, Chief Financial Officer at PDS Biotechnology]

This decrease was primarily due to lower clinical trial expenses. General and administrative expenses were $3,300,000 for the first quarter compared to $3,400,000 for the prior year quarter. Total operating expenses were $9,100,000 for the first quarter compared to approximately $10,100,000 for the prior year quarter. Net interest expenses were $600,000 for the first quarter, which compared to approximately $500,000 for the prior year period. Our cash balance as of 03/31/2025 was $40,000,000 compared to $41,700,000 as of 12/31/2024.

[Lars Boesgaard, Chief Financial Officer at PDS Biotechnology]

You'll recall that on February, 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 $11,000,000 upon the closing and with an additional $11,000,000 that may be funded upon full cash exercise of the warrants that were included in the agreement. Also more recently, at the April, we completed a refinancing of our debt with new lenders, resulting in the extension of the term to thirty six months, with the first four months being interest only. With that, operator, we can open the call to questions.

[Operator]

Thank you. We will now be conducting a question and answer session. You may press 2 if you would like to remove your question from the queue. We ask that analysts limit themselves to one question in the follow-up so that others can do so as well. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

[Operator]

One moment please while we poll for questions. Our first question comes from Mayank Mamtani with B. Riley Securities. Please proceed with your question.

[Mayank Mamtani, Senior Managing Director & Group Head of Healthcare at B. Riley Securities]

Yes. Good morning, team. Thanks for taking our questions and congrats on getting the Versatile three Phase three ramping up. So first on the Keytruda head and neck neoadjuvant data we saw at AACR, could you comment on how such a standard of care changing dataset impacts enrollment expectations of your Phase III? And did we sort of learn anything, if anything, on the HPV positive tumor set, and how maybe checkpoint inhibitors monotherapy response rate looks like in HPV16 positive?

[Mayank Mamtani, Senior Managing Director & Group Head of Healthcare at B. Riley Securities]

And then I have a follow-up.

[Frank Bedu-Addo, Chief Executive Officer at PDS Biotechnology]

Mike, you're referring to the KEYNOTE-six 89 trial?

[Mayank Mamtani, Senior Managing Director & Group Head of Healthcare at B. Riley Securities]

That's right.

[Frank Bedu-Addo, Chief Executive Officer at PDS Biotechnology]

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

[Kirk Shepard, Chief Medical Officer at PDS Biotechnology]

Sure. Can you hear me okay?

[Frank Bedu-Addo, Chief Executive Officer at PDS Biotechnology]

Yes, we can hear you.

[Kirk Shepard, Chief Medical Officer at PDS Biotechnology]

Great. The KEYNOTE-six 89 trial should not affect our RECITAL-three. The reason is June 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. That resulted in only three to four percent of the patients of this study being HPV positive.

[Kirk Shepard, Chief Medical Officer at PDS Biotechnology]

So the study was focused mainly on HPV negative patients and not positive.

[Frank Bedu-Addo, Chief Executive Officer at PDS Biotechnology]

Kirk, thanks a lot. So Mayank, 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 sixteen 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 neoadjuvant 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 sixteen recurrent metastatic head and neck cancer population.

[Frank Bedu-Addo, Chief Executive Officer at PDS Biotechnology]

And that's exactly what we saw as Kirk mentioned, only about three percent of the patients were actually HPV positive. Does that answer

[Mayank Mamtani, Senior Managing Director & Group Head of Healthcare at B. Riley Securities]

yes, does. Thank you both. And then second on this ASCO poster presentation coming up, could you talk to what we should be looking to learn on durability, incremental from what you have 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 my questions.

[Frank Bedu-Addo, Chief Executive Officer at PDS Biotechnology]

Thanks, Mayank. I'm not going to speak much about the EGFR inhibitors. I think they will make their presentations at ASCO, and 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.

[Frank Bedu-Addo, Chief Executive Officer at PDS Biotechnology]

But with regards to KDS Biotech and our VERSATILE two trial, as you know, one of the key characteristics of this technology and the product is the durability. Our corporate deck, one of the slides that shows how these patients react long term. I think one of the key things within oncology today with the current cytotoxic drugs, including cetuximab is you get pretty good responses upfront, 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 Versamune 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.

[Frank Bedu-Addo, Chief Executive Officer at PDS Biotechnology]

And that has translated also to survival, which is very important. And so as our last presentation at ESMO, as you recall, we presented a thirty months median overall survival. The standard today is approximately twelve months. So really just putting that into perspective, Today with the standard of care, if a patient had gone onto the standard of care, which have been KEYTRUDA or KEYTRUDA chemo, their probability of living twelve months was about fifty percent. You had a fifty percent probability of living for twelve months.

[Frank Bedu-Addo, Chief Executive Officer at PDS Biotechnology]

However, if that patient had gone onto our VERSAL two trial, they had a fifty percent probability of living for thirty months or more. Right, that's the kind of durability we've seen in this HPV sixteen population, which by the way, in some studies that have been performed and published have shown that in head and neck cancer, they found that in HPV sixteen 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 sixteen positive patients had by far the worst survival prognosis. So this is for us is an extremely encouraging result.

[Frank Bedu-Addo, Chief Executive Officer at PDS Biotechnology]

And what we intend to do is to give an additional update on a more recent data cut on that durability and survival of these patients in the BERZTAL two trial.

[Mayank Mamtani, Senior Managing Director & Group Head of Healthcare at B. Riley Securities]

Thank you, Frank.

[Frank Bedu-Addo, Chief Executive Officer at PDS Biotechnology]

You're welcome.

[Operator]

Our next question comes from Joe Pengenis with H. C. Wainwright. Please proceed with your question.

[Joseph Pantginis, MD & Senior Healthcare Analyst at H.C. Wainwright & Co.]

Hey, 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 six eighty nine, you know, 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, you know, comparing apples to oranges here, you know, at least from a perception standpoint.

[Joseph Pantginis, MD & Senior Healthcare Analyst at H.C. Wainwright & Co.]

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 in being able to want to participate in Versatile three? And then I have a follow-up.

[Frank Bedu-Addo, Chief Executive Officer at PDS Biotechnology]

No, to date, and I'll ask Kirk to give his opinions on that. But to date, have seen very strong enthusiasm from the investigators and the key opinion leaders in actually participating in the VERSATILE two 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-six 89?

[Kirk Shepard, Chief Medical Officer at PDS Biotechnology]

Yeah, the response was very brisk and all the same from our steering committee, which are the experts in head and neck cancer that keynote six eighty nine does not apply to HPV positive patients. And this is even before they saw the data broken down, we saw at the AACR. And sure enough, when we saw the data, as Frank had mentioned, I mentioned earlier too, only three percent 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 we have a number of versatile two investigators with us now who have experience with this drug and are very excited for three to get started.

[Frank Bedu-Addo, Chief Executive Officer at PDS Biotechnology]

Thanks a lot Kirk. So Joe, so along those lines, think very importantly, I think that the oncologists and the key opinion leaders in the space really understand that there are very few people who are going to be HPV positive who will be eligible for that neoadjuvant 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 versus mean HPV plus Keytruda in that neoadjuvant setting for HPV sixteen positive patients. And one of the key things that the KOLs mentioned on our last KOL call was that they have 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've already seen the experts in the field take based upon the promising results that we've seen in VERSAL-two, 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-six eighty nine since they're HPV positive, can we take our combination and apply now to those patients who may not be eligible for surgery, but can go on this neoadjuvantAdjuvant treatment with our combination.

[Frank Bedu-Addo, Chief Executive Officer at PDS Biotechnology]

So, we see a significant opportunity for this combination there too.

[Joseph Pantginis, MD & Senior Healthcare Analyst at H.C. Wainwright & Co.]

Great, I appreciate that added color Frank and Kirk. So, my second nuanced question is your newly or IND approved MUC-one 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, you know, for immunotherapy and or cancer vaccines for more than two decades now.

[Joseph Pantginis, MD & Senior Healthcare Analyst at H.C. Wainwright & Co.]

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, Chief Executive Officer at PDS Biotechnology]

Really great question, Joe. Well, I'll start by saying that very similarly in HPV sixteen positive head and neck cancer, cervical cancer over the last twenty 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 does now have really strong data, very durable responses and moving into a pivotal registrational trial for the first time, right? There have been many failures in HPV sixteen positive cancer over the last twenty 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.

[Frank Bedu-Addo, Chief Executive Officer at PDS Biotechnology]

The technology that is able to now perform the immunological function that the previous technologies had not been able to perform. That is 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 HPV antigens, we're now moving on to the MUC-one after this solid proof of concept that we've generated today.

[Frank Bedu-Addo, Chief Executive Officer at PDS Biotechnology]

With the MUC-one, these are novel antigens, agonist, what we call agonist epitopes that have been designed by the National Cancer Institute. And what these antigens have been designed to do is to be much more immunologically potent than the native MUC-one antigens. Therefore, having a much stronger ability to activate the immune system to recognize MUC-one as a foreign agent. And what we have now done is now taken our Versamune 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 MUC-one positive cancers.

[Frank Bedu-Addo, Chief Executive Officer at PDS Biotechnology]

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 antitumor response. And what we also doing in the study is combining it with our IL-twelve fused antibody drug conjugate, right? And so with the IL-twelve, we have demonstrated also with our HPV programs that by targeting the tumors and really driving the IL-twelve away from the circulating blood, but into the tumors, which is the tumors are the required site of T cell activation, right?

[Frank Bedu-Addo, Chief Executive Officer at PDS Biotechnology]

So by being able to get both our T cells and the IL-twelve into the patient's tumors, we've also demonstrated significantly enhanced survival and antitumor responses. So the goal is to apply this combination again to MUC-one. 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 three program.

[Joseph Pantginis, MD & Senior Healthcare Analyst at H.C. Wainwright & Co.]

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

[Frank Bedu-Addo, Chief Executive Officer at PDS Biotechnology]

You're welcome.

[Operator]

Our next question comes from James Molloy with Alliance Global Partners. Please proceed with your question.

[James Molloy, Managing Director, Senior Biotechnology & Specialty Pharmaceuticals Equity Analyst at Alliance Global Partners]

Hey, Good morning. Thank you for taking my question. Just a quick follow-up on three. As first patient, have you guys announced the enrollment of first patient yet? Did I miss that or what's the expectation on that?

[James Molloy, Managing Director, Senior Biotechnology & Specialty Pharmaceuticals Equity Analyst at Alliance Global Partners]

And then any anecdotal comments from the docs on enrollment and how sort of that's proceeding or how the conversations are going with the potential enrollees?

[Frank Bedu-Addo, Chief Executive Officer at PDS Biotechnology]

No, we have not made it public how enrollment is going. As you know, James, once the sites activated, we activate 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.

[Frank Bedu-Addo, Chief Executive Officer at PDS Biotechnology]

And the goal is to hopefully eventually get to a steady recruitment state. Also, as you know, 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 what the recruitment rates should be and when we'll get to those data readout points.

[James Molloy, Managing Director, Senior Biotechnology & Specialty Pharmaceuticals Equity Analyst at Alliance Global Partners]

That makes sense. Just starting the trial. It's little early to try to guess that yet, I guess. Then maybe I'm on a mechanistic looking at the print for the OpEx for the quarter. Is this sort of the level we should expect going forward or expect that to kind of ramp up going through 2025 or 2026?

[Frank Bedu-Addo, Chief Executive Officer at PDS Biotechnology]

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

[Lars Boesgaard, Chief Financial Officer at PDS Biotechnology]

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

[James Molloy, Managing Director, Senior Biotechnology & Specialty Pharmaceuticals Equity Analyst at Alliance Global Partners]

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 Doctor. Frank Badu Adew for closing comments.

[Frank Bedu-Addo, Chief Executive Officer at PDS Biotechnology]

Thank you, operator. In closing, we are very pleased to have initiated the Versal two registrational trial this quarter. This study is the first phase three clinical trial specifically in the growing population of HPV16 positive head and neck cancer. We are excited based on the strong Versal two 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 two VERSAL-two study at ASCO in a couple of weeks.

[Frank Bedu-Addo, Chief Executive Officer at PDS Biotechnology]

Our engagement with investors and clinical investigators has validated our approach and the long term opportunity that we believe the targeted immunotherapy presents in the HPV sixteen 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 concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

Participants

Executives

• Frank Bedu-Addo, Chief Executive Officer
• Lars Boesgaard, Chief Financial Officer
• Kirk Shepard, Chief Medical Officer

Analysts

• Mike Moyer, Managing Director at LifeSci Advisors, LLC
• Mayank Mamtani, Senior Managing Director & Group Head of Healthcare at B. Riley Securities
• Joseph Pantginis, MD & Senior Healthcare Analyst at H.C. Wainwright & Co.
• James Molloy, Managing Director, Senior Biotechnology & Specialty Pharmaceuticals Equity Analyst at Alliance Global Partners