Full Year 2024 Imunon Inc Earnings Call
Good morning, My name is Mike and I'll be your operator today at this time I would like to welcome you to <unk> full year 2024 financial results Conference call. All lines have been placed on mute to prevent any background noise. Following the speakers' prepared remarks, there will be a question and answer session. You May press star one.
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Please note this event is being recorded.
Speaker Change: I'd now like to turn the call over to Peter Vasu of ICR Health care Investor Relations representative for immuno <unk>. Please go ahead.
Thank you Mike Good morning, everyone and welcome to Immunize School year 2024 financial results and business update conference call. During today's call management will make forward looking statements regarding immunized expectations and projections about future events and general forward looking statements can be identified.
Speaker Change: By 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.
Speaker Change: May differ materially from such statements.
Speaker Change: I also caution that the content of this conference call is accurate only as of the date of the live broadcast February 27th 2025, immuno undertakes no obligation to revise or update comments made during this call except as required by law with that I would now like to turn the call over to Doctor Stacy Lindbergh Immunize, President and chief.
Speaker Change: Executive Officer Stacey.
Speaker Change: Thank you Peter and good morning, everyone.
Peter Vasu: Joining me on this call is Dr. Douglas Pfahler, you mean on new Chief Medical Officer, who joined earlier this month.
Dave: And Dave <unk>, our interim Chief Financial Officer, who will review our financial results for 2024.
Mr. Mikles: Mr. Mikles for gig no the executive Chairman of our board and Dr. Christian <unk>, Our Chief Scientific Officer are also on the line and will be available for Q&A.
Mr. Mikles: 'twenty 'twenty four was truly an exceptional year for immunology.
Mr. Mikles: Not only in our execution as a company, but also in our deliverables.
Mr. Mikles: In July we announced positive results from our large randomized and controlled phase two ovation two study.
Mr. Mikles: This study evaluated immune on Oh, one safety and efficacy in women with newly diagnosed advanced ovarian cancer women with stage three C and for cancer diagnosis.
Mr. Mikles: I am pleased to report that the results far exceeded not only our expectations but.
Mr. Mikles: But also those of our investigators and medical advisors.
Mr. Mikles: These phase two data are the basis for our optimism for immuno no Oh, one to go forward with our pivotal phase III phase III study.
Which has agreement from the FDA and we plan to initiate this quarter.
Mr. Mikles: I want to confirm our focus is to identify the most expeditious path to advanced immuno O one towards commercial potential.
Mr. Mikles: Potential commercialization.
Mr. Mikles: Our commitment to an aggressive timeline for initiation of the phase III study has the priority of every employee consultant and advisor.
Mr. Mikles: Yeah.
Mr. Mikles: Our ambition is supported and reinforced with data from the ovation. Two study that continues as we previously announced to get stronger and stronger.
Mr. Mikles: And I might add that at some point could warrant a discussion related to accelerated approval with F. D. A.
Mr. Mikles: Even though they should she was not powered for statistical significance. When you observe very large treatment effects in the trial small P values will emerge as we are observing with ovation too.
Mr. Mikles: I will now spend a few minutes recapping, our progress in providing a clinical and regulatory update on immune on Oh one.
Following the ovation two trial readout recall, we continued to monitor overall survival innovation two per protocol.
Mr. Mikles: In December last year, we announced that based on seven additional months of monitoring the data showed continued improvement in overall survival in the intent to treat population.
Mr. Mikles: With the benefit and median overall survival over the standard of care, increasing from 11 months to 13 months.
Based on this data immuno no one has the potential to be the first immunotherapy effective for the treatment of ovarian cancer.
Dr. <unk> will provide a review of the state of shortly and we are fully committed to any and all paths that lead to our ability to help women who are fighting this horrific disease.
Mr. Mikles: Following our positive end of phase two meeting and type C. CMC meeting both in the fourth quarter of 2024, we remain engaged with FDA, who have provided supportive feedback in a timely and collaborative manner.
Mr. Mikles: In all of these meetings FTA senior leaders have been engaged.
Mr. Mikles: And the after he took the unusual step to extend an invitation to connect and into phase two meeting in person.
Mr. Mikles: At its headquarters in Silver Spring, Maryland.
Speaker Change: Earlier this month, we announced new translational data from ovation too.
Speaker Change: Based on the exciting data from this trial, we know that immune on 001 has a highly beneficial benefit risk ratio.
Speaker Change: And this new data gives us added confidence and confirms a few things in women treated with the targeted dose they mean on O one for phase III.
Speaker Change: Number one there's a strong dose response in the IL 12 levels as measured in ascites or the fluid within the micro tumor environment.
Speaker Change: And this dose responses across five doses of immuno on Oh, one that have been studied.
Speaker Change: Furthermore, IL 12 levels in women, who received 100 milligrams per meter squared is about 20% higher <unk>.
Speaker Change: Compared to those who received 79 milligrams per meter squared, which was the previously highest dose studies.
Speaker Change: We also observed large increases in downstream anti cancer immune cytokines, including interferon gamma or FDA endorsed potency assay and T. J F Alpha.
Speaker Change: Based on these data and the compelling clinical data. We have concluded that 100 milligrams is the dose that will be used in the phase III study.
Speaker Change: Another positive aspect of our there plus technology is that it can finds the therapeutic in this case I'll talk to the local regional area of interest.
Speaker Change: Doing so we believe provides for meaningful efficacy and extraordinary safety profile.
Speaker Change: Which has been the Holy Grail of oncologists.
Speaker Change: The importance of this mechanism, which has been well established in the literature and pursued by many companies was demonstrated in the study.
Speaker Change: The IL 12 levels in blood in women treated with 100 milligrams per meter squared of immuno no one remain low and unchanged from baseline.
Speaker Change: Given the safety profile observed to date.
Speaker Change: This data in terms of IL 12 levels implied was expected.
Speaker Change: But this was important to confirm as elevated systemic IL 12 levels led to severe toxicity.
Speaker Change: Historical investigational IL 12 products administered IV.
Speaker Change: The data generated to date provide unequivocal evidence that immuno and Oh, one and the third plus technology more broadly works as it was designed to do.
Speaker Change: Recent translational data shows that the highest amount of IL 12 across all dose doses studied has been achieved with the dose that will be used in phase III and the anticipated downstream effect in critical cancer fighting cytokines is occurring.
Speaker Change: Clinical data demonstrate that the life of women treated with immune on O. One is extended.
Speaker Change: And if replicated in phase III immuno on 001 will reset the standard of care for women newly diagnosed with ovarian cancer.
Speaker Change: Yeah.
Based on the strength of data observed innovation to including the strong safety profile. We believe the probability of success is high amongst products entering phase three.
Speaker Change: So I want to turn to our important second phase two trial, the <unk> study being run in partnership with breakthrough Cancer Foundation.
Speaker Change: I am pleased to report that the speed of enrollment has picked up.
Speaker Change: This study will provide insight into two important areas first early insight into the potential treatment profile of immuno O. One administered together with platinum based chemo and avastin or Biosimilar bevacizumab.
Speaker Change: And number two the continued benefit of our the benefit of continuing immuno O one treatment and maintenance.
Speaker Change: If successful this trial will provide significant insight and approaches.
Speaker Change: And may potentially alter the treatment landscape, including new combination therapies predictive diagnostics and early clinical assessment of efficacy.
Speaker Change: We expect preliminary results later this year.
Regarding the phase III study ovation three as I've mentioned, we are on track to initiate treatment with the first patient in the study in March within just a few weeks.
Speaker Change: We have inventory of our investigational product ready for the trial.
Speaker Change: Following the end of phase two meeting the protocol was submitted to the FDA prior to the end of 'twenty 'twenty four for final review.
Speaker Change: And the feedback we've received from the Ft on the protocol has been helpful and focused in nature.
Speaker Change: There's been nothing new of substance nor significant points of disagreement.
Speaker Change: Everything that needs to be submitted to the FDA in advance of starting the trial has been submitted and.
Speaker Change: In short, we're exactly where we want to be.
The phase III study will enroll women at least 18 years of age newly diagnosed with advanced ovarian cancer.
Speaker Change: These women will also be candidates for new adjuvant chemotherapy with histological evidence of epithelium ovarian flipping tube or primary peritoneal carcinoma with stage three or four.
Speaker Change: And then E card performance score or Eastern Cooperative group score of zero, one or two.
Speaker Change: The primary endpoint will be overall survival.
Speaker Change: I want to point out that while O S is expected to take longer than PFS to assess the advantage is that it is a definitive endpoint there.
Speaker Change: There will be no second guessing our results or need for a second can conformational study to support approval.
Speaker Change: We are enthusiastic about the initial core set of clinical trial sites to be activated early.
Speaker Change: Which includes sites that were part of ovation, one innovation too.
Speaker Change: And we're also excited to bring new sites on board to accelerate enrollment of the trial.
Speaker Change: The strength of our clinical data is a key point of discussion.
Speaker Change: And this is how we will drive patient recruitment.
Speaker Change: There's optimism the immuno or 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 ovarian cancer.
Speaker Change: If the promised efficacy from ovation two are replicated in phase III.
Speaker Change: Regarding clinical trial material to product for <unk> III is ready for shipment to clinical sites.
Speaker Change: In a recent <unk> submission release criteria have been updated with phase III and commercialization in mind.
Speaker Change: We passed all release criteria.
Speaker Change: And with this strategic choice to move their production of active pharmaceutical ingredients or API in house.
Speaker Change: We are able to keep clinical trial cost extremely low and set the company up for attractive cost of goods and the future commercial setting.
Speaker Change: With that I would like to now turn the call over to Dr. Douglas father, who will discuss the phase two ovation two study <unk>.
Speaker Change: Including additional survival data, but first I want to formally welcome him to the company as Chief Medical Officer and properly introduce you to him.
Speaker Change: Dr. Fowler has over 30 years of experience with a rich background in both industry and academia.
Speaker Change: He is board certified hematologic, Hematologist and oncologist with extensive global clinical development regulatory and medical affairs expertise and a unique record of successful translational research.
Speaker Change: His broad experience in large pharma and biotech drug and biologics experience covering ecology immune disorders, hematology, CNS neuroscience psychiatry disorders, and genetics disease for all stages of drug development from first in human through product launch and.
Speaker Change: Being on the market working in companies like Takeda Skyhawk Therapeutics and horizon genomics.
Speaker Change: His career also includes pioneering programs and car T therapies in RNA splicing modifiers.
Speaker Change: And his academic appointment spanned two prestigious local institutions Harvard Medical School in Boston University School of Medicine.
Speaker Change: He serves as the founding director of the comprehensive cancer Center at Boston University, Underscoring his ability to build from the ground up and fostering environments, where innovation thrives.
Speaker Change: He received his MBA from Harvard Medical School, and a ph D in oncology and cancer biology from M. I T and I am confident that with Doctor followers guidance and leadership, we will not only advance our scientific objectives.
Speaker Change: Enhance our teams culture.
Speaker Change: Yes.
Speaker Change: Thank you Stacey.
Speaker Change: Let me, let me start by saying that my decision to join <unk> was an easy one.
Speaker Change: A rare opportunity for an oncologist like myself to be able to lead and support our program that already has the groundbreaking data reported by immunology in 2024.
Speaker Change: I'm very grateful for this opportunity.
In July immuno and announce the results of our phase II study ovation too.
Speaker Change: This large randomized study involving 112 newly diagnosed patients with advanced ovarian cancer exceeded expectations.
Speaker Change: Specifically an improvement in median overall survival of 11, one months nearly a year compared to standard of care.
Speaker Change: This is a clinically meaningful and unprecedented improvement in first line treatment for this deadly disease.
Speaker Change: For women, who were also administered PARP inhibitors in the immunology 001 arm. The median overall survival has not been reached indicating that more than one half of these patients in the immuno anr are still with us with some approaching the five year Mark since trial initiation.
Speaker Change: Importantly for those receiving at least 20% of the planned immunology 001 doses survival increased by a remarkable 17 months.
Speaker Change: These outcomes are particularly significant in a patient population, who was not witness an advance in frontline treatment, which extends patients lives for more than 25 years.
Speaker Change: More importantly, our ovation two study is the first study ever to demonstrate an improvement in overall survival in this context.
Speaker Change: For a deeper understanding of these data I encourage you to visit our R&D day presentation from September 18th of last year.
Speaker Change: This is available on our website under the news and investors tab and then under the scientific presentation staff.
Speaker Change: Furthermore, and very Excitingly as Stacy mentioned results from the additional monitoring of patients in ovation to indicate that the overall survival benefits are not only being maintained in the population of patients treated with <unk> 001, but have grown in <unk>.
Speaker Change: Strength, providing a strong additional validation of the potential of our novel IL 12, immunotherapy to represent and historic advance in the treatment of ovarian cancer.
Speaker Change: Specifically in the intent to treat population the hazard ratio dropped from 0.74 to 0.69 with the median difference in overall survival being extended by 13 months in patients treated with immune on 001 compared to standard of care.
Speaker Change: And women, who were also treated with PARP inhibitors. The hazard ratio dropped from 0.41 to 0.38 with over half the women in the immunology arm remaining alive in the trial.
Speaker Change: The median in the control arm was 37 one months.
Stacy Lindbergh: As Stacy referenced earlier in this call.
Stacy Lindbergh: There is a highly favorable benefit risk profile with no elevation of immune related adverse events and with no cytokine release syndrome occurring in any patients having the immunology 001 treatment.
We will further share these important and exciting data at the upcoming 2025 <unk> annual meeting in June.
Stacy Lindbergh: Clearly our commitment to accelerating initiation of the phase III study ovation II is strongly supported by the data I've just described.
Stacy Lindbergh: I look forward to reporting on our progress in the coming months.
Stacey Lindbergh: I'll now turn the call back to Stacey.
Stacy Lindbergh: Thanks Nicholas.
Stacy Lindbergh: As mentioned previously we have taken a number of steps to conserve cash and align our critical needs with available capital.
Stacy Lindbergh: Our cash runway accounting for cost associated with starting the phase III trial in March extend late into June.
Stacy Lindbergh: We're actively working on value added financing and partnerships, which will help secure our cash runway that supports our clinical timelines and long term strategic objectives.
Stacy Lindbergh: In addition, we are actively pursuing non dilutive.
Dilutive funding through partnerships, including focusing on third plus any mean an old one.
Stacy Lindbergh: We're having discussions with potential partners with significant investment in oncology drug development, some of which have invested heavily in IL 12 in the past.
Stacy Lindbergh: We're also exploring geographic partnerships and ways to accelerate development of immuno no one in other parts of the world.
Stacy Lindbergh: And finally, we intend to leverage the data from the proof of concept study using our novel, placing technology to sell or license that technology.
Stacy Lindbergh: Our technology offers multiple advantages over current vaccines.
We believe these attributes will be attractive to potential partners to target the development of a cancer vaccine. In addition to antigen based vaccines.
Stacy Lindbergh: For example, we announced new data earlier this week from a phase one clinical trial of our DNA vaccine in the treatment of COVID-19.
Results from the immuno on 101 proof of concept study demonstrate persistent immunogenicity and trial participants and further validate the processing technology.
Stacy Lindbergh: You mean on 101 induced to two to four fold increase in neutralizing antibody titers from baseline through week for it.
Stacy Lindbergh: Clear and convincing response to the vaccination.
Stacy Lindbergh: You mean on continues to show favorable safety profile and given this proof and Immunogenicity early indications of durability of protection and competitive advantages and the stability of our vaccine at workable temperatures compared with available in RNA vaccines, we believe that immuno on one.
Stacy Lindbergh: <unk> hundred one has significant potential as a superior next generation vaccine and will seek potential partnerships for future development.
Stacy Lindbergh: We are excited to share insights from research conducted in 2024 from policy in April at the 2025 American Association for cancer Research meeting.
Stacy Lindbergh: As a final note, we expect any potential financing for business development opportunities to be accomplished in a manner that.
Stacy Lindbergh: That will allow us together with our shareholders. The best accomplish our mission of improving the lives of people with unmet medical needs.
Stacy Lindbergh: Doing so we believe will enhance our ability to significantly improve the lives of people through our innovative technology platforms, our committed employees and our supportive medical community advisers and researchers.
Garo: Now I'd like to turn the call over to date Garo to review our financial results for the full year date.
Garo: Thank you Stacey details of immuno <unk> full year 2024 financial results are included in the press release, we issued this morning and in our Form 10-K, which we filed before the market opened this morning.
Garo: As of December 31, 2024, immuno <unk> had $5 $9 million in cash and cash equivalents.
Garo: With our continued focus on strategically managing our cash while continuing to advance our programs. We expect our capital resources to fund operations late into the second quarter of 2025.
Garo: Research and development expenses were $11 $6 million for 2024 compared to $11 $3 million for 2023.
Garo: The slight increase was driven primarily primarily by increased clinical spend related to ovation. Two in addition to startup costs for ovation II.
Garo: General and administrative expenses were $7 $5 million in 2024 compared to $9 $7 million in 2023.
Garo: The decrease was primarily driven by decreased professional fees and decreased employee related expenses.
Garo: Net loss for 2024 was $18 $6 million or $1 62 per share compared to a net loss of $19 5 million.
Garo: Or $2 16 per share for 2023.
Garo: With that financial review I'll turn the call back to Stacey.
Stacey Lindbergh: Thank you Dave.
Speaker Change: I open the call to your questions I want to remind you of the power of our technology.
Speaker Change: You mean on O. One allows durable therapeutic and dose dependent production and release of IL 12 into the tumor microenvironment.
Speaker Change: The lack of toxicity shows its advantages over other approaches to IL 12 delivery such that the ability of immuno O one to cheap well tolerated and durable levels of IL 12, and other anti cancer cytokines could usher in the first immune based gene therapy for ovarian cancer.
Speaker Change: We may have in our hands the first perhaps only immunotherapy that's effective for the treatment of ovarian cancer.
Speaker Change: We reported favorable and clinically meaningful topline results from ovation two in women with newly diagnosed ovarian cancer.
Speaker Change: We're on track to begin our pivotal ovation three trial in the first quarter of 2025.
Speaker Change: And we have an internal GMP manufacturing capability in place and Huntsville, Alabama, which will allow us to produce quality product at an order of magnitude lower cost compared to an external C. D. M O.
Speaker Change: Ovarian cancer represents a multibillion dollar unmet medical need.
Speaker Change: Our product has been granted fast track designation by the FDA and orphan drug status has been established in the U S and Europe.
Speaker Change: Thus, providing additional protected commercial runway.
Speaker Change: Our second phase III study in ovarian cancer is underway with an old one plus avastin evaluating M or D. At second look laparoscopy.
Speaker Change: This is largely funded by the breakthrough cancer Foundation and will give insights into combination treatment with avastin or biosimilar, bevacizumab and maintenance therapy with immuno <unk>.
Speaker Change: I'd like to finish with a comment on the strength of immunized company's culture.
Speaker Change: Which includes the longevity of commitment to I mean on by our employees across levels of the organization.
Speaker Change: This strength allows us to have a long term view of our past it.
Speaker Change: It brings trust, which enables a coach a culture of entrepreneur realism, and an ability to move fast.
Speaker Change: And strength of leadership is enabled by candor and data driven decisions, which spans science operations manufacturing and finance.
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 telephone keypad, if youre using a speakerphone. Please pick up your handset before pressing the keys.
Speaker Change: Anytime Youre 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.
Speaker Change: The first question comes from Emily partner with H C. Wainwright. Please go ahead.
Speaker Change: Hi, Good morning. This is joey on for Emily Thanks for taking our questions.
Speaker Change: Could you discuss the Covid booster neutralizing antibody data in the context of what would be expected from the approved mrna vaccine on the SBB one five variant.
Speaker Change: Did any of the participants enrolled in this study have prior COVID-19 infection.
Speaker Change: Yeah.
Speaker Change: And I'll ask Dr. Chris you don't want to take this question and I'll add add anything on the backend Christy.
Dr. Chris: Sure I'd be happy to.
Speaker Change: The loans, we have seen a neutralizing antibody response or baseline I'm ballpark with.
Hmm.
Dr. Chris: Hmm.
Dr. Chris: <unk>.
Dr. Chris: Your question about.
Dr. Chris: With that Shannon mentioned, that's a very very quick point.
Dr. Chris: Our study started.
Speaker Change: Summer of last year, Jerry and.
Dr. Chris: A lot of patients or subjects.
Dr. Chris: Sachin.
Dr. Chris: Sort of explanation is very hard to find them naive.
Subject by that time, so yes, they have.
Dr. Chris: And it has been known.
Speaker Change: Tomorrow name clients.
Dr. Chris: Higher infection, causing.
Dr. Chris: The reduction in the immune responses so.
Dr. Chris: Main point is that the level you had seen a fairly comparable to what you anticipate in this type of patient population with respective <unk> ballpark.
Dr. Chris: I see thank you that makes sense.
Speaker Change: Just one follow up question.
Just generally what is your updated strategy in terms of patient population for the phase III ovarian cancer study and any other details you can share about the trial design.
Speaker Change: Yeah, that's all I'll I'll take that thank you Joey.
Speaker Change: So we have a protocol that's under review and we expect to be finalized as early as the end of this week at the F D. A.
Speaker Change: Is.
Speaker Change: <unk> is targeting a very similar population to ovation, two and I'll I'll, Alaska Douglas to tick up a little bit more detail certainly happy to.
Speaker Change: The space you said I think the most important.
Speaker Change: Thing to take away is that our trial design.
Speaker Change: Eligibility.
Speaker Change: <unk> factors.
Speaker Change: He is very very similar to ovation two that I mentioned that because as you well know one of the.
Speaker Change: Rapid ways to get uninsured broker results is to change the way in which you're administering the drug where the patient populations. So by keeping this very very similar to ovation two in nearly every respect except size.
Speaker Change: This guarantees or I shouldn't say guarantees this gives us the best chance of reproducing and even strengthening the results we got innovation too so.
Speaker Change: So similar population of patients.
Speaker Change: A 500 patient study as opposed to 112 patients innovation too and the endpoints here.
Stacy Lindbergh: As Stacy mentioned earlier are twofold, two primary endpoints overall survival in the homologous repair deficient population, which gave us the strongest overall survival results innovation too and it's a second primary endpoint.
Stacy Lindbergh: Overall survival results and the intent to treat population, which includes both HR deficient and HR proficient tumors.
Stacy Lindbergh: Okay.
Stacy Lindbergh: Alright, Thank you that makes a lot more sense.
Stacy Lindbergh: Thanks for answering my questions really appreciate it.
Jerry: Thank you Jerry.
Stacy Lindbergh: Okay.
Speaker Change: The next question comes from David Bautz, Zacks small cap research. Please go ahead.
David Bautz: Hey, good morning, everyone. Thanks for the overview. This morning, it was really helpful.
Stacy Lindbergh: Stacy you're prepared in your prepared remarks, you had mentioned the possibility.
Stacy Lindbergh: Ability for accelerated approval and I kind of wanted to dive into that a little bit maybe you can discuss what pathways. There would be available for that is it certain patient populations are interim results what could potentially lead to the possibility for an accelerated approval.
Speaker Change: So David Thank thank you for the question I am pleased here on the on the call and I would say that the the thought behind my prepared remarks is really just reflecting on the.
Stacy Lindbergh: The evidence that's emerging so as you know we released.
Stacy Lindbergh: Updated overall survival data after seven months after we write off the trial when you look at the.
Stacy Lindbergh: The strength of evidence in some of these subgroups for example, women that have received PARP inhibitors as part of maintenance therapy, we have.
Stacy Lindbergh: P values that are emerging that are now if I recall off the top of my head that P values about point of sale.
Stacy Lindbergh: So it was really more but general comment that as as the data continues to mature. The protocol indicates we will continue to monitor overall survival through and into.
Stacy Lindbergh: Into the fourth quarter of this year.
Stacy Lindbergh: We expect that based on the evidence that we've seen that this could continue to grow and there would be a natural time, where that would be a conversation with the FDA. So it is not.
Stacy Lindbergh: Sharing plans at the moment, but really just an observation of the strength of evidence and that that would be a very natural step two to undertake Nicholas would you like that I'd just add.
Stacy Lindbergh: Matt.
Speaker Change: The one of the major criteria as I'm sure you know that the FDA has recently enforced.
Speaker Change: Is that a phase III confirmatory trial be underway.
Speaker Change: When considerations for accelerated approvals off the basis of the smaller study are concerned and we will be in that position.
Speaker Change: Data continue to strengthen.
Speaker Change: And the fact that we can have conversations with the FDA because of fast track approval.
Speaker Change: We can take that data back and ensure them that our phase III confirmatory study is underway. So there'll be a convergence of a number of events, which would allow us to be in a good position at that time.
Speaker Change: Okay is there currently and your protocol.
Speaker Change: Interim analysis is there a plan for one right now.
Speaker Change: Yes innovation through their two interim analyses on a final analysis is necessary.
Speaker Change: That's right. The protocol, we haven't talked a lot about it but it has some very exciting components to it. So we know from ovation two that we saw this really extraordinary response and women that are positive for HR deficiency and.
Speaker Change: We saw very similar.
Speaker Change: Hazard ratio in a clinical effect in and women, who received PARP inhibitors is a very very consistent.
Speaker Change: Consistent group and and so the protocol allows for a.
Speaker Change: Read out first in in that subgroup, which we expect could happen sooner.
Speaker Change: But as currently designed for an all comers population and and wood within test and the ITT population later, but this is something that we will continue to be.
Speaker Change: Be reflecting on carefully from a strategic standpoint.
Speaker Change: We know that we could choose if if if if this were.
Speaker Change: Really in the interest as we were talking with with the investors that will be.
Speaker Change: Helping fund the complete study that we could choose to go after an HRD focused population that would be a very coherent strategy in a very.
Speaker Change: A simple evolution out of this all comers or we could we could do this the full trial and this this trial design is it is very strong in that manner.
Speaker Change: Okay. So it sounds like.
Speaker Change: Youre going to have options after even after the trial gets underway, it's not necessarily.
Speaker Change: One path is defined it's you've got the whole study and then if you decide to go down. The route that you were just describing then that's possible in my understanding that correctly.
Speaker Change: Yeah. So.
Speaker Change: I've been clear that we need to raise capital to conduct a phase III trial. We designed this trial with an all comers population and that is what we will start with.
Speaker Change: As we work through our our capital and adding a adding money to the balance sheet. We will then decide the path if it's different from from our current plan.
Speaker Change: We will know that we have full endorsement for the all comers population and then that is a seamless transition if we choose to to revert to us.
Speaker Change: Our initial target of HR HR deficiency, so it will be well positioned and we'll follow the path that is most appropriate with with the capital that we have.
Speaker Change: Two two to use for for this for this trial they will both be extremely important contributions to our to the medical community.
Speaker Change: Okay, Yeah. It sounds great. Thanks for taking my questions.
Speaker Change: Yeah.
Speaker Change: The next question comes from James Molloy with Alliance Global Partners. Please go ahead.
James Molloy: Hey, guys. Thanks for taking my questions.
Speaker Change: What are your could you characterize how the purchasing environment.
James Molloy: Looks currently.
James Molloy: Sort of versus vis vis.
James Molloy: Central fund raise.
James Molloy: So given the impending.
Cash Crunch here, you guys talked about second quarter.
James Molloy: Of this year and how does that how is that impacting any potential partnership discussions.
Speaker Change: Yeah. Thanks, Thanks James.
Speaker Change: We've had very successful meetings with institutional investors.
Speaker Change: The recent past uneven.
Speaker Change: No.
Speaker Change: Prior to this.
Speaker Change: What we hear from them. They appreciate the quality of our recent phase II data.
Speaker Change: And we do have viable investors currently that could serve as lead or co leads of our financing that are still in discussions with us.
Speaker Change: But I think we all appreciate this is a very tough market, it's not just for <unk>, but virtually all microcap issuers are facing.
Speaker Change: But I want to point out two things that are really to our advantage and what we think will play.
Speaker Change: A significant role in our ability to fund this trial in full number one ovation two is the only trial to show an overall survival benefit.
Not just an improvement, but a clinically meaningful prolongation of survival over the standard of care.
Speaker Change: The second we know that we have the support of F. D. A in our plans and to move into phase III.
Speaker Change: And with these in mind.
Speaker Change: If we're patient I believe we will find the appropriate investors to proceed with the trial.
Speaker Change: And how does that sort of following up on that how is the.
Speaker Change: The anti vaccine sentiment and our recent administration impact any potential for <unk>.
Speaker Change: And in partnerships there, it's been kind of strange change.
Speaker Change: To be sure.
Speaker Change: It seems there's a lot that's evolving I would say that we have impressive impressive data.
Speaker Change: It is early and the data that we're reporting is a it was recently received.
Speaker Change: We're just starting to explore it as we make progress we'll provide timely timely updates, but we do believe there are important advantages that we bring that.
Speaker Change: That we bring to a two two though the landscape and that this is a valuable asset for the right partner.
Speaker Change: Could I also add that the technology and the platform is not restricted to infectious diseases, which seems to be what the current.
Speaker Change: Uncertainty is about but would also include such things as cancer vaccines, which are re emerging as a potentially very strong.
Speaker Change: Rob to care for hard to treat cancers.
Speaker Change: Right and the.
Speaker Change: The comment I made about.
Speaker Change: The meeting were attending in April.
Speaker Change: Is in fact sharing preclinical data that was done in 2024 with the in the cancer vaccine front, Chris heat I don't know if you want to add anything to the discussion.
Speaker Change: I can get available.
Speaker Change: Feedback on that question.
Speaker Change: Clearly.
That's all.
Speaker Change: <unk> said that yes.
The application.
Speaker Change: Yes.
Speaker Change: Could you maybe.
Speaker Change: Hum.
Speaker Change: James mentioned about government assumption, but cancer vaccine certainly and then.
Speaker Change: Application rates and better benefits have been published and we are we.
Speaker Change: We'll be sharing ACR data, they're using mouse model.
Speaker Change: Cancer, we did target some specific.
Speaker Change: P J.
Speaker Change: Sure.
Speaker Change: Parallel.
Speaker Change: Parallel to your personalized cancer vaccines and we demonstrate.
Speaker Change: Immune response activation and benefited.
Speaker Change: Clearly that's a solid set of <unk>.
Speaker Change: Hum.
Speaker Change: At Lindbergh.
Speaker Change: The application of value that you can back into it.
Speaker Change: There are certain local government level think that out of our control, but my bathroom application density.
Again, a lot of questions.
Speaker Change: Sure.
Speaker Change: And we have shown that.
Speaker Change: Our approach.
Speaker Change: The animal models to start with.
Speaker Change: I just wondered if one of them.
James Molloy: Comment on this front James before you go for it we've demonstrated proof of concept. This was our target and our goal but.
James Molloy: But I do want to be clear that policy is not our priority within the company. We are focused on IL 12 in our phase III study in there plus.
Speaker Change: It is important that we pursue and use the the strength placebo as a derivative I think as you know of our third plus technology platform. We saw an opportunity to bring this forward. We view this as an mrna better platform, but it will be something that we will not be proceeding.
With as a company.
Speaker Change: We will be looking for partnership and or opportunities to bring in non dilutive funding that will give you updates as we make progress.
Speaker Change: Because I guess my final question, you talked to a file or.
Speaker Change: Maybe.
Some impressive data out of the phase two the phase II, just getting going here.
Speaker Change: Sort of jumped out at you is sort of the most impressive.
Speaker Change: The data that you saw and said this is the time to be joining imminent.
Speaker Change: Well. Thank you further question James.
Speaker Change: Ive been practicing oncology for most of my life and.
Speaker Change: Ovarian cancer has been one of these diseases.
Speaker Change: Which we are treating today.
Speaker Change: Frontline the same way I treated it when I was in training.
Speaker Change: Chemotherapy alone in surgery.
Speaker Change: It's been it's been very frustrating for women. This is a very chemo sensitive tumor.
Speaker Change: Can eliminate the tumor as far as we can see.
Speaker Change: A large number of patients, but we know that it's going to come back.
Speaker Change: And this data these data are really the first that I've seen.
Speaker Change: Ovation, two data which have.
Speaker Change: Really impressed me that this is an opportunity to dramatically extend the life of patients.
Speaker Change: A relatively short treatment cycle, which adds to standard of care and stops.
Speaker Change: That there have been significant.
Speaker Change: Important prolongation and patient survival.
Speaker Change: I won't repeat everything I said in my presentation, but this is really stunning data.
Speaker Change: And really offers hope for patients and for the physicians, who care for them. It's a very exciting set of data.
Speaker Change: I'm really thrilled to be able to take those.
Speaker Change: And get an approval for patients to have something which is well tolerable. The FDA had no safety concerns how often do you heard the FDA say that.
Speaker Change: And this is a straightforward path to getting this drug to patients.
Speaker Change: Thank you for taking the questions.
Speaker Change: Thanks James.
Speaker Change: The next question comes from Jason Kolbert with <unk> capital. Please go ahead.
Jason Kolbert: They say well maybe Europe.
Jason Kolbert: Okay.
Jason Kolbert: Hi can you hear me.
Jason Kolbert: So again right now okay, great. So just a couple of quick questions.
Speaker Change: Stacey who put together the design of the trial what I'm getting at is what is the assumed effect and what is the power and how does that translate into the end value that would be helpful.
Speaker Change: Yeah, Great question, Jason So we worked with them.
Speaker Change: Really.
Speaker Change: <unk> well known group Calbury consultant sits out of the founder is on faculty at MD Anderson.
Speaker Change: They have played a really prominent role in oncology as well as a really innovative designs and we worked with them on this design to allow them.
Speaker Change: Two two shots on goal.
Speaker Change: And and really a very strong.
Speaker Change: Strong design, which allows us to act quickly if we see the same strength of effect in the HRD positive.
Speaker Change: Subgroup than we would be able to read that out early and and file for accelerated approval. While the all comers continued to mature so that was a very important.
Speaker Change: Part of the design, which did include a lot of clinical trial simulations. So you want to really get to those different when you're putting together these kinds of designs.
Speaker Change: The assumptions that we undertook.
Speaker Change: Are using assumptions.
Speaker Change: Assumptions that are.
Speaker Change: I'd say more pessimistic than what we're observing right now, especially as the data has continued to improve to strengthen innovation too. So we started with the intent to treat the initial readout and really if there is always uncertainty in what your control arm will look like.
Speaker Change: What maybe will occur across the time of the trial running in terms of treatment landscape changing downstream.
Speaker Change: And so we brought in a slightly more pessimistic.
Speaker Change: Assumptions, knowing that we had a trial is set up where if it's in fact it was stronger than we were assuming we would hit on an early interim and what we know based on the trial design is that with these realistic I think assumptions.
Speaker Change: And these are all of our all of our stimulations and the effects that were that were studied would be strong advancements for for the medical community right. So there they all represent positive value added.
Speaker Change: Product, but wanting to make sure we have the trial setup to be able to demonstrate that definitively and the power of our trial right now on the intent to treat population is about 95% and in the high.
Speaker Change: HRD population is is is is higher it's higher than that.
Speaker Change: So we have a very well powered trial a trial that allows for early readout. If there is warrants it and in fact in both HRD population and intent to treat population and then a.
Speaker Change: A final final readout, if the Interims don't yet werent stopping.
Speaker Change: And another question about when you're selecting <unk> and you're assuming enrollment numbers can you give us some idea on kind of what guidance you are getting in terms of how long it would take to completely enroll the trial.
Speaker Change: So we.
Speaker Change: I think have probably one of the best insights into enrolment feasibility, having just completed ovation too.
Speaker Change: We have a strong set of sites that are going to be continuing with the trial and through Douglas we have.
Speaker Change: Our proven track record of.
Speaker Change: Running trials in really difficult to recruit populations.
Speaker Change: I would say that we balance not only our own insight from you know what's realistic from a recruitment standpoint with the sites that we know, but also with than doing a full RFP and working with some large.
Speaker Change: Well established heroes that helped us kind of see through their lens. So I do think where we.
Speaker Change: We're confident in our ability to meet the enrollment that we're setting and I can tell you that Douglas knows I have pretty high expectations for him.
Speaker Change: We're going to we're going to improve over over what what we're assuming that we're going at this pragmatic and I think based on based on our experience. So circle a phone if you have anything you want to add.
Speaker Change: My intentions are to exceed expectations for enrollment.
Speaker Change: This is the data from ovation two has already generated excitement.
Speaker Change: Yeah.
Speaker Change: <unk> ability to deliver the drug at least the safety of the drug to date have gotten investigators quite enthusiastic so I'm, hoping we can.
Speaker Change: Go even faster because of excitement among the investigators and our CRO has suggested.
Speaker Change: And you mentioned one thing that I'd like to think about a little bit which is the delivery of the drug there are so many innovations in terms of drug delivery keeping drug on site and on target.
Speaker Change: An area, where you're constantly looking at how you improve the delivery so that you can expand.
Speaker Change: How long the drug is actually onside on target before it's eliminated from the body.
Speaker Change: Or maybe that's not an issue at all if you could just talk about that a little bit.
Speaker Change: Okay.
Speaker Change: The points you make are really extremely important.
Speaker Change: The fact that we can deliver IL 12 safely, which people have been trying to do for <unk>.
Speaker Change: <unk> years is I think a really impressive testament to where we are right now we can deliver IL 12 to our site. We don't have the kind of toxicities that one sees delivering its systemically or even or even locally.
Speaker Change: This is the technology that.
Speaker Change: As Stacy mentioned that allows us to treat these patients.
Speaker Change: Room for improvement room for new innovation, that's certainly something we're interested in both the platform.
Speaker Change: Also lends itself to delivering other hard to deliver.
Speaker Change: Cytokines for example, things that you could not deliver systemically, but delivering them locally.
Speaker Change: And capsulate it as a potential platform for a number of other cytokines, which have been too toxic to deliver systemically.
Speaker Change: Steve.
Speaker Change: Yeah.
Speaker Change: Yeah.
Speaker Change: You may begin.
Jason Kolbert: Jason This is a gene therapy products, a classical small molecule the protein you inject and they have.
Speaker Change: Kinetic but here in the south take up.
Speaker Change: The DNA and then expressed through that for a long period of time, so that add to the durability of the drug but clearly like with any drug improvements can be made polycom glycol as part of this club assistant that enhances the residence time of the nano particles that can be further enhanced by the second step would be.
Speaker Change: The expression, so that's doable too so.
Speaker Change: Some type of biologics or small molecules in terms of durability.
Speaker Change: Yes, that's exactly where I was going.
Speaker Change: I appreciate that I'm sure you're always looking at ways to kind of dial that in a little tighter. Thank you yeah, absolutely Jason one thing I want to add just for context, we have to keep in mind that when when we were successful at all I'll talk up very positively.
This will be the first IL 12, if approved this would be the first IL 12 product in any disease and the first immunotherapy gene therapy in ovarian cancer. So we will be moving forward progress and I expect we'll be able to to then rapidly be prepared to think.
Speaker Change: Other cancers Douglas mentioned of course, the fact that this is a platform and we have the ability to add multiple cytokines, we can adapt and with Chris <unk> as our CSO is the founder of this technology, we have great depth.
Speaker Change: <unk> strength within the company. So we are keeping line of sight on our future plans, but we're recognizing that this will be a monumental stuck as the first IL 12.
That would be approved if it if we and when we get to that to that place. So that's a very important perspective.
Speaker Change: Yes, I'm excited for patients. Thank you.
Speaker Change: Thank you Jay syndrome.
Speaker Change: Again, if you have a question. Please press Star then one our next question comes from kept Oliver with Brookline capital markets. Please go ahead.
Kept Oliver: Hi, good morning.
Speaker Change: First question.
Speaker Change: <unk> to the combination study and the pickup in enrollment.
Speaker Change: Can you tell us where where enrollment stands now and then also.
Speaker Change: What has driven the acceleration.
Speaker Change: So I'll start with the second the second question.
Speaker Change: We have had more sites coming on board. We had one site that was it had lost some personnel and and therefore their clinical trial support across the board with suffering that they have now been able to reengage. So really this is about.
Speaker Change: Engaging a very well established.
Speaker Change: Sites are.
Speaker Change: And and getting them up and running so you know we've had MD Anderson as the the lead them the lead side Dr. Amir <unk> that has delivered.
Speaker Change: I'm extremely well at his side and now others coming coming on board. So our goal is to enroll 35 patients.
Speaker Change: Patients this year, that's our corporate goal for the study and that would really be.
Speaker Change: Getting us to the point of completing the trials. So we see that as very extreme.
Speaker Change: Extremely.
Speaker Change: It is a goal that we will accomplish it is or it's the goal we've set for ourselves.
Speaker Change: And I guess, one last point I would add is that I do think that the.
Speaker Change: The updated data from our vision two is all it is also gives a lot of strength when we have calls with our RPI as they're able to now take take this data and what's being experienced innovation to and be able to then translate that to women that theyre trying to at all.
Speaker Change: I'll answer Okay. If I can also mentioned that our recruitment rate has picked up.
Speaker Change: And in addition, as the sites have opened.
Speaker Change: Sites slow site openings have legs.
Speaker Change: Clinical trials ever since the pandemic as I think you know but.
Speaker Change: I can also tell you that we had a DMC meeting.
Speaker Change: Earlier this or at the end of last week in which all patients enrolled were reviewed by an independent committee and the committee's recommendations were to continue the trial as designed so theres some safety issues.
Speaker Change: And Stacy just to be clear you mentioned a goal of enrolling 35 subjects. This year.
Speaker Change: Enrollment target for this trial remains at 50 is that correct.
Speaker Change: That's correct, so that would get us basically to the to the end of the enrollment period.
Speaker Change: Fabulous. Thank you second question relates to.
Speaker Change: 101 and.
Speaker Change: The topic of expected durability of protection how can you.
Speaker Change: Can you demonstrate.
Speaker Change: And appealing.
Speaker Change: The ability of protection without following the subjects for the full 12 months alright. Thank you have planned.
Speaker Change: So I might answer your question in another way and.
Speaker Change: I do think that as we're looking at the people that were enrolled in the trial and we look at their baseline values, we know by.
Speaker Change: The the early read out in the cellular data.
Speaker Change: And this has been confirmed with them with.
Speaker Change: With our consultant at Harvard that is so well versed in and.
Speaker Change: And in the vaccine space and COVID-19.
Speaker Change: Effectively our entire population.
Speaker Change: He he would say based on his his publications Doctor Farooq.
Speaker Change: Has been exposed to the virus mulch.
Speaker Change: Multiple times and that.
Speaker Change: We know from our baseline data that we see evidence not only of.
Speaker Change: Viral burden, but also of treatment with other vaccines. So I think that one of the most important things when we talk about durability.
Speaker Change: To really assess the full.
Speaker Change: Our ability of our platform to extend durability, which is one one of the components from the preclinical data that we have that we expect to be a differentiator relative to mrna vaccine platform.
Speaker Change: We believe that this really does need to be in a naive environment or in an environment that already the the the levels are not so high that you're showing this this differentiation and that is a that's been the topic of our conversation. So I do think that we'll be looking for ways.
Speaker Change: That we would be proposing are our partners in the future to help us elucidate what really should be one.
Speaker Change: Have a handful that are value added additions to our to the vaccine world.
Speaker Change: Yes.
Speaker Change: We thank you got it exactly.
Speaker Change: Ted.
Steve: We were pleased to see that business and then again this is Steve.
Speaker Change: And as you know that DNA vaccines.
Speaker Change: They in fact, unless you use the device electric creation are our jet injection device and we accomplished that with a simple needle injection method. So that's the first thing that the DNA vaccine.
Speaker Change: Genic and see.
Speaker Change: Now this was done in South Dakota to sit down with you guys.
Speaker Change: As we mentioned prior infection.
Speaker Change: Infection prior multiple explanation so not the best system correctly.
Speaker Change: Correctly durability lies in animal models, where you had naive animals, we've seen longer in duration on protection also so that's the program now for from this proof of concept of Entergy, Mississippi magnitude demonstrating the human phase to really expand this into other applications.
Speaker Change: <unk> very good certainly further follow forward visibility also evening.
Speaker Change: And the model that would be now this messy.
Speaker Change: Messy in terms of prior explanation section, so I think that would be a real.
Speaker Change: Our assessment.
Speaker Change: Acknowledging.
Speaker Change: Sorry in the animal models in terms of given thought to that.
On the dividend.
Speaker Change: To go after after this POC.
Speaker Change: Thank you. Thank you.
Kevin: Thanks, Kevin.
Kevin: This concludes our question and answer session I would like to turn the conference back over to taste test Stacy Lindbergh, President and CEO for any closing remarks.
Kevin: I want to thank everybody for the questions on really the engaging discussion that we had.
Kevin: And I'll just make it very brief comments before we close the call.
Kevin: Reflecting on that really most of the industry.
In ovarian cancer is focused on maintenance therapy or second line treatment in ovarian cancer.
Kevin: We chose to focus on the most significant challenge facing these patients and at the time that we can deliver the greatest value by altering the course of their life.
Kevin: Conventional wisdom across oncology is to engage as early as possible as a company. We took a bold decision to focus on newly diagnosed patients a decision that's different from most of our peers and we could be disruptive to the treatment landscape as a result.
Kevin: As our work in providing a new treatment option with women with ovarian cancer progresses in the Population's exposure.
Kevin: Two potential Pandemics increase.
Kevin: We remain very excited about reporting data from ongoing clinical studies in the upcoming months and I look forward to keeping you appraised of our progress.
Kevin: Thank you for joining us today and for your interest in immune line have a great day everybody.
Speaker Change: The conference has now concluded. Thank you for attending today's presentation you may now disconnect.