Q4 2020 Celsion Corp Earnings Call

[music].

Ladies and gentlemen, good morning, My name is David and I will be your operator today at this time I would like to welcome you all to Celsius 'twenty 'twenty financial results Conference call. All lines have now been placed on mute to prevent any background noise. Following our speakers' 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 are 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. At this time I would now like to turn the conference over to Mr. Kim go with <unk>. Please go ahead ma'am.

Thank you and good morning, everyone. This is Kim gala, that's what Jay welcome to Celsius corporations, 'twenty 'twenty financial results and business update conference call.

Has been Celsius practice and as noted by the operator prepared remarks will be followed by a question and answer period.

During this 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 re.

<unk> and uncertainties, including those set forth in the Companys 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 significant uncertainty about the duration and contemplated impact of the COVID-19 pandemic. This means results could change at any time and the contemplated impact of COVID-19 on cellphones operations financial 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 March 19th 2021 Celsius 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 tied to announce cellphones.

Chairman CEO and President Michael.

Thank you Kim.

Good morning, everyone.

Joining me today are Jeffrey Church, our Chief Financial Officer, who will provide an overview of <unk> recent financial results.

Dr. Chris <unk>, our Chief Science Officer, who will address questions regarding our recently announced vaccine initiative.

And Dr. Nicholas Borys, who will join us for Q&A Dr.

Dr Vorst as our Chief Medical Officer.

I'd like to start by saying that we kicked off 2020 with great hope and anticipation.

Never expecting to face a global pandemic, we're complete refocus for our company.

2020 turned out to be a year of enormous challenge.

I Trust that you recognize that in many ways, we rose to the occasion.

Today, the company is financially strong and focused on our pipeline of product candidates that have every potential to deliver significant value.

I'm proud of our staff from their ability to navigate the events of 2020 there.

Their work has positioned us for the opportunities that we have outlined in our recent press releases and that I wont be addressing on the call. This morning.

Importantly, we have been diligent in our capital formation responsibilities.

A broad range of facilities and incentives we have provided and.

In the most shareholder friendly ways, our cash runway that will see us through multiple anticipated value creating milestones.

Jeff Church will discuss these in more detail, but it's safe to say that our optimism that our gene based immunology will benefit patients and shareholders alike is supported with a strong balance sheet.

I have to say that we grow more confident in our future virtually each and every day.

Yeah.

We're advancing two immunology platform, starting with third plus or.

Our novel synthetic non viral delivery platform.

Good for them organically developed in our Huntsville, Alabama laboratories under the direction of Doctor on War.

This has been his life's work.

And underlies the basis for our platforms first drug candidate Gen. One our DNA mediated IL 12, immunotherapy now showing evidence of promise in later stage clinical oncology trials.

And adaptation of the surplus technology.

Forms our second product initiative this time, leveraging our delivery IP to unlock the potential of our novel multi <unk>.

For multiple gene.

Plasma technology, which has the potential for significant advancement over existing nucleic acid vaccine approaches.

As we envision it the placid DNA technology platform represents a highly capable basis for the development of next generation <unk> vaccines with the ability to target a range of infectious diseases, including Sars type pandemic factors and their continuing mutations, which as you know.

He had been wreaking havoc around the world.

Our third plus technology has proven it works.

This nanoparticle technology provides a means to transfect cells with DNA payloads coded for proteins for therapeutic value.

Unlike viral delivery systems that can only be administered once third classes not subject to the neutralizing activity of a patient's immune system. The beauty of our technology is that it does not have the risk of viral carriers and can be administered repeatedly as we have seen administered weekly.

Over a six month period, and our ovarian cancer studies.

Okay.

These characteristics make it ideal for tight trading cancer treatments, and particularly immuno therapy.

To date, approximately 100 patients have been treated with gen. One in ovarian cancer studies. These results. So far demonstrate excellent safety translational data that clearly show activation of a significant immune response and along with those dependent clinical observations, suggesting potential patient patient benefit.

Yeah.

I'll come back to a gen. One innovation in the ovation two study and in a minute, but first I want to talk about our recent and exciting news.

Let me just try to answer the question why are we participating in this crowded space of.

Covid vaccine development after.

After careful evaluation of a number of nucleic acid based COVID-19 vaccine programs.

We concluded that an adaptation of our <unk> technology may represent a significant advancement in this highly effective next generation a vaccinology.

Frankly after much consideration.

We felt obligated to pursue proof of concept I would say, even a moral obligation I mean, how could we not.

We trade name to say reputation of our proprietary plasma technology as the plasticine platform.

And it's the subject of a recently filed provisional patents.

That was announced in January of this year.

This broad application covers a family of novel composition of Multistem tronic sectors, and polymer nanoparticles that comprise pliocene for preventing.

And potentially simultaneously, providing therapeutic for their therapeutic activity for treating infectious agents, many of which have the capacity for global Pandemics.

Our provisional patent construct and claims support the potential for multiple features and benefits and I'd like to highlight a few of them for you now.

[noise] Glassine may offer broad spectrum, and mutational resistance against variance by targeting multiple antigens with a single placement vector.

By including a potent immune modifier like IL 12 that can be encoded into the single plasmid efficacy may be enhanced by improving humoral and cellular responses to viral antigens.

Being DNA based as opposed to RNA <unk>.

<unk> produces cellular activity that may result in longer and more durable antigen expression, providing a robust vaccine response to infection.

So I've seen allows for stability across the reasonable and readily achievable temperature range ambient to refrigeration.

It is compatible with global vaccine storage and distribution systems.

And pricing is a synthetic delivery system that should require a simple injection intramuscularly sub Q or intradermal <unk> that does not require a viral capsid or special equipment to deliver its payroll payload like electroporation.

Going forward, we expect to complete our proof of concept work in the lab, followed by IND, enabling in vivo small animal studies in nonhuman Primate studies over the course of this year. If the results are encouraging and we expect they will be.

We will be immediately petitioning the FTA for an M D and at the same time look for development partners and then and then begin work on a whole range of unaddressed infectious diseases.

Exciting times for the company and I promise you, we will keep you posted.

Yeah.

Meanwhile, we have the ovation two study a very important trial open labeled randomized phase II study of Gen. One in newly diagnosed advanced ovarian cancer patients.

Patients, whose tumor burden is too great for immediate surgical intervention intervention.

For ovation two study combines gen. One gen one with standard of care and Neo adjuvant chemotherapy or NAC T.

In patients with newly diagnosed stage three and for ovarian cancer.

The goal of any C. T is to shrink the cancer and dry up the societies as much as possible for optimal surgical removal of disease tissue.

Following <unk>.

And concurrently.

Eight weekly cycles of Gen. One are administered to patients patients that undergo integral de bulking surgery, which is then followed by three edge of in cycles of chemotherapy and concurrently up to nine additional weekly Gen. One treatments the goal of our treatment strategies to delay progression and improve overall survival.

<unk> two is 80% powered to show up and approximate 33% reduction in risk for cancer progression, otherwise known as progression free survival or PFS.

Yes.

To date.

Over 40% of the anticipated 110 patients have been or are being enrolled in this study among 23 active sites in the U S and Canada.

Through mid March.

28 patients have had integral de bulking surgery as we reported the following results are these.

13 of 16 or 81% of patients in the treatment arm had in our zero resection, which indicates and Microsoft microscopically margin negative complete resection in which no growth from Microsoft's microscopic tumor remains in the tumor bed.

Only 58 per cent of patients in the control arm.

Zero resection.

This interim data represents a 41% improvement in our zero resections for Gen. One patients and is consistent with our reported improvement in resection scores noted in the ovation one phase one study, which has been submitted for peer reviewed publication.

And as you know our zero resections represent a good predictor for improved survival.

Three more sites are expected to be added by the end of April for a total of 26 sites recently, our clinical investigators held a virtual meeting and express their optimism for gen one's potential to improve treatment options for advanced ovarian cancer patients.

For only about a quarter of these patients for effective immune therapies like PARP inhibitors for the remainder of there are a few options.

Our investigators believe that Gen. One can stimulate the immune system for an improved result in a much broader group of patients.

Importantly, despite the challenges in earlier delays posed by the COVID-19 pandemic, our P. I remain confident and committed to completing enrollment in the study well before the end of 2021 assuming of course, there are no surprises from the pandemic that would interfere with the trial.

We expect to release overall response rate and surgical resection scores as they become available during the course of 2021, our model suggests that the study's primary endpoint PFS.

Will be announced in late 2022 or early 2023.

In recent weeks. So we received fast track designation from the FDA for the ovarian cancer indication.

Which is an extremely important step in the development of the drug and has not given freely as you know.

Assuming a positive trial outcome. This designation supports an expedited path to market. We are hopeful that gen. One represents a game changer for women with advanced ovarian cancer.

Also I want to remind you that Gen. One has received orphan designation from both the U S FDA and EMA.

Which enhances the commercial value of Gen. One in particular, the orphan designation received from the EU in 2020 provides for among other thing other.

Other things 10 years of market exclusivity following market approval.

In the U S. Orphan designation provides seven years market exclusivity falling marketing approval.

But before I turn the call over to Jeff Church to review the financial results and our strong balance sheet I want to remind you.

Of one thing in our clinical study like the phase three Optima study does not mean a failed drunk.

Salsa and continues to work closely with and supports clinical and non clinical investigator sponsored Thermodox studies throughout the world.

In indications like breast cancer pancreatic cancer renal cancer rectal cancer.

G B M in solid tumors in children.

Okay.

Following inquiries from the NIH.

We intend to renew our cooperative research and development agreement a crater.

With the institutes at a nominal cost.

One goal of which is to pursue their interest in our study of thermodox to treat patients with bladder cancer.

To accommodate this research sales team is developing in an economically efficient business model to support these investigator sponsored studies in a manner that will not interfere with the company's new focus on our Gen. One programs and our vaccine development initiative.

We'll have more to say about that in the coming months.

With that I'll turn the call over to Jeff.

Jeff Thank Michael details itself beyond 2020 financial results were included in the press release, we issued this morning and in our form 10-K, which we filed today before the market opened as Michael indicated the company's balance sheet is as strong as it's been in many years and we ended the year 2020 was $17 $2 million in cash.

Cash and cash equivalents. This compares to $14 $9 million at the end of 2019. Shortly after year end. The company took steps to streamline our capitalization table and extend our cash operating runway, which I'll discuss in a moment for the full year 2020 net cash used for operating activities was <unk>.

Clean $6 million. This is down from $20 3 million used in 2019 total cash provided by financing activities. During the year was approximately $18 million and that was the result of $22 $8 million of net proceeds from sales of common stock less as Youll remember.

$5 $2 million related to the repayment and restructuring of our venture debt with horizon financial.

The company recognized a $1 $8 million income tax benefit from the sale of New Jersey net operating losses during the fourth quarter of 2020 and 2019 in late 2020, the New Jersey State Legislature expanded the technology business tax certificate transfer program by increasing the limitation.

From $15 million per company to $20 million per company, we took significant steps in 2020 to reduce our operating expenses, while maintaining a tight focus on our key value drivers.

Subsequent to year end, we raised over $43 million in gross proceeds from the sale of common stock.

When factoring in an estimate.

First quarter spending we currently have approximately $56 million in cash on our balance sheet. This provides an operating runway through 2023, and our current cash usage for $5 million per quarter.

We expect to receive net proceeds of 1 million eight.

<unk> thousand dollars.

From the sale of our New Jersey State Nols before April 15th of 2021.

Also recall that during the third quarter, we restructured our venture debt with horizon, thereby reducing our outstanding debt obligation from $10 million down to 5 million. Let me now turn to a review of our 2020 operating results for.

For 2020, the company reported a net loss of $21 $5 million or <unk> 67 per share. This compares to a net loss in 2019 of $16 $9 million or <unk> 77 per share operating expenses.

Were $19 million in 2020, which represented a $2.1 million or 10% decrease from the $21 $1 million reported in 2019, let me break this down by line item research and development expenses were $11 $3 million compared to $13.1 million a year ago.

So a 14% decrease.

Clinical development costs for the phase III Optima study decreased by $1 $9 million to $2 $2 million in 2020 costs associated with the ovation two study Gen. One in ovarian cancer increased.

<unk> increased to $1 $3 million in 2020 compared to $600000 in 2019 as enrollment of the phase II portion of this study commenced in the third quarter of 2020 other costs related to our clinical development programs decreased by.

$700000 in 2020 due to lower regulatory costs for the Thermodox development program General and administrative expenses were $7 $6 million in 2020 compared to $8 million in the prior year. This 5% decrease was primarily due to lower compensation costs, including non.

Noncash stock option compensation expense compared with 2019.

Now these lower operating expenses were offset by two non cash charges. In 2020. The first is a non cash charge of $1 $3 million related to the potential milestone payment for the Gen. One ovarian cancer product candidate and the second is a non cash charge of $2 $4 million related to.

The impairment of certain in process R&D assets, the company incurred one $3 million for interest expense and $1 4 million in the prior year.

Our interest income was $100000 in 2020 compared to $500000 in the prior year.

I'd now like to turn the call back to Michael Thank.

Thank you Jeff.

I want to close our prepared remarks by underscoring that Celsius.

It has great potential to create value for our shareholders and future patients and a highly capable staff committed to bringing life saving medicines to market.

We have versatile platform technologies in the exciting area of nucleic acid therapy, our competencies span the scope.

And what is required to rigorously evaluate our drug candidates our relationship with regulatory authorities, both in and outside the United States are exemplary.

And as Jeff pointed out we have cash sufficient and with smart spending and prudent cash management, we expect to deliver on our promises over the next three years.

During the months.

When we were working hard the refocus of the company were relatively quiet as you know, particularly with.

With respect to our activities in <unk>.

And with the investment community.

I'm pleased to note that we did recently participated in the 33 annual Roth Conference held virtually this week.

Including one on one meetings.

We expect to be participating in additional conferences of the year unfolds, we will keep you posted.

We also plan to conduct virtual non deal Roadshows.

And ultimately hopefully back to live events before the end of the year, so with that as an overview of our business and our financials, we'd now like to open the call to your questions operator.

Thank you ladies and gentlemen at this time the floor is open for your questions. If you would like to ask a question you may do so now by pressing star one on your Touchtone phone. Please.

Please make sure that your mute function or disabled to allow your signal to reach our equipment.

Again, if you'd like to ask a question.

Star One now and we'll give it just a moment to allow everyone an opportunity to signal for questions.

Yeah.

Yeah.

[noise] [noise], Okay, operator, alright, our first question comes from.

She'd been Doosan ROI with Brookline.

Yeah.

Good morning, Sheila.

Hi, Good morning, I'm sure bamboo on behalf of Tomorrow.

From really.

Appreciate the business update thank you Oh.

I was just I had a question with regards to the vaccine program.

The other.

I mean, the other preclinical data for <unk>.

Hum.

The only thing.

In terms of Goldman <unk>, neither for the technical problems downstream.

You anticipate challenges, especially for older patients and not that we were really happy with that seems all day.

No.

And that's a good question.

Nick do you want to try to adjust for instance.

Hi, This is Nick for US, yes, Thats a very good question and as you know the way we are dealing with the Covid is an evolving issue.

The U S. FDA has published guidance documents on them for consideration.

Doing clinical trials for the next generation of agents. So part of this might not require the same type of very large patient populations that you've seen with the previous virus.

Development plans, so we'd be working closely with the FDA to find the most efficient patient population and depending on the.

The aim of our vaccine will work with the FDA Accordingly, but I think youll see in the future there'll be different types of clinical trials, probably not as large as what we've been seeing in the past.

I'd like to add to that also.

[noise], then maybe more broadly more strategically you know.

This is a very crowded field as I pointed out in my prepared remarks sand.

Well as you know I mean, we're very new for this vaccine.

Vaccinology technology.

In our <unk>.

Median goal here is to establish proof of concept.

And to.

Petition and receive.

Approval for an IND from the FDA.

I think at this point that the companies the company will obviously outline a clinical.

Its pathway trial pathway going forward as Dr. <unk> pointed out.

But truly I think given the advantages that we anticipate from a DNA vaccine approach.

Particularly using a single plasmid multi <unk> or multi gene as we talked about it.

We will be looking for development partners at that point.

Particularly among those players who.

Have they already have a foothold in the market and so.

The company is very realistic very very realistic about the potential for challenges.

With a clinical program for COVID-19.

More importantly, however, more broadly however.

Once we've established proof of concept in a sars like environment.

Environment.

We intend as I said earlier, we intend to leverage that.

To begin addressing a number of <unk>.

Dressed vaccine or vaccine opportunities and I think before we get off the call. Since there is not all I'm doing a lot of questions in the queue maybe.

Doctor on <unk> could you talk about some of the other.

Vaccine opportunities that this DNA single plasmid multi gene approach.

Could address.

Yes, Michael.

Clearly.

Using DNA based vaccines, we have advantage over other today.

No.

Thanks.

Against the pathogen so as Michael said once we have proof of concept, we could really expand.

Spend technology into other pathogens and clearly that's something that is under consideration in house and.

We could really consider two different directions go after.

Pathogens, such as CMV honest suite.

Infections that there is no vaccine.

And so that could be certainly those types of pathogens.

Uh huh.

There's still work to do.

This type of vaccines are used so those are some other areas are under consideration now but.

But that's the sort of.

Thank you.

Constantly looking into what could be the potential market based on the potential partner also so symbiotic species include or was there some other.

What I can say type of packages, we could go after.

Thank you so much time for someone's whether it'd be dangerous listen I just had a quick question with regards to the approval of Gen. One milk from what's been done.

Blaine.

I believe you you'll have the water out and you have to do that by the end of the year so would that be.

For the expedited approval from.

[noise] well that's I mean, that's another good question worked for cause.

Ducting.

Randomized phase II study.

We are we're likely not.

The current construct and likely not to have enough patients for a definitive result.

But Dr. Boris is exploring an adaptation or an adaptive approach maybe you want to talk a little bit about that Nick Yes. Sure. You know as you mentioned the data that we have immediately right now is just to see.

The extent that the surgeons could remove the tumor at integral to bulking. So our zero rates are are very good at.

The primary endpoint of the study is progression free survival. So that takes place many months.

After the patients complete their chemotherapy. So we are exploring other avenues, where we could use an accelerated process.

With the FDA on on getting an approval type of design for a study.

There's much to be explored there may be using combination endpoints.

And at seeing if we can accelerate that so I think we'll be talking much more about that in the near future.

Sounds good. Thank you so much for taking my questions.

Okay.

Thank you. Our next question comes from stockholder, a junior menu will.

Good morning, Jay good.

Good morning, how are you doing today.

Very good thank you.

So you spoke of.

Thermodox in that you guys have or are not planning to give up on that technology and I applaud that.

Can you talk a little bit more about some of the other use cases, you are a little bit more in depth about the other direction do you think that you may be taking that you briefly touched on that but I was hoping you might elaborate a little bit more.

Yeah.

Well that's a good question.

As I said earlier in my prepared remarks on our clinical study does not mean a failed drug can we we know thermodox quite well.

Uh huh.

Feel that its mechanism has some potential value in medicine. Unfortunately, we did not demonstrate.

Efficacy and primary liver cancer.

And we can all speculate about the reason behind that.

So our role here going forward will be limited.

We have a number of.

Called Premier investigators, who have expressed an interest in continuing their research.

In both the preclinical and clinical.

Situations or trials.

We have promised them and we will continue to.

To support these trials with our.

In our institutional knowledge.

And with product.

We have a solid supply chain and can continue to share.

To support these activities, but there are I mean, we've talked about.

Some work Thats being done in Utrecht, some work Thats being done in Oxford more recently.

A very strong interest almost.

I almost call it a demand frankly, and I say that kind of tongue in cheek from the NIH.

And maybe.

Nick you can talk a little bit about the Oxford in the Utrecht studies, if you don't mind share.

Sure.

As you know Oxford University.

<unk> has probably the most experience in.

In terms of the clinical.

Experienced with Thermodox.

Published in the lancet two years ago on their work in liver cancer and now they'd like to apply that work into pancreatic cancer using this new cutting edge technology called HIFU or high intensity focused ultrasound. This is a new way of heating deep structures into the body.

Theyre very excited about that I think you'll be hearing more about that again. This year. We also have work that's being initiated in Utrecht and this is what Mike was alluding to in terms of breast cancer and the idea would be that thermodox can play an important role in patients.

That are interested in having lumpectomies instead of radical surgery. So this is where again HIFU is being applied thermodox is being applied and it might be a great alternative for patients that are good candidates for lumpectomy. So we continue to be excited about the future for Thermodox and saw many of our investigators.

As Mike said.

So I just.

Close this out with the.

We will we probably will.

We won't be hearing much from us with regards to our thermodox going forward.

The company's focus really would be in this area of immunology and vaccinology.

Unless of course, there are some breakthroughs there.

<unk>.

Important for medicine from frankly from these investigator sponsored studies.

Okay.

Yeah.

Thank you at this time, we have no other questioners in the queue. So I'll turn it back to our speakers for closing comments.

Well I want to thank all of you who are participating in the call. This morning.

I want you to know that we are.

Very committed to our work were driven by this commitment to bring new medicines to patients in need.

And by the work of the talented for clinicians and scientists and the technical staff that participate in our trials and our preclinical work.

And we think we have something very very important in terms of platform technologies that can add measurably to the.

Exciting new generation of vaccines that are currently addressing COVID-19.

If we're right the advance that we make.

Provides can provide substantial improvements and durability our range of treatments.

And capability to address the.

The <unk> capability of pathogens.

So we will continue our work there along with our very important work in oncology.

This phase II study for ovarian cancer patients extremely important to us certainly very important too.

The investigators from the patients with <unk>.

This newly diagnosed are very difficult to treat indications.

We will look forward to keeping you appraised of our progress and as always we are available to you for questions.

We will speak again shortly after the first quarter.

To you our 2021 first quarter results. We trust you will have a nice afternoon. Thank you very much.

Ladies and gentlemen that concludes this morning's presentation. Thank you for your participation you may now disconnect.

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Ladies and gentlemen, good morning, My name is David and I will be your operator today at this time I would like to welcome you all to <unk> 2020 financial results Conference call. All lines have now been placed on mute to prevent any background noise. Following our speakers' remarks, there will be a question and answer session at that time, you May press star one on your phone to <unk>.

Ask a question. Please keep in mind. If you are 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. At this time I would like to turn the conference over to Mr. Kim go well. That's please go ahead ma'am.

Thank you and good morning, everyone. This is <unk>.

Welcome to <unk> Corporation's 2020 financial results from business update conference call.

Has been cell phones practice and as noted by the operator prepared remarks will be followed by a question and answer period.

During this call management will be making forward looking statements regarding <unk> 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 re.

<unk> and uncertainties, including those set forth in the Companys 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 significant uncertainty about the duration and contemplated impact of the COVID-19 pandemic.

This means results could change at any time and the contemplated impact of COVID-19 on sales Jones operations financial results and outlook.

Guesstimate based on the information for today's discussion.

I also caution that the content of this conference call is back from it only as of the date of the live broadcast March 19th 2021 Celsius 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 join.

Joining me today are Jeffrey Church, our Chief Financial Officer, who will provide an overview of <unk> recent financial results.

Dr. Chris <unk>, our Chief Science Officer, who will address questions regarding our recently announced vaccine initiative.

And Dr. Nicholas Force, who will join us for our Q&A, Dr. Vorst as our Chief Medical Officer.

I'd like to start by saying that we kicked off 2020 with great hope and anticipation never.

Never expecting to face a global pandemic or complete refocus for our company 2020 turned out to be a year of enormous challenge.

I Trust that you recognize that in many ways, we rose to the occasion.

Today, the company is financially strong and focused on our pipeline of product candidates that have every potential to deliver significant value I'm.

I'm proud of our staff from their ability to navigate the events of 2020, there work has positioned us for the opportunities that we have outlined in our recent press releases and that I wont be addressing on the call. This morning.

Importantly, we have been diligent in our capital formation responsibilities.

Using a broad range of facilities and incentives we have provided.

In the most shareholder friendly ways, our cash runway that will see us through multiple anticipated value creating milestones.

Jeff Church will discuss these in more detail, but it's safe to say that our optimism that our gene based immunology will benefit patients and shareholders alike is supported with a strong balance sheet.

I have to say that we grow more confident in our future virtually each and every day.

Yeah.

We're advancing two immunology platform, starting with therapy class or.

Our novel synthetic non viral delivery platform.

That form organically developed in our Huntsville, Alabama laboratories under the direction of Dr around where.

This has been his life's work.

And unrealized the basis for our platforms first drug candidate Gen. One our DNA mediated IL 12, immunotherapy now showing evidence of promise in later stage clinical oncology trials.

And adaptation of the <unk> technology.

Forms our second product initiative this time, leveraging our delivery IP to unlock the potential of our novel multi cyst tronic.

For multiple gene.

Plasma technology, which has the potential for significant advancement over existing nucleic acid vaccine approaches.

As we envision it the placid DNA technology platform represents a highly capable basis for the development of next generation <unk> vaccines with the ability to target a range of infectious diseases, including Sars type pandemic factors and their continuing mutations, which as you know.

Had been wreaking havoc around the world.

Our third plus technology is proven it works.

This nanoparticle technology provides a means to transfect cells with DNA payloads coded for proteins of therapeutic value.

Unlike viral delivery systems that can only be administered once thermoplastic not subject to the neutralizing activity of a patient's immune system. The beauty of our technology is that it does not have the risk of viral carriers and can be administered repeatedly as we have seen administered weekly.

Over a six month period, and our ovarian cancer studies.

Okay.

These characteristics make it ideal for tight trading cancer treatments, and particularly immuno therapy.

To date, approximately 100 patients have been treated with gen. One in ovarian cancer studies. These results. So far demonstrate excellent safety translational data that clearly show activation of a significant immune response, and along with dose dependent clinical observations, suggesting potential patient patient benefit.

Okay.

I'll come back to a gen. One innovation in the ovation two study and in a minute, but first I want to talk about our recent and exciting news.

Let me just try to answer the question why are we participating in this crowded space of.

Covid vaccine development after.

After careful evaluation of a number of nucleic acid based COVID-19 vaccine programs.

We concluded that an adaptation of our <unk> technology may represent a significant advancement in this highly effective next generation a vaccinology.

Frankly after much consideration.

We felt obligated to pursue proof of concept I you know I would say, even a moral obligation I mean, how could we not.

We trade name this adaptation of our proprietary plasma technology as the plasticine platform.

And it's the subject of our recently filed provisional patents.

That was announced in January of this year.

This broad application covers a family of novel composition of Multistem Tronic factors and polymer nanoparticles that comprise Pliocene for preventing.

And potentially simultaneously, providing therapeutic for their therapeutic activity for treating infectious agents, many of which have the capacity for global Pandemics.

Our provisional patent construct and claims support the potential for multiple features and benefits and I'd like to highlight a few of them for you now.

[noise] Glassine may offer broad spectrum, and mutational resistance against variance by targeting multiple antigens with a single plasmid vector.

By including a potent immune modifier like IL 12 that can be encoded into this single plasmid efficacy may be enhanced by improving humoral and cellular responses to viral antigens.

Being DNA based as opposed to RNA <unk>.

<unk> produces cellular activity that may result in longer and more durable antigen expression, providing a robust vaccine response to infection.

So I've seen allows for stability across the reasonable and readily achievable temperature range ambient to refrigeration.

That is compatible with global vaccine storage and distribution systems.

And pricing is a synthetic delivery system that should require a simple injection intramuscularly sub Q or intradermal <unk> that does not require a viral capsid or special equipment to deliver its payroll payload like electroporation.

Going forward, we expect to complete our proof of concept work in the lab, followed by IND, enabling in vivo small animal studies in non human Primate studies over the course of this year. If the results are encouraging and we expect they will be will be immediately petitioning the FTA for an M D and at the same time look for development partners.

And then and then begin work on a whole range of unaddressed infectious diseases.

Exciting times for the company and I promise you, we will keep you posted.

Meanwhile, we have the ovation two study a very important trial open labeled randomized phase II study of Gen. One in newly diagnosed advanced ovarian cancer patients patient.

Patients, whose tumor burden is too great for immediate surgical intervention intervention.

Our ovation two study combines gen. One gen. One with standard of care Neo adjuvant chemotherapy or N T.

In patients with newly diagnosed stage three and for ovarian cancer.

The goal of MCT is to shrink the cancer and dry up the ascites as much as possible for optimal surgical removal of disease tissue.

Following the <unk>.

And concurrently.

Eight weekly cycles of Gen. One are administered to patients patients that undergo interval de bulking surgery, which is then followed by three edge of in cycles of chemotherapy and concurrently up to nine additional weekly Gen. One treatment the goal of our treatment strategies to delay progression and improve overall survival.

<unk> two is 80% powered to show up and approximate 33% reduction in risk for cancer progression, otherwise known as progression free survival or PFS.

To date.

Over 40% of the anticipated 110 patients have been or are being enrolled in the study among 23 active sites in the U S and Canada.

Through mid March.

28 patients have had integral de bulking surgery as we reported the following results are these.

13 of 16 or 81% of patients in the treatment arm had on our zero resection, which indicates and Microsoft microscopically margin negative complete resection in which no growth for Microstat microscopic tumor remains in the tumor bed.

Only 58 per cent of patients in the control arm had a Saar zero resection.

This interim data represents a 41% improvement in our zero resections for Gen. One patients and is consistent with our reported improvement in resection scores noted in the ovation one phase one study, which has been submitted for peer reviewed publication.

And as you know our zero resections represent a good predictor for improved survival.

Three more sites are expected to be added by the end of April for a total of 26 sites.

<unk>, our clinical investigators held a virtual meeting and expressed our optimism for gen one's potential to improve treatment options for advanced ovarian cancer patients.

For only about a quarter of these patients that are effective immune therapies like PARP inhibitors for the remainder of there are a few options.

Our investigators believe that Gen. One can stimulate the immune system for an improved result in a much broader group of patients.

Importantly, despite the challenges in earlier delays posed by the COVID-19 pandemic, our P. I remain confident and committed to completing enrollment in the study well before the end of 2021 assuming of course, there are no surprises from the pandemic that would interfere with the trial.

We expect to release overall response rate and surgical resection scores as they become available during the course of 2021. Our model suggests that the study's primary endpoint PFS will be announced in late 'twenty 'twenty two or early 2023.

In recent weeks. So we received fast track designation from the FDA for the ovarian cancer indication, which is an extremely important step in the development of the drug and has not given freely as you know.

Assuming a positive trial outcome. This designation supports an expedited path to market. We are hopeful that gen. One represents a game changer for women with advanced ovarian cancer I also want to remind you that Gen. One has received orphan designation from both the U S FDA and EMA.

Which enhances the commercial value of Gen. One in particular, the orphan designation received from the EU in 2020 provides for among other thing other.

Other things 10 years of market exclusivity falling market approval.

In the U S. Orphan designation provides seven years market exclusivity falling marketing approval.

Now before I turn the call over to Jeff Church to review the financial results and our strong balance sheet I want to remind you.

For one thing and a clinical study like the phase three Optima study does not mean a failed drunk.

<unk> continues to work closely with and supports clinical and non clinical investigator sponsored Thermodox studies throughout the world.

In indications like breast cancer pancreatic cancer renal cancer rectal cancer.

GBM and solid tumors in children.

Okay.

Following inquiries from the NIH.

We intend to renew our cooperative research and development agreement a crater.

With the institutes at a nominal cost.

One goal of which is to pursue their interest in our study of thermodox to treat patients with bladder cancer.

To accommodate this research sales team is developing in an economically efficient business model to support these investigator sponsored studies in a manner that will not interfere with the company's new focus on our Gen. One programs and our vaccine development initiative.

We'll have more to say about that in the coming months.

With that I'll turn the call over to Jeff Jeff. Thanks, Micro details itself beyond 2020 financial results were included in the press release, we issued this morning and in our form 10-K, which we filed today before the market opened as Michael indicated the company's balance sheet is as strong as it's been in many years and we ended the year 2020 with <unk>.

$17 $2 million in cash and cash equivalents. This compares to $14 $9 million at the end of 2019. Shortly after year end. The company took steps to streamline our capitalization table and extend our cash operating runway, which I'll discuss in a moment for the full year 2020.

Net cash used for operating activities was $15 $6 million. This is down from $20 3 million used in 2019 total cash provided by financing activities. During the year was approximately $18 million and that was the result of $22 $8 million of net proceeds from sales of <unk>.

Stock less as Youll remember up $5 $2 million related to the repayment and restructuring of our venture debt with horizon financial.

The company recognized a $1 $8 million income tax benefit from the sale of New Jersey net operating losses during the fourth quarter of 2020 and 2019 in late 2020, the New Jersey State Legislature expanded the technology business tax certificate transfer program by increasing the limitation for.

$15 million per company to $20 million per company.

We took significant steps in 2020 to reduce our operating expenses, while maintaining a tight focus on our key value drivers subsequent to year end, we raised over $43 million in gross proceeds from the sale of common stock.

Factoring in an estimate of first quarter spending we currently have approximately $56 million in cash on our balance sheet. This provides an operating runway through 2023 at our current cash usage of $4 $5 million per quarter, we expect to receive net pro.

<unk> of $1.800 million for.

From the sale of our New Jersey State Nols before April 15th of 2021 also recall that during the third quarter, we restructured our venture debt with horizon, thereby reducing our outstanding debt obligation from $10 million down to 5 million. Let me now turn to a review of our 2020 operating results.

For 2020, the company reported a net loss of $21 $5 million or <unk> 67 per share. This compares to a net loss in 2019 of $16 $9 million or <unk> 77 per share operating expenses.

For $19 million in 2020, which represented a $2.1 million or 10% decrease from the $21 $1 million reported in 2019, let me break this down by line item research and development expenses were $11 $3 million compared to $13.1 million a year ago.

A 14% decrease.

Clinical development costs for the phase III Optima study decreased by $1 $9 million to $2 $2 million in 2020 costs associated with the ovation two study Gen. One in ovarian cancer <unk>.

Increased to $1 $3 million in 2020 compared to $600000 in 2019 as enrollment of the phase II portion of this study commenced in the third quarter of 2020 other costs related to our clinical development programs decreased by.

$700000 in 2020 due to lower regulatory costs for the Thermodox development program General and administrative expenses were $7 $6 million in 2020 compared to $8 million in the prior year. This 5% decrease was primarily due to lower compensation costs, including non.

Noncash stock option compensation expense compared with 2019.

Now these lower operating expenses were offset by two non cash charges. In 2020. The first is a non cash charge of $1 $3 million related to the potential milestone payment for the Gen. One ovarian cancer product candidate and the second is a non cash charge of $2 $4 million related to.

The impairment of certain in process R&D assets, the company incurred $1.3 million for interest expense and $1 4 million in the prior year.

Our interest income was $100000 in 2020 compared to $500000 in the prior year.

I'd now like to turn the call back to Michael Thank.

Thank you Jeff.

I want to close our prepared remarks by underscoring that Celsius.

Has great potential to create value for our shareholders and future patients and a highly capable staff committed to bringing life saving medicines to market.

We have versatile platform technologies in the exciting area of nucleic acid therapy, our competency span the scope.

What is required to rigorously evaluate our drug candidates our relationship with regulatory authorities, both in and outside the United States are exemplary.

And as Jeff pointed out we have cash sufficient and with smart spending and prudent cash management.

We expect to deliver on our promises over the next three years.

During the months.

When we were working hard the refocus of the company were relatively quiet as you know.

Particularly with respect to our activities in <unk> and with the investment community.

I'm pleased to note that we did recently participated in the 33 annual Roth Conference.

Virtually this week.

<unk> one on one meetings.

We expect to be participating in additional conferences of the year unfolds, we will keep you posted.

We also plan.

To conduct virtual non deal Roadshows and ultimately hopefully back to live events before the end of the year.

So with that as an overview of our business and our financials, we'd now like to open the call to your questions operator.

Thank you ladies and gentlemen at this time the floor is open for your questions. If you would like to ask a question you may do so now by pressing star one on your Touchtone phone.

Please make sure that your mute function or disabled to allow your signal to reach our equipment again, if you'd like to ask a question.

From Star one now and we will give it just a moment to allow everyone an opportunity to signal for questions.

Okay.

Okay.

Okay.

Okay.

Okay.

Okay, Operator, alright, our first question comes from Shubin <unk> Roy with Brookline.

Yeah.

Good morning, Sheila.

Good morning, and.

On behalf of Kumar.

Appreciate the business update thank you.

I was just.

Listen with regards to the vaccine program.

The other preclinical data for it.

Hum.

For these promising.

In terms of Goldman's operations.

<unk> for the technical problems downstream.

You anticipate challenges, especially for your patience and all that we already have do that all day.

No.

And that's a good question.

Nick do you want to try to adjusted for this.

Hi, This is Nick for US, yes, Thats a very good question and as you know the way we are dealing with the Covid is an evolving issue.

The U S. FDA has published guidance documents on them for consideration and when.

Doing clinical trials with the next generation of agents. So part of this might not require the same type of very large patient population that you've seen with the previous virus development plans. So we'd be working closely with the FDA to find the most efficient patient population.

And depending on the the aim of our vaccine will work with the FDA Accordingly, but I think youll see in the future there'll be different types of clinical trials, probably not as large as what we've been seeing in the past.

I'd like to add to that also.

And then maybe more broadly more strategically.

This is a very crowded field as I pointed out in my prepared remarks sand.

We're.

As you know I mean, we're very new for this vaccine.

Vaccinology technology.

In our.

Immediate goal here is to establish proof of concept.

And two.

Petition and receive.

Approval for an IND from the FDA.

I think at this point that the company's net.

Company will obviously outline a clinical.

Pathway trial fast way going forward is as Dr. <unk> pointed out.

Truly I think given the advantages that we anticipate from a DNA vaccine approach.

Particularly using a single plasmid multi <unk> or multi gene as we talked about it.

We will be looking for development partners at that point.

Particularly among those players who.

Have they already have a foothold in the market.

The.

Company is very realistic very very realistic about the potential for <unk>.

Challenges.

With a clinical program for COVID-19, I think more importantly, however, more broadly however.

Once we have established proof of concept in a sars.

<unk> environment.

Environment.

We intend as I said earlier, we intend to leverage that.

To begin addressing a number of an address.

The address the vaccine.

<unk> opportunities and I think before we get off the call. Since there is not all I'm doing a lot of questions in the queue maybe a.

Doctor on <unk> could you talk about some of the other.

Vaccine opportunities that this DNA single plasmid multi gene approach could could address.

Yes, Michael.

Clearly.

Using DNA based vaccines, we have an advantage over other traditional.

Thanks.

Again for pathogen so.

As Michael said once we have proof of concept we could really.

Expand technology into other pathogens and clearly that's something.

Under consideration in house.

And we could really consider two different directions.

After.

Pathogens such as CMV.

Infections that there is no vaccine.

And so that could be certainly those types of pathogens.

So there's still a traditional type of vaccines are used so those are some other areas are under consideration now but.

But that's the sort of dynamic.

Constantly looking into what could be the potential market based on their potential partner also so yes, Tim reata species include goes there are some other.

What I can say.

Type of pathogens, we could go after.

Thank you so much. Thank you so much whether it be guidance I just had a quick question with regards to the approval of Gen. One.

Standpoint.

I believe you will have the <unk>.

By the end of the year, so would that be.

For the executive Board.

Well, that's I mean, that's another good question.

Ducting.

<unk> phase II study.

We were likely not.

The current construct and likely not to have enough patients for a definitive result.

But Dr. Boris is exploring an adaptation or Don adaptive approach, maybe you want to talk a little bit about that NEC.

Yeah sure as you mentioned the data that we have immediately right now is just to see.

The extent that the surgeons could remove the tumor integral to bulking. So our zero rates are are very good.

The primary endpoint for the study is progression free survival. So if that takes place many months.

After the patients complete their chemotherapy. So we are exploring other avenues, where we can use an accelerated process.

With the FDA on I'm getting an approval type design for our study.

There's much to be explored there may be using combination endpoints.

And seeing if we could accelerate that so I think we'll be talking much more about that in the near future.

<unk>.

Sounds good. Thank you so much for taking my questions.

Okay.

Thank you. Our next question comes from stockholder AJ and Manuel.

Okay.

Good morning, Jay good.

Good morning, How're you doing today.

Very good thank you.

So you spoke of.

Thermodox in that you guys are not planning to give up on that technology and I applaud that.

Can you talk a little bit more about some of the other use cases, you are a little bit more in depth about other direction. Do you think that you may be taking that you briefly touched on that but I was hoping you might elaborate a little bit more.

Well that's a good question.

Uh huh.

As I said earlier in my prepared remarks on our clinical study does not mean a failed drug can we we know thermodox quite well.

Uh huh.

Feel that its mechanism has some potential value in medicine. Unfortunately, we did not demonstrate.

<unk> efficacy and primary liver cancer.

And we can all speculate about the reason behind that.

So our role here going forward will be limited.

We have a number of I.

I called Premier investigators, who have expressed an interest in continuing their research.

In both the preclinical and clinical.

Situations or trials.

We have promised them and we will continue to support these trials with our.

In our institutional knowledge.

And with product.

We have a solid supply chain and can continue to.

Support these activities, but there are I mean, we've talked about.

Some work Thats being done in Utrecht, some work that's being done in Oxford for recently.

A very strong interest almost the.

I almost call it a demand frankly, and I say that kind of tongue in cheek from the NIH and maybe.

Nick you can talk a little bit about the Oxford in the Utrecht US studies, if you don't mind share.

Sure.

As you know Oxford University.

<unk> has probably got the most experience in.

In terms of the clinical.

<unk> with Thermodox they published in the last two years ago on their work in liver cancer and now they'd like to apply that work into pancreatic cancer using this new cutting edge technology called HIFU or high intensity focused ultrasound. This is a new way of heating deep structures into the body.

Theyre very excited about that I think you'll be hearing more about that again this year.

We also have work that's being initiated in Utrecht.

This is what Mike was alluding to in terms of breast cancer and the idea would be that thermodox can play an important role in patients that are interested in having lumpectomies instead of radical surgery. So this is where again HIFU is being applied for Thermodox is being applied and it might be a great alternate.

For patients that are good candidates for lumpectomy.

We continue to be excited about the future for Thermodox and saw many of our investigators as Mike said.

So I just.

Close this out with.

We will we probably will won't be hearing much from us with regards to our thermodox going forward.

All the company's focus really would be in this area of immunology and vaccinology.

Unless of course, there are some breakthroughs that.

Our.

Important for medicine for frankly from these investigator sponsored studies.

Yeah.

Okay.

Yeah.

Thank you at this time, we have no other questioners in the queue. So I'll turn it back to our speakers for closing comments.

Well I want to thank all of you who have participated in our call. This morning.

I want you to know that we are.

Very committed to our work or driven by this commitment to bring new medicines to patients in need.

And by the work of the talented for clinicians and scientists from the technical staff that participate in our trials and our preclinical work.

Well, we think we have something very very important in terms of platform technologies that can add immeasurably to the.

Exciting new generation of vaccines that are currently addressing COVID-19.

If we're right the advance that we make.

Provides can't provide substantial improvements and durability our range of treatments.

And capability to address the.

The <unk>.

Mutational capability of pathogens.

So we will continue our work there along with our very important work in oncology.

This phase II study for ovarian cancer patients extremely important to us certainly very important too.

The investigators from the patient's Smith.

This newly diagnosed are very difficult to treat indications.

We will look forward to keeping you appraised of our progress and as always we are available to you for questions.

We will speak again shortly after the first quarter total.

We'll present to you our 2021 first quarter results.

We trust you will have a nice afternoon. Thank you very much.

Ladies and gentlemen that concludes this morning's presentation. Thank you for your participation you may now disconnect.