Greetings and welcome to PDS Biotechnology Second Quarter 2021 Financial Results. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Deanne Randolph, Vice President of Commercial Development. Please go ahead.

Good morning, and welcome to PDS Biotechnology's second quarter 2021 earnings conference call and audio webcast. With me today are Dr. Frank Bedu-Addo, Chief Executive Officer; Dr. Lauren B. Wood, Chief Medical Officer; and Dr. Seth Van Voorhees, Chief Financial Officer. Earlier this morning, PDS Biotech issued a press release announcing financial results for the quarter ended June 30, 2021. We encourage everyone to read the press release as well as PDS Biotech's quarterly report on Form 10-Q, which was filed with the SEC earlier this morning. The company's press release is available on PDS Biotech's website at pdsbiotech.com, and the quarterly report will be posted later today. In addition, this conference call is being webcast through the company's website and will be archived there for future reference. Before we begin, I would like to caution listeners that comments made by management during this conference call will include forward-looking statements within the meaning of federal securities laws, including the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve material risks and uncertainties, and the company's actual results may differ materially. For a discussion of these risk factors, including, among others, the risks related to COVID-19, the impact such pandemic may have on the company's business operations, financial operations and results of operations and the company's ability to respond to the related challenges, including those noted in this morning's press release, please refer to PDS Biotech's SEC filings. Investors, potential investors and other listeners are urged to consider these factors carefully in evaluating the forward-looking statements and are cautioned not to place undue reliance on such forward-looking statements. Please note that the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, August 12, 2021. Except as required by law, the company undertakes no obligation to revise or update any statement to reflect events or circumstances that take place after the date of this call. Following today's prepared remarks, we will open the discussion for a question-and-answer session. With that, I would now like to turn the call over to Dr. Frank Bedu-Addo. Frank?

Mr. Bedu-Addo, your line is live. You may be muted.

Can you hear me?

Yes, sir.

I’m, unmuted. Can you hear me now?

Yes, sir. We can.

Can you hear? Okay. Okay. So let me start again then. Okay. Thank you, Deanne, and thanks to everyone on the call today. In the first half of 2021, PDS Biotech took a very significant step forward in our quest to develop transformative treatments for cancer. Over the past quarter, we obtained initial efficacy data in advanced refractory cancer patients whose cancer have continued to progress after treatment. In these advanced cancer patients, the observation of tumor shrinkage in about 70% of patients suggest that PDS0101's ability to induce in vivo large quantities of the right phenotype of HPV16 specific killer T-cells with strong killing potency may provide a powerful anti-tumor effect. This observation is an agreement with extensive preclinical studies as well as our Phase I clinical study of PDS0101. We will continue to evaluate and confirm the anti-cancer efficacy of Versamune in our three ongoing Phase II trials of our lead candidate PDS0101 in HPV related cancers. The demonstration of strong efficacy in preclinical and clinical studies of PDS0101 provides the scientific and clinical bases to aggressively pursue the next phase of growth for the company. We are preparing to advance our next two oncology pipeline products into human clinical testing, which both Lauren and I will discuss in more detail. Our recently completed financing provides us with the capital backing necessary to accomplish our plan of expanding our pipeline into clinical testing. These planned activities will enable us to continue to validate the Versamune platform at a highly promising approach to safe and effective cancer immunotherapy. We anticipate that the current data will also facilitate our path towards commercialization of our products and our plans to continue to grow shareholder value. The interim data for our National Cancer Institute led Phase II study of PDS0101, was reported…

Now, I'd like to pass the call to Dr. Lauren Wood, PDS Biotechnology's Chief Medical Officer, who will provide more comprehensive clinical updates on our immuno-oncology programs. Lauren?

Thank you, Frank, and thanks to all of you for joining us this morning. As Frank just detailed, we have made incredible progress with our oncology pipeline since our first quarter call. I'll begin with our ongoing oncology clinical trials. Starting with our lead candidate PDS0101, which targets HPV16 related cancers, there are three ongoing Phase II clinical trials. The most progress is a study being performed at the National Cancer Institute in advanced HPV associated cancers. Interim data for this study was presented in June at the 2021 ASCO meeting. As Frank mentioned, these PDS0101 data represents the first proof-of-concept human clinical data in advanced cancer for our Versamune technology platform. I'll begin with an overview of the clinical trials designed for this investigator initiated study of PDS0101 in combination with Bintrafusp alfa known as M7824, a first in class by a functional checkpoint inhibitor and M9241, an antibody conjugated cytokine designed to facilitate entry of the cytokine IL12 into tumors. Moving forward, I'll refer to Bintrafusp alfa as Bintraf. The study is designed to evaluate the treatment combination in both checkpoint inhibitor naive and refractory patients with advanced HPV associated cancers that have progressed or returned after treatment. Most HPV associated cancers, those associated with greater than 95% of all U.S cases are represented in this NCI data set. From epidemiology reports, we know that 70% to 80% of these cancers are caused by HPV16 infection. As Frank noted, the most autogenic high-risk HPV type. These cancers include anal, cervical, head and neck, vulvar and vaginal cancer. The composition of tumor types included in the trial to date is similar to that seen in the overall population, with the majority of patients having head and neck or cervical cancer, followed by anal, vaginal and vulvar cancers. In the…

Thank you, Lauren, and good morning, everyone. Let's now turn our discussion to a review of our financial results. For the 3 and 6-month period ending June 30, 2021, our loss from operations was approximately $5.1 million and $8.2 million, respectively, versus a loss of approximately $2.9 million and $7 million, respectively during the same periods in 2020. During the second quarter of 2021, our operating loss was positively impacted by approximately $4.5 million from the sale of our New Jersey tax benefit, pursuant to the New Jersey technology business tax certificate transfer net operating loss program. Our net loss for the 3 and 6 months period ending June 30, 2021 -- excuse me, June 30, 2021, was approximately $0.6 million and $3.6 million, respectively, or negative $0.03 and $0.16 per basic and diluted share versus our net loss for the 3 and 6-month period ending June 30, 2020 of approximately $2.9 million and $7 million, respectively, or negative $0.19 and $0.54 per basic and diluted share. For the 3 and 6-month period ending June 30, 2021 research and development expenses totaling approximately $2.8 million and $4.2 million, respectively, as compared to $1.4 million and $3.4 million respectively for the same period in 2020. These results reflect an increase of approximately $1.3 million and $0.8 million, respectively, for the 3 and 6-month period ending June 30, 2021 versus the same period in 2020, reflecting higher levels of clinical-related activity. For the 3 and 6 months period ending in June 30, 2021, general and administrative expenses were approximately $2.3 million and $4.0 million respectively, as compared to approximately $1.5 million and $3.6 million, respectively, for the same periods in 2020. These results reflect an increase of approximately $0.8 million and $0.4 million respectively, for the 3 and 6-month period ending June…

Thank you, Seth and Lauren. I would also like to thank our extremely valuable team members here at PDS Biotech, and all of our clinical partners for their continued excellent work. Without the expertise of our teams and the successful collaborative efforts, this quarter's milestones would not have been possible. The second quarter has been extremely important for PDS Biotech. The previously unseen level of objective responses in advanced refractory cancer reported by the National Cancer Institute in the PDS0101 trial provides the first proof-of-concept data in advanced refractory cancer for our Versamune technology platform. Our capital raise of approximately $52 million further strengthens our balance sheet and provides PDS Biotech with the funding necessary to aggressively advanced our immuno-oncology pipeline. The company is well-positioned, and we plan to build on the current momentum to move quickly to the next phase of growth by continuing to successfully execute our three ongoing Phase II clinical trials for PDS0101 and to progress PDS0102 and PDS0103 into human testing. We are also looking forward to continuing to build an awareness of PDS Biotech within the investment community. That concludes our prepared remarks. Operator, please begin our question-and-answer session.

Thank you. Our first question today is from Louise Chen of Cantor Fitzgerald. Please proceed with your question.

Hi. Congratulations on all the progress in the quarter, and thanks for taking my questions here. So my first question is why or how does the data that you've seen so far for 101 give you confidence in a positive outcome for your KEYTRUDA combo trial. Secondly, for PDS0103, just curious where you think you would fit in the treatment paradigm, if approved? Because some of the indications you're going up after are crowded like non small cell lung cancer. And then third question is for PDS0102, your TARP, you stated in your presentation that you're looking or potentially looking at AML. So just curious if key malignancy is an area you're interested in pursuing. And if so, how do you plan to build a franchise around that? Thank you.

Hi, Louise. Thanks a lot for your questions. And I'll start and Lauren will probably jump in also as we go ahead. So for the first question, regarded, the results from the PDS0101 NCI-led trial and how we believe the results impact the KEYTRUDA trial. So one key thing to note with the NCI trial is the fact that this was a basket trial and contains a number of different cancers, including head and neck cancer, which is specific to the KEYTRUDA trial. And we saw uniformly -- uniform efficacy across the various types of cancer including head and neck cancer. And also very importantly, as Lauren described, and the fact that we saw regression only in the HPV16 positive patient population suggests strongly that PDS0101 is specifically activating HPV16 CD8 T-cells as it is designed to do. This is the specific population that we are also looking at with KEYTRUDA. So the KEYTRUDA study is specific to HPV16 positive head and neck cancer. So the results we obtained from the NCI trial are highly encouraging, based upon that supported or implied activation of the CD8 T-cells which would be critical for the KEYTRUDA trial. Now, we have seen synergy between checkpoint inhibitors and diverse immune technology in preclinical studies. So as you know, with the checkpoint inhibitors KEYTRUDA, for example, has been shown to be quite effective at blocking the tumors defenses, and making the cancer or the tumor cells much more visible to the immune system. And so we see strong synergy with these checkpoint inhibitors where once those tumors are made more visible to the immune system Versamune by training, recruiting and generating a large number of T-cells can then go in and effectively kill the D camouflaged tumor cells, right. So that's the synergy that we are expecting with the KEYTRUDA trial, and that's what gives us a lot of -- what we believe is highly promising based upon the results that we have seen currently in the NCI-led trial.

Okay.

And Louise, does that answer the first question?

Yes, thank you.

Okay. And I'll go to the TARP study next. So with TARP, as we mentioned, the -- TARP has expressed in 100% of AML, approximately 90% of prostate cancers and about 50% of breast cancers. Now, the initial study that has been performed by the NCI that validated TARP as a target for these cancers, was done in prostate cancer. And as a risk mitigation strategy the approach PDS has taken is actually to start with prostate cancer, right. With AML, we understand that it is heavily expressed in AML. But one of the things we want to do is to take our time and really understand that blood cancer space before we rush into performing clinical trials in the blood cancer. So we are initially starting with prostate and breast and we will evaluate the AML space more closely before we actually get into any clinical trials for AML specifically. And then with PDS0103, the MUC1 cancers, again so with that currently -- what we are doing currently is looking at combinations with PDS0103 at the NCI. These studies are currently being performed at the NCI, just like they did with PDS0101. And then based upon that -- those results, as Lauren mentioned, those results will inform our clinical design and specifically, what indications in MUC1 or what stages of those cancers we will be addressing. But we will take a very close look and also just as we've done with PDS0101, we do intend to be very strategic in addressing those kinds of looking at the potential for whatever combination we go into in that specific population of patients that we start to address these trials in. We may actually start with a basket trial like we did with PDS0101 and to really understand exactly how it's impacting patients with the different types of cancers, and then make the final decision as to which ones we believe provide the greatest opportunity for PDS Biotech.

Thank you very much.

The next question is from Leland Gershell of Oppenheimer & Co. Please proceed with your question.

Great. Thanks and congratulations on the progress. Question maybe for Lauren or Frank, with respect to the VERSATILE trial. I know you reiterated the timelines for the initial data, late this year or Q1. With 16, I think 26 site activated, though, just kind of curious to ask about any insight that you're seeing from COVID-19 with respect to getting some of those remaining sites activated or with enrollment in various geographic spots? And I have a follow-up. Thank you.

Lauren, I'll hand that over to you.

Great. Yes, thank you, Leland. As everyone experienced, we did experience initial impacts from the COVID-19 pandemic. Our experience since we have reactivated the trial as of last fall, is that all of our institutions and partners that we're working with have already put in place, well established mitigation procedures to address COVID-19, and we've been able to progressively bring more and more sites on board. As the pandemic continues to evolve, regionally and globally, there is the potential that sites may be impacted, again, in terms of constraints on local resources. However, one of the issues that we have heard continuously from all of our sites is that because VERSATILE-002 targets patients with advanced recurrent cancers that have high unmet medical needs, they are among the priority trials that are supported to continue enrolling. Again, our enrollment has picked up and we do anticipate being able to report by the fourth quarter some initial data regarding safety or as early as first quarter of 2022.

Okay. Thank you. And then one question sort of higher altitude question. As you continue to study the Versamune platform in the context of different antigens, and particularly as you approach the completion of the preclinical work on 0102 with TARP, and you're also obviously looking at MUC1 with 0103, wanted to ask about what you're seeing in terms of the consistency with respect to the CD8 killer T-cell potency and durability that you're getting when you apply it in these different concepts, if there's any more you can share, in terms of the observations, you've seen preclinically. Thank you.

Okay, so Lauren, I can start with that. So, I think that's an interesting question. And one question that we often get is, what's the impact when you combine self antigens with Versamune, especially in some of these other cancers that -- were the antigens may already be present not due to foreign agents. Now, this is what we're evaluating with the TARP with Muc1 and we've also done that with TRP-2 in melanoma. And in each of these cases, what we have found out is that with Versamune by being able to effectively recruit T-cells and prime them to specifically recognize those antigens, that even though they are due to self antigens in each and every one of these cases, we have seen CD8 T-cell responses in the preclinical models very similar to what we saw with PDS0101. So, it is highly suggestive, that if we can actually activate the right immunological pathways and effectively present the antigen into the right processing and presentation pathways, that we may be able, even with those cell tumor -- cells antigen based cancers to generate very similar immune responses to what we see with PDS0101. And actually the study that was done by the National Cancer Institute and led by Dr. Wood, looking at TARP in prostate cancer patients, it's also very highly suggestive that if properly presented, that we should be able to potentially generate similar levels of anti-tumor responses even with these other types of antigens, which appears to be highly dependent on effective recruitment, effective presentation and activation of the right immunological signaling pathways.

Thank you for taking the question.

The next question is from Joe Pantginis of H.C. Wainwright. Please proceed with your question.

Hey, everyone. Good morning. Thank you for taking the question. Wanted to ask a question regarding your Farmacore update for the COVID vaccine. Frank, I was just curious, from a logistical standpoint in manufacturing the antigen, are there any technical issues that Farmacore is experiencing, any logistical issues or and is this cause any sort of missing of contractual obligations?

Well, good question. I think these are some of the key questions that we are seeking to understand with the review that we're currently performing with Farmacore. And so hopefully in the next couple of weeks, we will have a much better understanding of exactly what's going on, and exactly what the next steps could potentially be. But these are the key things that we are seeking to much better understand with our ongoing review of the program currently.

Got it. Thank you very much.

You’re welcome.

The next question is from Robert LeBoyer of Noble Capital. Please proceed with your question.

Good morning, and thanks for the comprehensive review of all the data. Could you just give the milestones that are upcoming for the three trials in O101?

Yes. So with -- Lauren, why don't you go ahead?

Sure. Good morning, Robert. Thanks for the question. So the key milestones for the NCI-led triple combination study, we anticipate accrual to that study is projected to complete during the first quarter of 2022. We also anticipate that more mature data regarding a greater complement to patients will be available in the first half of 2022. Regarding the PDS sponsored VERSATILE-002 study looking at PDS0101 in combination with KEYTRUDA, we project that we will have some preliminary data at the end of the fourth quarter or early Q1 of 2022 that specifically also includes the evaluation of the initial safety cohort, assessing the safety of the combination for the trial. And then for the MD Anderson led trial of PDS0101 in combination with standard of care chemoradiation therapy, we expect some preliminary data by the first half of 2022.

Right. Great. Thank you very much.

The next question is from Jim Malloy of Alliance Global Partners. Please proceed with your question.

Hey, guys. Thanks for taking my question. And I had -- just had a quick question on the $75 million cash, where do you -- as you allocate that to your pipeline, how do you see the allocation going between the multiple trials you’ve ongoing? And can you talk a little bit about does the infusion of cash increase spend in an integral direction that perhaps before you've been holding back on? And could you tell us about the runway for currently?

Right. So I think we should have a lot more information on that shortly. So what we are doing currently is, as I mentioned, we're looking to get PDS0102 and 0103 into human clinical trials this next year. We also have relationships with the National Cancer Institute. And one of the other things that we would potentially want to do, as we discussed at the R&D day, is hopefully to move the triple combination into a pivotal trial sometime late next year, right. So evaluating all those options. Now with moving into a pivotal trial involves discussions with our partners of NCI and also with EMD Serono. And those discussions will be initiated, as Lauren mentioned, we are looking to complete recruitment of that trial potentially early in the first quarter of next year. And what we want to do is to have enough data in the specific patient population before approaching the FDA to have discussions on what the regulatory pathway could potentially be. So that is in -- that is in the works in terms of what we do there and how we progress that program. What we have assumed is that we are going to be financially responsible for at least one of the PDS0102 trials moving forward. And what we are currently doing is actually in the process of designing that trial, right. So we will have more information once we understand exactly what that trial design is going to look like and how much that trial is going to cost. And with PDS0103 as both Lauren and I mentioned, the work that's being done currently at the National Cancer Institute is also going to inform specifically that trial design. And the agreement we have with under the with the NCI is that they will potentially fund that clinical trial. So as you can see there are a number of moving pieces that are currently in discussion. What we are confident about is the fact that we have the capital necessary to pursue these paths forward. But the deep specific details will depend on exactly what we're doing with our partners and the specific designs of those trials. And so we anticipate based upon what our projected forecast that we should potentially have enough time with the capital we've raised to get to some meaningful interim data points for these trials that are currently going to be started before we have to go back to the markets. But we will have a lot more information on that once we have decided exactly what the trial design is and how we're moving forward with the -- with any potential pivotal trial coming up.

Okay, great. Thank you. Then a quick follow-up. You had mentioned I think in the past for the Phase III for the triple combo, signed in on a potential marketing partner beyond NCI, and a industry partner. Any comments you can put around how those conversations may be going? Or any sort of partnership conversations may be going on in the interest levels post the ASCO data?

I think as I mentioned all parties are very interested. And based upon the very promising data that was generated, we think there is a potential path forward, especially with the checkpoint inhibitor refractory patients, because that's the patient population who have very few options for treatment, and the results were so encouraging in that population. However, it's one thing to go to the FDA with extremely good results in 12 patients versus going to the FDA with really good results in 30 patients, right. So I think what we all have decided to do is to give it some more time, let's wait to the fourth quarter or early first quarter when we have at least 30 patients recruited. And then based upon what the data looks like then, let's come up with a strategy and have initial discussions with the FDA to determine what the best regulatory path would be, and if there is some accelerated pathway we could potentially pursue. But we would like to have some data and a few more patients before we initiate those discussions with the FDA.

Great. Thank you for taking the questions.

No problem.

There are no additional questions at this time. I'd like to turn the call back to Frank Bedu-Addo for closing remarks.

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

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