Hello and welcome to PDS Biotechnology First Quarter 2022 Earnings Call and Webcast. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. . As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Gabby DeGravina. Please go ahead.

Good morning. And welcome to PDS Biotechnology's first quarter 2022 earnings conference call and audio webcast. With me today from the company are Dr. Frank Bedu-Addo, Chief Executive Officer, Dr. Lauren B. Wood, Chief Medical Officer, and Matt Hill, Chief Financial Officer. Earlier this morning, PDS Biotech issued a press release announcing financial results for the quarter ended March 31, 2022. We encourage everyone to read the press release as well as PDS Biotech's report on Form 10-Q, which was filed with the SEC earlier this morning. The company's press release is available on the PDS website at pdsbiotech.com and the 10-Q should be posted later today. In addition, this conference call is being webcast and will be archived on the company website for future reference. Before we begin, we need to remind everyone that, on today's call, the company will be making forward-looking statements regarding regulatory and product candidate development plans, as well as research activities. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. A description of these risks can be found in the PDS Biotech's most recent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this conference call. Except to the extent required by applicable law or regulation, PDSB undertakes no obligation to update the forward-looking statements included today to reflect subsequent events or circumstances. As you can see, we are using a different format for the earnings call today. Relying on slides to help summarize programs and milestones and aiming to streamline the presentation of background information and updates. We know your time is a precious commodity and we there’s much time as possible for Q&A. Your feedback on this new structure would be welcome. With that, I would now like to turn the call over to Frank. Frank?

Thank you Gabby. And thanks to all of you for joining us this morning. Before we get into the details of our recent achievements and financial results, we thought it would be helpful to give a brief review of our platforms and pipeline to put our accomplishments into content. We are also providing some visuals to aid our discussions. For those of you who maybe new to this story and as a quick refresher our pipeline is built on two proprietary T cell activating platforms Versamune on which I’m expanding pipeline of clinical and pre-clinical molecularly targeted immuno-oncology candidate are based and Infectimune on which our advancing pre-clinical infectious disease pipeline is based. The Versamune platform allows us to administer tumor specific protein by subcutaneous injection resulting in powerful CD8 killer T cells responses against the cancer. The Infectimune technology is administered predominantly by intramuscular injection and results in both pathogen specific T cell and antibody responses. PDS Biotech is developing multiple molecularly targeted cancer immunotherapy candidates such as our lead products, PDS0101. PDS0101 has been demonstrated in on-going studies to target cancers that express or contain HPV and is agnostic to the anatomic location of the cancer. These Versamune based immunotherapies therefore have the potential to treat a broad range of cancer types. With our Versamune platform, we seek to lead a transformation in the treatment of cancer towards not only more effective but also potentially safer therapies. We believe that we are well on our way to doing so. With our Infectimune technology, we seek to lead the development of more broadly protected vaccines, such as seen in the preclinical results reported with our universal flu vaccine. Here we provide a broad overview of on-going studies with our lead Versamune based candidate PDS0101 which has been evaluated in…

Thank you, Frank. And thanks to all of you on the call today. In this challenging environment we currently find ourselves in we're truly grateful to our investors and analysts for their support, and continued interest in the PDS Biotech story. For the first quarter ended March 31, 2022 here are some of the financials. Research and Development expenses increased to approximately $5.2 million for the three months ended March 31, 2022 from approximately $1.4 million for the three months ended March 31, 2021. The increase of approximately $3.7 million in 2022 was primarily attributed to an increase of $1.8 million in manufacturing services and quality costs, a million dollars in clinical and regulatory costs and $0.8 million in personnel costs. General and administrative expenses increased to approximately $3.3 million for the three months ended March 31, 2022 from approximately $1.6 million for the three months ended March 31, 2021. The increase of approximately $1.7 million is primarily attributed to an increase in a million dollars in personnel costs, $0.6 million in legal fees, and $0.1 million in marketing costs. In April, we were able to monetize our net operating loss carry forwards in the state of New Jersey receiving $1.2 million from the net sale of tax benefits to an unrelated profitable New Jersey Corporation pursuant to the company's participation in the New Jersey technology business tax certificate transfer net operating loss program for state fiscal year 2021. We ended the quarter with $58.9 million in cash, a strong position resulting from our partnering model and continuous financial discipline that we project will fund our operations into 2024. With that, why don't we open it up to questions? Operator?

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

Hi, congratulations on all the progress this quarter. And thanks for taking my questions. So I have two questions for you. First one is, you talked about a lot of different programs and initiatives. So what are the pushes and pulls on your cash runway that you mentioned that goes through 2024? And then secondly, as you think about allocating your resources and meaningful time and dollars, how do you think about how you're going to do that with oncology and infectious disease being on the front burner so to say. Thank you very much.

Louise thanks a lot for your questions. So addressing the first one in terms of where we allocate our resources as we look at both oncology and infectious diseases, with oncology SEC , we have instituted a pretty aggressive partnering program. I think one of the things you'll probably realize compared to our peers is the quality of partners that we brought on to our programs, which we believe in addition to providing significant validation of the approach we've taken, as Matt also said, and as I said in the presentation is also very important in how we allocate our financial resources and the benefit that these partnerships have also provided to PDS in terms of our ability to broadly cover the HPV cancer space and actually perform for clinical trials with PDS0101 across all HPV cancer indications, right? So this is really strategic. It was a very strategic approach for PDS, very importantly, addressing this question of allocation of financial resources. So other than other than the Keytruda trial, where we are responsible for financially managing that trial, our partners, there's a significant cost sharing benefit with for each of the other clinical trials. Right. So that approach is really what has allowed us to accomplish what we're doing today. As we look forward to going into pivotal trials, right? So part of what we will again do is determine how best and how financially, how financially efficiently, we can perform those pivotal trials, right. So two key pivotal trials that we would want to start talking about and start evaluating now are Keytruda trial, as well as the triple combination trial. Right. So those are key things that we will continue to update update folks on as we continue to progress, those trials. But the partnership agreements and…

Yes, it did. Thank you very much.

You're welcome.

Thank you. Next question today is coming from Leland Gershell from Oppenheimer. Your line is now live.

Hey, good morning, and thanks for taking my questions. As we look forward to the upcoming data at ASCO, just want to ask Frank, longer term as we think about the development path for PDS0101 and any regulatory perspectives on how we should think about next steps for this development program on route to potential delay filing? Thanks.

Hey Leland, thanks a lot for your questions. So for both programs, one of the key things that we would want to do would be to have discussions with the FDA sooner than later, probably sometime early in the third quarter to align on what the regulatory pathway would be for both programs. For the Keytruda program, the goal here, as we mentioned, is to really move the needle significantly in terms of the clinical benefits and improving the clinical benefit over what we see with Keytruda and also not compounding the toxicity. So the data we've seen really to date in the first 18 patients, we believe is very significant in allowing us to potentially achieve that goal of enhancing the clinical benefit without compounding the toxicities and that we believe would be very important in really positioning this combination. Very importantly, in the eyes of the oncologist who will be treating a lot of these patients. And what we found out from a lot of the market research we've done is how important safety is to these oncologist especially with the earliest stage cancer patients, right. So we believe if this continues, and this progresses, it positions this combination, very, very, very favorably. Leland , and we anticipate that we will have to perform a control study. And so those are some of the key things that we would want to discuss with the FDA in terms of what they would want to see in the control arm as we move into the pivotal trial. With the triple combination one of the key things we've done is really, if in this case, we're looking at three investigational agents, and one of the key questions that people have asked is, how quickly are we going to move this into…

Great, thank you. We look forward to the ASCO presentation.

Welcome.

our next question is coming from Jim Molloy from Alliance Global Partners. Your line is now live.

Hello this is Laura Suriel calling in for Jim Malloy, thank you for taking our questions. So a follow up on the last question that was asked regarding the versatile and the triple combination trial of PDS0101. So when does a company have an overall idea of when the completed enrollment might be finished for these two trials? Will that follow up after the ASCO meeting that's coming up this summer? Or will that follow after the talks of the FDA that the company is planning to have? And as a second question, are there any updates regarding the IMMUNOCERV Phase II trial of PDS0101? And is the company still in line to obtain preliminary data for this trial mid-year? Thank you.

Thanks a lot for your questions. So in terms of the first two trials and enrollments, so starting with a triple combination trial. As of the last release, we made regarding enrollment, the NCA had enrolled 45 patients and have achieved the goal of enrolling 30 in the checkpoint inhibitor refractory on. They have enrolled that are much more quickly than they are enrolled in naive arm. And so what they're doing now is enrolling all comers, both checkpoint inhibitor, refractory and checkpoint inhibitor naive in order to get to their goal of 56 total patients quickly. The last guidance they gave us was that they anticipate to complete enrollment for that trial sometime during the summer. Right and that's the last guidance that we received from the National Cancer Institute on that trial. With the VERSATILE-002 that's a larger trial. We anticipate based on the recruitment as you know is very difficult to predict. So we are hoping or hopeful that we should be able to at least get to the end of the stage the first arm. So we have the checkpoint inhibitor naive which started first and which we will be reporting on at ASCO and also the refractory arm. We are hopeful that we can make significant progress towards getting to the end of the recruitment. Hopefully early sometime early next year, I think it’s in the first stage. But what we want to do is to have discussions with the FDA, based upon the current data that we have generated, get a good understanding from the FDA, how much more data they would want us to collect, or whether they want us to collect any more data and then make a decision as to what we do moving forward. We will not be able to even if we make a transition to go to a pivotal trial, we will probably still have to keep this trial going just for ethical reasons to make sure that all the patients get their full treatments. So these – it’s a very good question. These are some of the things we are currently evaluating internally. And some of the discussions we will be having with FDA. So hopefully we will be able to provide you with some details and some more solid, solid decisions probably sometime in the third quarter regarding how this is going to progress, right. And in terms of the immunotherapy, immunotherapy is still on track. We still anticipate providing updates and preliminary data sometime early in the third quarter of this year. So that's still on track.

Thank you. Your next question is coming from Robert LeBoyer from Noble Capital. Your line is now live.

Good morning. My question has to do with the influenza program. And I want to know if you have any timeframes for filing INDs or starting clinical trials?

So with the influenza program, we have not received any details yet from the NIAID. We know Dr. Tedros is working with them. And we are hopeful that we will be able to receive some funding to go into human clinical trials. But until that, until we know for sure whether or not that's going to happen. It's very difficult to project any IND filing dates, a lot of it is it's really going to depend on whether or not we get the funding to take it into human clinical trials. I think in our minds, we've made the decision that our capital resources will be focused on the oncology programs and so we're really going to be depending are dependent on non-dilutive financing to take that program into human clinical trials. We are quite hopeful, but I think the moment we have some idea of whether that's going to happen or not. And when it is going to happen, we will then be able to provide much more solid details on when the IND filing will occur.

Okay, great. Thank you very much for that.

You're very welcome.

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.

Again thank you very much for joining us today. And we continue to look forward to updating all of you on our clinical and preclinical progress throughout the year. And we will certainly be in touch shortly with more details about our data presentations and events surrounding ASCO. In the meantime, we hope you have a great rest of the week. And again, thank you very much for all your support the company and thank you again for joining us today. Have a great day.

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