Earnings Call Transcript - IMNN Q1 2025

Operator, Operator

Good morning. My name is Dave, and I will be your operator today. At this time, I would like to welcome you to Imunon's First Quarter 2025 Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. Following the speakers' prepared remarks, there will be a question-and-answer session. I would now like to turn the call over to Peter Vozzo of ICR Healthcare, Investor Relations representative for Imunon. Please go ahead.

Peter Vozzo, Investor Relations Representative

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 the 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 Lindborg, CEO

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 Dr. 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, 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 shared the impact of 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 Imunon-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 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 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 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 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 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 for chemotherapy response score, clinical response, and time to second-line treatment. This 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 the primary endpoint is that it is a definitive endpoint. There will be no need for a second confirmational study to support approval. 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 US orphan drug designation. The initial core set of clinical trial sites 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 that 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 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-comer 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 I mentioned earlier, review of the full data from OVATION 2 will be published in the 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 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 Faller, Chief Medical Officer

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 of 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 IMUNON 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 anti-cancer activity and just as importantly, its safety. We initiated the first clinical site in our registrational OVATION 3 trial last week, with the 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 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 six months. I'll now turn the call back to Stacy.

Stacy Lindborg, CEO

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 that will help secure a cash runway that supports our clinical timelines 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 the 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 benefits over other vaccine platforms, such as exceptional stability being viable for one year at 4 degrees Centigrade 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 require less frequent booster shots and cost-effective manufacturing. We shared insights from the PlaCCine proof of concept trial and the preclinical trials last month 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 the OVATION 3 trial cost through corporate partnerships and equity. I'd now like to turn the call over to Dave Gaiero to review our financial results for the first quarter.

David Gaiero, Interim CFO

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 1 proof of concept PlaCCine DNA vaccine trial and the development of the 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. The 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 turn the call back to Stacy.

Stacy Lindborg, CEO

Thank you, Dave. With that, I would like to open the call to your questions.

Operator, Operator

We will now begin the question-and-answer session. Our first question comes from Emily Bodnar with H.C. Wainwright. Please go ahead.

Stacy Lindborg, CEO

Hello, Emily.

Emily Bodnar, Analyst

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 subgroup analysis or any new data analysis that we should be expecting at the ASCO presentation and will you potentially have the median OS for the HRD positive patients by then?

Stacy Lindborg, CEO

So we are, by nature of ASCO’s embargo, Emily, I know you’ll understand that we are not able to talk about the content of the presentation. They are very careful with what is shared in advance. We will be sharing new information, and I think it’s 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, I look forward to hearing Dr. Thaker's perspective on the data.

Emily Bodnar, Analyst

Okay. Makes sense. And then maybe just 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? Thanks.

Stacy Lindborg, CEO

I'll have Doug, when you take a step in.

Douglas Faller, Chief Medical Officer

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 prior 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 focused on HRD alone, as Stacy mentioned, the readout does not change. There are two interim analyses and a final analysis if needed, all based on HRD events. You asked the question.

Stacy Lindborg, CEO

A number of sites.

Douglas Faller, Chief Medical Officer

We are projecting about 45 sites at this point.

Stacy Lindborg, CEO

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

Emily Bodnar, Analyst

Got it. Okay. Thank you.

Operator, Operator

The last question comes from James Molloy with Alliance Global Partners. Please go ahead.

Laura Suriel, Analyst

Hello. This is Laura Suriel on for Jim Malloy. Thank you for taking my 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?

Stacy Lindborg, CEO

Yes, that's a great question. I want to emphasize that for this trial, we have brought the manufacturing of the core active pharmaceutical ingredients in-house. We are actively monitoring various enrollment plans to ensure we have a consistent supply of product available. The product has met all release specifications and has been ready for several weeks, positioning us well for the upcoming weeks and months.

Laura Suriel, Analyst

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?

Stacy Lindborg, CEO

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

Douglas Faller, Chief Medical Officer

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 re-staff 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.

Laura Suriel, Analyst

All right. Thank you for the answers. Thanks for taking the questions.

Stacy Lindborg, CEO

Thank you.

Operator, Operator

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.

Stacy Lindborg, CEO

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. As referenced earlier, our goal is to cover the OVATION 2 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 catalysts to further investor confidence and follow-on financings. 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.

Operator, Operator

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