Imunon Inc (IMNN) 2023 Q3 法說會逐字稿

Good morning. My name is Alan, and I will be your operator today. At this time, I would like to welcome you to the Imunon's Third Quarter 2023 Financial Results Conference call. (Operator Instructions) I would like now to turn the call over to Kim Golodetz. Please go ahead.

Thank you, and good morning, everyone. This is Kim Golodetz with LHA. Welcome to Imunon 2023 Third Quarter Financial Results and Business Update Conference Call. During today's call, management will be making forward-looking statements regarding Imunon expectations and projections about future events. In general, forward-looking statements can be identified by words such as expects, anticipates, believes or other similar expressions.

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

With that said, I would like to turn the call over to Dr. Corinne Le Goff, Imunon's President, and Chief Executive Officer. Corinne?

Thank you, Kim, and good morning, everyone. Joining me today is Jeffrey Church, our Chief Financial Officer. In addition, Dr. Khursheed Anwer, our Chief Science Officer, will be available during the Q&A session at the end of our prepared remarks. Imunon's growth and development is dependent on four pillars. Last quarter, I spent the bulk of our time on the development of our PLACCINE prophylactic vaccines modality as 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 IMNN-001, our DNA-based interleukin-12 immunotherapy for the localized first-line treatment of advanced ovarian cancer in combination with standard of care chemotherapy, and it's currently in Phase 2 clinical development.

Recall that in September 22, 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 three months benefit. And preliminary overall survival data followed a similar trend, showing an approximate nine months improvement in the treatment arm over the control arm.

This is how the ratio of 0.78 approaches the protocol-defined value of 0.75, set at an 80% confidence interval for the ITT population. Since OVATION 2 is an exploratory study with a total, so control plus study arms of only 110 patients, it was not powered to appeal inferior to 0.05 and the current trends looks promising.

Recall that this study is evaluating the dosing safety, efficacy, and biological activity of inter-operator or IMNN-001 in combination with new adjuvant chemotherapy or NACT. And this in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer.

NACT is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. And following NACT, patients undergo interval debulking surgery, followed by three additional cycles of chemotherapy to treat any residual tumor. And IMNN-001 is administered weekly during the course of NACT.

So, we also reported for the first time data on news, a subset of patients treated with PARP inhibitors. When we began the OVATION 2, Phase 2 trial, the PARP inhibitors were not part of the first-line maintenance treatment in ovarian cancer.

Now they form an important part of the patient's treatment plan. The subgroup analysis of patients who received IMNN-001 and post chemo maintenance therapy, which PARP inhibitors versus PARP inhibitors alone in the control group, shows positive impact. The median PFS in the PARP inhibitor plus NACT group was 15.7 months, yet PFS in the PARP inhibitors plus NACT plus IMNN-001 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 IMNN-001 group.

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 CRS 3 chemotherapy response score to approximately 30% in the treatment arm versus 14% in the control arm.

A complete tumor resection or a zero is a micro cosmetically margin negative resection in which no gross or microscopic tumor resection or R0 is a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed.

Chemotherapy response score is considered a good prognostic indicator in ovarian cancer. So that's why those endpoints are important to look at. And safety analysis continue to show good tolerability of IMNN-001 in this setting.

Now enrollment in our second Phase 2 study, which if you remember is done in collaboration with a breakthrough Cancer Foundation has begun with the first patient treated at MD Anderson Cancer Center last month.

This study is evaluating IMNN-001 in combination with bevacizumab. All in the study is expected to enroll 50 patients with Stage 3 for ovarian cancer at several sites, including Memorial Sloan Kettering and Dana-Farber.

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 PFS data are expected approximately three years following enrollment completion.

This trial will include a wealth of translational 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 six to seven months away from seeing this final readout data of our OVATION 2 program. And this is an incredibly exciting time for at all. If positive, this data would be transformational to the field and will confirm our hypothesis of IL-12 being a potent immunomodulator for cold solid tumors.

We will consult with the FDA on the potential regulatory path forward. Our small Phase 2 is showing promising trends in the ITT population and a strong benefit to standard maintenance PARP Inhibitors therapy, which could inform a registration study. PARP inhibitors are known to significantly increase PFS, 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 IMNN-001.PLA

Let's now turn to PlaCCine our proprietary monovalent or devalent DNA vaccines based on a DNA plasmid that controls the expression of pathogen antigens and the nonviral synthetic DNA delivery system. PlaCCine is currently being evaluated for the development of next-generation vaccines or as we call them the vaccines of the future.

We continue to bolster our preclinical data set with PlaCCine, which suggest this asset has been derisked and is performing as anticipated. Our first PlaCCine product is IMNN-101, which is in final stages of preparation for an IND investigational new drug application to the FDA.

IMNN-101 which we view as a proof of concept is designed to protect against task of to Omnicron XBB-15 varient, in accordance with the FDA's vaccines and related biological products advisory committee, the affect committee announcement that's been made in June 2023, and that established a framework for updated COVID 19 doses.

Imunon is targeting the first quarter of 2024 for submitting the IND and then enrolling the first subject in a Phase 1 trial in April 2024, with rapid advancement into a Phase 2 trial by mid 2024. 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 US and Europe.

For example, last month, Dr Anwer presented at the third International Vaccine Congress highlighting immunogenicity data and the development status -- test status of IMNN-101. Dr. Anwer's presentation described the multiple advantages of PlaCCine over current commercial vaccine platforms, including more durable antigen expression and T-cell responses versus protein and mRNA vaccines.

In addition, our preclinical studies show that PlaCCine is better antibody response kinetics following a single dose and demonstrate better shelf life of at least 12 months at four degrees Celsius and at least two weeks at very high temperatures of 37 degrees Celsius. These characteristics I suggest superior commercial handling and distribution properties compared with mRNA vaccines, as well as greater manufacturing flexibility.

Compared with viral or other DNA vaccines or protein vaccines or PlaCCine vaccines have advantages in T-cell responses, safety compliance and manufacturing flexibility. Dr. Anwer's presentation also described the versatility of the PlaCCine modality, demonstrating activity against Marburg and influenza viruses in collaboration with the Wistar Institute, and activity against Lassa virus, which is being evaluated at the NIH/NIAID.

I remind you that during the third quarter, we entered into a cooperative research and development agreement with the NIAID . This is a three-year agreement under which the NIAID will evaluate the immunogenicity and efficacy of two immunome DNA-based Lassa virus vaccine candidate.

The agency will assess the efficacy of the PlaCCine DNA constructs against Lassa virus in guinea pigs and non-human primate disease models, including both prime and prime boost vaccine strategies. We also announced our collaboration with Wistar in January of this year, and the Wistar institute vaccine of and immunotherapy center is uniquely positioned to advance new vaccine formulations to facilitate further expansion and development of vaccines.

Our collaboration with outside partners, particularly those that will provide some of -- all of the funding of the reserves are a key pillar of our growth strategy. Now, later today, Jean Boyer, our Vice President of Research and Development, will be presenting at the vaccine Summit in Boston.

Dr. Boyer's presentation describes preclinical T-cell responses and notes that the induced immune response in vaccinated mice, we're persistent with our 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 PlaCCine modality is revealing itself as an important potential option in addressing not only pandemic response, but also seasonal vaccine option.

It's stability at regular refrigerator temperatures of 12 months room temperature stability of at least one months and stability at high temperatures for at least two weeks, plus the immune response duration and the plug-and-play model using the plasmid DNA backbone has shown excellent preclinical results that are so important to a commercial vaccine product.

And this is particularly important as many pathogens such as Lassa Virus may arise in geographies where the alternatives with refrigeration, storage and distribution network. In addition, our ability to rapidly switch all out antigen and load multiple antigens into the same vaccine should be instrumental in addressing the spread of disease.

So in addition, our PlaCCine modality uses a DNA plasmid and a nonviral synthetic DNA delivery technology for the expression of pathogen antigens. And our DNA-based vaccines can be administered using a standard syringe an IM injection and are independent of viruses or specialized devices for delivery like electroporation.

Last quarter, I touched on our work to develop two modalities as logical extensions of our prophylactic vaccine modality. Sixth class concerns the application of our DNA technology to produce universal cancer vaccines, also called tumor associated antigen cancer vaccines.

We have initiated preclinical work to develop a trip-2 and NYSON tumor-associated antigen cancer vaccine in melanoma, which we call IMNN-201. 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 first modality in the place for personalized neo antigen cancer vaccine. And we plan to enter into new collaborations that focus on developing AI powered computational approaches instead of the [UPS] cell sequencing technologies to identify tumor antigen in patient samples into 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 and our decision to manufacture in-house offers us many strategic benefits, but notably the control on cost quality and time lines.

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?

Thank you, Corinne. Details of Imunon's Third Quarter 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 opened. Imunon ended the quarter with $19.5 million in cash and investments.

Our net cash usage for operating activities was $4.5 million for the third quarter of 2023, down slightly from $4.6 million 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 $1.8 million of planned future sales of Imunon'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.

Let me now turn to a review of our financial results. Imunon reported a net loss for the third quarter of 2023 of $3.5 million or $0.37 per share. This compares with a net loss of $6.1 million or $0.87 for the third quarter of 2022. Operating expenses were six point I'm sorry, $3.9 million in the current quarter, down 38% from the $6.3 million in the third quarter of 2022.

Breaking down these items by line item, research and development expenses were $2 million, a decrease of $400,000 from the prior year's third quarter more specifically, R&D costs associated with development of our PlaCCine DNA vaccine modality increase to $800,000 from $500,000 a year ago.

Clinical costs decreased to $400,000 from $1 million in the third quarter of last year. As a result of completing enrollment of the OVATION 2 study last September, which Corrine mentioned in her earlier comments. Other preclinical development costs were $300,000, compared with $600,000 in the prior year.

Our CMC costs increased to $0.5 million from $300,000 a year ago. This reflects the development of the in-house pilot manufacturing capabilities for DNA plasmid and nanoparticle delivery systems and the manufacture of supplies for IND-enabling studies as well as the Phase 1/2 clinical trial for our COVID vaccine.

General administrative expenses were $1.9 million in the third quarter of 2023, compared to $3.9 million in the comparable prior year period. This $2 million decrease was due to lower non-cash stock compensation expense, professional fees, primarily legal costs, employee related costs and insurance. Other nonoperating expenses were $400,000 in the third quarter 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 first quarter. I'm sorry, for the first nine months of the year. For the nine months ended September 30, 2023, we reported a loss of $14.6 million or $1.64 per share. This compares with a net loss of $22.7 million or $3.42 for the same nine month period of 2022.

Operating expenses were $15.1 million in the first nine months of 2023, an 18% decrease from $18.4 million for the same period of 2022. Cash used for operating activities was a little over $15 million for the first nine months of 2023. This compared to $18.1 million for the same period of 2022. The decrease was primarily due to a one-time payment of $4.5 million in interest expense resulting from the sale and subsequently --subsequent redemption of $30 million of Series AB convertible, redeemable preferred stock in the year ago period.

Cash used by financing activities of $3.7 million during the first nine months of '23 resulted from the early repayment of the company's loan facility with Silicon Valley Bank, that totalled $6.4 million, which was offset by $2.8 million of sales of equity under our at-the-market facility.

We also received net proceeds of $1.6 million from the sale of unused New Jersey NOLs in the first quarter of 2023. And as I mentioned earlier, we have an additional $1.8 million of annual sales that we anticipate this year, and next. Our projected cash utilization for the balance of '23 is approximately $4 million for the fourth quarter. The majority of expenses are related to the development of our PlaCCine modality, including the development of in-house pilot manufacturing capabilities mentioned earlier.

I'll now turn the call back to Corrine.

Thank you, Jeff. Imunon 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, while creating significant value for our shareholders. Collaborations are a key component of our strategy, and we are committed to ensuring that Imunon 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 additions of Dr. Patrick Ott, Clinical Director of the Melanoma Disease Center and the Director, Clinical Sciences, of the Center for Immuno-Oncology at the Dana-Farber Cancer Institute.

And Dr. Sachet 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 third quarter and recent weeks were exceptionally busy and full of achievements with more expected milestones to come. Among them, we reported a compelling interim data with IMNN-001 in the OVATION 2 study in advance of any cancer, particularly in a subset of patients taking part inhibitors in combination with chemotherapy and IMNN-001

Our next milestone from this study is to report top-line data in mid-2024. We derisked our PlaCCine modality across several pathogens of interest by demonstrating immunogenicity and safety of our vaccines. We generated compelling data in [FOSCOV2], and IMNN-101 our next-generation COVID-19 seasonal booster will be in the clinic in April, with human clinical data expected in the second quarter of 2024.

And we also generated excellent immunological response against pathogens of concerns, specifically monkeypox, flu, Lassa virus and Marburg virus. 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 quality of material, but also quality and cost. And we entered into collaborations to advance our technology with more to come and to build capabilities for the development of cancer vaccines.

Before we take your questions, I want to mention that we will be available for one-on-one 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. With that, I'll open up the call to your questions. Operator?

We will now begin the question and answer session. (Operator Instructions) The first question comes from Emily Bodnar of H.C. Wainwright. Please go ahead.

Hi, good morning, and thanks for taking the questions. I wanted to ask on OVATION 2, the recent data that you had. So obviously, it talks about the benefit you had with PARP inhibitors and assumingly also benefit and broker positive patients.

But you had a previous interim data readout where you mentioned that you had a benefit in bulk and 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 IMNN-001 broadly or specifically a combination with PARP inhibitor.

Thank you very much, Emily. And I will start and maybe that's also perceived as answer your questions. So you're absolutely correct that, if you remember, last year, we did a preliminary data cut, which with very mature data and we show benefits in bracket negative population. Now that we have more patients and more events. So this data cut was with 70 events across both arms.

We are showing a benefit in the ITT population, and we specifically said to look at patients treated with PARP inhibitors because -- the greater signature with bracket doesn't give the full answer. As you know, patients receive PARP inhibitors, if they are bracket positive even bracket negative patients get PARP inhibitors as it has been demonstrated that it is -- it can increase a progression-free survival in HRD-positive patients.

And so we wanted to be a bit more accurate in our description in designing, a sub group of patients who wanted to look at. And as you know, our HRD, which is homologous recombination deficiency, is very common. 50% of women with advanced ovarian cancer have tumors that is positive for HRD and only half of this recommendations.

So it's very interesting to look at -- patients treated 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 need in the chemotherapy.

We discussed this with our advisors and the hypothesis is that IL-12, So IMNN-001 kind of sensitizes the tumor for the PARP inhibitors. So that's the -- what they are thinking. Which makes sense, if you want and because I have a disease that IL-12, it has been very -- being very potent immunomodulator agents 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 their regulation regulatory path, and we'll we should do this sooner than later in anticipation of the top-line results in June.

Maybe Khursheed, if you'd like to add to what I have said?

No. I mean, I think you covered pretty much Corrine, but I just wanted to start with Emily's last part of the question which you just kind of address that potential mechanisms.

So Emily, as you know, back in our Phase 1 study, we did report change in the tumor microenvironment from the treatment where we saw increase in CD8 positive cells through immunosuppressive Marshall ratio, that suggests that the environment was transitioned from immunosuppressive demand immunostimulatory. So that itself, as Corrine said, you have this environment now before PAPR come in your tumor environment has changed to be more fighting for -- against tumor. That could be one potential mechanism.

In other words, you sensitize the tumor for PARP. As you know, PARP causes cell death DNA repair doesn't happen and that really does antigen. And if you have a good immune stimulatory environment that it really identical potentiate the immune responses, that's a potential mechanism and I think that's it, but I think that's potentially theoretically it makes sense.

Now first part of your question was about bracket negative. And currently it eloquently pointed that out as well, that was early data, but also the molecular signature, why it's a lot more to learn in ovarian cancer. Initially, we defined it as bracket positive, bracket negative. That's more systematic but in tumor also you have this homologous recombination deficiency, and that's a lot of variability, that IT there, that several enzymes, some are deficient and some patients. Some are not deficient and other patients.

So we're also trying to look into the database to better understand the molecular signature, not just breakup positive, breakup negative for the subtype as to really what's the extent of deficiency and see if we can make some correlate.

If you do that, then you really lowered the sample size because you already have about [70] a further breakdown but I think that's what we're trying to look into further understand these results, understand the mechanism maybe through some preclinical studies, but also what next type of broad application you ask or maybe more limited to. I think part combination, certainly direct us to a specific type of application. But as we learn more about molecular signature from this ongoing study, more data to come in. Perhaps that will shape up our future direction strategy.

That was very helpful. Thank you.

Thank you.

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

Hi guys, thank you for taking my questions. I just want to get your thoughts on the OVATION 2 data come out here mid next year. Can you walk through what the potential Phase 3 or not much of it is going to have data looks for a potential Phase 3 or Phase 2b trial design, our next steps on trial design might be from that.

And then on the OVATIAN trial, the Phase 1/2 OVATION trial, the interim data coming up here, what should we be anticipating here in the second quarter for that the interim look?

Thanks, James, so, as I mentioned, for the OVATION 2 program, we'll be discussing with the FDA on a potential regulatory pathway. We notably would be very interested in a 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 continuing enrolling in the current Phase 2. As we mentioned, this Phase 2 program is only exploratory. So with 110 patients. So we would need to increase the number of patients included in the trial.

And certainly we would look at a separation of trade with PARP inhibitor. 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 entity at this stage.

And Khursheed, do you want to comment on this point before I address the MRD study?

No, I think you're covered it. I think that's exactly, we're just still in formulating our strategy and perhaps and help from agency or feedback would be important.

And on the MRD study, right? So what we expect is likely a year from enrollment, we would have already some interesting data. So maybe, Khursheed, you want to comment on this and what we expect from this study, which also has in the protocol design, a number of a translational data accounted for that, I think would be super informational for us.

Do you want to comment on the -- (multiple speakers)

Of course. Thank you, James. as he said, maybe second quarter next year will kind of inflammation is anticipated from MRD study. So the MRD study, this is the first time we will be testing Imunon or one with [invested] in human. We have never done that before.

So as there is now in the new adjuvant setting, it's been approved. So I think the first lead Phase 1 part of the study is to really look at the safety with Avastin so that I think we want to get that out the way we don't anticipate any issues.

So that's something I guess it will be to move on from its safe combination and then open up the study into that population. Now what to anticipate is certainly more enrollment by that time second quarter, but down the road, as Corrine said, this study is really important because when patients get cytoreductive surgery after three cycles of chemo, a tumor burden is surgically removed and then you get another three cycles of chemo and then nothing happens to maintain this therapy.

But now we'll be looking at the peritoneum again after the surgery in one month after. And we anticipate that by immuno 1 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 promise in second quarter, we'll have that, like I said, safety file has to complete, but what you anticipate down the road will be the second look across KP, how many patients have you 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 and understand the tumor biology. That this probably will be done when all the patients have sort of all the samples have been collected. So I think safety plus some maybe update on minimal residual disease. And obviously, PFS data are zero data secondary endpoints. As innovation 2, we have been updating the community over the years or different time periods. So probably some of that. But clearly this study will have a lot of translational component to it, to understand the combinations.

Great. Thank you for that. And I see you also you guys trying to cooperative R&D agreement with NIAID, are you talking about it here in the third quarter Lassa Virus. Does Lassa Virus have that potential for priority review voucher down the road?

Yeah. So this -- Thank you James, that's a good question. So, as I mentioned, with the development of the PlaCCine modality, we would look at partnerships to develop the vaccine candidates. And if anybody's interested, why not. But maybe, Khursheed, you want to elaborate on this agreement that we have with NIH?

Yes, of course. So James, that initially of course, I mean PlaCCine in the new platform, as you know, the history suggests that we have just a couple 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 we can. Some we have facility like bio safety level for some virus, there you would need some collaborations and [IAD] is looking at Lassa.

They have looked at Lassa with different approaches in the past. They have ground forced in West Africa, including Mali, where they have done some clinical trials. So as commercial potential for the company, as Corrine said, it may not be as of today. It doesn't look like huge but it's increasing the report on Lassa that come out where there's more incidents coming to South America and perhaps also heading west. So who knows?

But certainly an IAD if the results are positive in animal studies, then IAD is interested in pursuing Lassa in West Africa, and that would be another sort of proof of concept approach for our technology between the different kind of virus.

So as such, company-wise. Again, I'd defer to kind of comment on that, but certainly that's not our big sort of commercial aspect, but through collaboration proof of concept. And if an IAD to do that further? Why not. would you -- company be taking a lead role at some point. I think Corrine may have comment on that, but right now we are focus on [softgoods] too.

Okay, great. Last question is for Jeff. I could -- Jeff OpEx been kind of trending down the last few quarters, guys are doing a good job [shepherding] cash. Is this a level we should anticipate going forward or we start seeing the OpEx perhaps bumping up going through '24?

Yeah, we anticipate our cash utilization in the sort of the low $4 million a quarter range, and we'll manage to that, the big driver will be the Phase 1/2 study. But as we mentioned, the OVATION 2 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. So we're going to manage to a quarterly cash utilization of $4 million to $4.25 million.

Thank you for taking the questions.

The next question comes from Kemp Dolliver from Brookline Capital Markets. Please go ahead.

All right. Thank you and good morning. So I have a couple of questions about the IMNN-001 trial in combination with Avastin. First, when do you expect to activate Dana-Farber and MSK?

Thank you, Kemp. Yes, very soon. We have not announced it yet, but we're expecting that there will be or at least an escape will be on board present. Khursheed, do you want to give you a bit more color to my answer?

Yes, exactly. Corrine is right with data site initiation call with them visit a couple of weeks ago, we did respond to their IRB question standard. So I think they could be very soon activated.

The other one is Johns Hopkins for Phase 1 part of identify harbor ahead from the very beginning, they would participate from the Phase 2 part of the trial. So as Corrine said, MSK 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 is basically setting up the contract all the different approvals from their committees, and we have made good headway in that direction. So MSK is very likely coming up soon.

That's great. Thank you. And this trial is using, I believe Carboplatin as 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?

Yeah, I mean that'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 did the centers that we are doing our studies are really big names. So the investigators at MD Anderson has not brought that detention in terms of the cancer center, having any deficiency and you're right, this chemotherapy is carboplatin and paclitaxel.

So we haven't really heard from the sites yet. Certainly this big centers and any deficiency issues cost, why is this a center of care normally given to patients, but to slot into that other, of course, you had a platinum-based drug. And as you saw, I'm not forecasting that you may have noticed, [PlaCCine] but I haven't heard anything about any problem with this cancer center side. I don't anticipate, but Mr. [Sutton] is always available there at another platinum drug.

So I probably don't want to say what they are because you did point out something and we haven't been really I told that will be a concern at least these centers, maybe a lot of small centers, perhaps that could be an issue as there was the docs are thinking about 25 sites or so. So here about four sites so far and name. So, I don't know -- look into that, certainly we haven't been told by the sites yet, I mean issue down the road certain.

And the cost of [Tendercare] paid by the breakthrough cancer foundation.

Right. So, two questions. I apologize. The first one is going to require you to repeat some information, but I just wanted to share I understand, stood for this trial. The timing of anticipated completion of enrollment and availability of the first set of interim data you'll provide because that I think the line was breaking up and it wasn't clear how those line up together.

Right. So I will start and let Khursheed 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 001 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 government, but Khursheed, please, if you could answer the second part of the question?

Right. I apologize if there was signal issue. So what we had said in response to, I believe Jame's question that initial set of the data would be safety, of course, because of action has not been combined with [GEN-1]. So we hope to finish that Phase 1 part of this study out, I mean, it all depends on the enrollment for sites have been put into place initially but we are trying to expand that. And I would think second quarter would be more of a safety clearance that indeed this new combination is safe in patients.

And then from second quarter on, if we get more sites on board, we can probably get more enrollment and begin to update on the secondary laparoscopy results over time and perhaps maybe in quarterly update or so.

But in terms of completing that study, I would say, Corrine and even Jeff can chime in here, I would say at least about it took two years to complete the enrollment and at least with three sites plus a couple of more sites. So I think immediate is the safety data and some effect efficacy data maybe trickle down, we can update this open label study.

So I would say within two years, maybe some significant data, but overall survival is a longer endpoint that will probably take a long time and to mature, but certainly appear. And secondly, laparoscopy, you could get within two years and some meaningful data. Hopefully, again, this is what we are anticipating and we'll also might get trusted with more sites.

Right. and came at this stage, we cannot give a very precise timelines, we're waiting for a most interest journal. So it's a preliminary assessment really.

correct.

Yeah. That's super. Thank you. And just the last question is for Jeff, and it relates to the trial and the breakthrough cancer reimbursement. Well those essentially the reimbursements just net against your R&D expense or will those show up as grant revenue?

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

Fabulous. Thank you very much.

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

Hey, good morning, everyone. Thanks for the update this morning. Let's have a question on the COVID seasonal booster vaccine plan for the Phase 1/2 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?

David, thank you for your question. Yes. So in vaccine development, in Phase 1 already we will have on immune response data, right? So you have the neutralizing antibody data that you get quite rapidly after the injection of the vaccine.

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 1/2. So we'll simply continue enrolling in a Phase 2 program with the chosen dose.

Okay. Well the Phase 2 have an efficacy outcome -- (multiple speakers)

Yeah, efficacy outcome in immunogenicity, reactogenicity as well.

Yeah, so vaccine trials efficacy has been a challenging human being, right? So it's really the titers of the antibodies, neutralizing antibody, really that's what you look at above baseline so I think that's essentially maybe what you're probably referring to efficacy part. So it will be look at that, that how much does the titers from baseline have gone up against this particular variant that we are targeting and the variant of the concern at that time.

So basically neutralizing antibody titers above the baseline. That's the major of efficacy in vaccine studies typically, as opposed to set therapeutic marker, right? in cancer. So yes, we will be looking at that, in Phase 2.

Okay, great. Thanks for taking the question.

Thank you, David.

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

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 of stable at workable temperatures, can be manufactured rapidly to respond to evolving pathogen and offer better compliance for mass immunization with no need for device or virus. We very much look forward to keeping you informed of our progress, have a very nice afternoon.

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