PDS Biotechnology Q3 2023 Earnings Call Transcript

Quartr
Provided by Quartr
November 14, 2023

There are 8 speakers on the call.

Operator

Greetings, and welcome to the PDS Biotechnology Third Quarter 2023 Earnings Call and Webcast. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Nicole Jones, Investor Relations for PDS Biotechnology.

Operator

Thank you. You may begin.

Speaker 1

Good morning, and welcome to PDS Biotechnology's Third Quarter 2023 Earnings Conference Call and Webcast. On the call from the company are Doctor. Frank Bediadou, Chief Executive Officer Matt Hill, Chief Financial Officer comes from the line of Karen B. Wood, Chief Medical Officer. Earlier this morning, PDS Biotech issued a press release announcing financial results for the quarter ended is on September 30, 2023.

Speaker 1

We encourage everyone to read the press release as well as PDS Biotech's report on Form 10 Q, which will be filed with the SEC shortly. The company's press release is available on the PDS website at pdsbiotech.com.

Speaker 2

May be recorded.

Speaker 1

In addition, this conference call is being webcast and will be archived on the company website for future reference. Before we begin, we need to remind everyone that on today's call, the company will be making forward looking statements regarding regulatory and clinical candidate development plans as well as research activities. Certain information in this presentation may include forward looking statements, including within the meaning of the is from Section 21E of the United States Securities Exchange Act of 1934 as amended and Section 27A of the United States Securities Act of 1933 as amended concerning PDF Biotechnology Corporation and other matters. May discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition or otherwise is based on current beliefs of the company's management as well as assumptions made by and information currently available to management. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted.

Speaker 1

A description of these risks can be found on PDS Biotech's and answer session. Most recent filings with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which speak only as of the date of this conference call. Except to the extent required by applicable law or regulation, PDS Biotech undertakes is no obligation to update the forward looking statements included today to reflect subsequent events or circumstances. I will now hand the call over to Doctor.

Speaker 1

Frank Battuato. Frank?

Speaker 3

Thank you, Nicole, and welcome to everyone to our Q3 2023 conference call. We are excited about the strides we're making, fueled by our commitment to developing groundbreaking therapies that revolutionize cancer treatment is based on our proprietary Versimmune platform and IL-twelve fused antibody drug conjugate, PDS-one ADC, formerly known as PDS0301 or M9241. The clinical data stemming from the PDS 1 ADC asset, which we acquired nearly a year ago from Merck KGaA Darmstadt, Germany, continues to advance and mature, Reinforcing our belief that this innovative ADC could potentially address the safety and efficacy limitations that has been observed with cytokine therapy to date. The combination of Versimmune based approaches And our IL-twelve ADC has demonstrated the potential to overcome the limitations of effectively treating advanced cancer have been treated with PDS-one ADC, supporting the early data suggesting that this innovative ADC effectively directs the IL-twelve into the tumor, therefore reducing its presence in the circulating blood and subsequently limiting the adverse events that have been reported with other cytokines. In addition, the increased And sustained presence of IL-twelve in the tumor has been shown in our ongoing trials to enhance the clinical activity.

Speaker 3

This novel modification of IL-twelve, therefore, presents us with a unique opportunity to address a broad range of cancers. We continue to move this ADC forward with various promising approaches. It is being developed as a monotherapy. It's also being developed in combination with Versamune based approaches and also in combination with other standards of care. I will talk more about these updates on PDS-one ADC later on the call.

Speaker 3

We are pleased with our current progress, driven by our mission to develop groundbreaking therapies that transform cancer treatment. Our immediate objective revolves around progressing our primary clinical candidate, PDS-one hundred and one, to the market. PDS-one hundred and one represents a novel investigational HPV-sixteen targeted immunotherapy that triggers a potent and precise T cell response against HPV-sixteen positive cancers. This quarter, we made significant progress on our Versimmune platform, specifically with our Phase 2 Versatile 2 trial. We hosted a positive key opinion leader or KOL event that included Key opinion leaders who have been part of the Verstel-two trial and others who have not oncologists view the trial results and the potential for PDS-one hundred and one in KEYTRUDA to become the standard of care for recurrent or metastatic head and neck cancer.

Speaker 3

Overall, the experts were enthusiastic about the updated Versatiles-two data and the planned initiation of the Phase 3 Versatile-three trial. At this event, we presented data from both the immune checkpoint inhibitor naive or ICI naive and the ICI resistant patient cohorts, both of which demonstrated impressive patient overall survival. For today's discussion on the Versatel-two trial, we will focus on the ICI naive group. With this population, we reported a 24 month overall survival rate of 74%, Which means that on the combination of PDS-one hundred and one in KEYTRUDA, the probability that a patient will live at least 2 years is 74%. To put this number into perspective, published 24 month overall survival rates for approved ICIs is less than 30%, Meaning that on today's approved therapies, the probability that the patient will live for at least 2 years is only about 30%.

Speaker 3

The versatile 2 data suggests that patients are living longer when treated with The PDS-one hundred and one plus KEYTRUDA combination. It is important to note that disease control, Tumor shrinkage was reported in 60% of patients and a confirmed objective response rate With respect to safety, the combination continues to be well tolerated with 13% of patients Having Grade 3 treatment related toxicities and no patients having any Grade 4 or Grade 5 treatment related events. To put this in context, in KEYNOTE-forty eight, it is reported that 17% of patients on KEYTRUDA monotherapy experienced Grade 3 to 5 treatment related toxicities and 72% of patients on KEYTRUDA plus chemotherapy experienced Grade 3 to Grade 5 treatment related toxicities. With this data, we believe that we are on track to revolutionize the treatment of head and neck cancer with improved clinical outcomes The combination of PDS-one hundred and one in KEYTRUDA appears to be promoting a predominant TH1 immunologic profile that is associated with enhanced CD8 killer T cell induction and activity. The combination also led to subsequent decreases in the population of CD8 killer T cells in the circulating blood.

Speaker 3

We are encouraged that these observations align with other Phase 2 studies reporting The PDS-one hundred and one induced polyfunctional CD8 killer T cells do not reside in the blood,

Operator

and answer session.

Speaker 3

Beyond the Versatile 2 trial, Our focus has remained on steadily advancing preparations for our Phase 3 versatile-three trial. In October 2023, we announced feedback from the FDA regarding the amended investigational new drug application and thereafter feedback on the final clinical trial protocol. We currently have up to 60 sites selected globally and answer session. As anticipated, the FDA reviewed Phase 3 clinical trial design has been pivotal to our business development discussions, which has yielded positive insights from prospective partners. Our clinical and medical teams are assessing final details of the trial, and therefore, we anticipate Versedel-three will now start in the Q1 of 2024.

Speaker 3

We'll keep you updated on our next steps as we progress toward trial initiation. Now turning to ImmunoCerib. In October 2023, Data from the Phase 2 clinical trial were featured in an oral presentation at the American Society For Radiation Oncology Annual Meeting known as ASTRO. These data demonstrated that PDS-one hundred and one in combination with standard of care chemoradiotherapy was associated with a rapid decline in HPV positive circulating tumor DNA. At 5 weeks of treatment, ctDNA clearance of 92% was reported with PDS-one hundred and one, Whereas 53% clearance was observed in patients receiving standard of care chemo radiotherapy alone.

Speaker 3

These biomarker data support the 100% response rate in patients receiving PDS-one hundred and one and standard of care, which was reported at SITC 2022. As this trial continues to progress, we will provide further updates. Now shifting to our IL-twelve fused antibody drug conjugate known as PDS-one ADC. PDS-one ADC is a novel ADC or antibody drug conjugate Let's begin by discussing the compelling updated data from the National Cancer Institute led triple combination trial That was reported on November 9. This study is a Phase 2 trial of PDS-one hundred and one, PDS-one ADC and an investigational ICI.

Speaker 3

This combination has undergone evaluation across multiple in 2 groups of advanced cancer patients. The ICI naive group constituted patients unresponsive to standard of care treatments that have not yet received ICI therapy. The ICI resistant group included individuals who had shown no response to multiple prior treatments, including Regarding the ICI naive group, the chart shows the confirmed objective responses recorded in Versedile 2 and the triple combination based on investigator assessment, both shown in green, as well as published KEYNOTE-forty eight data. Notable is the objective response rate of 75% with the triple combination and 27% with the dual combination. With KEYTRUDA monotherapy and KEYTRUDA plus chemotherapy, the published objective response rates were 19% and 36%, respectively.

Speaker 3

The next figure contains updated survival data from Versal002 and the triple combination trial in green as well as published data from KEYNOTE-forty eight. What is notable here is the fact that despite the lower objective response rate with PDS-one hundred and one plus KEYTRUDA, The survival benefit seen with the PDS-one hundred and one plus KEYTRUDA combination as well as the triple combination appears to be similar with 24 month survival rates of 74% 75%, respectively. The triple combination also shows a compelling 3 year survival of 75%. These data suggest that PDS-one hundred and one may play a significant role in extended survival in the ICI naive population Independent of objective response rate, while PDS-one ABC appears to promote strong objective responses in this population. The median overall survival has not yet been reached in either The Verstel-two or the triple combination studies.

Speaker 3

To contextualize, Published data on standard of care immune checkpoint inhibitors or ICI report that at 12 months, Only 30% to 50% of these patients would typically be expected to remain alive and less than 30% of the patients could be expected to remain alive at 24 months. Therefore, survival associated with the PDS-one hundred and one combination regimen At 2 years for Versedel-two and 3 years for the triple combinations is notable. Now looking at the ICI resistance group, where there is a significant unmet medical need and no FDA approved product. These are the patients who have failed all treatment options, including ICIs. In these ICI resistant patients with HPV positive cancers, the reported median overall survival is only about 3 to 4 months.

Speaker 3

In the ICI resistant patients, this slide shows that the published objective response rate with systemic therapies, including high dose chemotherapy is 42%. The objective response rate was 0% with PDS-one hundred and one plus KEYTRUDA in Versedel 2, 5% in patients who received PDS-one hundred and one with low doses of PDS-one hundred and one ADC and or ICI therapy and 63% in patients who received PDS-one hundred and one with initial high doses of PDS-one hundred and one ADC Let's now take a look at the overall survival rate in ICI resistant patients. On the slide, we will see that irrespective of objective response rate, the PDS-one hundred and one containing therapies shown by the green bars provide durable survival results. Despite the lack of confirmed objective responses with PDS 101 plus KEYTRUDA, the 12 month overall survival rate was 56% for BRESEL002 And 72% in the triple combination. With systemic therapies, the published 12 month overall survival rate PDS-one ADC in further extending survival and also promoting objective responses in this population.

Speaker 3

This study provides compelling evidence that supports the potential synergy between our first immune based targeted T cell immunotherapies and our IL-twelve fused antibody drug conjugate that provides the sustained presence of IL-twelve in the tumor, thus providing further expansion and activation of the first immune induced multifunctional killer T cells within the patient's tumor. We believe that this data supports broader application of this combination beyond HPV positive cancer and provides a unique potential to effectively address multiple advanced cancers in our development As a reminder, a safety update for this trial was announced in late December 2022 In 50 patients, 48% of patients experienced Grade 3 treatment related adverse events To put the safety profile in context, in the KEYNOTE-forty eight study, it is reported that The combination of KEYTRUDA and chemotherapy resulted in 72% of patients having Grade 3 will be answered through Grade 5 treatment related adverse events. We are therefore pleased with the tolerability profile that is emerging for PDS-one ADC even when administered in combination with other oncology agents. As I mentioned earlier, to date, we have safety data from over 250 patients dosed with PDS-one ADC. This provides further evidence that this novel modification of IL-twelve may be effective in mitigating device is continued development by PDS Biotech.

Speaker 3

PDS-one ADC is also being studied independently of diverse immune immunotherapies. The National Cancer Institute Recently presented data for the ongoing Phase 2 clinical trial of PDS-one ADC in combination with docetaxel chemotherapy with docetaxel in prostate cancer. The study is investigating the safety, immune responses and preliminary clinical activity of the combination in advanced prostate cancer patients. The trial evaluated 3 doses of PDS-one ADC in combination with docetaxel and show that the combination was well tolerated at all tested doses with less than 10% of patients having a grade 4 toxicity. Most importantly, over 60% of patients had a prostate specific antigen or PSA level reduction of greater than 60%, with some patients having a 90 to 100 PSA reduction.

Speaker 3

As shown, reduced PSA levels were documented in all 18 patients. PDS-one ADC activates T cells, natural killer cells and natural killer T cells, while reducing the presence of immune suppressive regulatory T cells. As a result, We believe that we now also have an opportunity to apply PDS-one ADC to advanced and difficult to treat tumors by combining PDS-one ADC with standard of care chemotherapy and radiation therapy. TDS-one hundred and eighty C is also being investigated by the National Cancer Institute in a Phase III study in patients with intermediate and high risk locally advanced prostate cancer in combination with radiation therapy. As mentioned previously, PDS-one hundred and eighty C is also being studied as a monotherapy by the National Cancer Institute in an ongoing Phase 2 clinical trial in Kaposi's sarcoma.

Speaker 3

At PDS Biotech, we are highly optimistic Switching now to preclinical development studies. The National Cancer Institute has developed a second novel approach to treating immune checkpoint inhibitor resistant cancers by using Versimmune based immunotherapy and PDS-one ADC in combination with histone deacetylase or HDAC inhibitors, another oncology standard of care. The preclinical data were presented during the recently concluded 2023 Annual Meeting of the Society For Immunotherapy of Cancer or SITC. In this preclinical study, Superior anti tumor activity was observed in ICI resistant tumor models with a Versimmune based immunotherapy, PDS-one ADC and entinostat, a Class 1 HDAC inhibitor. This novel triple combination proof of concept study is under consideration as a potential approach for initial clinical studies of PDS-one hundred and three to treat MUC1 specific cancers.

Speaker 3

We are encouraged by the potential of this combination. The National Cancer Institute will lead this clinical trial is under our established cooperative research and development agreement and we anticipate that it will begin in the first half of twenty twenty four. TDS Biotech has had a fruitful quarter and we are preparing to finish out the year strong As we move into 2024, to summarize, we hosted a successful KOL event Where we announced positive updated overall survival and safety data from the VERSTEL-two trial and gained important insights from head and neck oncology leaders about the potential of PDS-one hundred and one in the Preliminary biomarker data presented at ESMO from the Versedel-two trial supports the reported overall survival results. The biomarker data from the immunoServe trial presented at ASTRO demonstrates the role of PDS-one hundred and one in eliminating circulating tumor HPV DNA. The updated triple combination data demonstrates the role of PDS-one ADC in promoting durable overall survival and objective responses even in difficult to treat ICI resistant patients.

Speaker 3

Data from the PDS-one ABC And docetaxel trial presented at cytokine demonstrated tolerability of the combination and encouraging PSA biomarker results With that, I'd now like to turn the call over to Matt to discuss the financial summary. Matt?

Speaker 2

Now turning to our financial results for the 3 months ended September 30, 2023. Net loss for the period was approximately $10,800,000 or $0.35 per basic and diluted share is now open to a net loss of approximately $7,400,000 or $0.26 per basic and diluted share for the 3 months ended September 30, 2022. The higher net loss this quarter was primarily due to costs incurred in connection with our research and development and clinical programs. Research and development costs, which includes clinical and manufacturing expenses for the quarter ended September 30, 2023 increased to approximately $6,400,000 compared to $4,300,000 for the same period of 2022. The increase of $2,000,000 is primarily attributable to an increase of $1,300,000 in clinical trial costs and $700,000 in personnel costs, which includes $300,000 in non cash stock based compensation.

Speaker 2

General and administrative expenses for the Q2 of 2023 increased to approximately $4,100,000 is now open to the operator for the Q1 of 2019. The increase of $1,200,000 is primarily attributable to an increase of $700,000 in personal costs, including $500,000 in non cash stock based compensation and $500,000 and answer session. Our cash and cash equivalents as of September 30, 2023, totaled approximately is $54,300,000 We continue to be prudent with our cash expenditures, and we believe that with initiating the Versedile 3 will be answered by the Q1 of 2024. Our available cash resources will sustain our operational and research and development endeavors into the Q3 of 2024. We expect to execute our current operational and research and development endeavors by obtaining additional capital, principally through running into collaborations, strategic alliances or license agreements with third parties and or public or private debt and or equity financing.

Speaker 2

We've had and continue to provide what we believe to be favorable development milestones to the market and have upcoming development milestones we believe, may provide additional catalysts to investors. At this time, this completes my financial discussion. I would like to hand the call back over to the operator for the Q and A session. Operator?

Operator

Thank you. At this time, we'll be conducting a question and answer session. Our first question comes from the line of Louise Chen with Cantor Fitzgerald. Please proceed with your question.

Speaker 4

Hi, congratulations on all the progress this quarter and thank you for taking my questions. So I had a few questions for you. As you think about 2024 and we table set for next year. What are the key milestones, catalyst readouts that you think we should have on our radar? Secondly,

Speaker 1

how do

Speaker 4

you think about OpEx for Q4 'twenty three and 2024 in light of the fact that you're going to start this versatile 3 Phase 3? And the last question is when do you think we'll see data on Versatile 3? Thank you.

Speaker 3

Louis, thank you very much for your questions. I'll answer 2 and I'll hand over the OpEx to Matt. But in terms of the key milestones in As we move into 2024, as I mentioned, Key will be getting Verstel 3 up and running. We also have announced and stated that we do anticipate and expect the final data readouts from Versedal-two sometime in the Q2 of 2024. As I also just mentioned, we do expect to initiate the PDS-one hundred and three will be answered by the end of the year.

Speaker 3

We also are hopeful that we will have The preliminary data from our neo adjuvant trial ongoing at the Mayo Clinic in early stage oral cancer, PV positive oral cancer where we're looking at PDX-one hundred and one both as a monotherapy and also in combination with KEYTRUDA. We have not had any readouts from that study yet And we're hopeful that we will get that in sometime the first half of twenty twenty four based upon what we've been informed by the PI and their goal of presenting at and upcoming conference. And also we do expect to have additional data readouts on the immunoCerce cervical cancer trial. And so we do have a number of potential milestones coming up as well as readouts. And as you know, We don't talk too much about the trials going on also at the National Cancer Institute.

Speaker 3

We had the readout from the docetaxel as well as the PDS-one ADC. We also have those studies ongoing in early stage prostate cancer, locally advanced prostate cancer. We're hopeful that we'll see some data from that trial in 2024. We have the monotherapy trial going to Kaposi's sarcoma. Hopefully, we will see some data from that trial in 2024.

Speaker 3

And so I think we will have hopefully a pretty busy 2024 and hopefully we'll be able to provide quite a number of data readouts comes from the line of David. In terms of the Versailles-three trial, it will have much more clarity on when we'll have the data readout. So as When we will be able to provide the data readout will be at our 1st interim data readout. Now when we get to the 1st interim data readout depends on the number of that we have opened at the start as well as the enrollment rates that we will encounter or that we will be able to achieve as the trial goes, initiates What we are currently doing, as I mentioned, we have 60 sites that have been identified so far. The goal is to get to 100 sites.

Speaker 3

And what we're trying to understand now is how rapidly each site will come on board. And as we understand better how we will open the sites and the sequence of open the sites and how many sites in the timelines, we will be able to provide you as to when we will get to that interim data readout. But we are working aggressively on that now and hopefully should be able to provide that information very soon. Matt, I'll hand over to you for the operating costs.

Speaker 2

Thank you, Frank. Louise, thanks for your question. I want to let you know that it's a good question. We've been I would say we've been extremely prudent with the use of the company's cash and capital. When you look over the last probably 7 quarters or so, we burned about Little north of $6,000,000 per quarter and with the significant number of studies that we have ongoing, not only the Versatiles 2 trial, But also the trials with the NCI, the ITs with MD Anderson as well as Mayo.

Speaker 2

We've been extremely frugal in our opinion and how we manage these costs. But as we prepare to move forward into Phase 3 clinical trial, obviously those costs are going to increase. Now from the perspective of OpEx, the administrative costs will grow slightly, But we can expect that the company will incur costs in R and D of somewhere around Overall costs, I'm sorry, will be somewhere around between $12,000,000 to $15,000,000 once the study starts up. Some of that being front loaded for the normal deposits that are need to be made to get the consultant CROs and the like set up, Which is why under the current circumstances of us looking at a trial beginning in Q1, We've got cash into Q3 of 2024, which also gives us additional time to go out and look for Business development deals, we had the ferret data come out. We've had the MCI triple data come out.

Speaker 2

We've had the docetaxel data come out. We've had the KOL meeting. So there has been a significant number of data readouts and we're hopeful that that will be a catalyst for potential Business development deals as well.

Speaker 1

Thank you. Can I just ask

Speaker 4

you one follow-up question? So for Q4 'twenty three then, you would expect OpEx to be similar to Q3 Or would there be some ramp up for the start of

Speaker 2

the call? There will be some ramp up In Q4 of this year. So we spent about $10,500,000 in total in Q3. So my expectation would be around there or a little higher.

Speaker 4

Okay. Thank you.

Speaker 2

You're welcome.

Operator

Thank you. Our next question comes from the line of Mayank Mamtani with B. Riley Securities. Please proceed with your question.

Speaker 5

Good morning, team. Thanks for taking our questions and appreciate the comprehensive pipeline update. So maybe a high level question quickly for you guys. So given 1 hundred and one prolonged survival and the higher ORR you seem to have been driven by 1 ADC, Investors generally wonder if perhaps it makes sense to also evaluate Triple A in the first line Could you just clarify how you're thinking relative positioning of these 2 programs? And then I have a couple of follow ups.

Speaker 4

From Frank, if you're speaking, you may be on mute.

Speaker 3

Thank you very much. Hi, can you? Yes. So Mayank, I think you're absolutely right. We have seen highly encouraging survival data with PDS-one hundred and one as well as PDS-one hundred and one ADC As well as extremely encouraging ORR with the PDS-one ADC.

Speaker 3

Now we have certainly considered The application of the PDS-one ADC in the earlier line ICI naive. However, after talking to key opinion leaders in the field, As well as the regulatory experts, it's evident that the survival and safety data generated with the doublets presents the most straightforward regulatory pathway as well as the robust uptake if and when it becomes standard of care. Right. With the doublet, we'll also enable a more rapid potential approval path for early even early use. Now when we look at the triple in the ICI resistant population, it also presents the quickest path to approval and potentially This triple combination may then also subsequently find its way to an approval for use in ICI naive patients.

Speaker 3

So this is something we have actually seriously considered. But after talking to the experts in the field, the two options we're taking now appear to provide the quickest has to rapid approvals and uptake.

Speaker 5

Understood. Thank you for that clarification. And then maybe drilling down on the doublet trial protocol, are there any details on the SAP That you're able to share in terms of the target OS differential you're going for against standard of care. I recognize you're talking about sites, but not specific patient numbers, but just sort of It would be helpful to understand what sort of hazard ratio, what sort of delta on OS you're aiming for. And just a related question, your ESMO translation of biomarker data was actually quite novel in context of demonstrating CB8 T cell responses specific to tumor cells.

Speaker 5

I was wondering if there are any implications of that in terms of patient enrichment or response assessment strategies that you could deploy in your late stage development.

Speaker 3

Okay, Mayank, a lot of really good questions. So let me start with the biomarker data. So with the biomarker data, as you did mention, We're looking at a number of novel approaches to really understanding and documenting how PDS-one hundred and one is working And really documenting and clarifying the differentiation of our assets. So if you look at the data presented at ESMO, for example, Looking at the polyfunctional CD8 T cells confirming increase in polyfunctionality was very important, But also understanding the kind of immunological profile that PDS-one hundred and one is promoting, for example, going from a Th2 biased To a Th1, Th1 being well documented to be better associated with strong CD8 T cell responses, Right. And also showing that we have potential exit of the CD8 T cells from the blood To the tumor sites, right, showing the decline in circulating peripheral blood containing CDAT cells.

Speaker 3

So we have that approach in that study in the PDS-one hundred and one KEYTRUDA. Now when you also look at what's been done in terms of biomarkers In the immunoserve study, right, very complementary to what we've seen with the PDS-one hundred and one KEYTRUDA study. In the immunoCERF study, what MD Anderson was looking at is circulating tumor DNA. Circulating tumor DNA is essentially eliminate the tumors from the patient's body becomes extremely important. And how do you know that your technology or product is actually achieving that?

Speaker 3

What we have seen now with our circulating tumor DNA in that study is the strong potential for PDS-one hundred and one to actually dramatically eliminate and reduce and eliminate the circulating tumor DNA, right, at 5 weeks, 92% reduction versus 52% reduction with the standard of care. MD Anderson is extremely excited about that because They believe it has direct implications for patient survival and very importantly recurrence of the cancer, Right. So that is data that we will hopefully be expecting to see coming up in 2024, how that elimination of circulating tumor DNA To really quantify and understand the kinds of T cells that are actually accumulating in the patient's tumors, Right. So we talked about the CD8 T cells in the blood and exiting the blood, but it's also important to understand what's happening in the tumor. And what they also showed was a really strong correlation between this elimination of circulating tumor DNA and accumulation targeting accumulation of these CDAT cells within the patient's tumor.

Speaker 3

So again, very different. To date, most of our peers Have looked at T cells in the circulating blood looking at things like interferon gamma. But what we are showing here is that these T cells generated by the Versimmune technology Actually do target and accumulate in the patient's tumors. Right, so again, we have very complementary Studies which are in agreement with each other, which are given us a really good picture of how and why we've seen the results we've seen in these patients today. Now if you go to the triple combination, very similar studies have been performed by the National Cancer Institute in the triple combination, again showing That very strong correlation between induction of HPV16 specific T cells and the clinical responses And also showing that this triple combination in addition to inducing strong tumor specific multifunctional T cells also induces an inflammatory immunological profile, which is strongly believed to suppress The tumor's ability to hide from the immune system.

Speaker 3

Right. So now we're getting all the information that Helps us better understand how and why we're seeing the kinds of results we've seen today in these patients even in the very difficult to treat patients. Now coming to your earlier question, which had to do with the design of the Versatile 3 trial. Now we have not made details of the clinical design public yet, but I can give you some insight into how we're thinking about this. The delta today is quite significant when you look at the delta of what we've seen at the 2 year results versus what we've seen the published data.

Speaker 3

We know that by far exceeds what we will have to achieve for approval. But as a risk mitigation strategy in terms of our statistical design, What we are also looking at is we are also saying, well, let's assume PDS-one hundred and one that patients in our control arm taking KEYTRUDA will do much better than KEYNOTE-forty eight, right. And so in terms of our endpoints for the control arm, we're stating that they will be higher than KEYNOTE-forty eight. Oncologists are getting more used to administering KEYTRUDA. They're getting better understanding of which patients may respond better.

Speaker 3

And so we have to assume that those patients are going to do better than has been published today. What we are also assuming in that design is that our patients in the study at multiple sites all over the world We'll not do as well as we've seen in Versailles-two. So we are also reducing that target. And that risk mitigation allows us to overpower the study Based upon what we've seen today and mitigate the risk that we will not get to that clinical endpoint, right. So we're taking those strategies into consideration just based upon the really Large delta we've seen today allows us to narrow that delta, but also be reasonable in terms of trial size and the power of the trial to successfully achieve Those primary endpoints of overall survival.

Speaker 3

Mike, I hope that answered your question.

Speaker 5

Yes. No, very comprehensive, very helpful. And lastly for Matt, Just quickly on the strategic collaboration discussions, are you able to describe qualitatively interest from strategics on doublet versus triplet? And how maybe recent triplet data may have informed those discussions and also There's a full data set from your doublet expected in Q2. Would they want to see that mature analysis before Thanks for taking our questions.

Speaker 3

So Mayankapsun, you are not going to be able to do. I'm not going to be able to

Speaker 6

do those specific.

Speaker 3

Yes, I'll take that one. Yes. So Myakastin, I won't be able to go into very specific details as to what we are discussing. However, The data that we have today has been very helpful in clarifying certain things. So one of the key things that I mentioned over the last couple of earnings call has been the fact that we are waiting to see the data from the Versedel 2 refractory arm.

Speaker 3

That data was very important because it was key in giving us insight into the specific role of PDS-one hundred and one or the contribution of PDS-one hundred and one in extending life in head and neck cancer patients. And so looking After that combination of PDS-one hundred and one and KEYTRUDA in patients who have failed checkpoint inhibitors, the majority of which we know were on KEYTRUDA And still being able to extend those patients' lives significantly was very important for us to demonstrate and to get potential partners also comfortable that, okay, PDS-one hundred and one is actually biologically active in this population And even seeing this extension in even a much more difficult to treat population. So that was key. It was also important In the triple combination trial, as I mentioned previously, for us to have that understanding of what PDF-one hundred and one is doing in that combination because a lot of the questions we receive both from investors and prospective partners is, well, in the triple, how do we know Which of these components is working and what is contributing to what? Right.

Speaker 3

So now the role of PDS-one hundred and one becomes very clear. But with the data we have today, right, we also now see the critical role of PDS-one ADC. And so now both components, Both drugs have very clearly shown their biological activity. And what was also very important is if you look at Versatile 2, Right refractory arm, no IL-twelve, 0% of confirmed objective response. If you add a low dose IL-twelve, 5% confirmed objective response.

Speaker 3

If you go to the high dose IL-twelve, 63% confirmed objective response, Very clear in terms of what's happening with the IL-twelve, right. So all this data that is now available provides not just PDS, But potential partners with confidence in the biological activity of our drugs, right. In terms of and discussions, I'll say there are no issues with the current protocol, right. As you know, we have alignment with the FDA on the path forward. But what's happening with these discussions is not at all uncommon.

Speaker 3

And we believe that it is prudent to at least evaluate Suggestions that the Sirius potential partner may have, even though there are no guarantees that a partnership will resolve when all is said and done, Right. But there are a number of typical things that we typically want to evaluate at this case and we would not do this for every prospective partner or suggestion we receive, however. So I hope that gives you some flavor of what the data we've seen today and how it's impacting discussions that we are having.

Operator

Thank you. Our next question comes from the line of Joe Pantginis with H. C. Wainwright. Please proceed with your question.

Speaker 6

Hi, good morning, everybody. Thanks for taking the questions. Two questions, please. So first, for 101, wanted to ask about Currently, what you have ready to go followed by your intermediate near term needs and intermediate needs with regard to And then the second question is a little bit of the off the beaten path here because it's been nice to hear Such the encouraging data updates from an O-one hundred and one, but I wanted to ask about O-two zero two and the universal flu vaccine. You are sitting on what we consider to be a very strong asset profile on the data that you've accumulated to date.

Speaker 6

So Other than the rhetorical answer of financial resources, how what could you envision being a development plan for that asset? Thanks.

Speaker 3

Hey, thanks a lot, Joe. I'll start with the first question in terms of what we have ready to go with PDS-one hundred and one. So with PDS-one 101, we have done all the tech transfer. The material has been scaled up to our commercial process And the Phase 3 clinical product has already been successfully manufactured and released. So in terms of clinical product that has been scaled up to the final process and has been successfully manufactured.

Speaker 3

We are there today. So the material is ready to go. We don't have any additional needs from the perspective of PDS-one hundred and one materials in order to run the Phase 3 clinical trial with either program, Versedel-two or the triple combination. With PDS-two zero two, as you mentioned, this is a program that We are quite excited about today our resources financial resources are really focused on the oncology programs. However, We have made significant progress also with this program.

Speaker 3

As you know, the data was presented in September at the European Influenza Conference data from ferrets, right, ferrets being the gold standard for preclinical studies. So it was very important To be able to demonstrate that we can replicate the data that was generated in the mouse models in the ferrets, which are closest to humans in influenza. And again, all that was done has been done successfully. We've shown very similar levels or identical levels of broadly reactive neutralizing antibodies against multiple strains of the flu that was shown successfully in ferrets. We also showed successful Prevention of viral replication in the lungs when the animals were given lethal doses of the H1N1 virus as well as And protection against infection in the ferrets also.

Speaker 3

So we have shown very good translation. Now from PDS' perspective, For us, this is not surprising because again even in our oncology products, we've shown very good translation from preclinical models to human, Right. And so we expected this. The NIAID is extremely encouraged by the data that they've seen today. And so we have had some discussions.

Speaker 3

We are still hopeful that we will get some notification sooner or later regarding the next steps. What we would envision or what we would like to see would be for this to go into at least a Phase onetwo human clinical trial antibodies that we're seeing in the animal models in humans, hopefully provide very important data on safety. As you know, with Preventive vaccine safety is extremely important. We've seen very good safety profile today with PDS-one hundred and one. So We do expect to see very similar safety with the preventive vaccine.

Speaker 3

And then hopefully, depending on when in the year it's done, Get some data on actual prevention against infection with the flu. So we are very we are really hopeful. We still have Very good discussions with NIAID. They've indicated that this is something they would like to move forward. And so we are waiting to learn what the next steps will be and when those next steps will start.

Speaker 6

Appreciate the color, Frank.

Speaker 3

No problem.

Operator

Thank you. Our next question comes from the line of Jim Molloy

Speaker 7

So you mentioned an upcoming trial for your preclinical PDSL-one hundred and three candidate for the first half of next year. What are any other updates that you have for your preclinical PSL-one hundred and two and one hundred and four candidates?

Speaker 3

Hi, Laura. Thanks for your question. So with PDS-one hundred and three, as I mentioned, the goal is to start in the third in the Q3 in the first half of next year. And so that is going to be done under our collaboration with the NIH. Right now, we are finalizing the CMC section.

Speaker 3

We are finalizing the animal studies and looking at the new triple combination, which is potentially going to be Very likely the path we go down that's been evaluated now in specific tumor models that we would want to include in the IND filing. So we are working towards an IND filing hopefully in Q1 of next year to get this into the clinic hopefully by the Q2 of next year. With PDF-one hundred and two, we are also working now on the tech transfer. The formulation development has completed, preclinical work has been completed with PDS-one hundred and two. And just to remind the audience who may still be on PDS-one hundred and two, Specifically addressing prostate cancer.

Speaker 3

So I'm sure you can see how that potentially lines up with what we're doing with docetaxel. There is the potential that we could include that to make a new triple combination, but the goal here with that program is to get that dual combination as rapidly as possible to Commercialization, but there's potential for expansion in terms of even more difficult or latest treat cancer patients and decline of circulating tumor DNA Using that PDS-one hundred and two asset in which the target is TARP, TARP. TARP has been found in about 90 percent of prostate cancers at all stages of the disease and about 50% of breast cancers. So that's an asset that we do anticipate Hopefully getting into manufacturing sometime next year in 2024 to allow us to start to evaluate that asset also probably later in the year, but we will provide updates regarding what we're doing with that process program, what the potential partnerships, How we're going to move that forward, we'll provide some more of those details later as the year goes by in 2024. PDS-one hundred and four, we have not yet made any additional progress with PDS-one hundred and four.

Speaker 3

We've really concentrated on PDS-one hundred and one, one hundred and two and one hundred and three At this point, as well as PDS-one ADC.

Speaker 7

Got it. Thank you for the clarity. And also just for my question, Alongside the data presented for ImmunoCerv, for your other investigator initiated trial of PD-one hundred and one with the Mayo Clinic, do you have any estimates as to when you might get data announced here?

Speaker 3

No. So with the Mayo Clinic, starting with the Mayo Clinic, as I mentioned, that's you mentioned that that's another investigator initiated trial. It's evaluating early stage PV16 positive oral cancer in neoadjuvant setting, we have been informed, as I mentioned, by the PIs that they hope to present preliminary data at the scientific meeting in the first half of twenty twenty four. And so we'll keep you updated as we learn more as to what conference that would be and what the exact timing would be. But we are hopeful That we'll see some data, we'll see the first preliminary data from that trial hopefully in the first half of twenty twenty four.

Speaker 3

And with ImmunoCerv, With ImmunoCerf, the investigators are extremely encouraged with the data that they've seen today. Based on what we've been told by Doctor. Clough of MD Anderson, who leads this trial, she's actually planning on submitting interim results of the study for Scientific publication and particularly the recent circulating tumor HBV DNA outcomes reported at ASCO, So we are hopeful that we'll get an additional update on the trial in the near future.

Speaker 7

Understood. Thank you for taking the questions.

Speaker 3

Thanks a lot.

Operator

Thank you. There are no other questions at this time. I'll turn will back to Doctor. Bedu Ado for any final comments.

Speaker 3

Thank you very much. So thank you to all for participating in our Q3 earnings conference call today. The progress made this quarter has been Truly exciting. We remain enthusiastic about what lies ahead for the rest of this quarter and into 2024. We have made significant strides towards our objective of developing groundbreaking therapies that transform cancer treatments.

Speaker 3

We are confident that our efforts will positively impact these patients with critical unmet medical needs, leading to longer lives and improved quality of life. We appreciate your continued support and eagerly anticipate updating you on our accomplishments. Thank you very much again and have a wonderful day.

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Earnings Conference Call
PDS Biotechnology Q3 2023
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