8/5/2025

speaker
Dhawan
Conference Call Operator

Good morning. My name is Dhawan and I will be your operator today. At this time, I would like to welcome you to Immunon's second quarter 2025 financial results conference call. All lines have been placed on mute to prevent any background noise. Following the speaker's prepared remarks, there will be a question and answer session. You may press star 1 on your phone 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 our equipment. Again, that's star 1 to ask a question during the Q&A session. I would now like to turn the call over to Peter Vozzo of ICR Healthcare, Investor Relations Representative for Immunon. Please go ahead.

speaker
Peter Vozzo
Investor Relations Representative, ICR Healthcare for Immunon

Thank you, Darwin. Good morning, everyone, and welcome to Immunon's second quarter 2025 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, 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. 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, Peter, and good morning, everyone. Joining me on the call this morning is Dr. Douglas Pollard, Immunon's Chief Medical Officer, and Ms. Kimberly Graper, our Interim Chief Financial Officer, who will review our financial results for the second quarter of 2025. Mr. Michael Chardugna, the executive chairman of our board, and Dr. Krishid Anwar, 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 Immunano-01, 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 imunon-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 imunon-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 Immunana O1 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 great potential to redefine treatment for women with advanced ovarian cancer. I'm delighted to share that our phase three pivotal study of Immunon-001, which we refer to as Ovation 3, has had an impressive start This builds directly on the strong data from our Evasion 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 3 trial replicate these Phase 2 results, Immunon-001 could offer a transformative immune system engaging therapy. that extends life meaningfully for patients. Ovation 3, our pivotal phaser 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-001's potential. as evidenced by a couple of things. Number one, direct comments to the milestone that Ovation2 has delivered for ovarian cancer made in the Q&A portion of the live ASCO session. Number two, inclusion of Immunonda 01'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 001'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 28 weeks from protocol approval to enrollment opening, but we accomplished this in 15 weeks for evasion three, almost half of the time. This reflects our team's agility and both patient and investigator's 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. Lobation 3 evaluates imunon-001 combined with the standard of care 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 one-to-one, including a subgroup with homologous recombination deficiency, or HRD-positive status, including BRCA1 and BRCA2 mutations. And these women receive 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 Immunon 001 as a potential new standard if Phase 3 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 amid Phase 3, the ASCO oral presentation delivered by Dr. Premal H. Thakkar 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 Evasion2 data, and we discovered that in addition to unprecedented survival data and consistency of data with all clinical endpoints and key subgroups favoring Immunon-001, We learned that all patients in the experimental arm, those treated with Immunonda O1, 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 Fowler, Immunonda'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?

speaker
Dr. Douglas Pollard
Chief Medical Officer

Thank you, Stacy. This is really an exhilarating period for Immunon. 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 Gynecological Cancer 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 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 2 at two major scientific conferences this fall. Starting with the ESMO conference, I had the honor to present data which confirms that Immunon 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 peritoneal areas that previously contained ovarian tumor after the patients had been treated with Immunon 001. In many cases, no remaining tumor tissue could be observed pathologically. Turning to the Ovation 3 trial, as Stacey 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 2 are rejoining Ovation 3, driven by their confidence in Immunon 001'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 Stacey 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, Stacey.

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

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

speaker
Dr. Krishid Anwar
Chief Scientific Officer

Sure, Stacey. 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 Immunon 401 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 iminine O1 translates into anti-tumor activity at tumor microenvironment, which is not only driving the iminine O1 action, but could also promote actions of other immune agents, such as checkpoint inhibitors. We are truly excited to see continued development of Immunon 01. Thank you, Stacy.

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

Thank you, Krishid. 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 Immunon over time, you'll know that Krishid 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-through 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 Immunon's long-term growth potential. This initiative will benefit shareholders of record as of August 7th, 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 Aminata O1, this forward-thinking strategy aligns with our commitment to minimizing unnecessary dilution while promoting a greater liquidity and accessibility to our stocks. 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 June 30th, 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 Immunon-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 Immunon-001 development globally. Leveraging Placene, 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 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 our 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 our 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 Immunon 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 a dollar for 10 consecutive days. We'll provide an update to the hearing panel on the status of compliance with the bid price roll on August 8th. And we'll update the hearing panel on the status of our strategy to maintain compliance on shareholder equity requirements in the second half of August. I'm 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 over to Kim Graeber. Kim, if you will review our second quarter 2025 financial results.

speaker
Kimberly Graper
Interim Chief Financial Officer

Thank you, Stacey. Detail of Immunon'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 30th, 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 1 Plaxin DNA vaccine trial and development costs for the Plaxin DNA vaccine technology platform. GNA 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 affected on July 25th, 2025. With that financial review, I'll turn the call back to Stacey.

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

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

speaker
Dhawan
Conference Call Operator

Certainly. Thank you. We will now begin the question and answer session. To ask a question, you may press star, then one on your telephone keypad. If you were using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. Our first question comes from Emily Bodnar with HC Wainwright. Please go ahead.

speaker
Emily Bodnar
Analyst, HC 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?

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

Oh, I just said thanks, Emily. Please continue.

speaker
Emily Bodnar
Analyst, HC Wainwright

Oh. I already 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 enrollments. specifically in the HRD subset of patients that you spoke about, and then I'll ask a follow-up after.

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

Douglas, do you want to take this?

speaker
Dr. Douglas Pollard
Chief Medical Officer

I'd be happy to. The first part of your question was about whether investigators have patience 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 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 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-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. Stacey 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.

speaker
Emily Bodnar
Analyst, HC 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 3 trial?

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

Yeah, Emily, as you point out, yes, our expenses have declined. That is in part due to the Placine 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. 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 costs, 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 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 queue.

speaker
Emily Bodnar
Analyst, HC Wainwright

Okay, great. Thanks for answering questions.

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

Thank you. Thanks, Emily.

speaker
Dhawan
Conference Call Operator

Our next question comes from Will Heidel with Brookline Capital Markets. Please go ahead.

speaker
Will Heidel
Analyst, Brookline Capital Markets

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?

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

We are continuing to enroll patients. We have increased the number 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 Immunonta 01 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 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, you know, 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.

speaker
Will Heidel
Analyst, Brookline Capital Markets

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

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

Kim, would you like to take this?

speaker
Kimberly Graper
Interim Chief Financial Officer

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

speaker
Will Heidel
Analyst, Brookline Capital Markets

Okay, great. Thank you.

speaker
Emily Bodnar
Analyst, HC Wainwright

Thanks, Will.

speaker
Dhawan
Conference Call Operator

Our next question comes from David Botts with Zach's Small Cap Research. Please go ahead.

speaker
David Botts
Analyst, Zacks Small Cap Research

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 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?

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

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

speaker
Dr. Douglas Pollard
Chief Medical Officer

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 Ovation3. But in my experience, it's not been necessary to enroll patients in the EU.

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

And the first question was related to what's required to open additional sites. And I guess 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. 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.

speaker
Dr. Douglas Pollard
Chief Medical Officer

Well, and 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.

speaker
David Botts
Analyst, Zacks Small Cap Research

Okay, great. Thanks for taking the questions.

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

Thanks, David.

speaker
Dhawan
Conference Call Operator

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

speaker
James Malloy
Analyst, Alliance Global Partners

Hey guys, good morning. Thank you for taking my questions. 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 to 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?

speaker
Kimberly Graper
Interim Chief Financial Officer

No, please, go ahead.

speaker
Dr. Douglas Pollard
Chief Medical Officer

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 biomarkers driven approvals as the U.S. is. And having said that, I actually forgot your first question. I apologize.

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

It was the screening.

speaker
Dr. Douglas Pollard
Chief Medical Officer

Oh, the screening. Excellent question. 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.

speaker
James Malloy
Analyst, Alliance Global Partners

Excellent. Thank you. And I know you're guided to potentially having 20 sites open by year-end. Again, it's 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 through cancer foundation, you have less control over that.

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

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

speaker
Dr. Douglas Pollard
Chief Medical Officer

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 Immunon 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 immunon-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, in second look laparoscopy, what appears to be benefit from in the patients who got Immunon and both arms getting Bevacizumab.

speaker
James Malloy
Analyst, Alliance Global Partners

Well, great. Thank you. The 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?

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

Yeah, 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, you know, to come alongside as a partner in our Phase 3 plan. So, we are having discussions. We are pursuing follow-up, you know, conversations, but they do take time. So, unfortunately, I can't go into any greater detail at this time.

speaker
James Malloy
Analyst, Alliance Global Partners

Understood. Thank you very much for taking the questions.

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

Yeah, thank you.

speaker
Dhawan
Conference Call Operator

Thank you. Again, if you have a question, you may please press star, then one. We have no further questions at this time. I would now like to turn the conference back over to Dr. Stacey Lindborg for any closing remarks.

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

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 Immuno-01 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 Immunon.

speaker
Dhawan
Conference Call Operator

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

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.

-

-