Q4 2025 Imunon Inc Earnings Call

March 31, 2026

Operator: Good morning. My name is Desiree, and I will be your operator today. At this time, I would like to welcome you to Imunon's Q4 and Full Year 2025 Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. Following the speaker's prepared remarks, there will be a question and answer session. You may press star one on your phone to ask a question at this time. Please keep in mind if you are using a speakerphone, you must release your mute function to allow the signal to reach our equipment. Again, that's star one to ask a question during the Q&A session. I would now like to turn the call over to Peter Vozzo of ICR Healthcare, Investor Relations Representative for Imunon. Please go ahead.

Speaker #3: All lines have been placed on mute to prevent any background noise. Following the speaker's prepared remarks, there will be a question-and-answer session. You may press star one on your phone to ask a question at this time.

Speaker #3: Please keep in mind, if you are using a speakerphone, you must release your mute function to allow the signal to reach our equipment. Again, that's star one (*) to ask a question during the Q&A session.

Speaker #3: I would now like to turn the call over to Peter Vozzo of ICR Healthcare, Investor Relations Representative for Imunon. Please go ahead.

Speaker #2: Thank you, Desiree. Good morning, everyone, and welcome to Imunon's fourth quarter and full year 2025 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.

Peter Vozzo: Thank you, Desiree. Good morning, everyone, and welcome to Imunon's Q4 and full year 2025 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. 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 #2: In general, forward-looking statements can be identified by words such as expects, anticipates, believes, or other similar expressions. 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 #2: No forward-looking statements can be guaranteed, and actual results may differ materially from those statements. I also caution that the content of this conference call is accurate only as of the date of the live broadcast, March 31, 2026.

Peter Vozzo: 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, 31 March 2026. 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 Dr. Stacy Lindborg, Imunon's President and Chief Executive Officer. Stacy?

Speaker #2: 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 Dr. Stacy Lindborg, Imunon's President and Chief Executive Officer.

Speaker #2: Stacy?

Speaker #3: Thank you, Peter, and good morning, everyone. Joining me on the call this morning is Dr. Douglas Faller, our Chief Medical Officer, and Mr. Jeff Church, our Interim Chief Financial Officer, who likely needs no introduction given his tenure with Imunon.

Stacy Lindborg: Thank you, Peter, and good morning, everyone. Joining me on the call this morning is Dr. Douglas Faller, our Chief Medical Officer, and Mr. Jeff Church, our Interim Chief Financial Officer, who likely needs no introduction given his tenure with Imunon. He'll be walking through and reviewing our financial results for the Q4 and full year of 2025. Mr. Michael Tardugno, the Executive Chairman of our board, is also on the line and will be available for Q&A. We entered 2026 with strong momentum following a truly transformational year in 2025. Our proprietary IL-12 immunotherapy, IMNN-001, continues to demonstrate its potential to redefine frontline treatment for women with newly diagnosed advanced ovarian cancer based on all available data thus far, both translational and clinical. IMNN-001 is rapidly advancing in the OVATION 3 pivotal phase 3 study.

Speaker #3: He'll be walking through and reviewing our financial results for the fourth quarter and full year of 2025. Mr. Michael Tardugno, the Executive Chairman of our board, is also on the line and will be available for Q&A.

Speaker #3: We entered 2026 with strong momentum, following a truly transformational year in 2025. Our proprietary IL-12 immunotherapy, Imunon 001, continues to demonstrate its potential to redefine frontline treatment for women with newly diagnosed advanced ovarian cancer, based on all available data thus far, both translational and clinical.

Speaker #3: And IMNN-001 is rapidly advancing in the OVATION 3 pivotal Phase 3 study. The urgency of this program remains front and center for our efforts.

Stacy Lindborg: The urgency of this program remains front and center for our efforts to create value for our shareholders and to address the unmet need in ovarian cancer, which continues to claim far too many lives as the standard of care. Traditional chemotherapy in the frontline setting has not advanced in over 30 years. In our OVATION 2 study, IMNN-001 demonstrated the first ever overall survival benefit in a randomized frontline clinical trial for this patient population, with a final overall survival readout showing continued improvement in median overall survival across the trial through three different analyses that were conducted. Starting first with the original Phase 2 clinical trial data readout in July 2024, which was across all endpoints. The median overall survival benefit was reported as 11.1 months.

Speaker #3: To create value for our shareholders and to address the unmet need in ovarian cancer, which continues to claim far too many lives, as the standard of care—traditional chemotherapy in the frontline setting—has not advanced in over 30 years.

Speaker #3: In our OVATION 2 study, IMNN-001 demonstrated the first-ever overall survival benefit in a randomized frontline clinical trial for this patient population, with a final overall survival readout showing continued improvement in median overall survival across the trial through three different analyses that were conducted.

Speaker #3: Starting first with the original Phase 2 clinical trial data readout in July of 2024, which was across all endpoints. The median overall survival benefit was reported as 11.1 months.

Speaker #3: The median overall survival improvement observed in the subsequent clinical data readout in December 2024 was 13 months. And, as we disclosed this week, it has now expanded to 14.7 months in the final review of the trial results.

Stacy Lindborg: The median overall survival improvement observed in the subsequent clinical data readout in December 2024 was 13 months, and as we disclosed this week, has now expanded to 14.7 months in the final review of the trial results. Moreover, patients treated with PARP inhibitors as maintenance therapy in addition to IMNN-001 and standard of care chemotherapy demonstrated a median increase of an overall survival of more than 2 years. The timing of this final analysis was defined in the protocol to occur when the last patient enrolled in the trial had reached 3 years post-treatment, and these truly unprecedented Phase II results have given our laser-focused execution of the ongoing rigorous Phase III trial, which, as agreed to with FDA, is designed to confirm the Phase II results and support full regulatory approval.

Speaker #3: Moreover, patients treated with PARP inhibitors as maintenance therapy in addition to Imunon 001 and standard-of-care chemotherapy demonstrated a median increase in overall survival of more than two years.

Speaker #3: The timing of this final analysis was defined in the protocol to occur when the last patient enrolled in the trial had reached three years post-treatment.

Speaker #3: And these truly unprecedented Phase 2 results have given our laser-focused execution of the ongoing, rigorous Phase 3 trials—which, as agreed to with the FDA, are designed to confirm the Phase 2 results and support full regulatory approval.

Speaker #3: Throughout 2025, we showcased the strength of these Phase 2 clinical data and the compelling translational insights at major scientific forums, highlighted by the platform presentation at the 2025 ASCO Annual Meeting.

Stacy Lindborg: Throughout 2025, we showcased the strength of these Phase 2 clinical data and the compelling translational insights at major scientific forums, highlighted by the platform presentation at the 2025 ASCO annual meeting and the simultaneous publication of the OVATION 2 study results in the peer-reviewed journal Gynecologic Oncology. We capped off the year with a highly successful R&D day we hosted in November in New York City, and the investment community and leading clinicians heard directly from key opinion leaders about Imunon's ability to turn immunologically cold tumors hot, to remodel the tumor microenvironment, and deliver meaningful clinical survival benefits to women with newly diagnosed advanced ovarian cancer where none had existed before. This momentum carried into 2026 with OVATION 3 trial enrollment well ahead of plan.

Speaker #3: And the simultaneous publication of the OVATION 2 study results in the peer-reviewed journal Gynecologic Oncology. We capped off the year with a highly successful R&D Day.

Speaker #3: We hosted a November in New York City, and the investment community and leading clinicians heard directly from key opinion leaders about Imunon's ability to turn immunologically cold tumors hot, to remodel the tumor microenvironment, and to deliver meaningful clinical survival benefits to women with newly diagnosed advanced ovarian cancer, where none had existed before.

Speaker #3: This momentum carried into 2026 with ovation 3 trial enrollment well ahead of plan. In a protocol that is virtually identical to the phase 2 study, ovation 3 is a one-to-one randomized trial to evaluate Imunon 001 plus standard of care neoadjuvant and adjuvant chemotherapy which includes interval debulking surgery, versus the standard of care alone in women with treatment naive advanced ovarian cancer.

Stacy Lindborg: In a protocol that is virtually identical to the Phase II study, OVATION 3 is a 1:1 randomized trial to evaluate Imunon IMNN-001 plus standard of care neoadjuvant and adjuvant chemotherapy, which includes interval debulking surgery, versus the standard of care alone in women with treatment-naive advanced ovarian cancer. The adaptive trial design with interim analyses for early efficacy stopping rules provides 95% power on the primary endpoint of overall survival while offering the potential for accelerated timelines of a BLA for full approval. Key updates since our Q3 2024 corporate results conference call underscore the strength of our Phase II foundation and the accelerating progress in Phase III based on the strong response from patients, our clinical trial investigators, and the broader medical community. I'll just highlight a few areas, starting with site activation status.

Speaker #3: The adaptive trial design, with interim analyses for early efficacy stopping rules, provides 95% power on the primary endpoint of overall survival, while offering the potential for accelerated timelines of a BLA for full approval.

Speaker #3: Key updates since our Q3 2025 results conference call underscore the strength of our Phase 2 foundation and the accelerating progress in Phase 3, based on the strong response from patients, our clinical trial investigators, and the broader medical community.

Speaker #3: And I'll just highlight a few areas, starting with site activation status. Phase 3 trial enrollment remains strong, with seven clinical sites actively enrolling patients.

Stacy Lindborg: Phase 3 trial enrollment remains strong with 7 clinical sites actively enrolling patients and up to 43 additional high-quality centers under evaluation or in startup mode. Returning investigators from the OVATION 2 study have been joined by new top-tier centers, many proactively reaching out following our data presentations and publications. We have contracted a global CRO to support rapid advancement of Phase 3 trial site activation and the study overall. Turning to enrollment velocity. Building on the strong progress we reported in late 2025, patient randomization and treatment in the Phase 3 trial have continued at an impressive pace, and enrollment remains ahead of plan. The early sites have delivered higher than the assumed rate of 0.3 patients per month, with some sites delivering as high as 1 patient per month.

Speaker #3: And up to 43 additional high-quality centers under evaluation or in startup mode. Returning investigators from the OVATION 2 study have been joined by new top-tier centers.

Speaker #3: Many are proactively reaching out following our data presentations and publications. We have contracted a global CRO to support rapid advancement of Phase 3 trial site activation and the study overall.

Speaker #3: Turning to enrollment velocity—building on the strong progress we reported in late 2025, patient randomization and treatment in the Phase 3 trial have continued at an impressive pace.

Speaker #3: And enrollment remains ahead of plan. The early sites have delivered higher than the assumed rate of 0.3 patients per month, with some sites delivering as high as one patient per month.

Speaker #3: This early momentum—driven by the compelling Phase 2 study overall survival benefit—positions us well for continued acceleration of site activation and patient enrollment. Our goal is to have approximately 80 patients enrolled in the trial within the next 12 months, and enrollment completed in 2029.

Stacy Lindborg: This early momentum driven by the compelling phase II study overall survival benefit positions us well for continued acceleration of site activation and patient enrollment. Our goal is to have approximately 80 patients enrolled in the trial within the next 12 months, and enrollment completed in 2029. Turning to regulatory and design validation. Based on the FDA's endorsement of overall survival as the primary endpoint of the phase 3 trial, combined with a robust statistical framework and precedent in oncology clinical drug development, OVATION 3 continues to de-risk the path to a potential regulatory approval in both the US and Europe. On translational data and the MRD trial data, we have data from the ongoing phase II minimal residual disease or MRD study in collaboration with Break Through Cancer.

Speaker #3: Turning to regulatory and design validation, based on the FDA's endorsement of overall survival as the primary endpoint of the Phase 3 trial, combined with the robust statistical framework and precedent in oncology clinical drug development, OVATION 3 continues to de-risk the path to a potential regulatory approval in both the US and Europe.

Speaker #3: On translational data and the MRD trial data, we have data from the ongoing Phase 2 minimal residual disease, or MRD, study in collaboration with Breakthrough Cancer Foundation. This trial further reinforces Imunon's 001 novel mechanism of action, with demonstration of preferential uptake by peritoneal macrophages, profound tumor microenvironment remodeling, complete pathological responses, and durable IL-12 and interferon gamma expression with excellent tolerability.

Stacy Lindborg: This trial further reinforces Imunon's IMNN-001 novel mechanism of action with demonstration of preferential uptake of peritoneal macrophages, profound tumor microenvironment remodeling, complete pathological responses, and durable IL-12 and interferon gamma expression with excellent tolerability, even in combination with bevacizumab. We've successfully capped our enrollment in the MRD study at 30 patients, allowing the trial to meet all core objectives, and upon completion, channel resources and highly productive sites fully into the Phase 3 OVATION 3 trial. Preliminary data from the Phase 2 MRD study continue to align with the overall survival benefits shown in the Phase 2 OVATION 2 study and support potential label expansions in the future. I'll now turn over the call to Dr. Douglas Faller for clinical commentary. Douglas.

Speaker #3: Even in combination with bevacizumab. We've successfully capped our enrollment in the MRD study at 30 patients, allowing the trial to meet all core objectives, and upon completion, channel resources and highly productive sites fully into the Phase 3 OVATION 3 trial.

Speaker #3: Preliminary data from the Phase 2 MRD study continue to align with the overall survival benefit shown in the Phase 2 OVATION 2 study and support potential label extensions in the future.

Speaker #3: I'll now turn over the call to Dr. Douglas Faller for clinical commentary. Douglas.

Douglas V. Faller: Thank you, Stacy. The enthusiasm within the gynecologic community that we saw at our R&D day in November and throughout 2025 has only grown. The Phase 2 OVATION 2 clinical data showing a clinically meaningful 14.7-month median overall survival benefit and the ability of Imunon to activate both innate and adaptive immunity continue to resonate strongly with our investigators. Our multiple presentations at leading congresses in 2025 highlighted Imunon's unique profile, localized IL-12 delivery with negligible systemic exposure, favorable safety, and clear signals of immune activation predictive of superior outcomes. Interestingly, after seeing our data presentations, many investigators have been approaching us, asking us to join our Phase 3 OVATION 3 study rather than vice versa. I find this kind of initiative to be most unusual in my long experience conducting clinical trials, and also very gratifying.

Speaker #5: Thank you, Stacy. The enthusiasm within the gynecologic community that we saw at our R&D Day in November and throughout 2025 has only grown. The Phase 2 OVATION 2 clinical data showing a clinically meaningful 14.7-month median overall survival benefit and the ability of Imunon to activate both innate and adaptive immunity continue to resonate strongly with our investigators.

Speaker #5: Our multiple presentations at leading congresses in 2025 highlighted Imunon's unique profile: localized IL-12 delivery with negligible systemic exposure, favorable safety, and clear signals of immune activation predictive of superior outcomes.

Speaker #5: Interestingly, after seeing our data presentations, many investigators have been approaching us, asking to join our Phase 3 OVATION study, rather than vice versa.

Speaker #5: I find this kind of initiative to be most unusual in my long experience conducting clinical trials, and also very gratifying. It further supports the consensus of the significant potential of Imunon 001 to address the unmet medical needs in newly diagnosed ovarian cancer.

Douglas V. Faller: It further supports the consensus of the significant potential of IMNN-001 to address the unmet medical needs in newly diagnosed ovarian cancer. OVATION 3 has leveraged this interest from day one. As Stacy said, study startup was completed in record time and early sites have exceeded enrollment forecasts. Safety data remains clean, mirroring the excellent tolerability seen across our IMNN-001 clinical programs. The Phase 2 MRD study has provided real-time confirmation of the favorable safety profile, with no dose-limiting toxicities, no discontinuations due to IMNN-001, and very encouraging trends in progression-free survival and MRD negativity. These consistent findings across our studies give us high confidence as we scale the Phase 3 pivotal trial. Back to you, Stacy.

Speaker #5: Ovation 3 has leveraged this interest from day one. As Stacy said, study startup was completed in record time, and early sites have exceeded enrollment forecasts.

Speaker #5: Safety data remains clean, mirroring the excellent tolerability seen across our IMUNON 001 clinical programs. The Phase 2 MRD study has provided real-time confirmation of the favorable safety profile, with no dose-limiting toxicities, no discontinuations due to IMUNON 001, and very encouraging trends in progression-free survival and MRD negativity.

Speaker #5: These consistent findings across our studies give us high confidence as we scale the Phase 3 pivotal trial. Back to you, Stacy.

Stacy Lindborg: Thank you, Douglas. Before turning to our financial update, I want to highlight that 2025 was defined by disciplined execution and strategic focus. We advanced the most important development program in our history while navigating a challenging capital markets environment with prudence and foresight. Our multi-pronged financing strategy, combining targeted equity raises, opportunistic ATM usage, and ongoing partnership discussions, has allowed us to extend our cash runway while minimizing dilution and advance Imunon 001 as quickly as possible. Shareholder equity remains paramount. Every decision is stress-tested against our commitment to fully fund the OVATION 3 study with like-minded investors. We're making solid progress on this front and believe that once we secure a lead investor, we will be able to assemble a syndicate quickly.

Speaker #1: Thank you, Douglas. Before turning to our financial update, I want to highlight that 2025 was defined by disciplined execution and strategic focus. We advanced the most important development program in our history, while navigating a challenging capital markets environment with prudence and foresight.

Speaker #1: Our multi-pronged financing strategy, combining targeted equity raises, opportunistic ATM usage, and ongoing partnership discussions, has allowed us to extend our cash runway while minimizing dilution and advance Imunon 001 as quickly as possible.

Speaker #1: Shareholder equity remains paramount. Every decision is stress-tested against our commitment to fully fund the Ovation 3 study with long-minded investors. We're making solid progress on this front and believe that once we secure a lead investor, we will be able to assemble a syndicate quickly.

Stacy Lindborg: While the markets are improving and our ongoing calls with strong investors remain highly encouraging, we recognize that this process inherently takes time. We will continue to balance the ultimate goal of financing the trial with long-term oriented investors against the need to prudently extend our cash runway. We firmly believe that successfully completing this full financing is in the best interest of all of our constituents, including patients who are at the center of everything we do and all shareholders, as we believe this will enable our investors to realize significant value. We are encouraged by continued interests and potential non-dilutive partnerships for our TheraPlas® technology platform and IMNN-001. On the financing side, prudent use of our ATM facility and warrant exercises supplemented our cash position in 2025.

Speaker #1: While the markets are improving and our ongoing calls with strong investors remain highly encouraging, we recognize that this process inherently takes time. We will continue to balance the ultimate goal of financing the trial with long-term-oriented investors against the need to prudently extend our cash runway.

Speaker #1: We firmly believe that successfully completing this full financing is in the best interest of all of our constituents, including patients, who are at the center of everything we do, and all shareholders, as we believe this will enable our investors to realize significant value.

Speaker #1: We are encouraged by continued interest in potential non-dilutive partnerships for our TheraPlas technology platform and IMUNON 001. On the financing side, prudent use of our ATM facility and warrant exercises supplemented our cash position in 2025.

Stacy Lindborg: Monthly cash usage has been further optimized, and we announced a strategic reorganization in February 2026 to reduce non-essential costs and to sharpen our operational focus exclusively on OVATION 3, streamlining operations and focusing scientific leadership while preserving all critical expertise in the interest of all Imunon stakeholders. These actions, combined with our continued manufacturing and efficiencies, which are great, are designed to deliver on our milestone with maximum efficiency. Now over to Jeff Church for a review of our Q4 and full year 2025 financial results. Jeff?

Speaker #1: Monthly cash usage has been further optimized, and we announced a strategic reorganization in February 2026 to reduce non-essential costs and to sharpen our operational focus exclusively on Ovation 3.

Speaker #1: Streamlining operations and focusing scientific leadership, while preserving all critical expertise in the interest of all Imunon stakeholders. These actions, combined with our continued manufacturing efficiencies—which are great—are designed to deliver on our milestone with maximum efficiency.

Speaker #1: Now, over to Church for a review of our fourth quarter and full-year 2025 financial results. Jeff.

Jeff Church: Thank you, Stacy. Details of Imunon's Q4 and full year 2025 financial results were included in the press release we issued this morning and in our annual report on Form 10-K, which we filed before the market opened this morning. As of 31 December 2025, cash and cash equivalents were $8.8 million, reflecting disciplined cash management and net proceeds from warrant exercises and targeted ATM usage during the year. We project that this cash balance, together with our ongoing financial activities and cost-saving initiatives, extends our operating runway into H2 2026. Research and development expenses for 2025 were $7.8 million, which was significantly lower than 2024, primarily due to the completion of the OVATION 2 study, optimization of the MRD study, and focused spend on the OVATION 3 study's manufacturing and startup activities.

Speaker #6: Thank you, Stacy. Details of Imunon's fourth quarter and full-year 2025 financial results were included in the press release we issued this morning and in our annual report on Form 10-K, which we filed before the market opened this morning.

Speaker #6: As of December 31, 2025, cash and cash equivalents were $8.8 million, reflecting disciplined cash management and net proceeds from warrant exercises and targeted ATM usage during the year.

Speaker #6: We project that this cash balance, together with our ongoing financial activities and cost-saving initiatives, extends our operating runway into the second half of 2026.

Speaker #6: Research and development expenses for 2025 were $7.8 million, which was significantly lower than 2024, primarily due to the completion of the Ovation 2 study, optimization of the MRD study, and focused spend on the Ovation 3 study manufacturing and startup activities.

Jeff Church: General and administrative expenses were down 8% year over year through streamlined operations and renegotiated commitments. Net loss for 2025 was $14.5 million or $6.83 per share, compared to $18.6 million or $16.94 per share, reflecting meaningful improvement driven by our cost discipline. I just would like to remind everyone that all share and per share amounts reflect the 15-for-1 reverse stock split effective in July 2025 and the 15% stock dividend declared in Q3 of 2025. With that financial review, I'll turn the call back to Stacy.

Speaker #6: General and administrative expenses were down 8% year over year through streamlined operations and renegotiated commitments. Net loss for 2025 was $14.5 million, or $6.83 per share, compared to $18.6 million, or $16.94 per share, reflecting meaningful improvement driven by our cost discipline.

Speaker #6: I just would like to remind everyone that all share and per-share amounts reflect the 15-for-1 reverse stock split effective in July 2025, and the 15% stock dividend declared in the third quarter of 2025.

Speaker #6: With that financial review, I'll turn the call back to Stacy.

Stacy Lindborg: Thank you, Jeff and Desiree. With that, we'll open the call for questions.

Speaker #1: Thank you, Jeff. And Desiree, with that, we'll open the call for questions.

Operator: Thank you. We will now begin the question and answer session. If you have dialed in and would like to ask a question, please press star one on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press star one again. If you are called upon to ask your question and are listening via speakerphone in your device, please pick up your handset to ensure that your phone is not on mute when asking your question. Again, press star one to join the queue. Our first question comes from the line of Emily Bodnar with H.C. Wainwright. Your line is open.

Speaker #3: Thank you. We will now begin the question and answer session. If you have dialed in and would like to ask a question, please press *1 on your telephone keypad to raise your hand and join the queue.

Speaker #3: If you would like to withdraw your question, simply press *1 again. If you are called upon to ask your question and are listening via speakerphone on your device, please pick up your handset to ensure that your phone is not on mute when asking your question.

Speaker #3: Again, press *1 to join the queue. And our first question comes from the line of Emily Bodnar with HC Wainwright. Your line is open.

Emily Bodnar: Hi, Corinne. Thanks for taking the questions. My first one, have you presented the final data from OVATION 2 to the FDA, particularly on the PARP inhibitor patient population? Have you received any feedback from the FDA on focusing on this patient population first in your OVATION 3 study? Maybe if you could just kind of outline how you're thinking about upcoming milestones and catalysts for 2026 and any OVATION 3 updates that you're considering for this year. Thanks.

Speaker #7: Hi, good morning. Thanks for sending the questions. My first one: Have you presented the final data from OVATION 2 to the FDA, particularly on the PARP inhibitor patient population?

Speaker #7: And have you received any feedback from the FDA on focusing on this patient population first in your OVATION 3 study? And then maybe if you could just kind of outline how you're thinking about upcoming milestones and catalysts for 2026, and any OVATION 3 updates that you're considering for this year.

Speaker #7: Thanks.

Stacy Lindborg: Thanks, Emily. That's a very well-formulated and comprehensive question. Let me take it in steps. First, we have not presented the OS data to the FDA. You know, we are incredibly excited by the fact that it continued to improve. Really, this last analysis reinforces exactly the plans that we have in place. I think you specifically ask about the PARP-treated patients. You know, while this is even a larger effect than what we see in the intent to treat population, we know that this is a relatively small group in the trial, and it becomes important that we're replicating the findings. We will be presenting the data to the investor community, and we'll also be presenting it to the clinical community.

Speaker #1: Thanks, Emily. That's a very well-formulated and comprehensive question. So let me take it in steps. First, we have not presented the OS data to the FDA.

Speaker #1: We are incredibly excited by the fact that it continued to improve, but really, this last analysis reinforces exactly the plans that we have in place.

Speaker #1: I think you specifically asked about the PARP-treated patients. And while this is even a larger effect than what we see in the intent-to-treat population, we know that this is a relatively small group in the trial.

Speaker #1: And it becomes important that we're replicating the findings. So we will be presenting the data to the investor community, and we'll also be presenting it to the clinical community.

Stacy Lindborg: In fact, we got an abstract submitted over the weekend to a meeting that will really afford us to have some great discussions with potential new principal investigators. Our focus right now is really around the Phase 3 trial, ensuring that we're continuing to build the amazing momentum and excitement in the medical community around this data, and then ultimately delivering on the trial. Maybe I'll stop there really quickly and see if there's anything else, Douglas, you want to add to the latest data.

Speaker #1: In fact, we got an abstract submitted over the weekend to a meeting that will really afford us to have some great discussions with potential new principal investigators.

Speaker #1: So our focus right now is really around the phase-through trial, ensuring that we're continuing to build the amazing momentum and excitement in the medical community around this data, and then ultimately delivering on the trial.

Speaker #1: So maybe I'll stop there really quickly and see if there's anything else, Douglas, you want to add to the latest data.

Douglas V. Faller: Just that, although we're very excited about the results in the patients treated with PARP inhibitors, we're equally excited about the results that we see in the entire population. This greater than a year increase in survival is, as you know, Emily, unprecedented in ovarian cancer. No one has seen anything like this in the entire time I've been practicing medicine. So the ability, as we replicate this in the phase 3, this will be incredibly meaningful for patients. The whole population of patients is what I'm getting at, not just the patients who receive PARP inhibitors. If they continue to benefit as much as they did in the phase 2, that's wonderful. We're focused on providing benefit to the entire population of newly diagnosed women with advanced ovarian cancer.

Speaker #8: Just that although we're very excited about the results and the patients treated with PARP inhibitors, we're equally excited about the results that we see in the entire population.

Speaker #8: And this greater than a year increase in survival is, as you know, Emily, unprecedented in ovarian cancer. No one has seen anything like this in the entire time I've been practicing medicine.

Speaker #8: So, the ability as we replicate this in the Phase 3, this will be incredibly meaningful for patients. And the whole population of patients is what I'm getting at—not just the patients who receive PARP inhibitors.

Speaker #8: If they continue to benefit as much as they did in the Phase Two, that's wonderful. But we're focused on providing benefit to the entire population of newly diagnosed women with advanced ovarian cancer.

Stacy Lindborg: Thank you. Emily, if I remember correctly, the other questions were focused around upcoming catalysts and our plan for this year and beyond. You know, I would say that we have catalysts that we're going to be very excited to report back, one of them being around the momentum of the trial. You heard in my prepared remarks that our goal is to have 80 patients enrolled by this time next year. Reporting our momentum will be a very critical component of ultimately the overall timeline that we've been committed to. That will be one catalyst. We will continue to have presentations at medical and scientific congresses.

Speaker #1: Thank you. Emily, if I remember correctly, the other questions were focused around upcoming catalysts and our plan for this year and beyond. And I would say that we have catalysts that we're going to be very excited to report back.

Speaker #1: One of them being around the momentum of the trial. And so, you heard in my prepared remarks that our goal is to have 80 patients enrolled by this time next year.

Speaker #1: And reporting our momentum will be a very critical component of, ultimately, the overall timeline that we've been committed to. So that will be one catalyst.

Speaker #1: We will continue to have presentations at medical and scientific congresses. We have tissue samples still from OVATION 2 that we intend to analyze.

Stacy Lindborg: We have samples, tissue samples still from OVATION 2 that we intend to analyze and have in the near term a comprehensive analysis and publication around translational data that we think will really be very compelling for the scientific and medical community, that we'll be able to go beyond what we've presented to date. I think that'll be a very meaningful contribution. We have the potential for partnership progress that may provide opportunities to extend the runway further, and of course, we are continuing with our strategic goal of financing the trial with long-term investors. Those are all things that we're very, very actively involved with.

Speaker #1: And have in the near term a comprehensive analysis and publication around translational data that we think will really be very compelling for the scientific and medical community, that we'll be able to go beyond what we've presented to date.

Speaker #1: And I think that'll be a very meaningful contribution. We have the potential for partnership progress that may provide opportunities to extend the runway further, and of course, we are continuing with our strategic goal of financing the trial with long-minded investors.

Speaker #1: And those are all things that we're very, very actively involved with. So, our plans for 2026 really are going to be focused on our funding for the company, making sure we have the cash runway, and that we are really increasing our institutional base in parallel. And then second, enrolling the trial and ensuring that we're spending a lot of time with our partners that are involved in this trial and the broader medical community, as we're really helping translate the value for women newly diagnosed and bringing forward a product that really should revolutionize the standard of care.

Stacy Lindborg: Our plans for 2026 really are going to be focused on our funding for the company, making sure we have the cash runway and that we are really increasing our institutional base in parallel. Second, enrolling the trial and ensuring that we're spending a lot of time with our partners that are involved in this trial and the broader medical community as we're really helping translate the value for women newly diagnosed and bringing forward a product that really should revolutionize the standard of care.

Operator: Perfect. Thank you.

Emily Bodnar: Perfect. Thank you.

Stacy Lindborg: Thank you, Emily.

Speaker #1: Thank you, Emily.

Operator: Our next question comes from the line of James Molloy with Alliance Global Partners. Your line is open.

Speaker #9: Our next question comes from the line of James Molloy with Alliance Global Partners. Your line is open.

James Molloy: Hey, guys. Thank you very much for taking my questions. Could you walk us through now you gave your excellent guidance, a very clear guidance about 80 patients by this time next year and 2029 to complete enrollment of the trial. Could you walk us through what potential cut points for interim looks we might be able to anticipate going forward over the next 12 months?

Speaker #10: Hey, guys. Thank you very much for taking my questions. Could you all walk us through how you gave your excellent guidance—a very clear guidance—what 80 patients by this time next year, and 2029 to complete enrollment of the trial.

Speaker #10: Could you walk us through what potential cut points for interim looks we might be able to anticipate going forward over the next 12 months?

Stacy Lindborg: Yeah. Great question, James. Thank you. The interim analyses which have been laid out are all very carefully designed through, you know, comprehensive simulations, which are always looking at the timeframe in which you might expect to be able to see a successful hit, if you will. A P value that would allow you to file your BLA. As you know, we've described this in the past, and we've had reviews of our protocol. We've designed these studies for there to be two. The important component, given what we know very well from the literature and other immune agents, we need to observe patients long enough to be able to see events in the control arm for there to be really the ability to have success.

Speaker #1: Yeah, great, great question, James. Thank you. So the interim analyses, which have been laid out, are all very carefully designed through comprehensive simulations, which are always looking at the time frame in which you might expect to be able to see a successful hit, if you will.

Speaker #1: So a p-value that would allow you to file your BLA, and, as you know, we've described this in the past, and we've had reviews of our protocol.

Speaker #1: We've designed these for there to be two. So the important component, given what we know very well from the literature and other immunoagents, is that we need to observe patients long enough to be able to see events in the control arm for there to really be the ability to have success.

Stacy Lindborg: We've designed these interims to occur after the point that we would have fully enrolled the trial. We expect based on the simulations that we've done in the past, that the first interim would occur about a year after that. That is what we're actively working towards. You know, it's as always designed to allow for if we see a bigger effect than we have assumed in the protocol. This interim, in fact, the first interim may provide and would provide an opportunity for us to act more quickly than waiting. It also is important that we're being very careful with these interims. Of course, because you're using type one error rate, you know, as you're ultimately doing these formal analyses.

Speaker #1: So, we've designed these interims to occur after the point that we would have fully enrolled the trial, and we expect, based on the simulations that we've done in the past, that the first interim would occur about a year after that.

Speaker #1: So that is what we're actively working towards, and it's, as always, designed to allow for if we see a bigger effect than we have assumed in the protocol.

Speaker #1: This interim—in fact, the first interim—may provide and will provide an opportunity for us to act more quickly than waiting. But it also is important that we're being very careful with these interims and, of course, because you're using type I error rate as you're ultimately doing these formal analyses.

Stacy Lindborg: That's just kind of a bit of an insight into how we balance the various dimensions and what we can expect going forward.

Speaker #1: So, that's kind of a bit of an insight into how we balance the various dimensions, and what we can expect going forward.

James Molloy: Then maybe a follow-up question on the final data on the OVATION 2 showing the excellent survival data. How did that change the potential partnership environment, if all you can share with us?

Speaker #10: And then let me follow with a question on the final data on Ovation 2 showing the excellent survival data. How did that change the potential partnership environment, if at all, that you can share with us?

Stacy Lindborg: You know, it's obviously very early. We just released the data last week. We are participating tomorrow in the MedInvest Biotech & Pharma Investor Conference, and we are getting new inquiries that are occurring even as of this week. I expect that to continue to develop. These kinds of partnerships, whether they're geographic in nature or they're more fundamental with big pharma, really ultimately have to fit with a strategy and an interest and an intent from a timing standpoint. We're very pleased to see renewed and new inquiries.

Speaker #1: So, it's obviously very early. We just released the data last week. We are participating tomorrow in the MedImDes Biotech and Pharma Investor Conference, and we are getting new inquiries that are occurring even as of this week.

Speaker #1: But I expect that to continue to develop. These kinds of partnerships, whether they're geographic in nature or they're more fundamental with big pharma, really ultimately have to fit with a strategy and an interest and an intent from a timing standpoint.

Speaker #1: But we're very pleased to see renewed and new inquiries. Thank you.

James Molloy: Thank you for taking the questions.

Stacy Lindborg: Thank you.

Operator: Next question comes from the line of Jason McCarthy with Maxim Group. Your line is open.

Speaker #9: Next question comes from the line of Jason McCarthy with Maxim Group. Your line is open.

Jason McCarthy: Hey, Stacy. Thanks for taking the questions. Going back to OVATION 2, is there gonna be an opportunity when you continue to mine that data? Will you have anything related to minimal residual disease or any SLL looks for MRD, or any more immune data that might be suggestive of T-cell memory or something that's keeping these patients' disease kind of in check, and that could be driving these longer-term survivors?

Speaker #11: Hi, Stacy. Thanks for taking the questions. Going back to Ovation 2, is there going to be an opportunity when you continue to mine that data—will you have anything related to minimal residual disease, or any SLL looks for MRD, or any more immune data that might be suggestive of T-cell memory or something that's keeping these patients' disease kind of in check?

Speaker #11: And that could be driving these longer-term survivors.

Stacy Lindborg: Yeah, maybe I'll start, and then I'd like Douglas to pick up. We won't have anything from OVATION 2 that relates to the minimal residual disease or second-look laparoscopy because it's an additional procedure that is not part of standard of care, and therefore it wasn't implemented in OVATION 2, nor will it be implemented in OVATION 3. That is, you know, an exploratory, and it's an endpoint that I think has gotten a lot of interest as a potential predictor of overall survival that, you know, was incorporated into what we call the MRD study. The OVATION 2 won't give insights into that, but we will continue to contribute not only to our own learnings, but also the literature from that trial that we're doing in combination with Break Through Cancer.

Speaker #1: Yeah. Maybe I'll start, and then I'd like Douglas to pick up. So we won't have anything from OVATION 2 that relates to the minimal residual disease or second-look laparoscopy, because it's an additional procedure that is not part of standard of care, and therefore it wasn't implemented.

Speaker #1: In Ovation 2, nor will it be implemented in Ovation 3. So that is an exploratory, and it's an endpoint that I think has gotten a lot of interest as a potential predictor of overall survival that was incorporated into what we call the MRD study.

Stacy Lindborg: The OVATION 2 won't give insights into that, but we will continue to contribute not only to our own learnings, but also the literature from that trial that we're doing in combination with Break Through Cancer. We do have other data that we'll be able to get from OVATION 2, and I'll let Douglas go into some of that.

Speaker #1: So the OVATION 2 won't give insights into that, but we will continue to contribute not only to our own learnings, but also to the literature from that trial that we're doing in combination with Breakthrough Cancer.

Stacy Lindborg: We do have other data that we'll be able to get from OVATION 2, and I'll let Douglas go into some of that.

Speaker #1: But we do have other data that we will be able to get from OVATION 2, and I'll let Douglas go into some of that.

Douglas V. Faller: Yeah. Excuse me. Yes. We've been, over the last 9 months or so, as you know and alluded to, we've been releasing more and more translational data, and we have additional translational data to present, and we're planning on publishing that also. This may include looking at peripheral responses in addition to the responses that we've shown so dramatically in the tumor and the tumor microenvironment. We're very excited about the translational data. Just to expand on what Stacy said, even though we call one of our trials MRD is not really officially established for ovarian cancer. There are no criteria that have been shown to be predictive of a patient's outcome.

Speaker #11: Yeah. Excuse me. Yes. Over the last nine months or so, as you know and alluded to, we've been releasing more and more translational data, and we have additional translational data to present.

Speaker #11: And we will—we're planning on publishing that also. This may include looking at peripheral responses in addition to the responses that we've shown so dramatically in the tumor and the tumor microenvironment.

Speaker #11: So, we're very excited about the translational data, just to expand on what Stacy said. Even though we call one of our trials MRD, MRD is not really officially established for ovarian cancer.

Speaker #11: There are no criteria that have been shown to be predictive of a patient's outcome. The MRD study is an approach to start working on that.

Douglas V. Faller: The MRD study is an approach to start working on that, but that data has yet to evolve, and we will try to determine over time what the best approach to MRD might be for it to be predictive in ovarian cancer. It's something of great interest. This is in part why Break Through Cancer got involved in the MRD study because they also would like to be able to generate a test, like MRD, which could be predictive of patient outcomes. In addition, in our Phase 3, we will be looking at circulating tumor DNA. This may end up being a marker for MRD. It's not established yet in ovarian cancer, but our trial might be one of the ones that could establish circulating tumor DNA as a predictive marker. That's yet to come.

Speaker #11: But that data has yet to evolve. And we will try to determine over time what the best approach to MRD might be for it to be predictive in ovarian cancer.

Speaker #11: It's something of great interest. This is in part why Breakthrough Cancer got involved in the MRD study, because they also would like to be able to generate a test like MRD, which could be predictive of patient outcomes.

Speaker #11: And in addition, in our Phase 3, we will be looking at circulating tumor DNA. This may end up being a marker for MRD. It's not established yet in ovarian cancer, but our trial might be one of the ones that could establish circulating tumor DNA as a predictive marker.

Speaker #11: So that's yet to come.

Jason McCarthy: Great. Thank you. Are there going to be updates from the MRD study in 2026 that we could look towards as potential catalysts?

Speaker #12: Great. Thank you. Are there going to be updates from the MRD study in 2026 that we could look towards as potential catalysts?

Stacy Lindborg: It's possible. I think that it will ultimately depend really on our interactions with the study PI, Dr. Amir Jazaeri. We know that he presented data that was very exciting to see, the analytical data, and he decided to really take a cohort of patients and analyze them together rather than continuing to analyze, you know, patients over time, individual patients over time. The clinical data, of course, will be continuing to evolve. You know, we're in early discussions with him around where we may present that in the medical community, and we'll be thinking very much about bringing forward insights. It'll be an exciting other arena for information.

Speaker #1: It's possible. I think that it will ultimately depend really on the our interactions with the study PI, Dr. Amir Jazari, we know that he presented data that was very exciting to see that analytical data and he decided to really take a cohort of patients and analyze them together rather than continuing to analyze patients over time individual patients over time and the clinical data, of course, will be continuing to evolve.

Speaker #1: So we're in early discussions with him around where we may present that in the medical community, and we'll be thinking very much about bringing forward insights.

Speaker #1: It'll be an exciting other arena for information.

Jason McCarthy: I don't know. Last question. I don't know if I'm overlapping with James had asked previously about enrollment timing. When you get to the 80, are you going to release any details on the HRD status of the patients just so people can get a sense of the percentages that are in the trial or may be in the trial?

Speaker #12: I don't know. The last question. I don't know if I'm overlapping with James, who asked previously about enrollment timing. But when you get to the 80, are you going to release any details on the HRD status of the patients, just so people can get a sense of the percentages that are in the trial, or maybe in the trial?

Stacy Lindborg: It's an interesting question. I think right now, you know, and if I just step back and I look at what we've learned, with this final analysis, you know, the overall effect that we've observed in the all-comers population has continued to grow so substantially that, you know, while the underlying genetics, which right now plays a critical role in the maintenance therapy and becomes central to how the treating community is taking care of patients, what's interesting is that our principal investigators are probably as excited about the effect in the HR-proficient patients as they are in the HRD positive. It will continue to be a very interesting and important part of our phase 3 trial.

Speaker #1: It's an interesting question. I think right now and if I just step back and I look at what we've learned with this final analysis, our the overall effect that we've observed in the all-comers population has continued to grow so substantially that while the underlying genetics, which right now plays a critical role in the maintenance therapy and becomes central to how the treating community is taking care of patients, what's interesting is that our principal investigators are probably as excited about the effect in the HR proficient patients as they are in the HRD positive.

Speaker #1: And so it will continue to be a very interesting and important part of our Phase 3 trial. But I think that we will really be looking holistically at the full trial and be very excited because we're able to influence and extend the life of an all-comers population.

Stacy Lindborg: I think that we will really be looking holistically at the full trial and be very excited because we're able to influence and extend the life of an all-comers population. That's my thinking of this, and I think that we'll have to think very carefully about the exposure, you know, that we give to an ongoing phase 3 trial. It's an open label trial, and we'll have the ability where we find it important from an investor standpoint to think about maybe secondary endpoints and provide updates. Those will be taken with great caution just to preserve the integrity of the trial. Douglas, I don't know if you have anything more.

Speaker #1: So, that's my thinking on this. And I think that we'll have to think very carefully about the exposure that we give to an ongoing Phase 3 trial.

Speaker #1: It's an open-label trial, and we'll have the ability—where we find it important from an investor standpoint—to think about maybe secondary endpoints and provide updates.

Speaker #1: But those will be taken with great caution, just to preserve the integrity of the trial. Douglas, I don't know if there's anything more.

Douglas V. Faller: Yeah. The only thing I wanted to add is although this is an open label study, because, to preserve data integrity, we in the company are blinded in terms of efficacy, not safety, but efficacy. We will not, even ourselves be seeing the efficacy data as the trial progresses in terms of the primary endpoint.

Speaker #11: Sorry. Yeah. The only thing I wanted to add is, although this is an open-label study, to preserve data integrity, we in the company are blinded in terms of efficacy—not safety, but efficacy.

Speaker #11: So we will not even ourselves be seeing the efficacy data as the trial progresses, in terms of the primary endpoint.

Jason McCarthy: Okay. Just also. Sorry, one more. Just a hypothetical. I'm not sure if you'd have the answer for this or not. There is a trial that's going to read out in H2 this year for an oncolytic virus, in relapsed refractory setting for PROC for ovarian cancer that the expectations is that it can resensitize to platinum. So for chemotherapy, it suggests that if they're successful, that it could change the standard of care, potentially even in the neoadjuvant setting. I'm bringing it up because this trial is gonna take a long time. OVATION 3, and if you've thought about how some potentially new therapies that could be on the market could influence how patients are managed, by the time you get to the OVATION 3 full top-line data.

Speaker #12: Okay. So just to also—sorry, one more. Just a hypothetical. I'm not sure if you'd have the answer for this or not. There is a trial that's going to read out in the second half of this year for an oncolytic virus in the neuro-lapse refractory setting for PROC for ovarian cancer, and the expectation is that it can resensitize to platinum.

Speaker #12: So for chemotherapy, it suggests that if they're successful, it could change the standard of care, potentially even in the neoadjuvant setting. And I'm bringing it up because this trial is going to take a long time, Ovation 3.

Speaker #12: And if you've thought about how some potentially new therapies that could be on the market could influence how patients are managed by the time you get to the Ovation 3 full top-line data.

Douglas V. Faller: Thank you for that question. We're certainly very aware of the drugs that are being developed in the relapsed refractory space, both platinum sensitive and platinum resistant. The most patients, interestingly, their tumors are sensitive to platinum. The idea that you'd have to sensitize patients in the neoadjuvant setting or the adjuvant setting really is not something that is at all mainstream. Most patients do respond to chemotherapy. Unfortunately, durable responses are rarer, and then you get into second and third-line treatments. As you know, there have been at least 1 and soon 2 drugs approved in different settings in second, third, fourth line patients who are not being treated with platinum again. That's wonderful.

Speaker #11: Yeah, thank you for that question. We're certainly very aware of the drugs that are being developed in the relapsed refractory space, both platinum sensitive and platinum resistant.

Speaker #11: Most patients, interestingly, their tumors are sensitive to platinum. The idea that you'd have to sensitize patients in the neoadjuvant setting or the adjuvant setting really is not something that is at all mainstream.

Speaker #11: Most patients do respond to chemotherapy. Unfortunately, durable responses are rarer. And then you get into second and third-line treatments. As you know, there have been at least one, and soon two, drugs approved in different settings in second, third, fourth-line patients who are not being treated with platinum again.

Douglas V. Faller: We're very happy that there are drugs that provide a bit of a survival benefit in second or third line. As we all know on the phone and in this call, putting the best therapy up front and making the biggest impact on the tumor is critical if you're going to treat ovarian cancer successfully. We're very happy to be in front line, very proud of the fact that we're in front line, and we believe that we will be providing advantage over time in terms of increases in survival to the patients we're treating.

Speaker #11: And that's wonderful. We're very happy that there are drugs that provide a bit of a survival benefit in second- or third-line, but as we all know on the phone, and in this call, putting the best therapy up front and making the biggest impact on the tumor is critical if you're going to treat ovarian cancer successfully.

Speaker #11: So we're very happy to be in the front line, very proud of the fact that we're in the front line. And we believe that we will be providing an advantage over time in terms of increases in survival to the patients that we're treating.

Jason McCarthy: Got it. Thank you for taking all the questions.

Speaker #12: Got it. Thank you for taking all the questions.

Stacy Lindborg: Thank you, Jason.

Douglas V. Faller: You're welcome.

Speaker #1: Thank you, Jason.

Speaker #11: You're welcome.

Operator: Next question comes from the line of Kemp Dolliver with Brookline Capital Markets. Your line is open.

Speaker #13: Next question comes from the line of Camp Doliver with Brookline Capital Markets. Your line is open.

Kemp Dolliver: Great. Thank you for taking the questions. First, are the savings from the restructuring of any significance that we would see the impact of them in H1 of this year?

Speaker #14: Great, thank you for taking the questions. First, are the savings from the restructuring of any significance that we would see the impact of them in the first half of this year?

Stacy Lindborg: Kemp, really what we reported as a strategic restructuring really is around ensuring that we are using all of our resources to the best of our ability and focused on Phase III. You know, we're ensuring that we have the ability to hire and bring in needed expertise for the future as we're thinking about the commercial setting, and we're looking, you know, to the upcoming year and beyond.

Speaker #1: So, Camp, really what we reported as a strategic restructuring really is around ensuring that we're using all of our resources to the best of our ability and focused on Phase 3.

Speaker #1: So we're ensuring that we have the ability to hire and bring in needed expertise for the future as we're thinking about the commercial setting, and we're looking to the upcoming year and beyond.

Stacy Lindborg: It really is not about a pure number, but it is about just an ongoing evolution of making sure that we're taking the talent we have in-house, that we're focusing our attention for each person, you know, to ensure that we're bringing the most value possible and that we're really removing anything that is off target from the OVATION 3, which is our sole focus right now.

Speaker #1: So it really is not about a pure number, but it is about just an ongoing evolution of making sure that we're taking the talent we have in-house, that we're focusing our attention for each person to ensure that we're bringing the most value possible, and that we're really removing anything that is off target from the Ovation 3, which is our sole focus right now.

Kemp Dolliver: Okay. Thank you. You know, with regard to your commentary regarding the pace of enrollment at the site level, I'm gonna split a hair if I can because it may be informative. Is that pace increasing, say, month to month, or is it just, has it just been consistently above your forecast?

Speaker #14: Okay, thank you. And with regard to your commentary regarding the pace of enrollment at the site level, I'm going to split a hair, if I can, because it may be informative.

Speaker #14: Is that pace increasing, say, month to month, or has it just been consistently above your forecast?

Stacy Lindborg: I'll give you. You know, we only have, of course, the timeframe from the very first patient to now. But we see that for the entire trial, we are above the assumption of 0.3 points per month per site. If you look across all the sites, the average is above that. You know, the numbers that I was reporting of these sites that actually are delivering one patient per month or even just slightly below, that is across the whole time period that they're delivering. I do think you tend to see kind of episodic enrollment that can happen, but the numbers that we're reporting are not singular months. They're summarizing the entire time thus far.

Speaker #1: So, I'll give you—we only have, of course, the time frame from the very first patient to now. But we see that for the entire trial, we are above the assumption of 0.3 points per month per site.

Speaker #1: So if you look across all the sites, the average is above that. And when we— the numbers that I was reporting of these sites that actually are delivering one patient per month, or even just slightly below, that is across the whole time period that they're delivering.

Speaker #1: So, I do think you tend to see kind of episodic enrollment that can happen. But the numbers that we're reporting are not singular months.

Speaker #1: They're summarizing the entire time thus far. And I do think we're hearing phenomenal feedback. We're spending time in the site. In our sites that are actively enrolling patients, we're having calls regularly as well.

Stacy Lindborg: I do think we're hearing phenomenal, you know, feedback. We're spending time in the sites that are actively enrolling patients. We're having calls regularly as well. These conversations in terms of the data, you know, we get to see a broader set of the community. For example, with the abstract we were putting in over the weekend, you know, you have quite a few PIs that were part of OVATION 2. They all got to be on this abstract and to see the excitement in their responses, gratitude for being included and really just, you know, pure excitement with the data. Douglas, why don't you comment more?

Speaker #1: These conversations, in terms of the data that we get to see—a broader set of the community. For example, with the abstract we were putting in over the weekend, you have quite a few PIs that were part of Ovation 2.

Speaker #1: They all got to be on this abstract and to see the excitement and their responses. Gratitude for being included and really just pure excitement with the data.

Speaker #1: Douglas, why don't you comment more?

Douglas V. Faller: No, it's exactly right. This is the first time that they had seen the final data in terms of survival, and there was a great deal of enthusiasm, as you might expect. They were very happy that their patients have seen this much benefit.

Speaker #11: Well, it's exactly right. This is the first time that they had seen the final data in terms of survival, and there was a great deal of enthusiasm.

Speaker #11: As you might expect, they were very happy that their patients have seen this much benefit.

Stacy Lindborg: We really think this will be a difference maker for OVATION 3 compared to OVATION 2. You know, going into OVATION 2, we had a lot of promise. We had a mechanism of action that made a lot of sense, you know, very clearly established in the literature. Phase 3, now we have evidence of a clinical effect that's never been seen, and we continue to really hear that becomes very critical. You know, we can actually see the numbers that are entering pre-screening, and we see a very, you know, high rate ultimately coming through to randomization, with really the exceptions being things like, inclusion criteria not met. That will always be the case. Or, you know, inability, you know, perhaps somebody that's traveled a very long way and doesn't feel like they can make the schedule.

Speaker #1: So we really think this will be a difference maker for OVATION 3 compared to OVATION 2. Going into OVATION 2, we had a lot of promise.

Speaker #1: We had a mechanism of action that made a lot of sense, was very clearly established in the literature. Phase 3 now, we have evidence of a clinical effect that's never been seen.

Speaker #1: And we continue to really hear that—that becomes very critical. We can actually see the numbers that are entering prescreening, and we see a very high rate ultimately coming through to randomization, with really the exceptions being things like inclusion criteria not met.

Speaker #1: There will always be the case, or inability perhaps, of somebody that's traveled a very long way and doesn't feel like they can make the schedule.

Stacy Lindborg: Really, the rate of being exposed to this potential, you know, the way that one of our PIs who's been involved with our program for a long time, you know, talks about this with patients is you're going to get the standard of care, which you'll get in this trial if you do not have interest in research and in this protocol. If you want to consider being in this protocol and if you're randomized to the experimental arm, then you have a chance at a product that may extend your survival. It's been a very straightforward discussion as they're describing it to us, and we're getting, as we might expect, a positive response from patients and from the sites.

Speaker #1: But really, the rate of being exposed to this potential, the way that one of our PIs, who's been involved with our program for a long time, talks about this with patients is, 'You're going to get the standard of care, which you'll get in this trial.'

Speaker #1: If you do not have interest in research and in this protocol, if you want to consider being in this protocol and if you're randomized to the experimental arm, then you have a chance at a product that may extend your survival.

Speaker #1: So it's been a very straightforward discussion, as they're describing it to us. And we're getting, as we might expect, a positive response from patients and from the sites.

Kemp Dolliver: Great. Thank you.

Speaker #14: Great. Thank you.

Operator: Our last question comes from the line of David Bautz with Zacks Small-Cap Research. Your line is open.

Speaker #13: And our last question comes from the line of David Bouts with Wallcap Research. Your line is open.

David Bautz: Hey, good morning, everyone. Thanks for the overview this morning. I just have a couple of financial questions. As resources become available, is the company gonna look to open additional sites in the US, or are you looking ex-US to get any international sites open? As far as payments for the phase three trial, I guess I'm just trying to look at, you know, how is it being paid for? You know, did you have a bullet paid up front? Is it pay as you go? Like, how is it structured?

Speaker #15: Hey, good morning, everyone. Thanks for the overview this morning. So, I just have a couple of financial questions. As resources become available, is the company going to look to open additional sites in the US, or are you looking ex-US to get any international sites open?

Speaker #15: And then, as far as payments for the Phase 3 trial, I guess I'm just trying to look at how is it being paid for?

Speaker #15: Did you have a bolus paid up front? Is it pay as you go? How is it structured?

Stacy Lindborg: David, great questions. I was having a little trouble hearing you, so let me respond to your questions. If I don't hit on them, we'll have you ask further. We are actively enrolling and accelerating the enrollment of trials. Right now those are focused in the US, although we have sites in Canada that we know are very interested, and we have had conversations as we're looking to consider, you know, the strategy of if we want to accelerate further, adding a European country as well. We've already had some discussions with leading sites in central Europe. That's a conversation that we expect to advance over the next year.

Speaker #1: So David, great questions. I was having a little trouble hearing you. So let me respond to your questions, and if I don't hit on them, we'll have you ask further.

Speaker #1: So we are actively enrolling and accelerating the enrollment of trials, and right now, those are focused in the US, although we have sites in Canada that we know are very interested.

Speaker #1: And we have had conversations as we're looking to consider the strategy of if we want to accelerate further, adding a European country as well.

Speaker #1: So, we've already had some discussions with leading sites in Central Europe. So that's a conversation that we expect to advance over the next year.

Stacy Lindborg: Right now we believe that we'll be able to meet our enrollment accelerations, and we have a lot of confidence with the sites that we're going after and we're starting with in the US. We think that's actually the best way to start. In terms of payments for the trial, you know, these trials are structured, this trial is structured pretty traditionally. You have contracts with individual sites. There are start-up fees and then fees as patients are being treated as part of the protocol. We have an ability to take advantage of what is standard of care and to have that be paid through the traditional routes and some of the procedures not be due to be paid by Imunon.

Speaker #1: But right now, we believe that we'll be able to meet our enrollment accelerations, and we have a lot of confidence with the sites that we're going after, and we're starting with in the US.

Speaker #1: So, we think that's actually the best way to start. In terms of payments for the trial, these trials are structured—this trial is structured pretty traditionally.

Speaker #1: You have contracts with individual sites. There are startup fees, and then fees as patients are being treated as part of the protocol. We have an ability to take advantage of what is standard of care and to have that be paid.

Speaker #1: Through the traditional routes, and some of the procedures not be due to be paid by Imunon. And we've taken full advantage of that to really structure the contracts accordingly.

Stacy Lindborg: We've taken full advantage of that to really structure the contracts accordingly.

David Bautz: Okay, great. Appreciate you taking the questions.

Speaker #15: Okay, great. I appreciate you taking the questions.

Stacy Lindborg: Thank you, David.

Speaker #1: Thank you, David.

Operator: This concludes the Q&A. I'll turn the call back to Dr. Lindborg for closing remarks.

Speaker #13: This concludes the Q&A. I'll turn the call back to Dr. Lindborg for closing remarks.

Stacy Lindborg: Thank you, Desiree, and thank you all for joining this call. With the phase 3 study enrolling ahead of plan, as we've just been talking about, the enduring strength of our phase 2 overall survival data and the compelling translational evidence that Douglas spoke about and our sharpened financial discipline, we really know that Imunon is well positioned for milestones that will create value inflection in 2026 and beyond. We remain steadfast stewards of the resources you have entrusted to us and are fully committed to delivering a potential paradigm shift for ovarian cancer treatment while creating lasting shareholder value. We thank you for your continued support and look forward to future calls.

Speaker #1: Thank you, Desiree. And thank you all for joining this call, with the phase 3 study enrolling ahead of plan as we've just been talking about.

Speaker #1: The enduring strength of our phase 2 overall survival data, and the compelling translational evidence that Douglas spoke about, and our sharpened financial discipline—we really know that Imunon is well positioned for milestones that will create value inflection in 2026 and beyond.

Speaker #1: We remain steadfast stewards of the resources you have entrusted to us and are fully committed to delivering a potential paradigm shift for ovarian cancer treatment while creating lasting shareholder value.

Speaker #1: We thank you for your continued support and look forward to future calls.

Operator: Ladies and gentlemen, that concludes today's call. Thank you all for joining in. You may now disconnect.

Q4 2025 Imunon Inc Earnings Call

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