PDS Biotechnology Q2 2023 Earnings Call Transcript

Quartr
Provided by Quartr
August 14, 2023

There are 11 speakers on the call.

Operator

Hello, and welcome to the PDS Biotechnology Second Quarter 2023 Earnings Call and Webcast. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to your host, Gabby DeGravina, Investor Relations. Please go ahead, Gabby.

Speaker 1

Good morning, and welcome to PDS Biotechnologies' 2nd Quarter 2023 Earnings Conference Call and Audio Webcast. On the call from the company are Doctor. Frank Beduetto, Chief Executive Officer Matt Hill, Chief Financial Officer and Doctor. Lauren V. Wood, Chief Medical Officer.

Speaker 1

Earlier this morning, PDS Biotech issued a press release announcing financial results for the quarter ended June 30, 2023. 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 PBS website at pbsbiotech.com. In addition, this conference call is being webcast it 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.

Speaker 1

Certain information in this presentation may include forward looking statements, including within the meaning of Section 21E of the United States Securities Exchange Act of 1934 as amended in Section 27A of the United States Securities Act of 1933 as amended concerning PDS Biotechnology Corporation and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition or otherwise based on the 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. A description of these risks can be found in PDS Biotech's 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.

Speaker 1

Except to the extent required by applicable law or regulation, PDFB undertakes 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. Frank Fedueto. Frank?

Speaker 2

Thank you, Gabby, and thanks to all for joining our Q2 2023 call this morning. We are pleased with the progress we have made so far this year. Our primary goal is to create groundbreaking therapies that can significantly revolutionize cancer treatment. Our current primary focus on advancing and commercializing our lead clinical candidate PDS-one hundred and one designed for the treatment of recurrent or metastatic HPV16 positive head and neck cancer. CDS-one hundred and one is an innovative investigational HPV-sixteen targeted immunotherapy that stimulates a potent and precise T cell attack on HPV-sixteen positive cancers.

Speaker 2

In the upcoming controlled and randomized versatile-three trial, we will examine PDS-one hundred and one in combination with Merck's anti PD-one therapy, KEYTRUDA or pembrolizumab compared to KEYTRUDA monotherapy, which is the current standard of care for first line treatment of recurrent or metastatic head and neck cancer. I am pleased to mention that we filed the final Versatile-three Phase 3 protocol with supporting chemistry, manufacturing and controls or CMC information to our existing IND last week on schedule as planned and previously announced. I congratulate the PDS Biotech team on achieving another key milestone to another significant upcoming milestone, the initiation of the Phase 3 trial in the Q4 of this year. As you can imagine, we are all eagerly looking forward to the commencement of Versedal 3. This will hopefully move us towards the filing of a Biologics License Application or BLA and the increased potential to get PDS-one hundred and one successfully commercialized and available to head and neck cancer patients who are in desperate need of safer Advanced head and neck cancer, as many of you may already know, It's one of the most devastating and debilitating cancers with one of the highest suicide rates and unfortunately This quarter, we made significant progress on our Phase We presented positive interim data and the data was selected and featured At an expert head in neck cancer panel discussion session at this year's ASCO Annual Meeting.

Speaker 2

The data demonstrated a 12 month survival rate of 87% with only 8% of patients experiencing Grade 3 treatment related adverse events and no reports of more severe Grade 4 or Grade 5 toxicities. Doctor. Wood will provide more details on the ASCO data momentarily. Additionally, the naive arm of Versal 2 reached its efficacy threshold based on best objective response The threshold for efficacy was achieved when 14 of the 54 immune checkpoint inhibitor The naive patients achieved a confirmed objective response indicating tumor shrinkage of 30% or more in these patients. This achievement suggests that there is a statistically significant additive effect of PDAS-one hundred and one over immune checkpoint inhibitor monotherapy and this gives us more confidence to move into the Phase 3 registrational trial.

Speaker 2

Just last month, we announced that biomarker data demonstrating the induction of multifunctional HPV16 specific T cell responses in patients receiving the PDS-one hundred and one And KEYTRUDA combination treatment has been accepted for presentation at the European Society For Medical Oncology Congress 2023, or ESMO this October. The immunological clinical data we'll showcase the potential of this immunotherapy combination to generate clinically relevant multifunctional HPV16 The targeted killer in healthy T cells in advanced head and neck cancer patients. Moreover, the treatment has demonstrated minimal toxicity, further underlining its potential as an effective approach to treat this challenging cancer. Beyond the versatile 2 achievements, we've continued To successfully progress our 3 other PDS-one hundred and one clinical programs as well as the development of Our novel antibody conjugated IL-twelve cytokine therapy, PDS-three zero one, in multiple National Cancer Institute or NCI led Phase 2 clinical studies. We recently announced that an oral presentation by the lead investigator on the prostate cancer program at the National Cancer Institute will take place at the cytokines 2023 Annual Meeting.

Speaker 2

The presentation will detail results for the ongoing clinical study of our antibody conjugated IL-twelve in combination with the FDA approved standard of care chemotherapy, docetaxel, for metastatic prostate cancer. This Phase 2 trial, which is the first clinical study of an immunocytokine with docetaxel in prostate cancer, is being led by the National Cancer Institute and is investigating the safety, immune responses As we look to the remainder of the year and the first half of next year, we expect a number of key data readouts and milestones. For Versatiles-two, we anticipate providing additional data updates As recruitment of the naive arm has been completed, we project that the final data will be reported late in the Q2 of 2024. With Versatile-three, as already mentioned, we anticipate initiation of the trial later this year. Eye on our list is also the National Cancer Institute led triple combination study of PDS-one hundred and one, and survival data among head and neck cancer patients to inform the statistical design of the intended triple combination registrational study.

Speaker 2

That we reported late last year. Doctor. Anne Klop of MD Anderson Cancer Center At the SITC Conference in November 2022. This is an investigator initiated trial and we expect to have a steady update before the end of the year. The Phase 2 trial of PDS-one hundred and one After neoadjuvant treatment in HPV-sixteen related oral cancer is also in progress at Mayo Clinic.

Speaker 2

This is an investigator initiated trial and we have little control over the timing of data releases. However, we are hopeful that presentation of preliminary data from the trial at a scientific meeting will occur in the near future. Although our primary focus is on Versatile-three, we are also working to file our for PDS-one hundred and three, our MUC-one hundred and three, our MUC-one hundred and thirty five targeted immunotherapy before the end of this year. At this time, I will hand over to Lauren to walk us through the recent data. Lauren?

Speaker 3

Thank you, Frank. Let's now turn to the high level interim data presented in a poster at the ASCO 2020 3 Annual Meeting by Doctor. Catherine Price of Mayo Clinic and included as a featured poster reviewed by an expert panel in the head and neck cancer discussion session. The efficacy highlights include the following: a 12 month overall survival rate of 87% on the combination therapy. Published results document 12 month overall survival rates of 36% to 50% in patients with recurrent or metastatic head and neck cancer receiving approved immune checkpoint inhibitors used as monotherapy.

Speaker 3

The median progression free survival was 10.4 months. Published median progression free survival results report 2 to 3 months for approved immune checkpoint inhibitors when used as monotherapy in patients with similar PD L1 level expression in their tumors. The disease control rate, which is defined as disease stabilization or tumor shrinkage was seen in 71% of patients. In addition to the ASCO data, In July, we announced that we had achieved 14 confirmed responses, suggesting that PDS-one hundred and one has an additive effect over published results seen with immune checkpoint inhibitor monotherapy. In addition to the previously mentioned 12 month survival rate of 87%.

Speaker 3

This provided us with further confidence moving forward with the Phase 3 randomized trial. Importantly, in the versatile 3 Phase 3 trial, the primary efficacy endpoint will be overall survival rather than objective response. The endpoint that the FDA has prioritized for approval. Consequently, we have designed our Phase 3 trial to show improved overall survival of PDS-one hundred and one plus KEYTRUDA over KEYTRUDA alone to maximize our opportunity to achieve BLA approval. With respect to safety, we are finding the combination to be well tolerated with only 4 of the 48 patients or 8.3% having Grade 3 treatment related adverse events, also known as TRAEs at the time of ASCO.

Speaker 3

Furthermore, there were no Grade 4 or higher treatment related adverse events Observed. The published treatment related adverse event rate for KEYTRUDA monotherapy is approximately 17%. We continue to ramp up through the initiation of the Versatile-three trial. During the quarter, we completed the CMC required activities related to PDS-one hundred and one to initiate a global multicenter Phase 3 registrational trial. We have also received feedback from some European regulatory agencies on the Versatile-three study design.

Speaker 3

As Frank mentioned previously, this morning, we announced submission of the clinical protocol and the CMC package to the FDA in preparation to initiate the study by the end of the year. The planned design of the controlled Phase 3 trial will randomize subjects to PDS-one hundred and one in combination with KEYTRUDA as the active arm and KEYTRUDA monotherapy as the comparator control arm. We intend to conduct a trial at 90 to 100 sites globally, this study will be powered for overall survival with an interim analysis for potential accelerated approval pending the data readout. Initiating this trial is a significant milestone for PDS Biotech and we look forward to starting Versatile 3 in the Q4 of this year. In addition to the Versatile programs, we have been pleased with the ongoing results from the Phase 2 trial for the triple combination of PDS-one hundred and one, PDS-three zero one, which is our IL-twelve tumor targeting cytokine and an investigational immune checkpoint inhibitor.

Speaker 3

This combination has been evaluated in all types of HPV positive cancers, including anal, cervical, head and neck, Penal, vaginal and bovar cancers in both immune checkpoint inhibitor naive as well as immune checkpoint inhibitor refractory patients. As we've mentioned previously, we plan to continue to develop and commercialize this combination using an approved checkpoint inhibitor in immune checkpoint inhibitor refractory patients. HPV-sixteen positive head and neck cancer is the largest and most rapidly growing of the HPV related cancer markets. The proprietary combination of VersaMune and PDS-three zero one overcomes tumor immune suppression by a mechanism that's different from immune checkpoint inhibitors alone, we believe this technology represents a potentially transformative treatment approach for advanced cancer patients across multiple solid tumors. I would also like to highlight the advancement of our PDS 301 antibody conjugated IL-twelve programs being led by the NCI.

Speaker 3

We continue to expand our relationship with the NCI and are now exploring the potential of PDS-three zero one both as a monotherapy and in combination with other agents in multiple clinical trials of advanced answers. We are pleased to be able to evaluate PDS-three zero one with some of the leading experts in the field of immuno oncology. During the cytokine 2023 Annual Meeting in October, Doctor. Ravi Madan of the NCI will provide interim safety and immune data based on 18 patients involved in a fiercene human Phase 2 trial. This study is designed to evaluate PDS-three zero one in conjunction with docetaxel chemotherapy.

Speaker 3

We are excited about this trial as it represents a significant opportunity to understand the potential benefits of combining PDS-three zero one with chemotherapy and the opportunity to offer improved treatment possibilities for patients with metastatic castration sensitive and castration resistant forms of prostate cancer. The findings also have the potential to shed light on PDS-three zero one chemotherapy combinations in treating other solid tumors. With that, I'd like to now turn the call over to Matt to discuss the financial summary. Matt?

Speaker 4

Thank you, Lauren. Now turning to our financial results for the 3 months ended June 30, 2023. Net loss for the 3 months ended June 30, 2023 approximately $11,500,000 or $0.37 per basic and diluted share compared to a net loss of $5,800,000 or $0.20 Basic and diluted share for the same period in 2022. The higher net loss this quarter was due to costs incurred in connection with the research, development and versatile clinical programs. Research and development costs, which include clinical and manufacturing expenses for the quarter ended June 30, 2023 increased to approximately $8,000,000 compared to the $3,800,000 for the same period in 2022.

Speaker 4

The increase of $4,200,000 is primarily attributable to an increase of $1,400,000 in clinical trials, dollars 500,000 in personnel costs, which include $200,000 in non cash stock based compensation and $2,300,000 in manufacturing expenses. General and administrative expenses for the Q2 of 2023 increased to approximately $4,700,000 compared to $3,300,000 for the same period in 2022. The increase of $1,400,000 is primarily attributable to an increase of $500,000 in personnel costs, including $400,000 in non cash stock based compensation and $900,000 in professional fees. Total operating expenses for the quarter ended June 30, 2023 were approximately $12,700,000 compared to a total operating expenses of approximately $7,100,000 for the same period in 2022. Our cash and cash equivalents as of June 30, 2023 totaled approximately $60,600,000 and based on the company's cash resources and projections, we believe this balance is sufficient to fund operations and our research and developing clinical programs for the 12 months following the filing of our June 2023 quarterly report on Form 10 Q, which will be filed today.

Speaker 4

We continue to be engaged in business This completes my discussion. And at this time, I would like to hand the call back to the operator

Speaker 3

Operator?

Operator

Thank you. Our first question today is coming from Joe Pantginis from H. C. Wainwright. Your line is now live.

Speaker 5

Good morning, everyone. Thanks for taking the question and happy summer. So first, just wanted to get a sense of the operational readiness for the Phase is, randomization, is it 1 to 1, assuming the supplies all ready to go, the diagnostic? And then, of course, Lauren already discussed the benchmarks. We'll start with that.

Speaker 5

Thanks a lot.

Speaker 2

With respect to the operational readiness, As you know, there are a number of things that have to happen beyond just the submission of the IND amendments and updates to the IND. A number of those are actually actively ongoing currently. We have to activate the clinical sites. We're currently looking at, as Lawrence said, at 90 to 100 clinical sites. So in the process of getting those sites up and running, we have had Very good response, higher than expected.

Speaker 2

We actually have about 100 clinical sites who have already indicated interest in participating in the Phase 3 data. And we believe that is directly related to the data that was presented at ASCO, the Overall survival as well as the safety, as you know, head and neck cancer oncologists are really looking for something that can help their patients live longer with higher quality of life that's well So we believe that's really largely responsible for the larger than expected interest that we In these clinical sites, so really getting all those sites up and ready, waiting for the green light from the FDA. And then we actually have to start getting the institutional review boards at the various sites to also approve these trials. The good thing is that in terms of manufacturing, the manufacturing is done, the product has been manufactured And so all that information is what was utilized to update the CMC section. Right.

Speaker 2

So we're looking at the target enrollment of anywhere between, I would say between 200 to 300 patients pending. We are waiting for the final feedback from the FDA, right? As you know, we submitted those documents last week to the IND. And so once we have the final either green light or any feedback from the FDA, we can then make the final the actual final protocol available to everyone. But we've submitted what we anticipate could be the final protocol, but we always want to wait to get the FDA's feedback before we say this is the absolute final protocol that's moving into the Phase 3 trial.

Speaker 2

But so far, we are very pleased and we're excited to get this going and we think this a really solid protocol that was developed based upon inputs that we received from the FDA. So we actually took all the FDA's feedback into consideration in putting this protocol together. I think it's going to be a control trial, right, and with KEYTRUDA and as the control arm.

Speaker 5

That's very helpful, Frank. Thank you for that. And then I guess just well, maybe quickly on the 3,01 study with dose Axel, very intriguing. And I was just curious, what are the levels of translational data that you're looking to gather for that study. And then also, I guess, talking to the immune approach in combination with docetaxel, I guess, maybe you or Lauren can discuss sort of the approach that you're taking here because even going back years ago with data out of the Gully and Schlom Labs that talked about the benefit or lack thereof or what's best to do with regard to say concomitant dosing with docetaxel or sequencing or what have you.

Speaker 5

So Looking to get more info on the translational info. And then lastly, just curious since it's not discussed today, but it's always in the forefront of people's minds in the world is what's percolating in the background with regard to influenza? Thanks a lot.

Speaker 2

Really good questions, Joe. So I'll address the influenza and then I'll hand over to Lauren to address the translational studies with PDS-three zero one. So with the flu program, this program continues to progress under the NIAID Civics program. So Joe, as you know, it's and the most relevant to human results. So these studies in Pharos are currently ongoing with PDS-two zero two at the Civic selected centers.

Speaker 2

And so based upon what's going on now in those various studies, we will we do intend to provide an update when these results are available. And also once the clinical studies are confirmed by NIAID. So those studies are continuing to progress. Lauren, I'll hand over to you to discuss the translational studies for PDS-three zero one and with docetaxel.

Speaker 3

Great. Good morning and thanks for your question, Joe. So, your question is an excellent one. And one of the things that's coming out of Doctor. Madan's study is, there's actually concurrent dosing of PDS-three zero one and docetaxel.

Speaker 3

Specifically, there's also examination of different dose levels of PDS0301 in the docetaxel combination. And they're looking at both metastatic castration sensitive as well as castration resisting prostate cancer. The translational relevance here is that we really want to, 1, ensure the safety of the co delivery of the combination together. More importantly, since NHS IL-twelve is a tumor targeting immunocytokine, we really want to see if there are Differences in terms of the magnitude of immune responses and clinical outcomes that we see with different doses when it's delivered in combination with docetaxel. Our hope is that since we know docetaxel induces tumor necrosis that co delivery of PDS-three zero one could actually augment this tumor necrosis.

Speaker 3

From a translational standpoint, our interest is not only in the fact that PDS-three zero one is a Tumor targeting T cell immunocytokine, that we see augmentation of these tumor specific T cell responses, but also the possibility of augmenting natural killer cell responses to this combination therapy. So we're really looking forward to Doctor. Madan's presentation at cytokine 2023 and this would lead to building on further studies once we know what we see as as far as the clinical outcomes and the immune responses.

Speaker 5

Great. Thanks for all the color.

Operator

Next question today is coming from Louise Chen from Cantor Fitzgerald. Your line is now live.

Speaker 6

Hi, good morning and thank you for taking my Questions and congratulations on the quarter. This is Lucas Steffi on for Louise Chen from Canner. So I have two quick questions. I guess they're more Big picture strategyvision question. So first question is with regards to your VersaMune Platform, so you've had a lot of success to date leveraging it with PBS 101, 102, 3, 4, etcetera.

Speaker 6

So I guess like what is your vision for the future of developing the platform or how do you hope to expand on the And then the second question is if you could talk a

Speaker 7

little about your partnership with

Speaker 6

the NIH and If there's any like important developments there or how you see that progressing moving forward? Thank you.

Speaker 2

Thanks a lot. Two very good questions. So the Versumim platform is first be developed with PDS-one hundred and one. PDF-one hundred and one, we really see as a proof of concept study for the platform. Just based upon what's happened with the T cell activating technologies over the last couple of decades.

Speaker 2

We believe it's very important for us to really demonstrate this proof Strong proof of concept for the industry to really understand the potential of PDS-one hundred and one. So as you know, we've also performed preclinical studies with TDS-one hundred and two, which is utilizing the same platform in TARP specific Tumor, so these would address prostate cancer and breast cancer. We've also performed those preclinical studies with PDS-one hundred and three that addresses MUC1 positive cancer. So these are cancers like ovarian cancer, non small cell lung cancer, breast cancer and colon cancer. And in preclinical studies, we have demonstrated that we can generate the same levels of multifunctional tumor targeted killer T cells with each of these products, right.

Speaker 2

So really with the PDS-one hundred and one now, our goal is really to get this rapidly into commercialization. PDS-one hundred and one, as you know, addresses all types of HPV associated cancers. However, we have an initial focus on head and neck cancer, which is the largest and most rapidly growing of these HPV indications, Right. So as I mentioned, I think on the last call, we had a meeting with the FDA regarding the triple combination, which we intend to also move initially into head and neck cancer. We also have the studies ongoing currently at Mayo Clinic, which is looking at earlier stage as a neoadjuvant treatment in patients who have oral cancer ahead of their surgical removal of the lesions.

Speaker 2

So we're really looking to position strongly position PDS-one hundred and one, which is the first adverse immune based product We want PDS-one hundred and one to be synonymous with head and neck cancer treatment. And we believe based on our partnerships with the National Cancer institute what we do with Mayo Clinic that we will be able to successfully achieve this. We then also as you know have started studies in cervical cancer. The National Cancer institute actually looked at all types of HPV associated cancers. So we have very strong evidence that PDS-one hundred and one has potential far beyond just head and neck cancer, but broadly applied in HPV associated cancers.

Speaker 2

So as I mentioned, this is a proof of concept study and we do intend to move PDS-one hundred and two and one hundred and three also rapidly into the clinic. PDS-one hundred and three, as we mentioned on this call, we intend to file the IND for PDS-one hundred and three, which addresses MUC1 related cancers of MUC1 positive cancers to allow that to also go into the clinic after, so that will be the 2nd product coming after PDS-one hundred and one, Right. And also we also have a business development strategy, right. So we are looking to selectively and advantageously partner some of these programs to move them rapidly into the commercialization path, right? And so moving on to the second question you asked, Our partnerships with the NIH.

Speaker 2

So I think one of the key things that doesn't really become very obvious Very often is the importance of the partnership with the National Cancer Institute, partnerships with folks like MD Anderson and Mayo Clinic. These partnerships have come about after several years of many of these partners actually independently in preclinical studies, Our technology completely independent of PDF and convincing themselves that these technologies, our Versimmune technology as well as our antibody conjugated IL-twelve has the potential to significantly advance the science of clinical oncology. These Experts are looking for technologies that can advance clinical science. They're going to do their studies completely independent of what PDS is thinking. So from PDS or what PDS wants to see.

Speaker 2

So from PDS's perspective, we have to have enough confidence in our science and our technology that when we hand our technology over to experts such as the NIH, MD Anderson and Mayo Clinic that we are comfortable with them reporting whatever they find regarding our technology and our science. And so far as we can see from the results, right, they have provided strong validation, independent validation of the science and technology and the interest of these experts and key opinion leaders in actually transitioning this into from preclinical studies into human clinical trials and being interested in putting some of their own capital into progressing these trials is a very strong validation To date, we have 8 Phase 2 clinical trials ongoing and 5 of these trials are partnered with the National Cancer Institute. And so what you can see here is that based upon these partnerships And this buy in to the science that PDS Biotechnology is developing, we are able to progress a lot more clinical trials than we typically would, Right, at a significantly lower cost to PDS Biotechnology. So we are able to really advance these programs and what this allows us to do now is to understand how PDS-three zero one, for example, our tumor targeted IL-twelve, behaves in certain cancer solid tumors, how it synergizes with standard of care technologies, for example, combination.

Speaker 2

So this allows us then to look at the Phase 2 data, determine in which combinations and which indications we have the best chance to rapidly commercialize these products. So we see this relationship with the National Cancer Institute as a really strong validation. They are key experts in these fields and they also provide PDS with a lot of expert oversight and guidance in terms of how we design these trials In all things, what specific indications we look for. They have seen almost every technology that's been successful in oncology have actually gone through the National Cancer It's a very valuable relationship to PDF Biotechnology.

Speaker 6

Okay. Thank you very much for the answers and the color. No follow-up

Speaker 2

Thank

Operator

you. Next question is coming from Kapital from B. Riley Securities. Your line is now live.

Speaker 7

Yes. Hey, good morning and thanks for taking the question. First for the additional updates that you expect to report later this quarter, I believe you said. How many more months of follow-up should we expect for the 2 trial?

Speaker 2

So with PDS, you're talking about the Versedal 2 trial palpate, is that correct?

Speaker 4

Correct. Yes.

Speaker 2

Yes. So, I am not privy to the clinical data, but I am hopeful that when we provide the updates later this quarter, we'll hopefully have updates on the 12 month overall survival and hopefully also have an update on the 24 month overall survival. Those would be the 2 key updates that I would expect, especially since those were key for design of the Phase 3 clinical trial. As you know, the FDA is most interested in the overall survival and that's how the trial has been Those would be 2 key updates that I would be hopeful that we get right before the end of the quarter.

Speaker 7

Okay. And then based on your expectations of enrolling 90 to 100 sites in the Phase 3, Assuming let's assume you start in the Q4, when would you expect the interim analysis to hit the primary endpoint as well.

Speaker 2

So the interim the primary endpoint for the trial's overall survival, the planned interim analysis will be conducted after enrollment is complete and after a pre specified number of events have occurred. So since this endpoint is overall survival, the events will be death events a certain number of death events have to occur to meet either the interim endpoint or the final endpoint. And so Really the enrollment projections were informed by our CRO feasibility analysis and they estimate about an 18 to 24 month accrual period pending the actual enrollment rate and actual occurrence of these events. Right. So it's not very easy to predict exactly when that time will occur, but the initial interim endpoint will be Right after the completed enrollment for the trial.

Speaker 2

So that could be anywhere between an 18 to 24 month

Speaker 7

Okay, perfect. Thanks very much, Frank, for taking the question.

Speaker 2

You're welcome.

Operator

Our next question is coming from Leland Gershell from Oppenheimer. Your line is now live.

Speaker 8

Hi, thanks for taking our questions. I'm wondering, Frank and Lauren, what your view may be on Accelerated approval potential for PDX-one hundred and one in the Versatrial 3 study following the FDA draft guidance that came out in March, as you may be aware, with recommendations on development of drugs for Accelerated approval in oncology randomized trials such as Versatile 3 could use the ORR as a submissible endpoint for facility approval. So given the robust responses you've seen so far in that population, Wondering if there may be an opportunity for you to submit earlier ahead of the mature OS data and then use the OS data from 3 as confirmation of efficacy. Thanks.

Speaker 2

Leland, I'll take a stab at it and then I'll also hand over to Lauren to add to my response. So I think, Lynn, as you know, we do have fast track designation and we would like to take advantage of that to have more frequent discussions with the FDA as the data becomes available. So we do understand that Currently, the Versedile 2 data is extremely encouraging. And we are hopeful that if as we get to the interim data points, if the data looks anything close to what we're seeing currently with Versedal-two, that we'll have the opportunity to discuss an accelerated approval with the FDA. So even though overall survival is the primary endpoint, we also do have secondary endpoints such as objective response rates and PFS that we will be monitoring.

Speaker 2

But in head and neck cancer specifically, the FDA made it very clear to us Since objective response rates have not really correlated with overall survival, they are primarily interested in overall survival in head and neck cancer, right. And so that's why we powered this trial specifically for overall survival, But we'll definitely take advantage of the fast track to have discussions with the FDA earlier on as the data Lauren, anything you'd like to add to that?

Speaker 3

Yes. The only thing I'd like to echo Leland is that ultimately with accelerated approval like you mentioned a confirmatory trial is required. So while Versatile 3 is powered for the primary endpoint of overall survival, once we have our final data And follow-up from Versatile 2 next year and also have those final overall survival rates for 12 months 24 months as well as the objective response rates, that will be another opportunity for discussions with the agency in terms of additional accelerated approval discussions.

Speaker 2

That's all.

Speaker 8

Okay. That's helpful. And then with respect to MUC1, when might we see initial data from the MUC1 study?

Speaker 2

Well, we have not actually started that study yet. So at this point, I will not provide any timelines as to when we're going to see data. We are hopeful that we will file the IND by the end of this calendar year, which will allow us to get the clinical trial going probably by early next year. And so it's once we have more clarity on exactly what the clinical design is going to look like, we'll be able to provide more information on when we should expect to see data. So hopefully on the next call, we'll have some more clarity around that question.

Speaker 8

Thanks for taking the questions.

Speaker 2

You're welcome.

Operator

Thank you. Next question is coming from Robert Laboyre from NOBLE Capital Markets. Your line is now live. Good

Speaker 9

morning. Just one more follow-up question on the design of Versatyl 3. And in the interim analysis, OS and PFS had been mentioned previously. Is PFS Still going to be an interim analysis factor or endpoint that you can discuss with the FDA?

Speaker 2

We will certainly be collecting the PFS information, but both the interim and The final endpoints have been powered for overall survival.

Speaker 9

Okay. And one question on the triple combination. You had mentioned that The design of the Phase 3 was in progress. Any timing on the submission of an IND for that for the start of the Phase 3?

Speaker 2

So with that trial specifically, we are waiting to get so This is going to be, as I mentioned, in patients' checkpoint refractory head and neck cancer. And checkpoint refractory head and neck cancer is the indication that we're evaluating in the second arm of the Versed IL-two study. And so As we mentioned on the last call, we expect that this quarter we will be obtaining initial information from the first 21 patients who are being treated the first 21 checkpoint refractory head and neck cancer patients in the Versedile 2 trial. Primarily what we're looking for from that trial is overall survival and how it impacts and how treat additional PDX-one hundred and one to Keytruda may allow those patients to respond and continue to survive. That information is going to be critical together with the information we have from the triple combination trial to design the final what we intend and hope to be a registrational study.

Speaker 2

One of the things we will do with that Design is something very similar to what we did with KEYTRUDA, really maximize our interactions with the FDA, get the FDA's feedback. We would like to understand what key elements the FDA would like to see in that trial to allow it to be a registrational trial, right? And so that's interaction that we expect to be having with the FDA, Probably starting later this year. And so based upon those interactions and getting a really good understanding of what they would like to see in that trial to make it operational, we'll then be able to then project exactly when we start. But we would like to initiate those get the initial protocol done and start those interactions with the FDA before the end of this year.

Speaker 9

Okay. Thank you very much.

Speaker 2

You're very welcome.

Operator

Thank you. Next question is coming from James Molloy from Alliance Global Partners. Your line is now live.

Speaker 10

Hello. This is Laura Suriel calling for Gemaloy. Thank you for taking the questions. So for the Phase 3 versatile 3 trial, with it being set to be initiated by the end of the year. If it's not too early to tell, when do you think you might complete enrollment here or announce a first look or interim data?

Speaker 2

As we discussed earlier, that timing is we expected based upon what the potential enrollment projections are. So we looked at what our CRO projected enrollment could potentially be for the various sites and also based upon the actual accrual and occurrence of the events that we expect to see for the trial, we anticipate that the enrollment could take anywhere between 18 to 24 months to be completed. And at that point, we would then have our 1st interim analysis.

Speaker 10

Got it. And then also for the NCI led Phase 2 trial of 3,01, when might we get additional data for this trial following the cytokine meeting that's going to be held this October and some of the other timelines here as well.

Speaker 2

I'll hand that question over to Lauren since she has more information on that trial.

Speaker 3

So as it relates to the NCI triple combination study that examines TDS-one hundred and one or 301 and

Speaker 2

I think, Lauren, I think that was the docetaxel trial.

Speaker 3

Okay. I thought there was interest in updated data. So I just wanted to highlight the fact that there will be updated survival data before the end of this quarter. And then following the cytokines meeting presentation, I think there will be additional discussions in terms of further expansion of the study at the dose levels of PDS-three zero one and docetaxel that yielded optimum tolerability as well as immune responses that are being examined and that will be presented in cytokines 2023.

Speaker 10

Got it. Thank you for taking the questions.

Operator

Thank you. We have reached the end of our question and answer I'd like to turn the floor back over for any further or closing comments.

Speaker 2

Well, thank you very much, Lauren and Matt. And to our attendees, we very much Appreciate you joining our Q2 earnings conference call today. This quarter's progress has been truly exciting and we remain enthusiastic about what lies ahead for the rest of the year. Before concluding the call, I would like to mention that we are planning a key opinion leader event in the near future. The webcast will include experts who will provide their perspectives on PDS-one hundred and one, Any data updates and its potential in the treatment of advanced head and neck cancer.

Speaker 2

Please look out for more details as we get closer to the event. As you have seen from our press releases and as I have reiterated here on this call, we are excited to share the many data readouts that are on the horizon and that holds significant promise and potential value to our investors. We have made great strides on the path to achieve our goal advancing a paradigm shift in the way head and neck cancer is treated with a potentially well tolerated, safe and effective treatment that extends the survival of advanced head and neck cancer patients. We strongly believe that in the very near future, These patients who have a critical unmet medical need will live longer and have a higher quality of life as a result of the work we're doing here today. Thank you very much for your continued support, and we look forward to updating you on our progress.

Speaker 2

Thanks a lot.

Operator

Thank you. That does conclude today's teleconference webcast. You may disconnect your line at this time and have a wonderful day. We thank you for your participation today.

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Earnings Conference Call
PDS Biotechnology Q2 2023
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