5/12/2026

speaker
Tina
Conference Operator

Good morning. My name is Tina, and I will be your operator today. At this time, I would like to welcome everyone to the Immunion First Quarter 2026 Final Results Conference Call. All lines have been placed on mute to prevent any background noise. Following the speaker's remarks, there will be a question and answer session. You may press star 1 on your telephone keypad 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 your equipment. Again, that is star one to ask your question during the Q&A session. I would now like to turn the call over to Brandon Weiner of ICR Health Services. care, investor relations, representatives of Immunion, please go ahead.

speaker
Brandon Weiner
ICR Health Services, Investor Relations

Thank you. Good morning, everyone, and welcome to Immunion's first quarter 2026 financial results and business update conference call. During today's call, management will be making forward-looking statements regarding Immunion'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 accurately as accurate only as of the date of the live broadcast, May 12th, 2026. 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 Lindborg, Immunon's President and Chief Executive Officer. Stacey?

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

Thank you, Brandon, and good morning to everyone joining us on the call this morning. Joining me on the call is Dr. Douglas Fowler, our chief medical officer, and Mr. Jeffrey Church, our interim chief financial officer, who will review our financial results for the first quarter of 2026. Mr. Michael Tardugno, the executive chairman of our board, is also on the line and will be available for Q&A. We've entered the second quarter of 2026 with continued momentum following what was truly a transformative year in 2025 And we've made strong progress since our last conference call. We recently announced the final clinical data from our completed phase two study, Ovation 2, and Immunon 001, our proprietary IL-12 immunotherapy, continues to demonstrate its potential to redefine frontline treatment for women with newly diagnosed advanced ovarian cancer. The pivotal phase three study, Ovation 3, is advancing well. And we remain on track to randomize approximately 80 patients by the end of the first quarter of 2027. The capital funding environment has been challenging, not only for Immunon, but also for the biotech sector generally. We continue to take steps to sharpen our focus on enrolling this important Ovation 3 study as rapidly as possible and to conserve cash. The reaction from the investment community to our progress and the data we have presented to date, including the results from our evasion two phase two clinical study has been very positive. Focusing now on our phase three study, we do understand that the primary challenge is the time it will take to fully enroll this 500 patient trial and to generate sufficient data for a future BLA filing. Given the significant improvement in overall survival that we've seen in phase two and we expect to see in phase three, our primary endpoint, overall survival, is both a major strength and a practical time consideration. On one hand, overall survival remains the gold and definitive standard for demonstrating efficacy in oncology and would support a BLA filing based on a single pivotal trial. On the other hand, it requires some time for the data to mature and reach a formal readout, in fact, longer than some investors might prefer. We're solving this dilemma in two ways. First, through a disciplined bridge financing strategy that raises targeted capital to advance Ovation 3 and bring us closer to trial readout, positioning the company to attract new fundamental investors. Second, by structuring these financings in a creative, manner designed to minimize dilution and limit pressure on share price. This could include the upside of a deal utilizing preferred shares, which are not immediately tradable, have no warrants, with redemption at the market, and would also increase shareholder equity. This kind of a deal could compare favorably to register direct deals that are typically dilutive and often include investors with little long-term interest in the company. We'll have more to say on this in the near future and we will provide updates as they become available. As always, our goal is to finance the company while not forgetting our shareholders and to keep a sharp focus on our North Star, which is bringing an innovative and much needed new treatment option to women with advanced ovarian cancer. Our approach has always intended to be as investor friendly as the options available to us permit. Based on our unprecedented Immunon 001 clinical data thus far, we are confident that our program will attract investments from one or more strategic partners that is minimally dilutive or non-dilutive. Looking ahead, we are planning an R&D day event in Q3 of 2026. And I look forward to inviting you to hear from our immune on team trial investigators and oncology experts on the value of our immune on oh one program to clinicians and patients. The strong response from our current trial investigators patients and the broader medical community supports our belief in the significant potential of immune on oh one to make a meaningful difference in women's lives. I know your attendance will be rewarded with the inspiring attitude of the physicians and scientists who are intimately involved with our unique proprietary DNA-mediated recruitment of the entirety of the body's defense against rogue malignancies, something that we have the pleasure of experiencing on a regular basis. I'll now turn over to Dr. Douglas Fowler for clinical commentary. Douglas?

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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