Imunon Inc. Q1 2023 Earnings Call
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Speaker 4: Good morning and welcome to the IMMUNON first quarter 2023 financial results conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero.
Speaker 5: After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then 1 on your telephone keypad. To withdraw your question, please press star then 2.
Speaker 6: Please note, this event is being recorded.
Speaker 7: I would now like to turn the conference over to Kim Golodets. Please go ahead.
Speaker 8: Thank you and good morning everyone. This is Kim Golodets with LHA. Welcome to Immunon's 2023 first quarter financial results and business update conference call. During today's call management will be making forward-looking statements regarding Immunon's expectations and projections about future events.
Speaker 9: In general, forward-looking statements can be identified by words such as expect, anticipate, believe, or other similar expressions.
Speaker 10: 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 11: No forward-looking statements can be guaranteed, and actual results may differ materially from such statements.
Speaker 12: I also caution that the content of this conference call is accurate only as of the date of the live broadcast, May 11, 2023. Immunon undertapes no obligation to revise or update comments made during this call, except as required by law.
Speaker 13: With that said, I would like to turn the call over to Dr. Corinne Lagoff, Imminon's President and Chief Executive Officer. Corinne?
Speaker 14: Thank you, Kim, and good morning everyone.
Speaker 15: Joining me today is Jeffrey Church, our Chief Financial Officer. In addition, Dr. Kirshid Enver, our Chief Scientific Officer, will be available during the Q&A session at the end of our prepared remarks.
Speaker 16: Today, I will provide an update on our development programs with Placide, our prophylactic vaccine modality and with IMNN-001, which was previously known as Gen1.
Speaker 17: which is our interleukin-12 immunotherapy for the treatment of advanced ovarian cancer.
Speaker 18: During our last conference call in March, I reminded investors of our key strategies in some detail.
Speaker 19: I'll do so again briefly today.
Speaker 20: because I believe it is important for investors to understand where we are going as a company and our vision for the future.
Speaker 21: Then I'll provide an update on our various programs.
Speaker 22: Immunon is tightly focused on harnessing the power of the immune system by developing novel DNA-based approaches in immuno-oncology and infectious diseases.
Speaker 23: We believe that non-viral DNA will be a key driver of the future of global medicine.
Speaker 24: I say that because non-viral DNA has the potential to help create an unprecedented abundance and diversity of medicines that are currently beyond the reach of recovered and protein technology.
Speaker 25: Our platform does not require a device or a virus for facilitating DNA delivery.
Speaker 26: In addition, our medicines can be easily redosed.
Speaker 27: 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 non-viral DNA opportunity over the long term.
Speaker 28: Reaching patients with DNA medicines requires us to make
Speaker 29: patients with DNA medicines requires us to make several clear choices.
Speaker 30: including how much capital we devote to platform and modality development, drug development, and infrastructure.
Speaker 31: which programs with events and how, whether we advance programs alone or with strategic collaborators, and which capabilities do we build internally, and which do we outsource? To navigate these choices, we establish four strategic principles that guide our approach to creating value for patients and investors.
Speaker 32: First is our focus on immuno-oncology as an asset development opportunity.
Our strategy is to pursue indications characterized by a high disease burden and substantive unmet medical need where an immunological approach can improve both the risk of progression and survival compared with the current standard of care.
MNN001 is an example of one such asset.
system developed for more thorough plus good quality for the expression of proteins and cytokines.
There was a one-expressive IL-12. IL-12, as you know, is a cytokine that potentially stimulates both natural killer cells in the innate immune system and CBAT cells in the adaptive immune system.
those are one expresses IL-12. IL-12, as you know, is a cytokine that potentially stimulates both natural killer cells in the innate immune system and CDAT cells in the adaptive immune system. The in-situ expression of IL-12.
activates tumor suppressing immune response with a good safety profile. G001 is currently in a phase 2 study in advanced ovarian cancer. This program is a clear example of how Imminon 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 neo-antigen cancer vaccines.
This new modality is based on antigen selection and optimization, along with the option to include a potent immune modifier on a single nucleic acid vector.
It represents a promising strategy to induce a specific and long-lasting immune response against humanity genes.
It also is a logical extension of our prophylactic vaccine modality.
and we will keep you updated on our progress. Developing our Placin for Phylectic Vaccines Modality as an out licensing and publisher opportunity is the second prong to our business strategy. As I described last quarter, the need for new vaccine technologies is urgent, with fewer than 5% of pathogens having a commercially available vaccine. And we do discover new pathogens viruses every day. More than 80 pathogenic viruses were discovered since the 1980s.
So clearly, the market for vaccines is enormous. Even before COVID, the global market for prophylactic vaccines was about $35 billion, and it's expected to reach $125 billion in 2028. The reason we are so excited about the plastic
a multitude of infectious diseases with benefits that include durability and breath of protection.
Transmission advantage, safety and convenience.
Flexible manufacturing and stability are standard refrigerated temperatures. These attributes are all sought by various global health authorities. And the efficiency of a plug-and-press strategy is extremely valuable against emerging pathogens.
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-dilative partnerships to develop vaccines for pathogens of interest. We've had productive conversations.
and we will continue to have conversations with various government agencies to ensure we are pursuing the most urgent and important pathogens. We are delighted with the reaction we have received from these agencies regarding our progress in making DNA vaccines more effective and more appealing
continue to have conversations with various government agencies to ensure we are pursuing the most urgent and important pathogens. We are delighted with the reaction we have received from these agencies regarding our progress in making DNA vaccines more effective and more appealing. Our third
strategic principle. Focus is on the vertical integration of the co-elements of our business. Our goal here is to attract the interest of corporate partners.
while minimizing dependence on vendors so that we can 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 method development. We have TMPQC 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 the variety of animal disease models. We also have developed in-house pilot-scale manufacturing capabilities.
for their replacement and nanoparticle facilitating systems.
The next step in our vertical integration strategy is to build upon our pilot-scale capabilities to produce phase 1GMP materials to allow Immunon to control all aspects of product design, testing and manufacturing, meaning a complete bench to bedside capability.
In addition, owing to our strategic investment in transomic technologies, we are now able to construct vaccines against new variants in just weeks using a comprehensive array of CRISPR, RNA, and DIN expression tools and services.
Our vertical integration strategy has allowed us to reduce costs and timelines by more than 75 percent while trading a reliable, high-quality and predictable supply chain. Lastly, our fourth pillar, which is the bedrock of our long-term business model.
concerns strategic collaborations. Joining forces with partners is a great way to expand our capabilities, accelerate the development of our programs, and obtain non-duty funding to execute our strategy.
All these internal capabilities will allow us to control both the costs and development timelines in support of our goal to attract corporate partners. To that end, we have formed
several important collaborations in recent months.
In January we signed off first collaborative research agreement with the WISTO Institute to develop new vaccine formulations for infectious diseases using our plastic modality.
WISTER is a global leader in biomedical research, and our agreement is with their vaccine and immunotherapy center.
This builds upon our collaboration with the Biotechnology Company, Acreta's FairPulix, which is focused on developing delivery systems for nucleic acid vaccines and therapeutics based on lipid nanoparticles.
an agreement we entered into in November 2022. We also formed an alliance with the Breakthrough Cancer Foundation that allows us to obtain non-dilutive funding to initiate new innovative clinical programs in each indication, like ovarian cancer. We expect the first patient to be enrolled in a few weeks in a 50-patient...
intensive cancer center at Johns Hopkins.
and at Memorial Sloat-Kettering Cancer Center. The Core Institute for Integrative Cancer Research at the MIT, Massachusetts Institute of Technology, will provide Artificial Intelligence Services
actually funding the study. We were delighted that our work was presented at several important conferences during the first quarter.
We presented very promising preclinical data for placenta modality at the Vaccine Technology Summit 2023.
Dr. Karshid Anver, our Chief Scientific Officer, reviewed the company's work in advancing our passing modality and the promising preclinical data generated to date.
Among the topics presented was the ability of this multivalent technology to achieve broad spectrum immunity from a single DNA plasmid with a synthetic delivery system.
This ability is independent of virus, device, or liquid nanoparticle formulations. The preclinical data presented tick the box on many desirable features that would characterize the next generation vaccines. robust immunogenicity and protection.
in SARS-CoV-2 models, comparable protection activity to a commercial mRNA vaccine and a booster dose comparison.
Durable cellular and neural responses detectable for more than 12 months. I want to point out that such a robust cellular response that goes out past a year is an important advantage. I want to point out that such a robust cellular response that goes out past a year is an important advantage. I want to point out that such a robust cellular response that goes out past a year is an important advantage.
We have demonstrated that our vaccine creates memory cells that provide an additional layer of protective immunity and contributes to protection against severe disease. And lastly, superior immune quality versus the mRNA vaccine in a single-dose comparison.
In addition, the Plessin modality had important distinguishing advantages for commercial vaccine, including a shelf life at 4 degrees, for greater than 9 moles, and the ability for simple, reddit, and scalable manufacturing.
Based on this compelling data, in March we applied for a pre-I&D consultation with the US FDA to receive guidance on our proposed program for our seasonal COVID-19 booster vaccine.
We expect to submit an IND application in the fourth quarter of this year.
Again, our objective is to establish the safety and efficacy of our platform in a phase 1 human study and then seek to license this powerful technology to pharmaceutical companies for the utilization of our platform and or to establish non-dilutive partnerships to develop vaccines for pathogens of interest.
Subsequent to the end of the first quarter in April , Dr. Jean Boyer, immunos vice presidents of pre-clinical research,
presented a poster at the prestigious American Association for Cancer Research, ACR, conference. Dr. Boyer reported that IMA-001 demonstrated stimulation of the immune response in the ID8 ovarian tumor model.
Of the three dosing regimens tested, the once every two-week regimen demonstrated comparability to the weekly regimen while showing superiority to the one soup.
every three weeks regimen, particularly with respect to motility and tumor burden.
Thus, exploring once every two week doses of 001 in human studies is warranted.
It is an important step in developing the least cumbersome and best cancer treatment regimen to improve patient acceptability and compliance.
Before I turn the call over to Jeff Church for his financial review, I want to outline several value-creating milestones we expect over the next 6 to 18 months.
Building upon our compelling interim results with our phase I, II, Ovation II study in stage III, IV ovarian cancer, which reached full enrollment of 110 patients last year.
We expect to report an additional set of interim more material data in the second half of 2023.
And then we expect to report top-line results by mid-2024. As a reminder, interim data for this study reported a year ago showed that in 46 patients who had undergone interval debulking surgery, those treated with 001 in combination with chemotherapy standard of care.
showed an improvement in R0 surgical resection rates and CRS3 chemotherapy response goals compared with the 41 patients in the control arm.
Also in the second half of this year, we expect to file the IND for SARS-CoV-2 vaccine and announce proof of concept vaccine data for next pathogen. Moving to the first half of 2024, we'll be sharing press-1 results for SARS-CoV-2 study and interim results for the combination.
10Q, which we filed today before the market opened. Immunon ended the first quarter of 2023 with $37.3 million in cash and investments. Cash provided by financing activities of $2.5 million during the quarter was from an equity sales under at the market equity facility.
We also received net proceeds of $1.6 million during the quarter from the sale of our 2021 New Jersey net operating losses, which leaves us with about $1.9 million remaining of these NOLs to sell later this year.
Including these future planned NOL sales, the company believes it has sufficient capital to fund its operation into 2025, which will take us through several important value-creating milestones. The comments I delivered about the public equity markets during our fourth quarter conference call in late March are still relevant.
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 biotechs.
That said, our long-term growth plans do include raising funds from both equity and non-dilutive sources of capital, including the collaboration and partnerships Corinne mentioned earlier in this call. We continue to monitor the public equity markets with the hope that markets will begin to improve shortly. During the first quarter of 2023, the
We use $4.1 million in cash to fund operation. This compares with $8 million in last year's first quarter. This decrease in the use of funds was primarily due to the one-time payment in the prior year quarter of $4.5 million in interest and offering expenses.
resulting from the sale and subsequent redemption of $30 million of convertible redeemable preferred stock.
Let me now turn to our financial results. For the first quarter of 2023, Immunon reported a net loss of $5.6 million, or 68 cents per share. This compares with a net loss for the first quarter of 2022 of $10.5 million, or $1.82 per share.
Operating expenses were $5.7 million in the first quarter of 2023, which is down 5% from the $6 million in the first quarter of 2022. Breaking expenses down by line item, research and development expenses were $2.6 million in the first quarter of 2021.
million dollars in the first quarter of 2023, a decrease of a half a million dollars from the 3.1 million from the prior year's first quarter. More specifically, R&D costs associated with the development of the Placene DNA vaccine technology platform, as well as the Evasion 2 study, decreased slightly to 1.7 million dollars compared to 1.9 million in the year ago.
manufacturing capabilities for DNA plasmids and nanoparticle delivery systems. General administrative expenses were $3.1 million in the first quarter of 2023, which compared to $2.9 million in the comparable prior year period.
This increase is primarily attributed to lower non-cash stock compensation expense offset by higher professional fees, including legal fees to defend various lawsuits filed after the announcement in July 2022 of the Optima Phase 3 study results.
compared to other non-operating expenses of $4.6 million in the prior year period.
In the first quarter of 2022, the company incurred one time charges $4.5 million, which I had mentioned related to the preferred stock offering that I talked about earlier. In addition, the company incurred higher interest expense on its loan facility with Silicon Valley Bank in the first quarter due to rising interest rates. This loan facility
end of term payments. The $6 million collateral account, which we had classified when our balance sheet as restricted cash, was released and utilized to pay off the loan.
Interest income from the company's short-term investments increased by $0.3 million in the first quarter of 2023 compared with the prior year due to higher returns on our short-term investments.
As I indicated last quarter, we continue to expect operating expenses for the year to be approximately 20 to $22 million for the full year of 2022 with the majority of expenses related to the development of our Placene next generation vaccine modality. I will now turn the call back over to Corinne.
Thanks Beth. We have been using the phrase vaccine of the future to describe our work 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 breadth of protection, stability at workable temperatures.
rapid manufacturing to respond to evolving pathogens and better compliance for mass immunization with no need for a device or a virus vector.
I am delighted with our progress in support of this vision, which calls for the creation of a new category of medicines based on our non-viral plasmid DNA technology across a broad array of human diseases.
We are studying immuno-apology and infectious diseases and we will continue to invest to fully characterize the platform and to advance the technological frontier of plasmid DNA.
We will leave large, late-phase clinical trials to partners with the resources to contact them and we will view each program with an eye toward a licensing transaction.
In doing so, we will also expect to create considerable 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.
we will also expect to create considerable 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. Connor Qu Irk Man Khan
We will now begin the question and answer session. To ask a question, you may press star then 1 on your telephone keypad.
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To withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble our roster.
Our first question is from Emily Bodnar with H.C. Wainwright. Please go ahead.
Hi there, thanks for taking the question. I'm curious if the pre-IND meeting with the FDA was scheduled already, or has that already occurred? And then maybe if you could just comment on how you think about the market opportunity for a seasonal COVID booster now that people aren't really getting vaccinated as much. I'm curious how you think about long-term use of COVID-19.
And then it sounds like based on your commentary, you could potentially initiate a phase one study in early 2024. Does that timeline sound reasonable? Thanks. Thank you, Emily, for your questions.
So, regarding the pre-IND meeting, so we sent, as I mentioned, our pre-IND package in March. We do not necessarily expect a meeting. We expect definitely a feedback from the FDA that will come this month, I believe, in May. As you know, the FDA does not grant a lot of pre-IND meetings anymore.
So that's the expectation and if everything is on schedule, then to go to your last questions, yes, we would be in the position of fighting an IND at the very end of the year, potentially starting the Phase I even this year if possible, or early next year. So that's our plan.
You are asking also about the market opportunity for seasonal booster. So yes, there is a great demand from regulators which has been expressed by the FDA early this year. You might remember that the FDA had a VR PAC meeting.
four to six months. And the process they propose is that in June , they would select the strain to be put into manufacturing for the vaccines, the boosters, to be available for the fall and winter season.
the current commercial vaccines. And you can imagine that specifically in certain population of patients, namely the elderly population or the patients that are immunocompromised for some reason.
in the same way as the flu vaccine, a COVID vaccine will be necessary. I want to point out as well that, as I mentioned, the fact that we are looking at developing a vaccine that would demonstrate good cellular immunity would be a plus in this population of patients.
Again, if you have a question, please press star then 1.
The next question is from James Malloy with Alliance Global Partners. Please go ahead.
Hi Dr. O'Gough, thank you for taking my question.
Hi Dr. O'Gough, thank you for taking my question. My question is on the final question. Fourth quarter next.
Is that a little delight from where it had been previously? Tim, you're breaking up. I don't know if my colleagues could hear you better. Yes. Do you mind?
I apologize, I'm on a cell phone. Can you hear me okay? No, I can. Yes. Thank you. On the plasticine development, the IND filing fourth quarter of this year, is that on track or is that been delayed a little bit from previous?
It is on track. It is.
It is on track. It is.
And then when we're looking at the top line data coming out mid next year, how do you help us handicap, you know, whether the equivocal data, good data or bad data, and what do you anticipate seeing coming out mid next year? So, regarding the top line data for our Vision II program, we have a lot of data that's
You know, we'll see the results that we get. As you might remember, Jim, that we showed early cut of data that we did back in September . So again, it was very mature data because we only had 50% of the events, an event being a patient progressing.
But what we showed at that point in time is that we actually showed good signals in terms of R0 rates and CRS3, which is encouraging. But from those early data you cannot conclude anything really. So we'll have another cut of data this year when we reach about 17...
So we you know that we are
I think the partnership environment, I don't think that I can characterize the environment of partnerships. I can only reflect on the interest that we get on our technology. And we've had the opportunity to present our data to BARDA, for instance, in November . We've had the opportunity to present our data to IT and direct it to the Pilings Village Fatigue. The question here is, how could we not sit in a position about maybe a couple of months ago, when Dartmouth College actually Hard Undermined to introduce ourselves? This is what we started to discuss, and what problems we spark in November is. We talked about this africanption from some
for the development of the next generation of vaccines, because as I mentioned during the call, there's a number of features that are of interest in developing the future vaccine. So we see interest for sure, and the collaborative work that we have ongoing with the Worcester Institute is very productive.
I trust we conveyed our excitement about the potential for platform technologies. We look forward to keeping you informed of our progress. Have a very nice afternoon. Thank you. Thank you for having us.
The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
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