Q1 2025 PDS Biotechnology Corp Earnings Call and Business Update
Greetings and welcome to the P. D S. Biotech first quarter in 2025 earnings conference call. At this time, all participants are in a listen only mode.
Mike Moyer: Brief question and answer session will follow the formal presentation. If anyone should require operator assistance. During the conference. Please press star zero on your telephone keypad. As a reminder, this conference is being recorded it is now my pleasure to introduce your host Mike Moyer lifestyle advisors. Thank you Sir you may <unk>.
Again.
Speaker Change: Thank you operator.
Speaker Change: Everyone and welcome to PBF Biotechs first quarter 2025 results clinical programs update call.
Speaker Change: Joining the call today by the following members of the company's management team Dr. Frank <unk>, Chief Executive Officer, Dr. Curt Shepherd, Chief Medical Officer Marsh False-card, Chief Financial Officer, Dr. <unk> will begin with an overview of the company's recent progress in its clinical development program. Mr. Bose Garble review the financial results for the quarter ended March <unk>.
Speaker Change: 31, 2025 and Dr. Sheppard, while Jen will then join the call to help address questions from our covering analysts.
Speaker Change: 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 10-Q and annual report.
Speaker Change: Port on Form 10-K, and cautionary statements made during this call we assume no obligation to update any of these forward looking statements or information now I would like to turn the call over to Dr. <unk> to do adult Frank.
Speaker Change: Thank you, Mike and good morning, everyone.
Speaker Change: It's our pleasure to speak with you again and to provide this brief update on our progress in advancing our clinical programs.
Speaker Change: The first quarter of 2025, and recent weeks have been a productive period for PDF biotech led by the initiation of our Bruce thousand redo, a three phase III clinical trial versus HPV plus parallelism up.
Speaker Change: Burstein HPV, plus 10 balloons as a potential treatment for first line recurrent and metastatic HPV 16 positive head and neck squamous cell carcinoma head and neck cancer.
Speaker Change: Patients with recurrent or metastatic HPV 16 positive head and neck cancer.
Speaker Change: Got to treat.
Speaker Change: <unk> represents a large fast growing population in need of targeted therapies to treat the underlying costs.
Speaker Change: The cancer.
It is projected that by the mid 2030.
Speaker Change: HPV 16 positive head and neck cancer will become the most prevalent type of head and neck cancer in the United States and Europe.
Speaker Change: Considering the strength and durability of the clinical responses observed in our first town. There was there were two phase II study.
Speaker Change: We are excited to get the breast <unk> with three Registrational trial underway.
Speaker Change: Our confidence in the potential of the combination of <unk>, HPV and Pap realism up to significantly improve outcomes for patients with recurrent or metastatic HPV 16 positive head and neck cancer.
Speaker Change: 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.
Speaker Change: We look forward to the continued progression of this trial.
Speaker Change: As we announced previously.
Speaker Change: <unk> thousand three trial design includes approximately 350 patients.
Speaker Change: The two arm Registrational trial design has been given the go ahead by the U S food and drug administration or FDA.
Speaker Change: The two arms of the trial include a treatment of diverse HPV and <unk> combination.
Speaker Change: As the control arm of cannibalism up only.
Speaker Change: Patients are enrolled in a two one randomization.
Speaker Change: Median overall survival is the primary endpoints.
Speaker Change: The trial design is informed by the observed durability of the clinical responses in our various styles and resumed to clinical trial.
Speaker Change: Steve over the last year and a half with.
Speaker Change: With the most recent data presented at the European Society for medical oncology.
Speaker Change: ESMO Congress in September.
Speaker Change: The encouraging patient survival and clinical responses, coupled with promising tolerability as seen in the first half due to clinical trial.
Speaker Change: Will be the subject of a poster presentation at the 2025 American Society of clinical oncology annual meeting or <unk>.
Speaker Change: These data underscore our belief in the potential of the combination should be the first HPV 16 targeted therapy for head and neck cancer.
Speaker Change: And a significant advancement in the treatment of the growing population of patients with HPV 16 positive head and neck cancer.
Speaker Change: Yeah.
Speaker Change: Diverse styles zaremski with <unk> III trial in progress.
Speaker Change: First phase III trial in the high risk HPV 16 population and has also been accepted for presentation at the 2025 Costco annual meeting.
Speaker Change: Thirdly Mayo clinic will present the results of the M. C 20, O 710 study investigating burst immune HPV alone.
Speaker Change: All with embolism up prior to surgery or radiation therapy for locally advanced HPV 16 positive RF, our NGL cats.
Speaker Change: All three presentations will be held on Monday June the second 2025 from nine a M to 12 P M central daylight time during the head and neck cancer poster session.
Speaker Change: Elsewhere in our pipeline last week, we announced that the American Association of Immunologists Immunology 2025 annual meeting.
Speaker Change: Preclinical efficacy and immune response data in mice and fabrics with a novel infect immune based universal flu vaccine.
Speaker Change: Our featured in two presentations on universal influenza vaccines, including an oral symposium.
Speaker Change: These studies were funded by and performed by investigators of the National Institute of allergy and infectious diseases.
Speaker Change: Center.
Speaker Change: Influenza vaccine research for high risk populations.
The collaborative approach between Knight and Pds biotech allows pds biotech to focus our resources on our other styles the wisdom of three clinical trial.
Speaker Change: In March we were pleased to announce FDA clearance of our investigational new drug IND application for the combination of burst immune Mark one and our IL 12 fused antibody drug conjugates Pds <unk> ADC to treat metastatic colorectal cancer.
Speaker Change: Several highly prevalent solid tumors.
Speaker Change: One positive, including non small cell lung cancer.
Speaker Change: Ovarian cancer breast cancer liver cancer and others.
Speaker Change: We are pleased to continue our strong relationship with the National Cancer Institute NCI and this phase one two clinical trial is scheduled to be run under our collaborative research and development agreement with the NCI.
Speaker Change: Pdf's biotech, we will continue to focus our efforts on progressing diverse styles. The residual three phase III clinical trial.
Speaker Change: Now I will turn it over to last for a review of our results for 2020 loss.
Speaker Change: Thanks, Frank and good morning, everyone.
Speaker Change: So for the first quarter I've talked about 2025, we reported a net loss of approximately $8 $5 million or about 21 cents per basic and diluted share for the three months ended March 31 that compares to $10 6 million or <unk> 30 per basic and diluted share for the three months ended March 31 2024.
Speaker Change: Sure.
Speaker Change: This decrease was due to increased benefit from income taxes as well as lower operating expenses.
Speaker Change: 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.
Speaker Change: General and administrative expenses were $3 three minutes for the first quarter compared to $3 4 million for the prior year quarter.
Speaker Change: Overall total operating expenses were $9 1 million for the first quarter compared to approximately $10 1 million for the prior year quarter.
Speaker Change: Net interest expenses were <unk> 6 million for the first quarter, which compared to approximately <unk> 5 million for the prior year period.
Speaker Change: Our cash balance as of March 31, 2025.
Speaker Change: It was $40 million compared to $41 7 billion 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 health care focused institutional investors as well as participations with certain directors of the company.
Speaker Change: Under that arrangement, we raised approximately $11 million upon the closing with an additional $11 million may be funded upon school cash exercise of the warrants that were included in the agreement.
Also more recently.
Speaker Change: In April we completed the refinancing of our debt with new lenders, resulting in the extension of the term to 36 months.
Speaker Change: The first four months being interest only.
Speaker Change: With that operator, we can open the call to questions.
Speaker Change: 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 that your line is in the question queue. You May press star two if he would like to remove your question from the queue.
Speaker Change: We ask that analysts limit themselves to one question and a 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, one moment, please while we poll for questions.
Mum County: Our first question comes from my Mum County, with B Riley Securities. Please proceed with your question.
Speaker Change: Yes.
Hi, Yes, good morning, and thanks for taking my question then.
Speaker Change: Congrats on getting the worst of diabetes III phase III amping up so.
Speaker Change: So close to that Keytruda head and neck Neo adjuvant data, we saw at ACI could you comment on how such a standard of care changing data set in bags enrollment expectations of your phase III and the result of Landon anything.
Speaker Change: If anything on the SPV positive dealer said and how maybe checkpoint inhibitors.
Speaker Change: Therapy responds.
Speaker Change: To sponsor it looked like in <unk> 16 positive and then I have a follow up.
Mike Moyer: Mike you're referring to the keynote <unk> eight to nine trial.
Speaker Change: That's right.
Speaker Change: Okay.
Kirk: Kirk I will hand over to you to start if you have any comments on that.
Kirk: Sure can you hear me okay.
Speaker Change: Yes, we can hear you great.
Speaker Change: <unk> 689 trial should not affect our versatile zero-zero three the reason of this six to eight nine study, mainly HPV negative patients because the eligibility criteria of the study.
Speaker Change: 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%.
Speaker Change: The patients so the study soon.
Speaker Change: HPV positive.
Speaker Change: So the study was focused mainly on HPV negative patients and not positive.
Speaker Change: Kirk Thanks, a lot so Miami so that's that's very important because even if this does become standard of care.
Speaker Change: There is going to be very little impact on the HPV positive populate population and it may actually speed up.
Speaker Change: <unk> 16 population, becoming the predominant recurrent metastatic.
Speaker Change: Head and neck cancer population and this is something that we actually had our steering committee evaluates and give us advice on and they have their feedback to Pts was even if this neo adjuvant treatment is approved since very few HPV positive patients are actually legible post surgery at this stage there should be next.
Speaker Change: <unk> 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%.
Speaker Change: The patients were actually HPV positive.
So my answer to your question, Yes, yes. It does thank you both and then sticking on this article breath poster presentation coming up.
Speaker Change: Could you talk to what we should be looking to learn on durability incrementally from what you've shown before and maybe if you could comment on.
Speaker Change: This year, notably DIY.
Speaker Change: That would be tracking relative to also the emerging data from the next generation Egfr targeting therapies. Thanks again for taking my questions.
Mike Moyer: Thanks, Mike.
Speaker Change: I'm not going to speak much about the Egfr inhibitors I think they will make their presentations at <unk>, we will learn more at this point, we can say any more than they have currently presented to the markets. We have no additional information on how they are programs that are performing but with regards to PD as biotech and opera versatile as a reserve of two trial.
Speaker Change: As you know one on one of the key characteristics of this technology and the product if the durability right on our corporate deck one of the slides that shows how obese patients react long term I think one of the key things within oncology today with the current cytotoxic drugs.
Speaker Change: Including Cetuximab, if you get pretty good responses upfront a good objective response rates, but what we have not seen to date and head and neck cancer and many other cancers.
Speaker Change: Once you are able to achieve these clinical responses.
Speaker Change: Can you maintain these responses to long term.
Speaker Change: Is that is the challenge and that is exactly what we see with our burst immune HPV plus keytruda formulation, where the patients who have clinical responses, including stable disease partial.
Speaker Change: 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 are.
Speaker Change: Our lost.
Speaker Change: Presentation at ESMO as you recall, we presented a 13 months median overall survival.
Speaker Change: The standard today is approximated 12 months, so really just putting that into perspective right today with the with.
Speaker Change: With the standard of care, if a patient had gone on to the standard of care, which have been Keytruda Keytruda chemo.
Speaker Change: The probability of a living 12 months was about 50% you had a 50% probability of living for 12 months.
Speaker Change: However, if that patient had gone onto our diverse styles the reserve with two trial.
Speaker Change: They had a 50% probability of living for 13 months or more.
Speaker Change: That's the kind of durability, we seen in the HPV 16, <unk> population, which by the way in some studies that have been performed.
Speaker Change: And public have shown that in head and neck cancer, They found and HPV 16 patients had they.
Speaker Change: The worst prognosis for survival once the disease becomes an advanced recurrent metastatic disease right compared to HPV negative and other types of HPV HPV 16 positive patients have by far the worst survival prognosis. So this is for us to sit and extremely encouraging results and what we intend to do is to.
Speaker Change: An additional update on our more recent data cuts on that durability and survival obese obese patients and diverse styles. There was sort of a two trial.
Speaker Change: Okay.
Frank: Thank you Frank.
Speaker Change: Welcome.
Speaker Change: Okay.
Speaker Change: Our next question comes from Joe Penn Guinness with H C. Wainwright. Please proceed with your question.
Speaker Change: Hey, guys. Good morning, Thanks for taking the question so.
Speaker Change: I wanted to ask too nuanced questions regarding your two lead programs and part of it you've already started to discuss so first with keynote 689.
Speaker Change: You know when you are 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.
Speaker Change: 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.
Speaker Change: Physicians impact and being able to want to participate and versatile O L. Three.
Speaker Change: And then I have a follow up.
Speaker Change: Yeah.
Speaker Change: No no to date.
Speaker Change: Ill ask Kirk to give his his opinions on that but to date. We have we have seen very strong enthusiasm from the investigators and the key opinion leaders and actually participating in the <unk> two trial I'll ask you hand over to Kirk to give any comments before I get back to continuing my answer Kirk and any comments on interest in the trial based on keynote.
Speaker Change: 689.
Kirk Thanks: Yeah, No. The response was very brisk.
Kirk Thanks: All the same from our steering committee, which are the experts in head and neck cancer.
Kirk Thanks: At 689 does not apply to HPV positive patients and this is even before they saw the data broken down which we saw at the ACR and sure enough when we saw the data.
Kirk Thanks: Break had mentioned and I mentioned earlier to only 3% of the patients were HBV positive because it's not appropriate to treat these patients with surgery upfront. So it's it's.
Kirk Thanks: 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 versa power was there was there were two in there.
Kirk Thanks: The heaters with US now who have experience with this drug and are very excited for zero zero to three to get started.
Speaker Change: Thanks, a lot Kirk.
Speaker Change: So Joe so along those lines I think I think very importantly, I think that that.
Speaker Change: Oncologist 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 new icebound treatment and one of the things you can see in relation to that is that even at the Mayo clinic one of the studies that we will.
Speaker Change: Presenting at <unk> has to do with utilizing our <unk> HPV, plus keytruda and that new adjuvant setting for HPV 16 positive patients and one of the key things that the Kols mentioned on our last coal call was that they have very strong recommendation.
Speaker Change: <unk> for this combination.
Speaker Change: <unk> based upon the Tolerability that we've seen in the patients today would be to rapidly move it into earlier stage, setting, which would be locally advanced head and neck cancer right. So we've already seen the experts in the field based upon the promising results of Athene and <unk> zero zero to take that combination to stock evaluate.
Speaker Change: <unk> in this patient population, who who will not be really impact of who may not get any benefit from the keynote 689 since the HPV positive can we take our combination and applied now to those patients who may not be eligible for surgery, but can go on this neo adjuvant adjuvant.
Speaker Change: With our combination.
Speaker Change: So we see a significant opportunity for this combination there too.
Speaker Change: Great I appreciate that added color Frank and Curt.
Speaker Change: So my second nuanced question as your newly or IND approved.
Speaker Change: <unk> one program.
Speaker Change: Wanted to do a little bit of historical perspective to where we are today and especially your program.
Speaker Change: I want to focus on the antigen itself.
Speaker Change: This has been a key target I mean, mark one for immunotherapy and or cancer vaccines for more than two decades now.
Speaker Change: And there have been some pretty high profile failures with this target.
Speaker Change: So I wanted to just get a little more sense again from you guys. You know why are you differentiated here and I guess can you describe the interest from sites to participate knowing this history. Thanks a lot.
Speaker Change: Really great question Joe.
Speaker Change: I'll start by saying that very similarly in HPV 16 positive head and neck cancer cervical cancer over the last 20 years. We have also been some very high profile failures.
Speaker Change: However, with our technology, we now see that for the first time, we have a technology and product that is now hubs with strong data very durable responses and moving into a pivotal registrational trial for the first time right. There have been many failures in HPV 16 positive cancer over the loss.
Speaker Change: 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.
Speaker Change: Apologies the technology that is able to now perform the immunological function that the previous technologies had not been able to perform.
Speaker Change: 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 having strong antigen doesn't get you very far if it can be effectively presented in the right.
Speaker Change: Immunological pathways also activated.
Speaker Change: <unk> has to go hand in hand, right. So now moving from where we have demonstrated that this technology can do this effectively in head and neck cancer with the HPV antigens, we're now moving onto the Mark one.
Speaker Change: After this proof of concept solid proof of concept that we have generated today with the moc one.
Speaker Change: <unk> our novel antigens agonist, what we call I've done this epitopes that have been designed by the National Cancer Institute.
Speaker Change: And what they have what they these antigens have been designed to do is to be much more immunological potent than the native Mach one antigens, therefore, having a much stronger ability to activate the immune system to recognize mark one asset for an agent.
Speaker Change: And what we have now done is now take an hour versus some of your technology com.
Speaker Change: Combined it with those novel a 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 trains T cells to now be a lot more.
Speaker Change: Potent in attacking and killing the Mach one positive cancers.
Speaker Change: And so really we have to look at it and 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 studies combining it with our IL 12.
Speaker Change: Fused antibody drug conjugate bright 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 the tumors are the required site of T cell activation right. So bye.
Speaker Change: Being able to get both our T cells and IL 12 into the patients tumors. We've also demonstrated significantly enhanced survival and anti tumor responses. So the goal is to apply this combination again to Mach one now.
Speaker Change: Now. This this program is being performed as part of our collaboration collaborative research and development agreement with the National Cancer Institute right. 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.
Speaker Change: Our resources and efforts on running our versatile soon Richard with three program.
Speaker Change: Frank really appreciate that detailed explanation and looking forward to see initial data. Thanks a lot.
Speaker Change: Youre welcome.
Speaker Change: Okay.
Speaker Change: Our next question comes from James Molloy without Alliance Global Partners. Please proceed with your question.
James Molloy: Hey, Frank Good morning. Thank you for taking my question just a quick a follow up on the Oh sorry.
Speaker Change: First patient that you guys announced the enrollment of the first patient yet.
Speaker Change: I missed that or whats the expectation on that and then any any anecdotal comments from the docs on how they on enrollment and how sort of that's proceeding or how the how the conversations are going with the potential enrollees.
Speaker Change: No we have not made it public.
Speaker Change: How enrollment is going for US you know James once the sites are activated we ought to be a 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.
Speaker Change: And the goal is to hopefully eventually get to a steady recruitment state.
Speaker Change: Also as you know the largest sites such as Mayo clinic take longer to activate and get going so our goal here is to update the market. When we have a much better idea of how enrollment is going and when we are able to approximate any estimate when we're going to get to that interim and interim data readout point.
Speaker Change: So we will provide more updates when we have much better right.
Insight into.
Speaker Change: How the what the recruitment rates should be and when we will get to those data readout points.
Speaker Change: That makes sense, just just starting the trials literally to try to guess that yet I guess.
Speaker Change: The amount of mechanistic looking at the print for the Opex for the quarter is this sort of level should dissipate going forward or do you expect that to kind of ramp up going through 'twenty five 'twenty six.
Speaker Change: Last I'll hand over to you for that.
Speaker Change: Yeah, Hey, Jim. This is lost here, yes, we don't we don't currently provide financial guidance, but I think it's fair to say that we're happy to trial has started well.
Speaker Change: He has an issue as you probably aware right. We do tend to see a bit of a bit of a higher spend in the first first couple of quarters. So why do we get this year, we're up and running.
Speaker Change: So I think without giving you any specific numbers.
Speaker Change: We see a relatively stable in terms of in terms of the year.
Speaker Change: The trial spend going forward.
Speaker Change: Oh, great. Thank you very much for taking the questions.
Speaker Change: There are no further questions at this time I would now like to turn the floor back over to Dr. Frank <unk> for closing comments.
Speaker Change: Yeah.
Frank: Thank you operator.
Frank: In closing we are very pleased to have initiated the first calls there was there were two registrational trial this quarter.
Frank: This study is the first phase III clinical trial, specifically in the growing population of HPV 16 positive head and neck cancer.
Frank: We are excited based on the strong versus 002 results and our fast track designation about the potential for <unk> HBV in head and neck cancer.
Frank: We expect to provide updated results from our ongoing phase II <unk> thousand reserve to study <unk> in a couple of weeks.
Frank: Our engagement with investors and clinical investigators has validated our approach and the long term opportunity that we believe that it's being.
Frank: <unk> targeted immunotherapy presents in the HPV 16 positive head and neck cancer indication.
Frank: We look forward to keeping you updated on our progress and thank you very much again for your time and support thanks a lot.
Frank: Yeah.
Frank: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
Frank: Yes.
Frank: Yes.
Frank: Okay.
Frank: Yes.
Frank: Okay.
Frank: Yes.
Frank: Yes.
Frank: Yes.
Frank: Sure.
Frank: Yeah.
Frank: Okay.
Frank: Mhm.
Frank: [music].
Frank: Okay.
Frank: Yes.
Frank: Okay.
Frank: Okay.
[music].
Frank: Yes.