Greetings and welcome to the PDS Biotechnology's Fourth Quarter and Fiscal Year 2020 Earnings Call and Webcast. . A question-and-answer session will follow the formal presentation. As a reminder this conference is being recorded. It is now my pleasure to turn the call over to Deanne Randolph, Investor Relations for PDS Biotechnology.

Please go ahead Deanne. .

Good morning and welcome to PDS Biotechnology's fourth quarter and full year 2020 earnings conference call and audio webcast. With me today are Dr. Frank Bedu-Addo, Chief Executive Officer; Dr. Lauren V. Wood, Chief Medical Officer; and Seth Van Voorhees, Chief Financial Officer.

Earlier this morning PDS Biotech issued a press release announcing financial results for the three and twelve months ended December 31, 2020. We encourage everyone to read the press release as well as PDS Biotech's annual report on Form 10-K, 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 annual 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..

Thank you Deanne and thank you all for joining us this morning. During the year 2020 the PDS Biotech management team advanced numerous key initiatives supporting continued development of our Versamune platform based products.

The Versamune platform was designed to activate multiple immunological processes that are necessary to promote in vivo generation of antigen specific PDS killer T-cells. During the year we continued to progress our oncology and infectious disease programs despite the challenges posed by the COVID-19 pandemic.

In the second quarter of 2020 we initiated the first of three Phase 2 clinical trials of our flagship oncology candidates PDS0101 which is being developed to treat advanced HPV associated cancers such as anal, cervical, head and neck, penile, vaginal, and vulva cancers.

The additional two clinical trials of PDS0101 were initiated during the fourth quarter. We also successfully added $30 million of cash to our balance sheet during the year providing the company with sufficient capital resources to achieve key value enhancing milestones in 2021 through 2022. .

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 both our infectious disease and oncology pipelines since our third 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 bi-functional checkpoint inhibitor, and NHS-IL12 an antibody conjugated cytokine designed to facilitate entry of the cytokine IL12 into the tumor to enhance the local T-cell response was initiated in June with encouraging and faster than projected initial approval today.

This NCI led study was a result of independent preclinical animal studies performed at the National Cancer Institute, which showed strong synergy between the three agents. The triple combination resulted in enhanced anti-tumor activity when compared to treatment with the individual agents, or with dual combinations.

The details and findings of these preclinical studies were published in the June 17th issue of the Journal for Immunotherapy of Cancer, also known as JITC.

This investigator led study recently achieved its initial safety benchmark, meaning that fewer than two dose limiting toxicities were observed in the first six patients who received the triple combination. Furthermore, as Frank mentioned, the trial recently met its initial efficacy benchmark.

The observation of objective response in three or more of the initial eight patients that had been enrolled in the trial will now progress to full enrollment. We anticipate that additional data from this trial will be available during the second or third quarter of this year. 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. As a reminder, the primary endpoint of VERSATILE-002 is the objective response rate or ORR at nine months following initiation of treatment.

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

The study lead principle investigator 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 Care Center and we are thrilled to have Dr. Weiss involved in this study. Moving now to the M.D.

Anderson lead Phase 2 clinical trial of PDS0101 in combination with standard of care chemoradiotherapy for treatment of locally advanced cervical cancer. This study is also known as immunoserve.

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 importantly, 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. The earliest possible readout of clinical data from this study is also the second half of 2021. The study is being conducted by Dr. Ann Klopp M.D.

PhD, and Associate Professor of Radiation Oncology at the M.D. Anderson Cancer Center. Moving now to the planned clinical trial of our COVID-19 vaccine. In agreement with ANVISA, the randomized placebo controlled Phase 1-2 study of PDS0203 will evaluate safety, immunogenicity, and preliminary efficacy of PDS0203 in approximately 360 healthy adults.

Patients in the study will receive two doses of PDS0203 administered three 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. A 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 antibodies, as well as CD4 helper T-cells and CD8 killer T-cells 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 Stage 1-2 trial in an effort to react as quickly as possible to results.

If the Phase 1-2 study successfully establishes both safety and efficacy, we are prepared to quickly move into a Phase 3 trial to confirm PDS0203’s effectiveness in preventing COVID-19 infection. One of the planned analyses in the Phase 3 design is the assessment of efficacy against variants of the virus.

As Frank mentioned, the robust T-cell induction by Versamune may provide protection not only against virus, but also potentially against currently circulating variants of concern of the virus since PDS0203 is being designed to induce an immune response against conserved regions present in SARS-CoV-2.

Conserved 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, Seth Van Voorhees to review our full year 2020 financials. Seth..

Thank you, Lauren and good morning everyone. As this is my first conference call as CFO, I'd like to take a moment to discuss my view of the company and why I decided to join PDS early this year.

When I was interviewing for the CFO position, I saw a company that was developing an exciting platform capable of inducing killer CD8 T-cells in the right quantity, in the right quality, in the right location, and doing all these incredible things with a strong safety profile, providing with an opportunity to develop a broad range of therapies for cancer and infectious diseases.

I was impressed by the validating partnerships established with market leading institutions such as the National Cancer Institute, and the M.D. Anderson Cancer Center. These organizations dealt so highly at Versamune’s potential that they initiated two of the three Phase 2 combination studies currently underway.

So it's based on these validating partnerships, the company's three Phase 2 trials, its deep product pipeline in preclinical development, combined with an exciting pipeline in the disease candidates, my decision to join PDS was an easy one.

I'm excited to be part of the PDS team as we seek to develop this potential to create value for you, our shareholders and improve therapeutic care for all. Finally, as we move forward together, please feel free to contact me if I can be of assistance now or in the future.

Now I'd like to turn our discussion to a review of our financial results for the 12-month period, ending December 31, 2020. In addition, I would also like to touch on the financial implications of our recently announced commitment from the Brazilian government to fully fund the clinical program for PDS0203.

For fiscal year 2020, our loss from operations was approximately $14.9 million versus a loss of approximately $21 million during the same period in 2019.

When factoring in other income and expenses, primarily related to the merger in 2019, our net loss was approximately $14.9 million in fiscal 2020 or a net loss of $0.89 per basic and diluted share, compared to a net loss of negative $7 million or $1.44 per basic and diluted share for fiscal 2019.

Research and development expenses totaled approximately $7.9 million in fiscal 2020 as compared to $6.1 million for fiscal 2019, an increase of approximately $1.8 million or 30%. Most of this increase was a result of higher levels of Versamune related developmental expenditure expenditures.

For fiscal 2020, general and administrative expenses were approximately $7 million, compared to approximately $11 million for fiscal 2019, a decrease of approximately $4 million or 37%. Most of this decrease related to higher levels of reverse mergers expenditures in 2019 that did not reoccur in 2020.

From a cash flow perspective, we started 2020 with approximately $12 million of cash and raised approximately $30 million from the issuance of equity in 2020 that was offset by approximately $13 million of cash that was used in our operations in 2020, leaving us with a cash balance at the end of the year of approximately $29 million.

Now, I'd like to discuss the implications of our announcement last week regarding funding by MCTI of up to 330 million in Brazilian Real, which equates to approximately $60 million U.S. for the development of a Versamune based COVID vaccine.

The announcement both validates our confidence in the Versamune platform and provides the funding to support PDS0203 into a fully commercialized product.

Upon approval by the Brazilian drug regulatory agency ANVISA funding will be released to support an initial combined Phase 1-2 trial and assuming that trial is successful, the release of full financial support for a registration enabling Phase 3 trial. The government funding will also support the scale up of manufacturing of the PDS0203 product.

A portion of the committed funding will be paid to PDS for the support activities it will provide to this program, which will have a positive impact on our cash burn rate.

If successful, the Brazilian market represents a potential multibillion dollar revenue opportunity based on its population of 213 million people and reported COVID-19 vaccine pricing of approximately $20 to $74 for a two dose regimen.

Outside of Brazil our development partner Farmacore also has the rights to commercialize PDS0203 throughout Latin America, which increases this market potential by approximately three times based on the population. In summary, this announcement has two important financial implications for PDS.

First, it provides near term financial support for our clinical and scale up activities for PDS0203. And second, it represents a significant revenue potential starting in 2023 based on the commercialization of PDS0203 if the planned clinical trials are successful.

Thank you for your time today and I'd like to now turn the call back to Frank for final remarks..

Thank you, Seth and Lauren. 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.

Were it not for their ability to navigate through the unprecedented challenges posed by the COVID-19 pandemic, we would not have three active PDS0101 Phase 2 clinical trials nor would we have achieved the financial support of the MCTI.

We anticipate generating significant data from our ongoing clinical trials that will allow us to apply the Versamune technology to the next generation of cancer immunotherapies as well as novel vaccine that may induce a broader range of protection against infectious diseases. That concludes our prepared remarks.

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

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

Hi, everyone. Good morning and thanks for taking the question. My question really revolves around the NCI study and I guess it's sort of having a couple parts there.

So the first part of the question is maybe can you give a little more perspective around the patient population and their underlying demographics and why you can be encouraged -- even more encouraged about the responses that you're seeing early on? And then second, I think this talks to the broader theme as you see the immunotherapy landscape continue to expand, there's always going to be questions and ongoing questions about how do you tease out the individual contributions of each of the therapies within the regiments, now obviously the JITC journal article I think goes far in explaining that but I think that's part of the main question? And then lastly, that I hope would look to answer that.

The overall question is the type of work that NCI and you are doing with regard to translational data and looking at the actual impact of T-cell activation? Thanks a lot..

Thank you very much, Joe. And Lauren I'll hand over that question to you..

Okay, good morning, Joe and thank you for your question. So I'll try and address each of your questions systematically. Regarding the patient population, the individuals that are in the patient population are those that we would expect to have HPV related recurrent metastatic disease.

They include individuals with cervical cancer, anal cancer, vaginal and vulva cancer, as well as head and neck cancer. So that is the representative population that is targeted by this triple combination and that we are seeing as it relates to enrollment. The other aspect that she said was further clarification about the two populations in the study.

The study was focused and targeted on delivering this triple combination therapy to checkpoint inhibitor naive individuals based on the preclinical data that we noted that was published in the June 20th JITC article.

However, we also know that since immunotherapy has become the fourth cornerstone of cancer treatment, that there are now a lot of patients with checkpoint refractory disease.

We know that only about 20% on average, 15% to 20% depending upon the agent of patients respond to checkpoint inhibitor therapy and so there is an emerging and growing population of checkpoint refractory patients who have failed prior exposure to this class of drugs.

Investigators at the NCI were interested in also exploring in a preliminary manner, whether or not this triple combination will also have activity in the checkpoint refractory population. So those are the two cohorts for the NCI study.

Your point is very well taken regarding when you deliver triple combinations or dual combinations of any agent, whether it's immune-oncology agents, whether it's immune-oncology and chemotherapy or radiotherapy.

What is the specific contribution of each of the agents? We clearly know that from the preclinical studies, the triple combination was superior to any of the dual combinations, and all of the dual combinations were superior to any of the monotherapy combinations.

How we would tease this out in additional, subsequent potentially randomized Phase 2 studies might be to give the triple combination versus the best dual combination that was observed in the preclinical studies.

Again, it would really depend on the clinical data that we observe with the triple combination in both the checkpoint inhibitor naive as well as refractory populations, because you might want to be exploring differences in combinations when you're trying to figure out and tease out what is the most important component in the regimen or the relative contributions.

Your third question regarding the type of translational work and data that's being done, this is a critical question and it's one of the reasons why we're really thrilled to be partnering with Dr. Dr. Schlom and Dr. Gulley and Dr.

Strauss at the NCI and their group, because it's critically important for us to be able to not only confirm whether or not we see this potent induction of HPV 16 specific CD8 T-cells, but also whether or not we have evidence that these T-cells track into tumors.

And so, there is the plan for patients who may undergo subsequent surgical resection or biopsy to characterize those responses, there's going to be intensive interrogation of not only the T-cell repertoire, but also whether or not the HPV 16 specific responses that are induced, their quantity, as well as their potency as it relates to polyfunctional activity.

Did I get everything for you?.

No, you certainly did. And thank you. I know I threw a lot in there in one seemingly run on sentence, but thank you for the added details..

Thank you. Thank you, Joe. Thank you, Lauren.

And Joe, just to add a little bit to what Lauren said, one of the reasons why we set that bar at 40% approximately, is in this patient population if PDS0101 is actually inducing these in vivo killer T-cells and the state of the art, the highest response rate was approximately 30%, our projection was that if these T-cells are actually being induced, even in these patients with somewhat weakened immune systems, we would expect to see at least a 30% increase over what M7824 had shown in the clinical trials.

And so that was another reason why we wanted to see that bump up of about 30% to say, okay, this appears to be doing what we hoped it would do therefore, let's go ahead and enroll the full trial..

Got it. Thank you very much..

You are welcome..

Thank you. . Our next question is coming from Trevor Allred from Oppenheimer. Your line is now live. .

Hey, good morning and thanks for taking my question. I wanted to ask about the regulatory process for Brazil and how that might differ from the U.S.

if at all? And then how might that potential Brazilian approval, how might that impact commercialization across Latin America, will they require any further regulatory trials beyond Brazil or will emergency use enable no broad use? Thanks. .

Lauren, we'll start with you..

Okay. Good morning, Trevor and thanks for that question. So as many people are aware, ANVISA is the regulatory authority for Brazil regarding pharmaceutical products, devices, and other interventions and equivalent to the U.S. FDA. Their process is very similar to the FDA in that sponsors are able to submit pre-IMPD packages in the United States.

It would be a pre-IMD package, where the sponsor is able to have preliminary discussions with the regulatory agencies regarding their platform, their product and the proposed study of that product in first in human clinical trials. After the submission of a full IMPD, as Frank mentioned during the call, which is equivalent to the U.S.

IND which we submit to the FDA, that is then reviewed and the regulatory agency provides the go ahead to initiate studies of PDS0203 in human subjects. Importantly, once a trial is initiated, there is very frequent communication between sponsors and the regulatory agencies regarding safety, reactogenicity, as well as efficacy outcomes.

And we know that these are significantly accelerated as it relates to all COVID-19 vaccine platforms. Same thing happens in Brazil with very prompt review, evaluation, and communication that is ongoing.

Now regarding the regulatory process for the rest of Latin America and whether or not a EUA authorized vaccine that is manufactured in Brazil and approved by ANVISA, how rapidly it would be taken up by other regulatory agencies in Latin America is a question that really resides with each of the regulatory agencies of those countries.

As everyone is aware, there are three vaccines that are approved for COVID-19 in the U.S. There also vaccines approved in Europe as well as the UK, but individual health authorities have also elected to review COVID-19 vaccine packages based on their individual country's priorities.

And the presumption is that's exactly what would happen as well in other countries in Latin America..

Okay, great. Thank you. .

Thank you, 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 to all for your continued interest in PDS Biotechnology. We believe that 2021 will be an exciting year for the company. We have multiple ongoing clinical trials of PDS0101 in oncology and also the anticipated initiation of clinical trials for our second generation COVID-19 vaccine.

These studies should deliver proof of concept data for our lead asset PDS0101 and should also provide validation of our Versamune T-cell activating platform more broadly. We appreciate your ongoing support in this pursuit. For more information about the company and our ongoing clinical trials, please visit our website at pdsbiotech.com.

Thank you very much once again..

Thank you, and 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..

Thank you very much..