Imunon Inc (IMNN) 2022 Q4 法說會逐字稿

Good morning. My name is Marliese, and I will be your operator today. At this time, I would like to welcome you to IMUNON's Fourth Quarter 2022 Financial Results Conference Call. (Operator Instructions)

I would now like 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's 2022 Fourth Quarter and Full Year Financial Results and Business Update Conference Call.

During today's call, management will be making forward-looking statements regarding IMUNON's expectations and projections about future events. In general, forward-looking statements can be identified by terminologies such as expect, 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, March 30, 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 today's formal presentation.

Today, I will provide an update on our development programs with PLACCINE, our prophylactic vaccine modality and with IMNN-001, which was previously known as GEN-1, our interleukin-12 or IL-12 immunotherapy for the treatment of advanced ovarian cancer.

But before I dive into our various ongoing programs, I have to remind investors of some important strategic points conveyed earlier this month in my letter to shareholders. IMUNON is strictly focused on harvesting the power of the immune system by developing novel DNA-based approaches in immuno-oncologies and infectious diseases.

We believe that nonviral DNA will be a key driver of the future of global medicines. Nonviral DNA has the potential to create an unprecedented abundance and diversity of medicines that are currently beyond the reach of recombinant protein technology. Our proprietary platform does not require a device or a virus for facilitating the DNA delivery.

In addition, our medicines can be easily redosed, manufacturing is straightforward and scalable, and the administration to patients does not require painful electroporation. Our strategy is designed to deliver on the full scope of the nonviral DNA opportunity over the long term. Reaching patients with DNA medicines requires us to make several clear choices, including how much capital we devote to platforms and modality development, drug development and infrastructure, which programs we advance and how, whether we advance programs alone or with strategic collaborators and which capabilities we build internally versus outsource.

To navigate these choices, we established 4 strategic principles that guide our approach to creating long-term value for patients and investors. First is our focus on immuno-oncology as an asset development opportunity. Our strategy is to pursue indications characterized by high disease burden and substantive unmet medical need, where an immunological approach can improve both the risk of progression and survival compared with current standard of care.

You are aware of our first modality, which is TheraPlas for the expression in-situ of immunomodulating cytokines. We currently are in a Phase II study in advanced ovarian cancer with our IL-12 cytokine. IL-12 potently stimulates both natural killer cells in the innate immune system and CD8 T-cells in the adaptive immune system and therefore, potentially offers a powerful (inaudible) agent with a good safety profile. This program is a clear example of how IMUNON is pushing the boundaries of innovation in a difficult-to-treat tumor type.

We are now developing a second modality for the development of personalized neoantigen cancer vaccines. This new modality based on antigen selection and optimization along with the option to include a potent immune modifier on a single nucleic acid vector may represent a promising strategy to induce a specific and long-lasting immune response against tumor antigens. It is a logical extension of our prophylactic vaccine modality.

We just started a program in a melanoma model in mice, and we will keep you updated on our progress.

Developing our prophylactic vaccines modality, PLACCINE as an out-licensing and partnership opportunity is the second prong to our business strategy. As confirmed at the FDA's Vaccines and Related Biological Products Advisory Committee meeting, the VRBPAC meeting at the end of January, the need for new vaccine technologies is urgent.

Since 1980, more than 80 pathogenic viruses have been discovered yet fewer than 4% have a commercially available prophylactic vaccine. Before COVID, the global market for prophylactic vaccines was about $35 billion, which was roughly shared between Sanofi, Merck, GSK and Pfizer. The market grew to $61 billion in 2021 and is expected to reach $125 billion in 2028, which represents a great opportunity for new entrants.

The PLACCINE modality has several characteristics that may address the shortcomings of current nucleic acid, attenuated virus and protein subunit vaccines. For example, PLACCINE is engineered to be easily modified to create vaccines against a multitude of infectious diseases with benefits that include durability and breadth of protection, transmission advantage, safety and convenience, flexible manufacturing and stability at standard refrigerated temperatures. These attributes are all sought by various global health authorities, and the efficiency of plug-and-play strategy is very valuable against emerging pathogens.

Our objective is to establish the safety and efficacy of our platform in a Phase I human study and then seek to out-license this powerful technology in order to establish nondilutive partnerships to develop vaccines for pathogens of interest. We've held productive discussions with the Biomedical Advanced Research and Development Authority or BARDA, a division of the U.S. Department of Health and Human Services, and with the NIH, the Natural Institute of Allergies and Infectious Diseases division of the NIH to pursue certain pathogens identified as the most urgent and the most important.

There was a clear reaction that IMUNON has made real progress making DNA vaccines more effective and in the words of one of the participants, more appealing.

Our third strategic principle focuses on the vertical integration of the core elements of our business. As a small company, IMUNON must be nimble and thoughtful in deploying capital, investing just enough in building and integrating our operations to bring portfolio product to licensing inflection points.

Our goal is to attract the interest of corporate partners while minimizing dependencies and dependence on vendors so that we control costs, timelines and quality. Our range of capabilities is impressive. For example, our scientists can select any protein from the human or pathogen (inaudible) to be engineered.

We have R&D laboratory testing capability to support product and best of development. We have a GMP QC laboratory to test raw materials, finish products and to conduct our stability studies. And our labs also have the capacity and expertise to conduct testing and to run experiments in a variety of animal disease models.

We also have developed in-house (inaudible) manufacturing capabilities for DNA plasmids. Our objective is to establish the safety and efficacy of our platform in a Phase I human study and then seek to out-license this powerful technology in order to establish nondilutive partnerships to develop vaccines for pathogens of interest. We've held productive discussions with the Biomedical Advanced Research and Development Authority or BARDA, a division of the U.S. Department of Health and Human Services, and with the NIH, the Natural Institute of Allergy and Infectious Diseases division of the NIH. to pursue certain pathogens identified as the most urgent and the most important. There was a clear reaction that IMUNON has made real progress making DNA vaccines more effective and in the words of one of the participants, more appealing.

Our third strategic principle focuses on the vertical integration of the core elements of our business. As a small company, IMUNON must be nimble and thoughtful in deploying capital, investing just enough in building and integrating our operations to bring portfolio product to licensing inflection pois.

Our goal is to attract the interest of corporate partners while minimizing dependencies and dependence on vendors so that we control costs, timelines and quality. Our range of capabilities is impressive. For example, our scientists can select any protein from the human or pathogen proteomes to be engineered.

We have R&D laboratory testing capability to support product and best of development. We have a GMP QC laboratory to test raw materials, finished products and to conduct our stability studies. And our labs also have the capacity and expertise to conduct testing and to run experiments in a variety of animal disease models.

We also have developed in-house pilot-scale manufacturing capabilities for DNA plasmids and nanoparticle facilitating systems. To date, this has resulted in the production and testing of more than 60 vectors to support our vaccine and immunology programs. And the quality of the products we've produced has been excellent.

The next step in our vertical integration strategy is to build upon our pilot scale manufacturing capabilities to produce Phase I GMP materials. This includes the fermentation and purification of the plasmid DNA as well as the production of our facilitating systems. This would allow IMUNON to control all aspects of product design, testing and manufacturing, complete bench-to-bedside capability.

In areas that do not need to be integrated, our fourth quarter strategic investment in Transomic Technologies provides us with the capability to construct custom vectors. Transomic offers a comprehensive array of CRISPR, RNA and gene expression tools and services. And we now can construct vaccines against new variants in just weeks.

Implementing this thoughtful vertical integration strategy and expanding IMUNON's capabilities in-house presents many benefits. We notably managed to reduce our cost and timeline by more than 75%, and we are creating a reliable, high-quality and predictable supply chain.

Finally, our fourth pillar, which is the bedrock of our long-term business model, focuses on strategic collaborations. Joining forces with partners is a great way to expand our capabilities, accelerate the development of our programs and obtain nondilutive funding to execute our strategy.

To that end, we found several important collaborations in recent months. We signed our first collaborative research agreement with the Wistar Institute to develop new vaccine formulations for infectious diseases using our PLACCINE modality. Wistar is a global leader in biomedical research, and our agreement is with their vaccine in an immunotherapy center.

We also signed an agreement with the biotechnology company, Acuitas Therapeutics, which is focused on developing delivery systems for nucleic acid vaccines and therapeutics based on lipid nanoparticles. Under this agreement, we will explore the expansion of our technology with a broad spectrum of formulation capabilities as we position our nucleic acid-based modality as the future of vaccinology.

We also formed an alliance with the Breakthrough Cancer foundation that allows us to obtain nondilutive funding to initiate new innovative clinical programs in niche indications like ovarian cancer. I trust that these 4 strategic principles provide clarity to our shareholders on our capital allocation strategy and on our overall vision for the development of the company in the coming years.

Let me now switch gears and give you an update on the progress of our current development programs. I am pleased to report that IMUNON made significant progress during 2022. With IMNN-001, we reached full enrollment of 110 patients in a Phase I/II study in women with advanced ovarian cancer, the OVATION 2 Study.

Last year, we also reported data from 46 patients in the IMNN-001 treatment arm, who had undergone interval debulking surgery. The data showed an improvement in R0 surgical resection rates and CRS 3 chemotherapy response scores over -- in 41 patients in the control arm. We expect to report an additional set of interim more material data in the second half of 2023 and top line results by mid-2024.

As I mentioned earlier, we recently announced a collaboration with Break Through Cancer to evaluate IMNN-001 in a Phase I/II clinical trial in combination with bevacizumab or Avastin in ovarian cancer in the frontline neoadjuvant setting. Note that Break Through Cancer will be covering the majority of the cost of this clinical trial.

Working with some of the leading comprehensive cancer centers in the world, the goal of this project is to transform the care of women with ovarian cancer by developing unprecedented capabilities for understanding and targeting persistent minimal residual disease. We look forward to enrolling the first patient in the coming weeks at MD Anderson with expected additional participation at the Sidney Kimmel Cancer Center at John Hopkins, Dana-Faber Cancer Institute and Memorial Sloan Kettering.

The core institute for integrative cancer research at MIT will provide artificial intelligence services throughout the trial, including biomarker and genomic analysis. And this we expand our knowledge of the treatment paradigms.

Turning to our recent progress in developing our prophylactic vaccine modality. PLACCINE continues to be extremely robust, and it holds extraordinary potential to address an array of pathogens. In a COVID-19 model, our nonhuman primate work showed excellent immunological response and viral clearance.

We also demonstrated in a mouse study that a single dose of PLACCINE vaccine without a booster dose produce longer duration of IgG responses and higher T-cell activation than an mRNA vaccine. We are now 10 months into a 12-month PLACCINE stability study and have demonstrated continued product stability of standard refrigerated temperature, representing the significant commercial advantage over mRNA-based vaccines.

With respect to durability, we look forward to reporting data later this year comparing the durability of PLACCINE to mRNA vaccines. We also generated a strong (inaudible) and similar immunological responses with other pathogens like monkey pox and influenza. So we now have fully characterized our modality preclinically.

Our next step is to continue to derisk the PLACCINE modality in a Phase I human study. Based on our comprehensive preclinical data, we have already submitted our pre-IND package to the FDA for a seasonal COVID-19 booster designed for the next variant of interest.

According to our timelines, we are planning to start enrolling patients in the trial at the end of the year. In parallel, we have been presenting our preclinical data at important vaccine conferences around the globe and are delighted with the reception our work has received. It is important to receive validation for our work from scientific colleagues and the large pharma companies they represent.

So I've used the term of vaccine of the future, and that is exactly what our vision is, to be the provider of first and effective vaccines of the future that's superior to current vaccines in durability and breadth of protection, stability at workable temperatures, rapidity in manufacturing to respond to evolving pathogens and have better compliance for mass immunization by not requiring a device or virus.

Before I turn the call over to Jeff Church for his review of our financial position, I want to impress upon you that our long-term vision calls for the creation of a new category of medicines based on our nonviral plasmid DNA technology across a broad array of human diseases. We are starting in immuno-oncology and infectious diseases. And we will continue to invest to fully characterize the platform and to advance the technological frontier of plasmid DNA.

Now I will turn the call over to Jeff.

Thank you, Corinne. Details of IMUNON's 2022 financial results are included in the press release we issued this morning and in our Form 10-K, which we filed today before the market opened. IMUNON ended 2022 with $38.9 million in cash, investments and restricted cash, along with future planned sales of the remaining $3.5 million of New Jersey net operating losses, the company believes it has sufficient capital resources to fund its operations into 2025 and through several important value-creating milestones.

Subsequent to year-end, we received net proceeds of $1.6 million from the sale of our 2021 New Jersey NOLs, leaving us with $1.9 million in remaining NOLs to sell in 2023. Over the past few years, we have been opportunistic with respect to raising cash, and this leaves us in a much better position than many other development stage biotechnological companies.

That said, the longer-term growth plans include raising funds from both equity and nondilutive sources of capital, including the collaborations and partnerships Corinne just mentioned. We will be monitoring the public equity markets during 2023 and hope that market conditions begin to improve later this year.

Net cash used for operating activities in 2022 were $23.1 million. This compares with $16.2 million for 2021. The increase was primarily due to higher professional services, largely legal fees to defend various lawsuits and arbitration matters related to the July 2020 announcement around our OPTIMA Phase III study results and the subsequent closeout of the trial as well as higher operating costs attributable to the development of IMNN-001 and the PLACCINE DNA technology platform.

Cash provided by financing activities totaled $6.7 million in 2022, resulting from a registered direct equity offering in April of 2022, which was executed at the market with no warrants. Also, contributing to the equity raise was sales under the company's at-the-market equity facility in the fourth quarter of 2022 of approximately $0.5 million.

Let me now turn to our financial results. For 2022, IMUNON reported a net loss of $35.9 million or $5.03 per share, and this compares with a net loss of $20.8 million or $3.83 per share in the prior year. Operating expenses were $25.4 million for 2022, and this represented an increase of 18% over the prior year.

Let me break down these expenses by line item. Research and development expenses were $11.7 million for 2022, an increase of $1.1 million from the prior year. Research or R&D costs associated with the development of PLACCINE DNA vaccine technology platform as well as OVATION 2 Study increased to $6.1 million for the year compared to $4.3 million in 2021.

Costs associated with the previously mentioned Phase III OPTIMA Study decreased to $0.5 million for 2022 compared to $1 million in the prior year, which represented expenses associated with closing out this previously discontinued study. Other clinical CMC and regulatory costs were $1.2 million in 2022, which compares to $1.5 million in the prior year.

General and administrative expenses were $13.7 million in 2022 compared to $10.9 million in 2021. This $2.8 million increase was primarily attributable to higher professional fees, including legal fees, which I mentioned earlier, and higher compensation expenses related to the CEO succession plan, which we announced in July of 2022. These expenses were partially offset by lower noncash stock compensation expense.

Other nonoperating, I emphasize nonoperating expenses were $12.5 million in 2022, which compares to a little over $1 million in the previous 2021 period. This increase was attributable to 5 factors. First, due to the continued deterioration of the public capital markets in the biotech industry over the past 12 months and its impact on the market capitalization of companies in this sector, we reviewed our in-process research and development asset for impairment. After conducting a detailed analysis, the company determined that this intangible asset was permanently impaired. So as of December 31, 2022, the company wrote off the carrying value of this asset, thereby recognizing a noncash charge of $13.4 million.

Second, the company wrote off the earn-out milestone liability because the requirements for this milestone were not achieved, resulting in the recognition of a noncash gain of $5.4 million during the fourth quarter of 2022.

Third, the company recognized interest expense of $5 million for 2022, which compares to $600,000 in 2021. In June of 2021, IMUNON entered into a loan facility with Silicon Valley Bank, which was used to retire all outstanding indebtedness under a previous venture debt facility at a much higher interest rate.

In connection with these 2 loans, the company incurred $500,000 in interest expense in 2022 compared to $600,000 in the prior year. Our loan with the Silicon Valley Bank is now been assumed by First Citizens Bank under the same terms.

Fourth, in 2022, the company incurred additional interest expense attributable to a onetime payment of $4.5 million in interest and offering expenses resulting from the sale and subsequent redemption of $30 million of Series A and B convertible redeemable preferred stock. This unique transaction was necessary to increase the number of authorized shares and effect the reverse stocks split, which we announced in the first quarter of 2022.

Lastly, investment income from the company's short-term investments were $0.5 million in the current year. This increase was a result of improved returns on our short-term investment. Investment income in the prior year was insignificant.

Looking to 2023, we expect operating expenses of approximately $20 million to $22 million with the majority of these expenses related to the development of our PLACCINE modality.

I will now turn the call back over to Corinne.

Thanks, Jeff. We believe that innovative new technologies are intubated in companies like IMUNON. Just think about what BioNTech and Moderna have accomplished. And we believe that we are well positioned to develop new nonviral DNA-based approaches in immuno-oncology, cancer vaccines and in infectious disease prophylactic vaccines.

We leave large late-state clinical trials to partners with the resources to conduct them, and we will view each program with an eye towards a licensing transaction. In doing so, we will also expect to create great value for our shareholders.

So with that overview of our business and our recent financial results, we are ready to open the call to your questions. Operator?

(Operator Instructions) We'll start with a question from Emily Bodnar from H.C. Wainwright.

I have 2 on the COVID programs. So first question, could you maybe speak about the dose response that you're seeing in your preclinical studies since you're evaluating like a lower dose and a higher dose? Are you kind of seeing like an increase in neutralizing antibodies and viral clearance with a higher dose? And how are you thinking about which dose you plan to use for the booster approach?

And then second question, I know you said you're planning to speak to the FDA about which COVID variants to target, but are there any that you're currently looking at? And have you initiated any preclinical studies on those variants? Or do you think the preclinical data you have on the other variant would be sufficient to go into Phase I?

Thank you very much, Emily, for the questions. I will ask Khursheed to address those questions. Please, Khursheed.

Sure. Sure. Thank you, Corinne, and thanks, Emily, for your questions. Yes, so regarding dose response, we have reported from our nonhuman primate study, we have seen neutralizing antibody responses at 0.5 milligram, 1 milligram, 2 milligram and 5 milligram doses. There was slight improvement over dose, but essentially 1 milligram, 2 milligram were very comparable to 5. So based on that dose response in nonhuman primates, where we have done 1, 2 and 5 milligram, fairly comparable, we are proposing to go one level lower as a starting dose in human 0.5 mg and then we'll do 1 mg and 2 mg.

Those are the 3 doses will start out in Phase I study, and we'll do either a single injection, initially single injection in Phase I part of the study, demonstrates safety and pick a dose based on safety and immunogenicity whether it's 0.5, 1 or 2 milligram and then expand that cohort to a larger number of patients.

Also, we'll do a booster dose as well. Once the safety and immunogenicity is confirmed from 1 of the 3 doses, we'll do a booster as well to see if boosting will amplify the response. This is a 12-month follow-up for both single-dose and 2-dose study. So that's the dose response question. I know you have a question about new variants as well. I'll go into that, but let me stop here and see your dose response question, if it was addressed amicably.

Yes, that's very helpful.

And thank you, Emily. Now your second question was about new variants. I think that's a very good question. SARS-CoV-2 is a moving target. We just keep getting new variants. So yes, a lot of our database has been with the D614G, the Alpha variant, Delta variant, but our most recent target has been Omicron XBB.1.5. That's the variant of concern.

So we have demonstrated a construct we would have made with that strain or that variant in combination with a conserved antigen. The vector is successfully expressed in, in vitro with comparable amount of both proteins in vitro and then mRNA levels. And now the immunogenicity studies in mice are ongoing. We hope to have some results by next month to show IgG utilizing antibody response and T-cell responses with the variant of concern. That's the recent one, XBB.1.5.

And that's the vector we intend to take it to the Phase I study. We have submitted a pre-IND document recently proposing this strain per FDA guidelines as the January 26 meeting. So yes, indeed, we do have new variants data now.

We now have a question from James Molloy from Alliance Global Partners.

I was wondering with -- you mentioned we're looking for some interim data here in the OVATION 2 Study at the end of 2023. I was wondering if you could give an idea what we should be looking for in that interim data and what are you guys looking to see out of that study?

And then on the combo GEN-1 and Avastin plus neoadjuvant chemotherapy study Phase I/II, what's the expectation for the next interim -- potential interim look there? And I understand, is there still a plan to start a combo with OPDIVO potentially in 2023 in this patient population as well?

Thank you very much, Jim. So I'm going to start addressing your first question regarding the interim data for the OVATION 2 program. As you know, OVATION 2 is an open trial so we can do interim data cut. We -- the last data cut we did was at the beginning of September when we reached about 50% of the events, so very immature data.

For the next data cut, we will wait until we reach about 75% of the event. It is -- as you know, since it's an open study event driven, we cannot very precisely tell exactly when it's going to happen, but we estimate that it will be in Q3 this year. So that was for your first question.

Regarding the new Phase I/II program in collaboration with Break Through Cancer, so the combination study with bevacizumab, we are anticipating the start of this study in the coming weeks. MD Anderson is the first site to recruit in this trial, and the site is open for equipment.

We anticipate this Phase I portion of this clinical trial to go until the end of the year, and then we will start the Phase II portion after that next year. So Phase I portion is simply to adjust dose in the combination with Avastin. Did I answer your question, Jim?

Yes. And then there was a discussion, I think, before potentially running the trial with OPDIVO as well and (inaudible)

So for now, we've put this trial on the back burner. We wanted to, first, as you know, prioritize our development progress based on the evidence that we have. And we have very strong evidence that preclinically that the combination trial with bevacizumab could be potentially extremely interesting.

Our preclinical data showed a very strong synergistic benefit of Avastin with IMNN-001. So for that reason, for now, we are focusing on this, and we'll see if we go forward with OPDIVO as another combination option.

Okay. Great. And then maybe a last question on a bigger picture. Certainly been a lot of news about the Silicon Valley Bank. You guys addressed your issues with it. The same day that happened, Pfizer picked up Seagen for $40 billion. Is there -- how would you characterize the market for potential partnerships? Currently, a lot of your stock along with many certainly at very depressed levels, more than it perhaps should be. How has that changed the potential partnering environment currently?

Yes. Thank you very much for this question. I will give you my view of the partnership landscape as I see it. In fact, we just came back from BIO-Europe, and I have to say that they are still -- there's still a great level of interest for companies that have the right level of innovation. So what I mean by that is that companies who have the right technologies and can demonstrate that they are pushing the boundaries of innovation still generate interest.

I cannot comment on the acquisition of Pfizer -- by Pfizer of Seagen. It's certainly a very good accretive deal for Pfizer. But what I can say is that we -- of course, as soon as we can obtain proof-of-concept data in humans for PLACCINE modality, we will definitely engage with big pharma potential partners. And we actually believe that our technology could generate a lot of interest.

So that's clearly what we are doing. And we've been talking already with a number of companies. So we know that we are on their radar screen as well. So that's for business development opportunities with (inaudible) companies, big or small.

But as I mentioned, we are also looking at partnering with institutions as we -- I talked about our Wistar Institute agreement. I talked about our Break Through Cancer foundation agreement.

And we are looking, especially in the area of infectious diseases as potentially having the support of organizations like BARDA or the NIH. There is a great level of interest around the world on what's going to be the next pathogen. And I can tell you that all regulators are looking at the next technology as well.

So I feel very assured with the latest discussions we've had with those organizations. Our technology is not right for partnership right now. I mean, as I mentioned, we definitely need to have those human data. But as soon as we have that, we'll be looking for partnerships and meaningful funding.

And now we have a question from Kemp Dolliver from Brookline Capital Markets.

I want to dig into the cash runway assumptions in the context of programs that will complete. And in that bucket, I'm really thinking specifically of PLACCINE. And then also, there was reference to milestones. I want to clarify if there's any assumption with regard to proceeds from nondilutive transactions in the cash runway guidance.

Thank you, Kemp. I'd ask Jeff to address your question.

Sure. We've always done a very diligent budgeting process, and we've gone through that this year. We looked at our current cash on hand. And as I mentioned, we took advantage of a much more favorable market in the 2021, early 2022 time period, raised a good amount of money on very, very attractive terms. No discounts, no warrants that were done at the market, which we were very pleased with.

And the -- so we did a projection based upon the programs that we have in place, the OVATION 1 -- I'm sorry, the OVATION 2 program along with the second Phase I/II program with IMNN-001 with Avastin, which is going to be funded majority by a research foundation. We had to make certain decisions as it related to any other programs relative to that product, the combination with checkpoint inhibitors. And I think a lot of companies were going through the same sort of prioritization program.

So the OVATION 2 program, interim data reporting out in the third quarter of 2023 and then final top line data in the first half of 2024. We'll get some data on the Break Through Cancer program with the Avastin program with Phase I results.

I think the really important milestone coming up is the human data that we're looking to generate on the PLACCINE program with regard to the COVID vaccine. That program, as you know, will run very, very quickly from the standpoint of enrollment recruitment and getting some good data, which we hope will confirm what we saw in both the preclinical models and the nonhuman primate data.

And we always remain sort of opportunistic as it relates to financing. We've been in discussions with a number of different institutional research groups, government agencies on ways to move the programs forward in a nondilutive fashion. Those tend to take a little bit longer time. But I think we have a very, very good technology that's generated a lot of interest among individuals that are in this vaccine field.

That's great. And just a follow-up on the partnering comments from a moment ago. Are you at a point where you're exchanging CDAs and you have a data room set up, and people are taking a close look? Or are you at a point of introductory discussions and holding off on more intensive steps in the process until you have more data generated, more proof of concept in place?

Yes, Kemp. So yes, we have had some discussion on the CDAs already, yes. But as Jeff just reminded us, the key important milestone for the PLACCINE modality is the human data. So that's -- we're eagerly waiting for that.

And this concludes our question-and-answer session. I would like to turn the conference back over to Dr. Le Goff for closing remarks. Please go ahead.

So thank you all for your time this morning. I trust we conveyed our excitement about the potential of our platform technology. We look forward to keeping you in front of our progress.

Note that we plan to hold several days of one-on-one virtual meetings with the investment community next month. So please contact our IR firm, LHA, if you'd like to schedule a meeting. Have a very nice afternoon. Thank you.

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