Earnings call transcript: Imunon Q2 2025 highlights EPS miss, stock dips

Published 05/08/2025, 19:38
 Earnings call transcript: Imunon Q2 2025 highlights EPS miss, stock dips

Imunon Inc. reported its second-quarter earnings for 2025, revealing a significant earnings per share (EPS) miss compared to forecasts. The company posted an EPS of -$2.15, far below the expected -$0.32, marking a surprise of 571.88%. Following the earnings announcement, Imunon’s stock fell by 3.8% in regular trading and an additional 6.52% in pre-market activity, reflecting investor concerns over the larger-than-expected loss. According to InvestingPro data, the stock’s beta of 2.16 indicates significantly higher volatility than the broader market, with the company currently trading above its Fair Value estimate. InvestingPro subscribers have access to 14 additional key insights about Imunon’s financial health and market position.

Key Takeaways

  • Imunon missed EPS forecasts by a significant margin.
  • Stock declined nearly 10% in total, factoring in pre-market trading.
  • The company is advancing its OVATION III Phase 3 trial for ovarian cancer.
  • Cost-cutting measures led to reduced R&D and G&A expenses.
  • Imunon is pursuing strategic financing to regain NASDAQ compliance.

Company Performance

Imunon is navigating a challenging period, marked by a substantial net loss of $2.7 million, or $2.15 per share, for Q2 2025. This is an improvement from a net loss of $4.8 million, or $7.64 per share, in the same quarter of 2024. The company has made strides in reducing costs, with R&D and G&A expenses down significantly from the previous year.

Financial Highlights

  • Revenue: Not disclosed
  • Earnings per share: -$2.15 (compared to -$7.64 in Q2 2024)
  • Cash and cash equivalents: $4.7 million as of June 30, 2025
  • R&D expenses: $1.2 million (down from $2.8 million in 2024)
  • G&A expenses: $1.5 million (down from $2.2 million in 2024)

Earnings vs. Forecast

Imunon’s EPS of -$2.15 fell short of the forecasted -$0.32, resulting in a surprise of over 570%. This significant miss contrasts with the company’s previous quarters, where earnings were more aligned with expectations.

Market Reaction

The market reacted negatively to Imunon’s earnings report, with the stock price dropping by 3.8% during regular trading hours. In pre-market trading, the stock fell an additional 6.52%, bringing the price down to $8.60. This movement places the stock closer to its 52-week low of $5.55. InvestingPro metrics show the stock has declined nearly 50% over the past year, with a current ratio of 0.88 indicating potential liquidity concerns. The stock’s price movements have been notably volatile, which is one of several key insights available to InvestingPro subscribers analyzing this biotech company.

Outlook & Guidance

Imunon is focused on advancing its OVATION III Phase 3 trial and expanding its clinical trial sites to 20 by the end of the year. The company is also exploring non-dilutive financing strategies and potential partnerships for global expansion. Future EPS forecasts for FY 2025 and FY 2026 are projected at -$14.77 and -$23.17, respectively.

Executive Commentary

Stacy Lindborg, CEO, acknowledged the "challenging capital markets environment" affecting the company. Douglas Fowler, CMO, emphasized the stagnant nature of ovarian cancer treatments over the past 25 years and highlighted Imunon’s innovative approach to overcoming the limitations of previous therapies.

Risks and Challenges

  • Financial instability due to ongoing net losses.
  • Regulatory hurdles in gaining EU and FDA approvals.
  • Competitive pressures within the oncology treatment market.
  • Dependence on successful clinical trial outcomes.
  • Market volatility impacting stock price and investor confidence.

Q&A

During the earnings call, analysts inquired about the level of investigator interest in the OVATION III trial and the rapid HRD screening process. Imunon executives also discussed ongoing discussions regarding potential partnerships and international expansion opportunities.

Full transcript - Imunon Inc (IMNN) Q2 2025:

Dovan, Conference Call Operator: Good morning. My name is Dovan, and I will be your operator today. At this time, I would like to welcome you to ImmuNon’s Second 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.

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

Peter Voso, ICR Healthcare Investor Relations Representative, ICR: Thank you, Dolan. Good morning, everyone, and welcome to Immunon’s second quarter twenty twenty five financial results and business update conference call. During today’s call, management will be making forward looking statements regarding Immuunon’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, 08/05/2025. 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 Doctor. Stacy Lindborg, Immunon’s President and Chief Executive Officer.

Stacy?

Stacy Lindborg, President and Chief Executive Officer, ImmuNon: Thank you, Peter, and good morning, everyone. Joining me on the call this morning is Doctor. Douglas Foller, Immuneon’s Chief Medical Officer and Ms. Kimberly Graefer, our Interim Chief Financial Officer, who will review our financial results for the second quarter twenty twenty five. Mr.

Michael Chardugna, the Executive Chairman of our Board and Doctor. Khurshid Arnoire, our Chief Scientific Officer are on the line and will be available for Q and A. I want to begin by reviewing our progress and harnessing the potential of IMMUNAR-one, our gene mediated IL-twelve 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 twenty five years. Furthermore, prior to the OVATION II 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 II across all endpoints and key subgroups have shown a consistent outcome favoring IMMUN-one. 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 IMMUN-one plus the standard of care neoadjuvant and adjuvant chemotherapy achieved a median increase in overall survival of thirteen months compared to the standard of care alone. This is forty six months versus thirty three months with a hazard ratio of 0.69, a forty five percent improvement. Use of PARP inhibitors as part of maintenance therapy further enhanced outcomes with median overall survival not yet reached in the Immuno-one treatment arm after more than five years for many patients versus thirty seven 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 three pivotal study of IMMUN-one, which we refer to as OVATION three has had an impressive start.

This builds directly on the strong data from our OVATION two 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 three trial replicate these Phase two results, IMMUN-one could offer a transformative immune system engaging therapy that extends life meaningfully for patients. OVATION three, 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 IMMUNON-one potential as evidenced by a couple of things. Number one, direct comments to the milestone that OVATION II has delivered for ovarian cancer made in the Q and A portion of the live ASCO session.

Number two, inclusion of IMMUN-one’s results in ASCO’s highlights by medical journalists. And finally, interest expressed by principal investigators around the world to participate in our Phase three 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 IMMUNON-one’s clinical and regulatory status. Our collaboration with clinical investigators remains strong and clearly is visible by the high interest and commitment to enrollment.

A standout achievement is the speed of our Phase three launch. Industry benchmarks show an average of twenty eight weeks from protocol approval to enrollment opening, but we accomplished this in fifteen weeks for OVATION three, 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 three evaluates MNON-one combined with the standard of care neoadjuvant and adjuvant paclitaxel and carboplatin chemotherapy, which is administered before and after interval to bulking 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 one to one, 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 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 of 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 one and OVATION two 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 IMMUNON-one as a potential new standard if Phase three confirms OVATION II safety and efficacy. Our flexible strategy supports a 500 patient all comers trial or a two fifty 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 two fifty 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 II’s momentum alive amid Phase III, the ASCO oral presentation delivered by Doctor.

Premel H. Thacker and the simultaneous publication in gynecologic oncology platforms highlight the need for new therapies and the promise of our Theraplast platform. Preparing for these disclosures, we dove further into the OVATION two data and we discovered that in addition to unprecedented survival data and consistency of data with all clinical endpoints and key subgroups favoring IMMUN-one, we learned that all patients in the experimental arm, those treated with IMMUN-one remained progression free during the treatment protocol, while progressions were observed in the control arm. I’ll now hand the call over to Doctor. Douglas Fowler, IMMUNON’s Chief Medical Officer to comment further on the excitement from the medical community from ASCO and to share insights on OVATION three including with the discussions that you’re having with investigators during site activation and enrollment.

Douglas?

Douglas Fowler, Chief Medical Officer, ImmuNon: Thank you, Stacy. This is really an exhilarating period for Immuneon. Beyond our ASCO podium presentation and the journal publication of OVATION II results, we were invited to share new OVATION II data at the International ESMO Gynecological Cancer Meeting in June. We will also be delivering trial and progress presentations at both the full ESMO Annual Congress in October 2025 and at the International Gynecological 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 two at two major scientific conferences this fall.

Starting with the ESMO conference, I had the honor to present data which confirms that IMMUN-one delivers targeted IL-twelve gene therapy to tumors with minimal systemic exposure. This underpins both the safety and the efficacy that we’ve seen in the OVATION II trial. New insights we presented at that meeting demonstrated marked infiltration of immune cells including anti tumor lymphocytes and reprogrammed macrophages into the peritoneal areas that previously contained ovarian tumor after the patients have been treated with IMMUNON-one. In many cases, no remaining tumor tissue could be observed pathologically. Turning to the OVATION three trial, as Stacy mentioned, we’ve activated three clinical sites with additional site activations on deck including one tomorrow morning.

Many of the top institutions and investigators from OVATION two are rejoining OVATION three driven by their confidence in IMMUNON-one’s benefits. They are eager to advance our innovative therapy. As a result of our presentations at ASCO and ESMO Gynecological 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 a 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 III on 07/25/2025. Our seasoned clinical team is thrilled with the progress and we’re planning further trial expansion in the coming months. Back to you, Stacy.

Stacy Lindborg, President and Chief Executive Officer, ImmuNon: Thanks, Douglas. Actually before I proceed with a few comments around our plans to finance OVATION three, Khurshid, I wonder if you’d like to make any additional perspective, provide your thoughts on our translational data. Prasheet?

Khurshid Arnoire, Chief Scientific Officer, ImmuNon: Sure, Stacy. Yes, the outstanding survival benefits we have seen in OVATION two indeed are supported by the recent translational work. First, the local increases in cytokines in peritoneal space and not as much in blood following IMMINAN zero one 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 IMMN-nine thousand and one translates into antitumor activity at tumor microenvironment, which is not only driving the IMMN-one action, but could also promote actions of other immune agents such as checkpoint inhibitors. We are truly excited to see continued development of IMMN-one.

Thank you, Stacy.

Stacy Lindborg, President and Chief Executive Officer, ImmuNon: Thank you. Appreciate it. 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 Immuno overtime, you’ll know that Khrusheed, 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 three 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 three 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 non dilutive 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 one time stock dividend designed to enhance shareholder value and to underscore our strong confidence in Immuneon’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 MN-one thousand and one, 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 three milestones and beyond.

Since 06/30/2025, we bolstered our balance sheet by adding more than $3,000,000 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 and A expenses, aligning resources with priorities by removing work not contributing to regulatory approval and commercial launch of IMMUN-one and pursuing value enhancing opportunities. Our financing and partnership efforts include advancing the TheraPlus 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 IMMN-one hundred and one development globally Leveraging Placine, our DNA vaccine platforms proof of concept data for potential sale or licensing, highlighting its advantages of stability, a year refrigerated temperatures of four degrees centigrade or one month at room temperature of 37 degrees centigrade. Rapid adaptability from a manufacturing standpoint, durable protection, we had six months durability or recall discussed in recent earnings call and cost effective production.

We presented Placine 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 three 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 Immuneon has already achieved compliance with the 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 ten consecutive days. We’ll provide an update to the hearing panel on the status of compliance with the bid price roll on August 8, and we’ll update the hearing panel on the status of our strategy to maintain compliance on shareholder equity requirements in the August. I’m confident in our actions and that they will continue to provide a platform that deliver long term value for our shareholders. Now I’ll turn over to Kim Graecker.

Kim, if you will review our second quarter twenty twenty five financial results.

Kimberly Graefer, Interim Chief Financial Officer, ImmuNon: Thank you, Stacy. Detail of ImmuNon’s second quarter twenty twenty five 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 06/30/2025, cash and cash equivalents were $4,700,000 Following the end of the second quarter, the company received approximately $3,000,000 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 and D expenses were $1,200,000 for Q2 twenty twenty five, down from $2,800,000 in the same period last year, primarily due to completion of the OVATION II study and lower costs associated with the Phase I Plaxin DNA vaccine trial and development costs for the Plaxin DNA vaccine technology platform.

G and A expenses were $1,500,000 in Q2 twenty twenty five, down from $2,200,000 in the same period last year due to lower employee related and legal expenses. Net loss for Q2 twenty twenty five was $2,700,000 or $2.15 per share compared to $4,800,000 or $7.64 per share in the 2024. Please note that all share amounts and per share amounts have been adjusted to reflect a 15 for one reverse stock split of our common stock, which we affected on 07/25/2025. With that financial review, I’ll turn the call back to Stacy.

Stacy Lindborg, President and Chief Executive Officer, ImmuNon: Thank you, Kim. And with that, I’d like to open the call to your questions. Dorwin?

Dovan, Conference Call Operator: Certainly. Thank you. We will now begin the question and answer session. Our first question comes from Emily Bodnar with H. C.

Wainwright. Please go ahead.

Emily Bodnar, Analyst, H.C. Wainwright: Hi, good morning. Thanks for taking the questions and congrats on the progress with the Phase three trial. I know you talked quite a bit about sorry?

Stacy Lindborg, President and Chief Executive Officer, ImmuNon: I just didn’t thanks, Emily. Please continue. I

Emily Bodnar, Analyst, H.C. Wainwright: 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 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.

Stacy Lindborg, President and Chief Executive Officer, ImmuNon: Douglas, do want to take this?

Douglas Fowler, Chief Medical Officer, ImmuNon: 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 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 twenty five 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 three 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 three 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 inflamed. Ovarian cancer is not. We on the other hand are using a therapy IL-twelve 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 fifty percent 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.

Emily Bodnar, Analyst, H.C. Wainwright: 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?

Stacy Lindborg, President and Chief Executive Officer, ImmuNon: Yes, Emily. As you point out, yes, our expenses have declined and that is in part due to the Placine proof of concept trial that concluded and that we’re not starting any new work on that front. OVATION II, 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 three 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 startup cost with OVATION three 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.

Emily Bodnar, Analyst, H.C. Wainwright: Okay, great. Thanks for answering questions.

Stacy Lindborg, President and Chief Executive Officer, ImmuNon: Thank you. Thanks, Emily.

Dovan, Conference Call Operator: Our next question comes from Will Heidel with Brookline Capital Markets. Please go ahead.

Peter Voso, ICR Healthcare Investor Relations Representative, ICR: Hi, thank you for taking the questions. 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?

Stacy Lindborg, President and Chief Executive Officer, ImmuNon: 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 II trial and is a PI that is quite familiar with IMMUN-one 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 credibly well at rates that are far above the OVATION II 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 I’ve just gone through that leave us optimistic that we’ll be able to get to the 35 that we want to have by the end of the year, but we’ll give updates over time.

Peter Voso, ICR Healthcare Investor Relations Representative, ICR: Okay. Thank you. And then a quick clarification question. The $3,000,000 raised during the quarter between the warrants and ATM, what the mix between exercise warrants and the ATM?

Stacy Lindborg, President and Chief Executive Officer, ImmuNon: Yes. Kim, would you like to take this?

Kimberly Graefer, Interim Chief Financial Officer, ImmuNon: Yes. The mix between the ATM and the warrants was very close to fiftyfifty, each with $1,500,000

Will Heidel, Analyst, Brookline Capital Markets: Okay, great.

Peter Voso, ICR Healthcare Investor Relations Representative, ICR: Thank you.

Stacy Lindborg, President and Chief Executive Officer, ImmuNon: Thanks Will.

Dovan, Conference Call Operator: Our next question comes from David Botz with Zacks Small Cap Research. Please go ahead.

Will Heidel, Analyst, Brookline Capital Markets: Hey, good morning everybody. Thanks for taking the questions. 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 three 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? Thanks.

Stacy Lindborg, President and Chief Executive Officer, ImmuNon: Why don’t you take the second question first, Douglas?

Douglas Fowler, Chief Medical Officer, ImmuNon: Okay. It is it’s not been absolutely necessary for the EU that there 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 Probation three. But in my experience, it’s not been necessary to enroll patients in the EU.

Stacy Lindborg, President and Chief Executive Officer, ImmuNon: 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 timeline 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.

Douglas Fowler, Chief Medical Officer, ImmuNon: 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.

Will Heidel, Analyst, Brookline Capital Markets: Okay, great. Thanks for taking the questions.

Stacy Lindborg, President and Chief Executive Officer, ImmuNon: Thanks, Our

Dovan, Conference Call Operator: next question is from James Molloy with Alliance Global Partners. Please go ahead.

James Molloy, Analyst, Alliance Global Partners: Hey guys, good morning. Thanks for taking my questions. I had a question on the HRT, 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? Thought I apologize. I thought it was also potentially FDA filing as well fileable as well.

Douglas Fowler, Chief Medical Officer, ImmuNon: Brian, did you want to

Stacy Lindborg, President and Chief Executive Officer, ImmuNon: start Yes, please go ahead.

Douglas Fowler, Chief Medical Officer, ImmuNon: 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.

Stacy Lindborg, President and Chief Executive Officer, ImmuNon: It was the screening.

Douglas Fowler, Chief Medical Officer, ImmuNon: Oh, the screening. 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. It 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.

James Molloy, Analyst, Alliance Global Partners: Excellent. Thank you. And I know you guided to potentially having 20 sites open by year end again is funding dependent. Just a quick follow-up too on the Avastin trial. When can we potentially expect the next interim look or the next dataset coming out of that trial?

I know it’s run through the Breakthrough Cancer Foundation, you have less control over that.

Stacy Lindborg, President and Chief Executive Officer, ImmuNon: 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?

Douglas Fowler, Chief Medical Officer, ImmuNon: 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

Will Heidel, Analyst, Brookline Capital Markets: if

Douglas Fowler, Chief Medical Officer, ImmuNon: and how we can use bevacizumab in combination with IMMUN-one. Beva 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 INBN-one. So we established that we can combine the combination is safe.

And we’ve also shown in early, very early findings that we have second look laparoscopy, what appears to be benefit from in the patients who got immune on and both arms getting bevacizumab.

James Molloy, Analyst, Alliance Global Partners: Great. Thank you. Then final question would be, I know it’s hard to discuss, could you talk a little bit about the potential partnership environment and how things are looking in the current overall environment?

Stacy Lindborg, President and Chief Executive Officer, ImmuNon: Yes. 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 is 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 three 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.

James Molloy, Analyst, Alliance Global Partners: Understood. Thank you very much for taking the questions.

Stacy Lindborg, President and Chief Executive Officer, ImmuNon: Yes. Thank you. Thank

Dovan, Conference Call Operator: We have no further questions at this time. I would now like to turn the conference back over to Doctor. Stacy Lindborg for any closing remarks.

Stacy Lindborg, President and Chief Executive Officer, ImmuNon: Well, I want to thank you all for your questions. Maybe just a couple of concluding remarks. We remain focused on funding to fortify a position and to progress IMMUN-one through our pivotal trial OVATION three. We aim to fund this trial through partnerships and equity iteratively building on catalyst 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 Immuneon.

Dovan, Conference Call Operator: The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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