Q4 2023 PDS Biotechnology Corp Earnings Call

Operator: Good morning, and welcome to PDS Biotech's call... All participants are currently in... [inaudible] call for questions. Thank you, Operator, and good morning, everyone, and welcome to PDS Biotech's 2023 ERM Results and Clinical Strategy Update Call. Today, we will discuss financial results for the year ended December 31, 2023 and provide a business and clinical programs update. This morning, the company issued a press release with these results, which can be found in the Investor Relations section of the PDS Biotech website. I am joined on the call today by the following members of the company's management team: Dr. Frank Beduado, Chief Executive Officer; Lawrence Bozgaard, Chief Financial Officer; and Dr. Kirk Sheppard, Chief Medical Officer. Dr. Beto Addo will begin with the Corporate and Clinical Programs update, and then Mr. Bozgar will review financial results for 2023.

Good morning, and welcome to P. D S biotechs call to discuss the company's year end 2023 financial results and clinical strategy update conference call.

All participants are currently in listen only mode.

Following the formal presentation and.

Speaker Change: I'll open up the call for a question and answer session.

Speaker Change: I would now like to turn the conference over to Tom Johnson with Eisai Advisors. Please go ahead Sir.

Tom Johnson: Thank you operator, and good morning, everyone and welcome to the Tds Biotechs 20, twenty-three yearend results and clinical strategy update call. Today, we will discuss financial results for the year ended December 31, 2023, and provide a business and clinical programs update.

Tom Johnson: This morning, the company issued a press release with these results, which can be found under the Investor Relations section of the Tds biotech website.

Speaker Change: I am joined on the call today are the following members of the company's management team Dr. Frank Bennett.

Speaker Change: Chief Executive Officer, Laurie <unk>, Chief Financial Officer, and Dr. Curt Shepherd Chief Medical Officer.

Dr. Joe will begin with a corporate and clinical programs update and then Mr. Both Star will review financial results for 2023.

Operator: Following the company's prepared remarks, Dr. Shepherd will join the call to help address questions from covering analysts. As a reminder, during this call, we will be making forward-looking statements that are subject to various risks and uncertainties that could cause actual results to differ materially from these statements. Any such statements should be considered in conjunction with the cautionary statements in our press releases and risk factors discussed in our filings with the SEC, including our quarterly reports on Form 10-Q and annual report on Form 10-K, and cautionary statements made during this call. We assume no obligation to update any of these forward-looking statements or information. Now, I'd like to turn the call over to Dr. Bedu Addo, Frank.

Following the company's prepared remarks, Dr. Sheppard will join the call to help address questions from our covering analysts.

As a reminder, during this call we will be making forward looking statements, which are subject to various risks and uncertainties that could cause actual results to differ materially from these statements.

Speaker Change: Such statements should be considered in conjunction with the cautionary statements in our press releases and risk factors discussed in our filings with the SEC, including our quarterly reports on Form 10-Q, and annual report on Form 10-K and.

Speaker Change: Cautionary statements made during this call.

Speaker Change: Assumes no obligation to update any of these forward looking statements or information.

Dr. Jacob: Now I'd like to turn the call over to Dr. Jacob.

Dr. Jacob: Right.

Frank K. Bedu: Thank you, Tom, and good morning, everyone. I am pleased to be speaking with all of you today and to be joined by two new members of the PDS Biotech leadership team. Lars Bullsgaard joined us last November as Chief Financial Officer.

Dr. Jacob: Tom and good morning, everyone.

Dr. Jacob: I am pleased to be speaking with all of you today.

Dr. Jacob: And to be joined by two new members of the P. D S biotech leadership team.

Dr. Jacob: Lots of boys, Scott joined US last November as Chief Financial Officer.

Frank K. Bedu: He is an experienced CFO with an impressive track record of guiding biotech companies to create strategic growth. We welcome his insights as well as his financial expertise and oversight as we continue to mature our business and advance our clinical program. In January of 2024, we also announced the appointment of Dr. Kirk Sheppard. Kirk is a distinguished board-certified medical oncologist and hematologist with more than 30 years of experience in the pharmaceutical industry. Most recently, Kirk was chief medical officer.

Dr. Jacob: He is an experienced CFO with an impressive track record of guiding biotech companies to create strategic growth.

Dr. Jacob: We welcome his insights as well as his financial expertise and oversight as we continue to mature our business and advance our clinical programs.

Dr. Jacob: In January of 'twenty 'twenty four we also announced the appointment of Kirk shot.

Dr. Jacob: Kirk is a distinguished board certified medical oncologists, and Hematologists with more than 30 years of experience in the pharmaceutical industry.

Most recently Kirk was chief Medical Officer.

Frank K. Bedu: Senior Vice President and Head of the Global Medical Affairs Oncology Business Group at ESA. We are particularly pleased to have Kirk on board, as his wealth of oncology and clinical expertise will be invaluable as we begin to execute the updated clinical development strategy we will be discussing today. As Tom mentioned, Lars will walk you through our financial results for 2023 later in the call, and Kirk will be available to take questions during the Q&A session. So let's begin.

Dr. Jacob: Senior Vice President and head of Global Medical Affairs oncology business group at ESI.

Dr. Jacob: We are particularly pleased to have Kirk on board as his wealth of oncology and clinical expertise will be invaluable as we begin to execute the updated clinical development strategy, we will be discussing today.

Dr. Jacob: As Tom mentioned loss will walk you through our financial results for 2023 later on the call.

Dr. Jacob: And Kirk will be available to take questions during the Q&A session.

Speaker Change: So let's begin.

Frank K. Bedu: Our fourth quarter of 2023 and recent weeks have been a busy and productive period for PDS Biotech, during which we made significant advancements with our PDS-01-ADC, our IL-12 fused antibody drug conjugate clinical programs, as well as our PDS-01-01 phase 2 programs. During this period, compelling data from several Phase II trials became available. This includes long-term survival data from the National Cancer Institute-led triple combination trial of PDS-01-ADC in combination with versamune HPV, formerly known as PDS-0101, and an Investigational Immune Checkpoint Inhibitor, or ICI. We also obtained data from our own Versatile002 study of versamune HPV and Keytruda. Collectively, these data have provided us with clarity regarding how our drug platform technology works in advanced cancer and have informed the strategic decision we announced today to advance this triple combination of versamune HPV, PDS-01-ADC, and Keytruda in recurrent and or metastatic head and neck cancer, also referred to as head and neck squamous cell carcinoma. OH&SCC

Speaker Change: Our fourth quarter of 2023 and recent weeks have been a busy and productive period for P. D. S biotech.

During which we made significant advancements with our P. D. F O one ADC, our IL 12 fused antibody drug conjugate clinical programs.

Speaker Change: Well our P. D S 0101 phase II programs.

Speaker Change: Over this period compelling data from several phase two trials became available.

Speaker Change: This includes long term survival data from the National Cancer Institute that Triple combination trial of P. D. S. O. One ADC in combination with first immune H P V, formerly known as P. D. S 0101.

Speaker Change: And on investigational immune checkpoint inhibitor or ICI.

Speaker Change: Yeah.

Speaker Change: We also obtained data from our own adverse mortality reserve to steady.

Speaker Change: Often first immune HPV and Keytruda.

Speaker Change: Collectively these data have provided us with clarity regarding how our truck platform technology works in advanced cancer.

Speaker Change: And hot informed strategic decision, we announced today to advance this triple combination often first immune HPV.

Speaker Change: P D S O one ADC and.

Speaker Change: And keytruda in recurrent or metastatic head and neck cancer also referred to as head and neck squamous cell carcinoma.

Speaker Change: Or H N S C.

Frank K. Bedu: This program will be our top clinical development priority in place of the previously planned Versatile 003 trial. This decision enables us to focus our resources on a regimen that we believe has the highest potential benefit to patients with head and neck cancer and the potential to drive shareholder value. On today's call, we will walk you through the data that has driven this decision, discuss the careful vetting we've undertaken to confirm our approach, and outline the advanced preparations on trial design and regulatory engagement we've already begun. To set the stage, I'll first review the critical limitations that remain in the use of immunotherapies to treat solid tumors. First, the innate or acquired resistance these tumors have to immunotherapies, including immune checkpoint inhibitors, or ICIs, and CART T-cell approaches.

Speaker Change: This program will be our top clinical development priority in place of the previous new plan versus housing, let's see with three trial.

Speaker Change: This decision enables us to focus our resources on a regimen, which we believe have the highest potential benefit to patients with head and neck cancer.

Speaker Change: And the potential to drive shareholder value.

Speaker Change: On today's call, we will walk you through the data that has driven this decision.

Speaker Change: Discuss the careful vetting, we've undertaken to confirm our approach.

Speaker Change: And outlined the advanced preparations on trial design and regulatory engagement, we've already begun.

Speaker Change: Yeah.

Speaker Change: To set the stage.

Speaker Change: First review the critical limitation that remain in the use of immunotherapies to treat solid tumors.

Speaker Change: First the innate or a quiet resistance these tumors have to immunotherapies, including immune checkpoint inhibitor or ICI.

Speaker Change: And car T cell approaches.

Frank K. Bedu: These approaches all rely on activating T-cells to attack the cancer. They, therefore, attack the cancer from the outside. However, most advanced solid tumors house their protection against the immune system in their inner core. These tumors can therefore prevent T cells from recognizing or infiltrating the tumor. In addition, these tumors may be able to inactivate any infiltrating T-cells due to the presence of suppressive cytokines or inhibitory factors within the tumor.

Speaker Change: These approaches all rely on activating T cells to attack the cancer.

Speaker Change: They therefore attack the cancer from the outside.

Speaker Change: However, most advanced solid tumors houses there protection against immune system and they are cool.

Speaker Change: These tumors can therefore prevents T cells from recognizing infiltrating the tumor.

Speaker Change: In addition.

Speaker Change: These tumors may be able to activate Amy infiltrating T cells due to the presence of suppressor cytokines or inhibit risk factors within the tumor.

Frank K. Bedu: The second important limitation is that current immunotherapies have not demonstrated the ability to generate the right type and quantity of effective tumor-infiltrating and tumor-killing T-cells, unlike what we have demonstrated with our VersaMune platform today. Recent long-term survival results and clinical data provide clarity on the dual mechanism of action of combining PDS-01-ADC and Versimune and its potential to overcome most critical immuno-oncology limitations. The insights into the PDS-01-ADC mechanism of action provided by these recent data clarify the potential of this drug therapy in combination with verse immune HPV and an immune checkpoint inhibitor. PDS-01-ADC utilizes an antibody that binds to DNA found in the inner core of the tumor and therefore delivers IL-12 into the internal compartment of the tumor. IL-12 once within the tumor limits the presence of inhibitory factors within the tumor, thereby weakening Versimune HPV simultaneously generates a powerful T-cell attack on the exposed or less protected tumor, resulting in compelling anti-tumor responses, which we will discuss shortly. The data show that with this combination The mechanism uniquely acts on both the inside and outside of the tomb.

Speaker Change: The second important limitation is that current immunotherapies have not demonstrated the ability to generate the right type and quantity.

Speaker Change: Effective tumor infiltrating and tumor killing T cells.

Speaker Change: Unlike what we have demonstrated with our sourcing platform to date.

Speaker Change: Recent long term survival results in clinical data provide clarity on the dual mechanism of action of combining P. D. S O one ADC adverse in U.

Speaker Change: And its potential to overcome most critical immuno oncology limitations.

Speaker Change: The insights into the P. D. S O one ADC mechanism of action provided by this recent data.

Speaker Change: Clarify the potential of this drug therapy in combination with the first immune HPV and an immune checkpoint inhibitor.

Speaker Change: P. B S O. One ADC utilizes an antibody that binds to DNA found in the inner core of the tumor.

Speaker Change: And therefore deliver the IL 12 into the internal compartment of the tumor.

Speaker Change: The IL 12 once within the tumor.

Speaker Change: Limits the presence of inhibitory factor within the tumor.

Speaker Change: Thereby weakening the tumor defenses against the immune system.

Speaker Change: The first immune HPV simultaneously generates a powerful T cell attack on the exposed or less protected tumor, resulting in compelling anti tumor responses, which we will discuss shortly.

Speaker Change: The data shows that with this combination.

Speaker Change: The mechanism uniquely acts on both the inside.

And outside of the tumor.

Frank K. Bedu: Data was announced last November from a Phase II National Cancer Institute-led triple combination trial for the treatment of recurrent and or metastatic HPV16-positive ICI-naive and ICI-resistant cancer. This included head and neck cancer, among other tumor types, and provided proof of concept of the mechanism of action and support for prioritizing the triple combination. In the ICI resistance group, the 12-month overall survival rate was 72%, and the median overall survival was approximately 20 months. With current approaches, the 12-month overall survival rate in HPV-positive, ICI-resistant cancer is approximately 30 percent, and the median overall survival is only 3.4 months. A 63% overall response rate, or ORR, was observed in patients receiving the optimal dose of PDS-01-ADC. Publishing data to date suggests an ORR of less than 20% in ICI-resistant HPV-positive head and neck cancer in the ICI Naive group. 75% of patients remain alive at 36 months, and therefore, the median overall survival was not reached.

Speaker Change: The data was announced last November from the Phase two National Cancer Institute led Triple combination trial.

Speaker Change: The treatment of recurrent or.

Speaker Change: Or metastatic HPV 16 positive.

Speaker Change: I see I naive and I see I resistant cancers.

Speaker Change: This included head and neck cancer among other tumor types.

Speaker Change: And provided proof of concept of the mechanism of action and support for prioritizing the triple combination.

Speaker Change: In the ICI resistance group.

Speaker Change: The 12 months overall survival rate was 72%.

Speaker Change: And the median overall survival was approximately 20 months.

Speaker Change: With current approaches the 12 month overall survival rate in HPV positive ICI resistant cancer.

Speaker Change: Approximately 30% in.

Speaker Change: And median overall survival is only 3.4 months.

Speaker Change: A 63% overall response rate or are what's observed in patients with the optimal dose of P. D. S O one a D C.

Speaker Change: Publishing data to date suggest or are off less than 20% in ICI resistant HPV positive head and neck cancer.

Speaker Change: In the ICI naive group.

Speaker Change: 75% of patients remained alive at 36 months and therefore, the median overall survival was not reached.

Frank K. Bedu: With immune checkpoint inhibitors, published results show a 36-month survival rate of approximately 20%. Overall, a response rate of 75% was seen in patients treated with the triple combination, with a complete response rate of 38%. Published ORR of less than 40% is seen with immunotherapeutic agents.

Speaker Change: With immune checkpoint inhibitors published results show, a 36 month survival rate of approximately 20%.

Speaker Change: Overall response rate of 75% was seen in patients treated with a triple combination.

Speaker Change: With a complete response rate of 38%.

Speaker Change: Published O all of less than 40% as seen with immuno therapeutic agents.

Frank K. Bedu: With the triple combination, responses were seen in all HPV-positive tumor types. These data are further supported by our robust clinical data set in over 430 patients treated with either versimune HPV or PDS-01-ADC or the combination, including over 110 head and neck cancer patients to date, and importantly, with respect to safety.

Speaker Change: With the Triple combination responses were seen in all HPV positive tumors types.

Speaker Change: These data are further supported by our robust clinical data sets in both a 430 patients treated with either reversing U H P. P.

Frank K. Bedu: We have seen acceptable tolerability in over 300 patients treated with PDS-01-ADC and in over 170 patients with versamune HPV today. Additionally, the National Cancer Institute has completed a detailed dose optimization study for PDS01-ADC based on safety and clinical response, which is a critical consideration for the FDA. This large database of patients provides a robust clinical data set that validates the potential efficacy and safety of our platforms, which we believe supports our decision to prioritize our Versamune PDS-01-ADC platform in combination with Keytruda.

Speaker Change: Paul P. B S O one a D C or the combination.

Speaker Change: Including over 110 head and neck cancer patients to date.

Speaker Change: Importantly, with respect to safety.

Speaker Change: We have seen acceptable tolerability in over 300 patients treated with P. D. S O one ADC.

Speaker Change: And in over 170 patients with diverse immune HPV to date.

Speaker Change: Additionally, the National Cancer Institute has completed a detailed dose optimization study.

Speaker Change: P D. S O one a D C based on safety and clinical response, which is a critical consideration for the F. D. A.

Speaker Change: This large database of patients provides a robust clinical dataset that validates the potential efficacy and safety of our platforms.

Frank K. Bedu: Our triple combination trial to be progressed will therefore consist of versimune HPV, PDS 01 ADC, and Ketruda. We engaged the FDA regarding our decision, and the FDA has provided clear guidance on clinical study design and regulatory pathway for the triple combination. We also engaged with top U.S. and E.U.

Speaker Change: Which we believe supports our decision to prioritize our first immune P. D. S O one ADC platform in combination with Keytruda.

Speaker Change: Based on the totality of data generated to date from versatile is there was there were two.

Frank K. Bedu: key opinion leaders to confirm interest in the triple combination and participation in a clinical trial. We are pleased to announce that Dr. Katherine Price of Mayo Clinic, who is also an investigator on the VERSTYLE-002 trial, will be the lead investigator in the planned pivotal trial of the triple combination. We are also conducting rigorous evaluation of the competitive landscape in both ICI-naive and ICI-resistant head and neck cancer.

Speaker Change: And the National Cancer Institute lead Triple combination study.

Speaker Change: Our triple combination trials to be progressed, well therefore consist of burst immune HPV.

Speaker Change: P D S O one a D C.

Speaker Change: And Keytruda.

Speaker Change: Yeah.

Speaker Change: We engaged the FDA regarding our decision.

Speaker Change: And the FDA has provided clear guidance on clinical study design and regulatory pathway for the triple combination.

Speaker Change: We also engaged with top U S and EU key opinion leaders to confirm interest in the triple combination and participation in a clinical trial.

Frank K. Bedu: This careful research takes time, but we are taking the necessary steps to ensure that our decision is in the best interest of patients and our shareholders. We intend to move strategically and aggressively to advance the triple combination into a pivotal trial. By initially addressing the rapidly growing unmet medical need for recurrent metastatic HPV-16 positive head and neck cancer, we strongly believe that this approach has the potential to rapidly establish the combination of PDS-01-ADC and Versamil on the Transformative Oncology Platform.

Speaker Change: We are pleased to announce that Dr. Catherine price of Mayo Clinic, who is also an investigator on diverse tells you received with two trial.

Speaker Change: It'll be the lead investigator in the planned pivotal trial the triple combination.

Speaker Change: We are also conducting rigorous evaluation of the competitive landscape in both IC, I naive and ICI resistant head and neck cancer.

Speaker Change: This careful research takes time, but.

Frank K. Bedu: The data suggests that the triple combination may result in a significant improvement in overall survival rates for patients who currently lack an effective treatment option. We are deeply grateful to our patients who participate in our trials and to our collaborators who continue to show immense confidence in our platforms and who have been instrumental in working with PDS Biotech to achieve what we now believe are potentially significant advances in cancer treatment. With that, I will turn it over to Lars for a review of our financial results. Lars?

Speaker Change: But we are taking the necessary steps to ensure that our decision is in the best interest of patients and our shareholders.

Speaker Change: We intend to move strategically and aggressively to advance the triple combination into a pivotal trial.

Speaker Change: By initially addressing the rapidly growing unmet medical need in recurrent metastatic HPV 16 positive head and neck cancer.

Speaker Change: We strongly believe.

Speaker Change: That this approach has the potential to rapidly establish the combination of P. D. S O one ADC and diverse immune.

Lars Bullsgaard: Thanks, Frank, and good morning, everyone. I look forward to engaging with you as we advance the clinical program that Frank has just presented. Turning to our financial results, our net loss for the year ended December 31, 2023 was approximately $42.9 million, or $1.39 per basic and diluted share compared to a net loss of $40.9 million, or $1.43 per basic share and diluted share for the year ended December 31, 2022. The higher net loss was primarily the result of increased operating losses and increased net interest expense.

Speaker Change: I say transformative oncology platform.

Speaker Change: The data suggest that the triple combination may result in a significant improvement in overall survival rates for patients who currently lack an effective treatment option.

Speaker Change: We are deeply grateful to our patients who participate in our trial and.

Speaker Change: And to our collaborators who continue to show immense confidence in our platforms and who have been instrumental in working with P. D. S. Biotech to achieve what we now believe a potential significant advances in cancer treatment.

Speaker Change: With that I will turn it over to Laura for a review of our financial results Lars. Thanks.

Lars Bullsgaard: Our research and development expense for the year ended December 31, 2023 decreased to $27.8 million compared to $29.4 million for the year ended December 31, 2022. The decrease of $1.7 million was primarily attributable to the $10 million purchase of the rights to PDS-01-EDC in 2022. Partially offset by an increase in clinical costs of $6.1 million and an increase in personnel costs of $2.1 million. As a reminder, we entered into an exclusive worldwide license for PDS01-ADC in late 2022 for consideration of $5 million in cash and $5 million in company shares. General and administrative expenses for the year ended December 31, 2023 increased to $15.3 million compared to $12.2 million for the year ended December 31, 2022. The $3.1 million increase was primarily attributable to an increase in personnel costs of $1.5 million and an increase in professional fees of $1.6 million. Total operating expenses for the year ended December 31, 2023 were $43 million, an increase of approximately 3.3% compared to $41.7 million in total operating expenses for the year ended December 31, 2022. Net interest expense increased to $1.3 million for the year ended December 31, 2023, compared to $0.4 million for the year ended December 31, 2022.

Laura: Frank and good morning, everyone.

Laura: I look forward to engaging with you as we advanced the clinical program that frankly just presented.

Laura: Turning to our financial results net loss for the year ended December 31, 2023 was approximately $42 $9 million or $1.39 per basic and diluted share compared to a net loss of $40 $9 million or $1.43 per basic share and diluted share for the year ended.

Laura: December 31 2022.

Laura: The higher net loss was primarily the result of increased operating loss and increased net interest expense.

Laura: All our research and development expense for the year ended December 31, 2023 decreased to $27 $8 million compared to $29 4 million for the year.

Laura: At December 31, 2022.

Laura: The decrease of $1 $7 million was primarily attributable to the $10 million purchase of the rights to P. D. S. One ADC in 2022.

Laura: Partially offset by an increase in clinical costs of $6 $1 million and an increase in personnel costs are $2 $1 billion.

Laura: As a reminder, we entered into an exclusive worldwide license for PD, one ADC in late 2022 before consideration of $5 million in cash and $5 million in company shares.

Laura: General and administrative expenses for the year ended December 31, 2023 increased to $15 3 million compared to $12 $2 million for the year ended December 31 2022.

Laura: The $3 $1 million increase was primarily attributable to an increase in personnel costs of $1 5 million and an increase in personnel and professional fees of $1 $6 million.

Laura: Total operating expenses for the year ended December 31, 2023 were $43 million, an increase of approximately three 3% compared to $41 7 million and total operating expenses for the year ended December 31 2022.

Lars Bullsgaard: This change was due to higher interest rates, interest expense related to the company's notes payable, which was partially offset by higher interest income on our bank deposit. During the fourth quarter of 2023, we raised approximately $10.5 million in net proceeds from our at-the-market sales. In conclusion, our cash balance as of December 31, 2023 was $56.6 million. Our annual report, which will be filed within a few days, will contain growing concern and opinion, reflecting substantial doubt about our ability to meet our obligations for 12 months following the filing of the annual report. Based on our currently available cash resources and cash flow projections, we believe that without commencing a pivotal clinical trial and without our notes payable being called by the lenders, our current cash balance is sufficient to fund our operations and research and development programs into the fourth quarter of 2025.

Laura: Net interest expense increased to $1 $3 million for the year ended December 31, 2023, compared to <unk> 4 million for the year ended December 31 2022.

Laura: This change was due to higher interest rate interest expense related to the Companys notes payable, which was partially offset by higher interest income on our bank deposits.

Laura: Yeah.

Laura: During the fourth quarter of 2023.

Laura: We raised approximately $10 5 million in net proceeds from our at the market sales agreement.

Laura: Our cash balance as of December 31, 2023 was $56 6 million.

Laura: Oh annual report, which would be fine within a few days will contain a going concern opinion, reflecting substantial doubt about our ability to meet all obligations for 12 months following the filing of the annual report.

Based on our currently available cash resources and cash flow projections, we believe that without commencing a pivotal clinical trial and without all notes payable being called by the lenders. Our current cash balance is sufficient to fund our operations and research and development programs into the fourth quarter of 2025.

Lars Bullsgaard: With that, I'll turn the call over to the operator for our Q&A session. Thank you. We'll now be conducting a question and answer session. If you'd like to ask a question at this time, please press star 1 on your telephone keypad, and a confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to withdraw your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

Speaker Change: With that I'll turn the call over to the operator for a Q&A session.

Speaker Change: Thank you well now be conducting a question and answer session. If you'd like to ask a question at this time. Please press star one from your telephone keypad, a confirmation tone will indicate your line is in the question queue.

Speaker Change: Press Star two if he like to withdraw your question from the queue.

Speaker Change: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

Operator: One moment, please, while we poll for questions. Thank you. Thank you, and our first question will be coming from the line of Louise Chen with Candor Fitzgerald. Please receive your question. Hi, good morning, everyone.

Speaker Change: One of them. Please poll for questions. Thank you.

Speaker Change: Thank you and our first question will be coming from the line of Louise Chen with Cantor Fitzgerald. Please proceed with your question.

Speaker Change: Hi, Good morning, everyone. This is Carter on for Louise Chen from Cantor and thank you for taking our questions. Our first question is given your prioritizing P. D. Oh, what a D C. Triple combo study Oh per bushel towards your two or three how are you thinking opex management differently for the rest of the year I saw were sold off the switch.

Louise Alesandra Chen: This is Carly on behalf of Louise Chen from Canada. Thank you for taking our questions. Our first question is, given you're prioritizing the PDS-01-ADC triple combo study over Versatile-003, how are you thinking about opex management differently for the rest of the year as a result of the switch? And secondly, as we're thinking about the rest of this year and into 2025, what are your biggest milestones or data readouts in the next 12 to 18 months? Thank you so much. Hi Carvey.

Speaker Change: And secondly, that's really thinking about the rest of this year and into 2025. What are your biggest milestones are data readouts in the next 12 to 18 months. Thank you so much.

Speaker Change: Yeah.

Speaker Change: Hi, <unk>. Thanks for that question could you. Please.

Louise Alesandra Chen: Thanks for that question. Could you please go over the first one again? I lost the last part of the first question. Yes, essentially, we are asking about, since you guys are prioritizing the ADC-Triple Combo over Versatile 2033, how are you guys thinking about op-eds differently, or is it going to be similar? I just want to get Eric Kelly on that.

Speaker Change: Go over the first one again I lost the last part of the first question.

Speaker Change: Yes, essentially.

Speaker Change: We are talking about since you are you guys are prioritizing the agency triple combo or reversing.

Speaker Change: He was just a theory.

Speaker Change: How are you guys thinking about opex differently or is it could it be similar I'm just wanted to get a kelly on that thank you.

Lars Bullsgaard: Thank you. Okay, thanks a lot, Kavya. I'll answer the second part of the question first, and then I'll hand the OPEX portion to Lars to address. So in terms of our milestones for 2024, as you know, there are a number of programs that we are simultaneously running in parallel with, our lead programs with the triple combination and Verstyl 002. We do expect for Verstyl 002 that we will have an update sometime in the second or early part of the third quarter on where the trial is to date. We've completed recruitment for that trial, and we are hopeful that we will be able to give updates on survival in the 002 trial. As you may also be aware, we have the Immunoserve trial that's being run at MD Anderson Cancer Center that's looking at locally advanced cervical cancer.

Speaker Change: Okay. Thanks, a lot coffee also answer the second part of the question first and then I'll hand, the Opex.

Kelly: Portion to Lars to address that.

Kelly: In terms of our milestones for 'twenty 'twenty four as you know there are a number of programs that we are simultaneously running in parallel with with.

Kelly: Our.

Speaker Change: Lead programs with a triple combination and burst out 002, we do expect both bear styles. There was there were two that we will have an update sometime in the second or early and early part of third quarter.

Speaker Change: Where the trial is to date.

Speaker Change: We've completed recruitment in that trial and we are hopeful that we'll be able to give updates on survival and is there because he was here with two trial.

Speaker Change: As you also may be aware, we have the UNICEF trial, that's being run at the MD Anderson Cancer Center, that's looking at locally advanced cervical cancer and we have some updates in November but we expect this year in the second half of this year that will have an update a clinical update specifically so response rates of sale of survival.

Lars Bullsgaard: And we have some updates in November, but we expect this year, in the second half of this year, that we'll have an update, a clinical update specifically, so response rates as well as survival, potentially long-term survival, for those patients whose data was presented last year. And so that will be a very important update that we would be expecting in the second half of this year.

Speaker Change: Well. Thank you long term survival on those patients whose data was presented last year and so that will be a very very important update that we would be expecting in the second half of this year and of course, we also have the trial ongoing at the Mayo clinic, which is the new adjuvant trial of P. S 0101 monotherapy M P.

Frank K. Bedu: And, of course, we also have the trial ongoing at the Mayo Clinic, which is the neoadjuvant trial of PDS-0101 monotherapy and PDS-0101 plus Keytruda in early-stage oral cancer. We have not had any data from that trial yet, but we are hopeful that sometime in the second half of this year, we will have the preliminary data released for that trial. So those are key updates that we could potentially expect this

Speaker Change: Oh, why no one plus keytruda.

Speaker Change: In in our early stage oral cancer, we have not had any data from that trial, yet, but we are hopeful that sometime in the second half of this year, we will have the preliminary preliminary data released on EM.

Speaker Change: For that trial.

Speaker Change: So those are key updates that we could potentially expect this year and we are also planning to move our P. D. S 0103 program into the clinic. So we are looking to file the IND.

Lars Bullsgaard: And we are also planning to move our PDS-0103 program into the clinic, so we are looking to file the IND for PDS-0103 also in the second half of this year. And the information that we have obtained recently regarding how our assets are working becomes critical in designing that trial and also finalizing the combination for that trial, where, again, we expect to utilize the PDS-0103 versus immune combination in that program also. So those could be key updates that we could be expecting this year from PDS. And last, I'll hand over to you to address the operating costs for 2024. Thanks, Frank, and thank you for your question for me. So we'll be filing our RRK in a few days, and so it'll be clear from that.

Speaker Change: Four P. D. S 0103 also in the second half of this year and the information that we have obtained recently regarding how our assets are working becomes critical in designing that trial and also finalizing the combination for that trial, where again, we expect to utilize the P. D. S O one ADC burst immune.

Speaker Change: <unk> in that in that program also so those could be key updates that we could be expecting this year from Pds and last I'll hand over to you to address the operating cost for 2024.

Speaker Change: Thanks, Frank and thanks for your question probably.

Speaker Change: So we will be filing our RFP in a few days in and so it will be clear from that right. Now you can see you'll see that we incurred an operating burn of approximately $8 million per quarter.

Lars Bullsgaard: So right now, you'll see that we incurred an operating burn of approximately 8 million per quarter. As also stated in the pre-prepared remarks, without initiating the triple combination pivotal study, we expect that burn to continue through the first two to three quarters of 2024 as we wrap up versus hot OO2. And thereafter, you probably will see a slight decrease in that quantity burn.

Speaker Change: As also stated.

Speaker Change: In the.

Speaker Change: Prepared remarks without initiating the triple combination people study, we expect that burn to continue through the first two to three quarters of 2024.

Speaker Change: As we wrap up our Chicago tube and thereafter, you should probably see a slight decrease in that quarterly burn.

Lars Bullsgaard: I should also mention that during the first quarter or through the first quarter of 2024, we pulled down approximately 19 million under the ATM. So that, of course, also bolsters our current. Great, I got it. Thank you so much.

Speaker Change: I should probably also mention that during the first quarter or through the first quarter of 'twenty 'twenty four we pulled down approximately 19 billion under the ATM. So that of course also bolsters our current cash holdings.

Speaker Change: Okay got it thank you so much.

Speaker Change: Uh huh.

Mayank Mamtani: Our next question is from the line of Mayank Mamtani with B-Riley Securities. Please see if there are any questions. Good morning, team.

Speaker Change: Our next question is from the line of my Oh, Johnny with B Riley Securities. Please proceed with your question.

Johnny: Good morning team, thanks for taking our questions and appreciate the comprehensive update in the sense of the strategy to it is.

Frank K. Bedu: Thanks for taking our questions and appreciate the comprehensive update and the sensible strategy pivot here. Can you please clarify that the 38% CR in triplet has been confirmed for resist, and if there's going to be another update to that in 2024, that could be informative to how you think of your next study for the triplet. And maybe just a related question, what steps remain in finalizing the registration enabling study for the triplet, and is there an end of phase two meeting there that you feel you're prepared for, or is there some additional work you have to do given the PD-1 that was used in your earlier study has to be changed to Keytruda? And then I have a quick follow-up. Mayank, thanks a lot for your question.

Johnny: Can you. Please clarify the 38% see I didn't trip led has been confirmed but it has been and if there's going to be another update did that didnt do any 24 that could be informative to how you'd think of your next study with a triplet and maybe maybe just a related question what steps remain in.

Johnny: Finalizing the registration, enabling study with a triplet and is there is there an end of phase two meeting the.

Johnny: And you feel you are prepared for the.

Johnny: Some additional work you can do given the PD one that was he wont be any other earlier studies.

Johnny: We now changed to get through that and then I have a quick follow up.

Johnny: Yeah.

Johnny: Mike Thanks, a lot for your question so starting with the Triple combination in the complete responses. So about the Triple combination study that was led by the National Cancer Institute has been completed so that study that study is now final. The results that we we went through today are the final results from that study.

Frank K. Bedu: So, starting with the triple combination and the complete responses. So the triple combination study that was led by the National Cancer Institute has been completed. So that study is now final. The results that we went through today are the final results from that study. So, the 38% response rates are confirmed objective response rates, and as I mentioned, the follow-up for the naive patients was three years, and so one of the key things that we were looking for was not only the data from the VERSTL, the refractory arm of the VERSTL002 study to understand how the dual combination is working, but also to really understand the survival in the triple combination. So, we had really good survival rates for year one and the first 17 months.

Johnny: Right so the 38%.

Johnny: Response rates are confirmed objective response rates and as I mentioned the follow.

Johnny: Follow up for the naive patients was three years and so one of the key things that we were looking for was not only the data from the burst out that refractory all diverse styles. There was there were two study to understand how the dual combination it's working but also to really understand the long term.

Johnny: Survival in the Triple combination. So we had really good survival for year, one and the first 17 months, what we need to understand would we when do we get it it's a significant drop off after a one to two years or would this be a durable response in these patients continue to survive and what we saw and what that all patients who have life of two years remained alive at three.

Frank K. Bedu: What we needed to understand was, would we get a significant drop-off after one to two years, or would this be a durable response, and these patients would continue to survive? And what we saw was that all patients who were alive at two years remained alive at three years. That was very important, but what was also very important was safety.

Speaker Change: Yes that was very important.

Speaker Change: So very important was the safety.

Frank K. Bedu: Right, so as you may know, our PDS-01-ADC is an IL-12-based antibody drug conjugate. In the past, recombinant IL-12s have seen significant toxicity. And so one of the key reasons that we needed additional data was really to confirm the safety profile of our IL-12 antibody drug conjugate and also to really confirm that it is significantly different from the recombinant IL-12s that have been evaluated in the past and that continue to be evaluated today, right? So the safety data from the over 300 patients that we've evaluated today was very critical in forming this decision also, really confirming that safety profile and toler So that was, again, very important in this decision-making process also. Now, what was also very important is what you just brought up.

Speaker Change: Right.

Speaker Change: You May know our P. D. S. O. One ADC is an IL 12 based antibody drug conjugate and in the past will complement the IL 12, <unk> seen significant toxicity.

Speaker Change: And so one of the key reasons that we needed additional data was willing to confirm the safety profile of our IL 12 antibody drug conjugate and also to really confirm that it is significantly different from the recombinant IL 12 that have been evaluated in the past and that continue to be evaluated.

Speaker Change: Right. So the safety data from the three over 300 patients.

Speaker Change: That we'd be by the way to today was very critical informing this decision also really confirming that safety profile and tolerability in these patients who have taken the IL 12 mm antibody ADC that goes again very important in this decision making process also.

Speaker Change: Now what was also very important is what he just brought up.

Frank K. Bedu: Is there a clear regulatory pathway for the triple combination? And so that was why we initiated discussions with the FDA to get feedback from the FDA in terms of what they would want to see in a clinical trial design for PDS-01-ADC, versamune HPV, and Keytruda, with PDS-0101-KITRUDA forming the basis for that program. We've seen very good survival, impressive survival with just PDS-0101-KITRUDA based on the quality of T-cells that we're generating, and now adding the PDS-0180C on top of that to really overcome the tumor's defense. And so we had that discussion with the FDA last month, and the FDA has given us very clear guidance on what they would want to see in the clinical design. And so what we are currently doing is implementing the feedback from the FDA.

Speaker Change: Is there a clear regulatory pathway for the Triple combination and so that was why we initiated discussions with the FDA to get feedback from the FDA in terms of what they would want to see in a clinical design of P. B S O one ADC versus mean HPV.

Speaker Change: And Keytruda with.

Speaker Change: With P. D. S O 101, keytruda, forming the basis for that program we've seen it.

Speaker Change: Very good survival impressive survival with just P. D. S. O 100, wanting keytruda based upon the quality of T cells that we are generating and now adding the P. D. S. O. One ADC on top of that to really overcome overcome the tumor defenses right and so we have that discussion with the FDA last month and the FDA has given us very clear.

Speaker Change: Our guidance on what they would want to see in the clinical design.

Speaker Change: And so what we are currently doing is implementing the feedback from the FDA and then once we have done that we would want to get the alignment with the FDA that okay. We've taken these your concentration your.

Frank K. Bedu: And then once we have done that, we would want to get alignment with the FDA that, okay, we've taken your advice and guidance into consideration. Here is the trial in getting alignment with the FDA. And at that point, we will then make the protocol publicly available. But I would hate to go into saying exactly what the design is until we have gotten that alignment with the FDA based upon the feedback they gave us. But that's the valid process that we've gone through today. Yep, I got it. Very helpful. And then on the opportunity set here, like what specific indication are you looking for as your lead? Is it the same population where you have this data, or are you looking at this more broadly in HPV positives, positive tumor types, which there are many? If you can just categorize the broader opportunity set and also how you get there in terms of different trials you would need, that would be helpful.

Speaker Change: Your advice and guidance into consideration.

Speaker Change: Here was the trial and get alignment with the FDA and at that point, we will then make.

Speaker Change: We will then make the the protocol and publicly available, but I would hate to go into say exactly what the design is until we have.

Speaker Change: Gotten better alignment with the FDA based upon the feedback they gave us, but that's sort of out of the process that we've gone through to date.

Speaker Change: Yep got it they helpful and then on the opportunity set has I like what.

Speaker Change: Specific indication Youre looking as your lead is it are the same population that you had this data or are you looking at this more broadly and it's excuse me pause it as far as the dealer days, which there are many.

Speaker Change: If you can just categorize the broader opportunity set and also like how you get there in terms of different trial you would need.

Speaker Change: That would be helpful and thanks again for taking the question.

Frank K. Bedu: And thanks again for taking the, No, Mayank, that's a really good question. So we have done extensive market research talking to key opinion leaders to really understand the potential for both ICI naive and ICI resistant patients. From all the information we're getting, the KOLs see this as potentially very important in both.

Speaker Change: No Mike that's that's a really good question. So we have done extensive market research talking to key opinion leaders to really understand the potential in both ICI naive and ICI resistant patients.

Speaker Change: From all of the information, we're getting the Kols see this asset potentially very important in both the big unmet unmet needs in both the ICI naive and ICA resistant patient population as you know currently the response rates in ICI naive only about 20%.

Frank K. Bedu: There are unmet needs in both the ICI-naive and ICI-resistant patient population. As you know, currently, the response rates in ICI-naive patients are only about 20%. So there is a very significant unmet need there.

Speaker Change: Significant unmet need there and the ICI resistance practically nothing is really working in those patients. Our focus initially guided by the FDA is to focus on head and neck cancer, rather than going broadly into all types of HPV associated cancers. We just what we were initially thinking about like what what we've discussed with you at the end of the guidance we've been given is.

Frank K. Bedu: In ICI-resistant patients, practically nothing is really working in those patients. Our focus, initially guided by the FDA, is to focus on head and neck cancer rather than going broadly into all types of HPV-associated cancer, which is what we were initially thinking about. But what we've discussed with the FDA and the guidance we've been given is, let's focus first on head and neck cancer, which is where we've generated the bulk of our data to date, right? Over 110 patients with head and neck cancer have been treated with our product today. So we have really good confidence around the head and neck cancer patients. In the NCI trial, of course, we went beyond head and neck cancer to look at other HPV types where we saw equally good responses across the board.

Speaker Change: Let's focus first on head and neck cancer, we just where we've generated the ball.

Speaker Change: All of our day to day right over 110 patients in head to head and neck cancer patients have been treated with our product today. So we have really good confidence around the head and neck cancer patient.

Speaker Change: The NCI trial of course, we went beyond head and neck cancer to look at other HPV types, where we saw responses equaling good responses across the board.

Frank K. Bedu: And so the way we envision this is to first focus on the biggest market and the most rapidly growing market, which is the head and neck cancer space, get that done, and then potentially progress from there into the other HPV cancer tumor types. But our initial focus is going to be specifically recurrent metastatic head and neck. Thank you for taking our questions. Thank you. The next question is from James Molloy with Alliance Global Partners. Please proceed with your question. Hey guys, good morning.

Speaker Change: And so the way we envision this let's first focus on the biggest market in the most rapidly growing market with just the head and neck cancer space and get that done and then potentially progress from there into the other HPV cancer tumor types, but our initial focus is going to be specifically recurrent metastatic head and neck cancer.

Speaker Change: Certainly.

Speaker Change: Okay.

Speaker Change: Thank you for taking our questions.

Speaker Change: Okay.

Speaker Change: Thank you. The next question is from the line of James Molloy with Alliance Global Partners. Please proceed with your question.

James Francis Molloy: Hey, guys. Good morning, Thank you for taking my questions.

James Francis Molloy: Thank you for picking my question. So, I apologize, challenging to follow sometimes, so the versatile O3. Phase 3 combo with Keytruda, HPV positive, head and neck squamous cell, CPI in the E-pitch. That trial's now shelved, or that trial is now ongoing, but you're adding in the 01-ADC, formerly called 03-01. Hi James.

James Francis Molloy: So I apologize if it's Jonathan falls, sometimes the so first of all O three.

James Francis Molloy: Phase III combo, Keytruda, HPV positive head and neck squamous cell C. P I need patients that trials now shelved.

James Francis Molloy: Or that trial is now ongoing but add that you're adding in.

James Francis Molloy: The old one a D C. The formerly called <unk> 301.

Okay.

James Francis Molloy: Hi, James.

Frank K. Bedu: Thanks for your question. So Versailles 003, we're not performing Versailles 003. So, based upon the information we have today, our goal as a company is to provide patients with the drug in combination that we believe provides them with the best opportunity for managing their disease. And today, based upon the information we've generated and our understanding of the mechanism by which these assets work, we believe that the triple combination is what provides these patients with the best opportunity to manage their disease. But also, what's very important for us, based upon the key opinion leader research, is which combination is really going to put PDS Biotech in a dominant leadership position in head and neck?

James Francis Molloy: Thanks. Thanks for your question diverse styles USD three were not performing versus those who receive a three so based upon the information we have today our goal as a company.

James Francis Molloy: Two is to provide to the patients the drug in combination that we believe provides them with the best opportunity.

James Francis Molloy: For managing their disease and today based upon the information we've generated and our understanding of the mechanism by which these assets work. We believe that the triple combination is what provides these patients with the best opportunity to manage the disease.

James Francis Molloy: But also what's very important for us based upon the key opinion leader research is which combination is really going to put P. D. S. Biotech in a dominant leadership position in head and neck cancer.

Frank K. Bedu: And that comes down to where oncologists believe the combination has the best opportunity to help their patients and to continue to help their patients survive long-term, right? And when you look at it from all those angles in terms of potential market dominance, and potential for patients, it comes down to the triple combination. And so that is the decision we have made not to move forward with versatile 0023 but to add the IL-12-ADC to that combination as the best opportunity and the best combination for the patients and also for market success. All right. I think we'll worry about market domination later.

James Francis Molloy: And that comes down to where oncologists believe the combination has the best opportunity to help their patients tend to come.

James Francis Molloy: Continuing to help their patients survive long term.

James Francis Molloy: And when you look at all of those angle in terms of potential market domination potential for the patients. It comes down to the triple combination and so about this the decision we have made.

James Francis Molloy: Not to move forward with burst styles.

James Francis Molloy: Two three.

James Francis Molloy: To add the IL 12, ADC to that combination as the best opportunity and the best combination for the patients and also for market market success.

Speaker Change: Okay Alright.

Speaker Change: Wearable market domination later.

James Francis Molloy: So, I'll get through the trials first. I think versatile O2, the data that came out of that was that Ketruda with HPV positive, HPV 16 positive, head and neck squamous cell. The combination with Keytruda was best in the CPI nave, and that's why versatile O03 was going to go forward in the nave.

Speaker Change: First I think versatile O two.

Speaker Change: Data that came out of that was that.

Speaker Change: The keytruda.

But HPV positive H V C 16 positive Ed next one Michelle.

Speaker Change: The combination with the Keytruda was best in CPI naive and that's why were sell through was going to go forward in the naive.

James Francis Molloy: And the last guidance we had was back in November, October, first patient by year-end, but obviously, that's done. So O03 is wrapped up, it's done, it's not going forward. So then on the triple combo, O01 plus the commercial checkpoint inhibitor plus the ADC or CPI refractory patient. I think the plan had been for that, that was going to be for the CPI refractories, that trial still going forward. Again, so rather than having... This is the triple combo with the NIH NH3 cancer. Is that child not going forward?

Speaker Change: And the last guidance. We had was in the was back in November October 1st patient by ear, but obviously that that's done so all threes.

Speaker Change: Wrapped up its done its not going forward. So then on the triple combo.

Speaker Change: Oh, one plus the commercial checkpoint inhibitor.

Speaker Change: Plus the a D C C P I refractory patients.

Speaker Change: The plan had been for that that was gonna be with the CPI refractories that trials still going forward.

Speaker Change: Yeah.

Speaker Change: Against that so rather than having triple combo, we don't have any with the NIH cancers that trials are going forward.

James Francis Molloy: Correct. Now, rather than having two separate trials, one with the doublet and one with the triplet, if you recall, the triplet had an investigational immune checkpoint inhibitor, right? And so the Versatile-002 with the doublet, what we saw was extremely compelling long-term survival data. We had 74% survival at two years when we looked at the refraction of one of the keys.

Speaker Change: Correct, so now rather than having two separate trials, one with the top left and one with the triplet.

Speaker Change: If you recall, the triplex had an investigational immune checkpoint inhibitor.

Speaker Change: And so the versatile 002 with the double like what we saw was extremely compelling long term survival data, we have 74% survival at two years.

Speaker Change: When we look at one of the key.

Frank K. Bedu: That was in CPI-naive patients, not in refractory patients. Correct, so when we move to the refractory patients... So this is very important because, if you recall, that was some of the data that we mentioned over the last couple of earnings calls that we really needed to get the data in the resistant patients to really understand the impact of the various components, right?

Speaker Change: Pardon.

Speaker Change: That wasn't CPI naive patients no I don't want to refresh my naive.

Correct, so we need to move to the refractory patients.

Speaker Change: This is very important because if you recall back with some of the data that we've mentioned over the last couple of earnings calls that we really needed to get that data in <unk> resistant patients to really understand the impact of the various components right and so with that data in their refresh in the refractory patients with Berstein zero-zero too.

Frank K. Bedu: And so with that data in the refractory patients with VERSTAL002, what we found was, again, prolonged survival but 0% objective response. So PDS, the T-cell induction was really leading to prolonged survival in these patients, even though they weren't seeing prolonged tumor shrinkage. Now, when you compare that with what we found in the triple combination, where we then have the low-dose IL-12 and the higher-dose IL-12, with the low-dose IL-12, we were seeing a very strong correlation with what we saw with the doublet, very weak objective responses. With a higher dose of IL-12, we're seeing dramatically improved objective responses and also improved survival. So, when you look at those two together, that data was very informative for us in really understanding the role of each of those components.

Speaker Change: What we found was again prolong prolong survival, but zero percent objective responses.

Speaker Change: Right. So the T cell induction was really meeting to prolong survival of these patients even though they werent seen prolonged tumor shrinkage.

Speaker Change: Now when you compare that with what we found in the Triple combination, where we then have the low dose IL 12, and the higher dose IL 12, with a low dose IL 12, we were seeing very strong correlation with what we saw with the doublet <unk>.

Speaker Change: Very weak objective responses with the higher dose IL 12, we've seen dramatically improved objective responses and also improved survival.

Speaker Change: Right. So when you look at those two together so that data was very informative for us and really understanding the role of each of those components and Douglas Arthur critical and drove that decision.

Frank K. Bedu: And that was also critical and drove that decision to say, we have to provide our patients with the best opportunity. And by adding IL-12 to that doublet, which has shown a really good safety profile, right? We saw a really good safety profile with PDS-0101 and Keytruda, even better results than even Keytruda monotherapy, which I explained earlier as to why we believe we've seen such safety, very high safety, and then adding the IL-12-ADC on top of that validated combination. Right?

Speaker Change: Let's say, we have to provide our patients with the best opportunity and by adding the IL 12 onto that doublet, which has shown.

Speaker Change: A really good safety profile right. So really good safety profile with Pts Wanda wanting keytruda.

Speaker Change: Right, even even better results than even keytruda monotherapy, which I explained earlier on as to why we believe we have seen those safety very high safety and then I think the IL 12, ADC on top of that validated combination.

Frank K. Bedu: And so that's how these have come together, how the data has actually led us to this decision. So this is really, very simply put, a data-driven decision that's led us to this point where we've now merged the two trials into one trial. Okay, fair enough.

Speaker Change: Right and so that's that's how these have come together how is that data has actually led us to this decision. So this is really very simply put a data driven decision.

Speaker Change: That's led us to this point, where we've now merged the two trials into into one trial.

James Francis Molloy: The last part will be done. The arrival of the results from the two trials into one. This is the last question for me, then. Thank you for clarifying. Last question.

Speaker Change: Okay fair enough or rather they were realized from.

Speaker Change: From the two trials into one.

The last question for me then thank you for clarifying that of course is the phase two combo trial.

James Francis Molloy: Is the Phase II combo trial... PDS-01-ADC plus docetaxel and metastatic cancerous and prostate cancer with the NCI. It's a phase two trial. Is that still ongoing?

Speaker Change: P. S O one ADC plus docetaxel in metastatic, Minnesota can't say cancerous and prostate cancer with the NCI.

Speaker Change: Phase two trials, that's still ongoing.

Frank K. Bedu: Yes, so we have a number of other trials ongoing at the National Cancer Institute. So currently, as PDS, as a company, we are 100% focused on moving this triple combination into the pivotal trial. However, our collaboration with the NCI is still ongoing. And based upon one of the key things we're looking at there in prostate cancer, other MOC1 positive cancers, liver cancer, combining PDS01-ADC with other standards of care, the strategy there is, we understand how versamine is working. We understand that versamine is inducing tumor-specific T cells.

Speaker Change: Yes, so we have a number of other trials ongoing at the National Cancer Institute. So currently as PDF as a company. We are 100% focused on moving this triple combination into the pivotal trial. However, our collaboration with the NCI is still ongoing and based upon.

Speaker Change: Today, one of the key if you look at what we're looking at that in the prostate cancer.

Speaker Change: Mark one positive cancers liver cancer, combining PD, one ADC with other standards of care. The strategy. There is we understand how variety of munis working we understand adversity is inducing tumor specific T cells. We also know that not every cancer has a checkpoint inhibitor.

Frank K. Bedu: We also know that not every cancer has a checkpoint inhibitor as its standard of care. So it's now very important for us to understand how our IL12-ADC works with other standards of care. That then allows us to very rapidly progress into pivotal trials with a triple for some of those other cancers for which checkpoint inhibitors may not be the standard of care. So those trials are ongoing. They're being done as an IIT.

Speaker Change: EBITA as a standard of care. So what's now very important for us to understand is how our IL 12, ADC works with other standards of care that then allows us to very rapidly progress into pivotal trials with a triple for some of those other Kansas, but with checkpoint inhibitors may not be the stack.

Speaker Change: And out of care. So those trials are ongoing they are being done as in I I T. The prostate cancer trial with Docetaxel was phase II trial the.

Frank K. Bedu: The prostate cancer trial with docetaxel was a phase two trial. The locally advanced prostate cancer trial in combination with radiation therapy is also ongoing. The hepatic infusion pump study in liver cancer is also ongoing, as well as the study in Kaposi's sarcoma.

Speaker Change: Advanced locally advanced prostate cancer trial in combination with radiation therapy is also ongoing the hepatic infusion.

Speaker Change: Pump and studying liver cancer is also ongoing as well as the study in kaposi sarcoma. So all of those studies are still ongoing under the NCI collaboration while we focus 100% on our triple combination and getting that to the finish line.

Frank K. Bedu: So all those studies are still ongoing under the NCI collaboration, while we focus 100% on our triple combination in getting that to the finish. Great. Thank you for taking the question. No problem. Thank you. I am showing no further questions. I'll turn it back to Dr. Bedu-Addo for closing remarks. Thank you very much. Before we leave, I would like to express our gratitude again to all our patients who have participated in our trials, to all our collaborators, as well as our shareholders, and also to my colleagues and our employees at PDS Biotech, whose contributions have been essential in getting PDS Biotech to where we are today, with really strong potential to take a key step to make these key advances in cancer treatment. Thank you very much again for all your time today, and I wish Thank you very much. This will conclude today's conference. You may disconnect your lines at this time.

Speaker Change: Great. Thanks for taking the questions.

Speaker Change: No problem.

Speaker Change: Thank you I'm showing no further questions. So I'll turn it back to your Doctor a bedroom ideal for closing remarks.

Speaker Change: Thank you very much I would before we leave I would like to express our gratitude again to all our patients who have participated in our trials to all our collaborators as well as our shareholders and also to my colleagues and our employees are Pts biotech whose contributions have.

Speaker Change: <unk> been essential in guessing Pds biotech to where we are today with the really strong potential to take a key step to.

Speaker Change: To make these key advances in cancer treatment. Thank you very much again for all your time today and I wish you all a wonderful day. Thank you very much.

Speaker Change: This will conclude today's conference you may disconnect. Your lines at this time. Thank you for your participation.

Speaker Change: Okay.