Imunon Q1 2025 Earnings Call Transcript

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May 12, 2025

There are 7 speakers on the call.

Operator

Good morning. My name is Dave and I will be your operator today. At this time, I would like to welcome you to the Immuno's First Quarter twenty twenty five 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.

Operator

Session. I would now like to turn your call over to Peter Vazzo of ICR Healthcare Investor Relations representative for Immunon. Please go ahead.

Speaker 1

Thank you, Dave. Good morning, everyone, and welcome to Immunon's first quarter twenty twenty five 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 and other similar expressions. These statements are based on current expectations and are subject to a number of risks and uncertainties, including those set forth in the company's periodic filings with the Securities and Exchange Commission.

Speaker 1

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, 05/12/2025. Immune 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 Doctor. Stacy Lindborg, President and Chief Executive Officer.

Speaker 1

Stacy?

Speaker 2

Thank you, Peter, and good morning, everyone. Joining me on this call is Doctor. 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 twenty twenty five. Michael Chardigno, the Executive Chairman of our Board and Krishit Anwar, our Chief Scientific Officer, are also both on the line and will be available for Q and A. I want to start by saying that we may be close for the first time to unlocking the power of interleukin-twelve to effectively treat cancer in one of the worst forms of ovarian cancer.

Speaker 2

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 ImmuneOn 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 IMMUN-one. 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.

Speaker 2

Our Phase three study known as OVATION three 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 II 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-one'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 IMMUN-one.

Speaker 2

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 three will assess the efficacy of IMMUN-one 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 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.

Speaker 2

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 the primary endpoint is that it is a definitive endpoint.

Speaker 2

There will be no need for a second confirmation 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 of the primary endpoint. And you'll recall that we have orphan status established in Europe along with U. S. Orphan drug designation.

Speaker 2

The initial core set of clinical trial sites currently activating are highly encouraged by IMMUN-one's data and are enthusiastic about OVATION three. These include sites that were part of both the Phase one OVATION one study and the Phase onetwo OVATION two 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 ABN-nine thousand one 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 II are confirmed in Phase III.

Speaker 2

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 two fifty 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 IMMUN-nine zero one. As we shared in our last call, we will focus initially on HRD plus 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 readout two years earlier.

Speaker 2

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 IMMENON-one in the Phase three OVATION three trial, we do not want its achievements in OVATION two to go unnoticed. As previously announced, data from the OVATION two study will be reviewed in an oral presentation during ASCO's annual meeting next month.

Speaker 2

Doctor. Premel Thacker, who is Interim Chief of Gynecologic Oncology the David and Lee Molch 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 II 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 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 Theraplast platform technology.

Speaker 2

With that, I'd like to turn the call over to Doctor. Douglas Fowler, who will discuss the Phase III OVATION III study, including key points from his recent and ongoing discussions with study investigators as we initiate sites. Douglas?

Speaker 3

Thank you, Stacy. This is clearly a very exciting time for Indionna. In addition to the presentation of the results from our OVATION II 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 II trial at the International ESMO Gynecological Conference in June. The new data that we will present demonstrate that INNON-one technology performs exactly as it was designed, delivering highly potent IL-twelve gene therapy directly to the site of the tumor while keeping systemic exposure to IL-twelve extremely low. This is the proprietary biochemical basis for both Immunod's anti cancer activity and just as important its safety.

Speaker 3

We initiated the first clinical site in our registrational OVATION three 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 II. Their enthusiasm, actually their insistence for joining OVATION III speaks to their belief in the safety and potential benefit of IMUNON-one in the women they care for. They want to join with us in this crucial step towards bringing IMMUN-one forward as a novel and innovative therapeutic in ovarian cancer.

Speaker 3

Our highly experienced clinical development team is excited to have initiated the OVATION III trial and is eagerly planning the expansion of the trial over the next six months. I will now turn the call back to Stacy.

Speaker 2

Thanks, Douglas. As we look towards financing our Phase three 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.

Speaker 2

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 Placine, 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 IMMUN-one 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.

Speaker 2

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 three trial cost through corporate partnerships and equity.

Speaker 2

I'd now like to turn the call over to Dave Gallero to review our financial results for the first quarter. Dave? Thank you,

Speaker 4

Stacy. Details of ImmuneOn's first quarter twenty twenty five 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 03/31/2025, Ibnon had 2,900,000 in cash and cash equivalents. We remain focused on securing near term financing that strengthen the company's financial condition and advance OVATION three. Research and development costs were $2,200,000 for the first quarter of twenty twenty five compared with $3,300,000 for the same period in 2024.

Speaker 4

The decrease was due primarily to lower costs associated with the Phase one proof of concept Plascene DNA vaccine trial and the development of Plascene DNA vaccine technology platform. General and administrative expenses were $2,000,000 for the first quarter of twenty twenty five compared to $1,700,000 for the same period in 2024. The increase was primarily due to higher employee related expenses. Net loss for the first quarter of twenty twenty five was $4,100,000 or $0.28 per share compared to a net loss of $4,900,000 or $0.52 per share for the same period in 2024. With that financial review, I'll turn the call back to Stacy.

Speaker 2

Thank you, Dave. With that, I'd 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 Bodner with H. C. Wainwright. Please go ahead.

Speaker 2

Hi, thanks

Speaker 5

for taking the question. 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?

Speaker 5

And will you potentially have the median OS for the HRD positive patients by then?

Speaker 2

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 Doctor. Thacker's perspective on the data.

Speaker 5

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 ITP population or how are you kind of splitting up those statistical plans?

Speaker 5

Thanks.

Speaker 2

I'll have Douglas, why don't you take a stab at it?

Speaker 3

Sure. The analysis for the Phase three has always been predicated on analyzing the HRD population first. This is the population in which we think from OVATION II 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.

Speaker 3

There are two interim analyses and a final analysis if needed all based on HRD events. You

Speaker 4

asked the question at The

Speaker 2

number of sites.

Speaker 3

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

Speaker 2

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

Speaker 5

Got it. Okay. Thank you. The

Operator

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

Speaker 6

Hello. This is Laura Suriel on for Jim Malloy. Thank you for taking the questions and congrats on the progress. So for OVATION three, what's the current status that you have on like the inventory and the manufacturing capabilities for, you know, for this trial, especially with the two fifty to 500 patient enrollment plan that you have set up?

Speaker 2

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 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.

Speaker 6

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?

Speaker 2

You just had a call with the PIs. Can you give some

Speaker 3

insight from

Speaker 3

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,

Operator

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. Doctor. Lindbergh?

Speaker 2

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 IMMUN-one thousand one. 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 III trial cost, and we want to and we'll be seeking corporate partnering and equity financings. We expect this will be an iterative process driven by catalyst to further investor confidence and follow on financings.

Speaker 2

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 for our progress and thanks again for joining us today and for your interest in ImmuneOn.

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Key Takeaways

  • We have initiated the first clinical site for our Phase III OVATION III trial of IMMUN-one, targeting 500 patients (with a 250-patient HRD+ subgroup) and using overall survival as the primary endpoint to support both US and EU registration.
  • Results from the Phase II OVATION II study have been accepted for oral presentation at the upcoming ASCO Annual Meeting and will be published in Gynecologic Oncology, with new translational data on IL-12 delivery also slated for ESMO in June.
  • Immunon has brought core manufacturing in-house and holds product ready for shipment, ensuring sufficient supply to meet anticipated enrollment in the Phase III trial.
  • Our Plascene vaccine (“Placine”) platform offers exceptional stability (one year at 4°C, one month at 37°C), rapid pathogen adaptation, and cost-effective manufacturing, and is under active partnership discussions.
  • We are pursuing value-added financings and partnerships—including corporate, geographic, and equity deals—to fund OVATION III, strengthen the balance sheet, and limit shareholder dilution.
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Earnings Conference Call
Imunon Q1 2025
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