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 on schedule as projected during the second quarter.

Let's begin by reviewing this interim data which was presented by the National Cancer Institute at the American Society of Clinical Oncology annual meeting. PDS0101 is being developed to treat cancers caused by HPV type 16, including anal, cervical, head and neck, penile vaginal and vulvar cancers.

In the United States, approximately 43,000 patients are diagnosed with HPV related cancer annually. The vast majority of advanced HPV cancers about 70% to 80% of these cases are caused by HPV16. For HPV cancer patients, the first line of therapy is usually radiation treatment with or followed by chemotherapy, if necessary.

It is reported that after 30% or more of these patients will either fail treatment and progress to metastatic disease, or have a recurrence of the cancer.

These refractory patients who fail treatment with chemotherapy and radiation, but who have not been treated with checkpoint inhibitors, and are therefore checkpoint inhibitor naive, constitute the first group of patients evaluated in the trial.

It should be noted that checkpoint inhibitors have been FDA approved to treat these patients with refractory HPV cancer. About 12% to 24% of these patients, depending on the report, respond to checkpoint inhibitor therapy, meaning that 80% or more of these patients will not respond to checkpoint inhibitor therapy.

This group of checkpoint inhibitor refractory patients constitute the second group of patients being evaluated in the trial. These particular patients have very few options available to them. And the historical median survival of only 3 to 5 months.

PDS0101 is specifically designed to treat HPV16, which as I mentioned, is the most difficult to treat type of HPV cancer. Based on the patient population and their stage of illness, with potentially weakly functional immune systems and very short survival times, we have set an extremely high bar for PDS0101.

We believe that this is important to clearly understand and to demonstrate the potential of the Versamune platform to significantly advance the treatment of cancer. In this trial, PDS0101 is being evaluated in a triple combination, including two other clinical stage immunotherapies.

Bintrafusp alfa, bifunctional checkpoint inhibitor, TGF-β trap fusion protein, and M9241, an immuno-cytokine. PDS0101 is designed to activate the immune system to produce in vivo large quantities of powerful CD8 positive killer T-cells to target and kill tumors that are HPV16 positive.

This novel combination is being studied in patients with all types of advanced HPV associated cancers, whose cancer has returned or spread after treatment.

At the time of interim data reporting, it was found that of the initial six HPV16 positive patients who had not been treated with checkpoint inhibitors, the checkpoint inhibitor naive patients, 5 out of 6 or 83% demonstrated an objective response with a tumor reduction of 30% or more.

The object -- reported objective response rate in this population with current standard of care checkpoint inhibitor treatments ranges from 12% to 24%. Of the patients treated with the PDS0101 based triple combination, 100% were still alive at 8 months.

This historical median survival -- the historical median survival or lifespan for this patient population is 7 to 11 months.

Now of the 12 HPV16 positive checkpoint inhibitor refractory patients who had also failed treatments with checkpoint inhibitors, in addition to chemotherapy and radiation treatments, tumor reduction was observed in 7 out of 12 or 58% with an overall objective response rate of 42% already achieved at the time of reporting.

The objective response rate with a current standard of care ranges from 5% to 12%. 83% of patients treated with the PDS0101 based combination were still alive at the median of 8 months. In contrast, the historical median survival or lifespan for this patient population is only 3 to 4 months.

It is important to understand that PDS0101 is designed to train the body to generate killer T-cells that specifically target HPV16. This means that for the 20% or so, whose cancers are caused by a different type of HPV, the HPV16 specific T-cells generated by PDS0101 may not recognize their cancers.

It was interesting to note in the ASCO presentation, that 7 patients were recruited, whose cancer was HPV16 negative, meaning that their cancer was caused by a different type of HPV other than HPV16.

These 7 patients received the triple combination, and it was reported that none of these patients experienced tumor reduction compared to almost 70% of HPV16 positive patients who experienced tumor reduction.

These results highlight the potential role of PDS0101 in specifically recruiting, training and arming large numbers of cancer attacking HPV16 killer T-cells in these very ill patients. These killer T-cells are critical to generating an effective anti-cancer therapy.

As I mentioned at the beginning, we have set a really high bar for PDS0101 as our first proof-of-concept study.

These objective response rates are unprecedented in immuno-oncology, strengthening the evidence of the Versamune platforms potential ability to induce high levels of tumor specific CD8 plus killer T-cells that may attack the cancer and overcome a key limitation of cancer immunotherapy.

The data suggests that the Versamune based immunotherapies may have the potential to set the standard -- may have the potential to set the standard by which other oncology products and immuno-oncology products will be compared. Moving on now to the PDS Biotech initiated VERSATILE-002 trial.

The VERSATILE-002 study is designed to evaluate PDS0101 in combination with KEYTRUDA, also known as pembrolizumab in the treatment of advanced HPV16, associated head and neck cancer. The trial is currently being run at approximately 16 clinical sites in the United States, with an eventual target of 26 sites.

KEYTRUDA is FDA approved for the treatment of head and neck cancer, including HPV associated head and neck cancer. It is reported that about 70% of cancers of the may be linked to HPV, and about 90% of these are HPV16 positive. This highlights the need for effective therapies to address advanced HPV associated head and neck cancer.

Given the impressive interim results seen in the National Cancer Institute led study and the strong suggestions of effective HPV specific T-cell induction, even in patients who had failed checkpoint inhibitor therapy, we have expanded the VERSATILE-002 trial to also include checkpoint inhibitor refractory patients.

As previously reported, the other arm is evaluating the combination as first line therapy for recurrent or metastatic head and neck cancer in checkpoint naive patients. We believe there is a significant unmet medical need in advanced refractory head and neck cancer.

The combination of PDS0101 and KEYTRUDA has the potential to significantly improve clinical outcomes for these patients who have limited treatment options. We still anticipate that preliminary data will be available on schedule as we have been projecting late in the fourth quarter of 2021, or during the first quarter of 2022.

Moving on to the third trial, the IMMUNOCERV trial. The MD Anderson led immunotherapy trial is a Phase II study evaluating PDS0101 in combination with standard of care chemoradiotherapy, or CRT for the treatment of locally advanced cervical cancer. The study is investigating the safety and preliminary efficacy outcomes of this combination.

The single site study is actively recruiting and enrolling patients. Based on the reported impact of COVID-19 on clinical operations at MD Anderson, we believe that it is extremely unlikely for preliminary clinical data to become available during the fourth quarter of 2021.

Our most recent projections, due to the uncertainty regarding recruitment rates at MD Anderson were for the fourth quarter of 2021 through the first half of 2022. We now believe preliminary results will most likely be available with IMMUNOCERV during the first half of 2022.

As we revealed during our recent Research and Development Day, the interim data from these PDS0101 study provides early clinical proof-of-concept data that allows us to confidently advance our next to oncology pipeline products into human clinical trials.

PDS0102 combines the Versamune platform technology with the proprietary T-cell receptor gamma alternate reading frame protein, T-A-R-P, also known as TARP, a tumor antigen identified by the National Cancer Institute. This tumor specific protein is strongly associated with acute myeloid leukemia, AML, prostate and breast cancers.

Approximately half a million patients are projected to be diagnosed with AML, prostate or breast cancer this year in the United States alone. Most of these cancers will be associated with TARP. It is important to note TARP is a clinically validated target.

Studies performed and published by the National Cancer Institute in prostate cancer patients showed strong immunogenicity and significant slowing of the cancer growth rate.

In PDS0102 preclinical studies conducted by PDS Biotech, we have demonstrated the ability of Versamune to significantly enhance the in vivo induction of powerful TARP specific CD8 killer T-cells.

The majority of the formulation and preclinical work for PDS0102 has been completed, and our goal is to initiate a Phase I/II clinical trial in the first half of 2022. We announced last quarter that Dr. Mark Frohlich, a world renowned expert in prostate cancer and immunotherapy has joined the PDS Biotech Scientific Advisory Board.

It is also important to note that PDS Biotech already has the world's foremost experts in TARP immunotherapy, Dr. Lauren V. Wood, our -- leading our clinical programs. PDS0103 combines the Versamune platform technology with novel, highly immunogenic agonist epitopes of MUC1.

MUC1 is highly expressed in multiple tumor types, and has been shown to be associated with drug resistance and for disease prognosis. PDS Biotech is developing PDS0103 for the treatment of breast, colorectal, lung and ovarian cancers. In the United States alone, approximately 690,000 patients are diagnosed with these types of cancer annually.

Preclinical work for PDS0103 is ongoing both at PDS Biotech and at the National Cancer Institute. We expect that the results of those studies will be available by the end of this year and will inform the Phase I/II clinical trial design. As with PDS0102, I will go with PDS0103 to initiate a clinical trials in 2022.

Last quarter PDS Biotech announced the addition of Dr. Olivera Finn, a world renowned immunotherapy expert, and the discoverer of the MUC1 protein to the PDS Biotech Scientific Advisory Board. At PDS Biotech, our primary focus continues to be oncology.

However, based on the previously described potential to develop a new class of T-cell inducing vaccines using our Versamune platform, our partners are making progress with our infectious disease candidates as well. PDS0202 is being developed as a universal flu vaccine capable of providing protection against multiple strains of the flu virus.

PDS0202 combines the Versamune platform with novel influenza protein. Preclinical work for PDS0202 was initiated a few months ago in collaboration with our partner, Professor Gerald Woodward at the University of Kentucky School of Medicine.

The work has been progressing steadily in collaboration with researchers of the NIAID's CIVICs program according to the projected schedule. The initial results have been highly encouraging. And we still anticipate that preclinical work will be completed during the fourth quarter.

PDS0203 was designed with a goal to potentially provide long-term and broad protection against infection from COVID-19. Farmacore Biotechnology has licensed the Versamune in Latin America to develop PDS0203 in Brazil.

PDS0203 consists of two components Versamune, which is being produced by PDS Biotech and the SARS-CoV-2 antigen which is being developed and manufactured by Farmacore. In addition to manufacturing the antigen, Farmacore leads all regulatory and clinical trial efforts in Brazil.

As of today, Farmacore has not yet completed manufacturing of the antigen in order to submit the full chemistry, manufacturing and controls or CMC portion of the Investigational Medicinal Product Dossier, IMPD to ANVISA. This is required to complete ANVISA's review of the program.

As a result, this program has not progressed as expected by PDS Biotech, and we will be completing a full program review to determine next steps..

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 trial, objective response rate known as ORR, is measured by radiographic tumor responses according to RECIST 1.1. The study will ultimately evaluate the objective response rate in 56 patients.

Today we'll review an interim look at the data presented that includes a total of 25 patients, approximately half the patients to be accrued to the study. The study enrolled a challenging and difficult patient population to treat.

Of the 25 patients evaluated in this dataset, 96% had failed both chemotherapy and radiation treatment, and 56% had also failed checkpoint inhibitor therapy.

Patients also often come to the National Cancer Institute in Bethesda, Maryland when they have exhausted all other standard of care treatment options, and we can see that reflected in these demographic data. Importantly, of the 25 patients, 18 were HPV16 positives, and 7 were HPV16 negative.

Of 18 HPV16 positive patients, 6 were checkpoint inhibitor naive, and 12 were checkpoint inhibitor refractory. The median study follow-up represented was about 8 months. Let's begin with the 6 HPV16 positive checkpoint inhibitor naive patients. Again, objective response is defined by RECIST 1.1 as a reduction in tumor burden of at least 30% or more.

And these patients who had not previously received checkpoint inhibitors, the triple combination achieved an 83% objective response rate. This is an outstanding result thus far and exceeds expectation as this patient population is very difficult to treat, because they are so heavily pretreated.

The objective response rates with standard of care checkpoint inhibitors reported to date of advanced HPV cancer patients who have failed prior therapy is generally around 12% to 24%. Of the 5 objective responses in this population, 1 patient had already achieved a complete response.

Importantly, this triple combination also shows promising durability in these HPV16 positive checkpoint inhibitor patients. As 80% of these patients have an ongoing response at a median of 8ight months of follow-up and all 6 patients are alive. One patient came off the combination halting the response.

For context, this patient population has a historical mean survival of 7 to 11 months with standard of care in checkpoint inhibitor therapy.

These preliminary interim results suggest that PDS0101 adoption of in vivo, highly active tumor attacking HPV16 tumor CD8 T-cells documented in the published preclinical animal studies may also result in effective tumor shrinkage in humans. Moving now to the 12 HPV16 positive patients treated in a checkpoint inhibitor refractory arm.

These are patients who have failed treatment with chemotherapy, radiation therapy as well as checkpoint inhibitors. In this population, the triple combination achieved tumor reduction in 58% of patients. These 12 patients included the initial 8 patients reported in the abstract, were 5 of 8, or 63% had tumor reduction.

Of the 4 additional patients in this updated dataset, 2 patients already had ongoing tumor reduction at the time of reporting, but had not yet met the 30% or greater threshold criteria for objective response.

As might be expected with standard of care, the objective response rates reported in checkpoint refractory advanced HPV cancer patients are even lower than those 92 checkpoint inhibitors, generally only 5% to 12%.

Encouragingly, similar to the checkpoint inhibitor naive patients, the triple combination also showed potential promising durability in these HPV16 positive checkpoint refractory patients. 58% of patients have ongoing tumor reduction.

And importantly, 80% of patients who had achieved an objective response had ongoing responses had a median of 8 months. That 10 of 12, 83% of these patients are alive at a median of 8 months is also notable. As again this checkpoint refractory patient population generally has a historical median survival of less than half that, only 3 to 4 months.

These preliminary results suggest PDS0101 induction in vivo of highly active tumor attacking HPV16 killer CD8 T-cells, even in extensively treated unlikely immunologically limited patients present strong potential for effective disease reduction and unprecedented durable responses.

As with any other combination regimen, a common question that arises is the relative contribution of individual components in the triple combination to the encouraging results seen so far. Specifically, the top question posed to Dr.

Strauss following his ASCO presentation was, do you believe all three therapies are contributing to the clinical benefit? The data on HPV16 negative patients helps elucidate the role of PDS0101 in the triple combination.

You'll recall that this trial is being conducted in patients with advanced HPV related cancers, agnostic on the strain of HPV required to qualify for enrollment.

It's important to understand that PDS0101 is actually a molecularly targeted immunotherapeutic that leverages the specificity of the immune system to definitively and exclusively attack tumors expressing only the target tumor antigens, which in this case, includes HPV16, E6 and E7.

Among the checkpoint inhibitor naive and refractory patients in this study, 67% of HPV16 positive patients experienced tumor reduction at a median of 8 months. In contrast, in the 7 HPV16 negative patients, those with an HPV type other than HPV16 that do not express the molecular target of PDS0101, zero of 7 patients experienced tumor reduction.

These observations suggest that HPV16 specific CD8 and even CD4 T-cell induction by PDS0101 as predicted by preclinical studies, may promote tumor reduction and enhance clinical benefit of the triple combination.

Results in the 7 HPV16 negative patients also suggest a potential critical role of PDS0101 induced CD8 T-cell in promoting survival in the triple combination treatment. In these heavily treated advanced cancer patients, remarkably, the majority of patients are still alive at a median of 8 months of follow-up.

89% of the HPV16 positive patients are alive and 57% of the HPV16 negative patients are also alive. These preliminary data are particularly encouraging as they document impressive survival responses regardless of prior checkpoint inhibitor exposure.

Furthermore, these clinical responses were seen equally in all types of HPV16 positive cancer in patients with cervical, head and neck, anal, vaginal as well as vulvar cancers.

This is very important because what it suggests is that it may not matter where in the body the tumor is, so long as it expresses the tumor antigen that is combined with Versamune, and which Versamune train the T-cells of the immune system to specifically recognize.

This also has strong implications for effective treatment as well as elimination of metastatic disease. Turning now to the safety data associated with the trial. A very important consideration for combination oncology treatment regimen is to avoid additional or excess toxicity associated with limited anti-tumor activity.

Importantly, PDS0101 does not appear to compile toxicities of a triple combination therapy. The adverse events documented to date with a triple combination are consistent with those previously observed with Bintraf and M9241 monotherapy treatment. Specifically, Grade 3 treatment-related adverse events occurred in approximately 40% of patients.

The most frequent treatment-related adverse events also known as TRAEs, were anemia due to gross hematuria, decreased lymphocytes and the presence of flu like symptoms. As would be expected with both PDS0101 and MT -- M9241. being delivered subcutaneously, injection site reactions were seen in 20% of patients.

4 patients who originally had Grade 3 toxicities with the triple combination, including M9241 dose at 16.8 micrograms per kilogram tolerated the combination when the dose of M9241 was lowered by 50% to 8 micrograms per kilogram without any further Grade, greater than or equal to Grade 3 toxicities.

Again, as we seek to understand the contribution of each of the individual components to the safety as well as the efficacy profile of the triple combination, it's important to note that no new or worsening toxicities were observed from the addition of PDS0101 to the combination.

We look forward to the data from the continued evaluation of these patients as well as the addition of more patients to the data set to answer these very important questions regarding safety as well as clinical outcomes. Now onto the PDS sponsored VERSATILE-002 study.

As Frank discussed during his remarks, activation of sites and enrollment in VERSATILE-002 continues to progress, and we currently have 16 sites open to enrollment.

The VERSATILE-002 trial was also recently expanded to include checkpoint inhibitor refractory patients as a result of the impressive preliminary results observed in this population in the NCI-led triple combination study I just talked about.

As part of the revised two-stage design, objective responses after 6 months of treatment will be assessed in both the checkpoint naive and refractory patient arms. There is a leading cohort of 12 patients to assess the safety of the combination and the total number of patients is essentially unchanged at 95 with the revised design.

We estimate safety data on initial 12 subjects to be available in the coming months and anticipate preliminary efficacy data late in Q4 of 2021, or Q1 of 2022. The study lead principal investigator is Dr.

Jared Weiss, who serves as the Section Chief of Thoracic and Head and Neck Oncology at the University of North Carolina School of Medicine, Lineberger Comprehensive Cancer Care Center. We are thrilled to have Dr. Weiss involved in this important study.

As with the NCI-led trial, there is an enormous unmet medical need in advanced head and neck cancer patients who have failed multiple therapies, including chemotherapy, radiation and checkpoint inhibitor therapy.

We believe the combination of PDS0101 and KEYTRUDA has the potential to similarly significantly improved clinical outcomes for these patients who have limited treatment options.

Moving now to the MD Anderson led Phase II clinical trial of PDS0101 in combination with standard of care, chemoradiotherapy for the treatment of locally advanced cervical cancer. This study is also known as IMMUNOCERV. It will enroll approximately 35 patients and investigate the effect of the combination on safety and preliminary oncologic outcomes.

Importantly, the study is also exploring immune priming by PDS0101 by studying various biomarkers of immune response in both blood and tumor tissue. We believe the PDS0101 demonstrated ability to activate the immune system and induce tumor targeting killer T-cells may provide improved outcomes to patients with cervical cancer.

The first readout of clinical data from this study is anticipated during the second half of 2021. The study is being conducted by Dr. Ann Klopp, M.D., Ph.D., Associate Professor of Radiation Oncology at the MD Anderson Cancer Center. As Frank mentioned, this is a single site study, and it has been heavily impacted by the ongoing COVID pandemic.

We will continue to work closely with the excellent team at MD Anderson to monitor ongoing recruitment. As Frank noted, work is also ongoing for our infectious disease programs.

For our universal flu program, PDS0202 preclinical work has been progressing steadily, and I hope to have a more detailed update on those preclinical studies by the time of our next earnings call. For PDS0203, the planned Phase I/II clinical study cannot be initiated until ANVISA provides approval to our partner in Brazil Farmacore.

We will be conducting a full program review with Farmacore to determine the appropriate path forward. I would now like to turn the call over to our Chief Financial Officer, Seth Van Voorhees, to review our second quarter 2021 financials.

Seth?.

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 30, 2021 versus the same period in 2020, reflecting higher levels of personnel costs. Looking at cash flow, we started the second quarter of 2021 with approximately $25 million of cash.

We ended the second quarter of 2021 with $75 million, reflecting an increase over approximately $50 million. This increase in cash assets was a consequence of cash added from the sale of the New Jersey NOLS in May and the secondary offering completed in June, less cash used in operations during the second quarter of 2021.

An important highlight of the second quarter was the capital raised in our secondary offering. In June, we completed a public offering of approximately 6.1 million shares of common stock and raised gross proceeds of approximately $51.7 million before deducting underwriting discounts, commission and other expenses.

Cantor Fitzgerald & Company acted as the sole book running manager for this offering. This oversubscribed offering enabled PDS Biotech to successfully achieve one of its strategic goals to increase its institutional ownership by attracting investments from new and existing institutional investors.

Many of the institutional investors that participated in this offering have strong track records with their investments with other biotechnology companies.

PDS Biotechnology intends to use the proceeds from this offering to advanced its ongoing Phase II HPV cancer focused PDS0101 clinical programs advanced the development of its non-HPV cancer focused PDS0102 and PDS0103 programs based on TARP and MUC1 antigens respectively, including the initiations of clinical Phase I/II programs, and for the continued development of its Versamune technology platform.

The appreciation of our share price since the beginning of this year has coincided with a significant increase in the average daily trading volume of our shares, which has increased -- which has greatly increased liquidity for our existing and future investors.

In addition, our recent inclusion in the Russell Microcap Index may build on this momentum to further increase liquidity and to continue to grow shareholder value. Thank you for your time today. And I'd like to now turn the call back to Frank for final remarks..

Thank you, Seth and Lauren. 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..