Q4 2022 Imunon Inc Earnings Call
Speaker 1: The.
Speaker 2: Good morning. My name is Marlise and I will be your operator today.
Speaker 2: At this time, I would like to welcome you to Imunon's fourth quarter 2022 Financial Results Conference call.
Speaker 2: All lines have been placed on mute to prevent any background noise.
Speaker 2: Following the speaker's prepared remarks, there will be a question and answer session.
Speaker 2: At that time, you may press star 1 on your phone to ask a question.
Speaker 2: Please keep in mind, if you are using a speakerphone, you must release your mute function to allow the signal to reach our equipment.
Speaker 2: Again, that's star 1 to ask a question during the Q&A session.
Speaker 2: I would now like to turn the call over to Kim Gallaudet.
Speaker 2: Please go ahead.
Speaker 2: Thank you and good morning everyone. This is Kim Galadez with LHA. Welcome to Inuit Ons 2022 Fourth Quarter and Full Year Financial Results and Business Update Conference Call. Music playing
Speaker 2: During today's call, management will be making forward-looking statements regarding immunons' expectations and projections about future events.
Speaker 2: In general, forward-looking statements can be identified by terminology such as expect, anticipates, believes, or other similar expressions.
Speaker 2: 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.
Speaker 2: 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 30th, 2023. Immunon undertakes no obligation to revise or update comments made during this call.
Speaker 2: except as required by law.
Speaker 2: With that said, I would like to turn the call over to Dr. Corinne Legoff, Immune Arms President and Chief Executive Officer. Corinne?
Speaker 3: Thank you Kim and good morning everyone.
Speaker 3: Joining me today is Jeffrey Church, our Chief Financial Officer. In addition, Dr. Kirshi Denver, our Chief Science Officer, will be available during the Q&A session at the end of today's formal presentation.
Speaker 3: Today, I will provide an update on our development programs with Placine, our prophylactic vaccine modality, and with IMNN-001, which was previously known as Gen 1, or Interleukin-12, or IL-12, immunotherapy for the treatment of advanced ovarian cancer.
Speaker 3: But before I dive into our various ongoing programs, I want to remind investors of some important strategic points conveyed earlier this month in my letter to shareholders.
Speaker 3: Immunone is strictly focused on harvesting the power of the immune system by developing novel DNA-based approaches in immuno-oncologies and infectious diseases.
Speaker 3: We believe that non-viral DNA will be a key driver of the future of global medicine.
Speaker 3: Non-pyroDNA has the potential to create an unprecedented abundance and diversity of medicines.
Speaker 3: that are currently beyond the reach of recombinant protein technology.
Speaker 3: Our proprietary platform does not require a device or a virus for facilitating the DNA delivery.
Speaker 3: In addition, our medicines can be easily redosed, manufacturing is straightforward and scalable, and the administration to patients does not require painful electroporation.
Speaker 3: Our strategy
Speaker 3: is designed to deliver on the full scope of the non-biral DNA opportunity over the long term.
Speaker 3: Reaching patients with DNA medicines.
Speaker 3: requires us to make several clear choices, including how much capital we devote to platforms and modality development, drug development and infrastructure.
Speaker 3: 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.
Speaker 3: whether we advance programs alone or with strategic collaborators.
Speaker 3: and which capabilities we build internally versus outsourced.
Speaker 3: To navigate these choices,
Speaker 3: we establish four strategic principles that guide our approach to creating long-term value for patients and investors.
Speaker 3: First is our focus on immuno-oncology as an asset development opportunity.
Speaker 3: Our strategy is to pursue indications characterized by high disease burden and substantive...
Speaker 3: unmet medical need where an immunological approach can improve both the risk of progression and survival compared with current standard of care.
Speaker 3: You are aware of our first modality which is Teraplas?
Speaker 3: for the expression in situ of immunomodulating cytokines. We currently are in a phase two study in advanced civilian cancer with our IELTS website.
Speaker 3: IL-12 potently stimulates both natural kill cells in the innate immune system.
Speaker 3: and CDAT cells in the adaptive immune system.
Speaker 3: and therefore potentially offers a powerful therapeutic agent with a good safety profile.
Speaker 3: This program is a clear example of how Imminon is pushing the boundaries of innovation in a difficult to treat tumor type.
Speaker 3: We are now developing a second modality for the development of personalized neo-antigen cancer vaccines.
Speaker 3: This human model is based on antigen selection and optimization, along with the option to include a potent immune modifier on a single nucleic acid vector.
Speaker 3: may represent a promising strategy to induce a specific and low-lasting immune response against tumor antigens.
Speaker 3: It is a logical extension of our prophylactic vaccine modality.
Speaker 3: We just started a program in a melanoma model in mice and we will keep you updated on our progress.
Speaker 3: Developing our prophylactic vaccines modality, Placin, as an outlicensing and partnership opportunity is the second prong to our business strategy.
Speaker 3: As confirmed at the FDA's Vaccines and Related Biological Products Advisory Committee meeting, the VF-PAG meeting at the end of January .
Speaker 3: The need for new vaccine technologies is urgent.
Speaker 3: Since 1980, more than 80 pathogenic viruses have been discovered, yet fewer than 4% have commercially available, prophylactic vaccine.
Speaker 3: Before COVID, the global market for prophylactic vaccines was about $35 billion.
Speaker 3: which was roughly shared between Sanofi, Merck, GSK and Pfizer.
Speaker 3: 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.
Speaker 3: The plastic modality has several characteristics.
Speaker 3: that may address the shortcomings of current nucleic acid, attenuated virus and protein subunit vaccines.
Speaker 3: For example, Placin is engineered to be easily modified to create vaccines against a multitude of infectious diseases.
Speaker 3: with benefits that include durability and breath protection, transmission advantage, safety and convenience, flexible manufacturing and stability at standard refrigerated temperatures.
Speaker 3: These attributes are all sought by various global health authorities.
Speaker 3: and the efficiency of a plug-and-play strategy is very valuable against emerging passage jets.
Speaker 3: Our objective is to establish the safety and efficacy of our platform in a phase one human study and then seek to out-license this powerful technology and or to establish non-dilutive partnerships to develop vaccines for pathogens of interest. We have held productive discussions with the Biomedical Advanced Research and the Biomedical Advanced Research Center and the Biomedical Advanced Research Center.
Speaker 3: There was a clear reaction that Imminon has made real progress making DNA vaccines more effective, and in the words of one of the participants, more appealing.
Speaker 3: Our third strategic principle focuses on the vertical integration of the core elements of our business.
Speaker 3: As a small company, E-minon must be nimble and thoughtful in deploying capital, investing just enough in building and integrating our operations to bring portfolio products to licensing and fiction points.
Speaker 3: Our goal is to attract the interest of corporate partners while minimizing dependencies and dependence on vendors so that we control costs.
Speaker 3: the interests of corporate partners while minimizing dependencies and dependence on vendors so that we control costs, timelines.
Speaker 3: and quality. Our range of capabilities is impressive. For example, scientists can select any protein from the human or pathogen proteomes to be engineered. We have R&D laboratory testing capability.
Speaker 3: to support product and method 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.
Speaker 3: to conduct testing and to run experiments in a variety of animal disease models.
Speaker 3: We also have developed in-house pilot scale manufacturing capabilities for DNA plasmids and nanoparticle facilitating systems.
Speaker 3: To date, this has resulted in the production and testing of more than 60 vectors to support our vaccine and immunology programs.
Speaker 3: and the quality of the products we've produced has been excellent.
Speaker 3: The next step in our vertical integration strategy is to build upon our pilot scale manufacturing capabilities to produce phase 1 GMP materials. This includes the fermentation and purification of the plasmid DNA, as well as the production of our facilitating systems.
Speaker 3: This would allow Emunon to control all aspects of product design, testing and manufacturing. Complete bench to bedside capability.
Speaker 3: In areas that do not need to be integrated, our fourth quarter of strategic investment in trans-zooming technologies.
Speaker 3: 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.
Speaker 3: Implementing this thoughtful vertical integration strategy and expanding immuno capabilities in-house presents many benefits. We notably managed to reduce our costs and timeline by more than 75% and we are creating a reliable, high quality and predictable supply chain.
Speaker 3: Finally, our fourth pillar, which is the bedrock of our long-term business model, focuses on strategic collaborations.
Speaker 3: Joining forces with partners is a great way to expand our capabilities, accelerate the development of our programmes and obtain non-dilutive funding to execute our strategy.
Speaker 3: To that end, we formed several important collaborations in recent months.
Speaker 3: We signed our first collaborative research agreement with the WISTA Institute to develop new vaccine formulations for infectious diseases using R-placin modality.
Speaker 3: WISTR is a global leader in biomedical research and our agreement is with their vaccine in an immunotherapy center.
Speaker 3: We also signed an agreement with the biotechnology company Acuidas Therapeutics, which is focused on developing delivery systems for nucleic acid vaccines and therapeutics based on lipid nanoparticles.
Speaker 3: Under this agreement, we will explore the expansion of our technology with a broad spectrum of formulation capabilities as we position our nucleic acid base modality as the future for Graham- miner for our community at this time.
Speaker 3: We also formed an alliance with the Brexford Cancer Foundation that allows us to obtain non-dilutive funding to initiate new innovative clinical programs in niche indications like ovarian cancer.
Speaker 3: I trust that these four 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.
Speaker 3: Let me now switch gears and give you an update on the progress of our current development programs.
Speaker 3: I am pleased to report that Imunon made significant progress during 2022. With IMLN001, we reached full enrollment of 110 patients in a Phase 1 tooth study in women with advanced ovarian cancer, the Ovation 2 study.
Speaker 3: Last year, we also reported data from 46 patients in the IMNN001 treatment arm who had undergone interval debulking surgery.
Speaker 3: The data showed an improvement in R0's surgical resection rates.
Speaker 3: and CRS3 chemotherapy response scores over 41 patients in the control R.
Speaker 3: We expect to report an additional set of interim more mature data in the second half of 2023 and top-line results by mid-2024.
Speaker 3: As I mentioned earlier,
Speaker 3: We recently announced a collaboration with Breakthrough Cancer to evaluate IMN-001 in a phase 1-2 clinical trial in combination with Bevacizumab or Avastin in ovarian cancer in the frontline neoadjuvant setting.
Speaker 3: Note that breakthrough cancer will be converting 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 women with ovarian cancer.
Speaker 3: 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 Sydney-Kimmel Cancer Centre at John Hopkins, Dana-Farber Cancer Institute and Memorial Floten Catering.
Speaker 3: The Co-Institute for Integrative Cancer Research at MIT will provide artificial intelligence services throughout the trial, including biomarkers and genomic analysis.
Speaker 3: And this will expand our knowledge of the treatment paradigm.
Speaker 3: Turning to our recent progress in developing our prophylactic vaccine model, TIP, Placim continues to be extremely robust and holds extraordinary potential to address an array of pathogens.
Speaker 3: In a COVID-19 model, our non-human primate work showed excellent immunological response and viral clearance.
Speaker 3: We also demonstrated in a mouse study that a single dose of placenta vaccine without a booster dose produced longer duration of IgG responses and higher T cell activation than an mRNA vaccine.
Speaker 3: We are now 10 months into a 12-month Placine stability study and have demonstrated continued product stability at standard refrigerated temperature, representing the significant commercial advantage over mRNA-based vaccines.
Speaker 3: With respect to durability, we look forward to reporting data later this year comparing the durability of Placin to mRNA vaccines.
Speaker 3: We also generated strong humoral and cellular immunological responses with other pathogens like monkeypox and influenza. So we now have fully characterized our modality pre-kneically. Our next step is to continue to derive the classic modality in a phase 1 human...
Speaker 3: According to our timelines, we are planning to start enrolling patients in the trial at the end of the year.
Speaker 3: In parallel, we have been presenting our pre-clinical data at important vaccine conferences around the globe and are delighted with the reception our work has received.
Speaker 3: It is important to receive validation for our work from scientific colleagues and the large pharma companies they represent.
Speaker 3: So I've used the term vaccine of the future, and that is exactly what our vision is, to be the provider of safe and effective vaccines of the future that are superior to current vaccines in durability and breathable protection, stability at workable temperatures, rapidity in manufacturing to respond to evolving pathogens.
Speaker 3: and have better compliance for mass immunization by not requiring the device or virus.
Speaker 3: Before I turn the call over to Jeff Church for his review of our financial position,
Speaker 3: I want to impress upon you that our long-term vision calls for the creation of a new category of medicine.
Speaker 3: based on our non-biome plasmid DNA technology across a broad array of human diseases.
Speaker 3: We are studying in immuno-oncology and infectious diseases.
Speaker 3: and we will continue to invest to fully characterize the platform and to advance the technological frontier of plant-speed DNA.
Speaker 4: Now, I will turn the call over to Jeff. Thank you, Corinne. Details of Inmenon'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.
Speaker 4: Emanon 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.
Speaker 4: 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.
Speaker 4: 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 biotechnology companies.
Speaker 4: That said, the longer term growth plans include raising funds from both equity and non-dilutive sources of capital, including the collaborations and partnerships Corinne just mentioned.
Speaker 4: 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...
Speaker 4: 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 companies at the market equity facility in the fourth quarter of 2022.
Speaker 4: of approximately half a million dollars. Let me now turn to our financial results. For 2022, Ammonon 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.
Speaker 4: 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 R&D costs associated with the development of plastic
Speaker 4: for 2022 compared to a million dollars 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.
Speaker 4: 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's secession plan, which we announced earlier this year.
Speaker 4: million in the previous 2021 period. This increase was attributed to five 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.
Speaker 4: 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 non-cash gain of $5.4 million during the fourth quarter of 2022.
Speaker 4: 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.
Speaker 4: In connection with these two loans, the company incurred $500,000 in interest expense in 2022 compared to $600,000 in the prior year. Our loan with Silicon Valley Bank has now been assumed by First Citizens Bank under the same terms.
Speaker 4: Fourth, in 2022, the company incurred additional interest expense attributable to a one-time 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.
Speaker 4: This unique transaction was necessary to increase the number of authorized shares and affect the reverse stock split which we announced in the first quarter of 2022. Lastly, investment income from the company's short-term investments were half a million dollars in the current year. This increase was the result of improved returns on our short-term investments.
Speaker 4: 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 Placene modality. I will now turn the call back over to Corinne.
Speaker 3: Thanks Jeff. We believe that innovative new technologies are distributed in companies like Immunon. Just think about what BioNTech and Modena have accomplished.
Speaker 3: And we believe that we are well positioned to develop new non-viral DNA-based approaches in immuno-oncology, cancer vaccines and infectious disease prophylactic vaccines.
Speaker 3: We will leave large late-stage clinical trials to partners with the resources to contact them, and we will view each program with an eye toward a licensing transaction.
Speaker 3: In doing so, we will also expect to create great value for shareholders.
Speaker 3: So with that overview of our business and our recent financial results, we are ready to open the call to your questions. Operator? No standing ovation.
Speaker 5: Thank you. We will now begin the question and answer session. To ask a question, you may press start and 1 on your touch tone phone. If you're using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to ask a question, please
Speaker 5: from Emily Bodnar from HC Wainwright.
Speaker 5: Emily, please go ahead.
Speaker 6: Hi there, good morning and thanks for taking the questions. I have two 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 utilizing antibodies and viral clearance with the high...
Speaker 6: and have you initiated any preclinical studies on those variants or do you think the preclinical data you have on the other variants would be sufficient to go into phase one? Thank you.
Speaker 7: Thank you very much, Emily, for the questions. I will ask Karshid to address those questions, please. Karshid? Sure. Sure. Thank you, Corinne, and thanks, Emily, for your questions.
Speaker 8: Yes, regarding those response, we have reported from our non-human primate study, we have seen neutralizing antibody responses at 0.5 milligrams, 1 milligram, 2 milligram, and 5 milligram doses. There was slight improvement over dose, but essentially 1 milligram, 2 milligram were found.
Speaker 8: were comparable to five. So based on that dose response in non-human primates, where we have done one, two, and five milligrams fairly comparable, we are proposing to go one level lower as a starting dose in human, 0.5 mg, and then we'll do one mg and two mg.
Speaker 8: Those are the three doses. We'll start off in phase one study and we'll do either single injection, initially single injection in phase one part of the study, demonstrate safety and pick a dose based on safety and immunicity, whether it's 0.5, one or two milligrams.
Speaker 8: and then expand that cohort to larger number of patients.
Speaker 8: Also we will do a booster dose as well. Once the safety and immunicity is confirmed from one of the three 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 two-dose study.
Speaker 8: So, that's the bill of response question. I know you have a question about new variants as well. I'll go into that, but let's.
Speaker 8: Let me stop here and see your door response question if it was addressed amicably. Yes, that's very helpful. Thank you. 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.
Speaker 8: you know, you just keep getting new variants. So yes, a lot of our database has been with.
Speaker 8: B614, do 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…
Speaker 8: a construct we have made with that strain or that variant in combination with a conserved antigen, the vector successfully expressed in vitro with comparable amount of both proteins in vitro and then mRNA levels.
Speaker 8: And now the immunogenicity studies in mice are ongoing. We hope to have some results by next month to show IgG neutralizing 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 one study. We have submitted a pre-R&D document.
Speaker 8: recently proposing this strained per FDA guidelines as their January 26th meeting. So yes, indeed, we do have new variants data now.
Speaker 9: Okay, great. Thank you. That's very helpful.
Speaker 9: Okay, great. Thank you. That's very helpful. Thank you, Emily.
Speaker 5: We now have a question from James Malloy from Alliance Global Partners. James, please go ahead. We have a question from James Malloy from Alliance Global Partners.
Speaker 8: Hey guys, thank you very much for taking my questions. I was wondering with, you mentioned we're looking for some interim data here in the Ovation II study at the end of 2023. I was wondering if you could give us an idea of what we should be looking for in that interim data and what are you guys looking to see out of that study?
Speaker 8: And then on the combo Gen 1 and Avastin plus neoadjuvant chemotherapy study, phase 1-2, 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 Abdevo potentially in 2023 in this patient population as well? Thank you very much, Jim.
Speaker 3: 50% of the events, so very immature data. For the next data cut, we will wait until we reach about 75% of the events. It is, as you know, since it's an open study, event-driven sound stimulus.
Speaker 3: 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 probably our first question.
Speaker 3: Regarding the new Phase 1-2 program in collaboration with Brecht program, so the combination study with the Vembasizumab, we are anticipating the start of this study in the coming weeks. MD Anderson is the first site to recruit in this trial.
Speaker 3: and the site is open for equipment. We anticipate the 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 those in the combination with the phase II portion.
Speaker 3: 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, pre-councally, that the combination trial with the Vibasizumab could be potentially extremely interesting. Our pre-clinical data showed very strong synergistic.
Speaker 8: Certainly a lot of news about the Silicon Valley Bank, you guys addressed your issues with it. The same day that happened, you know, Pfizer picked up C-Gen for $40 billion. Is there, how would you characterize the market for potential partnerships currently? Your stock along with many, certainly at very depressed levels, more than it perhaps should be.
Speaker 8: How has that changed the potential partnering environment currently?
Speaker 3: 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 BioEurope and...
Speaker 3: I have to say that there are still 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.
Speaker 3: biffiizer oxgen.
Speaker 3: Um, uh, you know, it's, it's.
Speaker 3: It's certainly a very good, accretive deal for Spiter. But what I can say is that we, of course, as soon as we can obtain proof of concept data in humans for plastic models...
Speaker 3: you know 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 you know what we are doing and we've been talking already with with a number of companies so you know we we know that we are on the writer screen as well
Speaker 3: So that's for business development opportunities with the public school companies, people small. But as I mentioned, we are also looking at partnering with institutions as we've talked about our WISTR Institute agreement, I talked about our Breakthrough Cancer Foundation agreement.
Speaker 3: And we are looking, especially in the area of infectious disease, at 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.
Speaker 3: And I can tell you that all regulators are looking at the next technology as well. So I feel very reassured with the latest discussions we've had with those organizations. Our technology is not right for partnerships right now. As I mentioned, we definitely need to have those human data.
Speaker 5: from Brookline Capital Markets. Camp, please go ahead.
Speaker 8: Thank you and good morning. I want to dig into the cash runway assumptions in the context of...
Speaker 10: programs that will complete. And in that bucket I'm really thinking specifically of Placene. And then also there was reference to milestones. Want to clarify if there's any assumption with regard to proceeds from non-dilutive transactions.
Speaker 4: in the cash runway guidance. Thank you. Thank you, Kim. I suggest 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've been looking at the current cash on hand.
Speaker 4: 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-
Speaker 4: the second Phase 1-2 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.
Speaker 4: 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 Evasion II program interim data reporting out in third quarter of 2023.
Speaker 4: and then final top line data in the first half of 2024. We'll get some data on the breakthrough cancer program with the Avastin program with phase one results.
Speaker 4: I think the really important milestone coming up is the human data that we're looking to generate on the Placene 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 state.
Speaker 4: on ways to move the programs forward in a non-dilutive 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.
Speaker 10: That's great. Thank you. And just to follow up on the partnering comments from a moment ago, are you at a point where...
Speaker 10: you're exchanging CDAs and you have data have a data room set up and people are taking a close look or are you at a point of introductory discussions and
Speaker 10: holding off on more intensive steps in the process until you have more data generated, more proof of concept in place.
Speaker 3: Yes, we have had some discussion on the CDAs already. But as Jeff just reminded us, the key important milestone for the Placae modality is the human data. So we're eagerly waiting for that.TRANSMIT
Speaker 10: Thank you very much.
Speaker 5: And this concludes our question and answer session. I would like to turn the conference back over to Dr. LeGoff for closing remarks.
Speaker 3: 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 informed of our progress. Note that we plan to hold several days of one-on-one virtual meetings with the investment community next month.