Imunon Q4 2024 Earnings Call Transcript

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February 27, 2025

There are 11 speakers on the call.

Operator

Good morning. My name is Mike, and I will be your operator today. At this time, I would like to welcome you to Immuneon's Full Year twenty twenty four Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. Please note this event is being recorded.

Operator

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

Speaker 1

Thank you, Mike. Good morning, everyone, and welcome to Immunon's full year twenty twenty four financial results and business update conference call. During today's call, management will make forward looking statements regarding Immunon's expectations and projections 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 such statements. I also caution that the content of this conference call is accurate only as of the date of the live broadcast, 02/27/2025.

Speaker 1

Immunon 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 Lindborg, Immunon's President and Chief Executive Officer. Stacy?

Speaker 2

Thank you, Peter, and good morning, everyone. Joining me on this call is Doctor. Douglas Fowler, Immunon's new Chief Medical Officer, who joined earlier this month and Dave Gallero, our Interim Chief Financial Officer, who will review our financial results for 2024. Mr. Michael Tordugno, the Executive Chairman of our Board and Doctor.

Speaker 2

Krishit Anwar, our Chief Scientific Officer are also on the line and will be available for Q and A. 2024 was truly an exceptional year for Immuneon, not only in our execution as a company, but also in our deliverables. In July, we announced positive results from our large randomized and controlled Phase II OVATION II study. The study evaluated IMMUNON001's safety and efficacy in women with newly diagnosed advanced ovarian cancer, women with Stage IIIc and IV cancer at diagnosis. I am pleased to report that the results far exceeded not only our expectations, but also those of our investigators and medical advisors.

Speaker 2

These Phase two data are the basis for our optimism for IMU-nine thousand and one to go forward with our pivotal Phase three study, which has agreement from the FDA and we plan to initiate this quarter. I want to confirm our focus is to identify the most expeditious path to advance IMU-one towards commercialization potential commercialization. Our commitment to an aggressive timeline for initiation of the Phase three study has the priority of every employee, consultant and advisor at Immunon. Our ambition is supported and reinforced with data from the OVATION II study that continues as we previously announced to get stronger and stronger. And I might add that at some point could warrant a discussion related to accelerated approval with FDA.

Speaker 2

Even though OVATION II was not powered for statistical significance, when you observe very large treatment effects in a trial, small p values will emerge as we are observing with OVATION II. I will now spend a few minutes recapping our progress and providing a clinical and regulatory update on Immunon001. Following the OVATION II trial readout, recall, we continued to monitor overall survival in OVATION II per protocol. In December, we announced that based on seven additional months of monitoring, the data showed continued improvement in overall survival in the intent to treat population with the benefit in median overall survival over the standard of care increasing from eleven months to thirteen months. Based on this data, Immuno-one has the potential to be the first immunotherapy effective for the treatment of ovarian cancer.

Speaker 2

Doctor. Fowler will provide a review of this data 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. Following our positive end of Phase II meeting and Type C CMC meeting, both in the fourth quarter of twenty twenty four, we remain engaged with FDA who have provided supportive feedback in a timely and collaborative manner. In all of these meetings, FDA senior leaders have been engaged and the FDA took the unusual step to extend an invitation to conduct an end of Phase two meeting in person at its headquarters in Silver Spring, Maryland. Earlier this month, we announced new translational data from OVATION II.

Speaker 2

Based on the exciting data from this trial, we know that IMNON001 has a highly beneficial benefit risk ratio. And this new data gives added confidence and confirms a few things in women treated with the targeted dose of MENON-one for Phase three. Number one, there's a strong dose response in IL-twelve levels as measured in ascites or the fluid within the microtumor environment. And this dose response is across five doses of immunon-one that have been studied. Furthermore, IL12 levels in women who received one hundred mg per meter squared is about 20% higher compared to those who received seventy nine mg per meter squared, which was the previously highest dose studied.

Speaker 2

We also observed large increases in downstream anticancer immune cytokines, including interferon gamma, our FDA endorsed potency assay and TGF alpha. Based on these data and the compelling clinical data, we have concluded that one hundred milligrams is the dose that will be used in the Phase three study. Another positive aspect of our TheraPlus technology is that it confines the therapeutic in this case IL-twelve to the local regional area of interest. Doing so we believe provides for meaningful efficacy and extraordinary safety profile, which has been the holy grail of oncologists. The importance of this mechanism, which has been well established in the literature and pursued by many companies was demonstrated in the study.

Speaker 2

The IL-twelve levels in blood in women treated with one hundred milligrams per meter squared of immunon-one remained low and unchanged from baseline. Given the safety profile observed to date, this data in terms of IL-twelve levels in blood was expected. But this was important to confirm as elevated systemic IL-twelve levels led to severe toxicity in historical investigational IL-twelve products administered IV. The data generated to date provides unequivocal evidence that Immuno-one and the TheraPlas technology more broadly works as it was designed to do. Recent translational data shows that the highest amount of IL-twelve across all doses studied has been achieved with the dose that will be used in Phase three and the anticipated downstream effect in critical cancer fighting cytokines is occurring.

Speaker 2

Clinical data demonstrates that the life of women treated with immunon001 is extended And if replicated in Phase III, immunon001 will reset the standard of care for women newly diagnosed with ovarian cancer. Based on the strength of data observed in OVATION II, including the strong safety profile, we believe the probability of success is high amongst products entering Phase III. Now I want to turn to our important second Phase II trial, the MRD study being run-in partnership with Breakthrough Cancer Foundation. I am pleased to report that the speed of enrollment has picked up. This study will provide insight into two important areas.

Speaker 2

First, early insight into the potential treatment profile of IMN10001 administered together with platinum based chemo, Anavastin or biosimilar bevacizumab. And number two, the continued benefit of or the benefit of continuing IMU-one treatment in maintenance. If successful, this trial will provide significant insight and approaches that may potentially alter the treatment landscape, including new combination therapies, predictive diagnostics and early clinical assessment of efficacy. We expect preliminary results later this year. Regarding the Phase three study, OVATION III, 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 2

We have inventory of our investigational product ready for the trial. 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 and the feedback we've received from the FDA on the protocol has been helpful and focused in nature. There's been nothing new of substance nor significant points of disagreement. Everything that needs to be submitted to the FDA in advance of starting the trial has been submitted. And in short, we're exactly where we want to be.

Speaker 2

The Phase three study will enroll women at least 18 years of age newly diagnosed with advanced ovarian cancer. These women will also be candidates for neoadjuvant chemotherapy with histological evidence of epithelial ovarian, fallopian tube or primary peritoneal carcinoma with stage 3c or four and an eCOG performance score or Eastern Cooperative Group score of zero, one or two. The primary endpoint will be overall survival. And I want to point out that while OS is expected to take longer than PFS to assess, the advantage is that it is a definitive endpoint. There will be no second guessing our results or need for a second confirmational study to support approval.

Speaker 2

We are enthusiastic about the initial core set of clinical trial sites to be activated early, which include sites that were part of OVATION1 and OVATION2. And we're also excited to bring new sites on board to accelerate enrollment of the trial. The strength of our clinical data is a key point of discussion, and this is how we will drive patient recruitment. There's optimism that Immunon-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. If the promised efficacy from OVATION II are replicated in Phase III.

Speaker 2

Regarding clinical trial material, the product for OVATION III is ready for shipment to clinical sites. In a recent IND submission, release criteria have been updated with Phase three and commercialization in mind. We've passed all release criteria and with this strategic choice to move the production of active pharmaceutical ingredients or API in house, we are able to keep clinical trial costs extremely low and set the company up for attractive cost of goods in the future commercial setting. With that, I would like to now turn the call over to Doctor. Douglas Fowler, who will discuss the Phase II OVATION II study, including additional survival data.

Speaker 2

But first, I want to formally welcome him to the company as Chief Medical Officer and properly introduce you to him. Doctor. Fowler has over thirty years of experience with a rich background in both industry and academia. He is board certified hematologist and oncologist with extensive global clinical development, regulatory and medical affairs expertise and a unique record of successful translational research. He has broad experience in large pharma and biotech, drug and biologics experience covering oncology, immune disorders, hematology, CNS and neuropsychiatry disorders and genetics disease for all stages of drug development from first in human through product launch and being on the market working in companies like Takeda, Skyhawk Therapeutics and Horizon Genomics.

Speaker 2

His career also includes pioneering programs in CAR T therapies and RNA splicing modifiers. And his academic appointments span two prestigious local institutions, Harvard Medical School and Boston University School of Medicine. 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. He received his MD from Harvard Medical School and a PhD in oncology and cancer biology from MIT. And I am confident that with Doctor.

Speaker 2

Fowler's guidance and leadership, we will not only advance our scientific objectives, but will enhance our team's culture. Douglas?

Speaker 3

Thank you, Stacy. Let me start by saying that my decision to join Immunon was an easy one. It's a rare opportunity for an oncologist like myself to be able to lead and support a program that already has the groundbreaking data reported by immunon in 2024. I'm very grateful for this opportunity. In July, immunon announced the results of our Phase two study OVATION two.

Speaker 3

This large randomized study involving one hundred and twelve newly diagnosed patients with advanced ovarian cancer exceeded expectations. Specifically, an improvement in median overall survival of eleven point one months, nearly a year compared to standard of care. This is a clinically meaningful and unprecedented improvement in first line treatment for this deadly disease. For women who were also administered PARP inhibitors in the Immunon-one arm, the median overall survival has not been reached, indicating that more than one half of these patients in the Immunon arm are still with us, with some approaching the five year mark since trial initiation. Importantly, for those receiving at least twenty percent of the planned immunon-one doses, survival increased by a remarkable seventeen months.

Speaker 3

These outcomes are particularly significant in a patient population who has not witnessed an advance in frontline treatment which extends patients' lives for more than twenty five years. More importantly, our OVATION II study is the first study ever to demonstrate an improvement in overall survival in this context. For a deeper understanding of these data, I encourage you to visit our R and D Day presentation from September eighteen of last year. This is available on our website under the News and Investors tab and then under the Scientific Presentations tab. Furthermore and very excitingly as Stacy mentioned, results from the additional monitoring of patients in OVATION II indicate that the overall survival benefits are not only being maintained in the population of patients treated with IMEON-one, but have grown in strength providing a strong additional validation of the potential of our novel IL-twelve immunotherapy to represent an historic advance in the treatment of ovarian cancer.

Speaker 3

Specifically, in the attempt to treat population, the hazard ratio dropped from zero point seven four to zero point six nine with the median difference in overall survival being extended by thirteen months in patients treated with immunon one compared to standard of care. In 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 immunon arm remaining alive in the trial. The median in the control arm was thirty seven point one months. As Stacy referenced earlier in this call, 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 Immunon001 treatment. We will further share these important and exciting data at the upcoming twenty twenty five ASCO annual meeting in June.

Speaker 3

Clearly, our commitment to accelerating initiation of the Phase three study, OVATION3 is strongly supported by the data I've just described. I look forward to reporting on our progress in the coming months. I'll now turn the call back to Stacy.

Speaker 2

Thanks, Nicholas. As mentioned previously, we have taken a number of steps to conserve cash and align our critical needs with available capital. Our cash runway accounting for costs associated with starting the Phase three trial in March extends late into June. We're actively working on value added financing and partnerships, which will help secure a cash runway that supports our clinical timelines and long term strategic objectives. In addition, we are actively pursuing non dilutive funding through partnerships including focusing on TheraPlas and Immunon001.

Speaker 2

We're having discussions with potential partners with significant investment in oncology drug development, some of which have invested heavily in IL-twelve in the past. We're also exploring geographic partnerships and ways to accelerate development of Immunon001 in other parts of the world. And finally, we intend to leverage the data from the proof of concept study using our novel Placine technology to sell or license that technology. Our technology offers multiple advantages of recurrent 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.

Speaker 2

For example, we announced new data earlier this week from a Phase one clinical trial of our DNA vaccine in the treatment of COVID-nineteen. Results from the IMNON-one hundred and one proof of concept study demonstrate persistent immunogenicity in trial participants and further validate the Placine technology. Immunon-one hundred and one induced a two to fourfold increase in neutralizing antibody titers from baseline through week four, a clear and convincing response to the vaccination. Immunon continues to show favorable safety profile and given this proof in immunogenicity, early indications of durability of protection and competitive advantages in the stability of our vaccine at workable temperatures compared with available mRNA vaccines, we believe that Immunon-one hundred and one has significant potential as a superior next generation vaccine and will seek potential partnerships for future development. We are excited to share insights from research conducted in 2024 from Placine in April at the twenty twenty five American Association for Cancer Research meeting.

Speaker 2

As a final note, we expect any potential financing or business development opportunities to be accomplished in a manner that will allow us, together with our shareholders, to best accomplish our mission of improving the lives of people with unmet medical needs. 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 advisors and researchers. Now, I'd like to turn the call over to Dave Garrow to review our financial results for the full year. Dave?

Speaker 4

Thank you, Stacy. Details of Immunon's full year 2024 financial results are included in the press release we issued this morning and in our Form 10 ks, which we filed before the market opened this morning. As of 12/31/2024, Immuneon had $5,900,000 in cash and cash equivalents. 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 twenty twenty five. Research and development expenses were $11,600,000 for 2024 compared to $11,300,000 for 2023.

Speaker 4

The slight increase was driven primarily by increased clinical spend related to OVATION II in addition to startup costs for Ovation three. General and administrative expenses were $7,500,000 in 2024 compared to $9,700,000 in 2023. The decrease was primarily driven by decreased professional fees and decreased employee related expenses. Net loss for 2024 was $18,600,000 or $1.62 per share compared to a net loss of $19,500,000 or $2.16 per share for 2023. With that financial review, I'll turn the call back to Stacy.

Speaker 2

Thank you, Dave. Before I open the call to your questions, I want to remind you of the power of our technology. Immune-one allows durable therapeutic and dose dependent production and release of IL-twelve into the tumor microenvironment. The lack of toxicity shows its advantages over other approaches to IL-twelve delivery, such that the ability of IMN-one thousand and one to achieve well tolerated and durable levels of IL-twelve and other anticancer cytokines could usher in the first immune based gene therapy for ovarian cancer. We may have in our hands the first, perhaps only immunotherapy that's effective for the treatment of ovarian cancer.

Speaker 2

We've reported favorable and clinically meaningful top line results from OVATION II in women with newly diagnosed ovarian cancer. We're on track to begin our pivotal OVATION III trial in the first quarter of twenty twenty five and we have an internal GMP manufacturing capability in place in Huntsville, Alabama, which will allow us to produce quality product at an order of magnitude lower cost compared to an external CDMO. Ovarian cancer represents a multibillion dollar unmet medical need. Our product has been granted fast track designation by the FDA and orphan drug status has been established in The U. S.

Speaker 2

And Europe, thus providing additional protected commercial runway. A second Phase two study in ovarian cancer is underway with Immunon001 plus Avastin evaluating MRD at second This is largely funded by the Breakthrough Cancer Foundation and will give insights into combination treatment with Avastin or biosimilar gravisizumab and maintenance therapy with Immunon001. I'd like to finish with a comment on the strength of Immunon's company's culture, which includes the longevity of commitment to Immunon by our employees across levels of the organization. This strength allows us to have a long term view of our past. It brings trust, which enables a culture of entrepreneurialism and an ability to move fast.

Speaker 2

And strength of leadership is enabled by candor and data driven decisions, which spans science operations, manufacturing and finance. With that, I'd like to open the call to your questions. Operator?

Operator

We will now begin the question and answer session. The first question comes from Emily Bodnar with H. C. Wainwright. Please go ahead.

Speaker 5

Hi, good morning. This is Joey on for Emily. Thanks for taking our questions. Could you discuss the COVID booster neutralizing antibody data in the context of what would be expected from the approved mRNA vaccine on the XPD one point five variant? And did any of the participants enrolled in the study have prior COVID-nineteen infection?

Speaker 2

Yes. I'll ask Doctor. Krishita Moore to take this question and I'll add anything on the backend. Krishita?

Speaker 6

Sure. I'd be happy to. So, the, the loans we have seen in utilizing antibody response for baseline are involved part with the mRNA vaccines and your question about pre infection or pre vaccination, that's a very, very important point. Our study started in summer of last year, Jody and a lot of patients, all the subjects, the prior infection, prior vaccination. So it's hard to find a naive subject by that time.

Speaker 6

So yes, they have been and it has been known in case of mRNA that prior infection causes a reduction in the immune responses. So I think the main point is that the levels you're seeing are fairly comparable to what you anticipate in this type of patient population with respect to mRNA vaccines, ballpark.

Speaker 5

Okay. I see. Thank you. That makes sense. And just one follow-up question.

Speaker 5

Just generally, what is your updated strategy in terms of patient population for the Phase three ovarian cancer study? And any other details you can share about the trial design?

Speaker 2

Yes. So, I'll take that. Thank you, Joey. So, we have our protocol that's under review and we expect to be finalized as early as the end of this week at the FDA, is targeting a very similar population to OVATION II and I'll ask Douglas to give a little bit more detail.

Speaker 3

Certainly happy to. As Stacy said, I think the most important thing to take away is that our trial design eligibility exclusion factors is very, very similar to OVATION II. And I mentioned that because as you well know, one of the rapid ways to get uninterpreting results is to change the way in which you're administering the drug or the patient populations. So, So, by keeping this very, very similar to OVATION II in nearly every respect except size, this guarantees or I shouldn't say guarantees, this gives us the best chance of reproducing and even strengthening the results we got in OVATION II. So, similar population of patients, a 500 patient study as opposed to 112 patients in OVATION II.

Speaker 3

And the endpoints here, 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 in OVATION II and as a second primary endpoint, overall survival results in the intent to treat population, which includes both HR deficient and HR proficient tumors.

Speaker 5

I see. Thank you. That makes a lot more sense. Thanks for answering my questions. Really appreciate it.

Speaker 2

Thank you, Gerry.

Operator

The next question comes from David Botts with Zacks Small Cap Research. Please go ahead.

Speaker 7

Hey, good morning, everyone. Thanks for the overview this morning. It was really helpful. Stacy, in your prepared remarks, you had mentioned the possibility 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?

Speaker 7

Is it certain patient populations, interim results, What could potentially lead to the possibility for an accelerated approval?

Speaker 2

So David, thank you for the question. I'm pleased you're on the call. And I would say that the thought behind my prepared remarks is really just reflecting on the evidence that's emerging. So as you know, we released updated overall survival data after seven months after we read out the trial. When you look at the strength of evidence in some of these subgroups, for example, women that have received PARP inhibitors as part of maintenance therapy, we have P values that are emerging that are now, if I recall off the top of my head, that P value is about 0.06.

Speaker 2

So, it was really more of a general comment that as the data continues to mature, the protocol indicates we will continue to monitor overall survival through into the fourth quarter of this year. 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 sharing plans at the moment, but really just an observation of the strength of evidence and that that would be a very natural step to undertake. Douglas, would you like to add?

Speaker 3

I'd just add that the one of the major criteria as I'm sure you know that the FDA has recently enforced is that a Phase three confirmatory trial be underway when considerations for accelerated approvals off the basis of a smaller study are concerned. And we will be in that position if the data continue to strengthen and the fact that we can have conversations with the FDA because of Fast Track approval, we can take that data back and ensure them that our Phase three confirmatory study is underway. So, it will be convergence of a number of events which would allow us to be in a good position at that time.

Speaker 7

Okay. Is there currently in your protocol, an interim analysis, is there a plan for one right now?

Speaker 3

Yes. In Ovation three, there are two interim analyses and a final analysis if necessary.

Speaker 2

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 in women that are positive for HR deficiency and saw very similar hazard ratio and a clinical effect in women who receive PARP inhibitors. It's a very, very consistent group. And so, the protocol allows for a readout first in that subgroup, which we expect could happen sooner, but is currently designed for an all comers population and would then test the ITT population later.

Speaker 2

But this is something that we will continue to be reflecting on carefully from a strategic standpoint. We know that we could choose if this were really in the interest as we were talking with the investors that will be helping fund the complete study that we could choose to go after an HRD focused population that would be a very coherent strategy and a very simple evolution out of this all comers or we could do the full trial and this trial design is very strong in that manner.

Speaker 7

Okay. So it sounds like you're going to have options after even after the trial gets underway. It's not necessarily one path is defined. 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. Am I understanding that correctly?

Speaker 2

Yes. So I've been clear that we need to raise capital to conduct a Phase three trial. We designed this trial with an all comers population and that is what we will start with. As we work through our capital and adding money to the balance sheet, we will then decide the path if it's different from our current plan. We will know that we have full endorsement for the all comers population and then that is a seamless transition if we choose to revert to an initial target of HR deficiency.

Speaker 2

So, we'll be well positioned and we'll follow the path that is most appropriate with the capital that we have to use for this trial. They will both be extremely important contributions to the medical community.

Speaker 7

Okay. Yes, sounds great. Thanks for taking my questions.

Operator

The next question comes from James Malloy with Alliance Global Partners. Please go ahead.

Speaker 8

Hey, guys. Thanks for taking my questions. What are your do you characterize how the partnership environment looks currently sort of versus vis a vis into fundraise? So given the impending cash crunch here, you guys talked about second quarter of this year and how is that impacting any potential partnership discussions?

Speaker 2

Yes, thanks. Thanks, James. We've had very successful meetings with institutional investors in the recent past and even prior to this. What we hear from them, they appreciate the quality of our recent Phase two data and we do have viable investors currently that could serve as lead or co leads of a financing that are still in discussions with us. But, I think we all appreciate this is a very tough market.

Speaker 2

It's not just for Immunon, but virtually all microcap issuers are facing. But, I want to point out two things that are really to our advantage and what we think will play a significant role in our ability to fund this trial in full. Number one, OVATION II 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. The second, we know that we have the supportive FDA in our plans and to move into Phase three. And with these in mind, if we're patient, I believe we will find the appropriate investors to proceed with the trial.

Speaker 8

And how does sort of following up on that, how is the anti vaccine sentiment in the recent administration impact any potential for Plasine and partnerships there? It's been a strange change to be sure.

Speaker 2

There is a lot that's evolving. I would say that we have impressive data. It's early. The data that we're reporting was recently received. We're just starting to explore it and as we make progress, we'll provide timely updates.

Speaker 2

But we do believe there are important advantages that we bring to the landscape and that this is a valuable asset for the right partner.

Speaker 3

Could I also add that the technology and the platform is not restricted to infectious diseases, which seems to be what the current uncertainty is about, but would also include such things as cancer vaccines, which are reemerging as a potentially very strong route to care for hard to treat cancers.

Speaker 2

That's exactly right. And the comment I made about the meeting we're attending in April is in fact sharing preclinical data that was done in 2024 in the cancer vaccine front. Prashid, I don't know if you want to add anything to the discussion?

Speaker 6

No, I think that is valuable feedback on that question. Clearly, as Doctor. Balar said that the application to infectious disease maybe as James mentioned about government position, but cancer vaccine is certainly an important application and raising benefits have been published. And we are we'll be sharing an AACR data, we're using mouse model of cancer where we did target some specific antigens of tumor in parallel to the personalized cancer vaccines and we demonstrate immune response activation and benefit into the viral. So that's clearly, Doctor.

Speaker 6

Fowler said and Doctor. Lindbergh that that is an application and then you can branch into if there are certain levels government level things are not out of control, but clearly that's an application that's getting a lot of credence in the literature. And we have shown that that approach works at least in the animal models to start with.

Speaker 2

I just

Speaker 5

want to make one other comment on

Speaker 2

this front, James, before you go forward. We've demonstrated proof of concept. This was our target and our goal. But I do want to be clear that, placcine is not our priority within the company. We are focused on IL-twelve and our Phase three study and TheraPlas.

Speaker 2

It is important that we pursue and use the strength. Placine is a derivative, I think as you know of our TheraPlas 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. We will be looking for partnership and or opportunities to bring a non dilutive funding.

Speaker 2

But we'll give you updates as we make progress.

Speaker 8

Okay. So maybe a final question for Doctor. Feiler. Maybe some impressive day out of the Phase II, the Phase III just getting going here. What sort of jumped out at you as sort of the most impressive data that you saw and said, this is the time to be joining Immunence?

Speaker 3

Well, thank you for the question, James. I've been practicing oncology for most of my life and ovarian cancer has been one of these diseases, which we're treating today in frontline the same way I treated it when I was in training, chemotherapy alone and surgery. It's been very frustrating for women. This is a very chemo sensitive tumor. We can eliminate the tumor as far as we can see in a large number of patients, but we know that it's going to come back.

Speaker 3

And this data these data are really the first that I've seen, the OVATION II data, which have really impressed me that this is an opportunity to dramatically extend the life of patients with a relatively short treatment cycle, which adds to standard of care and stops that there have been significant important prolongations in patient survival. I won't go through I won't repeat everything I said in my presentation, but this is really stunning data and really offers hope for patients and for the physicians who care for them. It's a very exciting set of data and I'm really thrilled to be able to take this and get an approval for patients to have something which is well tolerable. The FDA had no safety concerns. How often do you hear the FDA say that?

Speaker 3

And this is a straightforward path to getting this drug to patients.

Speaker 8

Thank you for taking the questions.

Speaker 2

Thanks, James.

Operator

The next question comes from Jason Colbert with DeBoro Capital. Please go ahead.

Speaker 5

Jason, you may be muted.

Speaker 9

Hi, can you hear me? Yes,

Speaker 2

we can hear you.

Speaker 9

Okay, great. So just a couple of quick questions. Stacy, 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 2

Yes. Great question, Jason. So we worked with a really very well known group called Berry Consultants. The founder is on faculty at MD Anderson. They have played a really prominent role in oncology as well as really innovative designs and we worked with them on this design to allow two shots on goal and really a very strong design which allows us to act quickly if we see the same strength of effect in the HRD positive subgroup,

Speaker 5

then

Speaker 2

we would be able to read that out early and file for accelerated approval while the all comers continued to mature. So that was a very important part of the design, which did include a lot of clinical trial simulation. So you want a really good statistician when you're putting together these kinds of designs. The assumptions that we undertook are using assumptions that are, I'd say, more pessimistic than what we're observing right now, especially as the data has continued to improve to strengthen Innovation two. So, we started with the intent to treat the initial readout and really there's always uncertainty in what your control arm will look like, what maybe will occur across the time of the trial running in terms of treatment landscape changing downstream.

Speaker 2

And so we brought in slightly more pessimistic assumptions knowing that we had a trial set up where if 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 and these all of our simulations and the effects that were studied would be strong advancements for the medical community, right. So they all represent positive value added product, but wanting to make sure we have the trial set up to be able to demonstrate that definitively. And the power of our trial right now and the intent to treat population is about ninety five percent and in the HRD population is higher than that. So, we have a very well powered trial, a trial that allows for early readout if there is warranted in fact in both HRD population and intensive treat population and then a final readout if the interims don't yet warrant stopping.

Speaker 9

And another question about when you're selecting CROs and you're assuming enrollment numbers, best insights into

Speaker 5

enrollment feasibility,

Speaker 2

best insights into enrollment feasibility having just completed OVATION II. We have a strong set of sites that are going to be continuing with the trial and through Douglass we have a proven track record of running trials and really difficult to recruit populations. And I would say that we balance not only our own insight from what's realistic from a recruitment standpoint with the sites that we know, but also with then doing a full RFP and working with some large well established CROs that helped us kind of see through their lens. So I do think 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 that we are going to improve over what we're assuming.

Speaker 2

But we're going at this pragmatic and I think based on our experience. So Douglas, if you have anything you want to add?

Speaker 3

My intentions are to exceed expectations for enrollment.

Speaker 8

The

Speaker 3

data from Ovation two has already generated excitement and the ability to deliver the drug and the safety of the drug to date have got investigators quite enthusiastic. So I'm hoping we can go even faster because of excitement among the investigators than our CRO has suggested.

Speaker 9

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 and keeping drug on-site and on target. Is that an area where you're constantly looking at how you improve the delivery so that you can expand how long the drug is actually on-site on target before it's eliminated from the body or maybe that's not an issue at all, if you could just talk about that a little bit?

Speaker 3

The points you make are really extremely important. And the fact that we can deliver IL-twelve safely, which people have been trying to do for twenty years is I think a really impressive testament to where we are right now. We can deliver IL-twelve to a site. We don't have the kind of toxicities that one sees delivering it systemically or even locally. This is the technology that as Stacy has mentioned that allows us to treat these patients.

Speaker 3

Room for improvement, room for new innovation, that's certainly something we're interested in, but the platform also lends itself to delivering other hard to deliver cytokines for example, things that you could not deliver systemically, but delivering them locally and encapsulated is a potential platform for a number of other cytokines, which have been too toxic to deliver systemically. Stacy?

Speaker 6

So if I may add. Sorry, please. This is a gene Jason, this is a gene therapy product. So a cluster of small molecules of protein, you inject and they have a clearance kinetics. But here the cells take up the material, the DNA and then expresses it for a long period of time.

Speaker 6

So that adds to the durability of the drug. But clearly like with any drug, improvement can be made, polyglide glycol is part of this global system that enhances the presence kind of the nanoparticles that can be further enhanced, but the second step is the expression from the cell that's durable too. So it's a different type of biologics compared to the small molecules in terms of durability.

Speaker 9

Yes, that's exactly where I was going. So thank you. I appreciate that. I'm sure you're always looking at ways to kind of dial that in a little tighter. Thank you.

Speaker 5

Yes, absolutely.

Speaker 2

And Jason, one thing I want to add just for context, we have to keep in mind that when we're successful, right, I'll talk very positively. This will be the first IL12 if approved. This would be the first IL12 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 then rapidly be prepared to think about 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 Khurshid as our CSO is the founder of this technology, we have great depth and 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 step as the first IL-twelve product that would be approved if we and when we get to that place.

Speaker 2

So, that's a very important perspective.

Speaker 9

Yes, I'm excited for patients. Thank you.

Speaker 2

Thank you, Jason.

Operator

Our next question comes from Kempe D'Olivere with Brookline Capital Markets. Please go ahead.

Speaker 10

Good morning. First question relates to the combination study and the pickup in enrollment. Can you tell us where enrollment stands now? And then also what has driven the acceleration?

Speaker 2

So I'll start with the second question. We have had more sites coming on board. We had one site that was had lost some personnel and therefore their clinical trial support across the board was suffering that they have now been able to reengage. So really this is about engaging very well established sites and getting them up and running. So we've had MD Anderson as the lead site, Doctor.

Speaker 2

Amir Dazari that has delivered extremely well at his site and now others coming on board. So, our goal is to enroll 35 patients this year. It's our corporate goal for the study and that would really be getting us to the point of completing the trial. So, we see those very as extremely as a goal that we will accomplish it as our it's the goal we've set for ourselves. But I guess the last point I would add is that I do think that the updated data from OVATION II is also gives a lot of strength when we have calls with our our PIs.

Speaker 2

They're able to now take this data and what's being experienced in Ovation2 and be able to then translate that to women that they're trying to enroll.

Speaker 3

I'll also if I can also mention that our recruitment rate has picked up. And in addition, as the sites have opened, sites slow site openings have plagued clinical trials ever since the pandemic as I think you know. But I can also tell you that we had a IDMC meeting 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 there have been no safety issues.

Speaker 10

Good. And Stacy, just to be clear, you mentioned a goal of enrolling 35 subjects this year. The enrollment target for this trial remains at 50. Is that correct?

Speaker 2

50. That's correct. That's correct. So that would get us basically to the end of the enrollment period.

Speaker 10

Fabulous. Thank you. Second question relates to 01/2001 and the topic of expected durability of protection. How can you or can you demonstrate an appealing durability of protection without following the subjects for the full twelve months that I think you have planned?

Speaker 2

So I might answer your question in another way. And 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 the early readout in the cellular data and this has been confirmed with our consultant at Harvard that has so well versed in the vaccine space and COVID-nineteen. Effectively, our entire population, he would say based on his publications, Doctor. Baruch, has been exposed to the virus multiple times and that we know from our baseline data that we see evidence not only of viral burden, but also of treatment with other vaccines. So, I think that one of the most important things when we talk about ability of our platform

Speaker 5

to extend durability, which is one

Speaker 2

of the components from the preclinical data that we have that we expect to be a differentiator relative to mRNA vaccine platform. We believe that this really does need to be in a naive environment or in an environment that already the levels are not so high that you're showing this differentiation and that's been the topic of our conversation. So I do think that we'll be looking for ways that we would be proposing our partners in the future to help us elucidate what really should be one of a handful of value added additions to the vaccine world.

Speaker 6

Yes. Just to rementigate what exactly Stacy had said, I think we were pleased to see that there is immunogenicity of DNAVAX. As you know that DNAVAX teams have not been very effective unless you use a device, like separation or jet injection device and we accomplished that with a simple needle injection method. So that's the first thing that the DNA vaccine is immunogenic and safe. Now this was done in SARS CoV-two system which is as Stacy mentioned prior next infection, prior multiple vaccinations, so not the best system, but certainly, durability wise in animal models where you had naive animals, we've seen longer duration on protection also.

Speaker 6

So it just sets the program now for this proof of concept of anti gene specificity, I mean, gene specific demonstration human and faith to really expand this into other applications where it could really further follow for durability also in a model that would be not this messy in terms of prior vaccination infection. So I think that would be a real assessment of the technology of what we find the animal models in terms of durability would be in a different disease to go after this POC.

Speaker 10

Thank you. Thank you.

Speaker 2

Thanks, Kim.

Operator

This concludes our question and answer session. I would like to turn the conference back over to Stacy Lindborg, President and CEO for any closing remarks.

Speaker 2

I want to thank everybody for the questions and really the engaging discussion that we had. And I'll just make very brief comments before we close the call. Reflecting on that really most of the industry in ovarian cancer is focused on maintenance therapy or second line treatment in ovarian cancer. 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. Conventional wisdom across oncology is to engage as early as possible.

Speaker 2

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 destructive to the treatment landscape as a result. As our work in providing a new treatment option with women with ovarian cancer progresses and the population's exposure to potential pandemics increase. 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. Thank you for joining us today and for your interest in Immunon. Have a great day everybody.

Operator

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

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Earnings Conference Call
Imunon Q4 2024
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