Q2 2023 Imunon Inc Earnings Call
Good morning, My name is Allen and I will be your operator today at this time I would like to welcome you to immuno on second quarter 'twenty to 'twenty three financial results Conference call. All results have 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 proceed.
Star I'm on your phone to ask a question you May press Star one policies should you need assistance. Please signal a conference specialist by pressing the star key followed by zero. Please keep in mind. If you are using a speakerphone you must release your mute function to allow the signal to reach your equipment again, that's star one to ask a question during the Q&A session I would like now.
Ill turn the call over to Kim Garland at please go ahead.
Thank you and good morning, everyone. This is Kim gala that's L. A J.
To immunology 2023 second quarter financial results and business update conference call.
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 words, such as expects anticipates believes or other similar expressions.
These statements are based on current expectations and are subject to a number of risks and uncertainties, including those set forth in the company's periodic filings with the Securities and Exchange Commission.
No forward looking statements can be guaranteed and actual results may differ materially from such statements.
I also caution that the content of this conference call is accurate only as of the date of the live broadcast August jumped 2023, immuno undertakes no obligation to revise or update comments made during this call except as required by law.
With that said I'd like to turn the call over to Dr. Corinne Mcgough immuno <unk>.
President and Chief Executive Officer Doran.
Thank you Kim and good morning, everyone.
Today, joining me is Jeffrey Church, our Chief Financial Officer.
Dr character, she Denver, our Chief Science Officer will be available during the Q&A session at the end of our prepared remarks.
And I have discussed during previous calls.
Wilson development is dependent on four pillars.
The one I'd like to spend most of our time on today is the development of all machine prophylactic vaccines modality.
As an out licensing and partnership opportunities.
This gain is all proprietary mono Oh look this just trying to make no survival and synthetic DNA technology.
Well the expression of vessels in nitrogen.
It is currently being evaluated in preclinical studies for the development of next generation vaccine.
We have made exceptional progress advancing this technology as opposed to I think vaccine modality with important features for.
As a commercial product platform and as a potential solution to addressing the unexpected chance of injury.
I Wonder would you saw about most recent preclinical data with <unk>.
Which is as it has been the risk and it's performing as we anticipated.
During the quarter Dr. <unk> presented results from preclinical studies in a COVID-19 vaccine and the vaccine to ignore.
And the 'twenty two 'twenty three virus himself Gordon Research conference in Barcelona that demonstrated characteristic lets address the limitations of current commercial vaccine.
By offering enhanced breadth of protection to emerging science.
[laughter] assistance and robust.
As well as stability.
Workable temperatures.
Ultimately.
Humoral immune responses.
I spoke to spike antigen.
[laughter] weapon system over talking more with vaccination period.
Why is the T cell responses from basic COVID-19 vaccine after 14 months were higher than our commercial and R&D vaccine.
In another mouse that neither humoral response to a single dose of the commercial mrna vaccine platform within 14 days after vaccination, whereas the response continue to increase over time with a pristine vaccine demonstrating improved durability.
We believe that all did it just mean vaccine may provide greater protection against infection hospitalization or death.
More recently, we have shown that they see is stable for at least 12 months at refrigerated temperatures and for at least one more at room temperature.
I'm sorry.
You know how important these attributes all to a commercial vaccine products.
Especially as many of the pathogens that rise in geographies, where there are challenges with refrigeration storage and distribution networks.
In addition, our ability to rapidly switched health antigen and load multiple messages into the send button.
Should be instrumental in interesting just straight up tea.
Beyond the development of next generation Covid, 19, booster vaccine, which I will come back to in a minute.
We have immuno are interested in developing the placebos L. P.
Maybe if I could just go into it.
Like she goes I would say, though I've never viruses, where neither based approach may be beneficial.
Today, the U S and global public health policy and commercial vaccine manufacturers continue to play catch up with the the reoccurring.
<unk> and <unk>.
Pictures disease threats and new emerging pathogen.
Emerging fevers, which have caused by viruses like Marburg and Ebola.
Examples and are more than most.
Threat to public health or Indian didn't even regions of West Africa and worldwide due to high morbidity and mortality rates and these viruses caused at least little Haemorrhagic fever.
In severe cases, and Oh by the way school, which is we need to be handled in both states.
And there are also potential biodefense threat if fused.
Logical with them again.
So, let's now turn to item and it is 110 sneak one vaccine designed as the next generation could be Nike booster.
All the preclinical studies in mice and an HD have supported the development of a green light.
Package that we submitted.
Here this year to the FDA would have just received the written response from the FDA and I am pleased to tell you that the FDA provided encouraging feedback on all data and take on the Baldwin said, which gives us comfort that we are well on track to submit an IDE in the.
First quarter of 'twenty, 'twenty, four and enter the clinic soon thereafter.
Andy will be for a proposed phase two program, which is designed to provide proof of principle in human.
The FDA also confirmed that the plug and play strategy fall purposeful was acceptable.
So this confirms the flexibility and the best way to appeal to all my dog, which allows for the rapid production and department of Ed you'd like but simply changing E antigen could you.
I'm in and Wonder what is a more developed COVID-19 vaccine candidate would be on the call on X P. P. One 5 billion actually at the Fda's recommendation.
You remember that the FDA has the effect of vaccines and related balance sheet products Advisory Committee May met on June 15, this year to discuss and make recommendations for some strange for a day.
<unk> COVID-19 vaccine.
He was in the United States beginning in the fall of 323.
So the plug and play model using the test me DNA backbone has shown excellent results not only in COVID-19 strange.
But oh early work also suggest that she and vaccine, which could be useful in multi box and on the Suez and box initial data and beautiful from the validity of Pershing as a platform with broad applicability.
Nice immunize or did you in 14 with the and then pox vaccine and you said you had three separate immunological responses associated with the virus and we also have generated logical responses against flu viruses in preclinical work.
Last quarter.
I mentioned that we are developing two modalities as a logical extension, although prophylactic vaccines modality.
<unk> concerns the application of all getting the technology to produce universal cancer vaccine also cold tumor associated antigen cancer vaccines.
We have initiated preclinical work.
To develop the chip to NY ESO, one tumor associated antigen, hence the vaccine in melanoma, which we call I had been into a what.
These new modality is base antigen selection and optimization along with the option to include important immune when he fired on a single nucleic acid Victor.
This represents a promising stages between this is specific and no lessening immune response against tumor antigens.
We have completed all initial proof of concept study looking in a mouse melanoma model.
The potential propane I think benefits mobile chip too and bivalent chip to NY ESO one vaccine.
We are very happy with the results as they seek slash vaccination well followed by the tumor challenge delay to the tumor growth and improve survival.
No the therapeutic studies evaluating the therapeutic benefits, although vaccines and consisting of a tumor challenge.
Hello.
Asian are ongoing and will be completed in the second half of the year.
And we also in early discovery, although without the ended that full personalized neo antigen.
I'd like now to touch on the island and they won't do it one Oh DNA based immunotherapies for the localized treatment of advanced ovarian cancer currently in phase two development.
Recall that last September we reached full enrollment of the 110 patients.
And we expect to report an additional set of injuring more mature data in the second half of 'twenty 'twenty suite.
And we will launch with all that.
So D with breakthrough cancer is no open up and doing different.
And the breakthrough cancer Foundation is working to add more sites. This study as you remember is looking at eight am and in Georgia, one in combination with Avastin.
And first of all strategy to reduce reliance on outsourced manufacturers.
In June we unveiled a new cgmp clinical materials production facility.
The Huntsville, Alabama campus of the husband Alkylate Institute of Biotechnology.
The facility will support the R&D efficiencies and lower development cost well infectious disease and cancer vaccines and non viral DNA based immuno oncology therapy.
This new capability complements our existing cgmp quality coals.
People, just think nickel products at the Huntsville site.
We have designed and built our own manufacturing capabilities to produce GMP grade plus me DNA.
And then, especially taking agents to support phase when people studies without pushing infectious disease with LTE and now in the past and six less cancer vaccine modalities.
The especially D N. A unit that you did in Asia are key components.
Despite no vaccine formulation.
With the JMP fit and finish carried out to see be able partner sites.
Our currency is kind of noticed that like any protein from the human El Paso Didnt put him to be engineered all existing that also have the ability to convert testing and run experiments in a variety of animal disease models.
These integral capabilities will allow us to control both the costs and the process.
I'll turn the call over to Jeff Church, now who will discuss our financial results then I'll come back and provide a review of upcoming milestones and activities.
Yeah.
Thank you Corinne details of immunized second quarter 2023 financial results are included in the press release, we issued this morning and in our Form 10-Q, which we filed today before the market opened.
And to the second quarter with $24 $1 million in cash investments and accrued interest receivable or cash or net cash usage for operating activities was $6 $8 million in the second quarter of 2023 up from $5 4 million for the from the prior year period. The increase was primarily due to the cash settlement.
In April 2023, along with related legal costs for arbitration with a former contract manufacturer for Thermodox cash used by financing activities of $6 2 million during the second quarter of 2023 resulted from the early repayment of the company's loan facility with Silicon Valley Bank. This was offset by Ed.
Sales under at the market equity facility.
Combined with the $1.8 million in play and future sales of imminent state of New Jersey net operating losses, we believe we have sufficient capital resources to fund the company's operation through 'twenty 'twenty four.
Let me now turn to a review of our financial results.
<unk> reported a net loss for the second quarter of 2023 of $5 $6 million or 61 cents per share. This compares with a net loss of $6 million or <unk> 87 per share in the second quarter of 2022.
Operating expenses were $5 5 million in the second quarter of 2023, it was down about 10% from the $6. One that we reported in the second quarter of 2022.
Break down each one of these light items research and development expenses were $3 1 million in the second quarter of 2023, a decrease of about $100000 from the prior year second quarter, more specifically research and development costs associated with our placid DNA vaccine mortality increase to <unk>.
1.3 million from one.
<unk> increased from $1 3 million from $600000 a year ago R&D cautious support the ovation study as well as the phase III Optima program decreased to one or 2.3 million from point $8 million in the second quarter 2022.
R&D costs associated with the preclinical development of immunology, where one decreased $2 4 million in the second quarter compared to <unk> 8 million in the same period of 2022.
Other clinical and regulatory costs were <unk> 4 million. This.
This year compared to point 7 million in the prior year I.
CMC or manufacturing costs increased <unk> 7 million this year from point 3 million, reflecting the development of the in house pilot manufacturing capability, which.
Crim referred to earlier for DNA plasmids, and nanoparticle delivery systems General administrative expenses were $2 3 million in the second quarter of 2023 compared to 2.9 million for the comparable prior year periods. This decrease was primarily attributable to lower noncash stock compensation.
<unk> and lower professional fees, including legal fees offset by higher compensation expenses related to the CEO succession plan, which we announced in mid 2022.
Other non operating expenses were $85000 in the second quarter of 2023 that compared to 65000 in the prior year period, the company incurred and early debt extinguishment expense of $300000. When its loan facility with Silicon Valley Bank, which was offset by higher investor.
Income from short term investments due to the higher returns we're seeing when these investments were called out in April 2023.
We repaid the loan to first citizens Bank, which was previously Silicon Valley Bank for a total of $6 $4 million, which included principal interest prepayment fees and end of term fees. The 6 million dollar collateral account, which we are classified as restricted cash was really was real.
Alicia and utilize to pay off the loan.
Investment income from the company's short term investments increased by $300000 for the second quarter compared to the prior year due to higher returns on these investments.
We take a just a brief look at the first half of the year first and second quarter for the six months ended we reported a net loss of $11 2 million compares to $16 5 million and the.
The same period of 2022 operating expenses were $11 2 million in the first quarter 'twenty 'twenty I'm I'm sorry, the first half of 2023 which was an 8% decrease from the 12.1 that we reported in the same period last year.
Net cash used for operating activities was $10 8 million for the first six months of 2023 compared to $13 4 million for the same period. In 2022. This decrease was primarily related to a onetime payment of $4 $5 million and interest expense and relate.
Cost, resulting from the sale and subsequent redemption of 30 million of series a b.
Convertible redeemable preferred stocks in the year ago period.
Cash used by the financing activities of $3 $7 million. During the first six months of 2023 resulted from as I mentioned early the early repayment of our loan facility with Silicon Valley Bank offset by $2 $7 million of sales of equity under our at the market facility.
We also received net proceeds of $1.4 million from the sale of unused.
Our new Jersey net operating losses in the first quarter of 2023 or.
Our projected cash utilization for the balance of 2023 is approximately four and a half million dollars per quarter. The majority of expenses are related to the development of replacing modality. We will now turn the call back over to Corinne.
Thank you Jess.
Even though is tightly focused on harnessing the power of the system by developing novel DNA based approaches in immuno oncology and infectious disease.
We believe that the non viral DNA will be a key driver of the share of global medicines.
We're very excited about the potential and immuno and to improve the health of millions if not billions of people, while creating significant value for shareholders and won't go up shipments we have de risked our pension modality for several Purcell James of interest by demonstrating the Immunogenicity and safety of all that.
We have generated compelling data in a subsequent two and I am wondering why the next generation COVID-19 single booster will be in the clinic in Q1 next year.
We also have generated excellent immunological response for vaccine against that agenda concern, especially monkey pox, new Lassa virus Martin Parrish, we envy.
Neil.
State of the art manufacturing site in Huntsville to reduce our reliance on others.
We entered into collaborations designed to advance our technology.
And we are actively building capabilities for the development of cancer vaccines.
Looking forward, we expect to reach several value, creating milestones over the next six to 18 months.
And then recording additional they've got on aim and Ngos, you're one for ambitious to study and the combination study with you. This is Matt.
In advanced ovarian cancer.
And reporting top line data from the ovation two study.
Studying it also the AED four subsequent to vaccine and and I'm seeing proof of concept magazine data as well for another virus program.
We are very excited to tell you about our programs in more detail in an R&D day that we plan to hold this fall.
We would have signaled European meters discussing our work during this difficult program. So please keep an eye out for more details in the coming weeks.
With that I open up the call to your questions operator.
We will now begin the question and answer session to ask a question you May Press Star then one on your Touchtone phone, if you're asking if you're using a speakerphone. Please pick up your handset before pressing the keys to withdraw your question. Please press Star then two at this time, we will pause momentarily to assemble our roster.
Our first question comes from Emily burden of H C. Wainwright go ahead.
Hi, Thanks for taking the questions.
I guess two on the co brand program.
First can you touch on the remaining steps and study is that you might need before you could submit the IMD in the first quarter.
And then do you plan to have the phase one phase two study.
The speed and general healthy volunteers or.
Do you think you might focus development on either like elderly or immuno compromised patients.
And then just clarifying.
I'm lines for ovation, two I think you've previously talked about interim data in the third quarter.
That still happening or and then is topline data.
Still on track for the first half of next year.
Okay.
Thank you Emily I'll start with the timelines on the ovation, yes, I confirm that we should have additional interim data in just a quarter.
And for the top line, we're still planning on having the top lines at the end of this second quarter.
'twenty 'twenty full.
To your question on on Kobe, So and I'll ask.
A doctor or Christian.
Virtu can complete.
Complete my my answers.
Yeah, So we'll be ready to submit all R&D in the first quarter, which we are working on at the moment is the production of the clinical Victor you know we should we are you know pretty.
Pretty much sets and very much on track for the submission of R&D.
And when it comes to the phase one two Ah trial design will be looking at generally helps people want to use I think your question on looking at immunocompromised patients actually is interesting one oh.
Was there any patients or that's something that we actually little dress with advisers that could be a subsequent study.
Chris did you want to al to add to what I just said.
Yeah.
Sure.
Covered it well Emily.
Two sets of studies that are indeed, enabling are currently in progress one is to.
Look at the safety.
Animals, So that's a safety Tox study.
Due to start soon.
And bio distribution studies.
It is made and the delivery system goes and how long it takes to clear. So those are the two fundamental NDA, enabling studies that will complete the submission of D. I b.
And as Corrine said.
Well its phase one study will be healthy volunteers, but clearly for phase II part he could look into some stratification.
Chad maybe some.
Elderly morbidity, but discussion with our and why.
Right.
Okay, Great. That's very helpful. Thank you.
Thank you.
Our next question comes from David bouts of from Zacks go ahead.
Hey, good morning, everyone. Thanks for taking the questions.
First one is on the planting technology do we have any idea right now about how long.
The antigen is going to be expressed in someone who gets immunized with plas seen or are we talking days or weeks or months do you have any clue right now.
Hi, David Yes, we certainly do.
So Christian can you. Please answer the question Yeah, Yeah of course.
David you.
You know.
Compared to mrna or put the DNA.
Phase for longer period.
Especially in the Gulf.
So with other gene such as at a quarter generally have seen.
Your next question for several weeks.
So I anticipate it especially at the end of the last several weeks.
After a single injection or even months.
Is there any concern about tolerance development or even in an allergic reaction with such long expression of the antigen.
The love themselves.
R R.
Hi, or Super.
Back to be able to cause any intolerance issue that generally happens.
And then to Jim Oh, 10, bolus given over time, you know suppressed physiological levels than you see in tolerance. So these are levels that are enough to initiate our immune responses I've done eight.
Intolerance.
But again, we haven't specifically looked for that.
Okay.
Well David this is.
We believe.
Increased expression of the antigen no longer expression of the antigen is in fact, a benefit because it gives us time to Oh your immune system to.
To build memory shelves right.
And that's but maybe the concern or the basically the mrna is that you know memory cells or not too much presence.
Okay.
That sounds good and then as far as the Phase One study goes I guess, how do you determine which which variant you're going to target for that and then.
Can you change, which variant you target between going from say the phase one to the phase two.
So it's a great question so.
I mentioned that the F. D. A every year will tell them manufacturers manufacturers, which variant to go after so they're going to use the same principle.
Due for the true vaccines right.
So they've met the via package, making 950, <unk> said and what the manufacturers need to put into production is only Cornish PD, one five which is what we did.
The FDA agreed that that was the right thing for us and and then we'll do a phase one slash two which means that as soon as we started phase one when we get the.
Safe dose from the phase one would go immediately into a phase two program.
With the same volumes.
Okay. So is this system being set up kind of like the flu vaccine is where you're not gonna have to basically do animal studies again every year with a different variant youre, just going to be able to plug it in and.
Okay.
And that's that's what I mentioned and that's why we're so pleased that the FDA confirmed what we call plug and play strategy. But then you don't have to redo your Tox studies in animals, when your chance to catch that.
Yeah, Okay, great. Thanks for taking the questions.
The next question comes from campus, Delaware from Brooklyn Cabinet market capital markets go ahead.
Right. Thank you.
Just to continue on with the vaccine discussion so.
Do you expect you would have phase one data in the second half of 'twenty four given the.
Timing of the IND filing.
I believe so yeah, that's what we are starting to do.
I cant okay.
Alright, Thank you and then.
You had originally hoped to file the IND by the end of the year.
We're not talking about a significant change to the timeline, but I'm curious.
Does the change in the timeline reflect the timing of FDA feedback or or reflect the pre R&D functions that.
Or the IND, enabling functions that youre doing now.
Alright. Thank you, yes, we we use public would be a bit faster with all trendy with our Anda filing you're correct I think there.
The shift in the timelines, we expect to say that you wanted to hear.
To make sure that we would pursue a buy and that is the one recommended by the AR by D. M. D. E. So we wanted to wait until the 2016 see OPEC meeting.
And then of course, you know yeah F.
Feedback on how print package was a bit delayed compared to what we had thought as well. So that's the reason.
Great. Thank you very much.
Yeah.
Yeah.
Once again, if you have a question. Please press Star then one.
Our next question comes from James Molloy of Alliance Global Partners go ahead.
Okay.
Hi, Good morning, Thank you for taking my question.
Most of them answered, but I had a question on the.
Campbell with Avastin phase one two.
Under underway, what's the expectation for the for a potential interim look for that and.
Moving into the phase II portion of that trial.
Hi, good morning, James.
As I mentioned this this trial is a under the sponsorship of the breakthrough cancer Foundation.
We're supposed to have four centers.
And willing patients in this clinical trial, the first center I'm doing their son is up and running they have nothing.
Yes.
Definitely up and running and we are expecting the other centers to join this study in Q3 Oh.
I mean, maybe September October timeframe, Oh, well this year.
So it's just phase one slash two which means that the first phase of disk drive is really to evaluate the.
<unk>.
You know the dose that we need to administer to patients in combination with Avastin and then phase two would come after so it's a bit difficult at the moment to give you exactly when that when we can get for some first data.
But separately you know in the course of 'twenty 'twenty four will have more certainty as to new.
Didn't you centrifugal Christian do you want to add anything to what I said that I know you've been talking with investigator as well Sean.
No you're right I mean, and so part of that is to demonstrate safety and happiness.
With the vast in an email.
And what's the foresight.
Yeah I get it.
Come on board.
One should not take much I don't want to put a date or time, but I think it just starting now so.
A salesman should.
It should not take a longer time before we get into phase two so September October October time.
This debate on sites to be on board.
As a matter of perhaps I would say you know two to four months after that.
Okay, great. Thank you and is there I have on us at all.
Our model and expectations for maybe another combo at some point with with Opdivo is that something that you guys are still looking at for a feel of ovarian cancer.
Hi, James Yeah. So I think I would say in theory I believe that you know.
There is a lot of value in testing IL 12 in combination because mechanistically.
That makes a lot of sense to add.
Hum.
And I O 12, with a checkpoint inhibitor for instance, right because it's it's still about 18 to tumor microenvironment. So we might we might think about this I mean, you know when do I think that's one thing at a time right.
The reason why we engaged in a combination trial with Avastin now is because we have very compelling synergistic data in a preclinical model in mice.
But you know its not other question do you think that's a combination with a checkpoint inhibitor could be could be an interesting trial as well.
Absolutely. So I know you have limited resources as everyone does actually go down.
Is there been any discussion too.
Effective any larger pharma partners coming into it.
Its a partner to help out with.
With the R&D.
On the IL 12 program, you're asking basically.
Really a co IL 12 earlier across the board right technology pretty good we want to get in on that.
So, yes, I mean.
Operational and partnership will be key to our.
Operating model, so we'll suddenly well, let's take partnerships. That's why we also eager to.
To get into a phase one program with our with our vaccine.
Healthy so that we can get to this proof of principle in humans and then I'm sure that that's still open doors for collaborations after that.
Outstanding Thank you for taking the questions.
Thank you.
Yeah.
This concludes our question and answer session I would like now to turn the conference back over to Dr. Corinne Le golf for any closing remarks.
Thank you very much.
Yeah.
So.
You know we've.
I've been using the phrase sanction of the future to describe our work.
And this is exactly what our vision is to be the provider of safe and effective vaccines that are superior to current vaccines in terms of durability and personal protection.
State much more capable temperatures that can be manufactured rapidly to respond to evolving pathogen.
And offer a better compliance for mass immunization with no need for a device all virus.
We also believe our technology.
Excellent promise in immuno oncology.
We look forward to keeping you informed of our progress well joining us and we look forward to speaking with you again at our upcoming R&D day event has a very nice day.
The conference has now concluded. Thank you for attending today's presentation you may now disconnect.
Yeah.
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