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…

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…

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.