Executive readout · one minute
Webcast research workspace
Read the call alongside every captured source. Transcript, audio, 8-K earnings release, 10-Q stay in one workspace.
Substantial doubt about the company's ability to continue as a going concern.
“Such conditions raise substantial doubts about the Company's ability to continue as a going concern. Based on the above, management has determined there is substantial doubt regarding our ability to continue as a going concern.”View the 10-Q filed Aug 11, 2026
Earnings call · FY2026 Q3
Executive readout · one minute
Read the call alongside every captured source. Transcript, audio, 8-K earnings release, 10-Q stay in one workspace.
Research coverage
4 live sources
Switch sources without leaving this page or losing your listening position.
Open the source you need; every reader stays inside this workspace.
Welcome to the call.
And thank you for standing by. My name is Bella, and I will be your conference operator today. At this time, I would like to welcome everyone to Immunan's Third Quarter 2026 Financial Results and Business Update Conference Call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question-and-answer session. If you would like to ask a question during this time, simply press star, then the number 1 on your telephone keypad. To withdraw your question, press star 1 again. I would now like to turn the conference over to Walter Pinto, Managing Director at KCSA Strategic Communications for introductions. Please go ahead.
Thank you, operator, and good morning. Welcome to the Munon Third Quarter 2026 Financial Results and Business Update Conference Call. Joining us today are Dr. Stacey Lindborg, President and Chief Executive Officer, Dr. Douglas Fowler, Executive Vice President and Chief Medical Officer, and Josh Blatcher, Interim Chief Financial Officer. Michael Tarduno, Executive Chairman, is also available for the question and answer portion of today's call. Before I begin, I'd like to remind everyone that our remarks today include forward-looking statements. These statements are made pursuant to the State Department of Provisions of the Private Security Litigation Reform Act of 1995 and include but are not limited to statements regarding the timing and enrollment of the company's clinical trials, the potential of the company's therapies to address unmet medical needs. The market potential for its product candidates, if approved, and the company's plans and expectations for its development programs. Words such as may, will, expect, plan, anticipate, estimate, intend, identify these forward-looking statements. Actual results may differ materially from those projected. Additional information on the factors that could cause actual results to differ is detailed in Immunan's filings with the Securities and Exchange Commission, which are available at SCC.gov and on the company's website. The forward-looking statements made on this call speak only as of today's date, and the company undertakes no obligation to update them, except as required by law. With that, I'd now like to turn the call over to Dr. Stacey Lindberg, President and Chief Executive Officer. Stacey?
Thank you, Walter, and good morning, everyone. Thank you for joining us today and for your continued support of Immunon. On our second quarter call in August, I said our priorities were clear. Execute our Phase 3 Ovation 3 study, generate high-quality data, and deliver a much-needed therapy option for women with advanced ovarian cancer. The third quarter was a period in which we advanced all three. Continued Ovation 3 enrollment, additional external validation of the data, and further portfolio and capital structure actions. We recently hosted our 2026 R&D Day in New York City, where clinical investigators presented the full case for the Phase III Immunon-001 study in frontline ovarian cancer, which included the final Phase II overall survival results, the preliminary minimal residual disease findings, and the path to a confirmatory readout in Ovation III. Our North Star remains unchanged. Bring a much-needed treatment option to women with advanced ovarian cancer, a disease that affects approximately 300,000 women worldwide each year has five-year survival rates of approximately 41% for women diagnosed at stage 3 and approximately 20% for women diagnosed at stage 4. And has seen little advancement in frontline care, standard of care, for well over two decades. Before discussing our clinical progress, I'd like to highlight the three themes that shaped the quarter. First, independent validation of Immunon-001 from the National Cancer Institute, from an independent data monitoring committee, and from the investigators who presented at our R&D day. Second, continued enrollment momentum in our pivotal Phase 3 study, Ovation 3, now with a clearly defined path to two pre-planned interim analyses. And third, the steps we've taken to sharpen the portfolio and strengthen the balance sheet so that every dollar and every person is pointed at Ovation 3. Let me start with our R&D day. Because it brought the entire investment case together in one place. On September 23rd in New York, we set out to answer three questions. Why systemic IL-12 failed historically, why immunon-001 is different, and why the next stretch of Ovation 3 is the value-defining chapter of this program. We did not answer these questions alone. Dr. Primmel Thacker of Washington University School of Medicine and the study chair of both Ovation 2 and Ovation 3 presented the Phase 2 Ovation 2 Survival Results and the Phase 3 Design. Dr. Amir Dazari of MD Anderson Cancer Center, the lead principal investigator of our Phase 2 MRD study, presented the preliminary clinical and translational findings. Dr. William Bradley of the Medical College of Wisconsin, a principal investigator across Ovation 1, 2, and 3, joined a prerecorded conversation with a woman who was treated with immunon 001 as a trial participant in Ovation 1 and who nearly 10 years from her diagnosis reported remaining free of recurrence. The last conversation is the one I keep returning to. Everything else we discussed today, enrollment rates, interim analyses, capital structure, it all exists to make that outcome available to more women. The replay of the event and the full presentation materials are available on the Scientific Presentations page of our website. If you haven't already participated in the event, I highly recommend it. Turning to our LEAD Phase III asset, we remain very encouraged by the continued pace of enrollment in our pivotal Ovation III study. The trial continues to generate strong engagement from investigators and patients, reflecting the strength of data generated in Ovation II, including a well-established safety profile and compelling overall survival and efficacy results. That, frankly, we believe are unlike anything previously reported in this setting. At the R&D Day, we also put the operating plan on the record for targeting 50 percent enrollment in the first quarter of 2028 and completion of enrollment in the first quarter of 2029. The first, pre-planned interim analysis. Which is now aimed at the full intent-to-treat population versus the HRD-positive subgroup, will occur at 60 percent of the targeted overall survival events, and is currently estimated for the first quarter of 2030. These timelines assume continued site activation and enrollment rates consistent with recent performance. And remain subject to the usual variability of oncology trial execution. A word on how we're talking about enrollment. Earlier in the trial, we reported that we were running above plan in essentially every month. Monthly enrollment in a trial of this kind goes up and down, and we do not want to set an expectation against any single month's rate. Therefore, we believe a better way to describe where we are is this. We're enrolling consistent with our plan, we're continuing to add sites, and we're seeing screening and randomization activity across the network of sites rather than concentrated at a handful of centers. We continue to make solid progress on site activation for the Ovation 3 trial. At the end of the quarter, we had 18 sites selected with nine active and nine in startup. We also have additional sites that have expressed interest that we are currently under evaluation. Our goal remains to have all planned sites activated by the end of 2027. Patient enrollment is tracking consistently with our plan. Across active sites, average enrollment has been approximately .4 patients per site per month. Which is above the planning assumption of approximately 0.3. We are encouraged by the early pace, and if we continue to activate sites in line with our plan and maintain strong enrollment productivity across the network, we expect to achieve our ultimate goal of completing patient enrollment by the first quarter of 2029. We remain focused on executing against both our site activation and enrollment timelines. During the quarter, we also entered into a Cooperative Research and Development Agreement, or CRADA, with the National Cancer Institute's Cancer Therapy Evaluation Program, which is often referred to as CTEP. This agreement is designed to support the continued development of IME-9-001. And the work being conducted under the National Cancer Institute Experimental Therapeutics, or NEXT, program, which is managed by CTEP, with CTEP assuming regulatory sponsorship. Through this agreement, National Cancer Institute investigators will evaluate immunon-001 across additional solid tumor indications and combined regimens. Leveraging the expertise and clinical trial infrastructure of the National Cancer Institute and the National Clinical Trials Network. Given IL-12's broad immunologic activity and the preclinical research we have conducted in-house, we believe Immunon has potential, Immunon-001, has potential beyond ovarian cancer and that it's meaningful. Importantly, Imunon will retain ownership of this background, intellectual property, and of new intellectual property solely generated by Imunon under the collaboration, including the right to use data generated under the collaboration for the research and development of Imunon 001, while National Cancer Institute assumes operational responsibility for conducting the studies. What this all means is this provides a highly capital-efficient opportunity to explain the clinical trial evidence supporting Immunon-001 without diverting resources from our highest priority. Any additional studies conducted under the CRADA remain subject to National Cancer Institute resource allocation and prioritization. and are not expected to impact our primary focus on Ovation 3. We will make sure of this. And that our priority remains unchanged, our capital, our team, our execution, remain firmly focused on advancing Ovation 3 as rapidly as possible and in the most efficient way possible. The CRADA broadens the opportunity for Immunon 001. While allowing us to maintain our full commitment to completing the pivotal phase three trial in frontline ovarian cancer. Before I hand over to Douglas to add some additional context around the NCI-CRETA collaboration and broader operational updates, let me cover two additional corporate actions we've recently undertaken because they speak directly to that focus. Last month, we announced an agreement to sell our rights to Thermadox, our heat-activated liposomal formulation of doxorubicin, to Voseldox Therapeutics, which intends to advance the asset in glioblastoma. This is consistent with the strategy we have described for some time. We want to find a committed development partner for Thermadox rather than to carry it ourselves. And as many of you will be familiar with, Thermadox is a legacy asset that had been fully written off our balance sheet. So this transaction creates a path to future value from something currently carried at zero. Under the agreement, upon closing, Immunon would receive an equity interest of approximately 4.76% in Baseldox. Also, the potential for up to $16.5 million in aggregate development and sales-based milestone payments, along with tiered royalties ranging from 3.5% to 6% on net sales of Thermadocs-related products, if approved. The sale is contingent on Basel Ducks completing a planned $2.5 million financing. to support a phase one trial in glioblastoma. Milestone payments and royalties or value from our equity position depend on Baselbeck's succeeding in financing, developing, and commercializing the assets. This transaction reflects our disciplined approach to portfolio management and capital allocation. And by transitioning ThermaDocs to a development partner committed to advancing the program, we retain the opportunity to participate in future success while concentrating our resources on Immunon 001 and the Pivotal trial, where we believe we have the greatest opportunity to create meaningful value for patients and shareholders. On the balance sheet, in late September, we exchanged $1.2 million of outstanding debt plus accrued interest or non-convertible preferred stock, reducing the balance of that note by approximately 43% without issuing any common stock or warrants. Josh will take you through this detail. With that, I'll now turn the call over to Dr. Douglas Foller. Our Chief Medical Officer, who will expand on the data, and our Phase III progress in more detail. Douglas?
Thank you, Stacy. As Stacey mentioned, Ovation III is our pivotal phase III trial evaluating intraperitoneal immunon 001 at 100 milligrams per meter squared in combination with standard of care neoadjuvant and adjuvant chemotherapy in patients with newly diagnosed advanced epithelial ovarian cancer. It is a randomized one-to-one, approximately 500-patient trial in stage 3b or c or 4 disease recommended for neoadjuvant chemotherapy. Overall survival is the primary endpoint, and the design includes two pre-planned event-driven interim analyses intended to support a potential earlier submission for full approval if the survival signal crosses the pre-specified threshold. I had the opportunity to spend time at ESMO last month and came away further encouraged by the level of enthusiasm we continue to hear about Immunon001 from gynecologic oncologists from all over the world. In conversations with trial investigators and treating physicians, there is a consistent interest in our approach and in the potential to improve outcomes in the frontline setting. Importantly, those discussions and the program at ESMO, in addition to other major scientific conferences, also reinforced what we see in the broader landscape. We are not aware of any other programs in the industry pipeline that are expected to meaningfully change the frontline standard of care for newly diagnosed treatment-naive patients in the near term. That combination of physician interest and a relatively stable therapeutic landscape continues to support our conviction in the Ovation III program. We continue to be very encouraged by the trial's execution, as Stacy mentioned. Site activation has proceeded efficiently, advancing from protocol submission to site activation in approximately six months and from protocol approval to first patient randomized in approximately two months, roughly one-third of the external industry benchmarks. Enrollment is tracking to our projections. Our trial plan assumed 0.3 patients per site per month against historical ovarian cancer studies that have generally enrolled approximately 0.2 patients per site per month, and we have been running at or above our planning assumption of approximately 0.3 patients per site per month, recently averaging approximately 0.4. To translate that for anyone newer to the story, these trials have been historically slow to enroll, and we built our plan assuming we would do better than that history. We are delivering consistent to this plan. In oncology, enrollment is the single biggest determinant of when a trial reads out, which is why we spend so much time and effort on it. From a clinical perspective, we believe these enrollment trends reflect several factors. The encouraging survival and biomarker data generated in Ovation 2, growing familiarity with Immunon 001 among investigators, and a high conversion rate from prescreening to patient randomization, and operational efficiencies that simplify study participation without delaying initiation of standard of care treatment. Equally important, the quality of the study remains very strong. Patient compliance with scheduled visits has been excellent, electronic case report forms continue to be completed in a timely manner, and the resulting data are supporting the ongoing maturation of the trial database. Finally, the safety profile remains highly favorable and consistent with our prior experience. To date, across our randomized and controlled trials, Ovation 2, MRD, and Ovation 3, our largest trials to date, we have observed no cytokine release syndrome, no systemic toxicities, and no serious immune-related adverse events. Safety remains comparable across both treatment arms, and recent independent data monitoring committee reviews have identified no new safety concerns in Ovation 3. We are also making progress on two important operational fronts. We have prepared the regulatory submission of Ovation 3 to Health Canada, and in parallel to this submission have been meeting with potential sites across Canada. At the same time, we continue to expand our clinical site network with the goal of activating all planned sites by the end of 2027. Both of these initiatives are important to supporting enrollment and maintaining our planned development timelines. Turning now to our Phase II Translational Minimal Residual Disease, or MRD study, conducted in collaboration with Breakthrough Cancer and led by investigators at MD Anderson Cancer Center, we have had two notable developments this quarter. First, in July, we reported encouraging preliminary clinical and translational data. Second, in September, we reported that the Independent Data and Safety Monitoring Committee overseeing the study had reviewed all safety data to date and recommended that the study continue without modification, identifying no new safety signals and confirming comparable safety across both treatment arms. That recommendation matters for a specific reason. The MRD study has now demonstrated the safety and tolerability of Immunon001, both in combination with Fevacizumab and used in the maintenance setting. These are two distinct safety objectives in two settings we had not previously characterized. This study is designed not only to evaluate clinical activity, but also to better understand how immunon zero zero one remodels the tumor immune microenvironment following frontline treatment. Among patients who reached the study's primary assessment at second look laparoscopy, Treatment with immunon 001 was associated with a lower rate of MRD positivity compared to the control arm, 44.4% versus 66.7%. Higher clearance of circulating tumor DNA, 87.5% versus 62.5%. And a higher proportion of patients achieving no evidence of disease following frontline therapy, 100% versus 56%. While these are preliminary findings from a small cohort, they provide encouraging evidence of a deeper antitumor activity induced by immunon 001. At R&D Day, we also presented recurrence-free survival for the MRTD trial from the intent-to-treat cohort, where median recurrence-free survival was approximately twice as long in the immunon 001 arm, 26.1 months versus 11.4 months. I would underscore again that this is a 26-patient intent-to-treat cohort, and the log rank p-value is 0.17. This is a hypothesis generating, not a confirmatory study. Ovation 3 is the confirmatory study, but this trial provides evidence from an independent trial that there is directionally consistent and contains novel biomarker data that shows tumor microenvironment remodeling. Something that clinicians outside the company continue to remind me has long been a sought-after goal and is thought to be the holy grail in immune drug development for ovarian cancer. The translational analyses continue to support immunon001's proposed mechanism of action. We observe robust IL-12 expression within macrophages, activation of downstream cytokines, including interferon gamma. and evidence of both macrophage and T-cell activation consistent with remodeling of the tumor microenvironment from an immunologically cold state to one that is immunologically active or hot. This spatial and immune profiling identified macrophages as the principal cells taking up immunon 001 in peritoneal fluid and tumor tissue, and showed expansion of T cell receptor clones consistent with the induction of anti-cancer immunity. Finally, these encouraging biological and clinical findings continue to be accompanied by a highly favorable safety profile. Across the MRD study, we have observed no cytokine release syndrome, no systemic toxicities, and no serious immune-related adverse events, further reinforcing our belief that immunon-001 has successfully overcome the historic safety challenges previously associated with interleukin-12-based therapies. This work builds on the foundation established by Ovation 2, which demonstrated a 14.7-month increase in median survival, 45.1 months versus 30.4 months, and a 24.2-month increase in median survival among patients who received PARP inhibitor maintenance, 65.6 versus 41.4 months. With none of the systemic dose-limiting toxicities that closed earlier interleukin-12 programs. It is worth noting how the overall survival signal behaved as the data matured. At the July 2024 readout, the difference in medians was 11.4 months. At the final analysis in December 2025, it was 14.7 months. The benefit widened rather than eroded. I would also note that Ovation 2 was not powered for overall survival, which is precisely why overall survival is the primary endpoint in Ovation 3. For completeness, the 95% confidence interval around that 14.7-month difference runs from negative 3.8 to 33.3 months, with a one-sided p-value of 0.06. In a study of this size, that is what a consistent, meaningful survival signal looks like without the statistical power to confirm it. These data have been published in Gynecologic Oncology and were presented at ASCO in 2025. In addition, in July, we presented translational and clinical data from Immunine 001 at the inaugural AACR Conference on Drug Discovery and Development. Being included in this first edition of that meeting, alongside technologies the organizers identified as those shaping the future of cancer drug development, is a form of recognition we do not take for granted. We also presented additional translational data at the Society for Immunotherapy of Cancer meeting in November, and we plan to submit the final Ovation 2 overall survival analysis at a major medical meeting in 2027. I'll now hand the line back to Stacy.
Thank you. Before I close, I want to spend a moment on how we're running the business. Because in a company, our size capital allocation is strategy. Every decision we make is measured against one question. Does this advance Ovation 3 faster or more efficiently? Or both? If it does not, we do not. We do not do it. The Thermadocs Agreement and the September Exchange are both answers to that question. That discipline extends to how we pay ourselves. Members of our leadership team, a broader employee base in addition to consultants, have voluntarily elected to take a meaningful portion of their base salary in stock rather than cash. This conserves cash for the trial And also, and very importantly, aligned management compensation with shareholder interest. We've also seen that discipline on the expense line. General and administrative expenses have remained essentially flat year-over-year in the first three quarters of 2026. Now, we've been running a phase trial and a phase three trial, and Josh will take you through that detail in a moment. None of this is a substitute for the capital this program ultimately requires. It determines how far every dollar goes until we get there. Taken together, the June financing, the September debt for equity exchange, and the Thermadocs agreement reflect a consistent approach. Fund the Phase III trial, minimize dilution and overhang for existing shareholders, And convert non-core assets into potential future value, rather than carrying them. We have also been clear that completing Ovation 3 requires additional capital. That has been consistent in our filings, and it remains the case today. Late last month, we filed a registration statement with the SEC relating to a proposed offering of our securities. Because that registration statement is on file, I'm not going to discuss the proposed offering on this call beyond what it contains, and I would direct you to the filing itself for the terms. What I will say is this. Patients don't have time to wait, and we know that investors are also seeking valued near-term catalysts. Information 3 protocol includes two pre-planned event-driven interim analyses that could, if the pre-specified statistical thresholds are met, support an earlier registration submission. We also expect to provide regular operational updates on site activation and enrollment, as well as additional translational and clinical data from our ongoing studies as those data mature. The National Cancer Institute is taking immunon-001 into additional indications at its own cost. We've taped thermadocs off our plate and reduced it without issuing common stock. Every one of those actions was taken to make this program more fundable and that work continues. With that, let me turn the call over to Josh to review our financial results. Josh?
Thank you, Stacy, and good morning, everyone. Details of Immunon's third quarter 2026 financial results are included in the press release we issued this morning and in Form 10Q, which we filed before the market opened this morning. Research and development expenses for the third quarter were $1.8 million, largely unchanged, from $1.9 million for the same period last year. General and administrative expenses were $1.7 million, also largely unchanged, from $1.6 million a year ago. Non-operating expenses for the third quarter of 2026 totaled $302,000, which largely relates to financing costs of our debt and equity extinguishment of a portion thereof. This compares to a de minimis amount of non-operating income for the corresponding period last year. Net loss available to common shareholders for the third quarter was $3.8 million, or $0.64 a share, compared with the net loss available to common shareholders of $3.4 million, or $1.16, per common share in the third quarter of 2025. Net cash used in operating activities for the quarter was $3.2 million. The nine months ended September 30, 2026. Net cash used in operating activities was $10.2 million. At September 30, 2026, we had cash and cash equivalents of $4.0 million. In addition, we held $5.0 million of restricted cash in connection with the June financing. As disclosed in our filings, there is substantial doubt about our ability to continue as a going concern, and our independent registered public accounting firm included a going concern explanatory paragraph in its report on our financial statements. Addressing that is the purpose of the capital raising activity to which Stacey referred. With that, I'll turn the call back over to Stacey.
Thank you, Josh. And with that, operator, please open the line for questions.
At this time, I would like to remind everyone in order to ask a question, press star, then the number one on your telephone keypad. We will pause for just a moment to compile the Q&A roster. Your first question comes from the line of Jason McCarthy with Maxim Group. Your line is now open. Please go ahead.
Hi, guys. Thanks for taking the questions. Just wondering what you make of this, you know, sort of percolating activity we've been seeing in the IL-12 space, whether that's... You know, Estellos' preclinical licensing deal or Zileo's upcoming phase two data and what that means for Immunon being the latest stage program in the space.
Yeah, thanks for the question. I think the most obvious answer to that question is we've known that there has always been excitement about the potential of harnessing IL-12 within immunotherapy. We see that in all of the historic trials, and we know that the challenges were never the biology. So I view this as a resurgence. An acknowledgment that we've been able to overcome the historic. And we're returning to the realization, which is clearly documented in the literature, that IL-12 is an incredibly powerful cytokine that activates both arms of the immune system. And if we can administer it safely, as we've been able to show in the case of Immunata-01, that is generating certainly excitement and interest in our discussions, but it's exciting to see the activity more broadly that you're referencing. And, Douglas, I know that at CITSI last weekend, there was a second year of quite a bit of interest with IL-12. Maybe you want to make some comments just about your reflections there.
I'd be happy to. So I attended the CITSI meeting in Phoenix last weekend, and I presented some new translational data from the Ovation 2 trial, which demonstrated remodeling of the patient's tumor microenvironment from cold to hot by even on 001. One of the gratifying things to me was that there were a number of presentations using IL-12 as an anti-cancer therapeutic in either clinical or preclinical settings. Investigators and biopharma companies were employing various techniques to limit systemic exposure of interleukin-12, which we do very effectively, while still attempting to make it available to the tumor. Most of these approaches involved direct injection into the tumor, and some included additional limitations on interleukin-12 availability and or attempts to prolong its local activity because the protein is broken down very rapidly. And these included intratumoral activation of a precytokine or incorporation into a polymer or expression from a virus. These were all in early stages of clinical development and usually focused on melanoma, where the tumor is readily accessible, or in dose ranging. None of these pose any competition to immunon 001. We're years ahead in development of any of these programs and have already established a reassuring safety profile and demonstrated clinical activity in the randomized controlled trials. And we're in an ongoing pivotal trial. But the renewed widespread interest and enthusiasm for interleukin-12 in the immune oncology environment really validates our program and our approach. And I will also say personally that as I went to the different IL-12 presentations, And I talked with the investigators as soon as they realized I was from Indianan, they all wished me great success in our program because they thought that our success and our preeminent position in this area validates their activity. Daisy?
Thank you.
Next question comes from the line of Cam Dolliver with Brookline Capital Markets. Please go ahead.
Great. Thanks for taking my question or two. Just quickly, given some of the commentary regarding financing and what you have lined up with regard to site activations, how many more sites do you think you can activate with your current resources? I mean, can you get to – can you activate all – up to 18 sites, or – Will, um, you need additional capital to, um, make more progress?
Yeah, Kemp, it's, it's a, it's a great question, and we've, we've been clear, I, in my prepared remarks, I, I offered this, this perspective as well, um, to complete our trial and also to complete and activate 50 sites. We require additional capital. This has been the case, and of course, this is clearly shown in our filings, and we're addressing that. Through the capital raising activity, and that's the purpose of our capital raising activity. So we are actively working in enrolling sites, and we're ensuring that we bring capital in that's required for us to continue along this path.
Okay, and is there a deadline with the Thermidox transaction in terms of their ability to raise the $2.5 million and close the agreement?
There is not a deadline, and I think that when we ultimately reflect on a motivated partner, this is the source of advancing their company. We know there's a lot of motivation with them. We obviously are excited at the potential of a technology and a product that we still believed in, so we're delighted to see their progress, but we have not put any kind of artificial deadline around that.
Great. Thank you. Those are my questions. Thank you, Kim.
Again, if you would like to ask a question, press star 1 on your telephone keypad. That concludes our Q&A session. I will now turn the call back over to Stacey Lindbergh for closing remarks.
Thank you. Just a couple of remarks, really reflecting back on our last call. I said that our clinical data were strengthening, our enrollment was strong, and our external validation was growing. And when we reflect on this quarter, each of these moved from assertion to evidence. The National Cancer Institute selected Immunon-001 as the first gene-based immunotherapy for partnered clinical development under ACREDA. Our independent data monitoring committees reviewed all safety data in the MRD study, and the separate independent data monitoring committee reviewed Ovation 3 data earlier this year, and both recommended continuation without modification. And independent investigators presented the full clinical case for our R&D Day in September. We also sharpened the portfolio through the Thermadox Agreement and strengthened the balance sheet through the Debt for Equity Exchange, both without issuing common stock or warrants. We recognize there's still important work ahead, but we believe the foundation we've built leaves us well positioned for the next stage of development. Our priorities are clear. Advance Ovation 3 towards 50 percent enrolled in the first quarter of 2028, and completion of enrollment in the first quarter of 2029. Support the National Cancer Institute as it initiates work under the CRADA, complete the Thermadox transaction, and fund the program in a way that protects its shareholders, our shareholders. All of this serves one end. Which is delivering a much-needed treatment option to women with advanced ovarian cancer. For those who were not able to join us in September, I'd again encourage you to watch the R&D Day replay on our website. It is the most complete articulation of this program that we've put in the public. Lastly, I want to thank our employees, our investigators, and the women who've chosen to participate in these trials. And I want to thank our shareholders. For their continued confidence. Thank you for joining us today.
That concludes today's call. Thank you all for joining. You may now disconnect.
38:34 to 48:23 · One card per analyst, follow-ups included. Each plays from its start, and the one being answered is marked.
Hi, guys. Thanks for taking the questions. Just wondering what you make of this, you know, sort of percolating activity we've been seeing in the IL-12 space, whether that's... You know, Estellos' preclinical licensing deal or Zileo's upcoming phase two data and what that means for Immunon being the latest stage program…
Stacy R. Lindborg: Yeah, thanks for the question. I think the most obvious answer to that question is we've known that there has always been excitement about the potential of harnessing IL-12 within immunotherapy. We see that in all of the historic trials, and we know that the…
Also speaking: Douglas Fowler, Speaker 1
Great. Thanks for taking my question or two. Just quickly, given some of the commentary regarding financing and what you have lined up with regard to site activations, how many more sites do you think you can activate with your current resources? I mean, can you get to – can you activate all – up to 18 sites, or –…
Stacy R. Lindborg: Yeah, Kemp, it's, it's a, it's a great question, and we've, we've been clear, I, in my prepared remarks, I, I offered this, this perspective as well, um, to complete our trial and also to complete and activate 50 sites. We require additional capital. This has…
SEC filing · Item 2.02
Filed Nov 12, 2026 · complete as-filed document
SEC periodic report
Filed Nov 12, 2026 · complete as-filed document