Imunon, Inc. (IMNN) Earnings Call Transcript & Summary

Good morning. My name is Dave, and I will be your operator today. At this time, I would like to welcome you to the Imunon's First Quarter 2025 Financial Results Conference Call. [Operator Instructions] I would now like to turn your call over to Peter Vozzo of ICR Healthcare Investor Relations representative for Imunon. Please go ahead.

Thank you, Dave. Good morning, everyone, and welcome to Imunon's First Quarter 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. 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 this live broadcast, May 12, 2025. 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, President and Chief Executive Officer. Stacy?

Thank you, Peter, and good morning, everyone. Joining me on this call is Dr. Douglas Faller, Imunon's Chief Medical Officer; and David Gaiero, our Interim Chief Financial Officer, who will review our financial results for the first quarter of 2025. Michael Tardugno, the Executive Chairman of our Board; and Khursheed Anwer, our Chief Scientific Officer, are also both on the line and will be available for Q&A. I want to start by saying that we may be close for the first time to unlocking the power of interleukin-12 to effectively treat cancer in one of the worst forms, ovarian cancer. Our work in developing treatments for ovarian cancer, a disease that continues to challenge scientists and clinicians and researchers underscores our commitment to addressing unmet medical needs and driving long-term value. I'm amazed at the number of discussions I've had since joining Imunon in both personal and professional settings where people have shared impact from ovarian cancer at a close and personal level. Its devastation has no limits in taking the lives of women, young and old in their prime. We continue to make significant strides towards our goal of transforming the treatment landscape for women diagnosed with advanced ovarian cancer. To that end, I'm pleased to report that we have initiated the first clinical site in our Phase III pivotal study of IMNN-001. If the results from our highly successful Phase II study are replicated in Phase III, patients and doctors may potentially have a meaningful life-extending therapy that recruits and empowers the body's immune system to effectively target this disease. Our Phase III study known as OVATION 3 is being recognized by the medical community as a critical step towards the goal of delivering a new frontline treatment for women with limited options and unmet urgent medical needs. This recognition is exemplified by the acceptance of our new OVATION 2 results for an oral presentation at the upcoming ASCO Annual Meeting and for publication in the peer-reviewed journal, Gynecologic Oncology. It also underscores the scientific community's strong and historic evidence of IMNN-001's anticancer potential. We believe we have much to offer the future of oncology treatment, and I hope you are as excited as we are. Now I'd like to report on our recent progress and review our clinical and regulatory status of IMNN-001. We continue to work with our trial investigators to begin enrolling participants, all of whom have shown unwavering interest in the Phase III trial and are committed to advancing the study. The confirmatory Phase III trial of OVATION 3 will assess the efficacy of IMNN-001 plus the standard of care versus standard of care, which is neoadjuvant and adjuvant chemotherapy alone. The standard of care for women who are newly diagnosed and treatment naive is paclitaxel and carboplatin chemotherapy, both neoadjuvant and adjuvant to interval debulking surgery. The study will enroll women at least 18 years of age, newly diagnosed with advanced ovarian cancer. Study participants will have been randomized -- will be randomized 1:1, and there will be a subgroup of women positive for homologous recombination deficiency, HRD, which, as many of you will know, includes the familiar mutations BRCA1 or BRCA2. Participants within this subgroup will receive PARP inhibitors as part of standard maintenance therapy. The primary endpoint of the study is overall survival or OS. Secondary endpoints include surgical response score, chemotherapy response score, clinical response and time to second-line treatment. The study will also assess several exploratory endpoints, including quality of life measures, which will aid as we engage in payer and pricing discussions in the future as we entertain approvals and access around the world. The advantage of overall survival as a primary endpoint is that it is a definitive endpoint. There will be no need for a second confirmational study to support approval. And if results are positive, the Phase III trial is also expected to support EU registration as a direct result of the selection of overall survival as the primary endpoint. And you'll recall that we have orphan status established in Europe, along with U.S. orphan drug designation. The initial core set of clinical trial sites currently activating are highly encouraged by IMNN-001's data and are enthusiastic about OVATION 3. These include sites that were part of both the Phase I OVATION 1 study and the Phase I/II OVATION 2 study and we're excited to bring new sites on board to accelerate enrollment of the trial. The strength of our data is the key point of discussion, and we believe it will drive surgeons' interest and patient recruitment. There is optimism that IMNN-001 could potentially be a new product on the horizon and reset the standard of care for the frontline treatment of women newly diagnosed with advanced ovarian cancer, if the safety and efficacy from OVATION 2 are confirmed in Phase III. We have a strategy and statistical plan, which allows for a 500-patient trial in an all-comers population of newly diagnosed patients as well as a plan to focus on a 250-patient subgroup defined by a biomarker identifying patients who are HRD-positive. Both are strong options and have 95% power or higher, and both are capable of supporting an FDA approval for IMNN-001. As we shared in our last call, we will focus initially on the HRD-positive subgroup defined by a biomarker through a central lab. This highly cost-effective strategy allows us to enroll half the number of patients with an opportunity to achieve a readout sooner. We expect the study budget will be approximately 40% lower than the full study budget and could read out 2 years earlier. This population represents one-half of the neoadjuvant ovarian cancer market and would be an important advancement for patients. We would likely trigger a broadening of the inclusion criteria at a later date budget permitting to reach the 500-patient all-comers trial. Our strategy includes an interim analysis at high probability for success milestones. As we advance IMNN-001 in the Phase III OVATION 3 trial, we do not want its achievements in OVATION 2 to go unnoticed. As previously announced, data from the OVATION 2 study will be reviewed in an oral presentation during ASCO's Annual Meeting next month. Dr. Premal Thaker, who is Interim Chief of Gynecologic Oncology; David & Lynn Mutch Distinguished Professor of Obstetrics & Gynecology, also Director of Gynecologic Oncology Clinical Research all at Washington School, University School of Medicine. She will lead the discussion in the oral presentation. As I mentioned earlier, review of the full data from OVATION 2 will be published in a highly esteemed journal, Gynecologic Oncology on June 3, being released simultaneous to the ASCO presentation. Having our data presented in 2 of the premier global platforms in gynecologic oncology underscores both the critical need to develop new therapies to treat ovarian cancer as well as the strength and potential of Imunon's TheraPlas platform technology. With that, I'd like to turn the call over to Dr. Douglas Faller, who will discuss the Phase III OVATION 3 study, including key points from his recent and ongoing discussions with study investigators as we initiate sites. Douglas?

Thank you, Stacy. This is clearly a very exciting time for Imunon. In addition to the presentation of the results from our OVATION 2 trial at an oral session at ASCO in a few weeks and the simultaneous journal publication, which Stacy mentioned, we've also been invited to present new translational data from the OVATION 2 trial at the International ESMO Gynecological Conference in June. The new data that we will present demonstrate that IMNN-001 technology performs exactly as it was designed, delivering highly potent IL-12 gene therapy directly to the site of the tumor while keeping systemic exposure to IL-12 extremely low. This is the proprietary biochemical basis for both Imunon's anticancer activity and just as important, its safety. We initiated the first clinical site in our registrational OVATION 3 trial last week with a second site to be initiated in 2 days. More site initiations are planned in the coming weeks. It is gratifying to me as a clinician and informative to note that these leading hospitals and internationally known principal investigators were also major participants in OVATION 2. Their enthusiasm, actually their insistence for joining OVATION 3 speaks to their belief in the safety and potential benefit of IMNN-001 in the women they care for. They want to join with us in this crucial step towards bringing IMNN-001 forward as a novel and innovative therapeutic in ovarian cancer. Our highly experienced clinical development team is excited to have initiated the OVATION 3 trial and is eagerly planning the expansion of the trial over the next 6 months. I will now turn the call back to Stacy.

Thanks, Douglas. As we look towards financing our Phase III clinical trial, our goal is 2-fold. One is to ensure that we have done the best possible job for all stakeholders, including our shareholders; and 2, to raise capital in an amount that allows us to achieve our product development goals. And dilution is top of mind as we consider these options. Moreover and importantly, we have taken steps to conserve cash and align our critical needs with available capital on hand, while adding to the balance sheet through optimal opportunities. We're actively working on value-added financing and partnerships, which will help secure a cash runway that supports our clinical time lines and long-term strategic objectives. Focusing on both technologies, TheraPlas and PlaCCine, we are having discussions with potential partners that have significant investment in oncology as well as vaccine development, some of these under CDA. We are also exploring geographic partnerships and ways to accelerate development of IMNN-001 in other parts of the world. And finally, we intend to leverage the data from the proof-of-concept trial using our novel PlaCCine vaccine technology to sell or license that technology. Our PlaCCine technology offers several advantages and strong advantages over other vaccine platforms, such as exceptional stability being viable for 1 year at 4 degrees centigrade refrigerated temperatures and 1 month at 37 degrees Celsius. The platform also has the ability for rapid adaptation to new pathogens or variants, longer-lasting protection or durability, meaning it could be less frequent booster shots and cost-effective manufacturing. We shared insights from the PlaCCine proof-of-concept trial and the preclinical trials in this month, this last month, April 2025 at both the AACR Annual Meeting and at the World Vaccine Congress and are following up with companies in the vaccine space. We are actively working on value-added financing and partnerships, which will help secure a cash runway. We will provide updates when we're able, and our goal is to cover OVATION 3 trial costs through corporate partnerships and equity. I'd now like to turn the call over to David Gaiero to review our financial results for the first quarter. Dave?

Thank you, Stacy. Details of Imunon's first quarter 2025 financial results are included in the press release we issued this morning and in our Form 10-Q, which we filed before the market opened this morning. As of March 31, 2025, Imunon had $2.9 million in cash and cash equivalents. We remain focused on securing near-term financing to strengthen the company's financial condition and advance OVATION 3. Research and development costs were $2.2 million for the first quarter of 2025 compared with $3.3 million for the same period in 2024. The decrease was due primarily to lower costs associated with the Phase I proof-of-concept PlaCCine DNA vaccine trial and the development of PlaCCine DNA vaccine technology platform. General and administrative expenses were $2 million for the first quarter of 2025 compared to $1.7 million for the same period in 2024. The increase was primarily due to higher employee-related expenses. Net loss for the first quarter of 2025 was $4.1 million or $0.28 per share compared to a net loss of $4.9 million or $0.52 per share for the same period in 2024. With that financial review, I'll turn the call back to Stacy.

Thank you, Dave. With that, I'd like to open the call to your questions. Operator?

[Operator Instructions] Our first question comes from Emily Bodnar with H.C. Wainwright.

Congrats on the progress. I guess first one, I'll ask about the ASCO presentation. So congrats, obviously, on getting an oral presentation. Is there anything new in terms of like sub-group analysis or any new data analyses that we should be expecting at the ASCO presentation? And will you potentially have the median OS for the HRD-positive patients by then?

So we are by nature of ASCO's embargo, Emily, I know you'll understand that, not able to talk about the content of the presentation. They're very careful with what is shared in advance. We will be sharing new information and that, I think, is really quite central to being accepted as an oral presentation, although I think the full body of evidence that we've been discussing merits a view at this level and at a platform like ASCO. So we're incredibly excited for the presentation and look forward to hearing Dr. Thaker's perspective on the data.

Okay. Makes sense. And then maybe just a follow-up on the Phase III design. How many sites are you expecting to have in total for the trial for that, I guess, first half portion that you were discussing? And then are you having OS as a dual primary endpoint for HRD-positive and the ITT population? Or how are you kind of splitting up the statistical plan?

I'll have -- Douglas why don't you take a stab at it.

Sure. The analysis for the Phase III has always been predicated on analyzing the HRD population first. This is the population in which we think from OVATION 2 data, including data that will be presented at ASCO, in which we have the highest effect in terms of activity. And so the population that would be read out first, whether we proceeded with the entire HRD and HRP or whether we focus on HRD alone, as Stacy mentioned, the readout does not change. There are 2 interim analyses and a final analysis, if needed, all based on HRD events. You asked the question about.

N number of sites.

Number of sites. We are projecting about 45 sites at this point.

Emily, just to recap, so the overall survival of the primary is not dual, and it is consistent for all populations as the primary.

The next question comes from James Molloy with Alliance Global Partners.

This is Laura Suriel on for Jim Molloy. Congrats on the progress. So for OVATION 3, what's the current status that you have on like the inventory and the manufacturing capabilities for this trial, especially with the 250 to 500 patient enrollment plan that you have set up?

Yes. Great question. And I'll take the opportunity just to reiterate that for this trial, we have pulled the manufacturing of the core active pharmaceutical ingredients in-house. And we are prepared and are monitoring various enrollment plans and ensuring that we have and will have -- continue to have product available. So we have had a product that has passed all of the release specifications and has been ready to ship for weeks now and are well prepared for the weeks and months ahead.

Got it. And then also the clinical trial that you have in collaboration with the Break Through Cancer Foundation, what's the current status of this trial here? And are you still on track to have preliminary results announced later on this year?

You just had a call with the PIs. Can you give some insight on that?

We have a meeting with the principal investigators every 2 weeks, and the last one was a couple of days ago on Friday. We've initiated another site, University of Oklahoma and very excited about that. Johns Hopkins has managed to restaff its clinical research group. And so they're excited about starting to screen patients. We are expecting to have data at the end of this year, yes.

This concludes our question-and-answer session of the call. I now want to turn the call back over to Imunon's President and CEO for concluding remarks, Dr. Lindborg.

Thank you. I want to reiterate our near-term focus, which is on securing funds to strengthen the company's financial condition and advancing our Phase III trial and in the process advancing IMNN-001. We expect to have an update on this front by the end of this quarter. And as referenced earlier, our goal is to cover the OVATION 3 trial costs, and we want to and will be seeking corporate partnering and equity financings. We expect this will be an iterative process driven by catalysts to further investor confidence and follow-on financings. And as our work in providing a new treatment option for women with ovarian cancer progresses and as the population's exposure to potential pandemics increases, we remain very excited about reporting data from ongoing clinical studies in the months ahead. We look forward to keeping you appraised of our progress, and thanks again for joining us today and for your interest in Imunon.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.