Imunon Q3 2023 Earnings Call Transcript

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Provided by Quartr
November 14, 2023

There are 9 speakers on the call.

Operator

Good morning. My name is Alan, and I will be your operator today. At this time, I would like to welcome you to the Immunon Third Quarter 2023 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.

Operator

I I would like now to turn the call over to Kim Golodetz. Please go ahead.

Speaker 1

Thank you. Good morning, everyone. This is Kim Golodetz with LHA. Welcome to Immunon's 2023 Third Quarter Financial Results and Business Update Conference Call. During today's call, management will be making forward looking statements regarding immunon's expectations and projections about future events.

Speaker 1

In general, forward looking statements can be identified by words such as expects, Anticipates, believes or other similar expressions. These statements are based on current expectations and are subject to a number of risks and uncertainties, including those set forth in the company's periodic filings with the Securities and Exchange Commission. No forward looking statements can be guaranteed and actual results may differ materially from such statements. I also caution that the content of this conference call is accurate only as of the date of the live broadcast November 14, 2023. Immunon undertakes no obligation to revise or update comments made during this Call except as required by law.

Speaker 1

With that said, I would like to turn the call over to Doctor. Corinne Lagasse, Immunon's President and Chief Executive Officer. Karen?

Speaker 2

Thank you, Kim, and good morning, everyone. Joining me today is Jeffrey Church, our Chief Financial Officer. In addition, Doctor. Kirshid Enver, our Chief Science Officer, will be available during the Q and A session at the end of our prepared remarks. Immuneal's growth and development is dependent on 4 pillars.

Speaker 2

Last quarter, I spent the bulk of our time on the development of our plasine prophylactic This modality has an out licensing and partnership opportunity. While I will certainly update you on this modality and we did have some interesting developments, First, I'd like to highlight IMN001, our DNA based interleukin 12 immunotherapy for the localized first line treatment of Advanced Ovarian Cancer in combination with the standard of care chemotherapy and it's currently in Phase 2 clinical development. Recall that in September 2022, we reached full enrollment of 110 patients. And this year in September 2023, we reported an additional set of interim more mature data showing promising progression free survival and overall survival data. In the intent to treat population, We demonstrated a delay in disease progression in the treatment arm of approximately 33% or more than 3 months benefit.

Speaker 2

And preliminary overall survival data followed a similar trend showing an approximate 9 months improvement in the treatment arm over the control arm. The head of the ratio of 0.78 approaches the protocol defined value of 0.75 set at 80% confidence interval for the ITT population. Since OVATION II is an exploratory study with a total, so CONTROL plus study arms of only 110 patients, it was not powered to appear to 0.05 and the current trends looks Promising. Recall that this study is evaluating the dosing safety, efficacy and biological activity of intraperitoneal IMN001 in combination with Neuajevant Chemotherapy or NACT. And this in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer.

Speaker 2

NACT is designed to shrink the tumors as much as possible for optimal surgical removal after 3 cycles of chemotherapy. And following NACT, patients undergo interval debulking surgery, followed by 3 additional of chemotherapy to treat any residual tumor. And IMN001 is administered weekly during the course of MECP. So we also reported for the first time data on new subset of patients treated with PARP inhibitors. When we began the OVATION II Phase II trial, the PARP inhibitors were not part of the first line maintenance treatment in ovarian cancer.

Speaker 2

Now, they form an important part of the patient's treatment plan. The subgroup analysis of patients who received IMN001 And post chemo maintenance therapy with PoP inhibitors versus PoP inhibitors alone in the control group shows positive impact. The median PFS in the PoP inhibitor plus NACT group was 15.7 north. Yet PSS in the PARP inhibitors plus NACT plus IMN001 group was 23.7 months or 8 months longer. In addition, the median OS in the PARP inhibitors plus NACT group was 14.6 months and median OS Overall survival has not yet been reached in the PARP inhibitor, plus NACT, plus IMN001 group.

Speaker 2

So although these data are from a small number of patients, they are intriguing. We also saw Continued benefits in secondary endpoints, including a 20% higher R0 tumor resection score and a doubling of the CRS3 chemotherapy response score to approximately 30% in treatment arm versus 14% in the control arm. A complete tumor resection or R0 is a microcosmicly margin negative resection in which no growth of microscopic tumor remains in the tumor bed. Chemotherapy Skol Score is considered a good prognostic indicator in ovarian cancer. So That's why those endpoints are important to look at.

Speaker 2

And safety analysis continued to show Good tolerability of IMN001 in this setting. Now, enrollment in our second Phase 2 study, which If you remember, it's done in collaboration with the Breakthrough Cancer Foundation, has begun with the 1st patient treated at MD Anderson Cancer Center last fall. The study is evaluating AMN-one in combination with bevacizumab. All in, the study is The trial's primary endpoint is detection of minimal residual disease or MRD by second look laparoscopy And the secondary endpoint is PFS. Initial second look laparoscopy data are expected within a year following the completion of enrollment And final PSS data are expected approximately 3 years following enrollment completion.

Speaker 2

This trial will include a wealth of Endpoints aimed at understanding the clonal evolution and immunogenomic features of the MRD phase of ovarian cancer that is currently undetectable by imaging or tumor markers. We will keep you updated as sites are added. And as a reminder, Much of this trial is being funded by breakthrough cancer. So we are now 6 to 7 months away from seeing the final readout data of our OVATION II program. And this is an incredibly exciting time for This data would be transformational to the field and would confirm our hypothesis of IL-twelve Being a potent immunomodulator for cold solid tumors.

Speaker 2

We will consult with the FDA on the potential regulatory path forward. Standard maintenance PoP inhibitors therapy, which could inform a registration study. PoP inhibitors are known to significantly increase Yes, but the improvement in overall survival is not yet established and resistance to PARP inhibitor therapy is a concern, which warrants novel combination approaches such as with the immune agent, IMN-one. Let's now turn to Placine, our proprietary monovalent or multivalent DNA vaccines based on a DNA plasmid that controls The expression of pathogen antigens and the nonviral synthetic DNA delivery system. Placin is currently being evaluated for the development of Next generation vaccines or as we call them the vaccines of the future.

Speaker 2

We continue to bolster our preclinical with Classyme, which suggests this asset has been derisked and is performing as anticipated. Our first question product is IMN101, which is in final stages of preparation For an IND, investigational new drug application to the FDA. IMN-one hundred and one, which With you as a proof of concept, it's designed to protect against SARS CoV-two, Omicron XBB15 variant In accordance with the FDA Vaccines and Related Biological Products Advisory Committee, the VIRPAC Committee, Announcement that's been made in June 2023 and that established a framework for updated COVID-nineteen doses. Iaminon is targeting the Q1 of 2024 for submitting the IND and then Enrolling the 1st subject in a Phase I trial in April 2024 with rapid advancement into a Phase 2 trial by mid-twenty 24. So we are excited about the body of preclinical data and we have been active in presenting this data at various conferences, both in the U.

Speaker 2

S. And Europe. For example, last month, Doctor. Anver presented at the 3rd International Vaccines Congress, highlighting immunogenicity data and the development status of IMN101. Doctor.

Speaker 2

Engra's presentation described the multiple advantages of Placine over current commercial vaccine platforms, including a more durable antigen expression and T cell responses versus protein and mRNA vaccines. In addition, our preclinical studies show that Placine elicits better antibody response kinetics following a single dose and demonstrate better shelf life of at least 12 months at 4 degrees Celsius and at least 6 suggest superior commercial handling and distribution properties compared with Mirena vaccines as well as greater manufacturing flexibility. Compared with viral or other DNA vaccines or protein vaccines, our plasine vaccines Have advantages in T cell responses, safety compliance and manufacturing flexibility. Doctor. Enver's presentation also described The versatility of the placebo modality, demonstrating activity against Marburg and influenza viruses in collaboration with the Worcester Institute and activity against Lassa virus, which is being evaluated at the NIH NIA.

Speaker 2

I remind you that during the Q3, we entered into a cooperative research and development agreement with the NIAID. This is a 3 year agreement under which the NIAID will evaluate the immunogenicity and efficacy of 2 immunoDNA based Lassa virus vaccine candidates. The agency will assess the efficacy of placenta constructs against Lassa virus in guinea pig and non human primate disease models, including both prime and Prime Boost Vaccine Strategies. We also announced our collaboration with Wister in January of this year and the Wister Institute vaccine of and Immunotherapy Center is uniquely positioned to advance new vaccine formulations to facilitate Further expansion and development of Placine. Collaboration with our site partners, particularly those that will provide So some or all of the funding of the research are a key pillar of our growth strategy.

Speaker 2

Now later today, Jean Boire, our Vice President of Research and Development will be presenting at the Vaccine Summit in Boston. Doctor. Boire's presentation describes preclinical T cell responses and notes that the induced immune response in vaccinated mice We are persistent without decay for up to 14 months after vaccination. So as you might think, we are very pleased With the duration of response. So we believe that our Glacine modality is revealing itself as an important potential option In addressing not only pandemic response, but also the seasonal vaccine option, its stability at regular refrigerator temperatures of 12 months, room temperature stability of at Stability at high temperatures for at least 2 weeks, plus the immune response duration and the plug and play model And this is particularly important as many pathogens such as Lice virus may arise in geographies where There are challenges with refrigeration storage and distribution networks.

Speaker 2

In addition, our ability to rapidly Switch out antigen and load multiple antigens into the same vaccine should be instrumental in addressing the spread of disease. So in addition, our plasmid modality uses a DNA plasmid and a non viral Synthetic DNA delivery technology for the expression of pathogen antigens. And our DNA based vaccines can be administered using a standard syringe and I'm injection and are independent of viruses or specialized devices for delivery like electroporation. Last quarter, I touched on our work to develop 2 more modalities as logical extensions of our prophylactic vaccine modality. 6th class concerns the application of our DNA technology to produce universal We have initiated preclinical work to develop a TRP-two and NY ESO-one tumor associated antigen cancer vaccine in melanoma, which we call IMN201.

Speaker 2

This work is in a very early stage and I look forward to updating you as it progresses. We are also in early discovery of our 4th modality, Indiplast, for personalized neoantigen cancer vaccines. And we plan to enter into new collaborations that focus on developing AI powered computational approaches And state of the art cell sequencing technologies to identify tumor antigen in patient samples and create the next generation of personalized Cancer Vaccines. And as with Six Flags, we'll update you as our development work progresses. Importantly, recall that we manufacture our vaccines at our own cGMP facility in Alabama.

Speaker 2

And our decision to manufacture in house offers us many strategic benefits, but notably, the control on costs, So now, I will turn the call over to Jeff Church, who will discuss our financial results. Then I'll come back and provide a review of upcoming milestones and activities. Jeff?

Speaker 3

Thank you, Corinne. Details of Immunon's Q3 2023 financial results were included in the press release we issued this morning and in our Form 10 Q, which we filed today before the market Immune ended the quarter with $19,500,000 in cash and investments. Our net cash Usage for operating activities was $4,500,000 for the Q3 of 2023, down slightly from 4 point $6,000,000 for the comparable prior year period. Cash provided by financing activities of $100,000 resulted from Equity sales under our at the market facility. If we combine the $1,800,000 of planned future Sales of Immunon's State of New Jersey NOLs, we believe we have sufficient resources to fund operations at least 12 months from the filing date of our 10 Q, which we just filed.

Speaker 3

Let me now turn to a review of our financial results. Immunon reported a net loss for the Q3 of 2023 of $3,500,000 or $0.37 per share. This compares with a net loss of $6,100,000 or $0.87 for the Q3 of 2022. Operating expenses were $3,900,000 in the current quarter, down 38% from the 6 point $400,000 from the prior year's Q3. More specifically, R and D costs associated with development of our DNA vaccine modality increased to $800,000 from $500,000 a year ago.

Speaker 3

Clinical costs decreased to $400,000 from $1,000,000 in the Q3 of last year as a result of completing enrollment of the OVATION II study last Which Corinne mentioned in her earlier comments. Other preclinical development costs were $300,000 compared with $600,000 in the prior year. Our CMC cost increased to $500,000 $300,000 a year ago, this reflects the development of the in house pilot manufacturing capabilities for DNA Plasmid and Nanoparticle trial for our COVID vaccine. General and administrative expenses were $1,900,000 in the Q3 of 2023, compared to $3,900,000 in the comparable prior year period. This $2,000,000 decrease was due to lower non cash Stock compensation expense, professional fees, primarily legal costs, employee related costs and insurance.

Speaker 3

Other non operating expenses were $400,000 in the Q3 of this year compared to 26,000 for the prior year. This increase was due to higher interest income from the company's short term investments. I'll just briefly touch on our financial results for the Q1 I'm sorry, for the 1st 9 months of the year. For the 9 months ended September 30, 2023, we've reported a loss of $14,600,000 or $1.64 per share. This compares with a net loss of $22,700,000 or 3.4 $2 for the same 9 month period of 2022.

Speaker 3

Operating expenses were $15,100,000 in the 1st 9 months of 2023, an 18% decrease from $18,400,000 for the same period of 2022. Cash used for operating activities was a little over $15,000,000 for the 1st 9 months of 2020 3. This compared to $18,100,000 for the same period of 2022. The decrease was primarily due to a one time payment of 4 expense resulting from the sale and subsequently subsequent redemption of $30,000,000 of Series AB convertible redeemable preferred stock in the year ago period. Cash used by financing activities of $3,700,000 during the 1st 9 months of 'twenty three resulted from the early repayment of the company's loan facility with Silicon Valley Bank that totaled $6,400,000 which was offset by $2,800,000 of sales of equity under our at the market facility.

Speaker 3

We also received net proceeds of $1,600,000 from the sale of unused New Jersey NOLs in the Q1 of 2023. And as I mentioned earlier, we have an additional $1,800,000 of NOL sales that we anticipate this year and next. Our projected cash utilization for the balance of 2023 is approximately $4,000,000 for the 4th quarter. The majority of expenses are related to the development of our Plastine modality, including the development of in house pilot manufacturing capabilities mentioned earlier. I'll now turn the call back to Corinne.

Speaker 2

Thank you, Jeff. Immunon is tightly focused on harnessing the power of the immune system. Our goal is to provide more potent and durable immunity for millions of people with cancer or infectious diseases, Why creating significant value for our shareholders? Collaborations are a key component of our strategy, and we are committed to ensuring that Immunon has the most talented advisors available to help us achieve our goal. To that end, we are delighted to expand our scientific advisory board with the addition Institute and Doctor.

Speaker 2

Sasheb Shukla, Assistant Professor in the Department of Immunology, Division of Basic Science Research at MD Anderson, where he also serves as Director, Computational Biology, Eclipse or Evolution of Cancer Leukemia and Immunity Project. The Q1 recent weeks were exceptionally busy and full of achievements with more expected milestones to come. Among them, we reported compelling interim data with IMN001 in the OVATION II study in advanced ovarian cancer, Particularly in a subset of patients taking PARP inhibitors in combination with chemotherapy and IMN001. Our next milestone from this study is to report top line data in mid-twenty 24. We derisked our plasmodality across several pathogens of interest by demonstrating the immunogenicity and safety of our vaccines.

Speaker 2

We generated compelling data in SARS CoV-two and IMN101, our next generation COVID-nineteen seasonal booster, We'll be in the clinic in April with human clinical data expected in the Q2 of 2024. And we also generated Excellent immunological response against pathogens of concerns, specifically monkeypox, flu, lacer virus and marpiravirus. We unveiled a state of the art manufacturing site in Huntsville to Alabama to reduce our reliance on others, which is intended to give us control not only on quantities of material, but also quality and costs. And we entered into collaborations to advance our technology with more to come and to build capabilities for the development of Before we take your questions, I want to mention that we will be available for 1 on 1 meetings With the investment community, the week of January 8 in San Francisco, concurrent with the annual JPMorgan Healthcare Conference. So please contact our Investor Relations firm, LHA, if you would like to schedule a meeting.

Speaker 2

With that, I open up the call to your questions. Operator?

Operator

The first question comes from Emily Bodnar of H. C. Wainwright. Please go ahead.

Speaker 4

Hi, good morning and thanks for taking the questions. I wanted to ask on Ovation to the recent data that you had. So obviously, you talked about the benefit you had with PARP inhibitors and Assuming we also benefit in BRCA positive patients, but you had a previous interim data readout where You mentioned that you had a benefit in BRCA negative patients. So curious if you can maybe speak to Why you think you might be seeing the switch there and why you think there is synergy with PARP inhibitors? And then just discuss how you're thinking about next steps, whether you're planning to evaluate IMN001 broadly or specifically a combination with PARP inhibitors?

Speaker 4

Thanks.

Speaker 2

Thank you very much, Emily. So I will start and maybe I'll let also Rashid That's answered your questions. So you're absolutely correct. If you remember last year, we did preliminary data cut, which was very immature data and we Show benefits in the BRCA negative population. Now that we have more patients and more events, So this data cut was with 70 events across both arms.

Speaker 2

We are showing a benefit in the ITT population. And we specifically decided to look at patients treated with PoP inhibitors because The moniker signature with BRCA doesn't give the full answer. As you know, patients receive PARP inhibitors if they are BRCA positive, even BRCA negative patients get PARP inhibitors as it has It's been demonstrated that it is it can increase progression free survival in HIV positive patients. And so we wanted to be a bit more accurate in our description in designing the Group of patients who wanted to look at. And as you know, HRD, which is homologous recombination deficiency, is very common.

Speaker 2

50% of women with advanced ovarian cancer have tumors that test positive for HRD And only half of these are BRCA mutations. So it's very interesting to look at Patients treat with PARPs regardless of their broadcast status and then to get the granularity And we'll get this data as we get to the top line data. So What is our assumption here in terms of what's happening with the PARP inhibitors? So we call that the PARP inhibitors are administered after the chemotherapy. We discussed this with our advisors and The hypothesis is that IL-twelve, so IMN001, kind of sensitizes the tumor for the PARP inhibitors.

Speaker 2

So that's what they are thinking, which makes sense, If you want and because our hypothesis is that IL-twelve has Being a very potent immunomodulator agent can turn a cold tumor into a hot tumor. So as we progress, of course, we'll talk to the regulators. We want to discuss with them the Regulatory path and we should do this sooner than later in anticipation of the top line results in June. Maybe, Krishit, if you'd like to add to what I have said?

Speaker 5

No. I mean, I think you've covered Pretty much, Corinne, but I just wanted to start with Emily's last part of the question, which you just kind of addressed that potential mechanisms. So Emily, as you know, back in Phase 1 study, we did report change in the tumor microenvironment from the treatment where we saw increase in CD8 positive cells to immunosuppressive marker ratio. That suggests that the environment was Transition from immunosuppressive to immunostimulatory. So that itself, as Karim said, you have this environment now Before PARP come in, your tumor environment has changed to be more fighting against tumor.

Speaker 5

That could be one potential In other words, you have sensitized the tumor for PARP. As you know, PARP causes cell death, DNA repair doesn't happen and that releases antigen and if you have a good immune stimulatory environment that really that will potentially immune response. That's a potential And I think that's it, but I think that's potentially theoretically it makes sense. Now first part of your question was about BRCA negative and current did, I would currently point that out as well that That was early data. But also the molecular signature wise, it's a lot more to learn in ovarian cancer.

Speaker 5

Initially, we defined it as BRCA positive, BRCA negative. That's more of a somatic, but in tumor also you have this homologous recombinant deficiency and there's a lot of variability variety there. There are Several enzymes, some are deficient in some patients, some are not deficient in other patients. So we are also trying to look into the database to better And the microsignature, not just BRCA positive, BRCA negative, but for the subtypes as to really what's the extent of deficiency and see if you can make some correlate. If you do that, then you Lower the sample size because you already have about 70 and now you're going to further break down.

Speaker 5

But I think that's what we're trying to look into further Understand the mechanism maybe through some preclinical studies, but also what next type of broad application you asked or maybe more limited to. I think PARP combination certainly direct us to a specific type of application, but as you learn more about molecular signature from this ongoing study, more data will come in,

Operator

Our next question comes from James Molloy of Alliance Global Partners. Please go ahead.

Speaker 6

Hey, guys. Thank you for taking my questions. I just want to get your thoughts on the OVATION II Data come out here mid next year. Can you walk through what the potential Phase 3, I know much of it depends on how the data looks, what a potential Phase 3 Or Phase 2b trial design or next steps on trial design might be from that. And then on the Avastin trial, The Phase onetwo Avastin trial, the interim data coming up here, which we'll be anticipating here in the second quarter for that, the interim look?

Speaker 2

Thank you, James. So as I mentioned for the Innovation 2 program, we'll be discussing with the FDA on a potential regulatory pathway. We notably would be very interested in breakthrough designation that could shorten considerably the development timelines. So that's something that we are working on. And you can imagine that what we have in mind is, we could continue enrolling in the current Phase 2.

Speaker 2

As we mentioned, this Phase 2 program is only exploratory, right, so with 110 patients. So we would need To increase the number of patients included in the trial, and certainly, we would look at The subpopulation of treated with PoP inhibitors. So that's what we have in mind right now. But unless we speak with the regulators, we have we don't have Until we speak with the regulators, we have not confirmed any development plan at this stage. And Christian, do you want to comment on this point before I address the AMRT study?

Speaker 5

No, I think you've covered it. I think that's exactly good, just still in formulating our strategy and perhaps Help from agency or feedback will be important.

Speaker 2

And on the MRD study, Right. So what we expect is like a year from enrollment, we would have already Some interesting data. So maybe, Khushad, do you want to comment on this and what do we expect from this study, which also has In the protocol design, a number of translational data Accounted for that I think would be super informational for us. Do you want to comment on the M and A expenses, please, Richard?

Speaker 5

Of course, of course. Thank you. James, yes, so as you said, maybe Q2 next year, what kind of information is anticipated from MRD study? So the MARDI study, this is the first time we will be testing immunon-one with Avast Inhuman, we have never done that before. So Avastin is now in new adjuvant setting, it's been approved.

Speaker 5

So I think the first Lead Phase 1 part of the study is to really look at the safety with Avastin. So that's I think we want to get that out of the way. Don't anticipate any issues. So that's something I guess will be to move on from a safe combination and then open up the study into that population. Now, what to anticipate is certainly more enrollment by that time second quarter.

Speaker 5

But down the road, as Karim said, this study is really important because when Patients get cytoreductive surgery after 3 cycles of chemo, chemo burden is surgically removed and then you get another 3 cycles Chemo and then nothing happens until we maintain this therapy, but now we'll be looking at the Peritoneum again after the surgery and 1 month after and we anticipate that Bioimin Olin, Avastin We have preclinical data to show benefit would reduce the burden, the residual disease and lower the residual disease will be anticipated with longer Survival, so we expect to see maybe some patients. I can't promise in Q2 we'll have that, like I said, safety plan has to complete. But what you anticipate down the road will be the second look at proscopy, how many patients have you have seen those residual disease versus What's known, which is about 70% of patients have residual disease minimal versus we're trying to get it down to about 35%. So we might see some of that data coming in, but also we are collecting a lot of translational research, understand the tumor biology. That probably will be done when all the patients have sort of all the samples have been collected.

Speaker 5

So I think safety plus some maybe update on minimal residual These obviously PFS data are 0 data secondary endpoints. As with Ovation 2, we have been updating The community over the years or different time periods, so we'll probably some of that. But clearly, this study We'll have a lot of translational component to it to understand the combination.

Speaker 6

Great. Thank you for that. And I see also you guys signed a cooperative R and D agreement with NIAID or talking about it here in the 3rd quarter of Lassa virus. Does Lantavirus that potential proprietary view voucher down the road?

Speaker 2

Yes. So That's a good question. So as I

Speaker 5

mentioned with the development of the

Speaker 2

plasine modality, we would look at partnerships to develop Vaccine candidates and if Naid is interested, why not? But maybe, Krishi, do you want To elaborate on this agreement that we have with the NIH?

Speaker 5

Yes, of course. So James, initially, of course, I mean, Miplacine is a new platform. As you know, the history suggests that we have in a couple of years, we have kind of embarked on that. So our goal has been to demonstrate proof of concept or application in as many indication opportunities as we can. Some we have Like biosafety level for some viruses, there you would need some collaborations.

Speaker 5

And IND is looking at Lassa. They have looked at last hour with different approaches in the past. They have ground force in West Africa, including Mali, We have done some clinical trials. So, as commercial potential for the company, as Karim said, may not be as Today, it doesn't look very good, but it's increasing. There's a report on Lassa that come out where there's more incidents coming in South America and perhaps also heading west.

Speaker 5

So Who knows, but certainly in IAD, if the results are positive in animal studies, then an IAD is interested in Pursuing Lassa in West Africa and that would be another sort of concept approach for our technology to see the different kind of virus. So as such, company wise, again, I defer to Tony on that. But thirdly, that's not our big sort of commercial aspect, but Through collaboration to have concept and if an IED want to do that further, why not? Would the company be taking a lead role at some point? I think Karim may comment on that.

Speaker 5

But right now, we're focused on SARS CoV-two.

Speaker 6

Okay, great. Last question is for Jeff, if I could. Jeff, OpEx has been kind of trending down last few quarters. You guys are doing a good job Shepherding cash, is this the level we should anticipate going forward or we start seeing OpEx perhaps bumping up going through 'twenty four?

Speaker 3

We anticipate our cash utilization in the sort of the low $4,000,000 a quarter range We'll manage to that. The big driver will be the Phase III study. But As we mentioned, the OVATION II is fully enrolled. We're doing just a follow-up on that. And then the breakthrough cancer program with the Avastin is being funded largely by The foundation.

Speaker 3

So we're going to manage to a quarterly cash utilization of 4 4,250,000.

Speaker 6

Great. Thank you for taking the questions.

Operator

The next question comes from Kempe Dollyver from Brookline Capital Markets. Please go ahead.

Speaker 7

All right. Thank you and good morning. So

Speaker 5

I have

Speaker 7

a couple of questions about the I am NN-one trial in combination with Avastin. First, when do you expect to activate Dana Farber and MSK.

Speaker 2

Thank you, Kent. Yes, very soon. We have not announced it yet, but we're expecting that there'll be at least NSK will be on board pretty soon. Christian, do you want to Give you a bit more color to my answer?

Speaker 5

Yes. Exactly, Karim is right. We did a site initiation Call with them visit a couple of weeks ago. We did respond to their IRB caution standards. So I think They could be very soon activated.

Speaker 5

The other one is Johns Hopkins for Phase 1 part, but Dana Farber had from the very beginning, They would participate from the Phase 2 part of the trial. So as Kareem said, MS cable should be, there's no hiccups Unexpected, we should be making that announcement. They should be coming on board. A lot of paperwork has been completed with them. It's basically setting up the contract, All the different approvals from the committees, we have met good headwinds in that direction.

Speaker 5

So MSK is very likely coming up soon.

Speaker 7

That's great. Thank you. And this trial is using, I believe carboplatin is in the comparator arm and that's been in short supply. How have you been able to manage That in terms of, A, both availability, but then also cost.

Speaker 5

Yes. I mean, It's a good question. We did run into this issue back in 2012 with Doxil, if you remember, that was a big issue. But no, we haven't I mean, the centers that We are doing our studies, they are really big names. So, say investigators in MD Anderson has not brought that attention in terms of the cancer center Having any deficiency, and you're right, this chemotherapy is carboplatin and paclitaxel.

Speaker 5

So We haven't really heard from the sites yet. Certainly, these big centers have any deficiency issues. Cost wise, it's a center of care It's normally given to patients, but cisplatin is another, of course, a platinum based drug is used. So I'm not forecasting that You may be Mrs. Splatin, but haven't heard anything about any problem with these cancer centers.

Speaker 5

So I don't anticipate, but Mrs. Platinum is always available there as another Platinum drug. So I probably don't want to say anymore here because you did point out something and we haven't been really told That will be a concern at least these sellers. Maybe a lot of small sellers, perhaps that could be an issue as there was a DOCSIS and we have about 25 sites or so. So We have about 4 sites so far and names.

Speaker 5

So I don't know. I'll look into that. Certainly, we haven't been told by the sites yet. Any issues down the road, certainly.

Speaker 2

Yes. And the cost of Pindar Care are paid by the Breakthrough Cancer Foundation.

Speaker 7

Right. So, two questions. I apologize. The first one is going to require you to repeat some information. But I just want to be sure I understood for this trial the timing of anticipated completion of enrollment and The first set of interim data you'll provide because I think the line was breaking up and it wasn't clear

Speaker 2

So I will start and I'll let Krusch Continue. So, we anticipate that enrollment will be done cautiously for the first phase of the trial, which is The safety analysis of the combination of 1 and Avastin, at least that's what the investigators are telling us. And of course, as more centers come on board, you will see an acceleration in the enrollment. But, Khrushchev, please, if you could answer the second part of the question.

Speaker 5

Right. I apologize if there was a signal issue. So what we had said In response to, I believe, James' question that initial set of the data would be safety, of course, because So it has not been combined with GEN-one. So we hope to finish that Phase 1 part of the study out. I mean, it all depends on the enrollment.

Speaker 5

Four sites have been put into place initially, but we are trying to expand that. And I would think Q2 would be more of a safety clearance that indeed this new combination is safe in patients. And then from Q2 on, if we get more sites on board, we can probably get more enrollment and begin to update on the second leg laparoscopy results over time and perhaps maybe in quarterly update or so. But in terms of completing that Teddy, I would say, Corrine or even Jeff can chime in here. I would say at least about 2 years to complete the enrollment And at least with these 3 sites plus a couple more sites, so I think immediate is the safety data and some efficacy data may be trickled down, we can update this open label study.

Speaker 5

So I would say within 2 years maybe some significant data. But overall survival is a longer endpoint. That will probably take a long time to mature. But certainly, secondary laparoscopy could get within To hear some meaningful data hopefully. Again, this is what we are anticipating and we'll also get faster with more sites.

Speaker 2

Right. And Kim, at this stage, we cannot give very precise timelines while we're waiting for more centers to enroll. So It's a primary assessment really? Correct.

Speaker 5

Correct.

Speaker 7

No, that's super. Thank you. And just the last question is for Jeff and it relates So the trial and breakthrough cancer reimbursement, will those essentially the reimbursements just net against your R and D expense or will those show up as Grant revenue?

Speaker 3

It will be the former as we anticipate. We'll just treat what we're going to be paying as R and D expense.

Speaker 7

Fabulous. Thank you very much.

Operator

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

Speaker 8

Hey, good morning, everyone. Thanks for the update this morning. I just have a question on the COVID seasonal booster The plan for the Phase onetwo trial, so I'm assuming that the Phase 1 trial is going to be Safety study in healthy volunteers, but then will you look to do an efficacy study in Phase 2?

Speaker 2

David, thank you for your question. Yes. So in vaccine development in Phase 1 already, we will have Immune response data, right. So you have the neutralizing antibody data that you get quite rapidly after So the Phase 1 will already give us that data. And that's why in the design of our program, we are Looking for Phase onetwo.

Speaker 2

So we'll simply continue enrolling in a Phase 2 program with the chosen dose.

Speaker 8

Okay. And then will the Phase 2 have

Speaker 2

an efficacy outcome? And the Yes, efficacy outcome in immunogenicity, reactogenicity as well.

Speaker 5

Yes. So as you know, vaccine trials efficacy is really Challenging human being, right? So it's really the titers of the antibodies, neutralizing antibody really that's what you look at above base So I think that's essentially maybe what you're probably referring to efficacy part. So in Phase 2, we'll be looking at that, variant that we are targeting and the variant of the concern at that time. So basically neutralizing antibody titers About the baseline, that's the measure of efficacy in vaccine studies typically as opposed to therapeutic marker, right, in cancer.

Speaker 5

So, Yes, we will be looking at that in Phase 2.

Speaker 8

Okay, great. Thanks for taking the question.

Speaker 5

You're welcome. Thank you, David.

Operator

This concludes our question and answer session. I would like to turn the conference back over to management for any closing remarks.

Speaker 2

Thank you. So we believe that our technology holds excellent promise in immuno oncology as our work in providing options To women with ovarian cancer, looks very interesting. And we are excited about reporting Phase 2 data here on next Spring next summer. We've also been using the phrase vaccine of the future to describe our work. And that's exactly what our vision is, to be the provider of safe and effective vaccines that are superior to current vaccines in terms of Durability and breadth of protection are stable at workable temperatures, can be manufactured rapidly to respond to evolving pathogens and offer better compliance for mass immunization with no need for device or virus.

Speaker 2

We very much look forward to keeping you informed of Progress. Have a very nice afternoon.

Operator

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

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Earnings Conference Call
Imunon Q3 2023
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