Greetings, and welcome to PDS Biotechnologies Second Quarter 2021 Financial Results. At this time, all participants are in a listen only mode. 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 PDF Biotechnology's 2nd Quarter 2021 earnings conference call and audio webcast. With me today are Doctor. Frank Fadougato, Chief Executive Officer Doctor. Lauren B. Wood, Chief Medical Officer and Doctor.
Seth Van Voorhees, Chief Financial Officer. Earlier this morning, PDF 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 PDF 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 PDF Biotech's website at pdfbiotech.com and the quarterly report will be posted later today. In addition, this conference call is being webcast, please open the webcast 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-nineteen, 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 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 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 Doctor. Frank Baduato. Frank?
Mr. Bedu Addu, your line is live. You may be muted. Can you
hear me? Yes. I'm not muted. Can you hear me now?
Yes, sir. We can.
Can you hear me? Okay. Okay. I'm sure let me start again then. Okay.
Thank you, Diane, and thanks to everyone on the call today. In the first half of twenty twenty one, 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 may provide a powerful antitumor effect. This observation is in agreement with extensive preclinical studies as well as our Phase 1 clinical study of PDS-one hundred and one.
We will continue to in HPV related cancers. The demonstration of strong efficacy in preclinical and clinical studies of PDS-one hundred provides the scientific and clinical basis to aggressively pursue the next phase of growth for the company. We are preparing to advance our next 2 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 Versimmune platform as 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 2 study of PDS-one hundred and one was reported on schedule as projected during the Q2. 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. PDS-one hundred and one is being developed to treat cancers caused by HPV Type 16, including anal, cervical, head and neck, penile, vaginal and vulva 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 HPV-sixteen. For HPV cancer patients, the first line of therapy is usually radiation treatment with all followed by chemotherapy if necessary. It is reported that up to 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 failed treatment with chemotherapy and radiation, but who have not been treated with checkpoint inhibitors and are therefore checkpoint inhibitor naive, constitute the 1st 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 We'll not respond to checkpoint inhibitor therapy. This group of checkpoint inhibitor refractory patients constitutes the 2nd 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 4 months. PDS-one hundred and one 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 In their stage of illness, with potentially weekly functional immune systems and very short survival times, we have set an extremely high bar for PDS-one hundred and one.
We believe that this is important to clearly understand and to demonstrate the potential of the Versumine platform to significantly advance the treatment of cancer. In this trial, TDS-one hundred and one is being evaluated in a triple combination, including 2 other clinical stage immunotherapies. Bintrep stop alpha, a bifunctional checkpoint inhibitor TGF beta trap fusion protein and M9241 on immunocytokine. PDS-one hundred and one 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 HPV-sixteen 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 6 HPV-sixteen 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 reported objective response Rate in this population with current standard of care checkpoint inhibitor treatment ranges from 12% to 24%. Of the patients treated with the PDS-one hundred and one based triple combination, 100% were still alive at 8 months. This historical median survival or lifespan for this patient population is 7 to 11 months. Now of the 12 HPV-sixteen positive checkpoint inhibitor refractory patients Who had also failed treatment with checkpoint inhibitors in addition to chemotherapy and radiation treatment, tumor reduction was observed in achieved at the time of reporting.
The objective response rate with the current standard of care ranges from 5% to 12%. 83% of patients treated with the PDS-one hundred and one based combination we're still alive at the median of 8 months. In contrast, the historical median survival or life 0101 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 HPV-sixteen specific T cells generated by PDS-one hundred and one may not recognize their cancers. It was interesting to note in the ASCO presentation that 7 patients were recruited whose cancer was HPV-sixteen negative, meaning that their cancer was caused by a different type of HPV other than HPV 16.
These 7 patients received the triple combination and it was reported that none of these patients experienced tumor reduction compared to almost 70% of HPV-sixteen positive patients who experienced tumor reduction. These results highlight the potential role of PDS-one hundred and one 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 PDS-one hundred and one as our first proof of concept study. These objective response rates are unprecedented in immuno oncology, strengthening the evidence of the Versimmune platform's potential and overcome a key limitation of cancer immunotherapy.
The data suggests that diversaryum based immunotherapies 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 the Versatile-two trial. The Versatile-two study is designed to evaluate PDS-one hundred and one in combination with KEYTRUDA, also known as pembrolizumab, in the treatment of advanced HPV-sixteen 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 Orophonics may be linked to HPV and about 90% Of these are HPV-sixteen 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 PV specific T cell induction, even in patients who had failed checkpoint inhibitor therapy, we have expanded the versatile 2 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 catenact cancer in checkpoint naive patients. We believe there is a significant unmet medical need in advanced refractory head and neck cancer.
The combination of PDS-one hundred and one in 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 Q4 of 2021 or during the Q1 of 2022. Moving on to the 3rd trial, the immunoCERV trial. The MD Anderson led immunotherapy trial is a Phase 2 study evaluating PDS-one hundred and one in combination with standard of care chemo radiotherapy 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-nineteen on clinical operations at MD Anderson, we believe that it is extremely unlikely for preliminary clinical data to become available during the Q4 of 2021. Our most recent projections Due to the uncertainty regarding recruitment rates at MD Anderson were for the Q4 of 2021 through the first half of twenty twenty two. We now believe preliminary results will most likely be available for Uniserv during the first half of twenty twenty two. As we reviewed during our recent Research and Development Day, the interim data from these PDS-one hundred and one studies provides early clinical proof of concept data that allows us to confidently advance our next two oncology pipeline products into human clinical trials.
PDS-one hundred and two combines diverse immune platform technology With the proprietary T cell receptor gamma alternates reading frame protein, TARP, 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 500,000 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 that 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 PDS-one hundred and two 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 PDS-one hundred and two has been completed and our goal is to initiate a Phase onetwo clinical trial in the first half of twenty twenty two. We announced last quarter that Doctor. Mark Froelich, a world renowned in prostate cancer and immunotherapy has joined the PDS Biotech Scientific Advisory Board.
It is also important to note that TDS Biotech already has the world's foremost expert In TARP immunotherapy, Doctor. Lauren V. Wood, leading our clinical programs. TDS-one hundred and three combines diverse new 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 TDS Biotech is developing PDS-one hundred and three 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 PDS-one hundred and three 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 III clinical trial design. As with PDS-one hundred and two, our goal with PDS-one hundred and three is to initiate a clinical trial in 2022. Last quarter, PDS Biotech announced the addition of Doctor.
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 Versimmune platform, Our partners are making progress with our infectious disease candidates as well. PDS-two zero two It's being developed as a universal flu vaccine capable of providing protection against multiple strains of the flu virus. PDS-two zero two combines diverse immune platform with novel influenza proteins.
Preclinical work for PDS-two zero two was initiated a few months ago in collaboration with our partner, Professor Gerald Woodward of the University of Kentucky School of Medicine. The work has been progressing steadily in collaboration with researchers of the NIAID 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 Q4. PDS-two zero three was designed with a goal to potentially provide long term and broad protection against infection from COVID-nineteen. Pharmacore Biotechnology has licensed Versimmune in Latin America to develop PDS-two zero three in Brazil.
PDS-two zero three consists of 2 components: Versimil, which is being produced by PDS Biotech and the SARS CoV-two antigen which is being developed and manufactured by Pharmacore. In addition to manufacturing the antigen, Pharmacore leads all regulatory and clinical trial efforts in Brazil. As of today, Pharmacor 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 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.
Moving on to financials. This June, we completed a $52,000,000 public offering. Seth Van Voorhees, PDS Biotech's CFO, will provide further detail on the financing. PDS Biotech has built significant momentum over the past 3 months as evidenced in our recent addition to the Russell Microcap Index as part of the 2021 annual reconstitution. We plan to build on that momentum to execute efficiently to develop a new generation of cancer immunotherapies and to continue to grow shareholder value.
Now, I'd like to pass the call to Doctor. Lauren Wood, TDS 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 Q1 call. I'll begin with our ongoing oncology clinical trials. Starting with our lead candidate, PDS-one hundred and one, which targets HPV16 related cancers, There are 3 ongoing Phase II clinical trials. The most progressed 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 PDS-one hundred and one data represent the first proof of concept human clinical data in advanced cancer for our Immune Technology platform. I'll begin with an overview of the clinical trial design for this investigator initiated study of PDS-one hundred and one in combination with intrafusp alfa, also known as M7824, A first in class bifunctional checkpoint inhibitor, NM9241, an antibody conjugated designed to facilitate entry of the cytokine IL-twelve into tumors. Moving forward, I'll refer to ventralfulta as ventral. 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 HPV-sixteen infection, as Frank noted, the most oncogenic high risk HPV type. These cancers include anal, cervical and in 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 RESIST-1.1. Approximately half of 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 data set, 96% had failed both chemotherapy and radiation treatment And 56% had also failed checkpoint inhibitor therapy.
Patients also often come to the National to 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 HPV-sixteen positive and 7 were HPV-sixteen negative. Of the 18 HPV-sixteen 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 HPV-sixteen positive check F.
O. Inhibitor naive patient. Again, objective response is defined by RESIST-1.1 as a reduction in tumor burden of at least 30% or more. In 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 expectations 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 report to date in advanced HPV cancer patients who have failed prior therapy is generally around 12% to Of the 5 objective responses in this population, one patient had already achieved a complete response. Importantly, this triple combination also shows promising durability in these HPV-sixteen positive checkpoint inhibitor patients, As 80% of these patients had an ongoing response at a median of 8 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 Results suggest that PDS101 induction of in vivo highly active tumor attacking HPV-sixteen Killer CD8 T cells documented in the published preclinical animal studies may also result in effective tumor shrinkage in humans. Moving now to the 12 HPV-sixteen 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, where 5 of 8 or 63% had tumor reduction. Of the 4 additional patients in this updated data set, Two 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 naive to 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 HPV-sixteen positive checkpoint refractory patients. 58% All patients have ongoing tumor reduction and importantly 80% of patients who had achieved an objective response had ongoing responses at a median of 8 months. That 10 of 12, 83% of these patients Our lives at a median of 8 months is also notable, as again, this checkpoint refractory patient population generally has Historical median survival of less than half that, only 3 to 4 months. These preliminary results Suggest PDS-one hundred and one induction in vivo of highly active tumor attacking HPV-sixteen killer CD8 T cells, Even in extensively treated and likely immunologically limited patients presents 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 Doctor. 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 PDS101 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 PDS-one hundred and one is actually 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 the study, 67% of HPV-sixteen positive patients experienced tumor reduction at a median of 8 months. In contrast, in the 7 HPV-sixteen negative patients, Those with an HPV type other than HBV-sixteen that do not express the molecular target of PDS-one hundred and one, 0 of 7 patients experienced tumor reduction. These observations suggest that HPV-sixteen specific CD8 and even CD4 T cell induction by PDS-one hundred and one as predicted by preclinical studies may promote tumor reduction and enhance clinical benefit of the triple combination. Results in these 7 HBV-sixteen negative patients also suggest a potential critical role of PDX-one hundred and one induced CD8 T cells 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 HPV-sixteen positive patients are alive and 57% of the HPV-sixteen 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 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 First Immune, and which First Immune trains 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 regimens is to avoid additional or excess toxicity associated with limited anti tumor activity. Importantly, PDS-one hundred and one does not appear to compile toxicities of a triple combination therapy. The adverse events documented to date with the triple combination are consistent with those previously observed with FINRA 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 PDF-one hundred and one and M9241 being delivered subcutaneously, Injection site reactions were seen in 20% of patients. Core patients who originally had Grade 3 toxicities with Triple combination including M9241 dosed 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 PDS-one hundred and one 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 on to the PDF sponsored Versatiles-two study. As Frank discussed during his remarks, activation of sites and enrollment in 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 SIMON 2 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 the initial twelve 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 Doctor. Jared Weiss, He 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 Doctor. 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 PDS-one hundred and one and KEYTRUDA has the potential to similarly significantly improve clinical outcomes for these patients who have limited treatment options. Moving now to the MD Anderson led Phase 2 clinical trial of PDS-one hundred and one in combination with standard of care chemo radiotherapy for the treatment of locally advanced cervical cancer. This study is also known as ImmunoServe. 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 PDS-one hundred and one by studying various biomarkers The first readout of clinical data from this study is anticipated during the second half of twenty twenty one. The study is being conducted by Doctor. Anne Koff, MD PhD, 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, PDS 2/2. 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 PDS-two zero three, the planned Phase III clinical study cannot be initiated until ANVISA provides approval to our partner in Brazil, Pharmacor. We will be conducting a full program review with Pharmacore to determine the appropriate path forward. I would now like to I'll turn the call over to our Chief Financial Officer, Seth Van Voorhees, to review our Q2 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 6 month period ending June 30, 2021, our loss from operations was approximately 5.1 and $8,200,000 respectively, versus a loss of approximately $2,900,000 7,000,000 dollars respectively during the same periods in 2020. During the Q2 of 2021, Our operating loss was positively impacted by approximately $4,500,000 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 6 months period ending June 30, 2021 excuse me, June 30, 2021 was approximately $600,000 $3,600,000 respectively or negative 0 point 0 $3 and $0.16 per basic and diluted share versus our net loss for the 3 6 month period ending June 30, 2020 of approximately $2,900,000 $7,000,000 respectively, or negative $0.19 and $0.54 per basic and diluted share.
For the 3 6 month period ending June 30, 2021, Research and development expenses, totally approximately $2,800,000 $4,200,000 respectively, as compared to $1,400,000 $3,400,000 respectively for the same period in 2020. These results reflect an increase of approximately $1,300,000 $0,800,000 respectively, for the 3 6 month period ending June 30, 2021 versus the same period in 2020, reflecting higher levels of clinical related activity. For the 3 6 month period ending in June 30, 2021, general and administrative expenses were approximately $2,300,000 $4,000,000 respectively, as compared to approximately 1.5 and $3,600,000 respectively for the same periods in 2020. These results reflect an increase of approximately $800,000 and $400,000 respectively for the 3 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 Q2 of 2021 with approximately $25,000,000 of cash.
We ended the Q2 of 2021 with $75,000,000 reflecting an increase of approximately $50,000,000 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 our operations during the Q2 of 2021. An important highlight of the Q2 was the capital raised in our secondary offering. In June, we completed a public offering of approximately 6 1,000,000 shares of common stock and raised gross proceeds of approximately $51,700,000 before deducting underwriting discounts, commission and other expenses. Cantor Fitzgerald and Company acted as the sole book running manager for this offering. This oversubscribed offering enabled PDF 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 advance its ongoing Phase 2 HPV cancer focused PDS-one hundred and one clinical programs advanced the development of its non HPV cancer focused PDS-one hundred and two and PDS-one hundred and three programs based on TARP and MUC1 antigens respectively, including the initiations of clinical Phase III programs and for the continued development of its Firstimmune 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 Microcraft 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 Q2 has been extremely important for PDF Biotech. The previously unseen level of objective responses in advanced refractory cancer reported by the National Cancer Institute And the PDX-one hundred and one trial provides the first proof of concept data in advanced refractory cancer for our Versimmune technology platform.
Our capital raise of approximately $52,000,000 further strengthens our balance sheet and provides PDS Biotech with the funding necessary to aggressively advance 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 Our 3 ongoing Phase 2 clinical trials for PDS-one hundred and one and to progress PDS-one hundred and two and PDS-one hundred and three into human testing. We are also looking forward to continuing to build 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. Thanks for taking 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 Secondly, for PDS-one hundred and three, just curious where you you would fit in the treatment paradigm if approved because some of the indications you're going off after are crowded like non small cell lung cancer. And then third question is for PDS-one hundred and two, your TARP. You stated in your presentation that you're looking or potentially So just curious if he 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, Luis. 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 PDS-one hundred and one 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 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 HPV-sixteen positive patient population suggests strongly That PDS-one hundred and one is specifically activating HPV-sixteen 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 HPV-sixteen positive head and neck cancer. So the results we obtained from the NCI trial are highly encouraging based upon that supposed 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 the Versimmune technology in preclinical studies. So as you know with At the checkpoint inhibitors, KEYTRUDA, for example, has been shown to be quite effective at blocking the tumors defenses and making the cancer of 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, Versimmune by training, recruiting and generating a large number of T cells can then go in and effectively kill the de camouflage 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. And Louise, does that answer the first question?
Yes. Thank you.
Okay. I'll go to the TARP study next. So with TARP, as we mentioned, the TARP is 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's blood cancer space before we rush into performing clinical trials in the blood cancer. So we 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 PDS-one hundred and three, the MUC1 cancers, again, so with that Currently, what we are doing currently is looking at combinations with PDS-one hundred and three at the NCI.
These studies are currently being performed at the NCI, just like they did with PDS-one hundred and one. And then based upon those results, as Lauren mentioned, Those results will inform our clinical design and specifically what indications in MUC1 and 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 PDS-one hundred and one, 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 PDS-one hundred and one and to really understand exactly how it's impacting patients with the 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.
The
next question is from Leland Gershell of Oppenheimer and Company. 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 Hi, Ryan. It's for the initial data late this year or Q1.
With 16, I think, out of 26 Sites activated, though, just kind of curious to ask if there's any impact that you're seeing from COVID-nineteen with respect to getting some of those remaining sites activated or with
Lauren, I'll hand that over to you.
Great. Yes. Thank you, Leland. As everyone experienced, we did experience initial impacts from the COVID-nineteen 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-nineteen, 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 a 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 2 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 Q4 some initial data Regarding safety or as early as Q1 of 2022.
Okay. Thank you. And then one question, kind of a higher altitude question. As you continue to study The Versimmune platform in the context of different antigens and particularly as you've purchased the completion of the preclinical work on 1, 2 With tarp, and you're also obviously looking at MUC-one hundred and three. I want 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, So Lauren, I can start with that since. 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 Versimmune, especially in some of these other cancers that where the antigens may already be present not due to a foreign agent. Now this is what we're evaluating with the TARP with MUC1 and we have also done that with TRP2 in melanoma. And in each of these cases, what we have found out is that With Versmid, 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 CDAT cell responses in the preclinical models Very similar to what we saw with PDS-one hundred and one, right?
So it is highly suggestive that if we can actually activate the right immunological pathways and effectively present the antigens into the right processing and presentation pathways that we may be able even with those self tumor, self antigen based cancers to generate very similar immune And actually the study that was done by the National Cancer Institute and led by Doctor. Wood Looking at talk 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. It 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
The next question is from Joe Pantginis of H. C. Wainwright. Please proceed with your question.
Hey, everyone. Good morning. Thanks for taking the question. Wanted to ask a question regarding your Pharmacore update for the COVID vaccine, Frank. I was just curious, From a logistical standpoint, in manufacturing the antigen, are there any technical That pharmacore is experiencing any logistical issues or and does this cause any sort of
I think these are some of the key questions that we are seeking to understand with the review that we are currently performing with pharmacol. 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.
The next question is from Robert Laboyre of Noble Capital. Please proceed with your question.
Thanks for the comprehensive review of all the data. Could you just give the milestones that are upcoming for the Three trials in 1, 101?
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 projected to complete during the Q1 of 2022. We also anticipate that more mature data regarding a greater complement of patients will be available in the first half of twenty twenty two.
Regarding the PDS sponsored Versatile 2 study looking at PDS-one hundred and one In combination with KEYTRUDA, we project that we will have some preliminary data at the end of the Q4 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 PDS-one hundred and one in combination with standard of care chemoradiation therapy, we expect some preliminary data By the first half of twenty twenty two.
Right.
Great. Thank you very much.
The next question is from Jim Molloy of Alliance Global Partners. Please proceed with question.
Hey, guys. Thanks for taking my question. Eric, just a quick question on the $75,000,000 cash. Where do you as you allocate that to your pipeline, how do you see the allocation going between the multiple trials you have ongoing? And can you talk a little bit about does the infusion of cash increase spend in any particular direction Perhaps before you'd been holding back on.
And can 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 PDS-one hundred and two and one hundred and three into human clinical trials 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 R and D Day, It's hopefully to move the triple combination into a pivotal trial sometime late next year, right?
So evaluating all those options. Now with the moving into a pivotal trial involved discussions with our partners at And those discussions will be initiated. As Laura mentioned, we are looking to complete recruitment of that trial, potentially early in the Q1 of next year. And what we want to do is to have enough data in the specific patient population before So 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 1 of the PDS-one hundred and two trials moving forward. And what we are currently doing is 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 PDS-one hundred and three, 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 agreements we have with under the CRADA with the NCI is that they would 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 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 on exactly what the trial design is and how we're moving forward With any potential pivotal trial coming up.
Okay, great. Thank you. Then a quick follow-up. You'd mentioned, I think in the past, For the Phase 3, for the triple combo, signing on a potential marketing partner beyond NCI industry partner, Any comments you can put around how those conversations may be going or any particular partnership conversations may be going in interest levels post the ASCO data?
Right. So 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 Data that was generated. We think there is a potential, path forward, especially with the checkpoint inhibitor refractory patients because That's a 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 I think what we all have decided to do is to give it some more time. Let's wait to the Q4 or early Q1 when we have at least 30 patients recruited. And then based upon what the data looks at like then, Let's come up with a strategy and have initiate 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 Addu for closing remarks.
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 PDS-one hundred and one in various advanced HPV associated cancers. We appreciate your ongoing support in this pursuit. For more information about the company and our ongoing clinical trial, 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.