Q3 2021 Celsion Corp Earnings Call
Good morning, My name is Bobby and I will be your operator today.
At this time I would like to welcome you to the Celsius corporations third quarter 2021 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.
Please keep in mind, if you're using a speakerphone you must released the mute function to allow the signal to reach our equipment.
Thats Star one to ask a question during the Q&A session.
At this time I would like to turn the call over to Kim to Golar debts. Please go ahead.
Thank you and cause the morning, everyone. This is Tim calling out two at L. E K.
Welcome to Celsius third quarter, 'twenty, 'twenty, one financial results and business update call.
As has been cellphones practice and 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 celsius expectations and projections about future events.
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 Commission.
All forward looking statements can be guaranteed and actual results may differ materially from such statements. In particular, there's 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 Celsius operation right now.
Our results and outlook is the best estimate based on the information for 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 15th 2021, Halcyon undertakes no obligation to revise or update comments made during this call except as required by law.
That said I'd like to turn the call over to Michael <unk>, Chairman CEO and President Michael.
Thank you Kim good morning, everyone.
Joining me today are Jeffrey Church, our Chief Financial Officer, who will review Celsius third quarter financial results in just a moment Dr.
Dr. Nicholas Borys, our Chief Medical Officer, and Dr. Chris <unk>, Our Chief Science Officer will be available during the Q&A session to answer your questions regarding our work with Gen, one and our vaccine initiative.
During the third quarter, we continued to make progress with our leading research programs utilizing our proprietary plasma based technology as you may note from our press release as promising clinical observations were reported for our lead investigational product Gen one and its potential.
Our recruiting the immune system, we expect our immuno oncology agent to improve outcomes for patients with advanced ovarian cancer.
Also note that our vaccine technology in preclinical data were presented during oral sessions at the International vaccine Congress Congress. This last October supporting our hypothesis for the organization potential of Pliocene are formulated DNA plasmid based vaccine.
Our very strong balance sheet, along with our ability to access sources of non dilutive capital well Celsius to reach key milestones and complete our randomized phase two study of Gen. One through final read out and report our proof of concept results for plasticine early next year without the immediate need for additional capital.
Now I'll briefly review these programs and provide an update on the important catalyst as we see them now.
[noise] shelf fields in depth understanding of plasma technology and vector construction underlies our research focus and provides the basis for our two leading product platforms third plus our first platform is our synthetic non viral DNA.
Delivery platform that has demonstrated its ability to deliver DNA plasmid repeatedly and successfully for successful cell transfection.
Over extended periods of time as much as six months in our phase two study.
Gen. One is our lead drug candidate on the surplus platform Gen. One incorporates the plasma and encoded for IL 12, a powerful anti cancer cytokine.
In our trials have shown unequivocally, it's ability to modify the tumor mic macro and micro environment shifting at the pro immune and the highly immunosuppressive environment of advanced ovarian cancer.
Translational data from our recent phase one study in newly diagnosed ovarian cancer patients is clear on this and it's consistent with the well known pharmacology of IL 12.
Access to these data can be had on our website, there's a link in the press release discussing.
The the publication of these data.
Oh. These are biological data appear to support observed dose dependent improvements in tumor response surgical results and pathological responses progression free survival appears favorable when compared to published historical studies or and when compared to a synthetic control arm provided to us by the well respected data.
Management CRM metadata.
And while the N is small coming from our phase one study with our medical advisers firmly believe that the trends are highly supportive of our continued clinical development program. We are now evaluating gen one's potential to improve a progression free survival, that's PFS and an open label randomized phase II study.
[noise] of newly diagnosed treatment naive advanced ovarian cancer cancer patients.
The ovation two study is designed with an 80% confidence interval for an observed PFS hazard ratio of <unk> 75.
In layman's terms means they are.
An approximate 30% improvement in risk for cancer progression.
Median time to progression.
When comparing the Gen one treatment arm with the controller.
This trial is being conducted in 2021 centers in the United States and one in Canada.
Including NYU Langill mass General Wash U University of Wisconsin, Madison University of Alabama, UC, San Diego and M. D. Anderson Cooper among other Premier clinical research centers.
As we noted in this morning's press release to study will recruit as few as 110 patients and as many as 130 and is now approaching 70% enrollment is to target a.
Minimum population.
We expect to complete enrollment early in the first quarter or first half I'm sorry, depending upon the N number of patients in the study with.
With final PFS readout occurring when ADP offense occur or 16 months median time on the study occurs whichever comes first.
This will put the data read out somewhere in the first half of 2023.
Now onto our second platform Pliocene Pliocene is our proprietary next generation vaccine platform the.
The hypothesis of which is being evaluated in a preclinical proof of concept initiatives using mrna based vaccines as a baseline comparator.
He has seen in its current iteration.
With multiple viral antigens encoded for a single DNA plasmid vector delivered with a synthetic non viral DNA delivery polymer.
Our working hypothesis is that a DNA plasmid of this construct has the potential to be superior to mrna vaccines and a number of ways for example, the.
Plasma comprised of multiple antigens reduces the possibility that evolving virus variance will escape vaccine independent immunity.
The quality of the immune response will be improve through a higher affinity neutralizing antibodies immunoglobulin G or I G. G titers and T cell response against multiple strains of.
Antigens.
Is expected to be superior.
We expect a longer duration of immune response to the longer duration of antigen expression from DNA versus mrna and based on our many years of experience with Gen. One we expect a more commercially appealing more stable product that workable temperatures.
We are pleased with our progress so far in September we announced results from preclinical in vivo studies showing production of antibodies and cytotoxic T cell response specific to the spike in the genus Sars Covid two.
For COVID-19.
Well, then immunizing, a bulb C mice with our fourth generation vector construct.
We noted of antibodies to the Sars Covid two spike candidate prevented the infection of cultured cells.
Firewall neutralizing assay.
The production of antibodies predicts the ability of players seem to protect against Sars Covid two exposure and the elicitation of cytotoxic T cell response shows the.
Vaccine's potential to eradicate infected cells infected with Sars Covid two.
These early findings, suggesting a great deal of potential were presented by our Chief Science Officer Officer, Dr. Chris Shean on war at the International vaccine Congress in October.
Also noticed that theres more work to do to fully establish our proof of concept from which we expect to demonstrate broad spectrum protection and resistance against variance and improved vaccine stability at storage temperatures of four degrees Celsius and above.
And to facilitate cheaper and faster manufacturing as compare to him RNA vaccines.
So where are we going with this.
There are several commercial Sars COVID-19 two vaccines on the market and.
And hundreds of millions of dollars being committed to COVID-19, vaccines and therapeutics by deep pocket Big and small pharma sheen.
You may be wondering why are we are devoting resources to this program now.
Well, we're thinking longer term and I'm not falling our immediate goal is to validate our vector in delivery technology in preclinical studies using mrna vaccines as compares.
What's your hypothesis is proven.
There should be a commercial should there be a commercial possibility.
We will seek development partners for a COVID-19 clinical trials also once our hypothesis is proven.
We expect to begin development of DNA plasmid vaccines to address a broad range of other infectious viral agents.
So at this point I'd be remiss, if I Didnt mentioned the role of our dedicated staff and partners in this effort dragging our researches an outstanding group of scientists.
<unk> recently been reinforced with individuals who bring advanced knowledge in molecular biology, immunology and vaccine development.
Continue to build relationships with development partners and vector construction.
Analytical methods and supply chain capability, we've improved our capacity to produce high volumes of research quantities of vaccine prototypes for a proof of concept work.
[noise] assembled a vaccine advisory board comprised of highly regarded researchers in the field.
I conclude my comments on class seen by saying that we continue to be excited and cautiously optimistic about the platform and its highly advantaged potential.
Now just a few comments on our balance sheet.
We continue to take advantage of various sources of capital available to us and along with the most recent raise of $13 9 million completed early April.
April this year.
We improved our cash position with the sale of $2 million of our New Jersey State net operating losses losses also earlier. This year. We also just received approval to sell later this year, an additional $1 5 million in Nols.
All available to us by the way, there's an additional three and a half million in Nols that can be sold over the next few years.
We further strengthened our balance sheet improved our cash flow this year with a new $10 million loan facility with Silicon Valley Bank, which allowed us to repay 6 million of higher interest ventured debt last quarter.
Jeff will provide more details about that financing, but the bottom line is that we have smartly strengthen our balance sheet.
With investor friendly common stock transactions and non dilutive sources of capital all of which support our cash runway now extends through 2024.
Our cash position as I mentioned earlier will allow us to reach a number of important development milestones, including PFS from the ovation. Two study in proof of concept reports from the plastic initiative with that I'll turn the call over to Jeff Church, who will go into more detail about our very strong financial position Jeff.
Thank you Michael detailed itself since third quarter 2021 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 CLC I ended the third quarter of 2021 was $66 million in cash and investment securities restricted.
Cash and accrued interest receivable over the past three years.
Any dilution to our stockholders, we have raised nearly $15 million from the sale of our New Jersey State net operating losses.
Which is equivalent to nearly four years of operating expenses. We have a we have a further $5 million of unused New Jersey Nols available per sale between 2022 and 2024.
One and a half million of which was approved last week by the New Jersey Economic development authority for sale. This year, which is expected to net the company about $1 $4 million, coupled with future sale of unused New Jersey Nols given our current spending plans. We believe we have sufficient capital resources to fund our <unk>.
Operations through the end of 'twenty 'twenty four we are in an excellent position with respect to liquidity to support us through several important value, creating milestones. Let me now turn to a review of our third quarter and year to date 2021 financial results for the quarter ended September 32021, just yet.
We reported a net loss of $5 $4 million or six cents per share. This compares with a net loss of $8 $1 million or 24 cents per share for the quarter ended September 32020.
Operating expenses were $5 2 million in the third quarter of this year, which is up about $900000 or 21% from operating expenses of $4 3 million for the third quarter of 2020, Let me break this down by line item research and development expenses were two and a half million dollars for the third.
Quarter of this year as well as the third quarter of last year clinic.
Clinical development costs for the phase III Optima study decreased to $200000 compared with half a million dollars for the prior year quarter due to the discontinuation of this 556 patient trial in the first quarter of 2021.
Research and development costs associated with development of Gen. One to support the ovation II program.
As well as supply scene, our DNA vaccine technology platform increased to $1 $3 million from $900000 in the prior year quarter other costs related to the company's clinical development programs decreased $1 million from $1 1 million in the prior quarter, largely driven by higher manufacturing costs.
For Gen. One clinical supplies for the phase II portion of the patients to study offset by lower regulatory and manufacturing costs related to the discontinued Optima study.
General and administrative expenses were $2 $7 million in the third quarter of 2021, compared with $1 $8 million for the third quarter of 2020. This $900000 increase is primarily attributable to higher noncash stock compensation expense of $200000 in any.
Kris and professional fees. These are largely legal fees of $600000 and an increase in premiums for our director and officers insurance of 100000.
On a year to date basis net cash used for operating activities was $11 1 million, which compares to $11 9 million for the same period in 2020.
Cash utilization is in line with our projections for 2021 of approximately $17 million or an average of about four and a quarter million dollars per quarter.
Cash provided by financing activities was $54 $8 million during the first nine months of 2021 derived from equity offerings in January and April proceeds from the $10 million loan facility with Silicon Valley Bank in June and the sale of our New Jersey Nols in May.
I'll now turn the call back to Mike.
Thank you Jeff.
And then just I just want to make a quick comment.
Our industry.
Certainly, including us and our industry is seeing an enormous amount of litigation.
For the most part meritless claims.
Oh, the cost to us this year are quite high.
And thin for many companies like us our D&O insurance costs continue to increase.
I think.
This Maryland this litigation.
This is something that needs to be addressed.
Through a legislative action to our shareholders.
We would encourage you to contact your legislators.
Let them know that.
So use of investor capital to defend against Meritless claims is just.
Oh, it's just outrageous and that needs to be.
Controlled true that's.
It's through some kind of legislative action.
So with that I want to say to our shareholders that I watch it and all of that were driven by a commitment to bring new medicines to patients and the medical community.
Supported by the daily work of our talented scientists clinicians and technical staff, we remain focused delivering against our research objectives, and our drive to create value for our shareholders shareholders.
So with that overview of our business and our recent financial results.
We are ready to open the call to questions. So would you do that for US. Please operator.
If you'd like to ask a question. Please press the star key followed by the one key on your Touchtone phone now.
We'll pause for just a moment to allow everyone the opportunity to signal for questions.
Okay.
And our first question comes from Kumar <unk> with Brookline capital markets.
Thanks for taking my questions and congratulations on all the progress.
It looks like you are doing well in terms of the enrollment went away from Brian.
In terms of the clinical trial sites, what are you seeing bidding comes up.
But it could be back to the level that goes before the COVID-19.
What are you seeing bid them and how is it different from different thing.
And in terms of this.
To be.
Where do you think do you really end up in their dreams.
Yeah, So Ken I'd like to answer the second question first if you don't mind.
So you know our our this is a phase II study our goal here is to.
Use the data to power a phase three.
The statistical plan.
Is designed with a Mac with up to 130 patients but are this is an event driven study.
So we're looking for 80 events frankly too.
Data sufficient to pork or 16 months on trial to have data sufficient.
To be able to.
Power the pivotal trial.
Where do we expect to be.
I am hopeful that it will be north of 110 patients.
Our experience we have with this investigational product and more confidence we have in the design of the phase III study.
However, with regards to patient enrollment, we have seen some ups and downs as my comment I'm going to ask Nick to comment on this also.
When oh at the at the height of the COVID-19.
The original variant whether it was the European or the wild type grant.
We saw a challenge enrolling patients.
More recently this past summer when the.
Delta virus.
Variant raised its head we.
Saw some.
Reluctance of patients to join our study.
I think we're seeing a pickup now.
And I, just I guess from that.
That's my point of view, Nick you have you have any comments on that.
Thank you Mike.
As you probably can guess the pandemic has had an impact on the patient recruitment in all cancer studies.
Patients are hesitant to go in for screening and also as you know in ovarian cancer one of the one of the problems with ovarian cancer is that there isn't really a good screening process. It's just basically picked up sometimes just through ambiguous symptoms. So as Michael said, we saw an uptick in our enrollment during this.
Summer when the when people are feeling good and safe going back to their physicians for checkups and then the second wave hit in the fall and we've seen a decrease more recently, we're now getting reports from our hospitals that are their staffing problems at the centers, but we still continue to.
Enrolled patients and I think that's a pretty good rate compared to overall, so we're optimistic to meet our timelines as Michael mentioned before and and I have to say that are pretty well, 90% of our sites are in fact enrolling patients actively so we're getting very good participation.
Okay.
I mean some of.
The DNA vaccine what are the next steps there and are you looking for external funding to move that forward.
Yeah.
So.
We are we.
We have sufficient capital to support our our proof of concept work we have.
Applied for grants from various government agencies.
The and we'll apply for more and we think that's.
Important as a validation of our work or whether or not we'll be successful obviously.
Uh huh.
I can't predict that but we think it's important to apply quite for them.
Government funding.
But bottom line is we have we have sufficient capital to take us through a proof of concept with regards to what is left to do a doctor on whereas on the line got crocheted do you want to.
Pick up the rest of the question. Please.
Thank you Michael sure.
So uh huh.
Concept.
Jack desire to demonstrate that from a single.
DNA based plasmid.
Spreads.
And again for us.
Two different streams of providers.
We have been modeling Sars COVID-19 two as a benchmark.
Commercial products out there for competitive purposes. So our goal for next couple of quarters to demonstrate from a single vector you can generate neutralizing antibodies.
Detailed responses against two screens off I'm, sorry, Scooby Doo neutralization assay demonstrates that.
This single.
Effective against two strains horses.
Vaccine that's designed for Oh.
L. A strain on me so that's the key thing.
D&A inherently has.
Better stability the Nomura.
We have to demonstrate.
Ability to manage through experimentation as Michael had said earlier that DNA expresses for long period of time from skeletal muscle.
As opposed to him so.
So our hypothesis is that you'll be able to demonstrate.
Nobody else.
Immune response from RBC.
So do you have some of the key.
Objectives that are ahead of us in terms of demonstrating POC.
Oh boy.
Just let me just jump in here to create would it be accurate to say that.
Our current.
The vector.
Like the.
The most recent construct.
Is showing its ability to be able to produce the <unk>.
Antigens for which is coated.
And now we're looking for all.
Ways to optimize the activity of that.
Factors that is that reasonable to say.
Yes, Sir.
Okay.
[noise] okay.
Hum.
And then some fly using gen, one immunotherapy, but I'll bet oncology indication.
Who are their fluids that are being done in that front then when can we get an update there.
So I think we're optimistic that once we show.
In this phase II study some positive results and we fully expect to do so.
All of that any inter peritoneal.
Peritoneal cavity cancer as a target for us.
Well, we haven't decided on which.
But any any any of them could be a an immediate target.
And that would include the broad range from a colorectal cancers too.
Liver cancers.
Two.
Hum.
Paint pancreatic cancers.
Christine can you like can you expand more on that place.
Yeah sure so.
The product that we're developing gen. One.
This is Florida.
Sorry, Tony on delivery.
I got it you can make IL 12.
And favorable immune changes.
[noise] environment, So obviously right now.
Going after ovarian cancer, because over 90% of cancer patients.
Our particle size into the cavity and the disease.
Local is the result of that so you control that.
Along the same lines there are some other G I.
Cancers.
We used about somewhere between 25, 30% of different Gi cancers also metastasized to the.
These include gastric cancer liver cancer is Michael.
Cancer colon cancer, so it'll.
It would be the same principle and easily meet these cancers are also you may know genic, so that would be a really next schools. We have demonstrated in animal models that the activity of Gen. One against these Gi cancers. So as Michael said once we have proof of concept with a leading cancer than I.
Thank.
Concept would be almost like parallel for other cancers demonstrated immune response local control of disease ovarian it would be very likely that we could go after one of these Gi cancers that you just mentioned to you earlier.
Thanks, so much for taking my questions and I look forward to the updates.
Thank you.
Yeah.
And our next question comes.
It's from David Dauch.
With Zacks small cap research.
Hello, Good morning, good morning, everybody.
Hi, So my first question is for the Ovation study I guess, it's kind of a technical question. So when a patient is said to have no residual disease is that based on the surgeons opinion or is that somehow quantified them.
Nick.
Thanks, very much for that question, yes, it is quantified.
Two levels number one yeah, it's based on the surgeons evaluation of what the what if there's any residual disease left on the cavity and from tissue. That's sent to pathology for review to see if theres any disease left so those two are.
Into that role and and then on top of that we're also looking at overall response from the C. T findings and the final pathological court and as you know historically, our zero, where the surgeon feels that they completely remove the disease is typically found in most of the large studies that around.
50% of the time and in our studies so far very consistently we're seeing in our zero response and 75% of the time and this is probably our biggest topic of discussion in our PR meetings.
Okay, great thanks for that and as far as releasing additional data from the study.
When do you expect to do that we'll be at the next quarterly update call or will it be sometime between them.
Sometime in between then we're hopeful to be able to collect enough.
Information supported by the investigator is their investigator.
Our reported results.
To be able to collect enough information to provide an update probably within the next few weeks.
Okay sounds good and lastly on the Covid vaccine. So it kind of sounds like you're leaning more towards developing a multi strain vaccine versus the multi antigen vaccine am I understanding that correctly or is that still up in here.
You have it correct Christian you want to talk about that a little bit place.
Yes.
You remember correctly.
Sure.
Global sort of overall objective is to develop them.
Vaccine against two antigens.
Virus with immune modifiers.
However for last six seven months as this time could be too.
The pandemic is emerging and things have been changing.
I'll have learned that.
Actually the strain change modifications of wireless is also equally important you may have enough population that dominant.
And then in the emerging stream so we feel that.
Seeing the conditions that we had the widest is developing and it might be more prudent at this stage to develop the technology.
For two strains where you can quickly target the prevalent and an emerging a strain that wouldn't be the need of the hour at this stage now however for a multiple antigen approach that you had mentioned.
We have demonstrated the construction of <unk> plasmid from where we have shown the expression of spike antigen and M antigen.
Right.
We also have shown from the same single plasmid, though you can express I am 12.
So indeed, the construction of our multiple chronic vector.
Multiple genes to Gs talks clearly tier two sub unity trial, well four genes are expressed successfully so if you do have that eventual Goldman.
If you demonstrate the.
Activity against two screens off the charts. Good we do have to need of the hour, we can certainly build on it.
No you know two and did you just the same thing you know how to do genes are there. So you could have two different antigens and also certain viruses that are difficult to handle audits. We HIV you know theres no vaccine effective at this stage, we believe that if you could click expressed on immune modifier.
And you know with the same plasma, which we have shown IL 12 can be that could really address some of those challenges in a difficult to handle pathogens. So its an incremental approach to strains right now that's more what's needed and down the road with built our technology would you now going into our advantage.
Immune modifiers.
Yeah, I think it's just one of those.
As good as Dr. <unk> points out is there are pop assist that.
Singled DNA plasmids can produce.
More than one.
Protein or antigens along with the.
With an immune system modifier is not compromise at all by this minor change in direction, which we think is a more it's more.
Urgent.
And maybe.
It may be more attractive to a collaborator fill it demonstrate the capability for more than one variant of the disease.
And so I mean, and this is just the proof of concept. The variant that we also got variance that we ultimately may end up with could be different than those that are currently being evaluated.
Evaluated in the existing construct.
And that really is the beauty of this technology the ability to rapidly adapt the.
Vector construct for the most prevailing.
Medical issue.
So it sounds like your are you limited to just.
To antigens or proteins from different strains that you can express.
No I think that was pretty clear and and Chris sheets comments.
We've shown proof of concept with as many as four proteins to ask the gyms and the two sub unit proteins for IL 12.
Okay.
Yeah.
Alright, great I appreciate you taking the questions.
Thank you thank you for asking.
And as a reminder, if you would like to ask a question. Please don't star one.
Our next question will come from Mike Wirth Who's Celsius.
Well, while I was wondering if.
Hi, How're you doing Sir I was wondering if you guys had an update from you guys of the FDA as far as the fast track designation goes.
So fast track designation was granted based on an application that we submitted over.
Over the summer so that that was granted the.
Ovation two study well in our study of ovarian cancer generally with the Gen. One has been granted fast track along with orphan designation.
So orphan designation in the United States and.
Europe provides us with among many other things.
Hey, and exclusive market from a regulatory standpoint in the United States and Europe of seven and 10 years.
Track of course recognizes the importance of finding.
A therapeutics for some.
Very serious in unaddressed medical needs in this case its ovarian cancer.
But it is not granted on that basis alone.
F T eight we provide the FDA with evidence that.
Some early evidence that the approach that were taking has some.
Potential I would say a great deal of potential.
To provide an improvement in the treatment of these patients. So a disease that has a relatively high unmet medical need has emergency for.
A therapy or a cure along with data.
It suggests that the work that we're doing has a potential to be successful as required.
For the FDA to grant fast track, which has been granted for this program.
Right. So is it so the updates will come at the end of each phase or is there a way that it's good.
Good to go by the end of phase two with the if the data shows promising that it's currently showing there's more or less my question.
Oh I got you so fast track pre.
Provides the company with the opportunity and ongoing opportunity to interface with the agency.
On the question so as they come up during the course of the development.
Certainly on the design of the clinical trials, including the discussion of a surrogate endpoints that could give us a faster or quicker.
<unk> to be able to evaluate the drug's effectiveness.
Along with the you know as I said the study design I think we're.
Considering various approaches to reduce the amount of time in the clinic to demonstrate efficacy.
So that's that's kind of encore ultimately the value of course for fast track here.
Ends up at the.
At the approvals or the a N D. A in this case a BLA stage.
Where the fast track designation allows.
The F D a to consider a priority review.
For your application, which reduces the review time by a substantial amount.
So I hope that answers your question.
Okay. Thank you Sir.
Thank you.
And that concludes our question and answer session I will turn the call back over to Michael Giardina for closing remarks.
So I think all of you for joining our conference call. This morning and for those who've asked questions. We really do appreciate your questions. It gives an opportunity to expand more on.
On the on the work that we're doing and are related to the questions or concerns that you may have we encourage more questions Oh and I'm sure. We'll continue to get them as our studies progress, but again I want to thank all of you for your time. This morning I've Trust we've conveyed.
Our excitement about the potential of Gen. One.
Platte, Plas and vaccine development platform.
For which we have.
A great deal of hope.
Well given the number of.
Our infectious agents for which there is a.
Oh no no real.
In immunotherapy vaccine available.
We look forward to keeping you informed on our progress and are perhaps seeing some of you in San Francisco or in person.
Well as we understand it now J P. Morgan Health care conference will be.
Health and in person during the second week of January.
And if you are attending.
And wish to speak with us please.
You can make arrangements through our IR firm by contacting Jay to schedule a meeting.
So with that I will conclude this conference call. Thank you all very much.
Thank you. This concludes today's call you may now disconnect.
[music].
[music].
Good morning, My name is Bobby and I will be your operator today.
At this time I would like to welcome you to the Celsius corporations third quarter 2021 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.
Please keep in mind, if you are using a speakerphone you must released the mute function to allow the signal to reach our equipment.
Thats Star one to ask a question during the Q&A session.
At this time I would like to turn the call over to Kim to Golar debts. Please go ahead.
Thank you and good morning, everyone. This is Tim gobbling up to L. A chat welcome to Celsius third quarter, 2021 financial results and business update call.
It has been cellphones practice and 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 celsius expectations and projections about future events generally 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 Commission.
No forward looking statements can be guaranteed and actual results may differ materially from such statements. In particular, there is 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 Celsius operations then.
Actual results and outlook is the best estimate based on the information for 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 15th 2021.
<unk> 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 Michael <unk>, Chairman CEO and President Michael.
Thank you Kim good morning, everyone.
Joining me today are Jeffrey Church, our Chief Financial Officer, who will review <unk> third quarter financial results in just a moment.
Dr. Nicholas Borys, our Chief Medical Officer, and Dr. Chris Heat Anwar, our Chief Science Officer will be available during the Q&A session to answer your questions regarding our work with Gen, one and our vaccine initiatives.
During the third quarter, we continued to make progress with our leading research programs utilizing our proprietary plasma based technology. As you may note from our press releases promising clinical observations were reported for our lead investigational product Gen one and its potential.
We are recruiting the immune system, we expect our immuno oncology agent to improve outcomes for patients with advanced ovarian cancer.
Also note that our vaccine technology in preclinical data were presented during oral sessions at the International vaccine Congress Congress. This last October supporting our hypothesis for the organization potential of Pliocene are formulated DNA plasmid based vaccine.
Our very strong balance sheet, along with our ability to access sources of non dilutive capital while Celsius to reach key milestones and complete a randomized phase II study of Gen. One through final read out and report our proof of concept results for <unk> early next year without the immediate need for additional capital.
Now I'll briefly review these programs and provide an update on the important catalyst as we see them now.
Cell phones in depth understanding of plasma technology and vector construction underlies our research focus and provides the basis for our two leading product platforms <unk>. Our first platform is our synthetic non viral DNA.
Delivery platform that has demonstrated its ability to deliver DNA plasmid repeatedly and successfully for successful cell transfection.
Over extended periods of time as much as six months in our phase II study.
Gen. One is our lead drug candidate on the tariff last platform. Gen. One incorporates the plasma encoded for IL 12, a powerful anti cancer cytokine that in our trials has shown unequivocally its ability to modify the tumor mic macron microenvironment shifting at the pro a meal and a highly immunosuppressive environment.
<unk> of advanced ovarian cancer.
Published translational data from our recent phase one study in newly diagnosed ovarian cancer patients is clear on this and is consistent with the well known pharmacology of IL 12.
Access to these data can be had on our website, there's a link in the press release discussing.
The the publication of these data.
Oh. These are biological data appear to support observed dose dependent improvements in tumor response surgical results and pathological responses progression free survival appears favorable when compared to published historical studies or and when compared to a synthetic control arm provided to us by the well respected data.
Management CRM meta data.
And while the N is small coming from our phase one study with our medical advisers firmly believe that the trends are highly supportive of our continued clinical development program. We are now evaluating gen one's potential to improve a progression free survival, that's PFS and an open label randomized phase II study.
<unk> of newly diagnosed treatment naive advanced ovarian cancer cancer patients.
The ovation two study is designed with an 80% confidence interval for an observed PFS hazard ratio of <unk> 75.
In layman's terms means a an approximate 30% improvement in risk for cancer progression.
The median time to progression.
When comparing the Gen one treatment arm with the controller.
This trial is being conducted in 'twenty, one 'twenty one centers in the United States and one in Canada.
Including NYU Langill mass general Wash U and the University of Wisconsin, Madison University of Alabama, UC, San Diego and MD Anderson Cooper among other Premier clinical research centers.
As we noted in this morning's press release to study will recruit as few as 110 patients and as many as 130 and is now approaching 70% enrollment is to target a.
Minimum population.
We expect to complete enrollment early in the first quarter or first half I'm sorry, depending upon the N number of patients in the study with final PFS readout occurring when ADP offense occur or 16 months median time on the study occurs whichever comes first.
Put the data read out somewhere in the first half of 2023.
Now onto our second platform class St. Pliocene is our proprietary next generation vaccine platform.
Hypothesis of which is being evaluated in a preclinical proof of concept initiatives using mrna based vaccines as a baseline comparator.
<unk> has seen in its current iteration is designed with multiple viral antigens encoded for a single DNA plasmid vector delivered with a synthetic non viral DNA delivery polymer.
Our working hypothesis is that a DNA plasmids of this construct has the potential to be superior to mrna vaccines and a number of ways for example.
Plasma income comprised of multiple antigens reduces the possibility that evolving virus variance will escape vaccine independent immunity.
The quality of the immune response will be improve through a higher affinity neutralizing antibodies immunoglobulin G. R. I G G titers and T cell response against multiple strains of Paas.
<unk>.
Is expected to be superior.
We expect a longer duration of immune response due to the longer duration of antigen expression from DNA versus mrna and based on our many years of experience with Gen. One we expect a more commercially appealing more stable product that workable temperatures.
We are pleased with our progress so far in September we announced results from preclinical in vivo studies showing production of antibodies.
Inside of toxic T cell response specific to the Spike antigenic Sars Covid two.
For COVID-19.
Well immunizing, a bulb C mice with our fourth generation vector construct.
We noted of antibodies to the Sars Covid two spike antigen prevented the infection of cultured cells.
Firewall neutralizing assay the.
The production of antibodies predicts the ability of <unk> to protect against Sars Covid two exposure than the elicitation of cytotoxic T cell response shows the vaccines.
Vaccine's potential to eradicate infected cells infected with Sars Covid two.
These early findings, suggesting a great deal of potential were presented by our Chief Science Officer Officer, Dr. Chris sheet on war at the International vaccine Congress in October.
Also noted that there is more work to do to fully establish our proof of concept from which we expect to demonstrate broad spectrum protection and resistance against variance and improved vaccine stability at storage temperatures of poor degrees Celsius and above.
And to facilitate cheaper and faster manufacturing as compared to mrna vaccines.
So where are we going with this.
There are several commercial Sars COVID-19 two vaccines on the market and.
Hundreds of millions of dollars being committed to COVID-19, vaccines and therapeutics by deep pocket Big and small pharma shoot.
So you may be wondering why are we are devoting resources to this program now.
Well, we're thinking longer term and I'm not falling our immediate goal is to validate our vector in delivery technology in preclinical studies using mrna vaccines as compares.
What's your hypothesis is proven.
There should be a commercial should there be a commercial possibility.
We will seek development partners for a COVID-19 clinical trials.
So once our hypothesis is proven we.
Expect to begin development of DNA plasmid vaccines to address a broad range of other infectious viral agents.
Now at this point I'd be remiss, if I Didnt mentioned the role of our dedicated staff and partners in this effort driving our researches an outstanding group of scientists that has recently been reinforced with individuals who bring advanced knowledge in molecular biology, immunology and vaccine development.
We continue to build relationships with development partners and vector construction analytical methods and supply chain capability, we've improved our capacity to produce high volumes of research quantities of vaccine prototypes for our proof of concept work and have assembled a vaccine advisory board comprised of highly regarded researchers.
Field.
I conclude my comments on <unk> by saying that we continue to be excited and cautiously optimistic about the platform and its highly advantaged potential.
Now just a few comments on our balance sheet.
We continue to take advantage of various sources of capital available to us and along with the most recent raise of $13 9 million completed early April.
April.
This year.
We improved our cash position with the sale of $2 million of our New Jersey State net operating loss losses also earlier. This year. We also just received approval to sell later this year, an additional $1 5 million in Nols.
All available to us by the way is an additional three and a half million in Nols that can be sold over the next few years.
We further strengthened our balance sheet improved our cash flow this year with a new $10 million loan facility with Silicon Valley Bank, which allowed us to repay $6 million or higher interest ventured debt last quarter.
Jeff will provide more details about that financing, but the bottom line is that we have smartly strengthen our balance sheet.
With investor friendly common stock transactions and non dilutive sources of capital all of which support our cash runway now extends through 2024.
Our cash position as I mentioned earlier will allow us to reach a number of important development milestones, including PFS Kumar ovation. Two study in proof of concept reports from the plastic initiative with that I'll turn the call over to Jeff Church, who will go into more detail about our very strong financial position Jeff.
Thank you Michael detailed itself since third quarter 2021 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 sales team ended the third quarter of 2021 with $66 million in cash and investment securities restricted.
Cash and accrued interest receivable over the past three years.
About any dilution to our stockholders, we have raised nearly $15 million from the sale of our New Jersey State net operating losses.
Which is equivalent to nearly full years of operating expenses. We have a we have a further $5 million of unused New Jersey Nols available for sale between 2022 and 2024.
$1 5 million of which was approved last week by the New Jersey Economic development authority for sale. This year, which is expected to net the company about $1 $4 million, coupled with future sales of unused New Jersey Nols given our current spending plans. We believe we have sufficient capital resources to fund our <unk>.
Operations through the end of 2024, we are in an excellent position with respect to liquidity to support us through several important value, creating milestones. Let me now turn to a review of our third quarter and year to date 2021 financial results for the quarter ended September 32021 sales count.
Our reported a net loss of $5 4 million or <unk> <unk> per share. This compares with a net loss of $8 1 million or 24 per share for the quarter ended September 32020.
Operating expenses were $5 2 million in the third quarter of this year, which is up about $900000 or 21% from operating expenses of $4 3 million for the third quarter of 2020, Let me break this down by line item research and development expenses were $2 5 million for the third.
Quarter of this year as well as the third quarter of last year clinic.
Clinical development costs for the phase III Optima study decreased to $200000 compared with $5 million for the prior year quarter due to the discontinuation of this 556 patient trial in the first quarter of 2021.
Research and development costs associated with development of Gen. One to support the ovation II program.
As well as supply seen DNA vaccine technology platform increased to $1 $3 million from $900000 in the prior year quarter other costs related to the company's clinical development programs decreased $1 million from $1 1 million in the prior quarter, largely driven by higher manufacturing costs.
For Gen. One clinical supplies for the phase II portion of the <unk>, two study offset by lower regulatory and manufacturing costs related to the discontinued Optima study.
General and administrative expenses were $2 $7 million in the third quarter of 2021, compared with $1 $8 million for the third quarter of 2020. This $900000 increase is primarily attributable to higher noncash stock compensation expense of $200000 in any.
Kris and professional fees. These are largely legal fees of $600000 and an increase in premiums for our director and officers insurance of 100000.
On a year to date basis net cash used for operating activities was $11 1 million, which compares to $11 9 million for the same period in 2020.
Cash utilization is in line with our projections for 2021 of approximately $17 million or an average of about four and a quarter million dollars per quarter.
Cash provided by financing activities was $54 $8 million during the first nine months of 2021 derived from equity offerings in January and April proceeds from the $10 million loan facility with Silicon Valley Bank in June and the sale of our New Jersey Nols in May.
I'll now turn the call back to Mike.
Thank you Jeff.
And then just I just want to make a quick comment.
Our industry.
Certainly, including us and our industry is seeing an enormous amount of litigation.
For the most part and parcel meritless claims.
The cost to us this year are quite high.
And then for many companies like us our D&O insurance costs continue to increase.
I think.
This sub Maryland This litigation.
It is something that needs to be addressed.
Through a legislative action to our shareholders.
We would encourage you to contact your legislators and let them all of that.
This use of investor capital to defend against Meritless claims is just.
It's outrageous and that needs to be.
Controlled through us through some kind of legislative action.
So with that I want to say to our shareholders.
Watch it and all of that were driven by a commitment to bring new medicines to patients and the medical community.
Supported by the daily work of our talented scientists clinicians and technical staff, we remain focused delivering against our research objectives, and our drive to create value for our shareholders shareholders.
So with that overview of our business and our recent financial results.
We are ready to open the call to questions. So would you do that for US. Please operator.
If you'd like to ask a question. Please press the star key followed by the one key on your Touchtone phone now.
We'll pause for just a moment to allow everyone the opportunity to signal for questions.
Okay.
Okay.
Okay.
And our first question comes from Kumar, Roger with Brookline capital markets.
Thanks for taking my questions and congratulations on all the progress.
It looks like your green will in terms of the enrollment for the away from Brian.
In terms of the clinical trial sites.
Seeing bidding comes up.
But a group went back to the level that was before the COVID-19.
What are you seeing there and how is it different from different sectors.
And in terms of this.
101.
Hum.
Where do you think do you really end up being their dreams.
Yeah. So can I would like to answer the second question first if you don't mind.
So you know our our this was a phase II study our goal here is to.
Use the data to power a phase three.
The statistical plan.
Is designed with a Mac with up to 130 patients but are this is an event driven study.
So we're looking for 80 events are frankly too.
Data sufficient two or 16 months on trial data sufficient.
To be able to.
Power the pivotal trial.
Where do we expect to be.
I am hopeful that we'll be north of 110 patients. The more experience we have with this investigational product and more confidence we have in the design of the phase III study.
With regards to patient enrollment, we have seen some ups and downs as my comment I'm going to ask Nick to comment on this also.
At the at the height of the COVID-19.
The original variant whether it was the European or the wild type grant.
We saw a.
A challenge enrolling patients.
More recently this past summer when the.
Delta virus.
Variant raised its head.
We saw some.
Reluctance for patients to join our study I think we're seeing a pickup now.
And I, just I guess from.
That's my point of view the neck.
Do you have any comments on that.
Thank you Mike.
As you probably can guess the pandemic has had an impact on patient recruitment in all cancer studies.
Patients are hesitant to go in for screening and also as you know in ovarian cancer one of the.
And one of the problems with ovarian cancer is that there isn't really a good screening process. It's just basically picked up sometimes just through.
Ambiguous symptoms so as Michael said, we saw an uptick in our enrollment during the summer when the when people are feeling good and safe going back to their physicians for checkups.
Then the second wave hit in the fall.
And we've seen a decrease more recently, we're now getting reports from our hospitals that are there as staffing problems at the centers, but we still continue to enroll our patients and I think.
Pretty good rate compared to overall, so we're optimistic to meet our timelines as Michael mentioned before and and I have to say that.
Pretty well, 90% of our sites are in fact enrolling patients actively so we're getting very good participation.
Okay.
Hum the DNA vaccine what are the next steps there.
And are you looking for external funding to move that forward.
Yeah.
So.
We.
We have sufficient capital to support our our proof of concept work we have.
Applied for.
Grants.
From various government agencies.
The and we'll apply for more and we think that's it.
Important is validation.
Validation of our work whether or not we'll be successful obviously.
Uh huh.
You can't predict that but we think it's important to apply applied for.
Government funding.
But bottom line is we have we have sufficient capital to take us through a proof of concept with regards to what is left to do Dr. <unk> on the line Crocheted do you want to.
Pick up the rest of the question. Please.
Thank you Michael sure.
So as.
As a proof of concept objectives are to demonstrate that from a single.
DNA based plasmid.
Spreads.
Antigen for.
Two different streams of providers, who you have been modeling SAR excuse me too as a benchmark because commercial products out there for comparative purposes. So our goal for next couple of quarters is to demonstrate from a single vector you can generate neutralizing antibodies.
ITG.
Responses against two strains off.
Saar Scooby Doo neutralization assays demonstrate that.
This single.
Effective against two strains versus a vaccine that's designed for a single strain on me. So that's the key thing.
DNA inherently had.
Better stability the Nomura.
We have to demonstrate.
The ability to manage through experimentation as Michael had said earlier that DNA expresses for long period of time.
Healthy muscle.
As opposed to Jim.
Our hypothesis is that you'll be able to demonstrate.
The ability of.
Immune response from our vouchers as well.
Do you have some of the key.
Objectives that are ahead of us in terms of demonstrating POC.
Oh boy.
Great.
Let me just jump in here to create would it be accurate to say that.
Our current.
The vector.
The.
The most recent construct.
Is showing its ability to be able to produce the.
Antigens for which it is coated.
And now we're looking for.
All ways to optimize the activity of that.
That factors that is it reasonable to say.
Correct, Yes, Sir.
Okay.
Okay.
Hum.
And then some fly using gen. One immunotherapy funnel that oncology indication warrant their fluids that are being done in the front and when can we get an update there.
Yeah.
So I think we're optimistic that once we show all.
In this phase II study some positive results and we fully expect to do so.
That any inter peritoneal.
Peritoneal cavity cancer as a target for us.
Well, we haven't decided on which.
But any any any of them could be a an immediate target.
And that would include the broad range from colorectal cancers.
Liver cancers.
Two.
Hum.
Maybe paint pancreatic cancers.
Christine can you can you expand more on that please.
Yeah sure so.
The product that we're developing gen. One.
This is the first trial.
Tony I'll delivery.
Hi.
You can make IL 12.
Uh huh.
Favorable immune changes.
[noise] environment, So obviously right now.
We are going after ovarian cancer, because over 90% of cancer patients.
Size into the cavity and the disease local as a result of that so you control that.
On the same lines there are some other G I.
Cancers.
Somewhere between 25, 30% of different Gi cancers also metastasized to the.
These include gastric cancer liver cancer is Michael.
Cancer colon cancer. So it would be the same principle and easily meet these cancers are also you mean genic.
So that would be a really next school we have demonstrated in animal models that the activity of <unk> against these Gi cancers. So as Michael said once we have proof of concept with Davita and cancer, then I think that that cause.
So it would be almost like parallel for other cancers demonstrated immune response local control of disease.
Ian would be very likely that we could go after one of these G.
Gi cancer.
I mentioned to you earlier.
Yeah.
Thanks, so much for taking my questions and I look forward to the update.
Thank you.
And our next question comes from David <unk> with Zacks small cap research.
Hello, Good morning, good morning, everybody.
Okay.
So my first question is for the Ovation study I guess, it's kind of a technical question. So when a patient is said to have no residual disease is that based on the surgeons opinion or is that somehow quantified.
Nick.
Thanks, very much for that question.
Yes. It is quantify the on two levels number one yes, it's based on the surgeons evaluation of what the what if there's any residual disease left on the cavity and from tissue. That's sent to pathology for review to see if theres any disease left so those.
To play.
Play into that role and and then on top of that we're also looking at overall response from the <unk> findings and the final pathological court and as you know historically, our zero, where the surgeon feels that they completely removes the diseased.
Typically found in most large studies that around 50% of the time and in our study so far very consistently we are seeing in our zero response and 75% of the time and this is probably our biggest topic of discussion in our PR meetings.
Okay, great thanks for that and as far as releasing additional data from the study when do you expect to do that will it be at the next quarterly update call or will it be sometime between them.
Yeah.
Sometime in between then we're hopeful to be able to collect enough information.
Information supported by the investigator as their investigator our reported.
Good results.
To be able to collect enough information to provide an update probably within the next few weeks.
Okay sounds good and lastly on the Covid vaccine. So it kind of sounds like you're leaning more towards developing a multi strain vaccine versus the multi antigen vaccine am I understanding that correctly or is that still up in here.
You have it correct Christian you want to talk about that a little bit place.
Yes.
Hum.
Have you remember it correctly.
Global.
Overall objective is to develop.
[noise] vaccine against two antigens in.
On a virus with immune modifiers quality. However for last six seven months as this could be too.
The pandemic is emerging and things have been changing.
I'll have learned that.
Actually this trend change.
Modification the wireless is also equally important.
Having a population that dominant.
Strain and then an emerging strength, so we feel that.
<unk> seen.
Seeing the conditions the way the wireless is developing and it might be more prudent at this stage to develop the technology.
For two strains where you can quickly target the prevalent and an emerging constrained that would be the need of the hour at this stage now however for multiple antigen approach that you had mentioned.
We have demonstrated the construction of <unk> plasmid from where we have shown the expression of spike antigen and M antigen.
Yes.
We also have shown from the same single plasmid, though you can express IL 12.
Indeed, the construction of a multitude of Sonic vector.
These multiple genes to genes for tariffs clearly tier two sub unity trial, well four genes would express successfully so we do have that eventual goal.
If you demonstrate the activity against two strains of charges could we do that to need of the hour. We can certainly build on it.
You know two and did you just the same thing you know what to do with jeans out. There. So you could have two different antigens and also certain viruses are difficult to handle audits. We HIV. There's no vaccine effective at this stage, we believe that if you could call expressed on immune modifier.
And you know with the same plasma, which we have shown IL 12 can be that could really address some of those challenges.
Difficult to handle pathogens. So its an incremental approach to stands right now that's more what's needed and down the road, we built our technology.
Now going into.
Two antigen immune modifiers.
Yeah, I think just on the business.
As good as Dr. <unk> points out is there are if offices today.
Single DNA plasmids can produce.
More than one.
Protein or antigen.
Along with the.
With an immune system modifier is not compromised at all by this minor change in direction.
Which we think is a more it's more.
Urgent.
And.
They may be more attractive to a collaborator.
To demonstrate the capability for more than one variance of the disease.
And so this is just a proof of concept. The variant that we also got variance that we ultimately may end up with could be different than those that are currently being.
Evaluated in the existing construct.
And that really is the beauty of this technology the ability to rapidly adapt the.
Vector construct for the most prevailing.
Medical issue.
So it sounds like your are you limited to just two antigens or proteins from different strains that you can express.
No I think that was pretty clear in and Chris sheets comments that we've shown proof of concept with as many as four proteins two antigens in the two sub unit proteins for IL 12.
Okay.
Alright, great I appreciate you taking the questions.
Thank you thank you for asking.
And as a reminder, if you would like to ask a question. Please dial star one.
Our next question will come from Mike Wirth with Celsius.
Well, while I was wondering if how you doing Sir I was wondering if you guys had an update from you guys of the FDA as far as the fast track designation goes.
So fast track designation was granted based on an application that we submitted all.
Over the summer so that that was granted.
Ovation two study well in our study of ovarian cancer generally with Gen. One has been granted fast track along with orphan designation.
So orphan designation in the United States and.
Europe provides us with among many other things.
Hey, and exclusive market from a regulatory standpoint in the United States and Europe, a seven to 10 years.
Track of course recognizes the importance of finding.
Hmm.
<unk> therapeutics for some.
Very serious in unaddressed medical needs in this case its ovarian cancer.
But it's not granted on that basis alone.
F T H, we provide the FDA with evidence that.
Some early evidence that the approach that were taking has some.
Potential I would say a great deal of potential.
To provide an improvement in the treatment of these patients so a disease that has a.
Relatively high unmet medical need has some urgency for a therapy or a cure along with data.
That suggests that the work that we're doing has a potential.
Potential to be successful as required.
For the FDA to grant fast track, which has been granted for this program.
Right. So is it so the updates will come at the end of each phase or is there a way that it's.
Good to go by the end of phase two if the if the data shows promising that it's currently showing there's more or less my question.
Oh I got you so fast track.
Provides the company with the opportunity and ongoing opportunity to interface with the agency.
Questions as they come up during the course of the development and certainly on the design of the clinical trials.
Clothing, the discussion of surrogate endpoints that could give us a faster or quicker means.
It means to be able to evaluate the drug's effectiveness.
Along with as I said the study design I think we're.
Considering various approaches to reduce the amount of time in the clinic to demonstrate efficacy.
So that's that's kind of ongoing.
Ultimately the value of course for fast track.
Ends up at the.
At the approvals or the NDA in this case, a BLA stage.
Where the.
Fast track designation allows.
The F D a to consider a priority review.
For your application, which reduces the review time by a substantial amount.
So I hope that answers your question.
Okay. Thank you Sir.
Thank you.
And that concludes our question and answer session I will turn the call back over to Michael Giardina for closing remarks.
So I think all of you for joining our conference call. This morning and for those who have asked questions. We really do appreciate your questions. It gives an opportunity to expand more.
On the on the work that we're doing and related to the questions or concerns that you may have we encourage more questions.
And I'm sure, we'll continue to get them as our studies progress, but again I want to thank all of you for your time. This morning I've Trust we've conveyed.
Our excitement about the potential of Gen. One had our plat plas and vaccine development platform.
For which we have.
A great deal of hope.
Given the number of.
Infectious agents for which there is a.
No no real.
Immunotherapy vaccine available.
Well, we look forward to keeping you informed on our progress and are perhaps seeing some of you in San Francisco in person.
As we understand it now J P. Morgan healthcare conference will be.
Health and in person during the second week of January.
And if you are attending.
And wish to speak with us please.
You can make arrangements through our IR firm by contacting I'll, let Jay to schedule a meeting.
So with that I will conclude this conference call. Thank you all very much.
Thank you. This concludes today's call you may now disconnect.