PDS Biotechnology (NASDAQ:PDSB) reported first-quarter financial results on Wednesday. The transcript from the company's first-quarter earnings call has been provided below.

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Summary

PDS Biotechnology reported a net loss of $7.3 million for Q1 2026, an improvement from $8.5 million in Q1 2025, with reduced research and development and general administrative expenses.

The company made significant progress in its clinical programs, notably amending the versatile 003 trial to include progression-free survival as a primary endpoint, potentially reducing trial duration and costs.

PDS Biotechnology strengthened its intellectual property with new patents for PDS0101 in the US and Japan, extending market protection into the 2040s.

Positive results were reported from trials involving PDS01 ADC in prostate and colorectal cancer, supporting its potential across multiple solid tumor types.

Management highlighted the promising future outlook, focusing on advancing PDS0101 as a treatment for HPV 16 positive cancers, with late-stage trials in collaboration with key institutions.

Full Transcript

OPERATOR

Greetings and welcome to The PDS Biotech first quarter 2026 earnings conference call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. If anyone should require operating assistance, please press Star zero on your telephone keypad. It is now my pleasure to introduce your host, Dean Schwartz. Thank you. You may.

Dean Schwartz (Moderator)

Thank you, Operator. Good morning everyone and welcome to PDS Biotech's first quarter 2026 results and clinical programs. Update call I'm joined on the call today by the following members of the company's management team. Dr. Frank Baduodeau, Chief Executive Officer, Dr. Kirk Sheppard, Chief Medical Officer and Lars Bozgaard, Chief Financial Officer. Dr. Baduodeau and Dr. Sheppard will provide an overview of the company's recent highlights in its clinical development program, and Mr. Bozgaard will review the financial results for the quarter ended March 31, 2026. Following management's prepared remarks, we will take questions from 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. 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 10Q and annual report on Form 10K 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 Dr. Baduodeau, Frank.

Frank Baduodeau

Thank you, Dean 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. This past quarter, our major focus was on advancing our clinical programs and we made significant progress. So I will hand the call over to our Chief Medical Officer, Dr. Kirk Sheppard to provide an update. Kirk?

Kirk Sheppard

Thank you, Frank. During our first quarter, we adopted an amendment to our versatile 003 trial, revising the design to incorporate progression free survival as an interim primary endpoint, which we believe has the potential to enable a more efficient path to accelerated approval. We also believe this amendment may shorten the trial's duration and reduce the overall costs, all while retaining overall survival as the basis for full approval in accordance with FDA requirements. Additionally, this approach may also accelerate the availability of this promising treatment to the rapidly growing population of HPV 16 positive patients in dire need of effective treatment. For patients living with HPV 16 positive head and neck cancer, a disease with significant and growing unmet need, we believe PDS0101 represents a promising treatment option and we remain focused on advancing it as efficiently as possible. PDS0101, in combination with keytruda or pembrolizumab is the only late stage investigational head and neck squamous cell carcinoma therapy that requires only five doses and also the only subcutaneous therapy. These characteristics of PDS0101, together with the tolerability and survival data reported to date, make PDS0101 a potential compelling option for these patients. Key opinion leaders at institutions such as Mayo Clinic, Dana Farber, and Yale Cancer Institute are involved in our trial. HPV 16 positive cancers are rapidly increasing in the US and EU due to poor uptake of the human papillomavirus vaccine and other factors. Along with the unique pathophysiology of HPV16 cancers and the absence of approved targeted therapies, there's a significant unmet need we believe that PDS0101 is uniquely positioned to address elsewhere in our program. We recently reported promising results from ongoing trials for the treatment of prostate and colorectal cancer with PDS01 ADC, our novel investigational interleukin 12 or IL12 fused antibody drug conjugate that enhances the proliferation, potency, and longevity of T cells in tumor microenvironment. In March, the Journal of Clinical Oncology, JCO Oncology Advances published clinical and immunological biomarker Data from stage 1 of a phase 2 trial evaluating PDS01 ADC and colorectal cancer with liver metastasis. We refer you to these press releases issued this morning. Earlier in our first quarter, we also announced early results from the NCI led trial investigating PDS01ADC at the AACR Special Conference on Prostate Cancer Research in Patients with Metastatic Castration Resistant Prostate Cancer, the majority of whom received this therapy as a third line option. The combination of PDS01 ADC and docetaxel demonstrated encouraging results included in our press release this morning. The Results from these two trials reinforce the potential of PDS01 ADC to enhance the efficacy of existing therapies across multiple solid tumor types. We remain focused on advancing PDS01ADC as a key component of our immuno oncology pipeline. I will now hand the call back to Frank.

Frank Baduodeau

Thank you, Kirk. Finally, during our first quarter, we also strengthened the intellectual property estate for PDS0101 with new patents granted in the United States. In Japan, the new US patent combined with anticipated biologics exclusivity for PDS0101 extends our market protection into the 2040s. The Japanese patent adds broad composition of matter claims to existing protections across major markets. Now I will turn it over to Lars for a review of our results for the 2026 first quarter.

Lars Bozgaard (Chief Financial Officer)

thanks Frank, and good morning everyone. We reported a net loss for the quarter ended March 31, 2026 of approximately $7.3 million, or $0.13 per basic and diluted share. That compares to a net loss of $8.5 million, or $0.21 per basic and diluted share for the quarter ended March 31, 2025. Research and development expenses for the first quarter were $3.5 million compared to 5.8 million for the prior year period. Decrease was primarily due to lower clinical and manufacturing costs. General administrative expenses for the first quarter were $3.1 million compared to 3.3 million for the prior year period. The decrease was primarily due to lower professional fees. Total operating expenses for the first quarter were $6.5 million compared to 9.1 million for the prior year period. Net interest expense for the first quarter were 0.8 million dollars compared to 0.6 million for the prior year period. The company's cash balance as of March 31, 2026 was $21.7 million dollars and with that operator we can open the call to questions from analysts.

OPERATOR

Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press Star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press Star two to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing these star keys. One moment please While we poll for questions, Our first question comes from the line of Mayank Montani with Bally Securities. Please proceed with your question.

Mayank Montani

Yes Good morning team. Thanks for taking our questions and appreciate the updates on the versatile 003 restart enrollment activity. Could you remind us what remains sort of pending there and is there a consideration also maybe of including subcutaneous pembrolizumab as a combination partner? And I don't think fully follow what would be the procurement of pembrolizumab considerations that were there last year versus what you have today for versatile and then I have a follow up.

Frank Baduodeau

Hi Mayank, Thanks a lot for your questions. I'll hand over to Kirk. Kirk, why don't you go ahead.

Kirk Sheppard

Thank you Frank yes, regarding the enrollment, now that we have alignment with the FDA that we are going through the procedures of amending the protocol and going back to the sites to begin the study in the near future. We're happy to say that the sites all stayed with us during that period of a pause while we did the amendment and discussed it with the FDA. So we're very happy that we still have the momentum with us regarding the possibilities of using the drug with the subcutaneous pembrolizumab in the future. That's something that would be a possibility, but it's certainly not the target now of our research. Our research is with the pembrolizumab given IV in the usual amount that it has been in the past. But that option would remain open in the future for an entirely sub Q regimen.

Mayank Montani

Thank you. And then on the landscape external to you within HPV 16 positive head and neck, you know, it still seems like a relatively open white space or swim lane. Are there any emerging updates you've seen recently or you're expecting, you know, particularly from the EGFR bispecific class that, you know, you might be watching for? And then I also noticed the colorectal cancer cohort, you know, stage two is now fully enrolled and you obviously publish data from the stage one cohort. Maybe just remind us, when do you expect to have the next data update for Cohort 2? That would be very helpful

Frank Baduodeau

start and I'll hand over to Kirk to add anything to it. But in terms of the HPV 16 landscape, you're correct. Know that Biontech is also in a phase three trial, but both PDS and BioNTech remain the two late stage studies in the space. So you are correct, there are very few potential opportunities for these patients at this present time. And in terms of the colorectal cancer, yes, you are correct that we have completed enrollment into that colorectal cancer cohort of that study and we are anticipating that by the end of the year we should have some additional data on the full population of patients in the colorectal cancer study. Kirk, anything you'd want to add to that?

Kirk Sheppard

No, I would just refer them again to the article that was just published in our press release. But also we're very encouraged by the stage one of the phase two trial with the NCI. So we're anxious to move it on to the next trial, a controlled trial with this therapy.

Mayank Montani

Thanks so much, team.

OPERATOR

Thank you. Our next question comes from the line of Joe Pantogenis with A.C. wainwright. Please proceed with your question.

Joe Pantogenis (Equity Analyst at A.C. Wainwright)

Hey guys, good morning. Thanks for taking the questions and great to see the recent amendment. So I wanted to actually dive into that a little bit. If you could talk about maybe a little more color on the benefits here. Obviously Kirk, you mentioned about acceleration of the clinical timelines. I'm hoping you could hit that a little more with regard to attracting patients anecdotes you may be getting from doctors to be able to quickly get to those re enrolling quicker. And then next, sort of the second part of that is, from Lars standpoint, what, what do you believe the financial impact positively for these changes could be? And obviously would you then look to put, you know, keep that money towards the filing path or you know, put it towards a pathway sort of the ADC platform?

Kirk Sheppard

Yes. Thank you for your question regarding the amendments. As far as the protocol, of course this all started when we did our final data cut back in September of last year and we were very encouraged by those results. If anything though, we needed to consider how long the trial would take because the median overall survival, I think, you know, increased from around 30 months out to almost 40 months. And the trial would take a long time to complete. At the same time too, we saw the robustness of our pfs. So we went to the FDA to discuss the possibility of a CO primary which we have right now, having the PFS as a CO primary along with the median overall survival which would be needed for full approval. But we'd have a chance for an accelerated review with the pfs. So we're very happy with that as far as the trial design that has come as a result of the latest results as well as discussions with the fda.

Lars Bozgaard (Chief Financial Officer)

Hey Joe, this is Lars here. So to answer your question about the, the potential financial impact, the way we expect the amendment to the protocol to affect really the financial requirements for the trial is one, in terms of time and in terms of time to the interim readout in particular, so that we expect that to reduce costs, both external costs, but also our internal operating expenses, simply due to that shorter time period. Another aspect to bear in mind, Joe, is that we did as part of the amendment, we changed the randomization and the ratio from two to one to one to one. And so that also allowed us to essentially lower the number of patients from approximately 350 to approximately 250 patients. So that also in and of itself will drive lower external costs associated with completing the trial.

Joe Pantogenis (Equity Analyst at A.C. Wainwright)

Helpful details, thank you. And then just a quick follow up question. So look, things are late stage, they're progressing very quickly. Can you talk about your manufacturing needs for versimmune and the pipeline in the near term? And then heading beyond potential early commercialization.

Lars Bozgaard (Chief Financial Officer)

Yes, Joe, I can talk a little bit about that. So as you know, we have a pretty straightforward manufacturing process. So in terms of scale up in commercialization, some scale up has been done already by the commercialization. Commercial process is already established. And so what we anticipate doing is once in parallel with the phase three, doing the traditional CMC activities which involve validation of those processes. There may be some additional scale up required, but since the process is now fixed, fixed and established, we would look at the validation process. We need to do a number of those validation batches heading into the BLA filing. So those are really the major CMC activities remaining for the program. But in terms of manufacturing itself, the processes are completed and established. So pretty straightforward path to the BLA filing as pertains to the manufacturing specifically.

Joe Pantogenis (Equity Analyst at A.C. Wainwright)

Thanks for all the details, guys.

Lars Bozgaard (Chief Financial Officer)

No problem.

OPERATOR

Thank you. And we have reached the end of the question and answer session. I would like to turn the floor back to Frank Beruado for closing remarks.

Frank Baduodeau

Thank you, operator. Combined with early data from our PDS01ADC program and expanded patent protections extending into the 2040s for PDS0101, we believe we have meaningful opportunities ahead as we continue to execute against our priorities for 2026. We look forward to updating you on our progress and thank you very much again. Have a great day.

Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company's SEC filings and official press releases. Corporate participants' and analysts' statements reflect their views as of the date of this call and are subject to change without notice.