Q3 2025 PDS Biotechnology Corp Earnings Call
If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.
Please note that this conference is being recorded.
Frank Bedu-Addo: That's the most likely therapy that anybody who comes up PDS0101 will go onto.
At this time, we'll turn the conference over to Tom Johnson with lifestyle Visors, Tom you May now begin.
Frank Bedu-Addo: In terms of the VERSATILE-003 design and investigators being trained and how they look at things like pseudo progression, that's something that's very important with an immunotherapy, and some of the discussions that have been had with our steering committee. I'll hand over to Kirk to address that question.
Thank you operator, good morning, everyone and welcome to the PDF biotech third quarter 2025 results in clinical programs update call.
Speaker #3: one ADC PDS oh antibody presented translational biomarker the unique demonstrated . properties of studies The Pds0101 and one ADC , leading to PDS oh anti-tumor immune responses and the predictability of clinical responses .
I am joined on the call today by the following members of the company's management team Dr. Frank Bennett would do.
Executive Officer, Dr. Curt Shepherd, Chief Medical Officer, and large those are.
<unk> Financial officer, Dr. Beth <unk>, who will begin with an overview of the company's recent progress in its clinical development program.
Kirk Shepard: Yes, thank you, Frank. First of all, just a comment on the answer as far as the subsequent treatment after the protocol, you're correct. I mean, there's really nothing. It's tragic that for those who are ICI resistant, there's been nothing to show that they have any survival benefit or even a high response rate. Unfortunately, we're comfortable with the fact that after the protocol, most likely any effects would be from our drug PDS0101. Regarding the PFS, that's a good question because it's very important as we look at these patients that the investigators are trained as far as the response. Also, this will be reviewed, as you know, by a central review from experts who will be reading the scans, et cetera. We discuss this a lot.
Mr. <unk> will review the financial results for the quarter ended September 32025, and Dr. Sheppard will then join the call to help address questions from covering analysts.
As a reminder, during this call we will make forward looking statements, which are subject to various risks and uncertainties that could cause our actual results to differ materially from these statements any statements should be considered in conjunction with the cautionary statements in our press release and risk factors are discussed in our filings with the SEC, including our quarterly reports on form.
<unk> 10-Q, and our annual report 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'd like to turn the call over to Dr. But I would do Frank.
Okay.
Kirk Shepard: People are sensitive to the fact that there may be pseudo progression, and with patients who are still clinically well and yet not determined yet as far as the response, we will continue to follow them. This is very important and different than the 002 because in 002, remember, the primary was ORR as far as response rate, and after the patients had a response, some of them were not followed any further. We will be following these patients all along, not only for the response, but also for safety. We are comfortable now with the training we have had and the discussions we have had with the steering committee that we will be able to properly judge these patients as far as PFS.
Thank you Tom and good morning, everyone.
It's our pleasure to speak with you again and to provide brief updates on our progress in advancing our clinical programs.
During our third quarter of 2025, and recent weeks, we continue to advance <unk> hundred one overseen HPV.
In HPV 16, positive recurrent or metastatic head and neck cancer.
In August we announced completion of our Bristol Zero-zero two trial with.
With the final data further supporting the durable clinical benefit of <unk> hundred one in this patient population.
The strength of this final data.
Kirk Shepard: We're very fortunate that with the current site accruals that we have, a lot of the sites are returning who were on VERSATILE-002. They have been trained before, they are also familiar with the drug, and we're very happy to know that a number of them want to be a part of now the VERSATILE-003. We have a good core of sites that have had experience with the drug as well as judging these responses. Thanks for your question.
And of the data in sub analysis, we announced in September.
Led to our strategic decision to seek an amendment to our grid style zero three trial to include progression free survival.
Primary endpoint in addition to median overall survival.
Our rationale for taking this step will be the focus of today's call.
Let's begin.
Last August we announced the final top line survival data from diverse tells me resumed with two phase II clinical trial.
Joseph Pantginis: Appreciate all the feedback.
Lars Boesgaard: Thanks.
Frank Bedu-Addo: Thank you.
As you will recall the first thousand there was there were two trial evaluated <unk>, plus keytruda or <unk> in patients with HPV 16 positive head and neck cancer.
Operator: At this time, I'll hand the floor back to Madra for further remarks.
Frank Bedu-Addo: Thank you, operator.
Frank Bedu-Addo: Thank you to all for your time today. We are excited based on the strong VERSATILE-002 results and our Fast Track Designation about the potential for PDS0101 in head and neck cancer.
The final data showed a median overall survival was 39 three months in patients with combined positive school or cps of greater than or equal to one.
Frank Bedu-Addo: Our engagement with multiple leading clinical investigators.
Frank Bedu-Addo: Oncology institutions have validated our approach and the long-term opportunity that we believe our HPV16 targeted immunotherapy represents.
The lower limit of the 95% confidence interval was $23 nine months.
And the upper limit was not yet estimable.
Frank Bedu-Addo: In the HPV16 positive head and neck cancer indication, we look forward to keeping you updated on our progress. Thank you very much again.
Importantly, the progression free survival was six three months.
<unk> patients with Cps greater than or equal to one.
Operator: Thank you, ladies and gentlemen. Thank you for your participation. This does conclude today's teleconference. You may now disconnect your lines, and have a wonderful day.
This PFS result is notable considering the fact that over 62% of patients in diverse styles 002 study had low cps of 1% to 19.
These patients have historically had significantly lower PFS results.
A total of 53 patients were enrolled in the <unk>.
There were two truck.
Unlike the first half there was there were three phase III trial.
Primary endpoint for the <unk> two trial was objective response rate or R. R.
Diverse tells the reserve to study included nine sensitive patients who discontinued the study after the primary endpoint of overall was reached and therefore loss to follow up.
To understand the potential impact of these nine patients on PFS and OS.
The sensitivity analysis was performed in the second quarter of 2025.
Power to our presentation at <unk>.
Our statistical experts obtained the survival records and disease progression status will be nine patients.
The resulting censoring analysis showed no negative impact on either PFS or OS.
Diverse styles. There was there were two trial.
Since the first of patients in the recurrent and metastatic head and neck cancer population to report a median overall survival of almost 14 months.
The PFS and survival results also have important implications for the current design of our phase III <unk> III trial.
In the current trial protocol median overall survival is the primary endpoint and progression free survival is a secondary endpoint.
However.
Even before our final readout of <unk>.
The key concern external to PDF biotech.
Was the fact that <unk> relies on the occurrence of death events.
The concern being that if the drug works well enough to prevent patient death.
It may take a long time to get to the critical data readout.
With the further increased the final OS readout from various styles. There was there were two.
This concern was further exacerbated.
To hopefully address the potential for an extended trial duration, while also abiding by the Fda's recommendation to use MLS median overall survival as a primary endpoint.
We have amended the protocol to convert PFS to a surrogate primary endpoint.
As announced we have requested a meeting with the FDA to discuss the described amendments to the current trial protocol to include PFS as a surrogate primary endpoints independent of median overall survival, which will continue to remain as the primary endpoint for full approval.
Our request to meet with the FDA to propose an amendment to <unk> III.
Is based on careful consideration of the final data from versatile zero-zero too.
We believe the robust PFS data now presents us with an important opportunity to potentially shorten the time to regulatory submission wild.
While maintaining median overall survival as the endpoint for FDA approval.
Importantly, we believe 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.
Treatment with <unk> hundred one for currently enrolled patients in our <unk> zero three phase III trial will continue during the temporary pause of the trial.
We believe that the industry is waking up to the realization that HPV positive head and neck cancer is rapidly becoming a real problem.
And several industry publications just in the last few months have reported on this developing situation.
Some of you might be familiar with independent market research published by Delvon insights on the oral pharyngeal cancer market published this month.
The article states that they performed interviews with Kols at leading cancer research centers.
And based on a quote from the publication.
With declining rates of head and neck cancers related to alcohol and tobacco.
<unk> has become the principal etiologic factor in our referring jewel cancer <unk>.
Redefining prognostic outlooks.
And informing the development of tailored therapeutic approaches end of quote.
Based on established research over 90% of HPV positive are referring jewel cancers are HPV 16 positive.
We are therefore confident in the potential of our HPV 16 tailored approach and the potential of <unk> hundred one to ultimately provide a well tolerated treatment without chemotherapy.
As an option for the growing population of HPV 16 positive patients who currently have no effective therapies for this deadly disease, and who will soon become the majority of head and neck cancer patients.
Elsewhere in our pipeline, we announced that the National Cancer Institute or NCI presented new clinical data of the 2025 society for immunotherapy of cancer.
ITC annual meeting.
The NCI presented three abstracts, highlighting emerging clinical and translational findings from Pds Biotechnologies novel, investigational immunotherapy platforms, including Pds <unk> hundred one our lead phase III clinical stage HPV targeted immunotherapy.
And our tumor targeting IL 12 fused antibody drug conjugate <unk> ADC.
The presented translational biomarker studies demonstrated the unique immunological properties of <unk> hundred one and Pds <unk> ADC.
Leading to anti tumor immune responses and the predictability of clinical responses.
<unk> <unk> hundred one combination immunotherapy.
Observed to induce broad immune activation and quantitative measurements of various blood analytes predicted clinical benefit with good accuracy.
Tds <unk> ADC monotherapy in patients with advanced solid malignancies was observed to increase blood frequencies than like memory, and effector Dth and CD four T cells.
That has self renewing properties.
We believe the data presented at <unk> further validate the scientific underpinnings of our immunotherapy platforms and confirm that our development approach is achieving the intended immunological and clinical effect.
These findings provide a deeper understanding of how our immunotherapies are generating such promising results in advanced cancers.
Earlier in the quarter, we announced that the colorectal cancer cohort of the phase II clinical trial with <unk> <unk> ADC met the criteria for expansion to stage two following positive stage one results.
This trial is also being led by the National Cancer Institute.
Our phase II clinical collaborations with the National Cancer Institute.
Anderson Cancer Center.
<unk> clinic.
As well as our preclinical collaboration with Ni AIB allow us to focus our resources on our various styles. The reserve with three phase III clinical trial.
While progressing development of our pipeline via these investigator led studies.
Now I will turn it over to Lars for a review of our results for the third quarter of 2025 loss.
Thanks, Frank and good morning, everyone.
We reported a net loss of $9 million or <unk> 19 per basic and diluted share for the three months ended September 32025 that compared to $10 7 million or 29.
Per basic share.
In the prior year's quarter.
The decrease in net loss was primarily due to lower operating expenses.
Research and development expenses were $4 6 million for the three months ended September 32025, compared to $6 8 million for the prior year period the.
The decrease was primarily due to lower manufacturing and clinical expenses and personnel costs.
That had self-renewing properties.
General and administrative expenses were $3 $6 million for the three months ended September 32025, compared to $3 4 million for the prior year period.
The increase was primarily due to higher professional fees, which were partially offset by lower personnel costs.
We believe the data presented at sitc further validate the scientific underpinnings of our immunotherapy platforms and confirm that our development approach is achieving the intended immunological and clinical effects.
Total operating expenses were $8 $1 million for the three months ended September 32025.
These findings provide a deeper understanding of how our immunotherapies are generating such promising results in advanced cancers.
$10 2 million for the prior year period.
Net interest expense.
<unk> 9 million for the three months ended September 32025, compared to <unk> 5 million for the prior year period.
Earlier in the quarter, we announced that the colorectal cancer cohort of the Phase 2 clinical trial with PSO1 ADC met the criteria for expansion to Stage 2 following positive Stage 1 results.
The increase was primarily due to lower interest income from our cash deposits.
This trial is also being led by the National Cancer Institute.
Our cash balance as of September 32025 was $26 2 million, which compared to $41 7 million as of the beginning of the year.
Our Phase 2 clinical collaborations with the National Cancer Institute.
MD Anderson Cancer Center.
The Mayo Clinic.
Yesterday, we completed the sale of $5 8 million of our common stock or pre funded awards as well as $5 8 million accompanying warrants for gross proceeds of approximately $5 3 million.
And with that operator, we can open up the call for any questions.
As well as our pre-clinical collaboration. With niaid allow us to focus our resources. On our versatile 00003 face 3 clinical trial while. Progressing development of our pipeline via these investigator-led studies
Thank you for that.
We are conducting a question and answer session.
Now, I will turn it over to Lars for a review of our results. For the third quarter of 2025 Lars
If you'd like to ask a question at this time you May press star one from your telephone keypad, a confirmation tone will indicate your line is in the question queue.
Thanks Frank and good morning everyone.
You May press Star two if you like to withdraw your question from the queue.
For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
One moment. Please so we poll for questions.
We reported a net loss of $9 million or 19 cents per basic and diluted share for the 3 months. Ended September 30 2025 that compared to 10.7 million or 29 cents per basic share, uh, in the prior, uh, years quarter.
Thank you and our first question is from the line of my uncle Martone with B Riley Securities. Please proceed with your questions.
Decrease in the loss was primarily due to lower operating expenses.
Yes, good morning, and thanks for taking our questions and I appreciate the update so.
<unk> III protocol Baas.
Research and development expenses were $4.6 million for the three months ending September 30, 2025, compared to $6.8 million for the prior year period.
Can you touch on how you plan to handle that.
The decrease was primarily due to lower manufacturing and clinical expenses and Personnel costs.
The patients that are already enrolled in.
Assume that they will make it to the this new PFS analysis now.
Now you are going to propose to the agency.
General and administrative expenses were 3.6 million for the 3 months. Ed of September 30th, 2025 compared to 3.4 million for the prior year period.
If you could just give us an update logistically how.
The increase was primarily due to higher professional fees, which were partially offset by lower personnel costs.
Ah patients enrolled will be included there and then also what.
What's the new sample size.
Total operating expenses were 8.1 million dollars for the 3 months and this September 30th 2025.
I believe you might be.
Compared to 10.2 million for the prior year period.
Having some.
Awareness of <unk>.
The new protocol size would look like and was also curious what the net cost savings would be for you as it related to that.
Net interest expense was $0.9 million for the three months ended September 30, 2025, compared to $0.5 million for the prior year period.
Well my understand thanks, a lot for your question, but I think as we mentioned in the trial in the in the script that we just read through.
The increase was primarily due to lower interest income from our cash deposits.
We are going to continue to treat those patients who have already been enrolled on the trial and the steady trial.
Our cash balance. As of September 30th, 2025 was 26.2 million which compared to 41.7 million as of the beginning of the year.
In terms of incorporating them into the trial as a whole, but these are not significant amendments, but these are part of the discussions that we will be hopping with the FDA in terms of the new sites, we have not disclosed that publicly yet we don't want to do any of that until we have actually sat down with the FDA we've made certain proposal.
Yesterday, we completed the sale of 5.8 million of our common stock, or pre-funded warrants as well as 5.8 million. The company warrants for gross proceeds of approximately 5.3 million
And with that operator, we can open up the call for for any questions.
As to the FDA by the anticipation and the hope here is that we will address some of those concerns by getting to those clinical trial Readouts earlier Thunder currently designed trial will allow us to.
Thank you. We'll now be conducting a question and answer session.
If you'd like to ask a question this time, you may press star 1 from your telephone keypad and the confirmation tone. Indicate. Your line is in the question queue.
You may press star 2. If you like to withdraw your question from the queue,
To get there right, but I will I'll hand over to Kirk and CCF anything to add to that.
For participants that are using speaker equipment. I may be necessary to pick up your handset before pressing the star keys.
1 moment, please. So we Poll for questions.
No nothing to add Frank you said these discussions will take place soon we think they're a very reasonable amendments that were asking for we're also very happy that in reviewing these amendments and strategy for the study that the steering committee that we have as well as our investigators are with the program. They built.
Thank you. And our first question is from the line of Maya, marani with B Riley Securities. Please, just you with your questions.
We've very much with what we're doing and the emphasis here as Frank said is that these patients will be continued.
Due to receive drug on the protocol during the pause.
Thank you and are you able to share any information on what the.
Expected PFS would be under control Keytruda.
Yes, good morning Dean. Thanks for taking our questions, and appreciate the updates. So, uh, on the versatile Deal 3 protocol, pause um, can you touch on how you plan to handle uh the the patients that are already enrolled and um assume that they will make it to the this new PFS analysis that? Uh now you're going to propose to the agency. Um so yeah, if you could just give give us an update a logistically. How
It's obviously much lower than.
What we see relative to the U S. As you said, but just was curious what youre seeing in studies that have recently published.
BFS control.
Obviously that feeds into your analysis you are involved with the phase III study first and then thanks for the ambitious.
Our patients enrolled will be included there. And then also, uh, what's the new sample size? I I, you know, I believe you might be, uh, having some awareness of how, what, what, the new protocol size would look like. And, uh, was also curious what the net cost savings would be for you as a result of that.
So my answer I think I'll, just reiterate something that Kirk just mentioned.
These amendments and the work that's going into what we have suggested to the FDA is something that has been thoroughly discussed with the experts and principal investigators and is very strongly supported by those experts in the field and also what we are proposing is nothing unusually in terms of clinical trial design. So we the goal.
Thanks. Thanks a lot for your question. So I think as we mentioned in the trial in the um in the script that we just read through, um, we are going to continue to treat those patients who have already been enrolled on the trial on the study trial.
Here is to make sure that not only is it very well supported by investigators and experts in the field, but also that it is nothing unusual regarding the FDA regulations everything we are suggesting should be should abide by the regulatory guidelines right. So we are making sure we stick with that.
Yes.
And in terms in terms of the.
<unk> III trial Mike.
In terms of incorporating them into the trial as a whole. These are these are not significant amendments but these are part of the discussions that we will be having with the FDA. In terms of the new size, we have not disclosed that publicly yet. We don't want to do any of that until we have actually sat down with the FDA we've made certain proposals to the FDA but the anticipation and the Hope here is that we will address some of those concerns by getting to those clinical trial readouts earlier than the currently designed trial will allow us, um, to get there, right? But I will I'll hand over to Kirk and see if he has anything to add to that.
Just just to make just to make sure I address exactly what you asked could you just repeat the last part of that section.
Last question.
Dsos for the.
Controller.
Q right and calibrated and Schneider has changed relative to your prior assumption. When you initially started the study.
Correct. So the PFS as you know in the <unk>.
<unk> study as well as the leap <unk> study it was $3 two months for Cps greater than one in the in the chemotherapy for each study and it was two eight months in the leap <unk> study now.
No, uh, nothing to add Frank. She said, these discussions will take place soon. We think they're very uh, reasonable amendments that we're asking for. We're also very happy that in reviewing these amendments and strategy for the study that the steering committee that we have as well as our investigators are with the program. Uh, they believe very much in what we're doing. And the emphasis here as Frank said is that these patients will be continued to to to receive drugs on the protocol during the pause.
Now these studies were predominantly we assume the lead times that it was predominantly HPV negative.
It Hasnt been published yet, but we know that the keynote <unk> eight study.
It's predominantly in HPV negative patients.
We know that there are two studies that have been published that actually compared HPV 16 positive patients with HPV negative and other types of HPV infected head and neck cancer patients and so we know from those studies.
Uh, thank you. And are you able to share any information on what the expected PFS would be on the control, uh, khuddam? Um, you know, it's obviously much lower than, uh, what we see relative to the OS as you said, but this was curious what you're seeing in, uh, studies that have recently published on, uh, PFS control. Um, uh, and and obviously that, you know, feeds into your analysis for what you would power, the phase 3 study for, uh, thanks for taking a patient.
So my answer, I think just, I'll just reiterate something that Kirk just mentioned.
The prognosis, if you have HPV 16 positive head and neck cancer appears to be worse.
Then if you have HPV negative or other types of HPV positive head and neck cancer right and so at this point, we are conservatively assuming that the PFS in the control arm is going to be around the three month range, which has been reported for keynote <unk> eight and also in the leap <unk>.
<unk>, which was two eight months.
Thank you.
That's a big Delta. So lastly, there's been a lot of strategic interest in the head and neck cancer space.
These amendments and the work that's going into what we have suggested to the FDA is something that has been thoroughly discussed with the experts and principal investigators, and it's very strongly supported by those experts in the field. Also, what we are proposing is nothing unusual in terms of clinical trial design. So, the goal here is to make sure that not only is it very well supported by investigators and experts in the field, but also that it is nothing unusual. Regarding the FDA regulations, everything we are suggesting should abide by the regulatory guidelines, right? So we are making sure we stick with that.
A lot obviously.
On the.
<unk>.
Specific or ADC side of things.
In building at ESMO.
And in terms, in terms of The Versatile 0003 trial, um, my just just to make, just to make sure I address exactly what you asked, could you just repeat the last part of that section?
Any any thoughts on how youre looking at the broader landscape, especially.
On the SUV positive side with that.
It should be 16 bonds at a site visit.
Whole lot going on.
Thanks for taking the questions.
Mike as you mentioned that there is quite a bit of work going also with adcs and so forth in head and neck cancer.
As you May know those are really primarily targeted to HPV negative patients.
As I just mentioned it appears that there is becoming back realization now in the industry that HPV positive head and neck cancer is becoming a really serious medical problem right. Just in the last few months. We've had several publications report on the growing incidents of HPV positive head and neck cancer.
Yes, question. The the PFS, uh, for the controller that you have Incorporated and if that has changed relative to your prior, assumption, uh, you know, when you initially started the study, um, oh correct. So, the PFS as you know, in, in the keynote 048 study, as well as the leap 10 study, it was 3.2 months for CPS greater than 1 in the, in the, um, keynote 048 study, and it was 2.8 months in the leap 10 study.
Now these studies where predominantly we, we assume the elite 10 study was predominantly HPV negative. That hasn't been published yet. But we know that the keynote 048 study was predominantly in HPV negative patients
And this independent market Research report I mentioned.
Typically stated that HPV negative or the traditional head and neck cancers caused by tobacco and alcohol are on the decline and the new face of edge of head and neck cancer.
HPV positive head and neck cancer.
So as I mentioned, we are very confident in the approach we've taken to focus on HPV 16 positive head and neck cancer, which again in oral pharyngeal cancer. For example over 90% of these HPV positive our pharyngeal cancers are HPV 16 positive.
We know that there are 2 studies that have been published that actually compared hpv16 positive patients with HPV negative and other types of HPV, infected, head and neck cancer patients. And so we know from those studies that the prognosis. If you have hpv16 positive head and neck, cancer appears to be worse,
Then if you have HPV negative or other types of HPV positive, head and neck cancer.
We've shown on our slides the growing projection from some of the top medical journals, such as lunch that showing the significant increase in the prevalence of HPV 16 positive head and neck cancer.
Right. At this point, we are conservatively assuming that the PFS in the control arm is going to be around the 3-month range, which has been reported for Keynote 048 and also in the LEAP 10 study, which was 2.8 months.
And so we are very encouraged with the results we've seen today.
And we're also very encouraged that this growing population of patients, we'll hopefully have that.
Um, uh, thank you. Uh, that's a big delta. Uh, so lastly, uh, there’s been a lot of strategic interests in the head and neck cancer space. Um, a lot of the more, you know, on the...
European that specifically addresses this growing type of head and neck cancer, which it appears from the from the expert reports could potentially be the dominant type of HPV head and neck cancer in the next decade.
So we continue to be.
Pleased with the approach we've taken to really target and focus on HPV 16 positive head and neck cancer, but the majority of the majority of studies.
Specific or ADC side of things. Um, and you know, including it as well. Um, any thoughts on how you're looking at, you know, the broader landscape, especially, you know, on the HPV positive side, where there's not, not all HPV16 positive side. This is not a whole lot going on. Um, thanks for taking your questions.
<unk> is being developed in head and neck cancer are not focused on HPV positive head and neck cancer.
Right. Mike as as you mentioned there there is quite a bit of work going on with adcs and so forth in head and a cancer but as as you may know, those are really primarily targeted to HPV negative patients.
Thank you.
Our next question is from the line of Joe <unk> with H C. Wainwright. Please proceed with your question.
Hey, guys. Good morning, Thanks for taking the questions. So two questions. If you don't mind under a year or two can you remind us or informed us or what have you.
The patients that have been such long term survival and they've seen any additional.
Therapeutic interventions I don't believe they have and then second 003 since Youre looking at PFS can you tell us about the conduct of that study with regard to physician training and awareness into obviously have a lot more sites than zero zero too with regard to being able to adapt to and not make the calls early based on potential.
As I just mentioned, it appears that there there is becoming that realization now in the industry, that HPV positive head and neck. Cancer is becoming a really serious medical problem, right? Just in the last few months, we've had several Publications report on the growing incidents of HPV, positive, head and cancer, and this independent market research report. I mentioned specifically, stated that HPV negative or the traditional head and neck, cancer is caused by tobacco and alcohol are on the decline, and the new face of H of head and neck cancer is HPV positive, head and neck cancer.
Pseudo progression on the tumors from the cancer immunotherapy.
Joe I'll start then I'll hand over to Kirk.
In terms of what patients May go on after they come off the <unk> two trial. It is important to remember that at that stage, the patient or checkpoint inhibitor resistance.
Right. So as I mentioned, we we are very confident in the approach. We've taken to focus on hpv16 positive head head and neck cancer which again in order for angio cancer, for example, over 90% of these HPV positive or cancers are hpv16 positive.
In HPV positive disease. This is this was published.
The median overall survival is only three to four months.
Right. We've shown on our slides, the growing projection from some of the top medical journals such as Lancet showing the significant increase in the in in the prevalence of hpv16 positive head and neck cancer. And so we are very encouraged with the results we've seen today.
Right. So so we have to bear that in mind and this discussion once you become a checkpoint inhibitor resistance in HPV positive disease. Your median overall survival is three to four months.
And therefore, if you come of Pds or 101 and go onto some other therapy.
And we are also very encouraged that this growing population of patients will hopefully have a therapy that specifically addresses, this growing type of head and neck cancer which it appears from the from the expert reports could potentially be the dominant type of HPV of head and neck cancer in the next decade.
And all of a sudden you seen prolonged survival.
Then very likely it's only reasonable to assume that that prolonged survival came from was a result of the therapy Pds or 101 therapy right. Because it is very well established that if you're a checkpoint resistant you are not going to have long survival.
Right? So we continue to be pleased with the approach we take in to really Target and focus on hpv16 positive head and neck cancer but the majority of the majority of studies and depressed being developed in head and neck, cancer are not focused on HPV positive, head and neck cancer.
Now is when patients come off Pete divest how's the residual two trial. There is no FDA approved therapy for checkpoint resistant patients and so they will they will very likely going to Amy.
Thank you.
Our next question is from the line of Joe pinion with HC. Wayne Wright, please receive your question.
Investigator choice chemotherapy.
And that's the most likely therapy that anybody who comes of Pds <unk> hundred one will go onto.
In terms of diverse styles, zero-zero redesign and investigators being trained and how they look at things like pseudo progression, that's something that's very important and with an immunotherapy in some of the discussions that have been had with our steel <unk> comments, so I'll hand over to the curb to address that question.
Yes, thank you for it.
First of all just a comment on the answer as far as the subsequent treatment. After the protocol you are correct I mean, theres really nothing tragic that for those who are ICI resistant that really there's been nothing really to show that they have any.
Hey guys, good morning. Thanks for taking the questions. So, 2 questions, if you don't mind on 002, can you remind us or, um, inform us, or what have you, um, the patients that have had such long-term survival had they seen any additional, um, therapeutic interventions. I don't believe they have and then second on 003 since you're looking at. PFS, can you tell us about the conduct of that? Study with regard to physician training and awareness into obviously have a lot more sites than 00002 with regard to being able to adapt to and not make calls early based on potential, pseudo progression of the tumors from the uh, cancer Amino therapy. Thanks.
Hey Joe, I'll I'll start with and then I'll hand over to Kirk.
Survival benefit or even a high response rate so.
Unfortunately, we're comfortable the fact that after the protocol most likely effects would be from our drug.
Now, in in terms of what patients may go on after they come off, the vercel zero 2 trial. It is important to remember that. At that stage, the patients are checkpoint, inhibitor resistance.
And in HPV positive disease. This is this is public.
Pds <unk> regarding the PFS. That's a good question because it's very important as we look at these patients that the investigators are trained as far as the.
The median overall survival is only 3 to 4 months.
The response and also this will be reviewed as you know by a central review from experts, who will be reading the scans et cetera.
Right. So so we we have to bear that in mind. In this discussion, once you become checkpoint, inhibitor resistant in HPV. Positive disease. Your median overall survival is 3 to 4 months.
We discussed this a lot. So people are sensitive to the fact that there may be pseudo progression.
And therefore if you come off PDS 0101 and go on to some other therapy.
So that it with patients who are still clinically well and yet not determined yet as far as our response, we will continue to follow them. So this is very important and different than the O O to O. Two remember the primary was or is.
In all of a sudden, you seem prolonged survival.
As far as response rates and after the patients had a response.
Then very likely, it's only reasonable to assume that that prolonged survival came from was a result of the therapy PDS 0101 therapy, right? Because it is very well established that if your checkpoint resistant, you are not going to have long survival.
Some of them were not followed any further we will be following these patients all along not only for the response, but also for safety.
So we're comfortable now for training, we've had and the discussions we've had with the steering committee.
We will be able to properly judge these patients as far as PFS and also we're very fortunate that with the current site accruals that we have allowed the sites are returning who are on versatile zero-zero too so they've been trained before.
Right now, if when patients come off Pete, the Vestal 00002 trial. There is no FDA approved therapy for checkpoint, resistant. Patients. And so they will they will very likely go on to any um, investigator Choice chemotherapy.
1 will go on to.
They are also familiar with the drug and we're very happy to know that a number of them want to be a part of now the <unk> 003. So we have a good core of sites that have had experience with the drug.
As well as judging these responses.
Write in terms of The Versatile 0003 design and, um, investigators being trained and how they look at things like pseudo progression. That's something that's very important in with an immunotherapy and some of the discussions that have been had with our steering committee. So I'll hand over to to Kirk to address that question.
For your question.
I appreciate all the feedback thanks a lot.
Thank you.
At this time I'll hand, the floor back to management for further remarks.
Thank you operator.
So thank you to all for your time today, we are excited based on the strong <unk> results and our fast track designation about the potential for <unk> hundred one in head and neck cancer.
Our engagement with multiple leading clinical investigators and oncology institutions has validated our approach and the long term opportunity that we believe our HPV 16 targeted immunotherapy represents 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.
Thank you ladies and gentlemen, thank you for your participation. This does conclude today's teleconference. You may now disconnect your lines have a wonderful day.
Yes, thank you. Frank. Uh, first of all, just a comment on the answer as far as the, uh, subsequent treatment after the protocol, you're correct. I mean, there's really nothing. It's tragic that for those who are ICI resistant, that really, there's been nothing really to show that they have any, uh, survival benefit, uh, or even a high response rate. So, unfortunately, we're we're comfortable with the fact that after the protocol most likely any effects would be from, uh, our drug. Um, PDS 0101 regarding the PFS. Uh, that's a good question because it's very important as we look at these patients that, that the investigators are trained as far as, uh, the response and also, this will be reviewed as, you know, by a central review from experts, who, who will be reading the scans Etc? Um, we're we've discussed this a lot. So people are sensitive to the fact that there may be pseudo progression and so that it with patients, who are still clinically well. And yet
Not determined yet. As far as a response, we will continue to follow them. So this is very important and different than the O2 because the O2, remember the primary was uh Orr as far as response rate and after the patients had a response, some of them were not followed any further, we will be following these patients all along, uh, not only for the response, but also for safety, so, uh, we're comfortable now. If the training we've had and the discussions we've had with the steering committee that we will be able to uh properly judge these patients as far as PFS. And also we're very fortunate that with the current uh, site approvals that we have. A lot of the sites are returning, who are on versatile, 0002.
So they've been trained before. Uh they are they are also familiar with the drug and we're very happy to know that a number of them want to be a part of Now, The Versatile 003. So we have a good core of sites that have had experience with a drug as as well as judging these responses. Thanks for your question.
Appreciate all the feedback. Thanks a lot.
Thank you at this time, I'll hand the floor back to Metro for further remarks.
Thank you, operator.
So thank you to all for your time today. We are excited based on the strong versatile, 0002 results and our Fast Track designation about the potential for PDS 0101 in head and neck cancer.
Our engagement with multiple leading clinical investigators and oncology institutions has validated our approach and the long-term opportunity that we believe our HPV16-targeted immunotherapy represents in the HPV16-positive head and neck cancer indication.
We look forward to keeping you updated on our progress and thank you very much again.
Thank you, ladies and gentlemen, thank you for your participation. This does conclude today's teleconference, you may now disconnect your lines and have a wonderful day.