Q3 2023 Imunon Inc Earnings Call

Good morning, My name is Ellen and I will be your operator today at this time I would like to welcome you to the immune on third quarter 2023 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 one on your phone to ask a question. Please keep in mind, if you're using a speakerphone 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 like now to turn the call over to Kim Golar debts. Please go ahead.

Thank you and good morning, everyone. This is Kim call it up with L. A J welcome to Immunology 2023 third quarter financial results and business update conference call.

Today's call management will be making forward looking statements regarding immuno <unk> expectations and projections about future events and 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.

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 Cat November 14th 2023.

Undertakes no obligation to revise or update comments made during this call except as required by law.

But that said I would like to turn the call over to Dr. Corinne legal immuno <unk>, President and Chief Executive Officer Corinne.

Thank you Kim and good morning, everyone.

Joining me today is Jeffrey Church, our Chief Financial Officer.

You shouldn't Doctor Christian Enver, our Chief Science Officer will be available during the Q&A session at the end of our prepared remarks.

Even though its growth and development just dependent on four pillars last quarter I spent the bulk of all time on the development of all Christian prophylactic vaccines modality as an out licensing and partnership opportunities.

While I will certainly update you on this hotel to eat and we did have some interesting developments first I'd like to highlight.

And in deals you'll one Oh DNA based interleukin 12 immunotherapy for the localized first line treatment.

Advanced ovarian cancer in combination with the standard of care chemotherapy and its currently in phase two clinical development.

Recall that in September 22, we reached full enrollment of 110 patients.

And this year in September 23, we reported an additional set of insurance more mature data showing promising progression free survival and overall survival data.

In the intent to treat population, we demonstrated a delay in disease progression in the treatment of approximately 33% or more than three months finished it.

And preliminary overall survival data followed a similar trend showing an approximate nine months improvement in the treatment arm over the control arm.

But here's what the ratio of <unk> 78 for Coke she used to political defined value Oh boy 75 set at 80% confidence integral for the ITT population.

Since the ovation two is an exploratory study with a total so controlled study of only 110 patients. It was not powered to a P inferior to opine too, but and the current trends looks promising.

Recall that this study is evaluating the dosing safety efficacy and biological activity of interpret internal I'm, an NGL deal one in combination with new adjuvant chemotherapy or M. A C T.

And this in patients newly diagnosed with advanced epithelial ovarian.

Pelican tube or primary peritoneal cancer.

And then C. T is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy and filling in a C. T patients undergo interval de bulking surgery, followed by three additional cycles of chemotherapy to treat any vehicle.

Sure.

And I am in Israel, one is administered weekly during the course of any CPE.

So we also reported for the first time data on use.

Those patients treated with PARP inhibitors.

When we began the audition two phase two trials the pump inhibitor as well not to call on the first line maintenance treatment in ovarian cancer.

No they form an important part of the patient's treatment yet.

So quick analysis of patients who received a name and names there was the old one and plus chemo maintenance therapy with swap inhibitor, especially.

Pop inhibitors alone in the control group shows positive impact.

The median PFS in the pump inhibitor, plus and if Citigroup was 15 seven months yet.

Yes in the pocket neighborhood, plus initiative, plus I am in Israel, Israel, One group was 23.7 months or eight months longer.

In addition, the median OS in the pump inhibitors, plus any citigroup was 14, six malls and media the west overall survival has not yet been reached in the PARP inhibitor <unk>.

The lesson is to keep plus I am in Ncos or one group. So although these data from a small number of patients they are intriguing.

We also saw continued benefits in secondary endpoints, including a 20% higher all zero tumor resection school and a doubling of the Crs three chemotherapy response school to approximately 30% of treatment arm versus 14% in the call.

A complete tumor resection or zero is a micro caustically margin negative resection in which no well so microscopic tumor remains in the tumor bed.

Chemotherapy, we suppose school is considered a good prognostic indicator integrated cancer.

So that's why those are endpoints that are important to look at.

And safety analysis continued to show good to learn Tolerability of I am in Israel, one in this setting.

Now unwell nothing no second phase two study, which if you remember he's done in collaboration with the breakthrough cancer Foundation has begun with the first patient treated at MD Anderson Cancer Center last fall.

The study is evaluating aiming and he'll he'll one in combination with English isn't that Oh.

Oh in the study is expected to enroll 50 patients with stage three for ovarian cancer at several sites.

<unk> Memorial Sloan Kettering and Dana Farber.

The trials primary endpoint is depiction of minimal residual disease or <unk>.

My second look laparoscopy and the secondary end point S. P S.

The initial signals look laparoscopy data are expected within a year following the completion of enrollment and finally PSS data I expanded approximately three years slowing enrollment completion.

This trial will include a wealth of translational endpoints aimed at understanding the clonal evolution and immuno genomic features of the MLD stage ovarian cancer that is currently undetectable by imaging or tumor markers.

We will keep you updated as cycle at either as a reminder, much of this trial is being funded by breakthrough cancer.

So we are now six to seven months away from seeing the final everyday readout data of ovation two program.

And this is an incredibly exciting time for your dog.

If positive these data would be transformational to the field and what's called for how I put this out yourself IL 12, being a potent immuno modulator called cold solid tumors.

We will consult with the FDA on the potential regulatory path forward.

A small phase two is showing promising trends in the ITT population and a strong benefit to extended maintenance pump inhibitors therapy, which could inform registration study.

Pump inhibitors, all known to significantly increase PFS, but the improvement in overall survival is not yet established.

And resistance to PARP inhibitor therapy is a concern which warrants novel combination approaches such as with the immune agent and then see what the old one.

Let's now turn to play seen all proprietary mobile it's almost irrelevant do you need vaccines based on a DNA test meet that controls the expression of specials, you antigens and the nonviable synthetic DNA delivery system.

She is currently being evaluated for the development of next generation vaccines or as we call that the vaccines are in future.

We continue to bolster our preclinical dataset, which lessee, which suggests to us that has been de risked and is performing as anticipated.

Oh first Gretchen product is aiming to enter one or what.

Which is in final stages of preparation for a 90 investigational new drug application to the FDA.

I am wonder, one, which we view as a proof of concept is designed to protect against Sars Cov, two let me call. It used to be one 5 billion in accordance with U F D. A vaccines and related biological products Advisory Committee that committee.

Our announcement that's been met in June 'twenty, three three and that established a framework for updated COVID-19 doses.

I mean on is targeting the first quarter of 'twenty 'twenty four for submitting the A&D and then and willing to first subjects in a phase one trial in April 2020, full with rapid advancement into a phase two trial by mid 'twenty 'twenty. Four so we are excited about the body of.

Preclinical data and we have been active in presenting these data at various conferences both in the U S and Europe for example, less small doctor I never presented at the third International vaccines Congress.

Highlighting immunogenicity data and the development studies that has been in what to what.

Dr. <unk> presentation I'll describe the multiple advantageous of less seen over current commercial vaccine platforms, including our multi table antigen expression and T cell responses versus protein in mrna vaccines.

In addition, our preclinical studies show that the scene and it's it's better antibody responses kinetic are.

Following a single dose and demonstrate better shelf life of at least 12 months is 40 degrees Celsius and at least a two weeks at very high temperatures of 37 degrees.

Celsius this.

These characteristics or suggest superior commercial handling and distribution properties compared with a married of vaccines.

As well as greater manufacturing flexibility.

Compared with viral load other unit vaccines proteins vaccines, plus seems like scenes habits and tastes using T cell responses safety compliance and manufacturing flexibility.

Dr. <unk> presentation also described depends fertility of the Plessey modality are demonstrating activity against Marburg and influenza viruses.

In collaboration with the Wistar Institute.

And activity against lesser virus, which is being evaluated.

I H H.

I remind you that during the third quarter, we entered into a cooperative research and development agreement with their night.

This is a three year agreement under which the NIH will evaluate the immunogenicity and efficacy of two immuno DNA based let's say virus vaccine candidates.

The agency will assess the efficacy of that cdna construct against Lassa virus in the Guinea pig.

And nonhuman primate disease models.

Including both prime and prime boost vaccine strategies.

We also announced a collaboration with Mr. In January of this year and the Western Institute vaccine.

And immunotherapy center is uniquely positioned to advance new vaccine formulations to facilitate further expansion and did go up but a vaccine.

Our collaborations with outside partners, particularly those that we provide so some or all of the funding of the research a key pillar of our growth strategy.

No later today are Jim <unk>, our vice President of research and development will be presenting at the vaccine summit in Boston.

Dr. <unk> presentation describes preclinical T cell responses and notes that the induced immune response in vaccinated mice with persistent without decay for up to 14 months. After vaccination. So as you might think we are very pleased with the duration of.

Response.

So we believe that okay singled out T is revealing itself as an important potential option in addressing not only pandemic response, but also to see the seasonal vaccine option.

H stability, our tricolor refrigerator temperatures 12, bulks room temperature stability.

When malls.

And stability at high temperatures for at least two weeks plus the immune response duration and the plug and play model using depress me DNA backbone has shown.

Excellent preclinical results that are so important to our commercial vaccine products.

And this is particularly important as many peso trends such as less of ours may arise in geographies, where there are challenges with our refrigeration storage and distribution networks.

In addition, our ability to rapidly switch on antigen and load multiple antigens into the syntax seen should be instrumental in addressing the spread of disease.

So in addition.

Persimmon with L. T uses a guinea pig meat and the dog's viral synthetic DNA delivery technology for the expression of electrodes and empty checks.

And our DNA based vaccines can be administered using a standard series and I am injection and now independent of viruses all specialized devices full days very like any corporation.

Last quarter I touched Oh, no work to dip at up to mobile DAU Ts is logical extensions of all prophylactic vaccine modality.

Fixed class.

Concerns the application of our technology to produce universal cancer vaccines also cold tumor associated antigen cancer vaccines.

We have initiated preclinical work to develop a trip to and NY ESO, one tumor associated antigen cancer vaccine in melanoma, which we call aim in N two zero what.

This work is in the very early stage and I look forward to updating you as it progresses.

We are also in early discovery, although first modality indirect.

For personalized neo antigen Gibson vaccines, and we plan to enter into new collaborations that focus on developing AI powered computational approaches and state of the ops cell sequencing technologies. So I don't get my tumor antigen.

In patient samples and create the next generation of personalized cancer vaccines and as with six flags will update you as our development work progresses.

Importantly, recall that we manufacture all vaccines, although our own cgmp facility in Alabama.

And our decision to manufacture in house offers us many strategic benefits, but notably the control on cost quality and time lines.

So now I will turn the call over to Jeff Church, who will discuss our financial results then I'll come back and provide a review of upcoming milestones and activities.

Jeff Thank.

Thank you grant details of immune <unk> third quarter 2023 financial results were included in the press release, we issued this morning and in our Form 10-Q, which we filed today before the market opened.

And ended the quarter with $19 $5 million in cash and investments.

Our net cash usage for operating activities was $4 $5 million for the third quarter of 2023 down slightly from $4 6 million for the comparable prior year period.

Cash provided by financing activities of $100000 resulted from equity sales under our at the market facility.

If we combine the $1.8 million of planned future sales of immuno <unk> state of New Jersey Nols. We believe we have sufficient resources to fund operations at least 12 months from the filing date of our 10-Q, which we just filed.

Let me now turn to a review of our financial results <unk> reported a net loss for the third quarter of 2023 of three and a half million dollars or <unk> 37 per share. This compares with a net loss of $6 $1 million or <unk> 87 for the third quarter of 2022 operating expenses were.

Six point I'm, sorry, $3.9 million in the current quarter down 38% from the $6 3 million in the third quarter of 2020 to breaking down these items by a line item research and development expenses were $2 million a decrease of $400000 from the prior year's third quarter.

More specifically R&D costs associated with development of our plastic DNA vaccine modality increase.

$800000 from $500000, a year ago clinical costs decreased.

Two $400000 from $1 million in the third quarter of last year as a result of completing enrollment of the ovation. Two study last September which <unk> mentioned in her earlier comments.

Other preclinical development costs were $300000 compared with $600000 in the prior year.

Our CMC costs increased.

To half a million dollars from $300000 a year ago. This reflects the development of the in house pilot manufacturing capabilities for DNA plasmid and nanoparticle delivery systems.

And the manufacture of supplies for our IND, enabling studies as well as the phase one two clinical trial for <unk> Covid vaccine general and administrative expenses were $1 $9 million in the third quarter of 2023 compared to $3 9 million in the comparable prior year period, this $2 million decrease.

Due to lower noncash stock compensation expense professional fees, primarily legal costs.

Employee related costs and insurance other non operating expenses were $400000 in the third quarter of this year.

Impaired to 26000 for the prior year. This increase was due to higher interest income from the company's short term investments.

I'll just briefly touch on our financial results for the first quarter I'm, sorry for the first nine months of the year.

For the nine months ended September 32023, we reported a loss of $14 6 million or $1 64 per share. This compares with a net loss of 22.7 million or $3.42 for the same nine month period of 2022 operating expenses were $15 1 million in the first.

Nine months of 2023, an 18% decrease.

From $18.4 million for the same period of 2022.

Cash used for operating activities was a little over $15 million for the first nine months of 2023, this compared to $18 1 million for the same period of 2022. The decrease was primarily due to a onetime payment of $4 $5 million in interest expense, resulting from the sale and subsequently subsequent.

Redemption of $30 million of series B convertible redeemable preferred stock in the year ago period.

Cash used by financing activities of $3 $7 million during the first nine months of twenty-three resulted from the early repayment of the company's loan facility with Silicon Valley Bank that totaled $6 $4 million.

Which was offset by $2 $8 million of sales of equity under our at the market facility. We also received net proceeds of $1 $6 million from the sale of unused New Jersey Nols in the first quarter of 2023 and as I mentioned earlier, we have an additional $1 8 million of NOL sales.

We anticipate.

This year and next.

Our projected cash utilization for the balance of 'twenty. Two 'twenty three is approximately $4 million for the fourth quarter. The majority of expenses are related to the development of our Plastein modality, including the development of in House pilot manufacturing capabilities mentioned earlier I'll now turn the call back to Karen.

Thank you Jeff.

If you don't is tightly focused on harnessing the power of the Union system. Our goal is to provide more potent and durable immunity for millions of people with cancer or infectious diseases.

Why creating significant value for our shareholders.

Collaborations are a key component of our strategy and we are committed to ensuring that even though it has the most talented advisors available to help us achieve I'll go to that end. We are delighted to explain those tend to take advisory board with the additions of Dr. Patrick at clinical director of the melanoma disease Center and the director.

<unk> Sciences at the center for immuno oncology at the Dana Farber Cancer Institute.

Doctor Associates to claw assistant Professor in the Department of Immunology Division of Basic Science research at MD Anderson, where he also serves as director computational biology eclipse or if additional skin silicon NAV Unity project.

The first quarter and recent weeks were exceptionally busy and full of achievements with more expected microscopes to come.

Among them, we reported a compelling interim data with evidence yoga when you deal with two study in advanced ovarian cancer.

Hey, Kelly in a subset of patients they can taking part inhibitors.

In combination with chemotherapy and I'm, Amy then Jojo one.

Oh next milestone from this study is to report top line data in mid 'twenty 'twenty four.

We de risked okay sitting without T across several procedures of interest by demonstrating the immunogenicity and safety of all vaccines.

We generated compelling data in soft golf too and I emanating 101, our next generation COVID-19 seasonal booster.

We'll be in the clinic in April with human clinical data expected in the second quarter of 2024.

And we also generated excellent immunological response against special James of concerns specifically monkey pox through lassa virus in Marburg virus.

We unveiled a state of the art manufacturing site in Huntsville to Alabama to reduce our reliance on others, which is intended to give us control not only on our colleges with material, but also quality and cost.

And we entered into collaborations to advance our technology with more to come and to build the capabilities for the development of cancer vaccines.

Before we take your questions I want to mention that we will be available for one on one meetings with the investment community. The week of January eight in San Francisco concurrent with the annual J P. Morgan Health care conference. So please contact our Investor relations firm and they say if you would like to schedule a meeting.

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 telephone keypad, if youre 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.

The first question comes from Emily Bodnar of H C. Wainwright. Please go ahead.

Hi, good morning, and thanks for taking the question I wanted to ask on ovation. Two the recent data that you had so obviously you talked about the benefit you had with PARP inhibitors and assuming they also benefit in BRCA positive patients.

But you had a previous interim data readout, where you mentioned that you had a benefit in BRCA negative patients.

So curious if you can maybe speak to why you think you might be seeing the switch there and why do you think there is synergy with PARP inhibitors, and then discuss how youre thinking about next steps, whether you're planning to evaluate I am and then Oh, one broadly or.

Specifically, our combination with PARP inhibitor.

Thank you very much familiar so I want to start and maybe I'll, let also cause sheet a S. R.

Three questions.

So you're absolutely correct that if you remember last year, we did a preliminary data cut which was very material data and we show benefits in BRCA negative population.

Now that we have more patients and more events. So it's difficult.

With 70 events across both arms, we are showing a benefit in the ITT population.

And we specifically did you say to look at patients treated with PARP inhibitors because.

Yeah.

They're going through a signature with breakout doesn't give the full answer.

As you know you know pace.

<unk> received PARP inhibitors, if they all BRCA positive even BRCA negative patients get PARP inhibitors AR as it has been demonstrated that it is you know it it can increase a progression free survival in HRD positive patients right.

And so we wanted to be a bit more accurate and in a in a description in the in designing.

A group of patients who would want to look at and as you know a H L D, which is where it gets where it could be recombination deficiency is very common if 50% of women with advanced ovarian cancer.

Have tumors that test positive for it shall be and only half of these BRCA mutations.

So it's very interesting to look at.

You know patients treated with pops, regardless of their BRCA status, and then to get the granularity Oh and we'll get the state does as we would get to the top line data.

Hey, Tom.

So.

What what are what is our assumption here in terms of what's happening with the puppy Jupiter. So so we call that the PARP inhibitors are administered after Vicki.

Chemotherapy.

We discussed this with our advisers and their hypothesis is that IL 12, So I'm in and she also won a kind of sensitize to tumor for the PARP inhibitors. So that's the that's what they are thinking which makes sense. If if if you want.

And because I hope a disease that IL 12.

Has as being very being a very potent immuno <unk> agents can turn.

Cold tumor into a hot tumor.

So as we progress of course will talk to the regulators are we want to discuss with them the rigorous regulatory path and wheels, you should do this sooner than later in anticipation of the top line results in June.

Maybe Christian if you'd like to add to what I have said.

No I mean, I think you covered pretty much corrine, but I just wanted to start with Emily's.

Last part of the question, but just kind of address that potential mechanisms. So Emily as you know back in a phase one study we did report a J.

And in the tumor microenvironment from the treatment, where we saw in.

In Caribbean CDA positive cells to immunosuppressive Marshall ratio that suggests that the environment was.

<unk> transitioned from you, but that's the process demand the military so that itself. That's Corrine said you have is this environment now before I'm in the tumor environment has changed to be more fighting against tumor that could be a one potential mechanism. Another word.

It ties the tumor for PARP as you know a PARP causes cell.

Cell death.

Our repair doesn't happen and that really does antigen in the cabin.

Good immune stimulatory environment that I'd really like to get to potentiate. The immune response at that as a potential mechanism, but I think that but I think that's protecting the theoretically it makes sense now plus part of your question was about BRCA negative and call. It good eloquently pointed that out as well that that was early data, but also the molecular signature why it's a lot more to learn innovate.

You can count sure initially with behind it is BRCA positive BRCA negative that's more of a thematic but in tumor also you have this homologous recombination deficiency and that's a lot of variability, but I tell you. There are several enzyme sell are deficient in some patients some are not different than other patients. So we're also trying to look into the database to better under.

Standing back a signature not just break out positive and negative but for the subtypes as to really what's the extent of deficiency and see if we can make some correlate if you'd do that then you're really lowered the samples because you already have about 17 pardon me the breakdown, but I think that's what we're trying to look into further understand because it was all understand the mechanism.

There's some clinical studies.

But also what next type of broad application, you asked or maybe more limited to I think PARP combination currently direct up to work with the type of application, but as you learn more about like a signature of this ongoing study more data come in perhaps that will shape up our future direction strategy.

Got it very helpful. Thank you.

Thank you.

Our next question comes from James Molloy of Alliance Global Partners.

Please go ahead.

Yes.

Hey, guys. Thank you for taking my questions I just wanted to get your thoughts on that.

The ovation two data coming out in mid next year. So can you walk through what the potential phase III and how much will depend on how the data look what a potential phase three or phase two b trial design, our next steps on trial design.

Might be from that and then on the Avastin trial.

Because once you have asked in trial interim data coming up here, what should we be anticipating here.

In the quarter for that interim look.

Ah Thanks, Tim so.

As I mentioned, putting innovation two program, we'll be discussing with the with the FDA on a potential regulatory pathway, we necessarily would be very interested in a breakthrough designation that could shorten considerably. The development timelines are so that's something that we are working on.

And.

And you can imagine that's what it is.

What we have in mind is you know we could continuing to enrolling in the current phase two are as we mentioned you know there's there's two.

Two program easily extra tree right. So with the 110 patients. So we would need to to increase the number of patients.

During the trial.

And suddenly you know we would look at the supervision of street with PARP inhibitors. So that's what we have in mind right now now, but unless we speak with the with the regulators you know we have we don't have until we speak with the regulators we have not confirmed any dip off in Canada at this stage.

And Christian do you want to comment on the on this point before our dressy a multi study.

No I think your card it I think that's exactly we're just still in formulating our strategy and perhaps help from regency or no feedback will be important.

And then the MLD Ah study right. So what we expect is that you're from involvement.

We would have already so some interesting data so maybe cause should you want to comment on this and what do we expect from this study, which also has a in a political design a number of translational data.

Hum.

You know I think we'd be superb commercial force.

Do you want to comment on the on the Odyssey.

Of course, thank you Jim.

Is that maybe second quarter next year, what kind of information is anticipated from Novartis study. So there Marty study. This is the first time, we will be.

Testing, even on Oh, one rig avastin in humans, we have never done that before so everything is now in the new adjuvant setting in approved so I think the first lead phase one part of the study is to really look at the safety, where they are asking for that.

I think we want to get there I don't anticipate any issues. So that's something I guess it won't be to move on from it's a combination and then open up that study into that population now what do you anticipate is a certainly more enrollment by that time second quarter, but down the road as coincide.

This study is really important because bren.

Get Saturday that gets surgery after two cycles of chemo tumor burden to surgically removed and then you've got another three cycles of chemo and then nothing happens to maintain the therapy, but they haven't been looking at the Paratonia them again after the surgery and one month after and we anticipate.

Bye, you mean or Avastin.

The vast edinburg.

Preclinical data show benefit would reduce the burden the residual disease and lowered the residual disease will be dissipated with longer survival. So we expect to see maybe some patients I can't promise in the second quarter, we'll have that like I said 55 after complete but what do you anticipate that the reward will be.

Second looked across could be you know how many patients have you seen those you know residual disease.

Diseases, where it says what's known which is about 70% of patients that residual disease minimal work says, we're trying to get it down to about.

35%, so we might see some of that data coming in but also they're collecting a lot of translational research and understand the tumor biology that probably will be done when all the patients have sort of all the samples have been collected so I think 50, plus maybe update on minimal residual disease are the obvious.

I felt that a.

Zero data secondary endpoint, you know Asbury wishes to you know we have been updating the community over the years, Oh or different time periods, but it'll probably be some of that but clearly the study a we'll have a lot of translational component to it to understand the combination.

Great. Thank you for that and I see you also you guys are kind of cooperative R&D agreement.

The idea you are talking about it here in the third quarter of last of ours. There's lots of ours that are potential for priority review voucher down the road.

Yeah. So thank you Jim says that's a good question. So you know as I mentioned with the development of the person modality, we would look at partnerships to to disrupt vaccine candidates and if an idea just interested why not but maybe Christian do you want to do to just to elaborate on this.

The agreement that we have with NIH.

Yes of course, so Jim's initially of course I mean the class.

As soon as the new platform as you know the history suggests that we have.

A couple of years, we have kind of embarked on that so our goal has been to.

Demonstrate proof of concept or application and as many.

And the opportunities we can suddenly behalf facility like biosafety level for some modest improvement there.

There you would move some collaborations in Ied is looking at LASA.

I saw the different approaches in the past they have gone to <unk> in West Africa.

Africa, including Molly glad to have done some clinical trials, so as commercial potential for the company as Corrine said it may not be as of today.

Today, you know it doesn't look like it's increasing reported LASA.

There's more incidents coming to South America, and perhaps also having vast so who knows but certainly an I E. D. If the results are positive in our animal study been niet's interested in pursuing laughter in West Africa, and that would be another sort of proof of concept.

Approach for our pathology.

Isn't that a virus, so ah Ah such companywide again.

But certainly that's not a big sort of commercial uptake, but through collaboration proof of concept and if and I E. Do you want to do that further why not a company be taking a lead role at some point.

I think Korean my comment on that but that's another focus in South Dakota.

Okay. Great last question there just for Jeff if I could Jeff Opex been kind of trending down last few quarters of that you guys are doing a good job shepherding our cash as this level should just make going forward or we start seeing the opex, perhaps bumping up going through 'twenty four.

Yeah.

To date our.

Cash utilization in the sort of the low $4 million a quarter range and we will manage to that are the.

The big driver will be the phase one two study.

But as we mentioned the ovation two is fully enrolled and we're doing just a follow up on that.

And then the breakthrough cancer program with the Avastin is being funded largely up by.

That foundation, so what we're going to manage to.

Our quarterly cash utilization of four to four and a quarter.

Million.

Great. Thanks for taking the questions.

Yeah.

The next question comes from kept Oliver from Brookline Capital markets. Please go ahead.

Alright, Thank you and good morning so.

Couple of questions about the.

I am.

And yours are a one trial in combination with Avastin first when do you expect to activate Dana Farber and M. S. K.

Thank you can't yes very.

Rick.

We have not announced it yet, but we're expecting that there'll be a few cents escaped would be on book pretty soon.

Christian do you want to I'll give you a bit more color to my answer yes.

Yes.

Exactly occurring right with did a quiet initiation.

Call with them was it a couple of weeks ago, we did respond to their IRB caution standards. So I think they they could be very soon activated a the other one is johns Hopkins for phase one part of identifiable had from the very beginning they would participate from the phase two.

A part of the trial, so as Craig said M. S gave it should be there's no hiccups unexpected we should be making that announcement that should be coming on board. A lot of paper work has been completed with them. It basically setting up the contract all of the different approval from their committees I had made good headwind in that direction. So I'm SK is very likely coming up soon.

Yeah.

That's great. Thank you and.

This trial is using.

I believe carboplatin as in the comparator arm and you know that's been in short supply how have you been able to manage.

In terms of a both avail, you know availability, but then also cost.

Yeah, I mean, that's a good question we did run into this issue back in 2012 with docs. It looks you remember that was a big issue, but no. We haven't I mean did the centers that we are doing our studies that really big name So say.

Together with an M. D. Anderson has not brought that to your attention in terms of the cancer center, having any deficiency and Youre right. This is.

Chemotherapy is carboplatin and Paclitaxel.

Paclitaxel, so we haven't really heard from the sites yet.

Certainly the big centers, having any deficiency issues caused by this the standard of care.

Normally given to patients, but cisplatin is another course platinum based drug as you. So I'm not forecasting that you may have.

But I haven't heard anything about any problems with these Kansas Center, So I don't anticipate but a flattened always available there is another platinum drugs. So I, probably don't want to say here because you did point out something and if you haven't been really told that would be a concern. These centers, maybe a lot of smiles.

Perhaps that could be an issue as there was the docs are going to be about 25, five or so well have about four sites. So far it name. So I don't know I'm looking for that maybe we haven't been told by the sites yet.

Issue down the road certainly.

Yeah, and the corporate center, Okay, Oh, you know paid by the breakthrough cancer Foundation.

Right.

Two questions I apologize the first one is going to require you to repeat some information but.

I just wanted to be sure I understand it stood through this trial the timing of it.

Anticipated completion of enrollment and.

Availability of the first set of interim data youll provide cause.

I think the line was breaking up there it wasn't clear how those.

Line up together.

Okay.

Alright, so I will start and I'll, let Chris should continue so.

Anticipate that enrollment will be done cautiously for the first phase of the trial, which is a safety analysis of the combination of she was you went in and as Ive seen at least that's what the investigators are pinning us and of course.

So most centers come on board you know, what you will see an acceleration in new enrollment.

But Christian piece, if you could answer the second part of the question.

And.

Right.

Right.

I apologize if there was you know.

Sure. So what we had said.

In response to I believe James question that our initial cut of the data would be a safety of course, because it has not been combined with the gen. One so we hope to finish that phase one part of the study out I mean.

All depends on the enrollment for sites have been you know put into place initially, but they are trying to expand that.

And I would think second quarter.

That would be more of a safety clearance that are indeed this new combination is safe in patients and then from second quarter on a if you get more sites.

On board, we can probably get more enrollment and begin to update on a on the secondary equal across compute results over time, and perhaps maybe in quarterly update or so but in terms of completing that study I would say a korean or even Jeff can chime in here I would say, it's about a two years too.

<unk> completed the enrollment and are at least three sorry, it's just a couple more sites. So I think immediate as the safety data and sort of effect actually gets better maybe it trickled down you can update US open label studies, So I would say within two years, maybe it's maybe some significant data.

But overall survival is a longer end point that would probably take a long time.

Mature, but certainly peer and secondary necroscopy could get within two years. Some some meaningful data hopefully again this is what we're anticipating.

Also get frustrated with more sites.

Alright, Thank and came at this stage, we cannot give a very precise timelines are what we're waiting for our most interest are enrolled so it's a preliminary assessment really.

Correct.

Super.

Thank you.

And just the last question for Jeff or it relates to the trial and the breakthrough answer reimbursement well those essentially the reimbursements just net against your R&D expense or will those show up as grant revenue.

It'll be the former.

We anticipate.

We'll just treat what we're gonna be paying as R&D expense.

Okay.

Yeah.

Fabulous Thank you very much.

Okay.

The next question comes from David Bautz from Zacks small cap research. Please go ahead.

Hey, good morning, everyone and thanks for the update this morning, it's a question on the Covid seasonal booster vaccine plan for the phase one two trial, so I'm assuming that the phase one trials that can be.

T study in healthy volunteers, but then will you look to do an efficacy efficacy study in phase two.

David Thank you for your question Yeah. So in vaccine development and phase one already will have a immune response data right. So you'll have the neutralizing antibody data that you get quite rapidly you know after the injection of the vaccine so the phase one.

You already.

Give us that they tell you that's why I mean in the design of our program. We are looking for phase one slash two so we'll simply continue enrolling our interface to program with the chosen dose.

Yeah.

Yeah.

Okay, and then will the phase two having oh.

You can see in immuno yeah efficacy outcome in immuno J C D reactors in your city as well.

Yeah. So okay. Thanks.

The trial efficacy challenging human being right. So it's really the titers of antibodies neutralizing antibody really that's what you look at above baseline. So I think that essentially maybe what you're probably referring to African C. Part so it tasty.

At that that how much of it either.

From baseline and have gone up again. This particular variant that we're targeting in the variant of the you know our concern at that time, so basically neutralizing antibody titers above the baseline that's the measure of efficacy in vaccine studies typically as opposed to the therapeutic market alright and cancer. So yeah, there will be.

At that Investor.

Okay, great. Thanks for taking the question.

Thank you David.

This concludes our question and answer session I would like to turn the conference back over to management for any closing remarks.

Thank you.

We believe that our technology holds excellent promise in immuno oncology, it's all work in providing options to women with ovarian cancer looks very interesting and we're excited about reporting phase two data on her own.

Our next spring summer.

We've also been using the phrase a vaccine in the future to describe all work and that's 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 Bristol protection are stable at workable temperatures could be manufactured.

Rapidly to respond to evolving pathogen.

And offer better compliance for Maxim United States should with no need for device or virus, we very much look forward to keeping you informed of our progress has a very nice afternoon.

The.

France has now concluded. Thank you for attending today's presentation you may now disconnect.

Okay.

Okay.

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