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spk05: Hello, and welcome to the PDS Biotechnology first quarter 2022 earnings call and webcast. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Gabby DeGravina. Please go ahead.
spk01: Good morning, and welcome to PDS Biotechnology's first quarter 2022 earnings conference call in audio webcast. With me today from the company are Dr. Frank Feduado, Chief Executive Officer, Dr. Lauren Z. 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 31st, 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 risk and uncertainties that may cause actual results to differ from those forecasted. A description of these risks can be found on 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're 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 want to leave as 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?
spk04: 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 context. We are also providing some visuals to aid our discussion. For those of you who may be new to the story, and as a quick refresher, our pipeline is built on two proprietary T-cell activating platforms, Versamune on which an expanding pipeline of clinical and preclinical molecularly targeted immuno-oncology candidates are based, and InfectiMule, on which our advancing preclinical infectious disease pipeline is based. The VersiMule platform allows us to administer tumor-specific proteins by subcutaneous injection, resulting in powerful CD8 killer T-cell responses against the cancer. The infectimmune 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 product, PDS-0101. PDS-0101 has been demonstrated in ongoing 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 infectimmune technology, we seek to lead the development of more broadly protective vaccines, such as seen in the preclinical results reported with our universal flu vaccine. Here, we provide a broad overview of ongoing studies with our lead Versamune-based candidate, PDS0101, which is being evaluated in four phase two clinical trials as a combination treatment in advanced and refractory cancers and also in locally advanced cancer. In early stage cancer, PDS-0101 is also being evaluated as a monotherapy. PDS-0101 is a molecularly targeted immunotherapy that we're studying across the full spectrum of HPV-related cancers. By this, I mean that we are studying PDS0101 in all types of HPV-associated cancers, including anal, cervical, head and neck, penile, vaginal, and vulva cancers. Secondly, we are studying these cancers at all stages of the disease, from early-stage cancer in our neoadjuvant trial led by Mayo Clinic, to advanced checkpoint inhibitory refractory cancer in our National Cancer Institute-led trial. We estimate this could create an aggregate market potential of $5 to $6 billion in the United States and Europe for PDS0101. We are conducting these trials in collaboration with some of the most renowned institutions in the field, the National Cancer Institute, Merck, MD Anderson Cancer Center, and the Mayo Clinic. These strategic relationships have enabled PDS Biotech to achieve our goal of broadly covering the HPV cancer space. These relationships have provided multiple additional benefits to PDS Biotech. Not only have they enhanced our expertise in the space, but we believe they have facilitated enrollment in the clinical trial, and importantly, Through cost-sharing agreements, we have mitigated much of the financial burden of rapidly advancing our clinical studies. We are very excited that data from the first two studies listed here, our National Cancer Institute-led triple combination trial and our versatile 002 trial, will both be presented at this year's American Society of Clinical Oncology Annual Meeting, ASCEL, occurring from June 3rd through the 7th. We believe this is a real testament to the quality of work being done by our team and our partners, and we are very much looking forward to sharing these efficacy and safety results publicly. Do note that accepted abstracts are scheduled to be published on May the 26th. On Tuesday, June 7th at 8 a.m., After our presentations, we plan to host a conference call to further discuss the presented data from both trials. We'll issue a press release to announce this event. Turning to trial updates. Let's first review our triple combination study. In this trial, we are evaluating PDS0101 in combination with Bintrop sub-alpha, a bifunctional checkpoint inhibitor, and M9241, also known as NHS IL-12, two investigational immune-modulating candidates owned by Merck KGAA. By combining three components that activate the immune system by complementary anti-tumor mechanisms, our goal is to generate cancer-targeting killer T cells while successfully overcoming the immunosuppressive tumor environment. The triple combination is being evaluated across the range of HPV positive, advanced, relapsed, and refractory cancers that are well documented to be extremely difficult to treat and for which more effective therapies are desperately needed. The data from this trial to be presented at ASCO will be a continuation of the study and data that was presented at ASCO last year in both checkpoint inhibitor-naive and checkpoint inhibitor refractory patients. We expect an update on how the patients whose data was presented have fared over the last year. Essentially, how durable was the anti-cancer immune response and what fraction of the patients remain alive. Improving overall survival is one of the most important goals of cancer treatment. Secondly, what do the overall responses, including the more recently enrolled patients, look like? We anticipate that in addition to the solid preclinical data demonstrating the key contribution of each of the three agents towards the observed strong anti-tumor results, that the FDA may expect some demonstration of the clinical contribution of each of the agents in the combination. the role of PDS-0101 was very clearly demonstrated in the early data. To study the contribution of NHSIL-12, the National Cancer Institute is evaluating high and low doses of the drug, and we expect that some of this data may also be presented at ASCO. The preliminary efficacy data appears to support the Versamune platform's potential unique ability to aid in the recruitment training, and activation of large numbers of critical cancer-attacking killer T cells in vivo, even in very ill patients. We plan in the near future to initiate discussions with the FDA to align on the registrational path. Now turning to our Versatile 002 Phase 2 trial, which is studying PDS-0101 in combination with Merck and Co's checkpoint inhibitor Keytruda, or pembrolizumab in patients with HPV-16 positive, metastatic, and or recurrent head and neck cancer. As with the triple combination trial, this trial has two study groups, checkpoint naive patients and checkpoint refractory patients. In this trial, PDS Biotech is seeking to improve clinical benefit over that seen with Keytruda monotherapy. In addition to improved tumor shrinkage and overall survival, we believe that a significant treatment advantage will be achieved if enhanced clinical benefit is attained without compounding or increasing the toxicity profile over what has been reported with Keytruda monotherapy. In February of this year, promising preliminary safety data were presented at the Multidisciplinary Head and Neck Cancer Symposium. None of the first 18 patients showed any treatment-related grade 3 or higher toxicities. This is extremely unusual for any cancer therapy, and particularly for a combination therapy. To put the safety profile in perspective, I'll quickly refer to a news article in March out of the Hollings Cancer Center at the Medical University of South Carolina, one of the top head and neck cancer centers in the country. The principal investigator on our study, Dr. Kaczmar, had enrolled his first patient onto the study in August of 2021. The patient had a tumor mass of about eight centimeters and signs of spread. By March of 2022, the tumor had shrunk to two centimeters and the patient was reported to have continued to have a high quality of life through treatment. To quote Dr. Kaczmar, The treatments involved in this trial so far have been very tolerable, which is nice because sometimes investigative treatments can produce some side effects. The main side effects of the study treatment we've seen are some pain and redness around the injection site and fatigue. Do note that we have reported a small patient size of 18. However, If this combination of efficacy and safety continues to be seen in a significant number of patients, this approach of using the Versamune T-cell activating technology could be transformative in cancer treatment. We look forward to presenting detailed efficacy data from the first arm of the Versamune 002 trial at ASCO. Next, let's spend a minute or two on our preclinical Versamune-based oncology programs. PDS0103 targets Mucin 1 or MUC1. Given the presence of MUC1 across several solid tumors, we believe PDS0103 could have utility in the treatment of a broad range of cancers, including breast, ovarian, lung, and colon cancers, a very substantial global market. We previously discussed our positive preclinical data which demonstrated PDS-0103's ability to promote the induction of a large number of polyfunctional and highly potent MOC1-specific CD8 killer T cells. The PDS-0103 antigens have been successfully manufactured, and preliminary stability and immunogenicity testing of the new clinical-grade antigens is in progress by PDS Biotech. as is process development for manufacture of the PDS-0103 pharmaceutical product. Following a recent positive pre-IND meeting with the FDA, we continue to expect to file an IND for the program in the fourth quarter of 2022. We've also continued to make progress on our top program, PDS-0102. As you know, late last year, we in-license rights to the National Cancer Institute's proprietary T-cell receptor gamma-alternate reading frame protein tumor antigen, abbreviated TARP or TARP. Based on preliminary studies, we expect our candidate PDS0102 to facilitate the generation of TARP-specific CD8 killer T-cells and may have utility in the treatment of both solid and liquid tumors, including AML, prostate, and breast cancers. Manufacturing efforts here are ongoing. However, given all of our ongoing programs, we are not devoting significant resources to the TARP program and now expect clinical launch sometime in 2023. Lastly, before passing it over to Matt, I'd like to briefly discuss our infectimmune-based infectious disease preclinical pipeline. We believe that the key differentiating attributes of the infectimmune platform technology are strong indication or strong induction of virus or pathogens which can be leveraged to improve treatment and preventive options for several infectious diseases. In January of 2022, We announced preclinical data on our universal flu program sponsored by the NIAID, demonstrating potential of the infectimmune technology with computationally designed influenza proteins developed by the laboratory of Dr. Ted Ross at the University of Georgia. The universal seasonal flu vaccine, PDS0202, generated broadly protective anti-influenza immune responses across multiple strains of influenza. These data, as well as our COVID-19 data, has provided a unique opportunity to highlight infect-immune's potentially transformative utility in the development of more broadly effective and longer-lasting protective vaccines. We are hopeful that we could receive non-diluted financing from the NIH to progress our universal flu program into human clinical trials. Based on the highly promising data recently announced with the universal flu vaccine and the current focus of the NIAID on developing more effective flu vaccines, PDS Biotechnology has decided to strategically focus our near-term infectious disease activities to align with the interest of the NIAID to have a near-term focus on influenza. This will involve development of the universal seasonal flu vaccine and also potential development of a universal pandemic influenza vaccine based on similar computationally designed antigens as what has shown promise with infectamines. The company had outlicensed the COVID-19 vaccine PDS0203 to the Brazilian company Pharmacol specifically for development in Latin America. The progression of the Pharmacol development program was delayed in the fourth quarter of 2021. After review of the program by PDS, Biotech, and Pharmacol, the agreement with Pharmacol was extended through May 31, 2022, to provide additional time to Pharmacol to commence manufacturing and scale up of drug product for use in clinical trials. We have reevaluated the progress of the program, and as described above, have determined to strategically focus our near-term efforts on the development of the universal flu vaccine. The licensing agreement with Pharmacol will expire on May 31st, 2022. With that, I'll now turn it over to Matt for a review of our financial results. Matt?
spk06: Thank you, Frank, and thanks to all of you on the call today. In this challenging environment we currently find ourselves in, we are truly grateful to our investors and analysts for their support and continued interest in the PBS biotech story. For the first quarter ended March 31, 2022, here are summary 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, $1 million in clinical and regulatory costs, and $.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 $1 million 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 forward 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?
spk05: Thank you. And I'll be conducting a question and answer session. If you'd like to be placed in the question queue, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. For participants, using speaker equipment may be necessary to pick up your handset before pressing star 1. One moment, please, while we poll for questions. Our first question today is coming from Louise Chen from Cancer Fitzgerald. Your line is now live.
spk00: 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 know, 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 meaning both 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.
spk04: 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, as you see, 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've brought on to our programs, which we believe, in addition to providing significant validation of the approach we're taking, As Matt also said, and as I said in the presentation, it's 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 four clinical trials with PDS 0101 across all HPV cancer indications, right? So this is really, it was a very strategic approach for PDS very importantly addressing this question of allocation of financial resources. So other than the Ketrude trial, where we are responsible for financially managing that trial, our partners, there's a significant cost-sharing benefit with each of the other clinical trials. 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. 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 the TRUDA trial as well as the triple combination trial. Right. So those are key things that we will continue to update folks on as we continue to progress those trials. But the partnership agreements and partnership arrangements have been very significant and very important in allowing us to accomplish what we are accomplishing today. And as we go into PDS 0103 and 0102, we don't want to spread ourselves to a thing, right? We also have to keep shareholders in mind and ensure that we actually use utilizing our shareholders' investments judiciously. And that's one key reason why we're now focusing on going into PDS-0103, which would be the first program beyond HPV cancer, and hopefully getting that IND filed by the end of this calendar year. And again, strategically, one of the key things we'd want to do is, again, understand exactly how we're going to do that in terms of a potential partnership, or if we decide to finance that ourselves, again, designing a very efficient clinical trial approach. And then subsequent to that, looking at how best to progress PDS-01-02, which is also ready to go into human clinical trials, potentially also in partnership. But these are key things that we are looking at very strategically in just making sure that we're able to create the most value financially efficiently. And then as we progress into the infectious diseases with those activities, also one of the key things that you may notice is that we have really focused on utilizing non-dilutive financing to progress our infectious disease programs. The current program with the infectimmune and seasonal universal flu antigens was funded by the NIAID program. And we are also looking to hopefully obtain some additional NIAID or NIH funding to take that into human clinical trials. So when it comes to our capital resources, our goal currently is really to dedicate those to the oncology programs, which we believe will provide the near-term value creation to our shareholders and the company, and really to focus non-diluted funds on progressing the infectious disease programs. Louise, did that answer your questions?
spk00: Yes, it did. Thank you very much.
spk04: You're welcome.
spk05: Thank you. Next question today is coming from Leland Gershwell from Oppenheimer. Your line is now live.
spk03: Hey, good morning, and thanks for taking my questions. As we look forward to the upcoming data at ASCO, just want to ask Frank, you know, longer term, as we think about the development path for PDS 0101 and, you know, any regulatory perspectives on how we should think about next steps for this development program on route to a potential BLA filing? Thanks.
spk04: Hey, Milan. 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 benefit 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 oncologists 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 oncologists, especially with the earlier stage cancer patients. So we believe if this continues and this progresses, it positions this combination very, very favorably. And we anticipate that we'll have to perform a controlled 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, 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 a pivotal trial based upon the data that we've seen today, which is really unprecedented? And one of the key things I mentioned during the trial during my portion of the call was the fact that the NCI is looking at high and low dose NHSL-12. The reason we're doing that is we believe very strongly that the FDA will want to understand the role that each of these components, each of these drugs, is really playing in confirmation that each of them has a significant role to play in contributing towards the clinical output that we're seeing. And so to avoid going into a pivotal trial where we would be looking at multiple arms, looking at different combinations, we believe that it's prudent to understand sooner than later or to confirm sooner or later the role of each of these three components. So if you may recall, after the first last year's ASCO, it became very clear the role that PDS0101 was playing in the combinations. What the NCI is doing now is looking at high and low dose NHS IL-12 to try to tease out the role of NHS IL-12 and hopefully provide some confirmation of the important role that NHS IL-12 is playing. With the Bintra, it's already been evaluated as a monotherapy in this exact same patient population, right? So if we can go to the FDA, showing very clearly that each of these three agents is contributing significantly to the clinical outcome that we're seeing, it hopefully allows us to go in and perform a very focused and very quick pivotal trial and get this to commercialization sooner than later. So that's the strategy that we're taking. The goal is hopefully shortly after ASCO to be able to sit down with the FDA and come to some alignment on what that regulatory strategy and pathway would look like.
spk03: Great. Thank you. We look forward to the ASCO presentations. You're welcome.
spk05: Thank you. As a reminder, that's star one to be placed in the question queue. Our next question is coming from Jim Malloy from Alliance Global Partners. Your line is now live.
spk02: Hello, this is Laura Surrell 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 PDSO-101. 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 with the FDA that the company is planning to have? And as a second question, are there any updates regarding the immunoserve phase two trial of PDSO-101, and is the company still in line to obtain preliminary data for this trial mid-year? Thank you.
spk04: Thanks a lot for your question. So in terms of the first two trials and enrollment, so starting with a triple combination trial, as of the last release we made regarding enrollment, the NCA had enrolled 45 patients and had achieved the goal of enrolling 30 in the checkpoint inhibitor refractory arm. They have enrolled that arm much more quickly than they have enrolled the naive arm. And so what they are doing now is enrolling 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. 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 basic 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, at least 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 would 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 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 the FDA. So hopefully we will be able to provide you with some details and some more solid decisions probably sometime in the third quarter regarding how this is going to progress. And in terms of the UNICEF, the UNICEF 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.
spk05: Thank you. Our next question is coming from Robert LaBoyer from Noble Capital. Your line is now live.
spk07: Good morning. My question has to do with the influenza program and I want to know if you have any time frames for filing INDs or starting clinical trials.
spk04: No, so with the influenza program, we have not received any details yet from the NIAID. We know Dr. Ted Ross 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 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 really going to depend on whether or not we get the funding to take it into human clinical trials. And 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 or dependent on non-diluted financing to take that program into human clinical trial. We are quite hopeful, but I think the moment we have some idea whether that's going to happen or not and when it is going to happen, we'll then be able to provide much more solid details on when the IND filing will occur.
spk07: Okay, great. Thank you very much for that. You're very welcome.
spk05: 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 closing comments.
spk04: Again, thank you very much for joining us today. 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 to the company. And thank you again for joining us today. Have a great day.
spk05: Thank you. That does conclude today's teleconference and webcast. We disconnect our line at this time and have a wonderful day. We thank you for your participation today.
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