PDS Biotechnology Corporation (PDSB) Q3 2020 Earnings Report, Transcript and Summary

Greetings. Welcome to PDS Biotechnology's Third Quarter 2020 Earnings Call. [Operator Instructions] Please note that this conference is being recorded. At this time, I will turn the floor over to Deanne Randolph with Media Investor Relations. Deanne, you may now begin.

Thank you. Good morning, and welcome to PDS Biotechnology's Third Quarter 2020 Earnings Conference Call and Audio Webcast. With me today are Dr. Frank Bedu-Addo, Chief Executive Officer; Dr. Lauren Wood, Chief Medical Officer; and Michael King, Interim Chief Financial Officer. Yesterday afternoon, PDS Biotech issued a press release, announcing financial results for the 3 months ended September 30, 2020. We encourage everyone to read yesterday's press release as well as PDS Biotech's quarterly report on Form 10-Q, which will be filed with the SEC tomorrow. The company's press release is available on PDS Biotech's website at pdsbiotech.com, and the quarterly report will be posted tomorrow. 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 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 yesterday'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. In addition, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, November 12, 2020. Except as required by law, the company undertakes no obligation to revise or update any statements 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 thank you all for joining us this morning. During the third quarter, the PDS Biotech management team has advanced numerous key initiatives, supporting continued development of our Versamune platform-based products. We continue to progress our oncology and infectious disease programs, despite the challenges posed by the COVID-19 pandemic. On our second quarter call, we discussed several key objectives that we were seeking to accomplish by the end of 2020. These included initiation of 2 PDS0101 Phase II clinical trials; VERSATILE-002, in which PDS Biotech's lead immunotherapy, PDS0101, is combined with Merck's blockbuster cancer immunotherapy, KEYTRUDA; and secondly, another PDS0101 study, led by Dr. Ann Klopp at the MD Anderson Cancer Center. We also projected continued progression of our infectious disease programs, specifically in COVID-19 and universal flu. A quick summary of our progress since our last quarterly report includes 6 key topics: First, the recently announced initiations of the second and third Phase II clinical trials of PDS0101; the VERSATILE-002 trial in first-line recurrent or metastatic HPV16-positive head and neck cancers; and also the MD Anderson-led trial, evaluating PDS0101 in combination with standard of care, chemo radiation in locally advanced cervical cancer. Second, the NCI-led Phase II trial, which is the first and furthest progressed Phase II trial, is evaluating a triple combination of PDS0101 with 2 of EMD Serono's cutting-edge clinical stage immunotherapies in advanced HPV-associated cancers. In this trial, the safety benchmark has been successfully achieved, and recruitment of the first 8 patients also completed. The results from the first 8 patients will determine the initial efficacy assessment. Third, progression of preclinical studies by PDS Biotech and the National Cancer Institute for our pipeline products, PDS0103. The PDS0103 immunotherapy combines the utility of the Versamune platform with novel and proprietary highly immunogenic peptides derived from the cancer-associated protein known as Mucin 1, or MUC1. MUC1 is highly expressed in several types of cancer and has been shown to be associated with drug resistance and poor disease prognosis in breast, colorectal, lung and ovarian cancers for which PDS0103 is being developed. Fourth, this past Friday, November 6, Farmacore and the Brazilian regulatory agency, ANVISA, agreed on IND requirements to initiate clinical trials of PDS0203 in Brazil in collaboration with PDS Biotech and this is the COVID-19 vaccine. Fifth, preclinical development of PDS Biotech universal flu vaccine, PDS0202, was initiated. And finally, the successful raise of approximately $19 million via public offering, which we closed in August, in which we expect to provide approximately 2 years of working capital from that point. So I will start with our oncology pipeline. I would like to provide a bit more detail about recent advancements in our oncology pipeline. As of today, there are 3 ongoing Phase II trials of PDS0101, all of which have been developed through partnerships with well-renowned leaders in the oncology field, including Merck; the National Cancer Institute, or NCI; and the University of Texas; MD Anderson Cancer Center. The National Cancer Institute and MD Anderson trials are investigator initiated. As a reminder, PDS Biotech retains 100% ownership of PDS0101 and all other Versamune-based compounds. We have taken advantage of the Versamune platform's unique combination of safety and potency as demonstrated in our Phase I trial to pursue our strategy of combining PDS0101 with standard of care in 2 of the 3 ongoing Phase II trials to deliver higher-quality therapeutic options and outcomes to cancer patients. It is noteworthy that the VERSATILE-002 trial, 1 of the 2 combination studies with standard of care, is addressing first-line treatment of recurrent or metastatic disease. The third PDS0101 combination trial, the National Cancer Institute-led triple combination study, is based on the NCI's independent demonstration and publication of powerful anticancer effects in preclinical studies. If this preclinical data is successfully confirmed in the ongoing Phase II trial, this triple combination could form the basis of a unique platform, providing improved cancer treatments across multiple cancers. VERSATILE-002. On Monday, November 9, we announced the initiation of our VERSATILE-002 clinical trial. As a reminder, VERSATILE-002 is a multicenter, open-label, single-arm, non-randomized trial of approximately 100 patients. The study is evaluating the combination of our Versamune-based PDS0101 with the anti-PD-1 checkpoint inhibitor, pembrolizumab, also known as KEYTRUDA, for first-line treatment of recurrent or metastatic head and neck cancer. Our partner, Merck, will be providing drug, and PDS Biotech is fully responsible for the day-to-day management of the study. We have previously delayed the initiation of VERSATILE-002 due to the impact of the COVID-19 pandemic on clinical trial operations, and after careful consideration, in collaboration with Merck and the chosen clinical sites, we determined that it was safe to proceed with the trial. We believe that the combination of PDS0101 and KEYTRUDA as the first-line therapy for recurrent or metastatic head and neck cancer has tremendous potential to provide significantly improved clinical benefits to patients compared to treatment with KEYTRUDA alone. This means that patients whose cancer has returned or spread following initial treatment will be able to avoid chemotherapy and take this combination of 2 immunotherapy drugs, an approach that may be very appealing to patients. We are hopeful that enrolling patients with more functional immune systems that have not been compromised by extensive chemotherapy may allow for improved efficacy of the combination. Now moving on to our investigator-initiated trials. In addition to VERSATILE-002, we also have 2 ongoing investigator-initiated Phase II trials. The furthest progress of these 2 PDS0101 trial is a National Cancer Institute-led Phase II trial, evaluating a novel triple combination of PDS0101 with 2 other clinical stage immunotherapies: M7824, a first-in-class bifunctional checkpoint inhibitor; and NHS-IL12, an antibody conjugated cytokine designed to facilitate entry of the cytokine IL-12 into tumors to enhance local T-cell responses. This novel combination is being studied in patients with several types of advanced HPV-associated cancers. Any patient with an advanced HPV-associated cancer, including anal, cervical, head and neck, penile or vaginal, vulvar, squamous cell rectal, lung and esophageal cancers, who have failed prior first-line treatment is eligible to enroll in this trial. On October 26, we announced the initiation of an MD Anderson-led Phase II trial of PDS0101 in combination with standard of care chemo radiotherapy, or CRT, for treatment of locally advanced cervical cancer. This study will investigate the safety and preliminary efficacy outcomes of this combination. Dr. Wood will provide additional details about our ongoing clinical trials shortly. Our clinical development strategy of combining PDS0101 with standard of care treatment is designed to mitigate risk in our proof-of-concept Phase II trial. It is also designed to demonstrate the potential for significantly enhanced clinical benefit to patients over the current standard of care without compounding toxicity. If we do achieve this goal, we believe that we will have a clear path towards commercialization of PDS0101. After initial commercial approval, our strategy of combining PDS0101 with standard of care also positions us for rapid market penetration and expansion. As some of you may already know, the HPV cancer market is very large and 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 head and neck cancer has been described as a silent epidemic due to the rapidly increasing incidence of this cancer. The anal cancer incidents has also been steadily increasing. For both investigator-initiated trials combined, our financial responsibility is limited to approximately $1 million, plus an obligation to supply PDS0101. Now moving on to our pipeline and PDS0103. In April, we announced the expansion of our Cooperative Research and Development Agreements, or CRADA, with the National Cancer Institute to include studies of PDS0103. PDS0103 combines Versamune with novel proprietary peptides derived from the cancer-associated protein known as MUC1. These novel proprietary and highly immunogenic peptides were developed by the Laboratory of Tumor Immunology and Biology of the National Cancer Institute. MUC1 is expressed in a wide range of tumor types, including 4 cancers of interest to PDS Biotech: breast, colorectal, lung and ovarian cancers. Expression of MUC1 is often associated with poor disease prognosis due in part to drug resistance. In preclinical studies and similar to PDS0101, PDS0103 demonstrated the ability to generate powerful MUC1-specific CD8-killer T-cells. Our hope is that in humans, we will see a similar result, allowing the immune system to better recognize the MUC1 proteins expressed by malignant cells and attack and kill MUC1-expressing tumors. We are pleased to announce that PDS0103 formulation work is complete. For the final stage of preclinical development, the National Cancer Institute will be initiating preclinical studies of PDS0103 in combination with other immunotherapeutic agents ahead of a planned human clinical study. We anticipate that the preclinical studies will be completed during the first half of 2021. Turning now to our infectious disease pipeline. We announced on July 14 that PDS Biotech's collaborator has been granted an NIAID Award to develop a Versamune-based universal influenza vaccine. Preclinical development of this program has been initiated, and its goal is to develop a novel vaccine that will promote the induction of both T-cells and antibodies and be effective in protecting the population against multiple strains of the flu virus. Earlier this week, we announced an update to our COVID-19 vaccine development program in partnership with Farmacore. Based on promising preclinical results from the PDS0203 program and in agreement with our partner Farmacore, we have chosen to streamline our COVID-19 vaccine pipeline by advancing PDS0203 in Brazil. The PDS0203 program will replace PDS0204, the previous Farmacore product as we prepare for a human clinical study. To that end, as we announced on November 10, Farmacore met with ANVISA, Brazil's drug regulatory agency and FDA counterpart last Friday, November 6, to review the PDS0203 preclinical results. ANVISA and Farmacore agreed on the path forward for official submission of a final data package and the Phase I/II human clinical trial protocol. Farmacore is in discussions with specific agencies of the government to extend the preclinical funding to cover the upcoming human clinical trial anticipated to begin in Brazil during the first half of 2021. Please note that this is a developing situation, and we will provide more details as they become available. Based on emerging COVID-19 data from several countries, it is clear that T-cell responses as well as long-term durability of the immune response are paramount. As a result, we are conducting additional longer-term preclinical studies of PDS0203. While these studies are not critical for initially advancing this program into the clinic, they are important to help us attain a more complete understanding of the potential of this vaccine to provide robust, long-term protection against COVID-19. The full preclinical data set, including the durability of T-cell and antibody immune responses, will be submitted for peer review upon completion. As I have said in the past, our goal with the COVID-19 vaccine program is not to race to commercialization, but rather to design and develop a vaccine that presents the critical characteristics necessary to provide optimal long-term protection and also be globally successful. This means that the vaccine must induce antibody responses and the full breadth of immune responses, including virus-specific memory, CD4 helper T-cell and CD8-killer T-cells. For commercial success, the vaccine should also be safe, simple, rapidly scalable, capable of production at commercial scale and demonstrate long-term stability. PDS0203 is being developed to exhibit each of these qualities. We will keep informed as development progresses. Moving on to our financial position. As a reminder, in August, we completed a common stock offering, which raised approximately $19 million, and our cash balance as of September 30 is just under $34 million. Our ongoing strategy has been to partner with world-class institutions to strengthen our scientific knowledge and advance our pipeline while conserving our capital resources. As a result, our cash balance is sufficient to support our previously announced initiatives through the initial data readouts for our PDS0101 clinical trials. Michael King, our interim CFO, will provide additional details during his portion of today's prepared remarks shortly. Now to review our clinical updates, I'd like to turn the call over to our Chief Medical Officer, Dr. Lauren Wood.

Thanks, Frank. And once again, thank you, everyone, for joining us on this morning's call. As Frank discussed, since our last conference call, we have successfully advanced our robust pipeline of Versamune-based vaccines in oncology and infectious disease. Importantly, we initiated the first PDS-sponsored Phase II clinical trial of PDS0101, VERSATILE-002. As we discussed on our last call, sites have implemented institution-specific measures, securing the safety of patients and staff to ensure the integrity of the study in the face of the ongoing pandemic. Patients in the study will receive a total of 5 cycles of combination therapy in the context of receiving standard of care KEYTRUDA therapy administered every 3 weeks until disease progression. The primary end point 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 [indiscernible] and a formal planned interim analysis, evaluating response to treatment in the first 38 patients. Now that the study has been initiated, we estimate that enrollment of the initial 12 subjects for safety will be complete in early Q2 2021. More mature projections regarding recruitment of subsequent patients in the context of the ongoing COVID-19 pandemic will be possible after the winter flu season has concluded. 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. The investigator-initiated study of PDS0101 in combination with M7824, a first-in-class bifunctional checkpoint inhibitor; and NHS-IL12, an antibody conjugated cytokine designed to facilitate entry of the cytokine into the tumor to enhance local T-cell responses, was initiated in June was encouraging and faster-than-projected initial recruitment to date. This NCI-led study was the result of independent preclinical animal studies performed at the National Cancer Institute which showed very strong synergy between the 3 agents. The triple combination resulted in significantly enhanced antitumor activity when compared to treatment with the individual agents or with dual combinations of the agents. The details and findings of these preclinical studies were published in the June 17 issue of the Journal for Immunotherapy of Cancer. This investigator-led study recently achieved its initial safety benchmark, meaning that fewer than 2 dose-limiting toxicities were observed in the first 6 patients who received the combination. The trial has already completed recruitment of the first 8 patients sufficient to perform an initial efficacy assessment. If 3 or more of these initial 8 patients demonstrate an objective response to the triple combination, the trial will progress to full recruitment. In addition, the trial was amended in late August to allow enrollment of a separate 10-patient cohort of checkpoint inhibitor experienced patients for assessment of safety and activity of the triple combination in this population. We expect the initial efficacy results and a decision regarding planned expansion of the trial in the checkpoint inhibitor naive patients during the first half of 2021. We also anticipate that mature clinical data, our clinical outcomes from the study will be available in the second half of 2021. Moving now to the MD Anderson-led Phase II clinical trial of PDS0101 in combination with standard of care chemo radiation therapy for treatment of locally advanced cervical cancer. This study will enroll approximately 35 patients and investigate the combination safety and preliminary oncologic outcomes as well as explore immune priming by PDS0101 and other biomarkers of immune response in both blood as well as tumor tissue. We believe that PDS0101 demonstrated the ability to activate the immune system and induce tumor targeting killer T-cells may provide improved outcomes to patients with cervical cancer. The earliest possible readout of early clinical data from this study is also in the second half of 2021. The study is being conducted by Dr. Ann Klopp, MD, PhD and Associate Professor of Radiation Oncology at MD Anderson. I would now like to turn the call over to our Interim CFO, Michael King, to review our financial results. Michael?

Thank you, Lauren. I would like to review our financial results for the 3 months ended September 30, 2020. For the third quarter of 2020, our net loss was approximately $3.9 million or $0.23 per basic and diluted share compared to a net loss of approximately $5.6 million or $1.10 per basic and diluted share for the third quarter of 2019. R&D expenses totaled approximately $2.1 million for the third quarter of 2020 compared to approximately $1.8 million for the same period in 2019, an increase of 12%. For the third quarter of 2020, G&A expenses were approximately $1.8 million compared with approximately $3 million for the third quarter of 2019, a decrease of 40%. Total operating expense for the third quarter of 2020 were approximately $3.9 million compared to total operating expenses of approximately $5.8 million for the same period in 2019, a decrease of 33%. As of September 30, the company's cash balance was approximately $33.5 million. In August, PDS Biotech closed an underwritten public offering consisting of 6.9 million shares of common stock at a public offering price of $2.75 per share. The gross proceeds from this offering were approximately $19 million before deducting underwriting discounts, commissions and other offering expenses. We anticipate that our current cash balance will provide us with the necessary financial resources to advance all 3 currently planned PDS0101 Phase II clinical trials through initial human clinical data. This concludes our financial remarks. I would like to hand the call back to Frank for final remarks. Frank?

Thanks, Lauren and Michael. Before we begin our question-and-answer session, I would like to thank all of our fantastic team members here at PDS Biotech and all of our clinical partners for their dedication, where it not for their dedication and the ability to navigate through the unprecedented challenges posed by the COVID-19 pandemic, we would not have 3 active PDS0101 Phase II clinical trials open and recruiting patients today. As a result, we can continue to rapidly advance towards delivering novel immunotherapies based on our Versamune T-cell activating platform to cancer patients. Furthermore, we are excited to be closer to getting our COVID-19 vaccine program into human clinical trials with our partners at Farmacore and the financial support of the Brazilian government. We are grateful for these opportunities to leverage our team, tools and resources to generate potential benefits for patients and significant value for shareholders over the coming years. That concludes our prepared remarks. Operator, please begin our question-and-answer session.

[Operator Instructions] Our first question will be coming from the line of Joe Pantginis with H.C. Wainwright.

Two questions, please, if you don't mind. So first, real nice to see that the Phase IIs are really getting going in earnest. So I guess the question that I have for you is, what kind of, for lack of a better phrase, site vigilance is going on with regard to making sure that patients continue be able to get to the centers for their treatments with regard to any potential lockdowns in geographical areas, et cetera.

Joe, thanks a lot for your question. I'll hand over to Lauren.

Joe, good morning, and thanks for your question. So we are regularly communicating with sites. Once -- while we paused the study during the pandemic, we have communicated with sites every 6 weeks. Once sites are open, we communicate with them every 2 weeks. As we mentioned during the call, each site has put in risk mitigation measures that differ from site to site, depending upon the geographic region, and we will continue that kind of ongoing communication that's now more intensified as we enter into this flu winter season.

That's great. And then my second question is just focusing on the COVID aspect of 0203. So I guess it's a 2-part question. So first, can you tell us -- remind us what the differentiating factors were in choosing 0203 versus 0204? And then second, I'm glad you keep repeating the commentary, Frank, that you're not looking for speed in getting your -- but rather the best potential vaccine to the market, especially with regard to T-cell activation. So with that said, does a geographical choice with Brazil also come into play based on Pfizer basically looking to take the lead in the U.S.

Right. So thanks a lot, Joe. So I think like everyone else, we were thrilled to read the preliminary efficacy results that Pfizer recently published. And with drug development, as you know, it is quite common for some programs to advance while others are delayed or deprioritized. For PDS0203 and 0204, both of these programs were based on the Versamune platform, but they had different COVID-19 or SARS-CoV-2 antigens. And so for our COVID-19 vaccine programs, really the strength of the PDS0203 preclinical results are what led both parties to their decision to prioritize the PDS0203 in order to focus on the clinical development activities. So as you know, there is a lot that goes into preparation for a clinical trial. So as a result of this, we decided to streamline development and advance PDS0203, and that decision was made in conjunction with our partners at Farmacore and also was welcomed by the Brazilian regulatory agencies. And that's really was the reason for going down this path of PDS0203 versus 0204, or both.

The next question is from the line of Ahu Demir with NOBLE Capital.

I'll also follow-up on the coronavirus program. I am curious when this trial will be initiated next year? When do we expect to see data? And what would it mean for you to maybe seek for a partnership in U.S. or other geographic locations, Frank?

I think if we are able to start in the first half of next year and Lauren, jump in at any time. We believe that it will -- we will probably get initial data within 3 to 6 months. Now I think, importantly for us, one of the things that we have mentioned is that as we continue to communicate with both the government and nongovernmental agencies, we anticipate that after the first -- funded first generation vaccines are rolled out and data on the efficacy and safety of those products are assessed, there may be additional support for the development of second-generation vaccine, particularly vaccines that have the potential to provide longer-lasting, more durable protection. And based upon the studies that we plan to be doing in Brazil, we strongly believe that PDS0203 will be well positioned when those discussions begin. So for us, I think the key thing is and what you're probably alluding to is that generation of early data, understanding the immune responses, antibodies as well as T-cells, will be very important when we get to the second stage of clinical development of these vaccines.

That's helpful. So my second question would be on the investigator-initiated NCI triple combination study. So in terms of the safety, if it is proven to be safe with triple combination, that could -- I imagine that could open many doors for PDS. What would be the strategy if you provide some safety profile that's favorable with triple combinations? Like what other options would you try? What would it mean for PDS to move forward?

Sure. Thanks a lot, Ahu. Lauren, I'll hand over to you to take the first part of that question, and I can follow-up after you're done.

Okay. So if we confirm that the triple combination is safe, I think that in exploring partnerships with EMD Serono because both of those 2 agents that are part of the triple combination are owned by EMD Serono. I think that we would want to continue to explore potentially the combinations, not only in the advanced treatment setting, but if the safety and tolerability is demonstrated to move it earlier potentially in disease treatment settings, which has typically been happening in the immuno-oncology space. That would be ideal because we know that if we treat patients earlier in disease, their immune systems are less compromised by repeated rounds of chemotherapy and radiation therapy and more likely to respond optimally. It is also the reason why the investigators decided to make the decision to amend the study. After seeing that there was no safety signal among the checkpoint inhibitor-naive patients, they wanted to expand the study and add a cohort a checkpoint inhibitor experienced patients to see if, a, there would be the same safety and tolerability profile of the triple combination as well as a preliminary signal of efficacy.

Lauren, thank you very much. And Ahu, on the business side, I think the key thing here -- one of the key things we are seeking to demonstrate with these Phase II trials is the importance of a robust T-cell -- CD8-killer T-cell attack or generation. That has been one of the big limitations of immuno-oncology today, right? Even with the checkpoint inhibitors, we know that the CD8 T-cell induction is critical to allow those patients to effectively be treated. And so what we would want to show, as Lauren mentioned, is that if we do demonstrate the safety, which it appears to be safe in triple combination, then this powerful induction of CD8 T-cells can then be applied in several different combinations, including this triple combination to address multiple solid tumor types. And so these studies are quite important on the basis of those decisions and studies.

And Ahu, I would also add that the similar guiding principle is behind the MD Anderson trial because of PDS0101 is also demonstrated to be safe and tolerable, and as Frank noted, induce these HPV-specific tumor targeting T-cell responses in combination with chemotherapy. Then from all of our Phase II trials, we will have demonstrated an excellent safety profile with PDS0101 in combination, hopefully, with: one, immunotherapeutic agent that would be KEYTRUDA and the VERSATILE-002 trial; with, two, immuno-oncology agents; and then also in combination with chemo-radiation therapy. And being able to have more pertinent combinations, which we know and we desire are really required in solid tumors, with an enhanced safety profile and tolerability profile is something that would be very desirable.

[Operator Instructions] The next question comes from the line of Jim Molloy with Alliance Global Partners.

A quick follow-up as well on the Brazilian Farmacore partnership. And if you get data here, you started in the first quarter, you did 3, 6 months. What's sort of the number level of the cash partnership from Brazil you're anticipating getting? Or you think you'll need to run that trial? And then what sort of next steps -- is there optionality to becoming -- to think about the IND in the U.S. and starting trials here? Or would you be likely sort of partnering that out prior to bringing to the U.S.?

So in terms of the funding, that is still a developing situation. So -- and Farmacore is having the discussions directly on their end. We are not involved in those discussions with their government. So I will not be able to all discuss that in any detail. That's still a developing situation. And as we get more information, we will definitely let that be now. We anticipate that the initial clinical trials will certainly be done in Brazil, the Phase I/II, and there is potential that beyond those initial studies that we could potentially go globally filed with the FDA or other agencies and go into global trials for the pivotal clinical trial. But those decisions have not yet been made. A lot will depend on the results that we obtain from the impending trial.

Okay. Great. And then on the VERSATILE-002, you talked about the first 12 patients potential data here in the first half of -- or second quarter '21, I believe. And what -- can you walk through the optionality of next steps on that data, good, bad or different data?

So...

You're referring to the PDS0101?

Yes. I'm sorry. Yes, the VERSATILE-002. PDS0101 trial.

Right. Yes.

Lauren, I'll hand over to you.

Yes. So that is a planned safety cohort analysis of the first 12 patients just to assess the safety of the combination. In reviewing PDS0101 safety data from the Phase I trial, both the FDA and Merck were in agreement that a lead in of PDS monotherapy was not required, but that they did want the safety cohort. So the first 12 patients will be enrolled, and they will be evaluated for dose-limiting toxicities for 21 days, following that first cycle of combination therapy. The safety cohort evaluation is a formal review by the DMC, the data monitoring committee, which has been established for the trial. They will review the data on those 12 patients. The trial will be paused for the temporary time that it takes to evaluate this data, and then trial enrollment will resume.

At this time, I want to turn the floor back to management for closing remarks.

Okay. Thank you very much. So thanks very much again for joining us this morning. We are entering an exciting period for the company with 3 ongoing Phase II trials, which will deliver initial proof-of-concept data for both our lead immunotherapy PDS0101 in HPV-associated cancers and our Versamune T-cell activating platform in oncology more generally. We are also moving quickly to generate initial human data in infectious diseases with the planned initiation of Phase I studies in Brazil for PDS0203, a next-generation COVID-19 vaccine that we hope will confirm important induction of disease-specific CD8 T-cells in addition to antibodies. We appreciate your continued support of PDS Biotech. For more information about the company and our ongoing clinical trials, please visit our website at pdsbiotech.com. Thank you very much.

Thank you. This will conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.