PDS Biotechnology Q1 2026 Earnings Name: Full Transcript – PDS Biotechnology (NASDAQ:PDSB)

Thanks, Operator. Good morning everybody and welcome to PDS Biotech’s first quarter 2026 outcomes and medical packages. Replace name I am joined on the decision immediately by the next members of the corporate’s administration crew. Dr. Frank Baduodeau, Chief Govt Officer, Dr. Kirk Sheppard, Chief Medical Officer and Lars Bozgaard, Chief Monetary Officer. Dr. Baduodeau and Dr. Sheppard will present an summary of the corporate’s latest highlights in its medical improvement program, and Mr. Bozgaard will evaluate the monetary outcomes for the quarter ended March 31, 2026. Following administration’s ready remarks, we are going to take questions from masking analysts. As a reminder, throughout this name, we shall be making ahead trying statements that are topic to varied dangers and uncertainties that might trigger our precise outcomes to vary materially from these statements. Any such statements ought to be thought of along with cautionary statements in our press releases and danger elements mentioned in our filings with the SEC, together with our quarterly experiences on Type 10Q and annual report on Type 10K and cautionary statements made throughout this name. We assume no obligation to replace any of those ahead trying statements or info. Now I might like to show the decision over to Dr. Baduodeau, Frank.

Thanks, Frank. Throughout our first quarter, we adopted an modification to our versatile 003 trial, revising the design to include development free survival as an interim main endpoint, which we consider has the potential to allow a extra environment friendly path to accelerated approval. We additionally consider this modification could shorten the trial’s length and cut back the general prices, all whereas retaining total survival as the idea for full approval in accordance with FDA necessities. Moreover, this strategy may speed up the supply of this promising therapy to the quickly rising inhabitants of HPV 16 optimistic sufferers in dire want of efficient therapy. For sufferers dwelling with HPV 16 optimistic head and neck most cancers, a illness with vital and rising unmet want, we consider PDS0101 represents a promising therapy choice and we stay targeted on advancing it as effectively as attainable. PDS0101, together with keytruda or pembrolizumab is the one late stage investigational head and neck squamous cell carcinoma remedy that requires solely 5 doses and in addition the one subcutaneous remedy. These traits of PDS0101, along with the tolerability and survival knowledge reported to this point, make PDS0101 a possible compelling choice for these sufferers. Key opinion leaders at establishments comparable to Mayo Clinic, Dana Farber, and Yale Most cancers Institute are concerned in our trial. HPV 16 optimistic cancers are quickly rising within the US and EU because of poor uptake of the human papillomavirus vaccine and different elements. Together with the distinctive pathophysiology of HPV16 cancers and the absence of accredited focused therapies, there is a vital unmet want we consider that PDS0101 is uniquely positioned to handle elsewhere in our program. We lately reported promising outcomes from ongoing trials for the therapy of prostate and colorectal most cancers with PDS01 ADC, our novel investigational interleukin 12 or IL12 fused antibody drug conjugate that enhances the proliferation, efficiency, and longevity of T cells in tumor microenvironment. In March, the Journal of Scientific Oncology, JCO Oncology Advances printed medical and immunological biomarker Knowledge from stage 1 of a section 2 trial evaluating PDS01 ADC and colorectal most cancers with liver metastasis. We refer you to those press releases issued this morning. Earlier in our first quarter, we additionally introduced early outcomes from the NCI led trial investigating PDS01ADC on the AACR Particular Convention on Prostate Most cancers Analysis in Sufferers with Metastatic Castration Resistant Prostate Most cancers, nearly all of whom obtained this remedy as a 3rd line choice. The mixture of PDS01 ADC and docetaxel demonstrated encouraging outcomes included in our press launch this morning. The Outcomes from these two trials reinforce the potential of PDS01 ADC to boost the efficacy of present therapies throughout a number of stable tumor varieties. We stay targeted on advancing PDS01ADC as a key part of our immuno oncology pipeline. I’ll now hand the decision again to Frank.

Thanks, Kirk. Lastly, throughout our first quarter, we additionally strengthened the mental property property for PDS0101 with new patents granted in the US. In Japan, the brand new US patent mixed with anticipated biologics exclusivity for PDS0101 extends our market safety into the 2040s. The Japanese patent provides broad composition of matter claims to present protections throughout main markets. Now I’ll flip it over to Lars for a evaluate of our outcomes for the 2026 first quarter.

thanks Frank, and good morning everybody. We reported a internet loss for the quarter ended March 31, 2026 of roughly $7.3 million, or $0.13 per primary and diluted share. That compares to a internet lack of $8.5 million, or $0.21 per primary and diluted share for the quarter ended March 31, 2025. Analysis and improvement bills for the primary quarter have been $3.5 million in comparison with 5.8 million for the prior yr interval. Lower was primarily because of decrease medical and manufacturing prices. Basic administrative bills for the primary quarter have been $3.1 million in comparison with 3.3 million for the prior yr interval. The lower was primarily because of decrease skilled charges. Whole working bills for the primary quarter have been $6.5 million in comparison with 9.1 million for the prior yr interval. Web curiosity expense for the primary quarter have been 0.8 million {dollars} in comparison with 0.6 million for the prior yr interval. The corporate’s money stability as of March 31, 2026 was $21.7 million {dollars} and with that operator we are able to open the decision to questions from analysts.

Thanks. We’ll now be conducting a query and reply session. If you need to ask a query, please press Star one in your phone keypad. A affirmation tone will point out your line is within the query queue. Chances are you’ll press Star two to take away your self from the queue. For contributors utilizing speaker gear, it could be vital to choose up the handset earlier than urgent these star keys. One second please Whereas we ballot for questions, Our first query comes from the road of Mayank Montani with Bally Securities. Please proceed together with your query.

Sure Good morning crew. Thanks for taking our questions and respect the updates on the versatile 003 restart enrollment exercise. May you remind us what stays kind of pending there and is there a consideration additionally possibly of together with subcutaneous pembrolizumab as a mixture accomplice? And I do not assume totally observe what could be the procurement of pembrolizumab concerns that have been there final yr versus what you’ve immediately for versatile after which I’ve a observe up.

Thanks Frank sure, concerning the enrollment, now that we have now alignment with the FDA that we’re going by means of the procedures of amending the protocol and going again to the websites to start the examine within the close to future. We’re pleased to say that the websites all stayed with us throughout that interval of a pause whereas we did the modification and mentioned it with the FDA. So we’re very pleased that we nonetheless have the momentum with us concerning the probabilities of utilizing the drug with the subcutaneous pembrolizumab sooner or later. That is one thing that will be a chance, however it’s definitely not the goal now of our analysis. Our analysis is with the pembrolizumab given IV within the normal quantity that it has been previously. However that choice would stay open sooner or later for a completely sub Q routine.

Thanks. After which on the panorama exterior to you inside HPV 16 optimistic head and neck, , it nonetheless looks like a comparatively open white area or swim lane. Are there any rising updates you have seen lately otherwise you’re anticipating, , notably from the EGFR bispecific class that, , you is likely to be looking ahead to? After which I additionally seen the colorectal most cancers cohort, , stage two is now totally enrolled and also you clearly publish knowledge from the stage one cohort. Possibly simply remind us, when do you anticipate to have the following knowledge replace for Cohort 2? That might be very useful

begin and I am going to hand over to Kirk so as to add something to it. However by way of the HPV 16 panorama, you are right. Know that Biontech can be in a section three trial, however each PDS and BioNTech stay the 2 late stage research within the area. So you might be right, there are only a few potential alternatives for these sufferers at this current time. And by way of the colorectal most cancers, sure, you might be right that we have now accomplished enrollment into that colorectal most cancers cohort of that examine and we’re anticipating that by the tip of the yr we must always have some extra knowledge on the total inhabitants of sufferers within the colorectal most cancers examine. Kirk, something you’d need to add to that?

Hey guys, good morning. Thanks for taking the questions and nice to see the latest modification. So I wished to really dive into that somewhat bit. In the event you may speak about possibly somewhat extra coloration on the advantages right here. Clearly Kirk, you talked about about acceleration of the medical timelines. I am hoping you may hit that somewhat extra with regard to attracting sufferers anecdotes chances are you’ll be getting from medical doctors to have the ability to shortly get to these re enrolling faster. After which subsequent, kind of the second a part of that’s, from Lars standpoint, what, what do you consider the monetary influence positively for these adjustments may very well be? And clearly would you then look to place, , hold that cash in the direction of the submitting path or , put it in the direction of a pathway kind of the ADC platform?

Sure. Thanks to your query concerning the amendments. So far as the protocol, after all this all began once we did our closing knowledge reduce in September of final yr and we have been very inspired by these outcomes. If something although, we wanted to contemplate how lengthy the trial would take as a result of the median total survival, I believe, , elevated from round 30 months out to nearly 40 months. And the trial would take a very long time to finish. On the similar time too, we noticed the robustness of our pfs. So we went to the FDA to debate the potential of a CO main which we have now proper now, having the PFS as a CO main together with the median total survival which might be wanted for full approval. However we would have an opportunity for an accelerated evaluate with the pfs. So we’re very pleased with that so far as the trial design that has come on account of the newest outcomes in addition to discussions with the fda.

Hey Joe, that is Lars right here. So to reply your query concerning the, the potential monetary influence, the way in which we anticipate the modification to the protocol to have an effect on actually the monetary necessities for the trial is one, by way of time and by way of time to the interim readout particularly, in order that we anticipate that to cut back prices, each exterior prices, but additionally our inner working bills, merely because of that shorter time interval. One other facet to remember, Joe, is that we did as a part of the modification, we modified the randomization and the ratio from two to at least one to at least one to at least one. And in order that additionally allowed us to primarily decrease the variety of sufferers from roughly 350 to roughly 250 sufferers. In order that additionally in and of itself will drive decrease exterior prices related to finishing the trial.

Sure, Joe, I can discuss somewhat bit about that. In order , we have now a fairly simple manufacturing course of. So by way of scale up in commercialization, some scale up has been accomplished already by the commercialization. Business course of is already established. And so what we anticipate doing is as soon as in parallel with the section three, doing the normal CMC actions which contain validation of these processes. There could also be some extra scale up required, however because the course of is now fastened, fastened and established, we might take a look at the validation course of. We have to do numerous these validation batches heading into the BLA submitting. So these are actually the foremost CMC actions remaining for this system. However by way of manufacturing itself, the processes are accomplished and established. So fairly simple path to the BLA submitting as pertains to the manufacturing particularly.

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