Q2 2024 Imunon Inc Earnings Call
Speaker Change: Thanks for watching, yeah.
Operator: Good morning, everyone. My name is Jamie, and I will be your operator today. At this time, I would like to welcome you to Imunon's second quarter 2020 financial results conference call. All lines have been placed on mute to prevent any background noise.
Jamie: Good morning everyone. My name is Jamie and I will be your operator today.
Operator: Following the speaker's prepared remarks, there will be a question and answer session. You may press star and then 1 on your touchstone telephones to ask a question at that time. Please keep in mind that if you are using a speakerphone, you must release your mute function to allow the signal to reach our equipment.
Speaker Change: At this time, I would like to welcome you to Imunon's 2nd Quarter 2020 Financial Results Conference Call.
Speaker Change: All lines have been placed on mute to prevent any background noise.
Speaker Change: Following the speaker's prepared remarks, there will be a question and answer session. You may press star and then 1 on your touchstone telephones to ask a question at that time.
Speaker Change: Please keep in mind if you are using a speakerphone, you must release your mute function to allow the signal to reach our equipment.
Operator: Again, remember to star and then 1 to ask a question during the question and answer session. Please also note today's event is being recorded. At this time, I'd like to turn the floor over to Kim Golodetz. Please go ahead.
Speaker Change: Again, press star and then 1 to ask a question during the question and answer session.
Speaker Change: Please also note today's event is being recorded.
Speaker Change: At this time, I'd like to turn the floor over to Kim Golodetz. Please go ahead.
Kim Golodetz: Thank you and good morning everyone. This is Kim Golodetz with LHA. Welcome to Imunon's second quarter 2024 financial results and business update conference call. During today's call, management will be making forward-looking statements regarding Imunon's expectations and projections about future events. In general, forward-looking statements can be identified by words such as expects, anticipates, believes, or other similar expressions.
Speaker Change: Thank you and good morning everyone. This is Kim Golodetz with LHA. Welcome to Imunon second quarter 2024 financial results and business update conference call.
Kim Golodetz: These statements are based on current expectations and are subject to a number of risks and uncertainties, including those set forth in the company's periodic filings with the Securities and Exchange Commission. No forward-looking statements can be guaranteed, and actual results may differ materially from those expressed. I also caution that the content of this conference call is accurate only as of the date of the live broadcast, August 14, 2024. Imunon undertakes no obligation to revise or update comments made during this call, except as required by law. With that said, I would like to turn the call over to Michael Tardugno, Imunon's Executive Chairman.
Speaker Change: During today's call, management will be making forward-looking statements regarding Imunon's expectations and projections about future events. In general, forward-looking statements can be identified by words such as expects, anticipates, believes, or other similar expressions.
Speaker Change: These statements are based on current expectations and are subject to a number of risks and uncertainties, including those set forth in the company's periodic filings with the Securities and Exchange Commission.
Speaker Change: No forward-looking statements can be guaranteed, and actual results may differ materially from such statements.
Speaker Change: I also caution that the content of this conference call is accurate only as of the date of the live broadcast, August 14, 2024. Immunon undertakes no obligation to revise or update comments made during this call, except as required by law.
Speaker Change: With that said, I would like to turn the call over to Michael Tardugno, Immunom's Executive Chairman. Michael?
Michael Tardugno: Thank you, Kim, and good morning, everyone. I just wanted to take the liberty of saying a few words before turning the call over to Stacy Lindborg, our president and chief executive officer, and to David Gaiero, who is our interim chief financial officer as we seek a permanent replacement for retired CFO Jeff Church. And just a point, following our prepared remarks, there will be time for questions, and this is your opportunity.
Michael Tardugno: Thank you, Kim, and good morning, everyone.
Michael Tardugno: I just wanted to take the liberty to say a few words before turning the call over to Stacy Lindborg, our President and Chief Executive Officer, and to David Guiero, who is our Interim Chief Financial Officer as we seek a permanent replacement for our retired CFO , Jeff Church.
Speaker Change: And just a point, following our prepared remarks, there will be time for questions. And this is your opportunity. We encourage you to, if you have a question.
Michael Tardugno: We encourage you to, if you have a question... Artie, use this time to... (inaudible) I'm sorry, I'm sorry, I'm sorry, I'm sorry, I'm sorry, ask us. We're happy to respond to your questions and concerns. Well, on the fundamentals, I can report that your company is sound. The second quarter and recent weeks give testament to that and to Dr. Lindborg's strategy and leadership. As you know, we recently reported long-awaited top-line data from our Phase II study of Imunon-001, our unique IL-12 candidate in ovarian cancer. These are women with very few options facing a standard of care that has seen very little change over the past 25 years. And given that,
Speaker Change: to use this time to ask us. We're happy to respond to your questions and concerns.
Stacey Lundborg: On the fundamentals, I can report that your company is sound.
Stacey Lundborg: The second quarter and recent weeks give testament to that and to Dr. Lindborg's strategy and leadership.
Speaker Change: As you know, we recently reported long-awaited top-line data from our Phase II study of Imunon-001, our unique IL-12 candidate in ovarian cancer.
Speaker Change: These are women with very few options facing a standard of care that has seen very little change over the past 25 years.
Michael Tardugno: I can report that the results from our study were, in a word, outstanding, on a quibbically outstanding scale. In support of this remarkable outcome, Stacy has streamlined the company, refocused its attention, reduced expenses, and, despite the challenging comparable deal terms that we've seen recently, closed on a truly investor-friendly financing in this tough, tough capital market. I am delighted with our company's progress over the past quarter, as I hope you are, and with the future promise that Imunon-OA1 has for ovarian cancer patients.
Speaker Change: And given that, I can report that the results from our study, in a word, outstanding.
Speaker Change: Unequivocally outstanding.
Speaker Change: In support of this remarkable outcome, Stacy has streamlined the company.
Speaker Change: We focused its attention, reduced expenses, and despite the challenging comparable deal terms that we've seen recently, closed on a truly investor-friendly financing in this tough, tough capital market.
Speaker Change: I am delighted with our company's progress over the past quarter, as I hope you are, and with the future promise that Immune 101 has for ovarian cancer patients.
Michael Tardugno: I'll also remind you that during the second quarter, Dr. Lindborg was appointed President and Chief Executive of Imunon. I'm sure that it was a difficult decision for her as she left a similar position with a company that she very, very much believed in.
Speaker Change: I'll also remind you that during the second quarter Dr. Lindborg was appointed President Chief Executive of Imunon.
Dr. Lindborg: I'm sure that it was a difficult decision for her, as she left a similar position with a company that she very, very much believed in, to lead the development of our lead asset, I mean on all one end, to shape the company's strategy.
Michael Tardugno: To lead the development of our lead asset, Imunonononononononononononononononononononononononononon Stradigate. I trust that you will agree with me that she has hit the ground running. So now it's my pleasure to turn the call over to Stacy. Thank you. Bye, Cole.
Dr. Lindborg: I trust that you will agree with me that she has hit the ground running. So now it's my pleasure to turn the call over to Stacy.
Stacy Lindborg: As Michael has indicated, it has been an exciting and fulfilling time over the last few months at Imunon as the promise of our science comes closer to making a real difference in the lives of patients. I'm further enthused by the talent and dedication I see in the community of treating physicians and in the Imunon team. Let me assure you, we are ready for Imunon's next chapter.
Steve: Thank you. Bye, Cole.
Steve: And as Michael has indicated, it has been an exciting and fulfilling time over the last few months at Imunon as the promise of our science comes closer to making a real difference in the lives of patients.
Steve: I'm further emboldened by the talent and dedication I see in the community of treating positions and in Imunon team.
Speaker Change: Let me assure you, we are ready for Immunon's next chapter. We're motivated and honored by the role that we get to play in advancing the treatment of women with ovarian cancer.
Stacy Lindborg: We're motivated and honored by the role that we get to play in advancing the treatment of women with ovarian cancer. Just a short time ago, a couple of weeks ago, we reported toppling data from our evasion to study. As you know, a phase 2 trial in ovarian cancer, and we may have in our hands the first and only immunotherapy that is effective for the treatment of ovarian cancer. This is a treatable cancer that in the U.S. alone leads to more than 20,000 new diagnoses and about 13,000 deaths every year, with more than a quarter million women diagnosed with the disease globally each year.
Speaker Change: Just a short time ago, a couple of weeks we reported toppling data from our Ovation 2 study.
Speaker Change: As you know, a phase two trial in ovarian cancer, and we may have in our hands the first and only immunotherapy that is effective for the treatment of ovarian cancer.
Speaker Change: This is a terrible cancer that in the U.S. alone leads to more than 20,000 new diagnoses and about 13,000 deaths every year.
Speaker Change: with more than a quarter million women diagnosed with the disease globally each year.
Stacy Lindborg: I'll take just a moment to briefly review the trial before addressing our plaintiff. Imunon-01 is a DNA-mediated IL-12 immunotherapy being evaluated for the localized treatment of advanced ovarian cancer. Ovation 2 is an open-label, well-controlled, randomized study of 112 patients evaluating the dosing, safety, efficacy, and biological activity of interperitoneal administration of Imunon-001 in combination with neoadjuvant chemotherapy, or NACT, as we often refer to it. We're studying naive treatment, patient. Newly diagnosed with the disease, including epithelial, ovarian, Philippian tube, or primary peritoneal cancers.
Speaker Change: I'll take just a moment to briefly review the trial before addressing our plans.
Speaker Change: Immunon 01 is a DNA mediated IL-12 immunotherapy being evaluated for the localized treatment of advanced ovarian cancer.
Speaker Change: Ovation 2 is an open-label, well-controlled, randomized study of 112 patients.
Speaker Change: Evaluating the dosing, safety, efficacy, and biological activity of interperitoneal administration of Imunon-001 in combination with neoadjuvant chemotherapy, or NACT as we often refer to it.
Speaker Change: We're studying naive treatment patients newly diagnosed with the disease including epithelial, ovarian, ovarian, ovarian cancer.
Speaker Change: Philippian tube or primary peritoneal cancers.
Stacy Lindborg: The trial design compares NACT plus Imunon-001 administered weekly versus standard of care NACT alone. Patients randomized to the Imunon-001 treatment arm received up to 17 doses of 100 milligrams per meter squared of our drug in combination and in addition to NACT. So now to the extraordinary findings which have relevance to our contemplated Phase 3 Pivotal Trial, including the following: an 11.1 month improvement in overall survival with Imunono-01 in the intent-to-treat population with a hazard ratio translating to a 35% improvement in overall survival.
Speaker Change: The trial design compares NACT plus Imunon-001, administered weekly, versus standard-of-care NACT alone.
Speaker Change: Patients randomized to the Imunon-001 treatment arm received up to 17 doses of 100 milligrams per meter squared of our drug in combination and in addition to NACT.
Speaker Change: So now to the extraordinary findings which have relevance to our contemplated Phase 3 pivotal trial, including the following.
Speaker Change: An 11.1 month improvement in overall survival with Immunona-01 in the intent to treat population with a hazard ratio translating to a 35% improvement in overall survival.
Stacy Lindborg: This is, by all standards or measures, a clinically meaningful improvement in a difficult to treat disease. For the 90% of patients receiving three or more of the 17 specified doses, median overall survival was improved by close to 16 months. This is consistent with the dose-dependent signal that was clearly demonstrated in Ovation 1. Furthermore, we saw potential for a remarkable improvement in overall survival benefit with Imunon-001 in patients exposed to standard-of-care harp inhibitor therapy, and this was in 38% of the intent-to-treat population.
Speaker Change: This is, by all standards or measures, a clinically meaningful improvement in a difficult-to-treat disease.
Speaker Change: For the 90% of patients receiving three or more of the 17 specified doses, median overall survival was improved by close to 16 months.
Speaker Change: This is consistent with the dose-dependent signal that was clearly demonstrated in Ovation 1.
Speaker Change: Furthermore, we saw potential for a remarkable improvement in overall survival benefit with Immune-On-001 in patients exposed to standard-of-care HAARP inhibitor therapy.
Speaker Change: And this was in 38% of the intent-to-treat population.
Stacy Lindborg: For this group, the hazard ratio dropped to 0.41, and the median overall survival in the Imunon-01 treatment arm had not yet been reached at the time of the data lock, which compares with the median overall survival of 37.1 months in the standard of care treatment arm. Regarding our next steps, we have taken a number of steps to conserve capital and align our critical needs with available funds. We are within days of requesting an End of Phase II meeting with the FDA to validate our conclusions and clarify our path for the registration study ahead.
Speaker Change: For this group, the hazard ratio dropped to 0.41, and the median overall survival in the Immunonu-01 treatment arm had not yet been reached at the time of the data lock.
Speaker Change: which compares with the median overall survival of 37.1 months in the standard of care treatment arm.
Speaker Change: Regarding our next steps, we have taken a number of steps to conserve capital and align our critical needs with available funds.
Speaker Change: We are within days of requesting an End of Phase II meeting with the FDA to validate our conclusions and clarify our path for the registration study ahead.
Stacy Lindborg: This means we can expect an end-of-Phase 2 meeting with the FDA this fall, and this will permit us to begin our Phase 3 ovarian cancer study in the first quarter of 2025. The pace of the study will depend on several factors, including access to capital and patient recruitment. But at this point, we are targeting top-line data readout at the end of 2020. As you know, Ovation 2 is not the only study with Imunon Owan in ovarian cancer.
Speaker Change: This means we can expect an end of Phase 2 meeting with the FDA this fall, and this will permit us to begin our Phase 3 ovarian cancer study in the first quarter of 2025.
Speaker Change: The pace of this study will depend on several factors, including access to capital and patient recruitment.
Speaker Change: But at this point, we are targeting top-line data readout at the end of 2028.
Speaker Change: As you know, Ovation 2
Speaker Change: is not the only study with Imunona-Owan in ovarian cancer. We have an ongoing study principally funded by the Breakthrough Cancer Foundation that is proceeding at the University of Texas MD Anderson Cancer and Memorial Sloan Kettering Cancer Center.
Stacy Lindborg: We've an ongoing study principally funded by the Breakthrough Cancer Foundation that is proceeding at the University of Texas, Indie, Anderson Cancer, and Memorial Zone Kettering Cancer Center under the leadership of study P.I. Dr. Amir Disari.
Speaker Change: Under the leadership of StudyPI, Dr. Amir Jazari.
Stacy Lindborg: The study is evaluating Imunon-01 on Minimal Residual Disease, or MRD, as determined by second look laparoscopy when administered in combination with bioequivalent Avastin and NACT. Subjects newly diagnosed with ovarian cancer, fallopian tube, or primary peritoneal cancer will be included. And to date, seven patients have been enrolled and received treatment. As the first few patients have reached the primary endpoint, Dr. Jhaziri will now conduct a pilot study to test circulating tumor DNA levels following treatment using a next-generation ctDNA assay.
Speaker Change: The study is evaluating Imunon-01 on Minimal Residual Disease, or MRD.
Speaker Change: as determined by second look laparoscopy when administered in combination with bioequivalent avastin and NACT.
Speaker Change: Subjects newly diagnosed with ovarian cancer, fallipian tube, or primary peritoneal cancer will be included. And to date, seven patients have been enrolled and received treatment.
Speaker Change: As the first few patients have reached the primary endpoint, Dr. Jhaziri will now conduct a pilot study to test circulating tumor DNA levels following treatment.
Dr. Jhaziri: using a next generation ctDNA assay.
Stacy Lindborg: We look forward to sharing insights with you from this data and harnessing insights from this data for Ovation 3. Now, we switch to the proof-of-concept Phase 1 study of our DNA vaccine candidate for COVID-19. During the second quarter, we began patient enrollment with Imunon-101 as a seasonal COVID-19 booster vaccine, and we believe that the preclinical efficacy we've generated, along with the superior handling logistics, which we've discussed on past calls, will make this vaccine attractive to a pharma partner.
Speaker Change: We look forward to sharing insights with you from this data and harnessing insights from this data for Ovation 3.
Speaker Change: Switching now to the proof-of-concept Phase 1 study of our DNA vaccine candidate.
Speaker Change: for COVID-19.
Speaker Change: During the second quarter,
Speaker Change: We began patient enrollment with Imunon 101.
Speaker Change: as a seasonal COVID-19 booster vaccine. And we believe that the preclinical efficacy we've generated along with the superior handling logistics, which we've discussed on past calls, will make this vaccine attractive to a pharma partner.
Stacy Lindborg: Our plan is to complete Phase 1 data by the end of the year, and at that point, we will actively seek a partner to continue development. Now I'll turn the call over to Dave Gaiero, our interim CFO, for a discussion of our quarterly financial results. Dave?
Speaker Change: Our plan is to complete Phase 1 report data by the end of the year, and at that point we will actively seek a partner to continue development.
Dave Guerrero: Now I'll turn the call over to Dave Guerrero, our Interim CFO, for a discussion of our quarterly financial results. Dave?
Dave Gaiero: Thank you, Stacy. Details of Imunon's second quarter 2024 financial results are included in the press release we issued this morning and in our Form 10-Q, which we filed today before the market opened. As of June 30, 2024, Imunon had $5.3 million in cash investments and accrued interest receivables. Subsequent to the close of the quarter, we received net proceeds of approximately $9 million from a registered direct office. We will continue to focus on strong cash management, and as Stacy indicated, we have taken steps to evaluate and prioritize our spending and expect our cash runway to extend into the third quarter of 2025.
Dave Guerrero: Thank you, Stacy. Details of Imunon's second quarter 2024 financial results are included in the press release we issued this morning and in our Form 10-Q , which we filed today before the market opened.
Dave Guerrero: As of June 30, 2024, Immunon had $5.3 million in cash investments and accrued interest receivable.
Speaker Change: Subsequent to the close of the quarter, we received net proceeds of approximately nine million dollars from a registered direct offering.
Speaker Change: We will continue to focus on strong cash management, and as Stacy indicated, we have taken steps to evaluate and prioritize our spending and expect our cash runway to extend into the third quarter of 2025.
Dave Gaiero: Imunon reported a net loss for the second quarter of 2024 of $4.8 million, or $0.51 per share, compared with a net loss of $5.6 million, or $0.61 per share, for the second quarter of 2020. Operating expenses were $5 million for the second quarter of 2024, a decrease of $500,000 or 8% from the second quarter of 2020. R&D expenses were $2.8 million in the second quarter of 2024 compared with $3.1 million in the same period of 2023. BMC costs decreased to $500,000 compared with $700,000 a year.
Iminan: Iminan reported a net loss for the second quarter of 2024 of $4.8 million, or $0.51 per share, compared with a net loss of $5.6 million, or $0.61 per share, for the second quarter of 2023.
Iminan: Operating expenses were $5 million for the second quarter of 2024, a decrease of $500,000 or 8% from the second quarter of 2023.
Iminan: R&D expenses were $2.8 million in the second quarter of 2024, compared with $3.1 million in the same period of 2023.
Iminan: The MCD cost decreased to $500,000 compared with $700,000 a year ago.
Dave Gaiero: The lower CMC costs were primarily due to the establishment of internal capability to produce plasmid DNA. Costs associated with our Platzean program decreased by $200,000 in the second quarter of 2024 compared to the second quarter of 2020. These decreases were partially offset by a $200,000 increase in regulatory and other clinical costs in the second quarter of 2024 compared to the second quarter of 2020. General and administrative expenses were $2.2 million in the second quarter of 2024 compared with $2.3 million in the same period of 2023. The decrease was primarily attributable to lower non-cash stock compensation expense of $100,000 and employee-related expenses of $100,000.
Iminan: The lower CMC costs were primarily due to the establishment of internal capability to produce plasmid DNA.
Iminan: Costs associated with our Plat Seen program decreased by $200,000 in the second quarter of 2024 compared to the second quarter of 2023.
Iminan: These decreases were partially offset by a $200,000 increase in regulatory and other clinical costs in the second quarter of 2024 compared to the second quarter of 2023.
Iminan: General and administrative expenses were $2.2 million in the second quarter of 2024 compared with $2.3 million in the same period of 2023.
Speaker Change: The decrease was primarily attributable to lower non-cash stock compensation expense of $100,000 and employee-related expenses of $100,000, partially offset by an increase in legal fees of $100,000.
Dave Gaiero: Partially offset by an increase in legal fees of $100,000, Other non-operating income was $200,000 in the second quarter of 2024 compared with other non-operating expense of $100,000 in the same period of 2023. The company incurred a loss on an extinguishment of debt of $300,000 on its loan facility with Silicon Valley Bank in the second quarter of 2023 upon the repayment in full of this loan. Turning briefly to the financial results for the first half of 2020, the company reported a net loss of $9.7 million, or $1.03 per share, in the first half of 2024, compared with a net loss of $11.2 million, or $1.28 per share, for the first half of 2023.
Speaker Change: Other non-operating income was $200,000 in the second quarter of 2024, compared with other non-operating expense of $100,000 in the same period of 2023.
Speaker Change: The company incurred a loss on an extinguishment of debt of $300,000 on its loan facility with Silicon Valley Bank in the second quarter of 2023 upon the repayment and full of this loan facility.
Speaker Change: Turning briefly to the financial results for the first half of 2024.
Speaker Change: The company reported a net loss of $9.7 million, or $1.03 per share, in the first half of 2024, compared with a net loss of $11.2 million, or $1.28 per share, for the first half of 2023.
Dave Gaiero: R&D expenses were $6.1 million in the first half of 2024 compared with $5.8 million in the same period of 2022. Costs associated with the Placidne program increased to $2.8 million in the first half of 2024 compared to $2.3 million in the first half of 2020. Regulatory and other clinical costs increased to $1.1 million in the first half of 2024 compared to $700,000 in the first half of 2023. However, these increases were partially offset by a $600,000 decrease in CMC costs in the first half of 2024 compared to the same period in 2020.
Speaker Change: R&D expenses were $6.1 million in the first half of 2024, compared with $5.8 million in the same period of 2023.
Speaker Change: Cost associated with the PlaX Placene Program increased to $2.8 million in the first half of 2024, compared to $2.3 million in the first half of 2023.
Speaker Change: Regulatory and other clinical costs increased to 1.1 million dollars in the first half of 2024 compared to $700,000 in the first half of 2023.
Speaker Change: These increases were partially offset by a $600,000 decrease in CMC costs in the first half of 2024, compared to the same period of 2023.
Dave Gaiero: General and administrative expenses were $3.9 million in the first half of 2024, compared with $5.4 million in the same period of 2023. The decrease was primarily attributable to lower non-cash compensation expense of $400,000, legal expenses of $400,000, employee-related expenses of $300,000, and insurance expense of $100,000.
Speaker Change: General and Administrative expenses were $3.9 million in the first half of 2024, compared with $5.4 million in the same period of 2023.
Speaker Change: The decrease was primarily attributable to lower non-cash compensation expense of $400,000, legal expenses of $400,000, employee-related expenses of $300,000, and insurance expense of $100,000.
Dave Gaiero: Other non-operating income was $300,000 in the first half of 2024, compared with $8,505 in the same period of 2023. The company incurred interest expense of $200,000 as well as $300,000 in debt extinguishing expense associated with its loan facility with Silicon Valley Bank in the first half of 2021. Investment income from the company's short-term investments decreased by $200,000 for the first half of 2024 from the same period in 2023 due to lower investment.
Speaker Change: Other non-operating income was $300,000 in the first half of 2024, compared with $8,505 in the same period of 2023.
Speaker Change: The company incurred interest expense of $200,000 as well as $300,000 in debt extinguishing expense associated with its loan facility with Silicon Valley Bank in the first half of 2023.
Speaker Change: Investment income from the company's short-term investments decreased by $200,000 for the first half of 2024 from the same period in 2023 due to lower investment balances.
Stacy Lindborg: With that financial review, I'll turn the call back to Stacy. Thank you, Dave, and thank you for so seamlessly stepping in following Jeff's retirement. It's been very smooth. As Michael mentioned, we recently announced a financing with $10 million in gross proceeds under highly competitive terms. This was priced at $2 per share in an at-the-market deal that included one warrant for each share sold. The warrants have a stock price of $2.
Speaker Change: With that financial review, I'll turn the call back to Stacy.
Stacy: Thank you, Dave, and thank you for so seamlessly stepping in following Jeff's retirement. It's been a very smooth transition.
Stacy: As Michael mentioned, we recently announced a financing with a $10 million in gross proceeds under highly competitive terms. This was priced at $2 per share in an at-the-market deal that included one warrant for each share sold. The warrants have a stock price of $2.
Stacy Lindborg: The additional capital added to our June balance brings our cash to approximately $14.5 million, which historically is well over three and a half quarters of operating revenue before consideration of further capital conservation and assures a bridge to important catalysts, which we can discuss. Following our discussions and with many premier healthcare investors, we have every confidence in our ability to access capital going forward, including the use of our ATM and possible interest from partners.
Speaker Change: The additional capital added to our June balance brings our cash to approximately $14.5 million, which historically, this is well over three and a half quarters of operating runway.
Speaker Change: Before consideration of further capital conservation in districts and assures a bridge to important catalysts.
Speaker Change: Thank you. Thank you. Thank you.
Speaker Change: Following our discussions and with many premier healthcare investors we have every confidence in our ability to access capital going forward including the use of our ATM and possible interest from partners.
Stacy Lindborg: I hope that you'll agree that the future of Imunon is bright and that, together with shareholders, we will deliver on our mission to have a meaningful impact on patients' lives. With that, I'd like to open up the call to your questions, Operator. Ladies and gentlemen, at this time, we'll begin that question and answer session. To join the question queue, you may press the star and then one. To withdraw your questions, you may press star and two. If you are using a speakerphone, we do ask that you please pick up the handset prior to pressing the number to ensure the best sound quality.
Speaker Change: I hope that you'll agree that the future of Immunon is bright and that together with shareholders we will deliver on our mission to have a meaningful impact on patients' lives.
Speaker Change: With that, I'd like to open up the call to your questions, operator.
Speaker Change: Ladies and gentlemen, at this time, we'll begin that question and answer session. To join the question queue, you may press star and then one. To withdraw your questions, you may press star and two.
Speaker Change: If you are using a speaker phone, would you ask the police pick up the handset prior to pressing the numbers to ensure the best sound quality?
Operator: Once again, that is the star and then one to join the question will pause momentarily to assemble the roster. Our first question today comes from Emily Bodnar from H.C. Wainwright. Please go ahead with your question. Hi, good morning.
Speaker Change: Once again that is star and then 1 to join the question queue.
Speaker Change: Wil Pogman, materially two-symbol of roster [inaudible]
Speaker Change: Our first question today comes from Emily Bodnar from HC Wainwright. Please go ahead with your question.
Stacy Lindborg: Thanks for taking the question. It's kind of a follow-up to some of the financing and funding discussions that you mentioned. Could you maybe just talk about how you're thinking about the strategy for financing a Phase III study, given, obviously, those tend to be pretty large studies? Maybe if you could kind of comment on how expensive you think such a study could cost, and if you're potentially looking to raise additional capital or other strategies that you're evaluating, and potentially if you've gotten any partnership interest since the Ovation II data came out.
Emily Bondar: Hi, good morning. Thank you for taking me questions. Kind of a follow up to some of the financing and funding discussion that you made. Could you let me just talk about how you're thinking about strategy for financing of phase 3 study, given obviously those tend to be pretty large studies?
Speaker Change: Maybe if you can comment on how expensive you think such a study could cause, then...
Speaker Change: If you're...
Speaker Change: Potentially looking to raise additional capital or other strategies that you're evaluating.
Speaker Change: and potentially if you've gotten any partnership interest since the Ovation 2 data came out. And then second, on the COVID booster, could you discuss the blinding for the 50-in-1 study and if you're able to see the data as it kind of accrues? Thank you. Thank you. Thank you. Thank you.
Stacy Lindborg: And then second, on the COVID booster, could you discuss the blinding for the Phase I study and if you're able to see the data as it kind of accrues? Thank you. Yeah, Emily, thank you for the question. I'm great to hear from you. Yeah, so I'll start with both questions. And then Michael, I think you may want to add to it.
Stacy Lindborg: So, you know, we're anticipating that this trial could cost on the order of $50 million. So, you know, adding 10 million to the balance sheet. And as we talked about with our cash runway, really takes us, takes us very well into 2025, actually, you know, well into the third quarter.
Speaker Change: Yeah, Emily, thank you for the question.
Speaker Change: Great to hear from you. Yeah, so I'll start with both questions and then Michael, I think you may want to add.
Speaker Change: We're anticipating that this trial could cost on the order of $50 million, so adding $10 million to the balance sheet, and as we talked about with our cash runway, really takes us
Stacy Lindborg: Our goal, of course, is that this allows us to start the trial as we have planned. We're really intending, with the way that we manage our company, to continue to be able to achieve our core business objective. And this really is a bridge and provides time for us to raise additional capital. Michael, do you want to offer additional? Sure. A good question, Emily. It's always a challenge, particularly in recent days, for micro-cap companies to raise capital.
Michael Tardugno: It takes us very well into 2025, actually, well into the third quarter.
Michael Tardugno: Our goal, of course, this allows us to start the trial as we have planned, we're really intending with the way that we manage our company to continue to be able to achieve our core business objectives.
Unknown Executive: Good morning everyone, my name is Jamie and I will be your operator today.
Unknown Executive: At this time, I would like to welcome you to Imunon's second quarter, 2020 Financial Results Conference call. All lines have been placed on mute to prevent any background noise. Following the speakers' prepared remarks, there will be a question in the next session. You may press please keep in mind if you are using a speaker phone. You must release your mute function to allow the signal to reach our quick. Again, let us start and then one to ask a question during the question and answer session.
Pervite: And this really is a bridge and provides time for us to raise additional capital.
Michael Tardugno: And Michael, do you want to offer additional? Sure. I mean, good question, Emily. It's always a challenge, particularly in recent days for micro-cap companies to raise capital. You know that and you probably cover a number of them.
Michael Tardugno: You know that, and you probably cover a number of it. But I can say unequivocally that the quality of the investors that we spoke to during this financing roadshow was among the very best. And I think across the board, except maybe for a very small number, we spoke to a good number of quality investors. I think across the board, the reaction was overwhelmingly positive.
Michael Tardugno: But I can say unequivocally that the...
Michael Tardugno: The quality of the investors that we spoke to during this financing roadshow were among the very best.
Unknown Executive: Please also note today's event is being recorded.
Kim Golodetz: At this time, I'd like to turn the floor over to Kim Golodetz. Please go ahead. Thank you and good morning everyone. This is Kim Golodetz with LHA. Welcome to Imunon's second quarter, 2024 Financial Results and Business Update Conference call. During today's call, management will be making forward-looking statements regarding Imunon's expectations and projections about future events. In general, forward-looking statements can be identified by words such as expects, anticipates, believes, or other similar expressions.
Michael Tardugno: and I think across the board, except maybe for a very small number. We spoke to a good number.
Michael Tardugno: Quality Investors. I think across the board, the reaction was overwhelmingly positive.
Michael Tardugno: Market conditions, among other things, may have limited their recent interest. But I think that the story to tell from this financing roadshow is a little bit more time with the data. They'd like to see more maturity.
Michael Tardugno: Market conditions, among other things, may have limited their most...
Kim Golodetz: These statements are based on current expectations and are subject to a number of risks and uncertainties, including those set forth in the company's periodic filings with the securities and exchange commission. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. I also caution that the content of this conference call is accurate only as of the date of the live broadcast, August 14, 2024.
Michael Tardugno: Recent interest, but...
Michael Tardugno: I think that the story to tell from this Financing Roadshow is a little bit more time with the data. They'd like to see more maturity. I think that'll give us an opportunity to re-engage and re-engage successfully. In the meantime, the company is looking forward to some...
Michael Tardugno: I think that'll give us an opportunity to re-engage and re-engage successfully. In the meantime, the company is looking forward to some Additional Catalysts that may provide an opportunity either to use the ATM, engage strategic partners, or consider another equity round. On the whole, this has been kind of the history of many companies like ours, and I don't think, honestly, from the data that we've seen and the impact on the lives of... Oh, fuck, ovarian cancer patients, that this study will go without important Financial Support.
Michael Tardugno: Additional catalysts that may provide an opportunity either to use the ATM, engage strategic partners, or consider another equity round financing.
Michael Tardugno: On the whole, this has been kind of the history of many companies like ours, and I don't think, honestly, from the data that we've seen and the impact on the lives of
Kim Golodetz: Imunon undertakes no obligation to revise or update comments majoring this call except as required by law.
Michael Tardugno: of Ovarian Cancer Patients that this study will go without important financial support.
Michael Tardugno: With that said, I would like to turn the call over to Michael Tardunia, Imunon's executive chairman, Michael. Thank you, Kim. Good morning, everyone.
Stacy Lindborg: Emily, you asked one other question about the trial. So we are intending for this trial to be an open-label study, as I think we all understand that with the route of administration for Imunon being through a catheter, you know, directly into the microtumor environment. This is really more of an ethical decision that the only way you could preserve blindness would be to require the control arm to also have that, which would be an unnecessary surgical procedure.
Speaker Change: Emily, you asked one other question about the trial. So we are intending
Michael Tardugno: I just wanted to take the liberty to say a few words before turning the call over to Stacey Lundborg, our president, chief executive officer, and to David Gaero, who is our interim chief financial officer as we seek a permanent replacement for retired CFO Jeff Church. In just a point, following our prepared remarks, there will be time for questions, and this is your opportunity. We encourage you to, if you have a question, to use this time to ask us. We're happy to respond to your questions and concerns. On the fundamentals, I can report that your company is sound. The second quarter in recent weeks give testament to that and to Dr. Lundborg's strategy and leadership.
Speaker Change: For this trial to be an open-label study, as I think we all understand, that with the route of administration for aminon being through a catheter, you know, directly into the microtumor environment,
Speaker Change: This is really more of an ethical decision that the only way you can preserve blind would be to require for the control arm to also have that, which would be an unnecessary.
Stacy Lindborg: So we are intending that there will be full agreement with FDA that this will be open label, and we'll certainly get buy in on plans for event-driven endpoints and the ability to report out appropriately in the trial. Yeah, sorry.
Speaker Change: Surgical Procedure, so we are intending that there will be full agreement with FDA that this will be open label.
Speaker Change: And we'll certainly get buy-in on plans for event-driven endpoints and the ability to report out appropriately in the trial.
Michael Tardugno: As you know, we recently reported long-awaited top-line data from our Phase II study of Imunon 001, our unique IL-12 candidate in ovarian cancer. These are women with very few options facing a standard of care that's seen very little change over the past 25 years. Given that, I can report that the results from our study in a word, outstanding, on a quivically outstanding. In support of this remarkable outcome, Stacy has streamlined the company, refocused its attention, reduced expenses, and despite the challenging, comparable deal firms that we've seen recently, closed on a truly investor-friendly financing in this tough, tough capital market.
Speaker Change: I think she was talking about the COVID vaccine.
Stacy Lindborg: Okay, I apologize. I misunderstood. So you're going to batch the... So for the, for the Imunon 101. Yeah, that was your question? Oh, I apologize.
Speaker Change: Yes, sorry.
Speaker Change: Okay. Apologize. I misunderstood.
Speaker Change: So, you're going to batch the resorts rate.
Stacy Lindborg: So it is an open-label trial. We are with this trial, really, you know. Part of what will be very exciting and interesting are the immunogenicity data that we expect to have by the end of the year. So we, of course, can do them in batches, but really, we're expecting to have the full sample from the trial and to be able to report out, you know, based on the effects that we're seeing and which really will establish proof of concept, and we'll set up the partnership discussions full stop. In the meantime, the DSMB is being evaluated for safety. That's right.
Speaker Change: So for the Immunon 101.
Speaker Change: That was your question? Oh, I apologize. So it is an open-label trial. We are with this trial really, you know, we do have
Speaker Change: Part of what will be very exciting and interesting are the immunogenicity data that we expect to have by the end of the year.
Speaker Change: So, we of course can do them in batches, but really we're expecting to have the full sample from the trial and to be able to report out, you know, based on the effects that we're seeing. And truly we'll establish proof of concept and we'll set up the partnership discussions. So, we'll stop.
Michael Tardugno: I am delighted with our company's progress over the past quarter as I hope you are, and with the future promise that Imunon 011 has full ovarian cancer patients. I'll also remind you that during the second quarter, Dr. Lindborg was appointed President Chief Executive of Imunon. I'm sure that it was a difficult decision for her, as she left a similar position with a company that she very, very much believed in. To lead the development of our lead asset, Imunon 011, and to shape the company's strategy.
Stacy Lindborg: So we have an ongoing, as you would expect in a phase one trial, you know, where you're needing to have regular and planned DSMB reviews that trigger the release of additional patients being treated. We've gone through multiple DSMB reviews of our data, seamlessly getting approval to continue, and the study is enrolling exactly per the plan. So it's it's moving very, very well, very efficiently. Okay, great. Thanks for all the power.
Speaker Change: In the meantime, the DSMB is evaluating for safety. That's right. So we have an ongoing, as you would expect, in a Phase I trial, where you're needing to have regular and planned DSMB reviews that trigger the release of additional patients being treated.
Stacy Lindborg: I trust that you will agree with me that she has hit the ground running, so now it's my pleasure to turn the call over to Stacy. Thank you, Michael. As Michael has indicated, it has been an exciting and fulfilling time over the last few months in Imunon as the promise of our science comes closer to making a real difference in the lives of patients. I'm further emboldened by the talent and dedication I see in the community of treating physicians and in Imunon team.
Speaker Change: We've gone through multiple DSMB reviews of our data, seamlessly getting approval to continue, and the study is enrolling exactly per the plan, so it's moving very well, very efficiently.
Speaker Change: Okay, great. Thanks for all the color. I appreciate you taking the questions.
Stacy Lindborg: I appreciate the questions. Thank you. Our next question comes from Kent Dolliver from Brookline Capital Markets. Please go ahead with your question. And Kemp, is it possible that your phone is on mute?
Emily Bondar: Thank you, Emily.
Speaker Change: Our next question comes from Kent Oliver from Brookline Capital Markets. Please go ahead with your question.
Stacy Lindborg: Let me assure you we are ready for Imunon's next chapter. We're motivated and honored by the role that we get to play in advancing the treatment of women with ovarian cancer. Just a short time ago, a couple of weeks, we reported toppling data from our ovarian 2 study. As you know, a phase 2 trial in ovarian cancer and we may have in our hands the first and only immunotherapy that is affected for the treatment of ovarian cancer. This is a terrible cancer that in the U.S, alone leads to more than 20,000 new diagnoses and about 13,000 deaths every year with more than a quarter million women diagnosed with a disease globally each year.
Speaker Change: [inaudible]
Speaker Change: And Kemp, is it possible that your phone is on mute?
Kemp: Okay, sorry.
Operator: Okay, sorry. So, thank you for taking the question. Just quickly on 101, when you say the studies are rolling exactly to plan, you know, COVID waves are not what they were a couple of years ago, so are you seeing steady enrollment, or is this a case where as we get into the fall, you'll see some were spikin' and rolling? Yeah, so this, you know, this study is enrolling healthy, healthy subjects.
Kent Oliver: So, thank you for taking the question. Just quickly on 101, when you say the study's enrolling exactly to plan, you know, COVID waves are not what they were a couple of years ago. So, are you seeing steady enrollment or is this a case where, as we get into the fall, that
Speaker Change: you know with this potential spike in COVID you'll see a similar spike in enrollment.
Operator: We have a very experienced center that's running it. And per the numbers I've reviewed, and I look at them quite regularly, we're about 70%, above 70% of the patients that we will enroll in the trial, and they've been dosed. So I don't think, I don't think the flu season is likely to influence it.
Speaker Change: Yeah, so this, you know, this study is enrolling healthy, healthy subjects. We have a very experienced center that's running it.
Stacy Lindborg: I'll take just a moment to briefly review the trial before addressing our plans. Imunon O1 is a DNA-mediated IL-12 immunotherapy being evaluated for the localized treatment of ovarian cancer. Ovation 2 is an open label well-controlled randomized study of 112 patients evaluating the dosing safety efficacy and biological activity of Interparatoneal Administration of Imunon O1 in combination with neoagement chemo therapy or NACT as we often refer to it. We're studying naive treatment patients, newly diagnosed with the disease including epithelial ovarian, philippian tube or primary paratoneal cancers.
Speaker Change: Per the numbers I've reviewed, and I look at them quite regularly, we're, you know, we're about 70, above 70 percent of the patients.
Stacy Lindborg: In fact, we expect to be really ahead of it in terms of completing the trial. I'd like to comment on that also. I mean, there are a number of advantages that we believe will be demonstrated in this phase one study, not the least of which is durability and, of course, the handling characteristics of a lot of this formulation to be managed at temperatures that are very high.
Speaker Change: that we will enroll in the trial and they've been dosed. So I don't think the flu season is likely to influence it. In fact, we expect really likely to be ahead of it in terms of completing the trial and the observation.
Speaker Change: I'd like to comment on it also.
Speaker Change: Managed at temperatures that are very friendly for global distribution.
Michael Tardugno: Friendly for Global Distribution. That said, there may be an opportunity to replace mRNA vaccines, depending upon the data. That would be a booster. As you point out, the market is waning some, but I think the more important outcome from this study is the proof of concept that a DNA vaccine can provide in other indications. Yeah, I'd love to add to that. I mean, I do think that, you know, we were very thoughtful in choosing what we would study to establish proof of concept for our technology. But, as you guys are likely quite aware, there have been more than 80 pathogenic viruses discovered since 1980.
Stacy Lindborg: The trial design compares NACT plus Imunon O1 administered weekly versus standard of care in NACT alone. Patients randomized to the Imunon01 treatment arm received up to 17 doses of a hundred milligrams per meter squared of our drug in combination and in addition to NACT. So now to the extraordinary findings which we have, which have relevance to our contemplated phase three physical trial, including the following, an 11.1 month improvement in overall survival with Imunon01 in the intent to treat population with a hazard ratio, translating to a 35% improvement in overall survival.
Speaker Change: That said, there may be an opportunity to replace mRNA vaccines, depending on the data, that would be as boosters.
Speaker Change: As you point out the market is waning some but I think the more more important outcome from this study is the proof of concept
Speaker Change: that a DNA vaccine can provide.
Speaker Change: in other indications, and you may want to speak to that. Yeah, I'd love to add to that. I mean, I do think that, you know, we were very thoughtful in choosing the, what we would study to establish proof of concept of our technology.
Speaker Change: But as you guys are likely quite aware, there have been more than 80 pathogenic viruses discovered since 1980.
Stacy Lindborg: The target of choice would really need to be decided in conjunction with, you know, the party who's going to develop it. We think there is enormous value to the technology that we want to make sure we maximize through a partnership. And, you know, it's equally exciting when we think about our core and our strategy down the path. There's even the potential, you know, for an ecological vaccine.
Stacy Lindborg: This is by all standards or measures a clinically meaningful improvement in a difficult to treat disease. For the 90% of patients receiving three or more of the 17 specified doses, median overall survival was improved by close to 16 months. This is consistent with the dose dependent signal that was clearly demonstrated in Ovation 1. Furthermore, we saw potential for a remarkable improvement in overall survival benefit with Imunon01 in patients exposed to standard of care, harp inhibitor therapy.
Speaker Change: The target of choice would really need to be decided
Speaker Change: the party who's going to develop it. We think there is enormous value to the technology that we want to make sure we maximize through.
Speaker Change: through a partnership. And, you know, there's, there's equally exciting when we think about our core and our strategy down the path, there's even a potential, you know, for an ecology vaccine. So the platform itself, the technology is, is a very, very exciting.
Stacy Lindborg: So the platform itself, the technology, is very, very exciting for many. Thanks for the question, Kim. Sure, thanks, and also for the clarification. And then on 001 and the end of phase two process, you know, we're... Where does that stand? Are you in a position to request a meeting? You know, and if not, when do you anticipate it?
Stacy Lindborg: And this was in 38% of the intent to treat population. For this group, the hazard ratio dropped to 0.41 and the median overall survival in the Imunon01 treatment arm had not yet been reached at the time of the day-to-lock, which compares with the median overall survival of 37.1 months in the standard of care treatment arm.
Speaker Change: Thanks for the question, Kim.
Kim Golodetz: Sure, thanks. And also for the clarification, and then on 001 and the end of phase two process, you know, we're
Speaker Change: Where does that stand? Are you in a position that you have been able to request a meeting? And if not, when do you anticipate it? Because it strikes me that
Stacy Lindborg: Because it strikes me that, Given your expected timing for presenting the full data set and having clarity around the phase three trial design, Yeah, you can don't tell those two events together; you're going to have a lot more certainty in the eyes of Yes, it's a great question. And we are expecting to be able to present the entire full data set at a major stage in the fall, which we certainly will announce as soon as we have those plans.
Speaker Change: given your ...
Stacy Lindborg: Regarding our next steps, we have taken a number of steps to conserve capital and align our critical needs with available funds. We are within days of requesting an end-of-phase two meeting with the FDA to validate our conclusions and clarify our path for the registration study ahead. This means we can expect an end-of-phase two meeting with the FDA this fall, and this will permit us to begin our Phase III Ovarian Cancer Study in the first quarter of 2025. The pace of the study will depend on several factors, including access to capital and patient recruitment, but at this point, we are targeting top-line data readout at the end of 2021-28.
Speaker Change: expected timing for presenting the full data set and having clarity around the phase three trial design. You know, you can dovetail those two events together.
Speaker Change: I'm going to have a lot more certainty in the eyes of potential partners and investors.
Speaker Change: Yes, it's a great question and we are we are expecting to be able to present the entire the full data set at a major stage in the fall.
Speaker Change: which we certainly will announce as soon as we have those plans.
Stacy Lindborg: We are, as I shared in my prepared remarks, within days of requesting the End of Phase 2 meeting. And as we look at our ultimate goal, which we are very much in line with in terms of all the steps that really lead up to the first patient dose and kicking the study off, everything will align extremely well with doing that in Q1. So I do expect there will be many synergies around some of the catalysts you're describing as well as others. Great, thank you.
Speaker Change: We are, as I shared in my prepared remarks, we're within days of requesting the interface to meeting.
Stacy Lindborg: As you know, Ovation 2 is not the only study with Imunon01 in Ovarian Cancer. We have an ongoing study principally funded by the Breakthrough Cancer Foundation that is proceeding at the University of Texas, Indian, Anderson Cancer, and Memorial Sloan Kettering Cancer Center under the leadership of StudyPI, Dr. Amir Gisari. The study is evaluating Imunon01 on minimal residual disease or MRD, as determined by second-look laparoscopy when administered in combination with Bioequivalent Avastin in NACP.
Speaker Change: You know, as we look at ultimately, you know, our goal, which we are very much in line with in terms of all the steps that really lead up to first patient dose and kicking the study off.
Speaker Change: Everything will align extremely well with doing that in Q1. So, you know, I do expect there will be many synergies around some of the catalysts you're describing and as well as others.
Speaker Change: Great, thank you.
Operator: Our next question comes from David Bautz from Zapps. Please go ahead with your question. Hey, good morning, everyone.
Speaker Change: Our next question comes from David Belz from Zacks. Please go ahead with your question.
Stacy Lindborg: So, Stacy, I was wondering if you could talk about maybe what are some of the most important design factors for the Facebook trial that you're hoping to come into alignment with the FDA during your upcoming meeting. Yeah, David, that's a great question, and we are looking forward to certainly motivating what we believe is really a very strong design that, you know, we're coming to the table with input from leading clinicians that have been not only treating with Imunon but have dedicated their careers to women with ovarian cancer.
Stacy Lindborg: Subjects newly diagnosed with ovarian cancer, Philippiantube, or primary peritoneal cancer will be included, and to date, seven patients have been enrolled in received As the first few patients have reached the primary end point, Dr. Jazeera will now conduct a pilot study to test circulating tumor DNA levels following treatment, using a next generation CT DNA FA. We look forward to sharing insights with you from this data and harnessing insights from this data for Ovation 3.
David Belz: Hey, good morning everyone. So Stacey, I was wondering if you could talk about maybe what are some of the most important design factors for the phase 3 trial that you're that you're hoping to come into alignment with the FDA during your upcoming meeting?
Stacey Lundborg: Yeah, David, that's a great question, and we are looking forward to certainly motivating what we believe is really a very strong design that, you know, we're coming
Speaker Change: to the table with input from leading clinicians that have been not only treating with iminon but have dedicated their careers to women with ovarian cancer.
Stacy Lindborg: Switching now to the proof of concept phase one study of our DNA vaccine candidate for COVID-19. During the second quarter we began patient enrollment with Imunon 101 as a seasonal COVID-19 booster vaccine and we believe that the pre-clinical efficacy we've generated along with the superior handling logistics which we've discussed on past calls will make this vaccine attractive to a former partner. Our plan is to complete phase one report data by the end of the year and at that point we will actively seek a partner to continue development.
Stacy Lindborg: You know, coming out of the Ovation 2 study, we certainly see this tantalizing synergistic effect, potential synergistic effect, with PARP inhibitors, so one of the aspects that we're thinking very carefully about is ensuring that there's balance across the treatment arms in women that have genetic mutations that, you know, may predispose them to a strong response.
Speaker Change: Coming out of the Ovation 2 study, we certainly see this tantalizing synergistic effect, potential synergistic effect with PARP inhibitors.
Speaker Change: So one of the aspects that we're thinking very carefully about is ensuring that there's balance across the treatment arms.
Speaker Change: and women that have genetic mutations that
Speaker Change: may predispose a strong response.
Stacy Lindborg: You know, in the likely nature of, you know, with BRCA mutations, for example, HR deficiency, a very likely treatment with PARP inhibitors, so certainly we want to make sure that we can answer key questions clearly and bring evidence of, you know, a very strong treatment effect then across the entire study in addition to these key subgroups. So the primary endpoint, I think will be very straightforward. We're choosing the definitive endpoint, and we expect that to be a very smooth discussion. So those are the overall survival is primary.
Speaker Change: You know, in the likely nature of, you know, with BRCA mutations, for example, HR deficiency, a very likely treatment with PARP inhibitors.
David Gaiero: Now I'll turn the call over to Dave Gaiero, our interim CFO for discussion of our quarterly financial results. Dave? Thank you, Stacy.
Speaker Change: Certainly, we want to make sure that we can answer key questions clearly and bring evidence of a very strong treatment effect across the entire study in addition to these key subgroups.
David Gaiero: Details of Imunon 2nd quarter, 2024 financial results are included in the press release. We issued this morning and in our form 10Q which we filed today before the market opened. As of June 30th, 2024, Imunon had 5.3 million in cash investments in accrued interest receivable. Subsequent to the close of the quarter, we received net proceeds of approximately $9 million from a registered direct offering. We will continue to focus on strong cash management and as Stacy indicated, we have taken steps to evaluate and prioritize our spending and expect our cash runway to extend into the third quarter of 2025.
Speaker Change: So, the primary endpoint, I think, will be very straightforward. We're choosing the definitive endpoint. We expect that will be a very, very smooth.
Speaker Change: So those are the overall survival is primary. The list of endpoints really which are giving competence and consistency in the data which we're seeing very clearly in Innovation 2.
Stacy Lindborg: The list of endpoints, really, which is giving confidence and consistency in the data, which we're seeing very clearly in innovation two. Key factors that we're including in the design and then the establishment of the inclusion criteria, which really will set us up for a first line indication statement. Those are the key things on top of mind. Okay, great. Now, in regards to the MRD study, are you pleased with how enrollment is going, and is there anything maybe that can be done to kind of speed up enrollment in that study? Yeah, it's a great question.
David Gaiero: Imunon reported a net loss for the second quarter of 2024 of $4.8 million or 51 cents per share compared with a net loss of $5.6 million or 61 cents per share for the second quarter of 2023. Operating expenses were $5 million for the second quarter of 2024, a decrease of $500,000 or 8% from the second quarter of 2023. R&D expenses were $2.8 million in the second quarter of 2024 compared with $3.1 million in the same period of 2023.
Speaker Change: key factors that we're including into the design and then the establishment of the inclusion criteria which really will set us up for a first line indication statement. Those are the key things top of mind.
Speaker Change: Okay, great. Now in regards to the MRD study, are you pleased with how enrollment is going? And is there anything maybe that can be done to kind of speed up enrollment in that study?
Stacy Lindborg: I was reviewing this just yesterday with our team as doing a phenomenal job of managing the study internally. It turns out that the rate of enrollment is actually competitive. It's even higher than innovation too, but we have seven patients treated right now out of 50. What needs to happen so while MD Anderson has done phenomenally, we have two more sites, some memorials on catering are now on board, John Hopkins will be expected soon, so I think we can expect to see enrollment increasing as these sites now come into the fold and our meeting with patients and entering them into the study.
Speaker Change: Yeah, it's a great question. I was reviewing this just yesterday with our team that's doing a phenomenal job you know of managing the study internally
David Gaiero: DMC costs decreased to $500,000 compared with $700,000 a year ago. The lower CMC costs were primarily due to the establishment of internal capability to produce plasma DNA. Costs associated with our Placene program decreased by $200,000 in the second quarter of 2024 compared to the second quarter of 2023. These decreases were partially offset by a $200,000 increase in regulatory and other clinical costs in the second quarter of 2024 compared to the second quarter of 2023.
Speaker Change: It turns out that the rate of enrollment is actually competitive, it's even higher than Innovation 2, but we had, and we have 7 patients treated right now out of 50.
Speaker Change: What needs to happen, so while MD Anderson has done phenomenally, we have two more sites, so Memorial Sloan-Kettering is now on board, Johns Hopkins will be anticipated soon, so I think we can expect to see enrollment increasing as these these sites
Speaker Change: Now come into the fold in our meeting with patients and entering them into the study. You know, I think in terms of what we'll do, we'll certainly be meeting with each of the PIs, making sure that the data
David Gaiero: General administrative expenses were $2.2 million in the second quarter of 2024 compared with $2.3 million in the same period of 2023. The decrease was primarily attributable to lower noncash.compensation expense of $100,000 and employee related expenses of $100,000. Partially offset by an increase in legal fees of $100,000, dollars. Other non-operating income was $200,000 in the second quarter of 2024, compared with other non-operating expenses of $100,000 in the same period of 2023.
Stacy Lindborg: I think in terms of what we'll do, we'll certainly be meeting with each of the PIs, making sure that the data that has really, very recently come out of innovation too, is at their fingertips so that they can describe to these women that they're counseling the potential of our product and are really armed with what they need to enroll patients that meet with this inclusion criteria. We are there, please. I mean, we're starting to report some information at the end of the year, correct?
Speaker Change: That has really very recently come out of Ovation 2 is at their fingertips that they can describe, you know, to these women that they're counseling of the potential of our product and are really armed with what they need to
Speaker Change: to enroll patients that meet this inclusion criteria. But we are very pleased.
David Gaiero: The company incurred a loss on an extinguishment of debt of $300,000 on its loan facility with Silicon Valley Bank in the second quarter of 2023 upon the repayment and fall of the small facility.
Speaker Change: Okay. to report some information at the end of the year, correct? That is correct. So not only by the end of the year, but also, Dr. Jaziri, our PI is interested and is planning on looking at some
David Gaiero: Turning briefly to the financial results for the first half of 2024, the company reported a net loss of $9.7 million, but $1.03 per share in the first half of 2024, compared with the net loss of $11.2 million, or $1.28 per share for the first half of 2023. R&D expenses were $6.1 million in the first half of 2024, compared with $5.8 million in the same period of 2023. Cost associated with the PLACIN program increased to $2.8 million in the first half of 2024, compared to $2.3 million in the first half of 2023.
Stacy Lindborg: That is correct. So not only by the end of the year, but also Dr. Jhaziri, our PI, is interested in and is planning on looking at some, you know, a pilot study of this. I talked about this a little bit in the opening remarks about circulating tumor DNA, a very interesting biomarker.
Speaker Change: you know, a pilot study of this. I talked about this a little bit in the opening remarks.
Stacy Lindborg: He has, I think, worked out a lot of very interesting translational biomarkers for the rich data that will come out of this study. So instead of sitting and waiting passively, we're really looking at pilot studies. And then, with second look laparoscopy being the primary endpoint, we do expect to be able to release data on that endpoint before the end. Okay, great. And just to clarify, so it sounds like if positive results are achieved with 101, the company is going to look to partner to advance that program, but is that to just advance the COVID program, or is it for the whole vaccine platform that you're going to look to partner with?
Speaker Change: of Circulating Tumor DNA, a very interesting biomarker. He has, I think, worked a lot of very interesting translational biomarkers of the rich data that will come out of this study. So.
Speaker Change: Instead of sitting and waiting passively, we're really looking at pilot studies and then with Second Look laparoscopy being the primary endpoint, we do expect to be able to release data on that endpoint before the end of the year.
Stacy Lindborg: Yeah, so we would look to partner the entire platform. Okay. All right, thanks. Yeah, great. Thanks for taking the questions. And once again, if you would like to ask a question, please press star and one. To remove yourself from the question queue, you may press start and then... Our next question comes from James Molloy, from Alliance Global Partners.
Speaker Change: Okay, great. And just to clarify, so it sounds like if positive results for with 101,
David Gaiero: Regulatory and other clinical costs increased to $1.1 million in the first half of 2024, compared to $700,000 in the first half of 2023. These increases were partially upset by a $600,000 decrease in CMC costs in the first half of 2024, compared to the same period of 2023. General and administrative expenses were $3.9 million in the first half of 2024, compared with $5.4 million in the same period of 2023. The decrease was primarily attributable to lower non-cash compensation expense of $400,000, legal expenses of $400,000, employee-related expenses of $300,000, and an external expense of $100,000. Other non-operating income was $300,000 in the first half of 2024, compared with $8,505 in the same period of 2023.
Speaker Change: The company is going to look to partner to advance that program. But is that to just advance the COVID program, or is it for the whole vaccine platform that you're going to look to partner?
Speaker Change: Yeah, so we would look to partner the entire platform.
Speaker Change: Okay.
Speaker Change: Thanks for taking the questions.
Speaker Change: And once again, if you would like to ask a question, please press star and one.
Speaker Change: To remove yourself from the question queue you may press star and 2.
Speaker Change: Our next question comes from James Molloy from Alliance Global Partners. Please go ahead with your question.
Operator: Please go ahead with your question. Hey guys, thank you very much for taking my question. I had a question about Placenta, so the program in general and the preclinical development of PLX X and Z, 102. And he said you're looking at a part of the whole thing.
James Molloy: Hey guys, thank you very much for taking my question. I had a question on the Placene
David Gaiero: The company incurred interest expense of $200,000, as well as $300,000 in debt extinguishing expense associated with its loan facility with Silicon Valley Bank in the first half of 2023. Investment income from the company's short-term investments decreased by $200,000 for the first half of 2024, from the same period in 2023 due to lower investment balances.
Speaker Change: So the program in general and the preclinical development PLX, X and Z, 102, and you said you're looking at part of the whole thing.
Stacy Lindborg: To be fair to say, there's sort of a shift and maybe a reshift back to the immunotherapy rather than the Placene DNA Plasid vector for the focus going forward. And could you walk through how the partnership environment currently looks for Placene? And perhaps, as well, I imagine you're open to partnerships for the immunotherapy as well, should those be up to you present? Could you walk through how that partnership environment looks as well
Speaker Change: Would it be fair to say there's a sort of a shift and maybe a reshift back to the immunotherapy rather than the Placene DNA plasmid vector for the focus going forward?
Stacy Lindborg: With that financial review, I'll turn the call back to Stacy.
Speaker Change: And could you walk through how the partnership environment currently looks for Placene, and then perhaps as well, I imagine you're open to partnerships for the immunotherapy as well, should there's opportunity to present. Could you walk through how that partnership environment looks as well, please?
Stacy Lindborg: Thank you, Dave, and thank you for so seamlessly stepping in, following just retirement. It's been a very smooth transition. As Michael mentioned, we recently announced a financing with a 10 million in gross proceeds under highly competitive terms. This was priced at $2 per share in an at-the-market deal that included one warrant for each share sold. The warrants have a stock price of $2. The additional capital added to our June balance brings our cash to approximately $14.5 million, which historically, this is well over three and a half quarters of operating runway.
Stacy Lindborg: Yeah, James, thanks for the question. Um, you know, I think that if I reflect back on my time on the board before joining as an employee and a CEO, you know, Imunon really has been a very highly focused company. And from a strategic perspective, we always looked at the Placene platform as a wonderful offshoot of the IL-12 technology, right? So it's an adaptation.
Speaker Change: Yeah, James, thanks for the question. Um, you know, I think that if I reflect back on my time on the board before joining as an employee and a CEO,
Speaker Change: You know, Iminon really has been a very highly focused company, and from a strategic perspective, we always looked at the Placene platform as a wonderful offshoot of the
Stacy Lindborg: Before consideration of further capital conservation in ditches and assures a bridge to important catalysts, which we can discuss. Following our discussions and with many premier health care investors, we have every confidence in our ability to access capital going forward, including the use of our ATM and possible interest from parts.
Speaker Change: you know, our IL-12 technology, right? So it's an adaptation. We will continue to look for rich opportunities and the ability to bring transformative options.
Stacy Lindborg: We will continue to look for rich opportunities and the ability to bring transformative options into the marketplace, and then we'll also have to decide what we choose to drive forward and what we can gain in terms of furthering our business, non-deleted funding for our core business as well as, you know, really choosing strong partnerships. So I do think that, you know, for several, for several years, we've been talking about the potential of this proof of concept study, but it really was for the technology, not truly launching COVID-19.
Speaker Change: into the marketplace. And then we'll also have to decide what we choose to drive forward and what we can gain in terms of furthering.
Speaker Change: the, you know, our business, non-dilutive funding for our core business, as well as, you know, really choosing strong partnerships. So.
Stacy Lindborg: I hope that you'll agree that the future of Imunon is bright and that together with shareholders we will deliver on our mission to have a meaningful impact on patient's lives.
Speaker Change: I do think that, you know, for the, for several, for several...
Unknown Executive: With that I'd like to open up the call to your questions operator. Wait as a gentleman at this time we'll begin that question in the answer session to join the question to you may press star and then one so withdraw your questions you may press star in into if you are using a speaker phone would you ask me please pick up the handset prior to pressing the numbers to ensure the best sound quality. Once again that is star and then one we join the question to you.
Speaker Change: years we've been talking about the potential of
Speaker Change #100: This proof of concept study, but it really was...
Speaker Change #100: for the technology, not truly launching into COVID-19.
Stacy Lindborg: This was a vehicle to get us there, and I think that's something we wanted to really bring clarity to. So that was very, very much my intent coming in. In fact, you know, that resulted in really being very clear with our internal resources and ensuring we're allocating resources aligned with our priorities, and we've very effectively been able to accomplish that in the last quarter. It may be premature to comment on partnerships, but I do think that, you know, Michael offered some remarks. We're overwhelmed by the, if you just compare the current options, there are some strengths that we certainly have highlighted, and we'll be very thrilled to highlight on future calls, but there is amazing potential, and I think it just needs to be in the right hands with the right motivation. And in focus.
Speaker Change #100: This was a vehicle to get us there, and I think that's something we wanted to really bring clarity to.
Speaker Change #101: Very much my intent coming in. In fact, that resulted in really being very clear with our internal resources and ensuring we're allocating aligned with our priorities and we very effectively been able to accomplish that in the last quarter.
Unknown Executive: We'll pause materially to assemble the roster.
Emily Bodnar: Our first question today comes from Emily Bodnar from H.C. Wainery. Please go ahead with your question.
Speaker Change #101: It may be premature to comment on partnerships, but I do think that, you know, Michael offered some remarks.
Stacy Lindborg: Good morning, thank you for taking the questions. Kind of a follow up to some of the financing and funding discussion that you made. Could you let me just talk about how you're thinking about strategy for financing of phase three study given obviously those tend to be pretty large studies. Maybe if you can comment on how expensive you think such a study could cost and if you're potentially looking to raise additional capital or other strategies that you're evaluating and potentially if you've gotten any partnership interest since the ovation to data came out.
Michael Tardugno: You know, we're overwhelmed with the, if you just compare to the current options.
Speaker Change #102: There are some strengths that we certainly have highlighted and will be very thrilled to highlight on future calls, but there is amazing potential, and I think it just needs to be in the right hands with the right motivation and focus.
Operator: Great, thank you for taking the question. And ladies and gentlemen, with that, we'll be concluding today's question and answer session. I'd like to turn the floor back over to management for any closing remarks.
Speaker Change #103: Great, thank you for taking the questions.
Speaker Change #104: And ladies and gentlemen, with that, we'll be concluding today's question and answer session. I'd like to turn the floor back over to management for any closing remarks.
Stacy Lindborg: And then second on the COVID booster, could you discuss the blinding for the phase one study and if you're able to see the data of the kind of a cruise. Thank you. Yeah, Emily, thank you for the question. I'm great to hear from you. Yeah, so I'll start with with both questions. And then Michael, I think you may want to add to it. So, you know, we're anticipating that this trial could cost on the order of $50 million.
Stacy Lindborg: Thank you. And really, thank you to everyone for participating in this conference call. As our work in providing options to women with ovarian cancer progresses and the population's exposure to potential pandemics increases, we remain very excited about reporting data from ongoing clinical studies in the coming months.
Speaker Change #105: Thank you. And really, thank you to everyone for participating in this conference call. As our work in providing options to women with ovarian cancer progresses and the population's exposure to potential pandemics increases,
Speaker Change #106: We remain very excited about reporting data from ongoing clinical studies in the upcoming months.
Stacy Lindborg: And I also want to point out that I'm being interviewed in a pre-recorded fireside chat that will go live at 7 a.m. September 9th at the start of H.C. Wainwright's 26th Annual Global Investor Conference, which will be held in New York. We'll be putting that information out so you can watch the conversation. And for those that are interested, we'll be available for one-on-one meetings at the conference and virtually, so contact H.C. Wainwright if you'd like a meeting.
Speaker Change #107: And I also want to flag that I'm being interviewed in a pre-recorded fireside chat that will go live on 7 a.m. September 9th at the start of H.C. Wainwright's 26th Annual Global Investor Conference.
Stacy Lindborg: So, you know, adding 10 million to the balance sheet and as we talked about with our cash runway really takes us takes us very well into into 2025 actually, you know, well, well into the third quarter. Our goal, of course, this allows us to start the trial as we have planned. We're really intending with our, with the way that we manage our company to continue to be able to achieve our core business objectives.
Speaker Change #107: which will be held in New York.
Speaker Change #107: We'll be putting that information out so you can view the conversation. And for those that are interested, we'll be available for one-on-one meetings at the conference and virtually. So contact H.C. Wainwright if you'd like a meeting. But we look forward to keeping you informed of our progress and wish you a nice afternoon. Thanks for joining.
Operator: But we look forward to keeping you informed of our progress, and wish you a nice afternoon. Thanks for joining us. And ladies and gentlemen, with that, we'll conclude today's presentation. We do thank you for joining us. You may now disconnect your line. Thank you. Bye. Bye
Stacy Lindborg: And this really is a bridge then for and provides time for us to raise additional capital. And Michael, do you want to, do you want to offer additional? Sure. I mean, good question Emily. It's always a challenge, particularly in recent days for microcapped companies to raise capital. You know that and you probably cover a number of them. But I can say unequivocally that the quality of the investors that we spoke to during this financing road show were among the very best.
Speaker Change #108: And ladies and gentlemen, with that, we'll conclude today's presentation. We do thank you for joining. You may now disconnect your lines.
Stacy Lindborg: And I think across the board, except maybe for a very small number. We spoke to a good number, for Quality Investors. I think across the board the reaction was overwhelmingly positive. Market conditions, among other things, may have limited their most recent interest, but I think that the story to tell from this financing road show is a little bit more time with the data they like to see more maturity. I think that will give us an opportunity to re-engage and re-engage successfully.
Stacy Lindborg: In the meantime, the company is looking forward to some additional catalysts that may provide an opportunity to use the ATM, engage strategic partners, or consider another equity-round financing. On the whole, this has been the kind of the history of many companies like ours, and I don't think, honestly, from the data that we've seen in the impact on the lives of, of ovarian cancer patients, that this study will go without important financial support.
Stacy Lindborg: Ann, Emily, you asked one other question about the trial. So we are intending for this trial to be an open label study, as I think we all understand that with the route of administration for I mean on being through a catheter directly into the microtumor environment, this is really more of an ethical decision, that the only way you can preserve blind would be to require for the control arm to also have that, which would be an unnecessary surgical procedure.
Stacy Lindborg: So we are intending that there will be full agreement with FDA that this will be open label, and we'll certainly get buy-in on plans for event-driven endpoints and the ability to report out appropriately in the trial. I think she was talking about the COVID vaccine. Yeah, sorry. Okay, I apologize. I misunderstood. So you're going to batch the results right? So for the, for the immunon 101, yeah, that's your question. Oh, I apologize.
Stacy Lindborg: Three. So it is, it is an open label trial. We are with this trial really, you know, we do have part of what will be very exciting and interesting. Are they immunogenicity data that we expect to have by the end of the year? So we of course can do them in batches, but really we're expecting to have the full sample from the trial and to be able to, to report out, you know, based on the, the effects that we're seeing and which really will establish proof of concept and will set up the, the partnership discussions full, full stop.
Stacy Lindborg: In the meantime, the DSMB is being evaluated for safety. That's right. So we have, we have an ongoing, as you would expect, in a phase one trial, you know, where you're needing to have a regular and planned DSMB reviews that trigger the release of additional patients being treated. We've gone through multiple DSMB reviews of our data, seamlessly getting approval to continue. And the study is enrolling exactly per the plan. [inaudible] Thank you so much. Thank you so much.
Unknown Executive: Okay, great. Thanks, Roller. I appreciate you doing the question. Thank you, Emily.
Kemp Dolliver: Our next question comes from Kemp Dolliver from Brooklyn Capital Markets. Please go ahead with your question. And Kemp, is it possible that your photo is on mute? Okay, sorry. So thank you for taking the question. Just quickly on 101, when you say the studies and rolling exactly to plan, you know, COVID waves are not what they were. There are a couple of years ago. So are you seeing steady enrollment? Or is this a case where as we get into the fall that, you know, with this potential spike in COVID, you'll see a similar spike in enrollment.
Kemp Dolliver: Yeah, so this, you know, this study is enrolling healthy, healthy subjects. We have a very experienced center that's running it. For the numbers I've reviewed, I look at them quite regularly. We're, you know, we're about 70, about 70% of the patients that we will enroll in the trial and they've been dosed. So I don't think, I don't think the flu season is likely to influence it. In fact, we expect really likely to be ahead of it in terms of completing the trial and the observation.
Kemp Dolliver: I'd like to comment on it also. So I mean, there are a number of advantages that we believe will be demonstrated in this phase one study, not the least of which is durability. And of course, the handling characteristics a lot of this formulation to be managed at temperatures that are very friendly for a global distribution. And that said, there may be an opportunity to replace MR and Avax scenes depending on the data that would be as boosters. As you point out, the market is waiting some, but I think the more important outcome from this study is the proof of concept that a DNA vaccine can provide in other indications.
Stacy Lindborg: You may want to speak. Yeah, I'd love to add to that. I mean, I do think that, you know, we were very thoughtful in choosing the what we would study to establish proof of concept of our technology. But as you guys are likely quite aware, there have been more than 80 pathogenic viruses discovered since 1980. The target of choice would really need to be decided in conjunction with, you know, the party who's going to develop it.
Stacy Lindborg: We think there is enormous value to the technology that we want to make sure we maximize through a partnership. And, you know, there's equally exciting when we think about our core and our strategy down the path. There's even a potential, you know, for an ecology vaccine. So the platform itself, the technology is a very, very exciting, for many reasons. Thanks for the question, Camel. Sure, thanks and also for the clarification.
Stacy Lindborg: And then on 001 and the end of phase two process, where does that stand? Are you in a position that you have been able to request a meeting? You know, and if not, Wendy anticipated because it strikes me that given your expected timing for presenting the full data set and having clarity around the phase three trial design, you can dovetail those two events together. You're going to have a lot more certainty in the eyes of potential partners and investors.
Stacy Lindborg: Yes, it's a great question and we are expecting to be able to present the entire, the full data set at a major stage in the fall, which we certainly will announce as soon as we have those plans. We are, as I shared in my prepared remarks, we're within days of requesting the end of phase two meeting and, you know, as we look at ultimately, you know, our goal, which we are very much in line with in terms of all the steps that really lead up to first patient dose and kicking the study off. Everything will align extremely well with doing that in Q1. So, you know, I do expect there will be many synergies around some of the catalysts you're describing and as well as others.
Unknown Executive: Great, thank you.
David Feltz: Our next question comes from David Feltz from Zach. Please go ahead with your question. Hey, good morning, everyone.
Stacy Lindborg: So, Stacy, I was wondering if you could talk about maybe what are some of the most important design factors for the phase three trial that you're hoping to come into alignment with the FDA during your upcoming meeting? Yeah, David, David, that's a great question. And we are looking forward to certainly motivating what we believe is really a very strong design that, you know, we're coming to the table with input from leading clinicians that have been not only treating with immunon, but, you know, dedicated to their careers to women with a varying cancer.
Stacy Lindborg: You know, coming out of the Ovation 2 study, we certainly see this tantalizing synergistic effect, potential synergistic effect with PARP inhibitors. So, one of the aspects that we're thinking very carefully about is ensuring that there's balance across the treatment arms and women that have genetic mutations that, you know, may predispose a strong response. You know, in the likely nature of, you know, with bracket mutations, for example, HR deficiency, a very likely treatment with PARP inhibitors.
Stacy Lindborg: So, certainly, we want to make sure that we can answer key questions clearly and bring evidence of a very strong treatment effect than across the entire study in addition to these key subgroups. So, the primary endpoint, I think, will be very straightforward. We're choosing the definitive endpoint. We expect that will be a very, a very smooth, smooth discussion. So, those are the overall survival primary, the list of endpoints, really, which are giving confidence and consistency in the data, which we're seeing very clearly in the Ovation 2. Key factors that we're including into the design and then the establishment of the inclusion criteria, which really will set us up for our first line indication statement. Those are the key things, top of mind.
Stacy Lindborg: Okay, great.
Stacy Lindborg: Now in regards to the MRD study, are you pleased with how enrollment is going? And is there anything maybe that can be done to kind of speed up enrollment in that study? Yeah, it's a great question. I was reviewing this just yesterday with our team is doing a phenomenal job of managing the study internally. It turns out that the rate of enrollment is actually competitive, it's even higher than innovation too, but we had, and we have seven patients treated right now out of 50.
Stacy Lindborg: What needs to happen, so while MD Anderson has done phenomenally, we have two more sites. Some memorials on catering is now on board, Johns Hopkins will be anticipated soon. So I think we can expect to see enrollment increasing as these sites now come into the fold and are meeting with patients and entering them into the study. I think in terms of what we'll do, we'll certainly be meeting with each of the PIs, making sure that the data that has really very recently come out of innovation too is at their fingertips that they can describe to these women that they're counseling of the potential of our product and really armed with what they need to enroll patients that meet this inclusion criteria.
Stacy Lindborg: We are very pleased to report some information at the end of the year. That is correct, so not only by the end of the year, but also Dr. Jazeera, our PI is interested and is planning on looking at some pilot study of this. I talked about this a little bit in the opening remarks of circling to our DNA, a very interesting biomarker. He is, I think, worked a lot of very interesting translational biomarkers of the rich data that will come out of the study.
Stacy Lindborg: So instead of sitting and waiting passively, we're really looking at pilot studies and then with second look laparoscopy being the primary point, we do expect to be able to release data on that end point before the end of the year.
Stacy Lindborg: Okay, great.
Stacy Lindborg: And just to clarify, so it sounds like if positive results with 101, the company is going to look to partner to advance that program, but is that to just advance the COVID program or is it for the whole vaccine platform that you're going to look to partner? Yeah, so we would look to partner the entire platform. Okay. We were very full. All right, thanks. Yeah, great. Thanks for taking the questions. And once again, if you would like to ask a question, please press star and one. To remember stuff on the question key, you may press star and two.
James Malloy: Our next question comes from James Malloy from Alliance Global Partners. Please go ahead with your question. Hey, guys.
Stacy Lindborg: Thank you very much for taking that my question. I had a question on the on the platform. So the program in general and the preclinical development PLX X and Z, 102, and he said you're looking to partner the whole thing. Would it be fair to say there's a sort of a shift and maybe a reshift back to the immunotherapy rather than the Placene DNA Plasid vector for the focus going forward and could you walk through how the partnership environment currently looks for Placene and perhaps as well.
Stacy Lindborg: I[inaudible] platform as a wonderful offshoot of the, you know, our IL-12 technology, right? So it's an adaptation. We will continue to look for rich opportunities and ability to bring transformative options into the marketplace and then we'll also have to decide what we choose to drive forward and what we can gain in terms of furthering the, you know, our business, non-delute funding for our core business as well as, you know, really choosing strong partnerships.
Stacy Lindborg: So I do think that, you know, for the, for several years we've been talking about the potential of this proof of concept study but it really was for the technology not truly launching into COVID-19. This was a vehicle to get us there and I think that's something we wanted to really bring clarity to. So that is very, very much my intent coming in. In fact, you know, that resulted in really being very clear with our internal resources and ensuring we're allocating a line with our priorities and we very effectively been able to accomplish that, you know, in the last quarter.
Stacy Lindborg: It may be premature to comment on partnerships that I do think that, you know, Michael offered some remarks, you know, we're overwhelmed with the, if you just compare to the current options, there are some strengths that we certainly have highlighted and will be very thrilled to highlight on featured calls but there is an amazing potential and I think it just needs to be in the right hands with the right motivation and focus.
Unknown Executive: Great. Thank you for taking the questions.
Unknown Executive: And ladies and gentlemen, with that we'll be concluding today's question and answer session.
Stacy Lindborg: I'd like to turn the floor back over to management for any closing remarks. Thank you. And really thank you to everyone for participating in this conference call as our work and providing options to women with ovarian cancer progresses and the population's exposure to potential pandemics increases. We remain very excited about reporting data from ongoing clinical studies in the upcoming months.
Stacy Lindborg: And I also want to flag that I'm being interviewed in a pre-recorded fireside chat that will go live on 7 a.m. September 9th of the start of the HC Wainwright 26th Annual Global Investor Conference, which will be held in New York. We'll be putting that information out so you can view the conversation and for those that are interested, we'll be available for 101 meetings at the conference in virtually. We look forward to keeping you informed of our progress, and I wish you a nice afternoon. Thanks for joining.
Unknown Executive: And ladies and gentlemen, with that welcome concludes today's presentation. We do thank you for joining.
Unknown Executive: You may now disconnect your lines.