Q3 2022 Imunon Inc Earnings Call
Yes.
Please standby.
Okay.
Good morning, My name is Mar lease and I will be your operator today.
This time I would like to welcome you to immuno on stared quarter 2022 financial results conference call.
All lines have been placed on mute to prevent any background noise.
Following the speakers prepared remarks, there will be a question and answer session.
At that time, you May Press Star then one on your phone to ask a question.
Please keep in mind, if you are using a speaker phone you must release your mute function to allow the signal to reach our equipment.
Again, that's star one to ask a question during the Q&A session.
I would now like to turn the call over to Kim Gala that Investor Relations Representative. Please go ahead.
Thank you and good morning, everyone. This is Kim Collins with L. E. K welcome to immuno third quarter 2022 financial results and business update conference call.
As has been immunized practice sound as noticed as noted by the operator prepared remarks will be followed by a question and answer session.
During today's call management will be making forward looking statements regarding immuno <unk> expectations and projections about future events.
In general forward looking statements can be identified by terminology such as expects anticipates believes or other similar expressions. These statements are based on current expectations and are subject to a number of risks and uncertainties, including those set forth in the company's periodic filings with the securities and exchange.
Ange Commission.
No forward looking statements can be guaranteed and actual results may differ materially from such statements. In particular, there is significant uncertainty about the duration and impact of the COVID-19 pandemic.
This means results could change at any time and the contemplated impact of COVID-19 on immunized operations financial results and outlook is the best estimate based on the information with today's discussion.
I also caution that the content of this conference call is accurate only as of the date of the live broadcast November 14, 2020 to immunize 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 legal President and Chief Executive Officer.
Thank you Kim and good morning, everyone.
Joining me today is Jeffrey church of Chief Financial Officer.
You shouldn't Doctor Hershey, Denver, our Chief Scientific Officer, and Dr. Nicholas Borys, our Chief Medical Officer will be available during the Q&A session to answer your questions regarding our development programs with <unk>.
Electric vaccine modality and Gen. One Oh, IL 12 immunotherapy for the treatment of <unk>.
Finished ovarian cancer.
Today, I am going to spend most of my time speaking about crashing.
Our research progress in developing disability has been extraordinarily robust.
She is one of immuno DNA based platform technologies that relies on DNA delivery with novel synthetic delivery systems that are independent of viral vectors all devices.
Did it fixtures encompass molecular elements that they're all designed to improve the immune response by targeting multiple antigens, okay peso trade multiple variants of the same antigen.
You mean on has produced assembly of DNA vaccine victors expressing why don't more soft golf to surface antigens, and we have demonstrated expression of the uncoated genes.
These promising vaccine approach has brought applicability in infectious diseases and also in oncology.
We have been conducting preclinical proof of concept studies on a DNA vaccine candidate.
Targeting the soft golf to a virus in order to validate all modality.
To date, we are delighted with the results, which bodes well.
Our ability to broader applications.
Goodbye switches, but before I dive into the data I want to start by telling you why I am excited about the potential of all DNA based vaccine modality.
First the market opportunity is very large.
Vaccines are the most powerful and cost effective way to protect the health of billions of people around the world.
Before COVID-19.
The market for preventive vaccines, what about $35 billion grocery shifts between four key players Sanofi, Merck GSK and Pfizer.
The market grew to 61 billion in 2021 and is expected to reach $125 billion in 'twenty or 'twenty eight and new virus is all being discovered all the time in fact over the past 40 years 18 U S, which I think viruses have been discovered.
For leverage of two new viruses figure.
When it comes to the development of vaccines. If you consider all the viruses known to mankind from 100 years ago.
Commercial vaccines have been approved for only 4% of that sure.
So clearly there is a large addressable market, providing significant true for new technologies and that brings me to my second point.
I believe that DNA has the potential to be an entirely new class of vaccines.
In particular I'll play soon with the L. T has the potential to represent a valuable alternative to current commercial vaccines.
Cause I shouldn't technologies attenuated virus put in stipulate mrna and viral DNA vector vaccines have shortcomings that we want to address.
There are five important attributes that regulators and governments around the world work to seeing the next generation of prophylactic vaccines and we are addressing each with all technology.
The first one durability of protection.
Didn't antigen expression is small durable longer lasting than mrna and induces a robust immunological response.
Two breath of protection.
Royalty that one Victor increases the breadth of immune response and allows for combination vaccines.
Three.
This mission that advantage.
The DNA has a greater capability to induce T cell activity against infected cells.
We have the option you know fixed or four co expression of immune modifiers to further strengthen the immune response and decrease the risk of viral shedding.
Cool.
Safety and convenience.
Synthetic delivery systems present, no risk of renal toxicity. There is no virus invoked all risk of cytotoxicity.
There also is no device needed, which improves treatment compliance and makes it very convenient to handle immunization campaigns with suitability for potential pandemic control.
And five.
Flexible manufacturing, we are developing a truly versatile platform, enabling rapid response to changing messages much better stability and shelf life that mrna at workable refrigerated temperatures versus deep freeze temperatures, which simplifies handling and distribution.
The data we have generated to date is extremely encouraging.
Concept mouse immunology Immunogenicity studies.
We have demonstrated robust agg neutralizing antibody and T cell responses without placing vaccines did.
The data also demonstrated the ability of our place in vaccines to protect the soft skills to mouse model in your life I would challenge.
In this study mice were vaccinated with a placebo vaccine expressing yourself going to spike antigen from the district court in T. Valeant, the delta variant or combination vaccine expressing both variance.
Oldest vaccines were found to be safe and elicited IGT responses and inhibited viral load by 90% to 95%.
The key exciting fighting is that all bivalent vaccine was equally effective against both failures of this soft golf to virus we tested.
The Marine Muddle data also suggests that our approach provides not only flexibility, but also the potential for efficacy that is at least comparable to benchmark mrna commercial vaccines with durability of protection expected to exceed six months.
These encouraging results from the mouse studies from the basis of a nonhuman primates.
That study the partial results from this ongoing study were reported last month.
In the study were examining a single touch me DNA vector containing the susko after a spike antigen from the G. 614 G failure that is formulated with a synthetic DNA delivery system and administered by intramuscular injection.
We've exited its sign them always smokies with either the passing vaccine or a commercial mrna vaccine three times over 84 days.
I know, there's talk about samples for agg and neutralizing antibodies showed evidence of immunogenicity, both in the pricing and mrna vaccine idiots subjects.
In a head to head comparison, the protection efficacy as measured by viral clearance following challenge with a soft golf to virus was equivalent between placebo and the commercial mrna vaccine.
We look forward to the completion of this study and the final report by the end of this year.
Also of importance in an ongoing stability study there.
The future chemical properties and Immunogenicity of the pristine vaccine did not change during storage is full degree Celsius for up to six months. It is at play clear advantage of mrna vaccines with respect to transport and flexibility.
So what is next coalescing well.
Given the highly encouraging data to date and the potential for key commercial advantages over existing vaccines, we have moved to broaden and strengthen the platform and we entered into an agreement with accretive therapeutics to evaluate openness cynically you guys hit constructs formulated with our proprietary.
Lipid nanoparticle delivery system or LNP.
Our creators is known for its LNP systems for mrna vaccines have been worked with Pfizer bio intake on their commercial vaccine.
I'll work with accretive will focus on the various LNP formulations for gene expression and Immunogenicity in your in models.
The combinations of all technologies would expand all delivery portfolio, thereby enabling us to pursue a broad spectrum of formulation capabilities and delivery modalities with greater potential to improve currently available vaccines against the multitude of passages and also too.
They put up novel cancer vaccines.
No. That's all proof of concept studies using soft stuff to have yielded highly promising results.
We are considering an option to developing a multivalent pleasant DNA vaccine is a soft golf to booster vaccines.
And expanding testing vaccine to other pathogens.
With respect to developing a task of two booster vaccine in selecting the next vessels in full development less.
Last week, we held but ticked watch with the biomedical advanced research and development authority BARDA or the division of interest is responsible for strategy preparedness and response, Oh discussion with BARDA focus on the characteristics of blessing for developing the vaccines of the future.
Oh presentation was very well received there was a clear reaction that immuno and has made real progress, making classmates vaccines more effective they were impressed with our ability to make DNA technology potential strong contender in further vaccine development.
While our near term plan is to request a pre NDA meeting for Covid booster base on the next billions of interest. We also came to fight a second A&D for another pathogen.
We're looking for about his input on the vaccines of the future and hope to receive some non dilutive funding from them to apply to all development programs I.
I have used the term vaccines are 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 breath of protection stability had working with temperatures speed in manufacturing process that allows for quick response.
Two changing messages and have better compliance for mass immunization by not requiring a device or virus.
Now, let's turn to our clinical oncology program, which utilizes gen. One develop from a therapist modality.
As you know Gen. One is a DNA plasmid that is administered into the abdomen of patients twins yourselves to manufacture the potent natural immuno modulating agent interleukin 12, or IL 12.
Okay Cool studies have established that then one produces IL 12 and is favorably impacting the tumor microenvironment.
These data were published in the journal of cancer clinical research in 2021 and all the bases of the ovation two study.
The ovation two study is designed to determine how safe and active and one is in patients with advanced ovarian cancer, who will be undergoing new adjuvant chemotherapy therapy or a C T and.
In S. E. T is designed to shrink the tumors as much as possible for optimal surgical removal.
Growing surgery, another three cycles at administered to address any remaining tumor.
In the ovation two study of Gen. One is added to standard N S. C T.
Two goes to natural immune response to the cancer.
Ovation two is a randomized phase two study that compared to patients treated with standard new adjuvant chemotherapy against patients would get standard in S. E T plus Gen. One.
The results of this study will help us determine the course of registration for Gen. One in ovarian cancer.
As previously announced 110 patients for more than 20 centers in the U S and Canada have been enrolled in this study.
It is important to note that since the ovation. Two study was initiated several years ago, a new class of drugs called PARP inhibitors have been approved that benefit ovarian cancer patients who have a significant gene mutation called breakout positive or H D.
You know if city when we focus on the BRCA negative patients who have not received a PARP inhibitors. We can see that gen. One is providing a progression free survival benefit.
This data is interim and it's not statistically significant but it serves as a basis for interest and continuing evaluating BRCA negative population and initiating combination studies with other therapies.
Such as our best in order to checkpoint inhibitors.
The interim data has been reviewed by our independent data and safety monitoring board and experts in the field of ovarian cancer. They agree that the safety of Gen. One is acceptable and that the data supports continuation of Oatcake, all studies and exploration of combination regimens.
We expect top line data from the ovation two study in mid 2020 for this timing out however depends on how quickly patients progress in their disease.
As previously announced we are working in partnership with the breakthrough cancer Foundation with MTN doesn't Oh different cancer Center and three other major cancer centers to initiate a combination study of Gen. One with Avastin in patients who are newly diagnosed with advanced ovarian cancer.
The preclinical data supporting this combination is very exciting.
And is being prepared for submission at an upcoming cancer conference in 2023.
We hope to enroll our first patient in the first half of 'twenty to 'twenty three.
We are also preparing a phase one study to study with Gen. One in combination with checkpoint inhibitors.
See if there is a the results are exciting preclinical data also should be published in the coming months.
Yeah. There has accepted this protocol Nevertheless Ah.
In consideration of the need to conserve capital we might delay the start of this study.
So as I have just described.
We have a thoughtful and so applying fortune one for the treatment of advanced ovarian cancer.
Before I turn the call over to Jeff Church for his review all of our very strong financial position I want to impress upon you that.
Our long term vision for the creation of a new category of medicines based on our past with DNA technology across a broad array of human diseases. We all studying in immuno oncology and infectious diseases, and we will continue to invest to fully characterize the platform and to advance the technique.
Article frontier of recipe DNA.
Now I will turn the call over to Jay Okay. Thank you.
Detailed in neurons third quarter 2022 financial results are included in the press release, we issued this morning, although in our Form 10-Q, which we filed today, where the market opened.
You mean on the third quarter of 2022 with $43 $4 million in cash and investments.
Strictly cash and accrued interest receivable along with future planned sales of the company's state of New Jersey net operating losses. We believe we have sufficient capital resources to fund our operations into early 2025 other codes from rate over the past four years without any dilution to our shareholders where Bruce era.
$16 million from other wealth sales and we have a further three and a half million of unused Nols available for sale over the 2022 2024 type group.
We are in excellent position with respect to liquidity to support operations through several important value creating milestones.
Now I'll turn to our third quarter and year to date financial results for the quarter ended September 30 of 2022 reported a net loss of $6 $1 million or <unk> 87 per share. This compares with a net loss of $5 4 million or 94 cents per share for the third quarter of 2021.
Operating expenses were $6 $3 million for the third quarter of 2022, which is up $1 1 million or 21% from the third quarter last year breaking this down by line item research and development expenses were $2 $4 million.
Down slightly from the $2.5 million a year ago.
Research and development costs associated with the development of the plasma DNA vaccine platform as well as the Gen. One and vision two studies increased to $1.5 million for the current quarter up slightly from the $1 3 million a year ago costs associated with the off the phase III study were <unk> 1 million.
In the current quarter, which represented expenses associated with closing out this discontinued study.
Other clinical CMC and regulatory costs were $8 million in the third quarter of this year compared with $1 million for the comparable period in 2021.
General and administrative expenses were $3 9 million for the third quarter of 2022 compared to $2.7 million in the third quarter 2021. This $1 2 million dollar increase was primarily attributable to higher legal costs to defend various lawsuits well after the announcement of the Optima phase III.
The results in 2020, and higher compensation expenses, resulting from the CEO succession plan announced in July 2022, offsetting these higher G&A expenses were lower noncash stock compensation expenses.
We had non operating income of $26000 in the third quarter this compared to non operating expense of 300000 a year ago.
This improvement largely was attributable to lower interest expense under our loan facility with Silicon Valley Bank.
Income from invested capital in the current quarter.
On a year to date basis net cash used for operating activities was $18 $1 million and this compares to $11 4 million in the same period of 2021.
This increase was primarily due to the one time payment of four and a half million dollars in interest expense related to the sale and subsequent redemption of $30 million of series, a and B convertible redeemable preferred stock in the first quarter of 2022 and another $100000 in costs related to the special meeting of shareholders held in February two.
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Special meeting of shareholders was necessary to ensure that the company had an adequate number of authorized shares to continue funding.
Our R&D initiatives. Excluding these one time expenditures cash used in operation was $13 $5 million in the first nine months of 2022, which is in line with our projections.
Cash provided by financing activities of $6 $3 million from the first nine months of 2022 was a result.
Oh, the registered direct offering in April 2022 that was priced at the market with no warrants.
We also received proceeds of $1 $4 million from the sale of Nols in February 2022, our projected cash utilization for the balance of 2022 was approximately $5 million for the fourth quarter of 2022.
Ill turn the call back to Karen Thanks, Jeff.
Closing I want to mention that since I joined immuno back into summer I have been so highly impressed by the commitment of alternative scientists clinicians and staff to bring a new class of medicines to patients and the medical community in doing so we will also create great value for shareholders.
So with that overview of our business and our recent financial results, we already to open the call to your questions operator.
Thank you very much we will now begin the question and answer session to ask a question you May Press Star then one on your Touchtone phone.
We're using a speakerphone please pick up the handset before pressing the keys.
At any time if your question has been addressed and you would like to withdraw your question. Please press Star then two.
At this time, we will pause momentarily to assemble our roster. Thank you.
Yeah.
And our first question comes from Emily Bodnar from H G. Wainright. Please Emily go ahead.
Hi, good morning, and thanks for taking the questions I have a couple I want to talk about the co brand program and you've kind of mentioned your plans to evaluate them.
The vaccine and then new booster. So can you discuss if you need to show proof of concept and one of the established variance first prior to doing a clinical study for a booster program and are you kind of looking to evaluate and omicron variants are more towards the Pfizer.
But they're not vaccine boosters or are you kind of waiting to see if a new variant approaches.
And are you still planning to seek a partner for this program are you kind of at this point looking to evaluate it yourself.
I think candidly for these questions. So as I mentioned, we now have we believe a modality that is strong enough to stop thinking about Oh, when I N D for Kobe will start which seems obviously logical because.
Most of the world's population has either been vaccinated, all or had the infection right. So that's that's all focused and potentially another in a photo of a pathogen now are what we want to do obviously is to have a pre IND meeting with the FDA and that will drive how we.
Go about developing a booster strategy.
But what you mentioned is correct. We also obviously would have the conversation with the FDA about the kind of valeant. They want to look at what could be of interest moving forward. So that's the discussions we are going to help with the Christian you might want to have a few things.
Yeah, no exactly occurring.
As you know the <unk>.
Sorry merging.
They are.
B coupon one be Q1 brand one X P beyond horizon, so clearly.
We will be getting feedback from FDA on <unk>.
What's more what makes sense in terms of combination we do have army crop combination with downtime preclinical studies ongoing with <unk>.
One clearly is correct.
We need some feedback.
M D.
But our researches ready to plug in any period.
That would be of interest to go forward as a booster.
Got it Okay and are you still thinking.
A partner for that program or do you think you would move forward yourselves.
Yeah. So yeah. We definitely are you know we would like to seek partnerships in the future for sure for sure developers simply because as you know developing a vaccine and clinically you know it takes resources in many patients.
We now feel that we have enough data from all placing without a piece of that we can seek partnerships as I mentioned or an H P data and HP study is still ongoing so we'll have the final final results by the end of the year.
Okay.
And maybe the last question then could you just.
Acute us agreement, but more on how you're kind of planning to utilize their own P. Deliveries with would you use utilize that in your COVID-19 programmer or are you kind of looking to do that more on the cancer side.
Yeah.
Especially if you want to comment on this one sure yes, so Emily.
Hum that earlier Doug.
Impressive data with the current formulation that we have with cars could be too.
On the basis of these encouraging data we really.
So doing expanding our platform.
Maybe different routes of delivery. So that's why we wanted to expand our portfolio.
Stone unturned, so LNP as you know there is a.
Commercial vaccine. So right now this is more of a platform enrichment approach.
To see what we can do with Alan P plasma DNA, but currently our formulation.
Proposing to go forward for stocks could be too.
As we know today, but clearly LNP will give us a little bit more breadth.
No further potential for either rapid delivery of different pathogens to have that under our belt, it's supposed to be a platform for expansion.
Okay got it thanks, so much.
Yeah.
Yeah.
And we have a question now from Jim Jim Molloy from Alliance Global Partners. Jim. Please go ahead.
Hey, guys. Thanks for taking my questions I had a question on the on the Quita therapeutics agreements.
Monetary considerations that go back and forth.
We materially or any sort of a hard and fast lockups.
Good deal.
Yeah.
Oh, it's efficient you want to comment yeah sure.
Of course so.
Right now Jim.
The agreement with <unk>.
Uh huh.
Exploratory.
So we will be looking at their technology for fit with <unk>.
With DNA.
You know a lot more information.
An mrna based system. So at this stage, it's more of Steve that's valuable for us and a split or exploratory model and setting an agreement and if there is.
You know theres attractive data and we can discuss other terms such as monetary as you said, but right now it's very much.
See how that works well with plasma D&S would somebody exploratory at this stage.
Understood. Thank you and could you characterize how the partnership environment looks for the <unk>.
DNA is there, perhaps you know that the cause the frame.
Landscape, a little bit as sort of the closest competitor for anyone.
The DNA space.
Uh huh.
The most interesting potentially could be most interested or will be ideal for you guys to sign up as a partner plus going forward if things progress as you hope they will.
Yeah, that's a very good question.
You know I think.
And maybe I can convey the discussions we had with BARDA. The other day last week, because I believe that we are we have made a lot of progress in the name of DNA right.
And they were quite impressed with all resolved in terms of delivery of and gene expression.
And and that opens the door to a particularly new class of medicines studying with prophylactic vaccines for sure as we are sure to them you know that's what the purpose of all of our conversation with them was to show that the potential of a guesstimate DNA are in the fight of new pathogens.
So yes, there is great interest from BARDA, but also from from other players in looking at new technologies that will address the changing world of of vessels going forward.
Yeah, if I may add.
So the current DNA landscape, Jim is device space.
And <unk> seen of course.
The vaccine, it's very hard to have a massive sort.
Devices, but not as good compliance.
There is one approved device based vaccine in India. As you know there are lot of vectors to deliver.
DNA vaccines.
Has its own complications.
So our approach is devoid of our independent talk devices.
Viral vector so yeah, I think it's getting great.
Attraction attractive because of not having device or minuses. So that's the landscape.
Device and lateral basis, and Henry are with more Hum safer and better compliant approach. So I think that's that's what we hope to get more traction in terms of partnership.
The need for safer and.
A better compliance delivery Oh D interact.
Absolutely couldn't agree more thank you for taking the questions.
Okay.
At this time I'd just like to remind you if you would like to pose a question press star one.
And we now have a question from David Bautz from Zacks small cap research.
David Please go ahead.
Hey, good morning, everyone I have a couple of questions on the plant feed.
M D. How did the antibody and T cell responses compare between the plants being vaccinated animals and the mrna vaccinated animals.
And I'm also curious if you have any data for how long the animals immunized with Plas seen we're still making the antigen basically I'm trying to see how long that the vaccine stays active following a musician.
Yeah.
Yes Christian please go ahead.
Thank you David.
Very important questions. So we have done both.
Sorry comparison with.
Marshall mrna vaccine.
Both in Jordan.
Non human primates studies.
And grow it as we have seen very comparable IGT levels on T cell responses.
The better because we have seen is with our biases tronic are bivalent vaccine, we have seen that.
<unk> effective.
Explanation against both variance, but with the commercial vaccine.
Levels of neutralizing antibodies are not as effective against the mutated variant cause those vaccines.
Worked for wild type virus.
A clearance wise.
Yeah, similar clearance as Karim had said in the remarks.
Our statement that 95% to 99% clearance, so we compare head to head and NXP with commercial mrna clearances.
<unk> is a very comparable or similar.
Terms of the duration.
That's an important point we have initiated.
<unk> study, where we're looking at.
Neutralizing antibody responses following plus scene.
And we've been testing two single antigen vectors and one by beyond factor to eat months now.
We have not seen a significant drop in neutralizing antibodies at eight months.
Duration, it's ongoing studies that we hope to collect data beyond that.
And just to add a little bit more about the comparison.
Pointed out.
Stability study also that's ongoing.
Six month data shows that stable at four degrees.
[noise] advantages or whatever RNA vaccines. So yes, we are.
Ill make some comparisons.
The results, so far and we hope to have more characterization of our.
Responses.
Okay, Great and a quick question on the ovation two study what updates if any should we expect between now and the release of the data on the primary outcome.
Thank you David I'll ask a doctor or forced to come in but as you know it's a one to one randomized open trials. So we.
I have some data that we can discuss when the time is right and when do they taste mature enough.
Thank you for that question on the audition two so as Corinne announced today, we had an interim analysis of our data. We're at about mid point in terms of our data collection about 50% of our primary end point was collected and as current announced we're seeing.
Good activity and.
And it gives us confidence to move forward in the studies that you mentioned moving forward again, she announced that we expect the final data our statisticians project and around the middle of 2024.
And we will be doing data cuts. Meanwhile, so we haven't made an announcement yet on what our next data cut will be but we will share that as soon as that's been established.
Okay. Thanks for taking the questions.
Thank you David.
Thank you and this concludes our question and answer session I would like to turn the conference back over to Corrine look off for any closing remarks.
Thank you. Thank you all for your time. This morning, I Trust, we conveyed our excitement about the potential for all kept from technologies.
Look forward to keeping you informed of our progress. Please note that we will be participating in the last couple of quarters Virtual conference on November 30th December 1st.
Please contact a G. P. If you would like but wondering when meeting and we hope to see some of you in San Francisco as we prepare to hold when it wasn't meetings concurrent with the Jpmorgan Health care conference. During the second week of January 5th contact our IR firm, Alex Shea to schedule, a meeting will speak with you again.
And.
When we reported our 2022 fourth quarter financial results in much have a very nice rest of the day. Thank you.
And the conference has now concluded. Thank you for attending today's presentation you may now disconnect.