PDS Biotechnology Corporation

Greetings. Welcome to PDS Biotech second quarter of 2022 earnings call and webcast. At this time, all participants are in listen-only mode. Any question and answer session will follow the formal presentation. If anyone today should require operator assistance during the conference, please press star zero from your telephone keypad. Please note that this conference is being recorded. At this time, I'll turn the conference over to Gabby DeGrazina with the best relations. Gabby, you may now begin.

Good morning, and welcome to PDS Biotechnology's second quarter 2022 earnings conference call and online webcast. With me today from the company are Dr. Frank Bedouinot, Chief Executive Officer, Dr. Lauren V. 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 June 30th, 2022. We encourage everyone to read the press release as well as PDS Biotech's report on Form 10-Q, which will be filed with the SEC shortly. The company's press release is available on the PDS website at pdsbiotech.com. 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. Certain information in this presentation may include forward-looking statements, including within the meaning of Section 21 of the United States Securities Exchange Act of 1934, as amended, and Section 27 of the United States Securities Act of 1933, as amended. concerning PDS Biotechnology Corporation and other matters. These statements may discuss goals, intentions, and expectations as to future plans, trends, events, results of operations, or financial condition, or otherwise based on current beliefs of the company's management, as well as assumptions made by and information currently available to management. These statements are subject to risk and uncertainties that may cause actual results to differ from those forecasted. A description of these can be found in 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 which 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're utilizing slides to help summarize our programs and milestones, and aiming to streamline the presentation of background information and updates. We know your time is a precious commodity, and we want to leave as much time as possible for Q&A. Your feedback on this structure would be welcome. With that, I would now like to turn the call over to Dr. Frank Beduado. Frank?

Thank you, Gaby, and thanks to all of you for joining us this morning. This past quarter, the PDS Biotech team has worked diligently to advance the development of our oncology and infectious disease pipelines, and we have made tremendous progress on these fronts. Here, you can see the broad overview of our lead versimune-based candidate, PDS0101, an investigational immunotherapy designed to treat human papillomavirus, or HPV16-associated cancers. As a reminder, our Versamune technology platform promotes the delivery of tumor-associated proteins, also called antigens, to the immune system and simultaneously activates the immune system to induce antigen-specific killer T-cells. TDSR101 combines Versamune with HPV16 antigens and therefore promotes the induction of CD8-positive killer T cells that target and kill tumors that are HPV16-positive. Our second proprietary oncology platform combines Versimune with cytokines such as IL-12. This combination of Versimune with cytokines leads to the reduction in the population of immune-suppressive cells such as myeloid-derived suppressor cells, also called MDSC. Preclinical data with this platform suggests that this technology may allow us to treat a broader population of advanced cancer patients beyond those who respond to checkpoint inhibitors. We are evaluating PDS0101 across four ongoing phase two clinical trials. In the three most progressed studies, we are evaluating PDS0101 as a combination treatment with various anti-cancer agents in advanced and refractory cancers. We are studying these combinations in multiple HPV-associated diseases and at different stages of the disease from locally advanced cancer to terminally ill patients with recurrent metastatic checkpoint inhibitor refractory disease. We are performing these studies in collaboration with some of the most respected cancer centers in the world. In the fourth trial, investigators at Mayo Clinic are leading a study to evaluate PDS0101 as immunotherapy or in combination with Keytruda in early stage oral cancer. It is important to note that our approach of performing this broad range of studies is to enable us to understand in which indications the various combinations may work better and to allow us to select the most promising combinations and indications to rapidly progress into pivotal trials. This broad approach allows us to mitigate the risk of product development as we know that not every combination is likely to be as promising for every disease indication. As we look ahead, our key priority is to advance PDS0101 as rapidly as possible to commercialization. To date, we have reported efficacy and or safety data from 80 patients in two trials. and we are highly encouraged by the fact that the results continue to demonstrate the promising efficacy and safety of PDS-0101. These results have also been accurately predicted by our preclinical studies, which is highly encouraging. The clinical data generated to date is beginning to elucidate which indications and combinations could potentially be selected for pivotal studies. Importantly, we presented very encouraging data in June at ASCO from two of our ongoing Phase II clinical trials. The versatile 002 study is evaluating PDS0101 in combination with Merck's anti-PD1 checkpoint inhibitor therapy, Keytruda, or pembrolizumab in patients with HPV-16 positive recurrent and or metastatic head and neck cancer. The National Cancer Institute-led triple combination study is evaluating PDS-0101 in combination with a checkpoint inhibitor and NHS IL-12 in both checkpoint inhibitor-naive and refractory patients in a range of advanced HPV-positive cancer patients who have failed prior therapy. As I mentioned earlier, this combination of Versamune, a checkpoint inhibitor, and IL-12 may enable us to treat a broader population of refractory and very difficult to treat patients. Dr. Lauren Wood will be covering highlights from the ASCO data presentations shortly. In addition to the data presentations, we also have some exciting news announcements related to the Versatile trial during the quarter. As we announced in May, we received notification of the acceptance of the Clinical Trial Application, or CTA, to allow expansion of the versatile study into the UK. Our strategy is to expand the trial into various sites outside of the United States. Due to the time taken to prepare international sites for a trial, we believe that this approach of getting the various regulatory agencies familiar with our product could facilitate rapid transition to an efficiently enrolling pivotal trial to accelerate development. This goal of expanding the Versatile 002 trial into the European Union based on recent data is accounted for in our financial projection. We will provide updates as enrollment in Europe begins. Also during the quarter, based on the results so far from the Versatile 002 trial, we were granted fast track designation by the FDA for PDS-0101 in combination with pembrolizumab for the treatment of HPV 16 positive head and neck cancers. As you know, the FDA's fast track designation program is designed to aid in the development and to expedite the review of drug candidates that could potentially treat serious or life-threatening conditions and that demonstrate the potential to address an unmet medical need. Lastly, on Versatile 002, our Independent Safety Data Monitoring Committee, or DMC, met for its scheduled review of the administration of PDS-0101 in combination with Keytruda. The committee safety review included data from 43 patients in both the checkpoint inhibitor naive and checkpoint inhibitor refractory groups. This more than doubles the 19 patients whose data was presented at ASCO in June. EDS-0101 in combination with Keytruda continues to appear safe and well tolerated. Specifically, as of the DMC review, there were no drug discontinuations related to toxicity and no grade 3 or higher treatment-related adverse events attributed to the combination. The DMC recommended continuing the trial with no modifications. The safety profile of PDS-0101 plus Keytruda continues to hold up. and we continue to believe that the versamine-based immunotherapies may enable not only more effective cancer therapies, but also safer and better tolerated therapies. Our third PDS-0101 trial is the ongoing MD Anderson-led Phase II ImmunoServe study, which is evaluating PDS-0101 in combination with standard of care chemoradiotherapy or CRT in patients with locally advanced cervical cancer who have either lymph node metastasis or tumors of size greater than five centimeters. This study is evaluating clinical responses as well as immunological biomarkers both in the tumor environment and in the blood circulation to better understand how PDS-0101 may be working immunologically and how it may improve standard of care. In this trial so far, promising clinical results as well as immunological data have been generated. And we have been informed by the MD Anderson team that an abstract has been submitted for presentation at the Society for Immunotherapy of Cancer or SITC meeting in November. To avoid jeopardizing acceptance of their abstract, we will wait until the embargo has been lifted to present the data. We continue to believe that it is in the best interest of all shareholders for our data to be scrutinized, peer reviewed, and presented to a larger audience of investors, potential partners, and key experts in the field. As we've discussed previously, we are thrilled to have established a relationship with the Mayo Clinic. This relationship has progressed from simply being a site for the versatile 002 study to now include the ongoing investigator-initiated trial where PDS-0101 is being evaluated both as a monotherapy and in combination with Keytruda. This study is being conducted in newly diagnosed patients with HPV16-associated oropharyngeal cancer. Enrollment is ongoing, and we will provide updates as they become available. Finally, a quick regulatory note here. We plan on meeting with the FDA this quarter to discuss the registrational path forward for PDS-0101 in combination with Keytruda and are also expecting to meet with the FDA later in the year to discuss the NCI-led triple combination study. We are hopeful that these meetings could green light progression into pivotal trials for both programs. We project based on current results that the dual combination will focus on checkpoint inhibitor naive patients, and the triple combination will address checkpoint inhibitor refractory indications due to a greater breadth of anti-immune suppressive activity. Our goal is to prioritize commercialization of PDS0101, and this could therefore cause us to adjust the timelines for initiation of the PDS-0102 and PDS-0103 clinical studies. PDS-0102 and PDS-0103 are progressing according to schedule and are currently in clinical stage manufacturing. Similar to our reverse immune oncology pipeline, we continue to leverage strategic collaborations to advance our infectimmune infectious disease programs with minimal capital outlay. Last month, our collaborator, Dr. Ted Ross, and his team presented preclinical data on the universal flu vaccine at the 41st American Society of Virology meeting. Based on these promising results, we continue to work with the National Institute of Allergy and Infectious Diseases, also known as NIAID, to advocate for advancing PDS0202 into the clinic. Discussions with the NIAID continue to progress. As part of this process, last month, Dr. Ted Ross and Professor Jerry Woodward, PDS Biotech's collaborator at the University of Kentucky School of Medicine, presented the preclinical universal flu efficacy data to the larger NIAID group. Last week, PDS presented the Infectimmune Clinical Manufacturing and Human Safety data to NIAID program staff. I'll turn the call over to Lauren, who will discuss these data in detail. Lauren?

Thank you, Frank, and thanks to all of you for joining us on the call today. As Frank just mentioned, we recently presented encouraging preclinical data from our influenza vaccine program in a poster at the American Society of Virology meeting. In this study, it was found overall that PDS0202 neutralized multiple strains of influenza and provided full protection against lethal infection in animals. The PDS0202 universal flu vaccine contains the infectimmune nanoparticles formulated with computationally optimized broadly reactive antigens, or COBRA, influenza antigens, developed by the laboratory of renowned influenza expert Dr. Ted Ross. The vaccine was evaluated for its potential ability to induce broadly neutralizing and diverse types of influenza antibodies. These antibodies were demonstrated to be effective against multiple influenza strains, and also provided full protection against lethal doses of the flu virus. Highlights of the poster included animals vaccinated with PDS-0202 demonstrated significantly higher antibody levels against multiple influenza strains compared to animals vaccinated without infectamines. 100% of animals vaccinated with PDS-0202 survived a lethal dose of the flu virus without sickness. All animals in the Cobra antigen only group got sick and showed significant body weight loss and only 40% survived. None of the untreated animals survived the lethal challenge. PDS-0202 was equally effective using 25-fold lower doses of the Cobra antigens. Importantly, no detectable virus was found in lungs from animals vaccinated with PDS-0202. Another advantage of PDS-0202 is the induction of T cells in addition to antibodies to provide robust protection against disease. Currently, there is no universal flu vaccine that provides broad protection against multiple strains of influenza. According to the World Health Organization, the flu is estimated to result in about 3 to 5 million cases of severe illness and up to 650,000 deaths each year. We are pleased by these data, which suggests that PDS-0202 has the potential to achieve the goal of providing the broad protection sought in a universal influenza vaccine. Let's turn now to our 2022 ASCO data. Here, we summarize the data presented from our Versatile 002 Phase II clinical trial, providing an update on the first arm of the trial, which is being conducted in checkpoint inhibitor-naive patients. The goal of the Versatile 002 study is to double the objective response rate or ORR, over that seen with Keytruda monotherapy, reported to be about 17% in the Keynote 048 study. The ORR refers to tumor size reduction of 30% or more. Keeping that in mind, let's get into the data presented at ASCO. An objective response was seen in 7 of 17 patients or 41.2%. Additionally, two of the seven patients had no evidence of disease or complete response. Please note that these data include both confirmed and unconfirmed responses. 89% of patients treated were alive at a median of nine months, suggesting a survival benefit when PDS-0101 is administered with Keytruda. Clinical benefit, which is the percentage of patients who have stable disease, plus those who have experienced objective responses, was 76.5%. At the time of the data cutoff, patients had received a median of 4 out of 5 doses of PDS-0101 and 9 out of 35 doses of Keytruda. On the safety side, there were no treatment-related adverse events greater than or equal to grade 3 in the 19 patients and no patients discontinued treatment as a result of toxicity. The same was observed in the 43 patients included in the recent data monitoring committee review. This compares favorably to Keytruda monotherapy, where grade three or greater treatment-related adverse events were reported in 17% of patients. The interim data from this study appears to demonstrate the clinical efficacy of PDS0101 and confirms the synergy with checkpoint inhibitors documented in preclinical studies. As Frank mentioned, we'll be discussing these data further with the FDA soon to determine a path forward to potentially begin our registrational phase of development. Turning now to the 2022 triple combination trial data. As a reminder, this is the NCI-led triple combination study evaluating PDS-0101 in combination with two investigational immune-modulating agents owned by Merck KGAA, Bintrafusp Alpha and M9241, which is also known as NHS IL-12. The triple combination is being studied in patients with extremely difficult-to-treat HPV-positive advanced, relapsed, and refractory cancers. Historically, objective response rates in checkpoint inhibitor refractory patients have generally been less than 10%. Ultimately, most patients treated with checkpoint inhibitor therapy will continue to progress and become checkpoint inhibitor refractory. Median survival for these patients usually is in the range of only three to four months. As Frank mentioned, the proprietary combination of versamune and NHS IL-12 is expected to expose a greater population of tumors to the immune system than can be achieved with checkpoint inhibitors alone. This may allow PDS0101 induced killer T cells to kill a greater number of HPV16 positive cancer cells, resulting in better clinical outcomes. Understanding the historical survival data in this difficult to treat population helps put our findings into context. Now, moving into the data. It was observed that 88% of checkpoint inhibitor naive patients had evidence of an objective response. This is the highest response we are aware of to date in any recurrent or refractory HPV-related cancer. 77% of checkpoint inhibitor refractory patients were alive at a median follow-up of 12 months. As I mentioned, These terminally ill patients historically would have been expected to live generally for a median of only three to four months. Seventy-five percent of checkpoint inhibitor naive patients were alive at a median follow-up of 17 months, again suggesting promising durability of the immune response. There were no grade five treatment-related adverse events. 43% of patients experienced Grade 3 treatment-related adverse events, with 7% experiencing Grade 4 events. This safety profile compares very favorably with pembrolizumab plus chemotherapy, where Grade 3 and higher treatment-related adverse events were reported in 72% of patients in the Keynote 048 study. Importantly, similar responses occurred across the entire range of HPV16 positive cancers, including anal, cervical, head and neck, vaginal, and vulvar cancers. The results presented at ASCO suggest that the proprietary versus immune IL-12 combination may have the ability to overcome additional tumor immune suppression that is not addressed by checkpoint inhibitors alone. These results combined with the previously reported data from this trial showing that tumor shrinkage only occurred in HPV16 positive subjects, suggests the potency of PDS0101 across both trials. The data also suggests that this novel combination of Versamune and IL-12 has the potential to provide improved clinical outcomes and overall survival for patients with refractory HPV-associated cancers. With that, I'll now turn it over to Matt for a review of our financial results. Matt?

Thank you, Lauren, and thanks to all of you on the call today. We continue to manage our cash carefully and have been fiscally prudent with our clinical strategy, leveraging partners to allocate costs to cover the investigation of a wide range of HPV 16 associated cancers. We wish to warmly thank all of those partners for their interest and confidence in PDS 0101 and Diverse Immune Platform. Moving into our summary financials for the second quarter ended June 30, 2022. Research and development expenses increased to $3.8 million for the three months ended June 30, 2022. from $2.8 million for the three months ended June 30, 2021. The increase of $1 million was primarily attributable to an increase of $0.4 million in clinical study and research development costs, $0.7 million in personnel costs, $0.1 million in facilities. And this is partially offset by decrease of $0.2 million in manufacturing services. General and administrative expenses. increased to $3.3 million for the three months ended June 30, 2022, up from $2.3 million for the three months ended June 30, 2021. The increase of $1 million is primarily attributable to an increase of $0.8 million in personnel costs and $0.2 million in legal fees. We finished the quarter with nearly $53 million in cash, a strong position as a result of our partnering model and continuous financial discipline, which we expect will fund our operations into 2024. PDS has brought in key resources to set ourselves up for the next stage of growth. We've also expanded our team with the addition of experienced biotech and pharma veterans to lead our business development and legal functions. In May, we welcomed Sanjay Zavari as Senior Vice President business development to lead our business strategy and manage the company's potential licensing and partnering opportunities in support of our pipeline. And in June, we welcome Spencer Brown as Senior Vice President and General Counsel. With that, let's open it up to questions. Operator?

Thank you. We'll now be conducting a question and answer session. If you'd like to ask a question today, please press star 1 from your telephone keypad and the confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Once again, that's star 1. Thank you. Thank you. Our first question is from the line of Louise Chen with Cantor Fitzgerald. Please receive your questions.

Hi, congratulations on all the progress this quarter and thanks for taking my questions. So I have a few here for you. First question I wanted to ask you was you talked about the EU opportunity. So I'm curious if you could size that or help us think about that opportunity for you. And then the next steps for your flu vaccine, what are you thinking about here and could you compare and contrast your platform with the mRNA platforms we've seen some data from? And the last question I had for you is, what was the physician feedback on your pipeline at ASCA when you presented your data? Thank you.

Thank you very much for the question. I will start answering and I'll also hand over to Lauren to add any additional comments. With the EU opportunity, I think, as you know, head and neck cancer is widely spread and we One of the key components of an efficient clinical trial is recruitment. We believe that expanding the trial into EU is going to significantly enhance our ability to enroll patients and to run the trial efficiently. Now, we are looking forward to potentially moving into a pivotal trial pending the feedback from the FDA. And we anticipate that getting the EU sites, getting those regulators familiar with our product and our data today, even if we have to transition into a pivotal trial, will be very beneficial in getting those trials running outside the United States. As you may be aware, sometimes it takes several months and even sometimes close to a year to get some of those ex-US sites up and running. And so getting those activities going sooner than later, we believe, could potentially be very important in allowing us to efficiently enroll in the trial and get the trial executed efficiently. And so that is one of our key goals in getting the EU sites up and going. And that is, as I mentioned, it's already taken account in our financial projections. So it's not a new activity that we are undertaking currently. Moving on to the flu vaccine. Yes, the mRNA platforms have been extremely impressive in the ability to rapidly generate vaccines against multiple agents and the viral agents, for example. I think there has been some data announced recently showing that the seasonal flu vaccine results is comparable to what's seen with the current flu vaccines, flu zone, for example. Now, what we are doing is very different. What we are developing is a vaccine that will be broadly active against multiple strains of the flu. Right, and so the way we see it is that with a successful universal flu vaccine, the current approach of trying to understand what strain of flu is going to be prevalent in a particular year and rapidly trying to generate a vaccine for that particular strain of the flu, more or less becomes obsolete because you have a universal flu vaccine that is effective against multiple strains of the flu, right? And that's the ultimate goal of an effective universal flu vaccine, a vaccine that is going to be effective against several strains. And that's the approach, the computational approach that Professor Ted Ross has taken has been to evaluate multiple strains of the flu over the last couple of decades and to try to incorporate the immunogenic regions of those particular flu strains into these COBRA proteins. And what we now show is that by combining those COBRA proteins with versed infectimmune, we're able to induce potent and broadly reactive neutralizing antibodies. And so that would be the goal. The goal would be that a universal flu vaccine would make the current approaches of having to rapidly develop a new vaccine every year more or less obsolete. And I think with the physician feedback, I will hand over to Lauren, and Lauren can give us some update on what the physician feedback has been today.

Yes, thanks, Frank, and thanks for the question, Luis. The feedback at ASCO 22 regarding the Versatile 002 poster, as well as the NCI triple combination poster, was significant. The feedback from physicians on Versatile 002 was not only the objective response rate of 41%, which is historically greater than a doubling of the 17% objective response rate seen with Keynote 048. So they were impressed by that. There was a lot of commentary regarding that. The second focus of the comments that we got was the tolerability of the regimen and specifically that there were no greater than or equal to grade three treatment related adverse events and that there were no discontinuations of drug therapy associated with the combination regimen. This contrasts to greater than grade three events of 17% reported with Keynote 048. So physicians were very impressed by that differentiating tolerability of the combination. Regarding the triple combination, everyone was very, very impressed, and there was a lot of commentary on the survival data, not only in the CPI-naive patients, where the follow-up was more extended, 17 months of follow-up, but the fact that even in CPI refractory subjects that had received the triple combination, whether it was low dose or high dose, that the survival was approximately 77%. So it was really about survival associated with the triple combination, as well as the differentiating tolerability of the dual combination profile in the versatile OO2 study.

Thank you.

The next question comes from the line of Jim Malloy with Alliance Global Partners. Please receive your questions.

Hi, good morning. Thank you for taking my questions. I had a quick question. I was wondering if you could talk a little bit about characterization of potential partnership markets. I know, obviously, of Katrina and Merck, the obvious elephant in the room, but how would you characterize opportunities for potential partnerships, given some of the strong data you've seen so far?

Jim, thanks a lot for the question. I think the more data we continue to generate, the stronger and stronger the PDS story becomes and the more compelling the data also becomes. And I think also, I mean, with... The large pharma companies, as you know, partnering is one of our strategies, but I think they will make their internal decisions as to what is critical or important for them in their partnering strategy. But I think at PDS, we continue to progress our data generation, and we believe that the more data we continue to generate, the stronger the story becomes and also creates strong opportunities for partnering with Merck and beyond Merck, right? So I think we are looking at a broad business development strategy. And also, very importantly, if we get the green light from the FDA to move into pivotal trials, that ultimately puts us in a different category, right? That makes us even more attractive for potential partnering. And we have brought on a senior vice president of business development whose key focus is really to start understanding and generating those business development opportunities. So we are certainly looking broadly. We believe the data that has been generated today, as I mentioned, we have data already from 80 patients across both trials. The data from both trials provide strong indications that PDSO 101 is working across both indications of both trials and across the entire spectrum of HPV cancers. So that's a very compelling package of data. 80 patients is a very significant number of patients. And so we believe we have very strong data, and that's what has caused us to activate this approach of beginning those business development discussions. So yes, Jim, it is an important piece of our business strategy, and that's something that we are focused on, and we are looking very broadly just beyond our current partners.

Thank you for that update. Maybe a quick follow-up if I could. Could you talk a little bit on timing on end of phase two and potentially starting pivotal phase three for the versatile program, the combo with the CUDA, and then initial timing for starting phase one for the universal flip? Thank you.

Jim, could you please repeat the first part of the question, the first part?

Sure. I'm sorry. The timing, current expectations and timing for an end of phase two of the FDA and starting potentially pivotal phase three for it. the Keytruda combo. Okay.

So we're anticipating talking to the FDA regarding that trial and our proposal for a pivotal trial this quarter. And so by the end of this quarter, we should have strong feedback from the FDA in terms of whether or not we can move that trial forward into a pivotal. If we do get the green light to do so, we anticipate that the trial could be started sometime during the first half of next year. But again, that is contingent on the response that we get from the FDA. That would be our hope, and that's what we are preparing to do. And hopefully we will be able to move that into pivotals early next year. With the universal flu vaccine, I think, as I mentioned during the earlier part of the call, We are working with the NIAID. We are hopeful that we will be able to attract some non-dilutive funding to move that into human clinical trials. It's very difficult to project what the exact timing would be. Dr. Ted Ross is really a strong advocate for the program, and he's working with the NIAID to... to also present to them the data, the opportunity, and so forth. And as I mentioned, Ted Ross himself and the NIAID have met. The PDS team has also met with the NIAID to provide them with the information that they would hopefully need to make that decision. So we are hopeful, but that decision has not been finalized at the NIAID yet. And so my anticipation is that I would say the earliest it could potentially go into human clinical trials would be sometime next year if everything works out and this program is green-lighted and funded by the NIAID. But we will keep you updated on that progress.

Thank you for taking the questions.

No problem. Thanks a lot.

Our next questions come from the line of Leland Gershelt with Oppenheimer. Please proceed with your questions.

Hey, good morning, and congratulations on the progress. A couple questions from me. Just one kind of sort of science question. Frank, in the versatile O2 data you presented at ASCO, there was an analysis based on the complete, you know, the CPS, the complete positive score. I'm wondering, you know, it didn't show sort of any clear correlation between those levels and response with the regimen. I'm just wondering if there's any further analysis you've done to look at that. Thank you.

Lauren, do you want to take that?

Yes, I can. Thanks so much, Leland. Well, for everyone on the call, just to reinforce, the entry criteria for all study subjects on Versatile 002 is that the composite score, the CPS score, measuring PD-L1 in the patient's tumor tissue, they must have a CPS score greater than or equal to one. That is the cause, that is the current standard of care requirement to receive Keytruda monotherapy. In doing the PD-L1 characterization, we also look to see whether or not individuals have composite scores that are greater than one, specifically greater than 20%. At this preliminary stage, Lewin, we have not seen any correlation at all between CPS score and greater than 20, but this is a small number of subjects that we presented at ASCO, and we're going to continue to characterize and look at whether or not the CPS score has any impact on correlation with the clinical outcomes. We have additional studies that are planned regarding characterizing immunogenicity and HPV-16 specific responses to see whether or not that correlates with clinical outcomes as well. But that's what we have to date.

Okay, thanks. And then just a question on the cervical cancer side. Obviously, you know, we're looking forward to the phase two immunoserve data that will be coming up. And Frank, I just wanted to ask how those data may change or... add to your plans in 23 and beyond with respect to continued development of the candidate in cancer? I mean, there's obviously a huge need in cervical cancer as well. So I just wanted to ask how you may look to deploy resources alongside the true to combo and head and neck as, you know, pending the immunosurgical test.

Right. That's an important question. One of the things to bear in mind is the strategy that we've currently taken of looking at multiple combinations and multiple indications is very important in our strategy of really rapidly understanding which combinations provide the most benefit in which indications. And so I think one of the things that we would have to do is also to look at the standard of care and how quickly we can improve or what the potential is to improve the standard of care. So I think the data that's been generated with Versatile and the triple combination are very compelling to date, right? But those are more or less in later stage patients. The early data that's been generated by MD Anderson is also very compelling, but it's still early. So I think we would like to see what the data looks like, the full data package, when it's available. And I think at that point, we will have to make a decision. If we see some compelling improvement over the standard of care, and as we see with MD Versatile 002, no compounding of the toxicity. I think that would be, again, very compelling. We will have to determine how we prioritize the trials and which ones we want to move into pivotals, as we're planning to do now with the triple and the dual. But that's a little bit behind those studies and very interesting data to date. But I think once the whole package is available, we'll sit down and determine what the real opportunity is in terms of that specific indication.

Great. Thank you. Thanks for taking the question.

No problem. You're welcome.

Our next question comes from the line of Joe Pankinis with HCU Aynright. Please proceed with your question.

Hey, everybody. Good morning. Thanks for taking the question. So, Frank, more on the flu program, and I want to balance my question by saying, obviously, you know, the field over the years has been constantly teased with a universal flu vaccine and the the data that you've presented seem to differentiate and position you well. So I guess I wanted to take the question further beyond the details you provided today and say, at least what's your broad view of how you can get this to market quickly? Because I know you said you're looking at potential non-dilutive capital or potential grant money from the NIH. How competitive do you think that process is? what would PDS look to potentially do on its own to rapidly advance this asset?

Thanks a lot. Good question. A lot of the things that we have been discussing internally I think with the universal flu vaccine, one of the things we want to do currently, looking at the infectious diseases versus oncology, is to really focus our resources on the oncology and move those programs towards commercialization as rapidly as possible and to be overall financially efficient. And that's why we've taken the approach of at least trying to get the early data for that universal flu program available via some non-dilutive funding approaches. That's really been our key desire to accomplish today. In terms of the differences, I think what's unique here is the antigens that are being utilized. You are right, universal flu vaccines have been discussed for over a decade. And the approach that has typically been taken has been to put together probably viruses two or three different strains of the flu together into a single vaccine, right, and with the hopes of generating antibodies against those specific strains of the flu that have been incorporated into that particular vaccine. What's being done differently here is the antigen approach, right, in terms of that computational design where a much broader number of strains have been taken into consideration over the last several decades in terms of, okay, what strains of flu have we seen over this last decade? How have they changed over the years? What are the consistent regions of those strains that can be modeled into a specific antigen? Now, when that is done, when you give that vaccine, even without infecting, you can see that you get some immune responses, but they are not as broadly protective as when you combine those novel Cobra antigens with Infectimmune. The beauty of Infectimmune is its ability to do what is necessary to generate a powerful immune response, right, which is presentation of the antigens into the right processing presentation pathways, as well as activating the critical immunological signaling pathway. When you put those two together, we've seen for the first time broadly neutralizing highly potent antigens anti-flu antibodies, as well as very importantly, T cells, right? And we see in the animal studies, complete protection, right? And no viral presence in the lungs after vaccination with that vaccine. So I think there is a very significant opportunity. I think one of the things that we will do is our business development activities will not just focus on oncology only, will very much look at opportunities in infectious diseases too. However, we believe that having some early human clinical data confirming the breadth of immune response in humans, as well as confirming the safety, will be very significant in allowing us to bring on additional partners in the infectious disease space too. Just like we've done with oncology, generated that early human data, we've generated significant data today, really demonstrating very compelling results. Right, our goal is we believe that that could potentially be important in attracting similar partnerships in the infectious disease space. But those are key goals for PDS, and those are key things that we're working on to hopefully get it to the clinic, generate that data while also potentially talking to prospective and potential partners.

Got it. Thanks. Very helpful, Frank.

You're welcome.

We have time for one more question.

And the question is coming from the line of Robert LaBoyer with Noble Capital Markets.

Good morning. I'll keep my question short and just ask about the trial, the pivotal trial that could potentially start next year. In terms of what you're seeing, do you have any projections as to the number of patients or length of trial? And secondly, in terms of the out-licensing and business opportunities, Do you have any milestones or any parameters as to whether these things are going to be entirely licensed, early stage collaborations to a certain development point, or any specific strategy related to those products?

Robert, thanks a lot. I'll take the first step and hand it over to Lauren to also give you some additional information on the trial strategy. But in terms of the trials, I think that one of the key things we want to do is to have that discussion with the FDA, just have them understand what we're thinking and also get some feedback on what they would like to see in that trial. In terms of how we move forward, we have all options on the table. We are preparing that we would at least, the goal would be that we could potentially partner one or both of them or we're also preparing just in case we would want to move them forward on our own independently, right? So currently what we would want to do would be to, we have between now and when we get those trials going, to really understand what the partnering opportunities are and will be, and look at what those opportunities are and hopefully make the best decision as we typically would strive to do for the company and the company's shareholders. But currently, we are evaluating all options and all potential options available to the company. Lauren, would you want to add anything on the clinical trial, the pivotal trials?

Yes, thanks. Thanks so much for that question, Robert. We estimate that a pivotal trial looking at the Versatile 002 combination, which would involve PDS0101 plus Keytruda versus Keytruda monotherapy in the exact same population that we are currently studying Versatile002 would require approximately 250 to 270 subjects. This is dependent on screen fail rates that can vary globally, as well as regionally, as well as the incidence of HPV16. As Frank had mentioned, The concurrence with the FDA and advice from the FDA regarding the strategy and the pivotal trial design is going to be critical and we will hear about that before the end of this quarter with the hopes that we would start the study in the first half of 2023. The other issue is that, as Frank also mentioned during the call, our expansion into Europe we believe is laying the groundwork to not only introduce versatile o2 xus but also set up that infrastructure for a global study the projected enrollment would be approximately a window of anywhere from 18 months following initiation of the study dependent on enrollment rates okay great thank you very much

Thank you. We've reached the end of our question and answer session. I'll hand the floor back to management for closing remarks.

Thank you very much. Again, thank you for joining us on today's call. As you can see, we've made significant progress during the first half of the year. To date, PDS-0101 has been administered to over 100 patients in the ongoing Phase II trials, and we have provided data from 80 patients in both the Keytruda combination and the National Cancer Institute-led triple combination. The fact that recruitment is progressing well and that both the safety and efficacy continue to appear to be strong is extremely encouraging and we believe provides validation and proof of concept. We look forward to continued progress and success during the next six months ahead. We appreciate your continued support and will update you as we progress our clinical and preclinical programs. We wish you all the best for the remainder of the summer. Thank you very much.

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