Hello, and welcome to the PDS Biotechnology First Quarter 2021 Earnings Call and Webcast. [Operator Instructions]. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Deanne Randolph. Please go ahead..

Good morning, and welcome to PDS Biotechnology's First Quarter 2021 Earnings Conference Call and Audio Webcast. With me today are Dr. Frank Bedu-Addo, Chief Executive Officer; Dr. Lauren B. Wood, Chief Medical Officer; and Dr. Seth Van Voorhees, Chief Financial Officer.

Earlier this morning, PDS Biotech issued a press release announcing financial results for the quarter ended March 31, 2021. We encourage everyone to read the press release as well as PDS Biotech's quarterly report on Form 10-Q, which will be filed with the SEC later today.

The company's press release is available on PDS Biotech's website at pdsbiotech.com, and the quarterly report will be posted later today. In addition, this conference call is being webcast through the company's website and will be archived there for future reference.

Before we begin, I would like to caution listeners that comments made by management during this conference call will include forward-looking statements within the meaning of federal securities laws, including the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

These forward-looking statements involve material risks and uncertainties, and the company's actual results may differ materially.

For a discussion of these risk factors, including, among others, the risks related to COVID-19, the impact such pandemic may have on the company's business operations, financial operations and results of operations and the company's ability to respond to the related challenges, including those noted in this morning's press release, please refer to PDS Biotech's SEC filings.

Investors, potential investors and other listeners are urged to consider these factors carefully in evaluating the forward-looking statements and are cautioned not to place undue reliance on such forward-looking statements.

Please note that the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, May 13, 2021. Except as required by law, the company undertakes no obligation to revise or update any statement to reflect events or circumstances that take place after the date of this call.

Following today's prepared remarks, we will open the discussion for a question-and-answer session. With that, I would now like to turn the call over to Dr. Frank Bedu-Addo.

Frank?.

Thank you, Deanne, and thanks to everyone on the call today. 2021 has so far been an exciting year for PDS Biotech. The company has continued to advance clinical development of our Versamune-based immuno-oncology pipeline through key initiatives and we are making significant progress with our clinical trials.

Since we last spoke to you on our fourth quarter call, we have made further progress with our ongoing Phase II clinical trials as well as with our preclinical pipeline products. Our lead oncology candidate, PDS0101, as you may recall, is currently being studied in 3 Phase II clinical trials in advanced HPV-associated cancer.

The most advanced of these trials is a National Cancer Institute-led study evaluating a novel triple immunotherapeutic combination of PDS0101 with 2 of EMD Serono clinical-stage immunotherapies, bintrafusp alfa or M7824, which is a bifunctional checkpoint inhibitor and NHS IL-12 or M9241, which is an immuno cytokine.

This triple combination is being evaluated in HPV16 positive relapsed or refractory advanced HPV-associated cancers. And these include anal, cervical, head and neck, vaginal and vulva cancers. This population is a well-documented and difficult-to-treat patient population in which more refractive therapies are desperately needed.

In January, we announced that this National Cancer Institute-led trial have achieved its preliminary efficacy benchmark with 3 or more of the first 8 patients, which approximates at least 40% achieving tumor regression.

This benchmark represents a doubling of the response rates seen in this population of refractory patients with standard-of-care checkpoint inhibitors and at least a 30% increase over the results reported with the most promising experimental agents in this population to date, which is bintrafusp alfa.

As a result of the significant preliminary efficacy achievement, a second arm was opened up to study the combination in refractory HPV16 positive patients who have, in addition, also failed treatment with checkpoint inhibitors.

In this population, who have few options, the treatment response rate is only about 10%, with a medium survival time of about 3 to 4 months.

A few weeks ago, we announced that more mature interim data from this triple combination trial has been accepted for oral presentation on June 7 of the 2021 American Society of Clinical Oncology, also known as ASCO, annual meeting. As you may know, it is quite uncommon for Phase II trial interim data to be selected for oral presentation.

We are hopeful that the promising data from the ongoing trial will demonstrate the potential of the platform in oncology and PDS0101, in particular, in the treatment of advanced HPV-related cancers. We look forward to sharing the data with the scientific and the investment communities.

The most critical limitation to effective cancer immunotherapy has been the ability to induce in the body large numbers of potent tumor-attacking killer T-cells that can infiltrate and kill tumor cells.

A recently published preclinical study of the novel triple combination by the National Cancer Institute demonstrated the ability of PDS0101 to promote the induction of large numbers of tumor-infiltrating killer T-cells, when administered in combination with either bintrafusp alfa or M17 -- or M9241 or as a triple combination.

Most importantly, the study revealed that Versamune had effectively recruited a large number of killer T-cells and primed these T-cells to specifically recognize target and kill HPV16 positive cancers, leading to superior regression of advanced tumors with the triple combination.

The ongoing National Cancer Institute-led study seeks to study this triple combination in humans.

Successful translation of the results from preclinical to human will be significant and could provide a demonstration of the potential of the Versamune-based immunotherapies to overcome one of the major limitations inhibiting broader efficacy of cancer immunotherapy.

As I already mentioned, the interim data from this trial will be presented by the National Cancer Institute at the ASCO Conference next month in an oral presentation. Our second trial is the PDS Biotech-initiated VERSATILE-002 trial.

As with the NCI-led trial, we are seeking to confirm the strong synergy between PDS0101 and checkpoint inhibitors demonstrated in preclinical studies.

VERSATILE-002 is a multicenter, open-label, single-arm, non-randomized trial of approximately 96 patients, evaluating the combination of PDS0101 with the anti-PD-1 checkpoint inhibitor, pembrolizumab, also known as KEYTRUDA. This combination is being evaluated in first-line treatment of recurrent or metastatic head and neck cancer.

Our partner, Merck, is providing the drug and also sits on the joint steering committee for the trial, while PDS Biotech has responsibility for the day-to-day management and financing of the study.

We believe that the combination of PDS0101 and KEYTRUDA, which is FDA-approved as standard-of-care in this indication has the potential to provide significantly improved clinical benefit compared to treatment with KEYTRUDA alone.

This means that patients whose cancer has returned or spread following initial treatment will be able to take this chemotherapy sparing combination of 2 immuno-oncology agents, an approach that may be very appealing to patients.

Patients are actively being screened and enrolled at multiple sites in the United States, and we anticipate that preliminary data will potentially be available late in the fourth quarter of 2021 or during the first half of 2022.

Similarly to the triple combination trial, a successful trial of KEYTRUDA with PDS0101 that confirms the published preclinical data could justify the evaluation of several of our pipeline products with checkpoint inhibitors. Moving on to the third trial, the IMMUNOCERV trial.

The MD Anderson-led IMMUNOCERV trial is a Phase II trial of PDS0101 in combination with standard of care chemoradiotherapy or CRT for the treatment of locally advanced cervical cancer. The study will investigate the safety and preliminary efficacy outcomes of this combination. We announced the initiation of the study in October.

This study is based on the observation by MD Anderson Cancer Center that cervical cancer patients with tumor infiltrating T-cells may have a better clinical outcomes after CRT treatment.

The study is also actively recruiting and enrolling patients, and we anticipate that preliminary data will be available during the fourth quarter of 2021 or during the first quarter of 2022. Dr. Lauren Wood, our Chief Medical Officer, will provide additional details about our ongoing clinical trials shortly.

As I have mentioned before, based on the potential for a unique combination of potency and safety, suggested by our Phase I clinical trial, 2 of our 3 Phase II trials combined PDS0101 with standard-of-care, that has been FDA-approved and shown to be effective in the specific indications.

Now based on the observed efficacy of the PDS0101 monotherapy with respect to CD8 T-cell induction and regression of CIN lesions observed in the Phase I clinical trial, we believe that this ability to combine PDS0101 with FDA-approved standard-of-care mitigate development risk.

In addition, if the studies demonstrate significantly enhanced clinical benefits over the standard-of-care alone, without compounding toxicity, we believe that this will present a clear and more rapid path to commercialization of the combination.

After initial commercial approval, our strategy of evaluating PDS0101 in all HPV-associated cancers as well as combining PDS0101 with standard-of-care, we believe also positions us for rapid market penetration and expansion. I'll briefly discuss the target markets for PDS0101.

As some of you already may know, the HPV cancer market is large and is expected to remain robust for the next several decades despite the use of preventive HPV vaccines, first introduced in 2006. There are currently about 43,000 new incidences of these cancers every year in the United States alone.

HPV-associated cancer continues to present a critical medical concern, as some of these cancers continue to be on the rise. HPV-associated head and neck cancer, for example, has recently been described as a silent epidemic due to the rapidly increasing incidents of this cancer. Anal cancer incidents has also been steadily increasing.

By far, the vast majority of these cancers are caused by HPV16, which is the most oncogenic type of HPV. Next, I'll provide an overview on the continued development of our oncology pipeline.

PDS0102 combines the Versamune platform technology with the proprietary tumor-specific protein or antigen known as T-cell receptor gamma alternate reading frame protein, also known as TARP or T-A-R-P.

TARP was identified by the National Cancer Institute and is strongly associated with prostate and breast cancers as well as acute myeloid leukemia or AML. It is estimated that TARP is associated with almost 400,000 cancers each year in the United States, including 90% of prostate cancers, 50% of breast cancers and 100% of AML.

AML is a particularly deadly disease with a 5-year survival rate of less than 30%. In a human clinical study in prostate cancer patients, the TARP antigen was found to be highly immunogenic in the patients, leading to a significant reduction in the tumor growth rates.

In preclinical studies conducted at PDS Biotech, PDS0102 demonstrated the ability to dramatically enhance the induction of in vivo TARP-specific CD8 killer T-cells. The majority of the preclinical work for PDS0102 has been completed, and our goal is to move PDS0102 into the clinic next year. Also in late clinical development is PDS0103.

In April of 2020, we announced the expansion of our Cooperative Research and Development Agreement, or CRADA, with the National Cancer Institute to include studies of PDS0103, which combines the Versamune technology with novel peptides derived from the cancer-associated protein known as MUC1.

These novel proprietary and highly immunogenic peptides were developed by the Lab of Tumor Immunology and Biology of the National Cancer Institute. MUC1 is expressed in a wide range of solid tumor types, including breast, colorectal, ovarian and lung cancers.

In preclinical studies conducted at PDS Biotech, PDS0103 has demonstrated the ability to generate powerful in vivo MUC1-specific CD8 killer T-cells.

In humans, due to Versamune's ability to effectively promote important immunological processes and to activate the type I interferon signaling pathway, we anticipate strong in vivo tumor targeting CD8 T-cells that may present the potential to more effectively treat MUC1 expressing tumors.

As part of our collaboration with the National Cancer Institute, the institute is performing preclinical combination studies of the clinical formulation of PDS0103 with other immunotherapeutic agents ahead of the planned human clinical study next year. Moving on now to our infectious disease pipeline.

This March, we announced that the COVID-19 vaccine consortium consisting of PDS Biotech, Farmacore Biotechnology and Blanver received the commitment from the Ministry of Science, Technology and Innovation of Brazil, the MCTI, to fund up to approximately USD 60 million to support the clinical development in commercialization of a Versamune-based COVID-19 vaccine in Brazil.

PDS Biotech will be providing Versamune for the program, and our partner, Farmacore is responsible for manufacture of the antigen and also for performing the human clinical trial in Brazil. Farmacore is in active discussions with ANVISA to progress the clinical program in Brazil.

Farmacore have indicated to PDS Biotech that they plan to begin the combined Phase I/II trial before the end of the year. I'll move on now to PDS0202, which combines Versamune with novel influenza vaccine antigens in a preclinical universal flu vaccine.

We announced last year that PDS Biotech's collaborator, Professor Jerold Woodward of the University of Kentucky School of Medicine was awarded a grant from the NIAID to support preclinical development of this program. Dr.

Woodward initiated those studies earlier this year in partnership with the collaborative influenza vaccine innovation centers network of the NIAID to develop a more durable, broadly protective and longer-lasting vaccine, effective against multiple strains of influenza, specifically including pandemic strains.

We anticipate results from those studies and a clinical formulation will be available by the end of the calendar year. Now I'd like to pass the call to Dr. Lauren Wood, who will provide more comprehensive clinical updates for both our oncology -- for all our oncology programs.

Lauren?.

Thank you, Frank. And once again, thanks to all of you for joining us this morning. As Frank just detailed, we have made significant progress in our oncology pipeline since our fourth quarter call. I'll begin with our ongoing oncology clinical trials.

The investigator-initiated study of PDS0101 in combination with bintrafusp alfa, also known as M7824, a first-in-class bifunctional checkpoint inhibitor and M9241, an antibody conjugated cytokine designed to facilitate entry of the cytokine IL-12 into the tumor microenvironment and to enhance the local T-cell response was initiated in June 2020 with encouraging and faster than projected initial approval despite the COVID pandemic.

This NCI-led study was a result of independent preclinical animal studies conducted by the NCI, which showed strong synergy between the 3 agents. Specifically, the triple combination resulted in enhanced antitumor activity when compared to treatment with the individual agents or with dual combinations of these agents.

The details and findings of these preclinical studies were published last year in the June 2020 issue of the Journal for ImmunoTherapy of Cancer, also known as JITC.

We previously announced that this investigator-led study achieved both its initial safety benchmark, meaning that fewer than 2 dose-limiting toxicities were observed in the first 6 patients who received the triple combination and its initial efficacy benchmark.

The initial observation of objective response in 3 or more of the initial 8 patients indicated that the triple combination was at least 2x more, 100% more effective in reducing tumor burden compared to the standard of care outcomes in this patient population to date. As a reminder, this patient population is very difficult to treat.

The best objective responses reported to date in advanced HPV cancer patients who have failed prior therapies is 12% to 24%. Many of these patients have failed multiple treatments before enrolling in the NCI-led trial.

With the achievement of this initial efficacy threshold, the NCI has added a second arm to the trial to explore the effectiveness of the triple combination in patients who have failed checkpoint inhibitors, raising the bar significantly. Advanced HPV cancer patients who have failed checkpoint inhibitor therapy have very few treatment options left.

The highest objective response rates reported to date in this population who, in addition, have failed checkpoint inhibitor therapy are generally 10% to 15%. Dr.

Julius Strauss, the principal investigator of this trial will be presenting more mature data from the study at the upcoming 2021 Annual Meeting of the American Society of Clinical Oncology in early June.

ASCO is arguably the world's preeminent oncology meeting, and we were thrilled to learn that those data have been accepted for oral presentation as part of the main program. As you know, there are tens of thousands of abstracts submitted to ASCO each year, and only a handful of those are selected for oral presentation.

We believe that these data were selected because of the historic difficulty in treating this patient population and the compelling interim data from this trial. Patients often come to the National Cancer Institute when they have exhausted all other treatment options.

Advanced HPV cancer patients enrolled in this study have failed multiple therapies, and we believe that PDS0101's published preclinical efficacy, when combined with these 2 immunomodulating agents demonstrates the potential to significantly improve clinical outcomes for patients with advanced and currently untreatable HPV-associated cancers.

Now on to the PDS-sponsored VERSATILE-002 study. As Frank discussed during his remarks, activation of sites and enrollment in VERSATILE-002 continues to progress, and we currently have 14 sites open to enrollment. As a reminder, The primary endpoint of VERSATILE-002 is the objective response rate or ORR at 9 months following initiation of treatment.

There will be a leading cohort of 12 patients to assess safety of the combination and a formal planned interim analysis, evaluating response to treatment in the first 38 patients. We estimate the data on the initial 12 subjects for safety will be available sometime between the fourth quarter of 2021 or the first half of 2022.

The study's lead principal investigator is Dr. Jared Weiss, who serves as the Section Chief of Thoracic and Head and Neck Oncology at the University of North Carolina School of Medicine, Lineberger Comprehensive Cancer Center, and we're thrilled to have Dr. Weiss involved in this study.

Moving now to the MD Anderson-led Phase II clinical trial of PDS0101 in combination with standard-of-care chemoradiotherapy for treatment of locally advanced cervical cancer, also known as the IMMUNOCERV study. This study will enroll approximately 35 patients and investigate the safety of the combination and preliminary oncologic outcomes.

In addition, it will explore immune priming by PDS0101 as well as other biomarkers of immune response in both blood and tumor tissue. We believe that PDS0101's demonstrated ability to activate the immune system and induce tumor-targeting killer T-cells may provide improved outcomes to patients with cervical cancer.

Preliminary data from this trial, we anticipate will be available sometime between Q4 2021 and early 2022. The study is being conducted by Dr. Ann Klopp MD PhD and Associate Professor of Radiation Oncology at the MD Anderson Cancer Center. Moving now to our infectious disease program and the planned clinical trial of our COVID-19 vaccine, PDS0203.

If approved by ANVISA, the randomized, placebo-controlled Phase I/II study will evaluate safety, immunogenicity and preliminary efficacy of PDS0203 in approximately 360 healthy adults. Patients in the study will receive 2 doses of PDS0203, administered 3 weeks apart.

Study participants will be divided based on age with an 18 to 55 age group and a greater than 56 years of age group. Low dose and high-dose vaccine or placebo will be tested in each of these age groups. Initial evaluations of efficacy will be conducted starting 14 days following receipt of the second dose of vaccine.

Specifically, we're seeking to characterize safety, reactogenicity and validate the induction of SARS-CoV-2-specific neutralizing antibodies as well as CD8 killer and CD4 helper T-cells directed against SARS-CoV-2.

Our co-development partner, Farmacore will be meeting on a regular basis with regulatory officials from ANVISA to review ongoing data from the Phase I/II trial in an effort to react as quickly as possible to results.

Contingent upon release of funds by the Brazilian MCTI, if the Phase I/II study successfully establishes both safety and efficacy, we are prepared to scale up into a Phase III trial to confirm PDS0203's effectiveness in preventing COVID-19 infection.

One of the planned analyses in the Phase III design is the assessment of efficacy against variants of the virus. The robust T-cell induction by Versamune may potentially provide protection against currently circulating variance of concerns.

PDS0203 is being designed to induce an immune response against conserved regions present in SARS-CoV-2 and to specifically generate long-term T-cell memory, To serve regions of the virus are those that remain stable despite ongoing viral mutations. I would now like to turn the call over to our CFO, Dr.

Seth Van Voorhees, to review our first quarter 2021 financials.

Seth?.

Thank you, Lauren, and good morning, everyone. I'd like to turn our discussion to a review of our financial results for the quarter ending March 31, 2021.

For the first quarter of fiscal '21, our loss from operations was approximately $3 million versus a loss of approximately $4 million during the same period in 2020, or a net loss of $0.14 per basic and diluted share compared to a net loss of $0.39 per basic and diluted share for the first quarter of 2020.

Research and development expenses totaled approximately $1.4 million in the first quarter of 2021 as compared to $2 million for the first quarter in 2020, a decrease of approximately $0.6 million or 28%.

For the first quarter of 2021, general and administrative expenses were approximately $1.6 million compared to approximately $2.1 million for the same period in 2020, a decrease of approximately $0.4 million or 19%.

From a cash flow perspective, we started 2021 with approximately $28.8 million of cash and used approximately $3.8 million in our operations in the first quarter of 2021, leaving us with a cash balance at the end of the period of approximately $25 million.

Our business strategy allows us to keep our cash burn at relatively low levels as demonstrated by our first quarter results.

This strategy utilizes the cash we raised from the capital markets on our oncology development programs, while continuing to develop our infectious disease products through non-dilutive financing sources or out-licensing agreements.

In addition, 2 of the 3 oncology clinical trials, currently underway, are investigator-sponsored studies, which involve low levels of financial commitment from PDS, while at the same time, maintaining 100% ownership of the commercial rights of the Versamune products being investigated.

As a consequence, we are able to utilize our cash resources in a most efficient manner to create value for our shareholders. Thank you for your time today. And I'd like now to turn the call back to Frank for final remarks..

Thank you very much, Seth and Lauren. Before we begin our question-and-answer session, I would like to thank our stellar team members here at PDS Biotech and all of our clinical partners for their untiring work.

It is an exciting time at PDS Biotech with the potential of having some solid initial proof-of-concept data for our Versamune platform in oncology next month.

It is through their dedication and the expertise of our team that we have been successful in significantly progressing 3 active PDS0101 Phase II clinical trials in oncology, while also continuing to develop our preclinical pipeline.

The data now being generated from our ongoing clinical trial programs will serve as the foundation to allow us to build our Versamune-based pipeline into the next generation of cancer immunotherapies as well as novel vaccines that may induce a broader range of protection against infectious diseases. That concludes our prepared remarks.

Operator, please begin our question-and-answer session..

[Operator Instructions]. Our first question today is coming from Joe Pantginis from H.C. Wainwright..

I have two sets of questions, and I'd like to start with the COVID platform, first. Obviously, you have a very defined program in Brazil and the funding to go along with it. And I guess, I wanted to approach my question this way.

How can we view as the importance of T-cells continues to increase in visibility, further potential reach -- I'm sorry, geographical reach of the program. And I'm thinking specifically of all the volatile environments and the significant problems that India is having and discussions about freeing up intellectual property for other vaccines.

It's just a very dynamic environment. So I guess I just want to get a sense of potential geographical reach that you might be working on..

Well, Joe, thank you very much for your question. This is Frank. And I think one of the -- I wouldn't call it a challenge, but one of the facts of the matter is that, this program, we anticipate, as it continues to build up, that it will become more and more visible.

One of the key things that you did mention that's becoming very prevalent today is the key role or importance of T-cells in robust immunity against COVID-19.

One of the things that we have mentioned quite often is the fact that we believe very strongly that the next generation of COVID-19 vaccines should be able to demonstrate robust T-cell responses, importantly, against conserved regions of the virus because we know today that this virus has a very high propensity for mutation, and therefore, being able to generate or develop a vaccine that can provide a broader range of protection becomes very important.

Now we continue to focus on our oncology pipeline. We are providing support to Farmacore in terms of Versamune expertise, but they have the responsibility for developing this vaccine and performing the human clinical trials in Brazil, specifically.

So in terms of the regional components, the trial now is really going to be performed in Brazil by Farmacore. However, I think once that data does become available, the initial data does become available, PDS retains the right to be able to develop the vaccine as we see fit, right? So we will continue to evaluate the situation as it progresses.

And as data becomes available, hopefully, we will be making the appropriate decisions and determine where to go from there. And one of the things that we've also mentioned right from the start is our goal isn't really to rush to be one of the first to market, right? We've called this a second-generation COVID-19 vaccine.

What we would like to do here is to develop a vaccine that has the attributes that are critical for a successful global COVID-19 vaccine. That means it must achieve or have certain critical characteristics. It should have induced a broad range of immune responses.

So not only neutralizing antibodies, but very importantly, CD8 and CD4 T-cells as well as memory T-cells that recognize conserved regions of the virus. Secondly, it should be stable, should have long-term stability, overcoming the cold chain situation that we see with a number of the vaccines today.

And very importantly, it should be safe and very well tolerated. And we believe the diverse immune-based COVID-19 vaccine checks each of these boxes. And so the goal is really to develop this and really make sure that we have something that is highly competitive in the global markets today..

That's actually really helpful. And thanks for reemphasizing having the second-generation and not necessarily rushing. So thanks for restating that again. My second question has to do with 0101. It's really 2 parts. The first part is a logistical question, saying, obviously, we'd love to know the data, but I can't wait till ASCO.

But I guess, can you share with us sort of the general or range of number of patients that we can expect data on and any sort of translational data that might be presented as well, just the types of and scope of data..

Sure. So the abstract will be made available by ASCO on May 19. So you won't have to wait too long to get an insight into what the data looks like. But I think it's going to be in the range of, I would say, probably around 20 to 25 patients. So it will be at least, I would say, approximately midway through the full trial.

So I think it will be a robust enough data package that would give us some very good insight into what's actually going on with the triple combination in these patients..

Got it. Got it. And then the second part is, and this goes to some of your prepared comments and also something that we've discussed before with you. And that is one of the key challenges in IO studies or IO combination studies is how to tease out the impact of a particular asset, in this case, Versamune.

So with 0101, as part of your prepared comments, you certainly talked about the preclinical data and study that the NCI have done with regard to the significant increases in the CD8 T-cells.

Now I guess, how does -- you guys have given some of your views, and I'd like for you to repeat it, but also how does the NCI view this? Like you said, these are patients that no longer have any options and the NCI's view of the true importance of the significant boost in CD8 T-cells that can infiltrate the tumor and any perceived risks around, again, the concept I started with about teasing out the individual contribution?.

Right. No, that's a really good question, very important and something that we have spent a lot of time discussing. And so without really going into the specifics of the data, I think the way the trial was run and the patient population addresses some of these questions.

And hopefully, in the next couple of weeks, we will be able to delve much deeper into the data and really answer some of those questions. But we are quite confident that a lot of these questions are addressed in the data package that will be released in the next few weeks..

And can I -- Joe. So the other thing that I'd like to add is, is that, your question is very timely. And we believe one of the strengths of the NCI trial is, is that this same group was responsible for conducting the Phase I/II study of bintrafusp alfa M7824 monotherapy in the HPV-advanced cancer population.

And there, they saw objective response rate of approximately 30%. Importantly, this same group also conducted the Phase I trial of the immune targeting cytokine M9241, NHS IL-12. There, they saw 0 objective response rates in that human clinical trial. Although, they do see 5 or 6 patients that had stable disease.

So I think the NCI Group is uniquely positioned to be able to evaluate the activity and the efficacy preliminarily of this triple combination because they did the monotherapy studies of the individual investigational immunotherapeutic agents, apart from PDS0101.

And so again, as we highlighted earlier during our comments, it was quite impressive in terms of the preclinical data. Clearly, dual combination therapy was superior to monotherapy in the preclinical studies and clearly triple combination therapy was superior to the dual combination therapy.

So in the context of that preclinical translational background, we anticipate that we will see more potent outcomes with the triple combination in humans and then have to evaluate those outcomes in the context of what's already been documented with treatment with the monotherapy agents. And the NCI Group is well-poised to be able to comment on that..

Got it. And what I think is a real important benchmarking and looking forward to the data..

[Operator Instructions]. Our next question is coming from Leland Gershell from Oppenheimer..

Congrats on all the great progress.

I wanted to ask on the VERSATILE study, once we begin to see data from that and as you contemplate further development, sort of a regulatory question, how you would see a registration study design? I mean, would that be kind of KEYTRUDA plus/minus 0101? Would we need to have survival data for approval? Could you file off of response rate? Maybe just give us some color on your thoughts there for what that would look like? And then also a question on the COVID-19 side, just kind of maybe teeing off of dose question, just more in a focused way? Are there any gating factors that we're waiting for from ANVISA? Or is it just a process as a review and kind of complete their assessment for the trial to begin?.

Lauren, do you want to take the VERSATILE question? And then after you're done, I'll address the COVID question..

Great. Yes. So thanks for your question. We do anticipate that the FDA would want to see a randomized Phase II trial that was blinded for a registrational trial. They made it pretty clear in the statement of July of 2018 that they really want to see randomized trials that definitively established activity of the agents.

And so as you mentioned, it would likely be KEYTRUDA with and without PDS0101 in a randomized trial. We clearly would be going for primary endpoints of objective response rate, first and foremost. Our target objective response rate for the VERSATILE-002 study is 33%.

So as people may be aware, with pembrolizumab monotherapy in the KEYNOTE-048 study, the objective response rate is approximately 20% and those who have adequate tumor marker expression of PD-L1. 20% is 1 in 5 patients.

And the goal of the VERSATILE-002 study is to see objective response rates of 33% or more, which moves the needle from 1 in 5 patients responding to 1 in 3 patients responding. So objective response rates would be the primary outcome, probably also accompanied by duration of response as a key secondary endpoint and then subsequently overall survival.

We believe those would be the 3 major endpoints in a randomized trial that the FDA would be considering. Of course, the design of any trial is going to be driven by the objective data that's observed in our VERSATILE-002 study.

And so there may be flexibilities for adaptive trial designs, depending upon what the data should -- yes, would be the most efficient regulatory pathway to proceed with. But we believe....

So Leland, does that address your question before I move on to COVID?.

That's helpful, Frank. Please go ahead..

Okay, thanks. So regarding any gating items that are necessary to get the trial going. So as I mentioned in my remarks that Farmacore is responsible for the manufacturing of the antigen that's going to be used in the trial. PDS will be providing Versamune. The Versamune is ready to go.

And Farmacore is in discussions with ANVISA, which is their regulatory agency, regarding providing a final package prior to entering into human clinical trials. Completion of their manufacturing process is going to be important in the final documents that are provided to ANVISA.

So as we -- as far as we understand it today, that would be a key gating item in their discussions with ANVISA, given them the green light to initiate human clinical trials, getting the manufacturing done and providing what we would call in the -- with the FDA, our CMC package or the IMPD package to allow them to initiate those clinical trials..

Got you. Okay. That's helpful. And then one last question, if I may. I mean given the potential for the Versamune platform and a lot more that could be done versus your bandwidth.

Just kind of curious if you may see kind of partnerships or sort of deals with third-party companies materialize down the road, as others become more and more aware of the potential of the platform and what they may be able to bring to bear with regard to incorporating that with their own strategies as obviously, you move forward with your core programs..

Yes. No, that's very important. So as you may notice, our primary focus is immuno-oncology, right? And that's really one reason why our infectious -- the 2 infectious disease programs actually being run pretty much 100% by the partners.

We will probably never have the resources we need to really develop all the products we could potentially develop with Versamune in immuno-oncology. Now our current Phase II clinical trials provide a very important proof of concept in immuno-oncology.

And we believe that this is going to be very critical for our rapid expansion and growth in terms of developing these immuno-oncology products. This proof of concept, the first real proof-of-concept data is what's going to be presented at ASCO next month.

And so we anticipate that, that would provide a springboard to really start the second portion of our business plan, which is to partner with other companies developing immunotherapy. So other companies will have suitable antigens that we could combine with Versamune to develop some of these more reflective T-cell activating immunotherapies.

But what you said is absolutely correct.

The proof-of-concept data that we are currently generating with these multiple Phase II clinical trials is really what the industry needs to see to confirm or validate the potency and the potential of this technology to be utilized in multiple immunotherapies and also, very importantly, in partnerships with other companies to build out these programs..

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

Thank you very much, and thank you very much to all for your continued interest in PDS Biotech. We believe that 2021 will continue to be an exciting year for the company. We have multiple ongoing clinical trials of PDS0101 in various advanced HPV-associated cancers.

And as I mentioned, interim data from our most advanced proof-of-concept Phase II trial will be presented on June 7 at the ASCO Conference in an oral presentation. The presentation abstract will be made publicly available by ASCO on May 19.

We anticipate that interim data will provide validation of Versamune and PDS0101's potential to overcome the critical limitation of immunotherapy by activating large numbers of potent tumor-targeting killer T-cells in vivo and therefore, facilitating more effective therapy.

We anticipate that this will also provide a springboard to focus primarily on building out our oncology pipeline and also to partner with other companies to accomplish this goal. We appreciate your ongoing support in this pursuit. For more information about the company and our ongoing clinical trial, please visit our website at pdsbiotech.com.

Thank you very much again..

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