Imunon, Inc. (IMNN) Q2 2025 Earnings Report, Transcript and Summary

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

Thank you, Darwin. Good morning, everyone, and welcome to IMUNON's Second 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 those such statements. I also caution that the content of this conference call is accurate only as of the date of the live broadcast, August 5, 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, IMUNON's President and Chief Executive Officer. Stacy?

Thank you, Peter, and good morning, everyone. Joining me on the call this morning is Dr. Douglas Faller, IMUNON's Chief Medical Officer; and Ms. Kimberly Graper, our Interim Chief Financial Officer, who will review our financial results for the second quarter 2025. Mr. Michael Tardugno, the Executive Chairman of our Board; and Dr. Khursheed Anwer, our Chief Scientific Officer, are on the line and will be available for Q&A. I want to begin by reviewing our progress in harnessing the potential of IMNN-001, our gene-mediated IL-12 therapy as an effective treatment for ovarian cancer, one of the most challenging forms of malignancies today. Our efforts reflect a deep commitment to unmet needs in oncology and to creating lasting value for patients and our stakeholders. The personal stories that I hear on an ongoing basis about the impact of ovarian cancer reinforce the urgency of our mission. It affects women across all ages and stages of life with profound devastation. Recall that the frontline ovarian cancer treatment landscape has not seen an improvement in the standard of care platinum-based chemotherapy in over 25 years. Furthermore, prior to the OVATION 2 study, there has never been an overall survival benefit observed in a frontline ovarian cancer clinical trial. In addition, and importantly, clinical data from OVATION 2 across all endpoints and key subgroups have shown a consistent outcome favoring IMNN-001. And while not powered for statistical significance, our trial has shown unprecedented improvement in overall survival. Patients in the intent-to-treat population who were administered IMNN-001 plus the standard of care, neoadjuvant and adjuvant chemotherapy achieved a median increase in overall survival of 13 months compared to the standard of care alone. This is 46 months versus 33 months with a hazard ratio of 0.69, a 45% improvement. Use of PARP inhibitors as part of maintenance therapy further enhanced outcomes with median overall survival not yet reached in the IMNN-001 treatment arm after more than five years for many patients versus 37 months median overall survival in the control arm with a hazard ratio of 0.38. We are advancing rapidly and have a great potential to redefine treatment for women with advanced ovarian cancer. I'm delighted to share that our Phase III pivotal study of IMNN-001, which we refer to as OVATION 3, has had an impressive start. This builds directly on the strong data from our OVATION 2 study, which was showcased in an oral platform presentation at the recent ASCO Annual Meeting and was simultaneously published in the peer-reviewed journal, Gynecologic Oncology. Should results from the Phase III trial replicate these Phase II results, IMNN-001 could offer a transformative immune system engaging therapy that extends life meaningfully for patients. OVATION 3, our pivotal Phase III trial is gaining traction in the medical community as a vital advancement for frontline treatment in a population with few options. The ASCO presentation and Gynecologic Oncology publication validate the robust evidence supporting IMNN-001 potential as evidenced by a couple of things: number one, direct comments to the milestone that OVATION 2 has delivered for ovarian cancer made in the Q&A portion of the live ASCO session. Number two, inclusion of IMNN-001's results in ASCO's highlights by medical journalists. And finally, interest expressed by principal investigators around the world to participate in our Phase III trial. We are poised to contribute significantly to oncology's future, and I hope this excitement is shared. I'll now provide an update on recent progress with IMNN-001's clinical and regulatory status. Our collaboration with clinical investigators remain strong and clearly is visible by the high interest and commitment to enrollment. A standout achievement is the speed of our Phase III launch. Industry benchmarks show an average of 28 weeks from protocol approval to enrollment opening, but we accomplished this in 15 weeks for OVATION 3, almost half of the time. This reflects our team's agility and both patient and investigators' enthusiasm. I want to congratulate Douglas and his team for this great start to the trial. To date, three sites have been activated, and we have randomized and treated our first patient last week. OVATION 3 evaluates IMNN-001 combined with the standard of care in neoadjuvant and adjuvant paclitaxel and carboplatin chemotherapy, which is administered before and after interval debulking surgery. And this is compared to the standard of care alone in newly diagnosed treatment-naive women 18 years of age or higher with advanced ovarian cancer. Participants are randomized 1:1, including a subgroup with homologous recombination deficiency or HRD-positive status, including BRCA1 and BRCA2 mutations in these women received PARP inhibitors and maintenance therapy. The primary endpoint is overall survival with secondary endpoints, including surgical response score, chemotherapy response score, clinical response and time to second-line treatment. Exploratory endpoints such as quality-of-life measures will inform future pricing and payer discussions globally. We believe overall survival as the primary endpoint provides a clear path to approval without needing a follow-up study. In addition, it supports potential European registration alongside our orphan designations in both Europe and U.S. The initial group of sites that will be activated this year, many from the prior OVATION 1 and OVATION 2 studies are highly motivated by the data we have produced to date. We plan to expand enrollment with new sites, which we anticipate will boost recruitment, positioning IMNN-001 as a potential new standard if Phase III confirms OVATION 2 safety and efficacy. Our flexible strategy supports a 500-patient all-comers trial or a 250-patient HRD-positive subgroup, both with 95% power or higher on the primary endpoint for an FDA approval. We're starting the trial with a 250-patient HRD-positive subgroup identified through central laboratory biomarker testing, which will reduce the cost by 40% and enable early stopping for efficacy for successful milestones. This population addresses half of the neoadjuvant population, and we may expand to the 500-patient all-comers population later budget permitting. To keep OVATION 2's momentum alive and mid-Phase III, the ASCO oral presentation delivered by Dr. Premal H. Thaker and the simultaneous publication in Gynecologic Oncology, two preeminent platforms highlight the need for new therapies and the promise of our TheraPlas platform. Preparing for these disclosures, we dove further into the OVATION 2 data, we discovered that in addition to unprecedented survival data and consistency of data with all clinical endpoints and key subgroups favoring IMNN-001, we learned that all patients in the experimental arm, those treated with IMNN-001, remained progression-free during the treatment protocol, while progressions were observed in the control arm. I'll now hand the call over to Dr. Douglas Faller, IMUNON's Chief Medical Officer, to comment further on the excitement from the medical community from ASCO and to share insights on OVATION 3, including with the discussions that you're having with investigators during site activation and enrollment. Douglas?

Thank you, Stacy. This is really an exhilarating period for IMUNON. Beyond our ASCO podium presentation and the journal publication of OVATION 2 results, we were invited to share new OVATION 2 data at the International ESMO Gynaecological Cancers Meeting in June. And we'll also be delivering trial in progress presentations at both the full ESMO Annual Congress in October 2025 and at the International Gynecologic Society International Congress in November 2025. Additionally, in the last few days, we've also had invitations to present the newer translational data from OVATION 2 at two major scientific conferences this fall. Starting with the ESMO conference, I had the honor to present data which confirms that IMNN-001 delivers targeted IL-12 gene therapy to tumors with minimal systemic exposure. This underpins both the safety and the efficacy that we've seen in the OVATION 2 trial. New insights we presented at that meeting demonstrated marked infiltration of immune cells, including antitumor lymphocytes and reprogrammed macrophages into the peroneal areas that previously contained ovarian tumor after the patients have been treated with IMNN-001. In many cases, no remaining tumor tissue could be observed pathologically. Turning to the OVATION 3 trial. As Stacy mentioned, we've activated three clinical sites with additional site activations on deck, including tomorrow morning. Many of the top institutions and investigators from OVATION 2 are rejoining OVATION 3, driven by their confidence in IMNN-001's benefits. They are eager to advance our innovative therapy. As a result of our presentations at ASCO and ESMO Gynaecological Conference, we're actually getting calls from investigators around the country and internationally asking if they could participate in our study. This is certainly unusual in my experience and very encouraging. The ability to employ a tumor-targeted immune therapy in the neoadjuvant setting holds great appeal among gynecologic oncologists and medical oncologists. I'm also very pleased to report, as Stacy mentioned, that we enrolled our first patient in OVATION 3 on July 25, 2025. Our seasoned clinical team is thrilled with the progress, and we're planning further trial expansion in the coming months. Back to you, Stacy.

Thanks, Douglas. Actually, before I proceed with a few comments around our plans to finance OVATION 3, Khursheed, I wonder if you'd like to make any additional perspective, provide your thoughts on our translational data. Khursheed?

Sure, Stacy. Yes, the outstanding survival benefits we have seen in OVATION 2 indeed are supported by the recent translational work. First, the local increases in cytokines in peritoneal space and not as much in blood following IMNN-001 administration supports the drug objectives in achieving local effects without producing systemic toxicity. Second, the immunological changes in the tumor microenvironment that Douglas has described provide mechanistic insight into how the increase in local cytokine levels by IMNN-001 translates into antitumor activity at tumor microenvironment, which is not only driving the IMNN-001 action, but could also promote actions of other immune agents such as checkpoint inhibitors. We are truly excited to see continued development of IMNN-001. Thank you, Stacy.

Khursheed, I know we'll have a lot more to say about our translational data, which we're quite excited about in addition to our clinical, and we can certainly take more questions as they come. And for those of you that have been following IMUNON over time, you'll know that Khursheed, our Chief Scientific Officer, has been central to many parts of our business, including the translational strategy. So I appreciate those insights. Turning to financing, the OVATION 3 study. I want to reflect on the fact that we have been caught in a challenging capital markets environment, along with many other companies. Our strategy to emerge out of this turmoil in a stronger position is being followed almost exactly as we planned. Our priorities are to optimize outcomes for all stakeholders, including shareholders, while raising sufficient capital for our development goals. We recognize that dilution is a top concern for our shareholders, particularly as a biotech company that must raise capital to advance our promising Phase III program. We are fully committed to minimizing shareholder dilution wherever possible while acknowledging that not every financing option will be ideal. To this end, we're actively pursuing nondilutive strategies and working to attract long- term institutional investors who align with our vision and can support sustainable growth for all stakeholders. I'll provide an update on these fronts, but first, I'm excited to announce that we have introduced a onetime stock dividend designed to enhance shareholder value and to underscore our strong confidence in IMUNON's long-term growth potential. This initiative will benefit shareholders of record as of August 7, two days from now, by distributing a 15% dividend in common stock, effectively increasing their ownership stake without any cash outlays from the company. As a late-stage pre-revenue biotech firm dedicated to advancing transformative therapies like IMNN-001, this forward-thinking strategy aligns with our commitment to minimizing unnecessary dilution while promoting a greater liquidity and accessibility to our stock. By thoughtfully increasing the number of shares outstanding, we aim to broaden our investor base spark heightened demand and drive sustainable value creation for all stakeholders as we advance through our Phase III milestones and beyond. Since June 30, 2025, we bolstered our balance sheet by adding more than $3 million through the exercise of warrants and sale of shares off of our ATM facility. Carefully balancing stakeholder needs and minimizing dilution, we continue to prioritize partnerships and aim to expand our institutional investor base to extend our cash runway for clinical and strategic objectives. We've implemented cash conservation methods, including reducing monthly rent commitments, reducing G&A expenses, aligning resources with priorities by removing work not contributing to regulatory approval and commercial launch of IMNN-001 and pursuing value-enhancing opportunities. Our financing and partnership efforts include advancing the TheraPlas technology through discussions with potential partners who are oncology leaders, which include meetings held in person at ASCO, some under CDA, exploring geographic partnerships to speed IMNN-001 development globally, leveraging PlaCCine, our DNA vaccine platform's proof-of-concept data for potential sale or licensing, highlighting its advantages of stability, a year at refrigerated temperatures of 4 degrees centigrade or one month at room temperature or 37 degrees centigrade. Rapid adaptability from a manufacturing standpoint, durable protection. We had six months durability, you'll recall discussed in our recent earnings call and cost-effective production. We presented PlaCCine insights at AACR, the American Association for Clinical Research Annual Meeting and the World Vaccine Congress in April 2025 and are engaging vaccine companies. We'll provide updates on these efforts as they progress. The goal is to fund OVATION 3 through partnerships and equity. Partnerships take time to develop. And while I can't share more at this time, we are seeing interest. On our NASDAQ listing, we're pleased to confirm that we've received support from NASDAQ staff as we implement our compliance plan to return to full compliance. Following the NASDAQ hearing panel in early July of this year, we were granted additional time, time that was tailored to what we need to regain compliance. The panel noted that IMUNON has already achieved compliance with shareholder equity rule through recent fundraising activities, and we anticipate that we will meet the minimum bid price requirement as early as this Friday when the share price is expected to remain above $1 for 10 consecutive days. We'll provide an update to the hearing panel on the status of compliance with the bid price rule on August 8, and we'll update the hearing panel on the status of our strategy to maintain compliance on shareholder equity requirement in the second half of August. I am confident in our actions and that they will continue to provide a platform that will deliver long-term value for our shareholders. Now I'll turn it over to Kim Graper. Kim, if you will review our second quarter 2025 financial results.

Thank you, Stacy. Detail of IMUNON's second quarter 2025 financial results are included in the press release, which we issued this morning and in our Form 10-Q, which we filed before the market opened this morning. As of June 30, 2025, cash and cash equivalents were $4.7 million. Following the end of the second quarter, the company received approximately $3 million of net proceeds from the exercise of warrants and sales under its ATM facility. The ATM facility carries a nominal 3% fee with no warrants. R&D expenses were $1.2 million for Q2 2025, down from $2.8 million in the same period last year. primarily due to completion of the OVATION 2 study and lower costs associated with the Phase I PlaCCine DNA vaccine trial and development costs for the PlaCCine DNA vaccine technology platform. G&A expenses were $1.5 million in Q2 2025, down from $2.2 million in the same period last year due to lower employee-related and legal expenses. Net loss for Q2 2025 was $2.7 million or $2.15 per share compared to $4.8 million or $7.64 per share in the second quarter of 2024. Please note that all share amounts and per share amounts have been adjusted to reflect a 15-for-1 reverse stock split of our common stock, which we effected on July 25, 2025. With that financial review, I'll turn the call back to Stacy.

Thank you, Kim. And with that, I'd like to open the call to your questions. Darwin?

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

Congrats on the progress with the Phase III trial. I know you talked a bit about the enthusiasm from the investigator side with the Phase III trial. I was curious if you could talk a bit about initial demand from the patient side, if these investigators have, say, a set of patients that they'd initially like to enroll on the trial? And I guess, how you're kind of thinking about pace of patient enrollment, specifically in the HRD subset of patients that you spoke about? And then I'll ask a follow-up after.

Douglas, do you want to take this?

I'd be happy to. The first part of your question was about whether investigators have patients for this study. And there are a couple of parts to the answer. One is, as I'm sure you know, because we've said it many times before, improvements in frontline treatment in ovarian cancer have really not changed for 25 years. We're treating patients the same way we treated patients when I was a medical student. This has helped people, but it has certainly not been enough. There have been many efforts to improve frontline treatment of patients with ovarian cancer. But the most recent ones, including using checkpoint inhibitors, all four of them, large Phase III studies failed in the last year. And there really is very little now for patients. So we believe that the demand and the opportunity for our Phase III study is high. Let me also mention, though, since I said that the checkpoint inhibitors have not worked, that is an immunotherapy, but it is completely different than our approach. The checkpoint inhibitors depend on having a tumor that is immunologically hot and inflamed, ovarian cancer is not. We, on the other hand, are using a therapy, IL-12, which actually activates and causes, let's say, inflammation immune activity in the tumor cell and in the tumor microenvironment. So our approach gets around the problems that led to checkpoint inhibitors not being active. The second part of your question involved our interest in the HRD population. Stacy mentioned that a focus on this is likely to give us the strongest signal and the strongest benefit in patients with ovarian cancer. About 50% of frontline patients with ovarian cancer are HRD mutant. And so this represents half of the entire population of ovarian cancer patients, frontline who are underserved currently.

Got it. Okay. Also, I guess, on the expenses side, it looks like your operating expenses declined pretty significantly this quarter. Can you just talk a bit about how you're expecting expenses to change for the remainder of the year as you're kind of bumping up enrollment in the Phase III trial?

Yes, Emily, as you point out, yes, our expenses have declined. That is in part due to the PlaCCine proof-of-concept trial that was concluded and that we're not starting any new work on that front. OVATION 2, as you know, is also winding down, and we're closing sites on a monthly basis as the sites reach the point of no longer having patients ongoing. But really, we've been very diligent to control cost and to make sure that we're allowing the time that we need to fund -- to fully fund our trial. And that's been -- that's proven to be very important. I think it's also very critical for our staff to understand that we're investing in places we need to invest, and we're minimizing other expenses. In terms of the OVATION 3 trial cost, as you know, in advance of starting the trial, we, of course, had to manufacture and produce active pharmaceutical ingredients, which we're doing in-house ahead of the final fill and finish well in advance of the first patient being enrolled. So the investment in start-up costs with OVATION 3 really proceeded well in advance of the first patient. And as a result, really, we're manufacturing in a manner that is modeling and planning for enrollments. We'll be monitoring them in real time. And so we'll really see fairly stable expenses that will continue consistent with, I think, what you're seeing in our filing from this Q.

Our next question comes from Will Hidell with Brookline Capital Markets.

I have two questions. One, the combination study with Avastin, is that still on track for enrollment? I think the updated number is 15 patients as of June. Is that going as expected?

So we have -- we are continuing to enroll patients. We have increased the number that has -- that have been treated and have some recent activities that have been long underway that are going to give added strength to this trial's speed of enrollment. So we have a site that was part of the OVATION 2 trial and is a PI that is quite familiar with IMNN-001 and enrolled extremely well that will be -- I'm being assured by lawyers on both sides that this contract really is ready to sign and is just going through the finishing touches. And in discussions with our other PIs, MD Anderson is continuing to enroll incredibly well at rates that are far, far above the OVATION 2 numbers as a trial as a whole. And we have Memorial Sloan Kettering that has met their internal goals and will be continuing -- have set new goals before the end of the year. So we're -- frankly, we'd love to see this trial be increasing in speed. We have a corporate goal for this year, which we are, I would say, observing and working very closely with the sites to see if we're able to get it done. But we do have some changes as I've just gone through that leave us optimistic that we'll be able to get to the $35 million that we want to have by the end of the year, but we'll give updates over time.

Okay. And then a quick clarification question. The $3 million raised during the quarter between the warrants and ATM, what was the mix between exercised warrants and the ATM?

Yes. Kim, would you like to take this?

Yes. The mix between the ATM and the warrants was very close to 50-50 each with $1.5 million.

Our next question comes from David Bautz with Zacks Small-Cap Research.

So I have a couple on the clinical trial sites. What needs to be done for any remaining sites that want to be open? Basically, what I'm asking, is it just financing that's holding that up at this point? And you also indicated that positive results from the OVATION 3 study may set you up for filing in the EU. My question is, will the EU require to open any sites over there during the trial? Or does the company have any plans to open sites over there?

Why don't you take the second question first, Douglas?

Okay. It is -- it's not been absolutely necessary for the EU that there will be patients enrolled in a study for them to give approval. The issues -- most of the issues with approval in the EU have been with trials that don't have OS as an endpoint. And so demonstrating an OS benefit in a disease like this should not present any difficulties for approval in the EU. We are considering sites in Europe. We have collectively a great deal of experience in working with sites in Europe, I know many of the investigators. And so that is something we are considering as we expand and hopefully accelerate OVATION 3. But in my experience, it's not been necessary to enroll patients in the EU.

And the first question was related to what's required to open additional sites. And I guess I'll -- maybe I'll start, and Douglas, please add. I mean I think it's very common that you have a plan of kind of a time line around activating sites. It is -- you want to move quickly, but it needs to be staged and I think ordered. And so we have the three sites that are activated, as Douglas shared, we expect another site to be activated tomorrow. And in the reviews that I'm getting every single week, we have an additional three that have been selected and are very close to being activated, four that have been selected and that we expect could be activated in the near future and then so on and so on. So there's just a natural order to the activations. Douglas, I don't know if you want to add anything more.

Well, you asked if there were any barriers and the answer to that is no. We're actually getting requests. The only barriers I would mention are we're getting requests internationally. And right now, we're simply not -- we want to activate our U.S. sites and Canadian sites. before thinking about international activations.

Our next question is from James Molloy with Alliance Global Partners.

I had a question on the HRD screening, does that potentially slow or speed up? I know, obviously, the idea being you can look at a smaller group. But does that hamper the potential enrollment to go through this process? And just a follow-up on the previous question. Is the HRD positive if you have positive interim data, is that only a potential for EU approval? I thought -- I apologize. I thought it was also potentially FDA filing as well -- fileable as well.

So, did you want to start?

Go ahead. No. Please, go ahead.

So with respect to the second question, HRD as a biomarker would be certainly acceptable to the EU. The EU is as interested or EMA is as interested in having biomarker-driven approvals as the U.S. is. And having said that, I actually forgot your first question, I apologize.

It was the screening...

The screening. Excellent, excellent question. In some -- well, first of all, screening for HRD is standard of care for newly diagnosed patients with ovarian cancer because it determines their maintenance, doesn't determine their frontline therapy, but does determine what they would get in maintenance or if they would get maintenance. We have gone to great lengths to work with our partner, Foundation Medicine to deliver results from HRD extremely quickly. We have no interest in delaying treatment of patients or delaying patients starting on the trial. And so far, we've not had any issues with this. Foundation prioritizes our assays so that patients will get tested, randomized and treated quickly.

Excellent. And I know you guided to potentially having 20 sites open by year-end, again, I guess, funding dependent. Just a quick follow-up too on the Avastin trial. When can we potentially expect the next interim look or the next data set coming out of that trial? I know it's run through the Break Through Cancer Foundation, you have less control over that.

We have a call with the study PI actually coming up very soon. The last time we met to discuss the potential, there were some cutting- edge assays that he was particularly interested in, and we're excited to talk to him about the viability of translational data from the trial being able to be released in a scientific forum, but we're in regular contact with the sites. So, do you want to add anything?

Well, I would just add that we've already gotten some very useful information from this trial. One of our goals for this was to determine if and how we can use bevacizumab in combination with IMNN-001. Bev, as you know, is an anti-angiogenic antibody. It's used in ovarian cancer to some extent, but has never improved survival on its own. But it's something that we've been interested in combining with IMNN-001. So we established that we can combine the combination is safe. And we've also shown in early -- very early findings that we have a second look laparoscopy, what appears to be benefit from -- in the patients who got IMUNON and both arms getting bevacizumab.

Great. And final question would be, I know it's hard to discuss, but could you talk a little bit about the potential partnership environment and how things are looking in the current overall environment?

Yes. I mean it is hard to go much more than what I've already shared in my prepared remarks, Jim. But we are facing interest. In fact, we're even getting incoming calls. And again, as I shared in my prepared remarks, we have an interest in any business opportunity that makes sense for our company and our shareholders, which include dimensions of accelerating development in geographic locations outside of the U.S. in thinking about new indications that could proceed with our technology platform. We know that it is a very exciting and very broadly applicable to many large tumors. I'm sure Douglas would love to talk to you about our thoughts and dreams along those lines. And of course, to come alongside as a partner in our Phase III plan. So we are having discussions. We are pursuing follow-up conversations, but they do take time. So unfortunately, I can't go into any greater detail at this time.

[Operator Instructions] We have no further questions at this time. I would now like to turn the conference back over to Dr. Stacy Lindborg for any closing remarks.

I want to thank you all for your questions. Maybe just a couple of concluding remarks. We remain focused on funding to fortify our position and to progress IMNN-001 through our pivotal trial, OVATION 3. We aim to fund this trial through partnerships and equity iteratively building on catalysts and milestones. And as we advance ovarian cancer treatment and our DNA-based technology platform, along with vaccine innovations more broadly, we can tell you we are eager to share upcoming data and updates. We thank you for your insightful comments and questions on this call and look forward to future discussions. So thank you for joining and for your interest in IMUNON.

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