Q2 2025 Imunon Inc Earnings Call & Business Update
Dovin: Good morning. My name is Dovin, 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 one on your phone to ask a question at that time. Please keep in mind, if you are using a speaker phone, you must release your mute function to allow the signal to reach our equipment. Again, that's star one 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.
Good morning. My name is doin and I will be your operator today.
At this time, I would like to welcome you to immunes 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 speaker phone, 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,
Peter Vozzo: Thank you, Dovin. 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 5th, 2025. Immunon undertakes no obligation to revise or update comments made during this call, except as required by law.
I would now like to turn the call over to Peter. Volo of icr healthcare investor relations representative for riman. Please go ahead.
Thank you, darling. Good morning, everyone and welcome to mun's. Second quarter 2025, Financial results and business update conference call.
During today's call management will be making forward-looking statements regarding immune expectations and projections about future events in general. Forward-looking statements can be identified by words, such as expects anticipates beliefs, 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 4 looking statements can be guaranteed an actual results May differ materially from those such statements
Peter Vozzo: With that said, I would like to turn the call over to Dr. Stacy Lindborg, Immunon's President and Chief Executive Officer. Stacy?
Stacy Lindborg: Thank you, Peter, and good morning, everyone. Joining me on the call this morning is Dr. Douglas Faller, 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 Tardugno, the Executive Chairman of our board, and Dr. Khurshid 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 Immunon O1, 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.
I also caution that the content of this conference call is accurate. Only as of the date of the live broadcast, August 5th, 2025 in mun 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 immunized, president and chief executive officer, Stacy.
Thank you, Peter and good morning everyone.
Joining me on the call this morning is Dr. Doug Douglas pauler amun's chief medical officer and Miss 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. Christe arnuar. Our chief scientific officer on the line, and will be available for Q&A.
I want to begin by reviewing our progress and harnessing the potential of immuno. 01, our Gene mediated aisle 12 therapy as an effective treatment for ovarian cancer 1 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, in our, in our stakeholders.
Stacy Lindborg: 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 Immunon O1. 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 Immunon O1, 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.
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.
Platinum based chemotherapy.
In over 25 years.
Furthermore.
prior to the evation 2 study, there has never been an overall survival benefit observed in a front line of varying cancer, clinical trials,
in addition, an importantly, clinical data from Ovation 2 across all employees and key, subgroups have shown a consistent outcome. Favoring immuno 01.
And while not powered for statistical significance, our trial has shown unprecedented improvement in overall survival.
Stacy Lindborg: 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 Immunon 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 a great potential to redefine treatment for women with advanced ovarian cancer. I'm delighted to share that our phase three pivotal study of Immunon O1, 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 of Gynecologic Oncology.
Patients in the intent, to treat population who were administered. Immuno 1 plus the standard of care Neo addivon and adant 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.
45% improvements.
use of parp Inhibitors as part of Maintenance therapy, further enhanced outcomes,
With media and overall survival. Not yet reached in the imuno, 01 treatment arm after more than 5 years for many patients.
Versus 37 months median over 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 3, pivotal study of immuno 01 which we referred to as Ovation 3 has had an impressive start.
Stacy Lindborg: Should results from the phase three trial replicate these phase two results, Immunon O1 could offer a transformative immune system-engaging therapy that extends life meaningfully for patients. Ovation 3, our pivotal phase three 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 O1's 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 Immunon O1'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.
This builds directly on the strong data from our Vision 2 study, which was showcased in an oral platform. Presentation at the recent ASCO annual meeting and will simultaneously published in the peer-reviewed journal, gynecologic oncology
Should results from the phase 3 trial, replicate these Phase 2 results. Immune on 001 could offer a transformative. Immune system engaging therapy, that extends life, meaningfully for patients.
Ovation 3, our pivotal basic trial is gaining Traction in the medical community.
As a vital in advancement for Frontline treatment in a population with few options.
The ASCO presentation and gynecologic oncology publication validate the robust evidence supporting immune o1's potential, as evidenced by a couple of things. Number 1, 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 2. Inclusion of immuno 1's, results in askos, highlights by medical journalist.
and finally,
Interest expressed by principal investigators around the world to participate in our phase 3 trial.
Stacy Lindborg: I'll now provide an update on recent progress with Immunon O1'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 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 Immunon O1 combined with the standard of care neoadjuvant and adjuvant paclitaxel and carboplatin chemotherapy, which is administered before and after interval debulking surgery.
We are poised to contribute significantly to oncology future and I hope you're excited. This excitement is shared
I'll now provide an update on recent progress with imuno 1'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 3 launch.
Industry benchmarks show an average of 28 weeks from protocol approval to enrollment opening, but we accomplished this in 15 weeks for Aviation 3—almost half the time.
This reflects our team's agility and both patient and investigators enthusiasm.
Want to congratulate diagnose and his team for this great start to the trial.
To date 3 sites have been activated and we have randomized and treated our first patient last week.
Stacy Lindborg: 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 the US.
Ovation, 3 evaluates immuno, 001 combined with the standard of care, and new adant and agant pacful and carboplatin chemotherapy which is administered before. And after interval to bulking surgery, and this is compared to the standard of Care Loan, a newly diagnosed treatment naive, women 18 years of age or higher with Advanced ovarian cancer
Participants are randomized, 1 to 1 including a subgroup with homologous recombination deficiency or hrd positive status.
To mutations.
In these women, we receive PARP inhibitors and maintenance therapy.
The primary endpoint is a while survival was secondary endpoints, including surgical response or chemotherapy response score clinical response and time the second line treatment.
Exploratory. Endpoints, such as quality of life, measures will inform future pricing and payer discussions globally.
We believe overall survival is the primary endpoint, which provides a clear path to approval without needing a follow-up study.
Stacy Lindborg: The initial group of sites that will be activated this year, many from the prior Ovation 1 and Ovation 2 study, 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 O1 as a potential new standard if phase three 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.
In addition, it supports potential European registration, alongside our orphan designations in both Europe and the U.S.
The initial group of sites that will be activated this year, many from the prior Ovation, 1 Innovation and 2 studies are highly motivated by the data. We have produced to date.
We plan to expand enrollment with new sites, which we will anticipate will boost recruitment positioning. Imon 01, as a potential new standard if phase 3 confirms Ovation to 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.
Stacy Lindborg: To keep Ovation 2's momentum alive amid phase three, the ASCO oral presentation delivered by Dr. Primel H. Thacker and the simultaneous publication in Gynecologic Oncology, two preeminent platforms, highlight the need for new therapies and the promise of our Theraplast platform. Preparing for these disclosures, we dove further into the Ovation 2 data, and we discovered that in addition to unprecedented survival data and consistency of data with all clinical endpoints and key subgroups favoring Immunon O1, we learned that all patients in the experimental arm, those treated with Immunon 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.
Population, addresses, half of the Neo 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. PML hacker.
And the simultaneous publication in gynecologic, oncology to preeminent platforms.
Highlight the need for new therapies and the promise of our therapists platform.
Preparing for these disclosures, we Dove further into the evasion 2 data and we discovered that in addition to unprecedented survival data and consistency of data with all clinical endpoints and key. Subgroups favoring immuno. O1, we learned that all patients in the exper experimental. Arm those treated with Amino o1 remained progression free, during the treatment protocol while progressions were observed in the control arm.
Stacy Lindborg: Douglas Faller, Immunon'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?
Douglas Faller: 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 at 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.
I'll now hand the call over to Dr. Douglas fir, I mean on his chief medical officer to comment further on the excitement from the medical community from ASCO and to share insights on Innovation 3 including um with the discussions that you're having with investigators during site activation and enrollments Douglas
Thank you, Stacy.
This is really an exhilarating period for Imon.
Beyond our Pasco Podium presentation and the journal publication of Ovation to results. We were invited to share new Ovation to 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 of 2025,
Additionally in the last few days, we've also had invitations to present the newer translational data from Ovation to at 2, major scientific conferences this fall.
Starting with the esmo conference. I had the honor to present data which confirms that immune 0001 delivers targeted IO 12 gene therapy to tumors with minimal systemic exposure.
Douglas Faller: 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 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 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.
This underpins both the safety and the efficacy that we've seen in the Ovation to trial.
New insights presented at that meeting demonstrated marked infiltration of immune cells, including anti-tumor lymphocytes and reprogrammed macrophages.
In many cases, no remaining tumor tissue. Could be observed pathologically.
Many of the top institutions and investigators from Ovation to are rejoining Ovation, 3 driven by their confidence in IM non 0001 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.
Douglas Faller: 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 3 on July 25th, 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.
This is certainly usual in my experience and very encouraging.
The ability to employ a tumor, targeted, immune therapy. In the Neo have been setting holds great appeal. Among gynecologic oncologists and medical oncology.
I'm also very pleased to report as Stacy mentioned that we enrolled. Our first patient Innovation 3 on July 25th, 2025
Our seasoned clinical team is thrilled with the progress and we're planning further trial expansion in the coming months.
Stacy Lindborg: Thanks, Douglas. Actually, before I proceed with a few comments around our plans to finance Ovation 3, Khurshid, I wonder if you'd like to make any additional, you know, perspective, provide your thoughts on our translational data. Khurshid?
Back to you. Stacy. Thanks, Douglas.
Actually before I proceed with a few comments around our plans to finance Ovation 3 crashed. I wonder if you'd like to make any additional, um, you know, perspective provide your thoughts on our translational data.
Khursheed Anwer: 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 Immunon O1 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 antagonistic insight into how the increase in local cytokine levels by Immunon O1 translates into antitumor activity at tumor microenvironment, which is not only driving the Immunon 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 O1. Thank you, Stacy.
Hershey.
Sure. Stacy um yes. Um the outstanding um, survival benefits. Uh, we have seen in Ovation 2.
Um, indeed are supported by the recent uh translation work.
um, first the local increases in cyto in peraton space and not as much in, uh,
Blood following imienin 1 administration, supports the drug objectives in achieving local effects without producing. Systemic toxicity.
Um, second the imal changes in the tumor micro environment that Douglas has described.
Um, provide mechanistic insight into how the increase in local sarine levels by IM Nano 1 translates into anti-tumor activity at the tumor microenvironment.
Which is not only driving the imuno 1 action, but all but could also promote actions of other immune agents such as checkpoint inhibitors.
Stacy Lindborg: Thank you, Khurshid. 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 Khurshid, 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 are truly excited to see continued uh development of imienin or 1. Um thank you Stacy.
Thank you.
Christine, I know we'll have a lot more to say about our translational data which we're we're quite excited about in addition to our clinical. And, um, we can certainly take more questions as they come. And for those of you that have been following me on over time, you'll know that crashed are C. Uh Chief scientific officer has been Central to many parts of our business including the translational strategies. I appreciate those insights
I'm turning to financing the Ovation 3 study. I want to reflect on the fact that we have been caught in a, in a, 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.
Stacy Lindborg: 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 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.
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 programs.
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 all stakeholders.
I'll provide an update on these fronts. But first, I'm excited to announce that. We have introduced a 1-time stock dividend designed to enhance shareholder value, and to underscore our strong confidence in imun long-term growth potential.
This initiative will benefit shareholders of record as of August 7.
For 2 days from now.
By Distributing a 15% dividend in common stock.
Stacy Lindborg: As a late-stage pre-revenue biotech firm dedicated to advancing transformative therapies like Immunon O1, 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 June 30th, 2025, we've 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.
Effectively, increasing their ownership stake without any cash outlays from the company?
As the late as a late stage, pre-revenue biotech firm.
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 3 milestones and Beyond
This June 30, 2025, we bolstered our balance sheet by adding more than $3 million through the exercise of warrants and the sale of shares off of our ATM facility.
Stacy Lindborg: 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 O1, and pursuing value-enhancing opportunities. Our financing and partnership efforts include advancing the Theraplast 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 O1's 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 or 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.
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 monthly rent. Commitments reducing GNA expenses
Aligning Resources with priorities by removing work not contributing to regulatory approval and Commercial launch of immuno o1 and pursuing value. Enhancing opportunities.
Our financing and partnership efforts include advancing that they are a plus technology. Through discussions with potential Partners who are inkology leaders which include meetings held in-person at ASCO some under CDA
Exploring Geographic Partnerships to speed immuno, 01 development globally.
Leveraging. Plascene our DNA vaccine platforms proof of concept data for potential sale or licensing highlighting, its advantages of stability, a year at refrigerated temperatures of 4 degrees, Centigrade or 1 month at room temperature or 37 degrees. So
Centigrade.
Stacy Lindborg: We presented PLACENE 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.
Um, rapid adaptability from a manufacturing standpoint durable protection. We had 6 months durability or recalls discussed in our, in our recent earnings, call and cost-effective production.
we presented plascene 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.
Stacy Lindborg: 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 rule on August 8th, 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'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 Graper. Kim, if you will review our second quarter 2025 financial results.
Time, that was tailored to what we need to regain compliance.
The panel noted that Imunon has already achieved compliance with the shareholder equity rule through recent fundraising activities. We anticipate that we will need 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 role 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 hack.
Half of August.
I am confident in our actions and that they will continue to provide a platform.
That will that will deliver long-term value for our shareholders.
Kimberly Graper: Thank you, Stacy. Details 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 carried 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 one PLACENE DNA vaccine trial and development costs for the PLACENE DNA vaccine technology platform.
Now I'll turn over to Kim Gregor. Um Greg Kim, if you will review, um, our second quarter, 2025 Financial results
Thank you, Stacy.
Detail of immune, on 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.
Kimberly Graper: 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 the 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 one 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 Stacy.
Study and lower costs associated with the phase 1 faxing DNA vaccine trial and development costs for the flax seed. 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 the Q2 20225 was 2.7 million or $2.15 per share compared to 4.8 million or 7.64 cents 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.
Stacy Lindborg: Thank you, Kim. And with that, I'd like to open the call to your questions. Dovin?
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 at to your questions.
Dovin: 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 speaker phone, 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 Bodner with HC Wainwright. Please go ahead.
Door win.
Certainly, thank you. We will now begin the question and answer session.
to ask a question, you may press star then 1 on your telephone keypad,
If you were using a speaker-phone, 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 2
At this time, we will pause momentarily to assemble our roster.
Emily Bodnar: 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?
Our first question comes from Emily, bodnar with 8C Wayne Wright, please go ahead.
Hi, good morning. Thanks for taking the question and congrats on the progress with the phase 3 trial. Um, I I know you talked quite a bit about
Stacy Lindborg: Oh, I just said thanks, Emily. Yes, please continue.
sorry.
Emily Bodnar: Oh, I know you talked a bit about the enthusiasm from the investigator side with the phase three 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.
Stacy Lindborg: Douglas, you want to take this?
Oh, I just don't think. Thanks Emily, please continue. Oh um I only talked a bit about the enthusiasm from the investigator side with the phase 3 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, um, specifically in the hrd subset of patients that you spoke about. And then I'll ask a follow-up after
Douglas Faller: 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 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.
be happy to, um,
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.
Uh, this has helped people, but it has certainly not been enough.
Um, there have been many efforts to, uh, improve frontline treatment of patients with ovarian cancer. But the most recent ones, including using checkpoint inhibitors, uh, all 4 of them, large Phase 3 studies, uh, failed in the last year.
Douglas Faller: 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. Stacy mentioned that a focus on this is likely to give us the strongest signal and the strongest benefit in patients with ovarian cancer.
And there really is very little now for patients. So we believe that the demand and the opportunity for our phase 3 study is high. Let me also mention those 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 in flame.
Ovarian cancer is not we, on the other hand are using a therapy dial 12, which actually activates and causes. Let's say inflammation immune activity, in the tumor cell and in the tumor micro environment. So our approach gets around the problems that led to checkpoint Inhibitors not being active.
Douglas Faller: 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.
Um, the second part of your question involved, uh, 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
Emily Bodnar: Got it. Okay. Also, I guess on the expensive 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 three trial?
Stacy Lindborg: Yeah, Emily. As you point out, yes, our expenses have declined. That is in part due to the PLACENE 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 fully fund our trial, and 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.
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,
Stacy Lindborg: 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 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.
Uh, yeah, Emily. They um as as you you point out, um, yes, our expenses have have declined, um, that is in part due to um, the plascene proof of Concepts trial. That was that was concluded and um, and that we're not starting any new work on that front of nation 2. As you know, is, is also winding down. And we're closing sites. Um, on a, on a monthly basis, as, um, as the sites, uh, reached the point of no longer having, um, patients ongoing. But really, we've been very diligent, um, to control costs. And to make sure that we're um, we're allowing, um, the time that we need, um, to, to fund to fully fund our trial. And that's been that's proven to be very important. I think it's also a very critical for our staff to understand that we're investing in places. We need to invest and we're we're minimizing, um, other other expenses. Um, in terms of the
Reservation 3 trial cost.
Um, as you know, in advance of starting the trial, we, of course, had to manufacture and produce active pharmaceutical ingredients, um, which we're doing in house, um, ahead of the final fill and finish, um, well in advance of the first patient being enrolled. So the investment in startup cost with a patient 3, really preceded, well, in advance of um, of the first patient. And as a result really, we're we're Manufacturing.
In a manner that is, um, is modeling and planning for enrollments will be monitoring them in real time. And so we'll really see fairly stable, um, expenses that will continue, uh, consistent with. I think what you're saying. Um, in the in our filing, um, from from this queue,
Emily Bodnar: Okay. Great. Thanks for answering the questions.
Stacy Lindborg: Thank you. Thanks, Emily.
Okay, great. Thanks for answering questions.
Dovin: Our next question comes from Will Heidel with Brooklyn Capital Markets. Please go ahead.
Thank you. Thanks Emily.
Our next question comes from, will hyal with Brookline Capital markets, please go ahead.
Will Heidel: 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: So we have, 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 Immunon O1 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 above the Ovation 2 numbers as a trial as a whole.
Hi. Thank you for taking my questions. I had 2 questions 1. Um the combination study with the Bastion is that still on track for enrollment? I think the updated numbers 15 patients as of June, is that going as expected
So we have, um, we We are continuing to, um, to enroll patients. We have increased the number um, that has, uh, that have been treated. Um, and have some, um, recent activities that that have been long underway that are going to, um, give added strength to this trials, uh, speed of enrollment. So we have a site that was part of the Ovation 2 trial and, um, and is a, um, you know, P Pi that is, is quite familiar with Amino o1 and enrolled extremely well, that will be, um, I'm being assured by lawyers, uh, on on both sides that this contract. Um, really is ready to sign in is just going through the finishing touches, um, and in, in discussions with our other Pi's, um, you know, in MD Anderson's, continuing to enroll incredibly, well, at rates that are far far above, um, the Ovation, uh, Ovation 2, uh, number
Stacy Lindborg: 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 that 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.
as a trial as a whole, um, and we have more, more more memorial stone catering that, um, has met their, their internal goals and will be continuing, um, have set new goals before the end of the year. So we're, you know, frankly, we'd love to see this trial, um, the increasing, um, in in speed we have a corporate goal for this year, which we are
Um, I I would say observing and and working very closely with the sites to see if we're able to to get it done. But um, we we do have some changes as I've just gone through that that leave us optimistic, that we'll be able to, uh, to get to the 35 that we want to have by the end of the year. But but we'll give updates over time.
Will Heidel: Okay. Thank you. 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?
Okay, thank you. And then um,
A quick clarification question. The $3 million raised.
During the quarter between the warrants. And hm. What was, what was the mix?
Stacy Lindborg: Yeah. Kim, would you like to take this?
Between exercise warrants and the ATM.
Kimberly Graper: Yeah. The mix between the ATM and the warrants was very close to 50/50, each with $1.5 million.
Would you like to take this?
5 million.
Will Heidel: Okay. Great. Thank you.
Stacy Lindborg: Thanks, Will.
Okay, great. Thank you.
Thanks, Phil.
Dovin: Our next question comes from David Botts with Zacks Small Cap Research. Please go ahead.
David Bautz: 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? Thanks.
Our next question comes from David Bots with Zach's Small Cap Research. Please go ahead.
Hey, good morning, everybody. Uh, thanks for taking the questions. So I have a couple on the clinical trial sites. Um, what needs to be done for any remaining sites that want to be open? Basically, what I'm asking is, is it just financing that's holding that up at this point? And you also indicated that.
Stacy Lindborg: Why don't you take the second question first, Douglas?
Positive results from the Ovation 3 study may set you up for filing in the EU. My question is: will the EU require you to open any sites over there during the trial? Or does the company have any plans to open sites over there? Thanks.
Douglas Faller: Okay. It's not been absolutely necessary for the EU that there be patients enrolled in a study for them to give approval. 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.
Um, it is.
It's not been absolutely necessary for the EU that there would be patients enrolled in a study for them to give approval. Most of the issues with approval in the EU have been with trials that don't have OSS and endpoints.
Stacy Lindborg: And the first question was related to what's required to open additional sites. And I guess maybe I'll start and Douglas take that. 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.
Um, and so demonstrating, an OS benefit in a disease. Like this should not present any difficulties for approval in the EU. Um, we are considering, uh, sites in Europe. Uh, we have, uh, collectively a great deal of experience in working with sites in Europe, uh, know many of the investigators. And so that is something we are considering as we expand and, uh, hopefully accelerate Ovation 3. But in my experience, it's not been necessary to enroll patients in the media.
And, um, the the the first question was related to what's required to open additional sites and I guess, I'll maybe I'll start and take a look at that. I mean, I I think it's very common that you have a plan, um, of, uh, kind of a timeline around. Um, you know, activating sites, um, it is, uh, you you want to move quickly, but it needs to be, um, staged and I think, um, or ordered. And so we have the 3 sites that are activated as Douglas, um, shared. We expect another site to be activated tomorrow and in the reviews that I'm getting um every single week we have an additional 3 that have been selected and are very close to being activated for that have been selected and that we expect could be activated in the near future and then so on and so on. So there there there's just um, a natural order um, to to the activity.
Douglas Faller: Well, and you had 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 US sites and Canadian sites before thinking about international activations.
That tickles. I don't know if you want to add anything more well, and you would ask if there were any barriers in the answer to that is no. Um, we're we're actually getting requests. The only barriers I, I would mention, are, we're getting requests internationally and right now, we're simply not, uh, we want to activate our us sites and Canadian sites um, before thinking about International activations,
David Bautz: Okay. Great. Thanks for taking the questions.
Stacy Lindborg: Thanks, David.
Okay. Great. Thanks for, uh, thanks for taking the questions.
Dovin: Our next question is from James Malloy with Alliance Global Partners. Please go ahead.
James Molloy: Hey, guys. 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, filable as well.
Our next question is from James Malloy with Alliance Global Partners. Please go ahead.
Hey guys. Good morning. Thank you for taking my questions. Um, I had a question on on the HRT, the hrd screening. Uh, does that does that potentially slower speed up? I know, obviously the, the idea being you can look at a smaller group, but does that does that hamper the potential enrollment to go through this process and just to follow up on, on the previous question. Um, is the hrd positive if you have positive interim data,
Douglas Faller: So why did you want to stick with?
Is that only a potential for EU approval? I thought I apologize. I thought it was also potentially FDA filing as well. Followable as well.
Stacy Lindborg: Go ahead. Yeah, please. Go ahead.
Douglas Faller: So with respect to the second question, HRD as a biomarker would be certainly acceptable to the EU. The EU is as interested, EMA is as interested in having biomarker-driven approvals as the US is. And having said that, I actually forgot your first question. I apologize.
So um, did you want to start? No, please go ahead.
Um,
So, with respect to the, the second question, um, hrd as a, uh, biomarker would be certainly acceptable to the EU. The EU is, as interested, in EMA, as is interested in having biomarker driven approvals, as the US is.
Stacy Lindborg: It was the screening.
Douglas Faller: Oh, the screening.
Stacy Lindborg: Does it affect?
Douglas Faller: 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. 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.
And having said that, I actually forgot your first question. I apologize. It was the screening and does it actually. Excellent question. Um,
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.
Deliver results from hrd extremely quickly. We have no, uh, interest in delaying treatment of patients or delaying patients, uh, 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, uh, randomized and treated, uh, quickly.
James Molloy: Excellent. Thank you. And under your guidance, I hope potentially having 20 sites open by year-end. Again, I guess funding dependent. Just a quick follow-up, too, on the Avastin trial. Now, 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 Breakthrough Cancer Foundation. You have less control over that.
All right. Excellent, thank you. And then you guided to potentially having a 20 sites open by year end again. It's funding dependent. Um just a quick follow up on the on the avastin trial.
Stacy Lindborg: Yeah. 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?
Now, 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 Breakthrough Cancer Foundation, so you have less control over that.
Douglas Faller: 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 very early findings that we have, at second look laparoscopy, what appears to be benefit from in the patients who got Immunon and both arms getting bevacizumab.
The DPI actually coming up very soon. Um, the the last time we met to discuss, um, the potential there were some, um, you know, Cutting Edge assays, that he was particularly interested in. Um, and we're, we're excited to, to talk to him about, um, you know, the viability of translational data from The Trial, being able to be released, um, in a, in a scientific Forum. Um, but you know, we're we're in regular contact with um, you know, with the the, 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. Um, 1 of our goals for this was through the
Determine if and how we can use that decision. They have in combination with immune on 001 um Bev as you know, is an anti-angiogenic antibody. Um it's used in uh ovarian cancer to some extent but uh as never improved Survival on its own.
Um, but it's something that we've been interested in combining with immune 001. So we established that we can combine. Um, the combination is safe. And we've also, uh, shown in, in early, very early findings that we have a second look, laparoscopy what appears to be benefit from, in the patients, uh, who got immune on
And folks, both arms are getting deficits enough.
James Molloy: Oh, 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?
Well, great. Thank you. The final question would be. I know it's, uh, hard to discuss with. But could you talk a little bit about the potential partnership environment and, uh, how things are looking, uh, in the current, uh,
Overall environment.
Stacy Lindborg: 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, you know 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 US. In thinking about new indications that could proceed with our technology platform, we know that it is 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 three plan. So we are having discussions. We are pursuing follow-up conversations, but they do take time.
Yeah, I, I mean, I it it is hard to go much more than what I've already shared, um, in, in my prepared, remarks Jim. But, um, we are, we are facing interest. In fact, we're even getting incoming calls. And again, I as I shared in my prepared remarks,
you know, we we have an interest in, um, in in any business opportunity, that is, uh, makes sense, for our company, and our shareholders, um, which in which include dimensions of accelerating development in Geographic locations, um, outside of the US,
Stacy Lindborg: So unfortunately, I can't go into any greater detail at this time.
James Molloy: Understood. Thank you very much for taking the questions.
Um, in thinking about new indications, um, that could proceed with our technology platform. We know that it is a very exciting and very, uh, broadly applicable to many large tumors. I'm sure Douglas would love to to talk to you about uh, about our, our thoughts and dreams along those lines. And of course, you know um to to come alongside of a as a partner in our in our phase 3 plan. So we we are having discussions. Um we are pursuing follow-up, you know, conversations but they do they do take time. So unfortunately, I I can't uh, go into any any greater detail at this time.
Stacy Lindborg: Yeah. Thank you.
Understood, thank you very much for taking the questions.
Dovin: 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. Stacy Lindborg for any closing remarks.
Again, if you have a question, you may, please press star, then 1
Stacy Lindborg: 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 Immunon O1 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
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.
Well, I want to thank you all for your questions.
Maybe just a couple of concluding remarks.
We uh, remain focused.
On funding to fortify a position to progress. I mean on 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 our very cancer treatment and our DNA based technology platform along with vaccine Innovations more, broadly,
Dovin: insightful comments and questions on this call, and look forward to future discussions. So thank you for joining and for your interest in Immunon.
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 Amman.
Speaker 2: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.
The conference has now concluded.
Thank you for attending today's presentation. You may now disconnect.