Imunon, Inc.

Good morning. My name is Dave, and I will be your operator today. At this time, I would like to welcome you to the Immunons First Quarter 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, then 1 on your phone to ask a question at that 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 your call over to Peter Vazio of ICR Healthcare Investor Relations Representative for Immunon. Please go ahead.

Thank you, Dave. Good morning, everyone, and welcome to Immunon's first quarter 2025 financial results and business update conference call. During today's call, management will be making forward-looking statements regarding Immunon'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 the date of this live broadcast, May 12, 2025. Immunon 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. Stacey Lindbergh, President and Chief Executive Officer. Stay tuned.

Thank you, Peter, and good morning, everyone. Joining me on this call is Dr. Douglas Fowler, Immunon's Chief Medical Officer, and Dave Gallero, our Interim Chief Financial Officer, who will review our financial results for the first quarter of 2025. Michael Tardigno, the Executive Chairman of our Board, and Krishid Anwar, 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 Immunon 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 three pivotal study of Immuno-001. If the results from our highly successful phase two study are replicated in phase three, patients and doctors may potentially have a meaningful life-extending therapy that recruits and empowers body's immune system to effectively target this disease. Our phase three 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 Immunon-001's anti-cancer 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 ME-9001. 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 three trial elevation three will assess the efficacy of Immunon-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 one-to-one, 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 treatments. 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 conformational study to support approval And if results are positive, the phase three 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 US orphan drug designation. The initial core set of clinical trial sites currently activating are highly encouraged by Immi901's data and are enthusiastic about Ovation 3. These include sites that were part of both the Phase 1 Ovation 1 study and the Phase 1 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 Immune 901 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 evasion two are confirmed in phase three. 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 Immuno-901. 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 two 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 Immunonta 01 in the phase 3 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 Thakkar, who is interim chief of gynecologic oncology, the David and Lee Mulch Distinguished Professor of Obstetrics and Gynecology, also Director of Gynecologic Oncology Clinical Research all at Washington 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 3rd being released simultaneous to the ASCO presentation. Having our data presented in two 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 Immunon's TheraPlas platform technology. With that, I'd like to turn the call over to Dr. Douglas Fowler, who will discuss the Phase 3 Ovation 3 study, including key points from his recent and ongoing discussions with study investigators as we initiate sites. Douglas?

Thank you, Stacey. This is clearly a very exciting time for Immuno. In addition to the presentation of the results from our Ovation 2 trial and an oral session of ASCO in a few weeks, Stacey 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 Immunon 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 This is the proprietary biochemical basis for both Immunon's anti-cancer 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 two 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 Immunon 001 in the women they care for. They want to join with us in this crucial step towards bringing Immunon 001 forward as a novel and innovative therapeutic. and 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 six months. I will now turn the call back to Stacey.

Thanks, Douglas. As we look towards financing our Phase 3 clinical trial, our goal is twofold. One is to ensure that we have done the best possible job for all stakeholders, including our shareholders. And two, 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 timelines and long-term strategic objectives. Focusing on both technologies, TheraPlas and Plasene, 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 Immunon-001 in other parts of the world. And finally, we intend to leverage the data from the proof of concept trial using our novel Placine vaccine technology to sell or license that technology. Our Placine technology offers several advantages and strong advantages over other vaccine platforms, such as exceptional stability, being viable for one year at four degrees centigrade, which is refrigerated temperatures, and one 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 Placine 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 Dave Gallero to review our financial results for the first quarter. Dave?

Thank you, Stacey. Details of Immunon's first quarter 2025 financial results are included in the press release we issued this morning and in our form 10Q, which we filed before the market opened this morning. As of March 31st, 2025, Immunon 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 one proof of concept Placine DNA vaccine trial and the development of Placine 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 28 cents per share, compared to a net loss of $4.9 million, or 52 cents per share, for the same period in 2024. With that financial review, I turn the call back to Stacey.

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

We will now begin the question and answer session. To ask a question, you may press star then 1 on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star and then 2. Our first question comes from Emily Bowdner with HC Wainwright. Please go ahead.

Hi, thanks for taking the questions. Hello, and 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 subgroup 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 ESCO'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. 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. Thacker's perspective on the data.

Okay, makes sense. And then maybe just follow up on the phase three 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? Thanks.

I'll have Douglas, why don't you take a stab at this? Sure. for the phase three has always been predicated on analyzing the HRD population first. This is the population in which we think from probation two 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 Stacey mentioned. The readout does not change. There are two interim analyses and a final analysis, if needed, all based on HRD events. You asked a question.

The number of sites.

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

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

Got it. Okay. Thank you.

Thank you.

The next question comes from James Malloy with Alliance Global Partners. Please go ahead.

Hello. This is Laura Serial on for Jim Malloy. Thank you for taking the questions and congrats on the progress. So for Ovation 3, what's the current status that you have on the inventory and the manufacturing capabilities for this trial, especially with the 250 to 500 patient enrollment plan that you have set up?

Yeah, 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 continue to have product available. So we have had 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, thank you. And then also the clinical trial that you have in collaboration with the Breakthrough 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 from that?

We have a meeting with the principal investigators every two 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.

All right, thank you for the insights and for taking the questions.

Thank you. This concludes our question. and answer session of the call. I now want to turn the call back over to Immunon's president and CEO for concluding remarks, Dr. Lindberg.

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 three trial and in the process advancing Immunon 01. 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 cost, and we want to and will be seeking corporate partnering and equity financing. We expect this will be an iterative process driven by Catalyst to further investor confidence and follow-on financing. 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 your praise for our progress, and thanks again for joining us today and for your interest in Immunon.