Q1 2025 Imunon Inc Earnings Call
Results Conference call all lines have been placed on mute to prevent any background noise.
Stacy Lindborg: So we are, by nature of ESCO's embargo, Emily, I know you'll understand that, not able to talk about the content of the presentation. They're very careful with what is shared in advance. We will be sharing new information, and that I think is really quite central to being accepted as an oral presentation, although I think the full body of evidence that we've been discussing merits a view at this level and at a platform like ESCO. So we're incredibly excited for the presentation and look forward to hearing Dr. Thaker's perspective on the data.
Following the Speakers' prepared remarks, there will be a question and answer session.
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I would now like to turn your call over to Peter <unk> of ICR Healthcare Investor Relations representative for immuno. Please go ahead.
Peter: Thank you Dave Good morning, everyone and welcome to Immunize first quarter 2025 financial results and business update conference call during.
Speaker Change: During today's call management will be making forward looking statements regarding immunize, the expectations and projections about future events and general forward looking statements can be identified by words, such as expects anticipates believes or other similar expressions.
Douglas Faller: Okay, makes sense. And then maybe just follow up on the phase three design. How many sites are you expecting to have in total for the trial for that, I guess, first half portion that you were discussing? And then are you having OS as a dual primary endpoint for HRD positive and the ICT population? Or how are you kind of splitting up the statistical plan? Thank you.
Speaker Change: These statements are based on current expectations that are subject to a number of risks and uncertainties, including those set forth in the companys periodic filings with the Securities and Exchange Commission.
Speaker Change: Forward looking statements can be guaranteed and actual results may differ materially from such statements. I also caution that the content of this conference call is accurate only as the date of this live broadcast May 12 2025.
Douglas Faller: Douglas, why don't you take a stab at it? Sure. The analysis for the phase three has always been predicated on analyzing the HRD population first. This is the population in which we think from Probation 2 data, including data that will be presented at ASCO, in which we have the highest effect in terms of activity. And so the population that would be read out first Whether we proceeded with the entire HRD and HRP, or whether we focus on HRD alone, as Stacy mentioned, the readout does not change. There are two interim analyses and a final analysis, if needed, all based on HRD .
Speaker Change: Undertakes no obligation to revise or update comments made during this call except as required by law, but that said I would like to turn the call over to Dr. Stacy Lindbergh.
Stacy Lindbergh: President and Chief Executive Officer Stacy.
Speaker Change: Thank you Peter and good morning, everyone join.
Stacy Lindbergh: Joining me on this call is Dr. Douglas Fowler Chief.
Stacy Lindbergh: Chief Medical Officer, and David <unk>, Our interim Chief Financial Officer, who will review our financial results for the first quarter of 2025.
Michael <unk>: Michael <unk> executive Chairman of our board and Christian on where our Chief Scientific Officer are also both on the line and will be available for Q&A.
Emily Bodnar: You asked a question about the number of sites. We are projecting about 45 sites. Yeah, Emily, just to recap, so the overall survival of the primary is not dual, and it is consistent for all populations as the primary. Okay, thank you.
Stacy Lindbergh: I would just start by saying that we may be close for the first time to unlocking the power of interleukin 12.
Stacy Lindbergh: It's effectively treat cancer in one of the worst forms ovarian cancer.
Stacy Lindbergh: Our work in developing treatments for ovarian cancer, a disease that continues to challenge scientist.
Stacy Lindbergh: And clinicians.
Stacy Lindbergh: And researchers underscores our commitment to addressing unmet medical needs and driving long term value.
James Molloy: The next question comes from James Molloy with Alliance Global Partners. Please go ahead.
Speaker Change: I'm amazed at the number of discussions I've had since joining immune on in both personal and professional settings, where people have shared impact from ovarian cancer at a close to a personal level.
Laura Suriel: Hello, this is Laura Suriel on for Jim Molloy. Thank you for taking the questions and congrats on the progress. So for Ovation 3, what's the current status that you have on like the inventory and the manufacturing capabilities for, you know, for this trial, especially with the 250 to 500 patient enrollment plan that you have set up? Great question, and I'll take the opportunity just to reiterate that for this trial, we have pulled the manufacturing of the core active pharmaceutical ingredients in-house and we are prepared and are monitoring various enrollment plans and ensuring that we have and will continue to have product available.
Speaker Change: Its devastation has no limits and taking the lives of women young and old in their prime.
Speaker Change: We continue to make significant strides towards our goal of transforming the treatment landscape for women diagnosed with advanced ovarian cancer.
Speaker Change: To that end I'm pleased to report that we have initiated the first clinical site in our phase III pivotal study.
Immuno O one.
Speaker Change: If the results from our highly successful phase two study are replicated in phase III.
Stacy Lindborg: So we have had product that has passed all of the release specifications and has been ready to ship for weeks now and are well prepared for the weeks and months ahead. Got it.
Speaker Change: <unk> and doctors may potentially have a meaningful life extending therapy that recruits and empowers the body's immune system to effectively target this disease.
Speaker Change: Our phase III study known as ovation three is being recognized by the medical community is a critical step towards the goal of delivering a new front line treatment for women with limited options and unmet urgent medical needs.
Stacy Lindborg: Thank you.
Stacy Lindborg: And then also the clinical trial that you have in collaboration with the Breakthrough Cancer Foundation. What's the current status of this trial here? And are you still on track to have preliminary results announced later on this year? You just had a call with the PIs. Can you give some insight from that? We have a meeting with the principal investigators every two weeks. And the last one was a couple of days ago on Friday. We initiated another site, University of Oklahoma, and very excited about that. Johns Hopkins is. managed to restaff its clinical Group, and so they're excited about starting to screen page.
Speaker Change: This recognition is exemplified by the acceptance of our new ovation two results for an oral presentation at the upcoming <unk> annual meeting and for publication in the peer reviewed journal gynecologic oncology.
Speaker Change: It also underscores the scientific community is strong and historic evidence of immune on O O ones anti cancer potential.
Speaker Change: We believe we have much to offer.
Stacy Lindborg: We are...
Speaker Change: The future of oncology treatment.
Unknown Executive: Expecting to have data at the end of Alright, thank you for the insights and for taking the questions. This concludes our question and answer session of the call.
Speaker Change: And I Hope you are as excited as we are.
Speaker Change: Now I'd like to report on our recent progress and review, our clinical and regulatory status of immuno O. One.
Speaker Change: We continue to work with our trial investigators to begin enrolling participants all of whom have shown unwavering interest in the phase III trial and are committed to advancing the study.
Stacy Lindborg: I now want to turn the call back over to Imunon's President and CEO for concluding remarks, Dr. Lindborg. Thank you. I want to reiterate our near-term focus, which is on securing funds to strengthen the company's financial condition and advancing our phase through trial, and in the process, advancing Imunon-01. We expect to have an update on this on this front by the end of this quarter. And as referenced earlier, our goal is to cover the Ovation 3 trial cost. And we want to and will be seeking corporate partnering and equity finance. We expect this will be an iterative process driven by catalysts to further investor competence and follow on finance.
Speaker Change: The confirmatory phase three trial ovation three will assess the efficacy of immune on O. One plus the standard of care versus standard of care, which is neo adjuvant and adjuvant chemotherapy alone.
Speaker Change: The standard of care for women, who are newly diagnosed and treatment naive as paclitaxel and Carboplatin chemotherapy.
Speaker Change: Both neo adjuvant and adjuvant to interval de bulking surgery.
Speaker Change: The study will enroll women at least 18 years of age newly diagnosed with advanced ovarian cancer.
Speaker Change: Study participants will have been randomized will be randomized one to one and there will be a subgroup of women positive for homologous recombination recombination deficiency HRD, which.
Stacy Lindborg: And as our work in providing a new treatment option for women with ovarian cancer progresses, and as the population's exposure to potential pandemics increases, we remain very excited about reporting data from ongoing clinical studies in the months ahead. We look forward to keeping you appraised of our progress. And thanks again for joining us today and for your interest in.
Speaker Change: As many of you will know includes the familiar mutations BRCA, one or BRCA too.
Speaker Change: Participants within the subgroup will receive PARP inhibitors as part of standard maintenance therapy.
Speaker Change: The primary endpoint of this study is overall survival or O S.
Unknown Executive: The conference is now concluded. Thank you for attending today's presentation.
Speaker Change: Secondary endpoints include surgical response score chemotherapy response score clinics.
Speaker Change: Clinical response and time to second line treatment.
Speaker Change: The study will also assess several exploratory endpoints, including quality of life measures.
Speaker Change: Which will aid as we engage in pur and pricing discussions in the future as we entertain approvals and access around the world.
Speaker Change: The advantage of overall survival as the primary endpoint is that it is a definitive endpoint.
Speaker Change: There will be no need for a second conformational study to support approval.
Speaker Change: And if results are positive the phase III trial is also expected to support EU registration as a direct result of the selection of the of overall survival as the primary endpoint.
Speaker Change: And you'll recall that we have orphan status established in Europe, along with U S orphan drug designation.
Speaker Change: The initial core set of clinical trial sites currently activating are highly encouraged by <unk> data.
Speaker Change: And are enthusiastic about <unk> III.
These include sites that were part of both the phase one ovation, one study and the phase one to ovation two study.
Speaker Change: And we're excited to bring new sites on board to accelerate enrollment of the trial.
Speaker Change: The strength of our data is the key point of discussion and we believe it will drive surgeons interest and patient recruitment.
Speaker Change: There is optimism that Amy not no one could potentially be a new product on the horizon and reset the standard of care for the frontline treatment of women newly diagnosed with advanced ovarian cancer, if the safety and efficacy from ovation two are confirmed in phase III.
Speaker Change: We have a strategy and statistical plan, which allows for a 500 patient trial in an all comers population of newly diagnosed patients as well as our plan to focus on a 250 patient subgroup defined by a biomarker identifying patients who are HRD positive.
Speaker Change: Both are strong options and have 95% power or higher and both are capable of supporting an FDA approval for immuno on I O. One.
Speaker Change: As we shared in our last call. We will focus initially on the HRD positive subgroup defined by a biomarker to a central lab.
Speaker Change: This highly cost effective strategy allows us to enroll half the number of patients.
Speaker Change: With an opportunity to achieve a readout sooner.
Speaker Change: We expect this study budget will be approximately 40% lower than the full study budget and could read out two years earlier.
Speaker Change: This population represents one half of the neo adjuvant ovarian cancer market and would be an important advancement for patients.
Speaker Change: We would likely trigger a broadening of the inclusion criteria at a later date budget permitting.
Speaker Change: To reach the 500 patient all comers trial.
Speaker Change: Our strategy includes an interim analysis at high probability for success milestones.
Speaker Change: As we advance you may not know Oh, one in the phase III <unk> III trial, we do not want its achievements innovation Chu to go unnoticed.
Speaker Change: As previously announced data from the ovation two study will be reviewed and an oral presentation.
Speaker Change: During <unk> annual meeting next month.
Speaker Change: Dr promo factor.
Speaker Change: As interim chief of Gynecologic oncology.
Speaker Change: David and Lee Mulch Distinguished Professor of obstetrics and gynecology.
Speaker Change: Also director of Gynecologic oncology clinical research all at Washington School University School of Medicine.
Speaker Change: She will lead the discussion in the oral presentation.
Speaker Change: As I mentioned earlier review of the full data from ovation shoe will be published in a highly his team journal gynecologic oncology on June 3rd being released simultaneous to the <unk> presentation.
Speaker Change: Having our data presented in two of the Premier global platforms, and gynecologic oncology underscores both the critical need to develop new therapies to treat ovarian cancer as.
Speaker Change: As well as the strength and potential of Ami non immune on their <unk> platform technology.
Speaker Change: With that I'd like to turn the call over to Dr. Douglas fall or who will discuss the phase III <unk> III study.
Speaker Change: Including key points from his recent and ongoing discussions with study investigators as we initiate sites Douglas Thank you Stacey.
Speaker Change: This is clearly a very exciting time for a new law.
Speaker Change: In addition to the presentation of the results from our ovation II trial in an oral session at Astro in a few weeks and the simultaneous journal publication that Stacy mentioned, we have also been invited to present, new translational data from the ovation two trial at the International ESMO Gynecological Conference in June.
Speaker Change: The new data that we will present demonstrate.
Speaker Change: 001 technology performs exactly as it was designed delivering highly potent IL 12 gene therapy directly to the site of the tumor while keeping systemic exposure for IL 12 extremely low.
Speaker Change: This is the proprietary biochemical basis for both immunology anti cancer activity.
Speaker Change: Just as important.
Speaker Change: We initiated the first clinical site at our Registrational ovation II trial last week with a second site to be initiated within two days.
Speaker Change: More site initiations are planned in the coming weeks.
Speaker Change: It is gratifying to me as a clinician and then.
Speaker Change: Formative to note that we use leading hospitals internationally known principal investigators were also major participants innovation too.
Speaker Change: Uzi awesome actually their assistance for joining ovation three speaks to their belief in the safety and potential benefit of <unk> 001, and the women they care for.
Speaker Change: They want to join with us in this crucial steps towards bringing <unk> 001 forward as of now.
Speaker Change: <unk> an innovative therapeutics.
Speaker Change: And to answer.
Speaker Change: Our highly experienced clinical development team is excited to have initiated the ovation through trial and is eagerly planning the expansion of the trial over the next six months.
Stacey: I'll now turn the call back to Stacey.
Stacey: Thanks Douglas.
Speaker Change: As we look towards financing our phase III clinical trial. Our goal is twofold. One is to ensure that we have done the best possible job for all stakeholders, including our shareholders.
Speaker Change: And two to raise capital in an amount that allows us to achieve our product development goals.
Speaker Change: And dilution is top of mind as we consider these these options.
Speaker Change: Moreover, and importantly, we have taken steps to conserve cash and align our critical needs with available capital on hand.
Speaker Change: While adding to the balance sheet through optimal opportunities.
Speaker Change: We're actively working on value added financing and partnerships, which will help secure our cash runway and supports our clinical timelines and long term strategic objectives.
Speaker Change: Focusing on both technologies surplus imply scene, we are having discussions with potential partners that have significant investment in oncology as well as vaccine development. Some of these under CDA.
Speaker Change: We are also exploring geographic partnerships on ways to accelerate development of immuno on Oh, one in other parts of the world.
Speaker Change: And finally, we intend to leverage the data from the proof of concept trial, using our novel <unk> vaccine technology to sell or license that technology.
Speaker Change: Our <unk> technology offers several advantages and strong advantages over other vaccine platforms, such as exceptional stability being.
Speaker Change: Being viable for one year at four degrees centigrade refrigerated temperatures and one months at 37 degrees Celsius.
Speaker Change: The platform also has the ability for rapid adaptation to new pathogens or variance longer lasting protection or durability.
Speaker Change: Meaning it could be the less frequent booster shots and cost effective manufacturing.
Speaker Change: We shared insights from the <unk> proof of concept trial and the preclinical trials.
Speaker Change: This month, the first month April 2025 at both the ACR annual meeting and at the World Vaccine Congress and are following up with companies in the vaccine space.
Speaker Change: We are actively working on value added financing and partnerships, which will help secure our cash runway.
Speaker Change: We will provide updates when we're able and our goal is to cover ovation three trial cost through corporate partnerships and equity.
Speaker Change: I'd now like to turn the call over to Dave <unk> to review our financial results for the first quarter Dave.
Speaker Change: Thank you Stacey.
Details of immuno <unk> first quarter 2025 financial results are included in the press release, we issued this morning and in our Form 10-Q, which we filed before the market opened this morning.
Speaker Change: As of March 31, 2025, immuno and had $2 $9 million in cash and cash equivalents.
We remain focused on securing near term financing thats strengthening the company's financial condition and advance ovation free.
Speaker Change: Research and development costs were $2 $2 million for the first quarter of 2025.
Speaker Change: Compared with $3 3 million for the same period in 2024.
Speaker Change: The decrease was due primarily to lower costs associated with the phase one proof of concept busing DNA vaccine trial and the development of Athene DNA vaccine technology platform.
Speaker Change: General and administrative expenses were $2 million for the first quarter of 2025 compared to $1 7 million for the same period in 2024.
Speaker Change: The increase was primarily due to higher employee related expenses.
Speaker Change: Net loss for the first quarter of 2025 was $4 $1 million or 28 cents per share compared to a net loss of $4 9 million or <unk> 52 per share for the same period in 2024.
Speaker Change: With that financial review I'll turn the call back to Stacey.
Speaker Change: With that I'd like to open the call to your questions operator.
Speaker Change: We will now begin the question and answer session to ask a question you May Press Star then one on your Touchtone phone.
Speaker Change: If youre using a speakerphone please pick up your handset before pressing the keys.
Speaker Change: Any time your question has been addressed and you would like to withdraw your question. Please press Star and then two.
Speaker Change: Our first question comes from.
Emily Wagner: Emily Wagner.
Emily Wagner: With H C. Wainwright. Please go ahead.
Speaker Change: Alright family to getting the questions Hello, all and congrats on the progress.
Speaker Change: I guess first one I'll ask about the off coal presentation. So congrats obviously on getting an oral presentation.
Speaker Change: Is there anything new in terms of like subgroup analysis or any new data analyses that we should be expecting at the opco presentation and will you potentially have a median OS for the HRD positive patients by then.
Speaker Change: So we are by nature of <unk> embargo, Emily I know, you'll you'll understand understand that I'm not able to talk about the content of our presentation there.
Speaker Change: Careful with what is shared in advance.
We will be sharing new information and that I think is really quite central to being accepted as an oral presentation. Although I think the full body of evidence that we've been discussing merits a view at this at this level and that's at a platform like.
Speaker Change: Like <unk>, so we're incredibly excited.
Speaker Change: For the presentation and look forward to hearing Dr factors perspective perspective on the data.
Speaker Change: Alright, Thanks, and then maybe just follow up on the phase III design.
Speaker Change: Many sites are you expecting to have in total for the trial for the I guess first half portion that you were discussing and then are you having a wife is a dual primary end point for HRD positive and the ITT population or how are you kind of splitting up the statistical plan.
That goes once you take a step at it.
Speaker Change: Sure.
Speaker Change: The.
Speaker Change: These analysis.
Speaker Change: The phase III has always been predicated on analyzing the HRD population.
Speaker Change: This is the population and which room probation two data, including data that will be presented at Astro.
Speaker Change: In which we have the.
Speaker Change: Highest effect in terms of activity.
Speaker Change: The population that would be brought up first.
Speaker Change: Whether we.
Speaker Change: Proceeded with the entire team.
Stacy Lindbergh: HRD and HRC or whether refocus on HRD alone as Stacy mentioned.
Stacy Lindbergh: The readout does not change either two interim analyses and a final analysis if needed all based on the chart.
Stacy Lindbergh: Yes.
Speaker Change: You asked the question, but the number of sites saw a number of sites.
Stacy Lindbergh: We are projecting about 45 sites at this point.
Stacy Lindbergh: Yeah, Mike just to recap so the overall survival as the primary is not dual and it is consistent for all populations as the primary.
Speaker Change: Got it okay. Thank you.
Stacy Lindbergh: Yeah.
Stacy Lindbergh: The next question comes from James Molloy.
Stacy Lindbergh: Malloy with Alliance Global Partners. Please go ahead.
Laura: Hello. This is Laura three all on for Jim Malloy. Thank you for taking the questions and congrats on the progress.
Speaker Change: So for ovation three what's the current status that you have on like the inventory and the manufacturing capabilities for you know for this trial, especially with the 250 to 500 patient enrollment plan that you have set up.
Speaker Change: Yeah, Great question and I'll I'll take the opportunity just to reiterate that for this trial, we have pulled the manufacturing of the core active pharmaceutical ingredients in house.
Speaker Change: And we are prepared and are monitoring various.
Speaker Change: Enrolment plans and ensuring that we have and will have continue to have product available. So we have had.
Speaker Change: On a product that has passed all of the release specifications and it's been ready to ship four for weeks now and are well prepared for for the weeks and months ahead.
Speaker Change: Got it. Thank you and then also the clinical trial that you have in collaboration with the breakthrough cancer Foundation, what's the current status of this trough here and I spell on chalk to have preliminary results announced later on this year.
Speaker Change: You just had a call with the Pea ice can you also give us some insight from that we have a meeting with the principal investigators every two weeks and the last one was a couple of days ago on Friday.
Speaker Change: We've.
Speaker Change: Initiated another site University of Oklahoma, and very excited about the Johns Hopkins is.
Speaker Change: Managed to re staff, it's clinical research group and so they're excited about starting to screen patients.
Speaker Change: We are expecting to have data at the end of this year, yes.
Speaker Change: Hi, Thank you for the insights and particularly in the questions.
Speaker Change: Thank you.
Speaker Change: This concludes our question and answer session of the call I now want to turn the call back over to immuno <unk>, President and CEO for concluding remarks Doctor Lindbergh.
Speaker Change: Yeah.
Speaker Change: I want to reiterate our near term focus which is unsecured funds to strengthen the company's financial condition and advancing our phase III trial and in the process advancing I mean on the old one.
Speaker Change: We expect to have an update on this on this front by the end of this quarter and as referenced earlier our goal.
Speaker Change: Is to cover the ovation II trial cost and we want to and will be seeking corporate partnering and equity financings.
Speaker Change: We expect this will be an iterative process driven by catalyst to further investor confidence and follow on financings.
Speaker Change: And as our work in providing a new treatment option for women with ovarian cancer progresses and.
Speaker Change: And as the Population's exposure to potential Pandemics increases we remain very excited about reporting data from ongoing clinical studies in the months ahead.
Speaker Change: We look forward to keeping you appraised of our progress and thanks again for joining us today and for your interest in immunology.
Speaker Change: The conference has now concluded. Thank you for attending today's presentation you may now disconnect.