Q2 2021 Celsion Corp Earnings Call
Your operator today.
At this time I would like to welcome you to the <unk> Corporation second quarter 'twenty 'twenty, one 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.
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 release your mute function to allow your signal to reach our equipment again 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 Golar. That's please go ahead.
Thank you and good morning, everyone. This is Kim gala, that's with LH, a welcome to Celsius second quarter, 'twenty 'twenty, one financial results and business update conference call.
It has been in cell phones practice and as noted by the operator prepared remarks will be followed by a question and answer session. During.
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.
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 Celsius operations financial results and outlook is the best estimate based on the information for today's discussion.
Also caution that the content of this conference call is accurate only as of the date of the live broadcast August 12th 'twenty 'twenty one.
<unk> 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 Jordan, Chairman, CEO and President Michael.
Thank you Kim.
Good morning, everyone joining.
Joining me today are Jeffrey Church, our Chief Financial Officer, who will provide a review of Celsius.
<unk> financial results.
Dr. Nicholas Borys, our Chief Medical Officer, who will discuss our ovation two study Dr. Cruciate Anwar always in Huntsville, Alabama, Our Chief Science Officer will be available during the Q&A session to answer your questions regarding our recently announced vaccine initiatives.
Now if you read our press release. This morning, you know that the first half of 2021 has been very busy and productive for Celsius.
I'd like to think that we are well positioned as we continue to make good progress in advancing our programs with supporting interim clinical data and growing recognition of our lead investigational product Gen. One and its promise to address advanced ovarian cancer.
Moreover, our strong cash position along with our ability to access additional sources of funds is sufficient to reach key milestones in both our ovation two study with Gen. One and to establish proof of concept with a 90 filing for <unk>. Our next generation vaccine platform assuming of course that our preliminary research is positive.
During today's call. We will briefly review these programs and provide an update on where things stand now.
Briefly I'd like to cover two of our lead technology platforms I'll start with surplus which is our lead technology platform.
Third class and its adaptations are our proprietary synthetic non viral carrier engineered to deliver plasma DNA in messenger RNA therapeutics.
John one incorporating the immune stimulating cytokines IL 12 is the first investigational product on this platform and is currently being evaluated in the phase II ovation two study.
I can say unequivocally that the pace of study enrollment has allowed us for a look at some encouraging albeit early data.
Among advanced ovarian cancer patients Dr. Vorst, we'll be discussing this more in a few minutes.
And then a further adaptation of our technology, our unique understanding of plasma vector construction provides the basis for our next generation vaccine platform that we call Pliocene.
So it is seen as a proprietary approach to DNA plasma based vaccine and in its current iteration is designed with multiple viral antigens within immune modifier.
Like Sonic cytokine IL 12, all delivered within a single plasmid vector.
We believe that this approach to nucleic acid vaccine design holds the promise of clinical and technical advancements over the highly efficacious and very impressive new generation of mrna vaccines and we will talk more about this in a few minutes.
Driving our research is an outstanding group of scientists that have recently been reinforced with individuals with advanced knowledge in molecular biology, and immunology and vaccine development.
We continue to build relationships with development partners and vector construction analytical method development and supply chain capability, we have improved our capacity to produce high volumes of research quantities of vaccine prototypes for a proof of concept work.
In addition, as you know from our press releases, we have assembled a vaccine advisory board comprised of highly recognized researchers along with.
Our new board members, whose experience and backgrounds, who will provide new and enabling perspectives on our work.
To date in 2021, we've taken advantage of favorable market conditions to raise more than $60 million and equity capital with the most recent raise of almost $14 million completed in early April our.
Our cash position was additionally, improve with the sale of $2 million of our New Jersey net operating losses.
We further strengthened our balance sheet with a new $10 million loan facility with Silicon Valley Bank, which allowed us to repay $6 million of much higher interest venture that Jeff will provide more details.
Regarding this financing.
And.
And in hit during his comments, but bottom line.
Is that we have smartly strengthened our balance sheet with investor friendly straight common stock deals and non dilutive financings all of which provide a cash runway comfortably through 2024 that assumes of course, our current spending projections.
That's a period of time sufficient to reach a number of important development milestones, including progression free survival data from the ovation two phase II study.
And proof of concept from our vaccine initiative.
Now before asking Dr. Vorst to give you his perspective on the ovation two study I want to remind you that the subject of the trial is gen. One.
One is our DNA based immuno oncology candidate and as I mentioned its foundation is therapy class. Unlike viral delivery systems that can only be administered once because of the immune response to the delivery system itself. Gen. One is not the subject of neutralizing activity an amendment, if an individual's immune system.
This ability to dose repeatedly makes gen. One.
Our unique formulation of IL 12, an ideal candidate for study in oncology.
To date more than 100 ovarian cancer patients have been treated with gen. One in our clinical trials.
The results so far demonstrates excellent safety and recently published clinical data supported by translational data that clearly show activation of a significant dose dependent innate and adaptive immune response and remodeling of the immune microenvironment to pro immune.
So just let me cap showed that a little bit the way I like to characterize gen ones observed mechanism, it's like taking one foot off the immune systems break.
And putting the other foot squarely on the immune systems gas pedal.
So with that as kind of a descriptor I'm going to turn the call over to Nick Force for an overview of Gen. One and our ovation clinical program John.
Nick I'm sorry, Thank you very much Mike.
Our ovation two study is an open label randomized phase II study in treatment naive advanced ovarian cancer patients. This is a subset of patients whose tumor burden is too great for immediate surgical intervention ovation. Two combines gen. One with standard of care chemotherapy and our study half of the chemotherapy.
Gen. One is giving before surgery and the other half is given after surgery. The purpose of this approach is to shrink the tumor as much as possible to make the surgeons job as easy as possible usually in about half of the cases, the surgeon is able to remove all the visible tumor when gen. One is added to the chemo.
<unk> therapy than the surgeon is able to remove all of the tumor and about 80% of the cases. This is good news for our patients. Following the surgery patients are given the other half of the chemotherapy plus or minus to gen. One in order to address any remaining disease.
The study's primary objective is to see if gen. One can delay any return of the cancer. This is called progression free survival. The ovation. Two study is designed to see if we can delay the return by at least 30%. The statistical language is that this study is designed with an 80% confidence interval for an observed progression free.
Survival hazard ratio of 0.75, which means an approximately 33% improvement in risk for cancer progression.
We are now closing in on 60% of the projected 110 patients have been or are being enrolled in this study in July following a pre planned interim safety review of 55 asked treated patients the data the data safety monitoring board or DSM be unanimously recommended that the study.
Continue treating patients with a dose of 100 milligrams per meter squared.
The DSM be further determined that safety is satisfactory with no dose limiting toxicities reported.
During this pre planned review, we also reported interim clinical data from the first 36 patients who are integral de bulking surgery. The data showed that 20 patients were treated with gen. One at a dose of 100 milligrams per meter squared plus the neo adjuvant chemotherapy with 16 out of 20 patients.
Our 80%, having no residual disease or are zero and our zero is good news for the patients and suggested an improved survival outcome.
16 patients were treated with chemotherapy only with nine out of those 16 patients or 56%, having no residual disease a favorable comparison for gen. One when we look at these ongoing findings and the published results from our ovation. One study there is consistency in our data and we show that Gen. One.
It's working because of higher doses patients do better in terms of resection rates and chemotherapy response scores in other words, our patients are doing better than the control group in our patients at higher doses do better than those at lower doses to good indicators of strong treatment activity.
As I review 2021 has definitely been a Europe progress for Gen, one and the ovation program.
In February the FDA awarded Celsius fast track designation for Gen. One. This designation is a recognition that gen. One as a potentially important therapy in patients with ovarian cancer.
In March one of the most important scientific meetings on women's cancer annual meeting of the society of gynecological oncology accepted for presentation. The ovation two study that other so that other physicians and researchers can get acquainted with our work.
And last week, perhaps our most important scientific milestone this year was having the findings of our ovation. One study published in the prestigious peer reviewed journal from the American Association for Cancer Research. This publication is open access and can be downloaded by anyone interested in reading at the current version is in.
Form while the nicely types that form will be available in a few weeks you can find a link to it on the <unk> website.
The key finding of this published study is that Gen. One can be safely administered in combination with chemotherapy in newly diagnosed patients with advanced ovarian cancer patients receiving gen. One at higher doses did better and we also show that Gen. One activating the immune system against the cancer.
During this time the lead medical researchers of the gynecological oncology group contacted us to discuss our partnership with Celsius for developing Gen. One in ovarian cancer.
Working together, we have developed plans to collect molecular profile of patients enrolled in our ovation two study to help understand who would benefit most from gen. One.
This may result in a future amendment of our study, which would focus our research on the patients with the greatest likelihood of treatment success.
Throughout the second quarter of our ovation two investigators continue to work through the pandemic and to recruit patients collect data getting us to the point, where we now have a robust base of data.
We will be using for future designs. We also held two data safety management more board meetings to ensure the safety of Gen. One and to keep a careful watch on the integrity of the study itself to date. The ovation. Two study is experiencing good enrollment and we are seeing consistent efficacy as we did innovate.
<unk> won with manageable safety at a dose that is clearly impacting ovarian tumors with that overview I'll turn it back over to Michael.
Okay. Thank you Nick Great overview as usual I, just thought I would just like to make a comment about the G O G.
The gynecological oncology group represents over 200 of the most important investigational sites for ovarian cancer in the United States in some some of the.
Institutions outside of the United States their interest in our trial.
Yeah quite humbling, and then I think very important.
As we continue our work so your interaction with them is very important to the company. We thank you for that.
Now I'd like to turn to our <unk> initiative.
Of course, we have a working hypothesis I'd like to share that with you.
The DNA plasma has the potential to be superior to an mrna vaccine and a number of very important ways and I'd like to share those with you.
Plasma comprised of multiple antigens reduces the possibility that evolving virus variants will escape vaccine dependent immunity think covid 19. The D variant for example.
A DNA based vaccine allows for a longer more durable response longer activity, meaning production of the antigens and accompanying cytokine may potentially improve memory T cell vaccination activation.
A DNA based vaccine that co expresses the cytokine IL 12 may induce a better quality immune response and last but not least.
Formulated DNA based vaccine will have improved stability had better working temperatures as shown in actual use in our immunotherapy product Gen. One.
These we believe are important advantages now onto progress important potential advantages.
A lot of progress our scientists has successfully produced a family of vaccine vectors. They verify their composition and formulated these factors with a proprietary with our proprietary non viral delivery systems. In addition, they have demonstrated expression of S. One and M antigens and IL 12 cytokines by.
Elisa RTC Peach, PCR and Western Blot analysis, following transfection and cell culture systems.
Immunization of mice with one or more of these factors resulted in the production of immunoglobulin G antibodies.
Cytotoxic T cells response too specific.
Specific.
Two.
The spike antigen at the Cove.
The Sars Covid two virus.
Parallel in vivo studies are in progress to optimize vector composition.
Delivery route dosing and dosing frequencies and production of neutralizing antibodies.
Hopefully.
And I would say.
And I'm quite confident that we'll be able to present some of these data at upcoming scientific conferences. Later. This fall, we look forward to doing that and sharing that information with you our investors.
So you may be asking yourself why now you know we pose this question at our last conference why now since the current <unk>.
Marni vaccines are so highly effective.
Another question might be.
Our chances for commercial success. These two fundamental questions have three answers I'd like to share with you first our immediate goal is to validate our vector in delivery technology in preclinical studies using the current mrna vaccines as compares.
Once we have demonstrated with our hypothesis that our hypothesis has proven should there be a commercial possibility. We will seek development partners for Covid 19 clinical trials.
Second and even more importantly to our strategy once our hypothesis has been demonstrated.
Once it's been proven.
We'll begin development of vaccines to address a broad range of other infectious viral agents.
And third as I have said before we may be on the verge of a potential breakthrough combining antigens with IL 12 has the potential.
To be both prophylactic and therapeutic.
The development of a vaccine technology that could.
Had that has the potential to be truly therapeutic a therapeutic vaccine. If you will could revolutionize our approach to infectious disease. Needless to say, we are very excited about the <unk> platform and its prospect prospects and look forward to continuing our research and reporting our developments to you.
Now before turning the call over to Jeff I want to raise an important issue that has intensified during this year's proxy season with respect to many many shareholders not voting their shares.
Yes.
And this is an important issue and that's why I want to share with you. During this call I'm not talking about voting for or against a management proposal.
I'm talking about simply voting.
As you know, we had to adjourn and reschedule our annual shareholder meeting to a later date to allow our proxy solicitors, along with Jeff tempt to them, an allo and me to bring in enough votes to obtain a quorum.
And we're not the only company to have the journal's annual meeting a quick Google search finds that many companies resetting their annual meeting dates.
Order to muster a quorum.
This challenge of securing a quorum was a first for US this year and it was largely due to a confluence of circumstances.
Data show that on average only 32% of retail shareholders cast their ballots for shareholder meetings and this percentage is even lower for small cap firms like Celsius.
However, under stock exchange rules banks brokers and other holders of record who can aggregate client chairs and street named typically have discretion early on.
The heavier discretionary authority to vote those shares on routine proposals in the absence of voting instructions from beneficial owners and they have done so for as long as I recall in the past.
However, this year.
Many online brokers, such as Charles Schwab and its affiliate TD Ameritrade have declined to exercise its discretionary option.
<unk> a federal rule rule.
Rule 2251 as prohibitive of this practice when in fact, the rural states that a broker may exercise its discretionary votes for routine matters and the absence of shareholder proxy instructions.
Oh Wow.
Which had a policy of voting for discretionary items in the same proportion as customer proxies that were actually submitted.
Wired TD Ameritrade earlier, this year concentrating retail investors.
Essentially one brokerage house compounding the problem robinhood.
Also declines to vote shares held by customers on discretionary items.
Needless to say for.
For companies with large retail holdings like Celsius, it's difficult to get 50% of shares voted in order to reach quorum.
Okay.
So where do we go from here Your company has decided Chelsea and has decided to bring attention to this problem and push for a solution.
Perhaps starting with making sure that brokers are interpret interpreting rules to 251 properly.
We're in the process of moving forward with a plan that will hopefully.
Return brokerages to their press past practices.
But also we'd like to improve our engagement with individual investors as a part of our strategy first.
We need to identify who has the authority to clarify the rules language and cut through the finger pointing between the various organizations in.
In the administrative bureaucracy, a stock exchange governance. This I can tell you is a challenge.
Finding who will step up to the plate for interpretation is not easy, but we will look for fine we'll find the means to do so.
In parallel we're working to create grassroots supports for the correct interpretation because there are many parties that may be adversely impacted aside from the issuers, including investment banks law firms auditors and proxy solicitors.
We're in contact with a lobbyist who is engaged by the National Investor Relations Institute and the society for corporate governance, which comprised of corporate secretaries.
We're also investigating ways to improve direct retail engagement via new service offerings, such as phone apps as well as to lower the threshold for what constitutes a quorum.
Which would have to be affirmatively voted.
<unk> investors.
I'd like to say, we certainly should not be doing this it's an extraordinary use of our time, but bottom line is the companies, including Celsius Spa.
Spending way too much time and money on proxy solution.
Solicitation.
<unk> been forced in to doing this.
The lack of participation from investors and voting is discouraging.
As you know one share one vote, a central tenant of corporate governance.
And let's not lose sight of when investors are voting on.
As oftentimes proxy proposals are necessary to facilitate company's future success.
Chelsea and is passionate about this initiative, we value our investors and impress upon them that Theyre disinterest may impact human health as we work to advance the development of life saving therapeutics.
So with that now I'd like to turn the call over to Jeff Jeff. Thank you Michael.
Details of <unk> second quarter 2021 financial results are included in the press release, we issued this morning and in our form 10-Q, which we filed today before the market opened the company ended the second quarter of 2021 with $64.5 million in cash and investment securities restricted cash and accrued interest receivable.
Included in this amount is $1.85 million in net cash proceeds received in may from the sale of approximately $2 million of our unused New Jersey net operating losses over the past three years, we have raised nearly $15 million from the sale of these Nols, which is equivalent to nearly a full.
Full year's operating expenses without any dilution to our investors and.
And we have an additional $5 million of unused New Jersey Nols available to the company for sale between 2022.
In 2024 at current spending levels, we have sufficient cash to fund operations through 2024, and as Michael said these funds provide a runway to see us through several important value, creating milestones. Let me now turn to a review of the second quarter and the first half.
2021 financial results for the quarter ended June 32021, <unk> reported a net loss of $5.4 million or <unk> <unk> per share. This compares with a net loss of $5.3 million or <unk> 18 per share for the quarter ended June 32020.
Operating expenses.
Were $5.2 million for the current quarter, which is up $300000 or 6% from operating expenses of $4.9 million for the second quarter of last year, breaking this down by line item research and development expenses. They were $2.6 million for the second quarter of 2021, and this compares to 3 million.
A year ago, a decrease of 16% clinical trial costs for the phase III Optima study decreased to $200000 compared to 600000 in the prior year quarter R&D and <unk>.
Costs associated with the development of Gen. One to support the ovation two study as well as the <unk> DNA vaccine technology platform increased to $1.4 million from $900000 in the prior year quarter other costs related to the company's clinical development programs decreased by about half a million dollars due to lower regulatory.
Tori and manufacturing costs related to the Thermodox program.
General and administrative expenses were $2.6 million for the second quarter. This year compared with $1.9 million for the second quarter last year to $700000 increase is primarily attributable to higher noncash stock compensation expense.
$100000, an increase in professional fees of $400000 and an increase in premiums on our director and officers insurance of 100 pounds.
In June 2021, the company entered into a new $10 million loan facility with Silicon Valley Bank and use $6 million of the facility to retire all outstanding indebtedness with Horizon Technology Finance Corporation, we recognized $200000 loss for the debt.
So LCI and incurred interest expense of $200000 during the second quarter of this year largely in line with the 300000 in the comparable prior year period, both related to horizon interest. This new loan facility provides five months of operating runway at.
At a very low cost of capital the new loan carries an interest rate of 3%, which compares to an interest rate close to 10% when the previous venture debt with horizon.
On a year to year on a year to date basis net cash used for operating activities was $7.3 million, which compares to $7.9 million in the first half of 2020.
This is in line with our projected cash utilization for 2021 of approximately $17 million or an average of $4 million to $5 million per quarter cash provided by financing activities was <unk>.
To $55 million during the first six months of 2021, resulting from equity offerings in January and April and proceeds from the Silicon Valley Bank loan facility and the sale of our New Jersey.
I'd now like to turn the call back over to Mike. Thanks, Jeff could view good overview.
I want to close our prepared remarks today by underscoring that we believe that Chelsea on holds great potential to.
To benefit patients in need and to create value for our shareholders.
We have a highly capable team of researchers and clinicians who are committed to bringing life saving medicines to market.
When we look ahead to our anticipated complement our accomplishments.
Helpful to remind you.
Of all of the assets that reside within Celsius.
We have a versatile technology platform.
More than one versatile technology platforms in the exciting area of nucleic acid medicine.
Our competency spanned the scope of what is required to rigorously evaluate drug candidates.
Our relationship with regulatory authorities in both in the United States and outside the United States are exemplary.
And with smart spending great science, and prudent cash management, we have sufficient capital to deliver on our timelines and support our promises.
Before we open the call to your questions I want to mention that we will be presenting at the H C. Wainwright Global investment conference being held virtually this year.
Between September 13th and 15th.
We plan to present that hold one on one meetings at the investment conference. We look forward to your participation in meeting you virtually.
So now with that overview of our business and financials, we'd like to open the call to questions.
Before I turn it over to the operator, we do have a writing question that I think I'll address upfront.
The question is where do we stand with our breakthrough status application for Gen. One in ovarian cancer.
It's a good question and we've and we've addressed that I believe before but I think we probably have some more detail to share with you.
We submitted a briefing document to the FDA outlining our intention to.
To submit for breakthrough status and a preliminary meeting to a screening group. While the result of that meeting was very very strong encouragement from FDA to continue our clinical research or clinical review evaluation of Gen. One in newly diagnosed ovarian cancer patients.
They were very complimentary of the primary endpoints in our trial design.
But they indicated to us that we may not have enough data for Europe proper review for breakthrough.
For breakthrough designation.
We then took the additional step to compare the single arm data.
Two a synthetic control arm.
Thought the us.
Matching our patients treated in the phase one study.
With patients in control arms or.
Who would have otherwise qualified for our study.
Matching them to the to the treatment patients in our phase one study might provide the FDA with enough assurances that what we were seeing was not random.
We reached we did submit a breakthrough therapy application on that basis again.
Very lengthy conversation with the agency.
A very strong endorsement of our work in ovarian cancer, but they are concerned that a synthetic control arm not yet validated it might not be the best way to evaluate our proposal for breakthrough consideration. They did encourage us to come back when we had more data from the <unk>.
<unk> two study, which you know includes randomized patients in the meantime, they suggested to us that we have.
Apply for fast track designation, having many of the same advantages.
This breakthrough designation.
I guess as impactful with the investment community, but from a practical standpoint breakthrough status gives them.
Fast track status gives us quite a few advantages with the agency and.
We submitted an application for.
For a fast track status. It was approved in short time.
We announced that once we had the approval.
Too long ago.
In the meantime, it's our intention.
FDA suggested once we have some additional data.
And we're getting close.
Additional data from the Phase II study, we will consolidate that with a phase one data and reapply for breakthrough status.
So with that operator, I think we can go onto our questions from the attendees.
Attendees meeting attendees.
Thank you and if you would like to ask a question. Please signal by pressing star one on your telephone keypad.
If you're using a speaker phone. Please make sure your mute function is turned off to allow us to reach our equipment.
Thats Star one to ask a question and we'll pause for just a moment to allow everyone an opportunity to signal.
Yeah.
And our first question comes from Kumar <unk> with Brookline capital.
Please go ahead.
Hi, good.
Good morning, Thanks for taking my questions.
So congratulations on all the bulk of it.
So with regards to the gentleman over there and try and you know with the.
Let me go he started placing our game.
What are the odds on.
The putative goldmine and in terms of the number of sites onboard where do we stand with regard to that.
Yes, so I think.
Nick is probably the best person to answer this question I'd just like the proceeded with.
We've been in the business of running clinical trials now together as a team here for for some 10 or 11 years and I would just characterize the enthusiasm among our investigators is as good as it gets now that being said the Nick.
The trial sites and what our expectations are.
Yeah. Thank you very much for your question.
It's clear that the pandemic has impacted everyone, including cancer research in cancer patients.
We saw an increase in our patient enrollment for example in June and I think it was a result of the pandemic easing and patients going back for their checkups and follow ups.
It looks like to be maybe tightening again, but we hold regular conference calls with all of our <unk> as a matter of fact I had one yesterday to review of the current situation.
We're all doing our best to continue enrollment Luckily, we don't have too much competition from other studies. So a lot of focus is on the ovation. Two study in terms of our sites we have over 20.
Two sites I believe are recruiting patients at the moment in both.
In both U S and Canada. Our most recent site opening was in Albuquerque, New Mexico and they are currently screening a number of patients. There. So we're going to continue working hard through the pandemic and hopefully we'll meet all our objectives and timelines for getting the patients in.
Okay and.
With regard to the bank of the Arctic investigative sponsored trials how much involvement.
Dan.
Granted it does.
Yeah. So this is in terms of the study that we're working with Oxford University in England.
We've worked very closely with the with the study team we were involved in the study protocol design.
Were obviously supplying the product then we're supplying.
Consulting on any issues of safety.
So.
I'm not sure if they've enrolled their first patient yet, but theres certainly open for enrollment at the moment.
I'd like to add a little bit more to that if you don't mind Kumar so.
Celsius has decided to focus the majority of its energy on immuno oncology.
Immunology and vaccines, we've recently announced that we've established.
A subsidiary in Zug, Switzerland, and are placing all of our intellectual property assets for Thermodox Enzo.
Along with we have a managing director one of our board members are physician Andreas Force has been named our managing director.
He is working directly so as not to.
Distract the Celsius team from our immuno oncology and our immunology and vaccine programs.
The <unk>.
Management of these relationships and support for <unk>.
The.
Clinical trials will be coming through <unk> and through our managing director.
And Transformers.
I'd just say one more thing so we do have a small budget to support these activities.
We want to be sure that it is unless there is a reason to do so.
And we're seeing a you know a significant.
A reason to do so we don't expect our support for the Thermodox Act.
Activities to.
Have any significant impact on our cash position.
Okay great.
With regard to the vaccines that you'll maintain about my table and began using multiple R&D games.
So with some other companies want to be how many stock.
But my vote on pizza and they have been comparatively lower neutralizing antibodies are.
Come back they're using this income line P than what.
What has been you and expedient.
Uh huh.
In the preclinical models and maybe you can provide us some thoughts on what two ways unexpectedly.
So Chris you are you in a position to answer that question. Please.
So kumar thank you for that question.
Yeah.
Yes.
Building a composition of different vaccines.
And we have seen.
In response to multiple antigens.
Yeah, I haven't gotten to a point of protect.
Protection neutralization assays.
With respect to what's being known.
Reed's where people are using some.
The plasmid Iron bridge that lowered the expression of second antigen.
Maybe sub unit vaccine, so I think it would be.
Approach excuse in HIV people have shown multiple HIV antigen expression of Wow.
You know, we haven't gotten to that point, yet, but we're hopeful.
Concrete.
We should be able to demonstrate benefit.
Okay, great. Thank you so much.
Thank you.
Thank you we have no additional questions at this time I'll turn the call back over to Mr. Carlino for closing remarks.
Well. Thank you very much and thank you all for your time. This morning, we certainly do appreciate your interest in Celsius.
I want you to know we are we are.
We enjoy speaking with our.
Investors and we look forward to your participation only encourage you.
You have any.
Other shareholders that you communicate with we encourage you to.
Ask them to join US in these conference calls are going to find a way to reach out to the investors to increase participation.
And so with that I'd like to say that at <unk>, we continue to be driven by our commitment to bring new medicines to patients in need.
And this is exemplified by our work and our talented scientists and clinicians and technical staff.
We look forward to keeping you appraised of our progress in throughout the year.
We will be bringing you up to speed if any events that are important outside of the regular quarterly meetings, you can count on us to make sure that you have the information.
So with that we are we hope you have a reason to participate in the upcoming <unk>.
Wainwright a virtual conference.
If not we will be speaking to you again, when we report on our 2021 third quarter financial results in November have a great rest of your day. Thank you again.
And this concludes today's call. Thank you all for your participation you may now disconnect.
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Yeah.
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My name is Nick and I will be your operator today.
At this time I would like to welcome you to the selfie on corporations second 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 release your mute function to allow your 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 call over to Kim Golar. That's please go ahead.
Thank you and good morning, everyone. This is Kim gala, that's what they'll H a welcome to Celsius second quarter 'twenty 'twenty, one financial results and business update conference call and it has been in cell phones 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.
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 Celsius operations financial results and outlook is the best estimate based on the information for today's discussion.
Also caution that the content of this conference call is accurate only as of the date of the live broadcast August 12th 'twenty 'twenty one SEC.
<unk> undertakes no obligation to revise or update comments made during this call except as required by law, but.
With that said I'd like to turn the call over to Michael Jordan, Chairman, CEO and President Michael.
Kim good morning, everyone.
Joining me today are Jeffrey Church, our Chief Financial Officer, who will provide a review of <unk> recent financial results and Dr. Nicholas Borys, our Chief Medical Officer, who will discuss our ovation two study.
Dr. Crocheted Anwar always in Huntsville, Alabama, our Chief Science Officer will be available during the Q&A session to answer your questions regarding our recently announced vaccine initiatives.
Now if you read our press release. This morning, you know that the first half of 2021 has been very busy and productive for Celsius.
I'd like to think that we are well positioned as we continue to make good progress in advancing our programs with supporting interim clinical data in a growing recognition of our lead investigational product Gen. One and its promise to address advanced ovarian cancer.
Moreover, our strong cash position along with our ability to access additional sources of funds is sufficient to reach key milestones in both our ovation two study with Gen. One and to establish proof of concept with a 90 filing for Pliocene are next generation vaccine platform assuming of course that our preliminary research is positive.
During today's call. We will briefly review these programs and provide an update on where things stand now.
Now briefly I'd like to cover two of our elite technology platforms I'll start with surplus which is our lead technology platforms.
Third place and its adaptations are our proprietary synthetic non viral carrier engineered to deliver plasma DNA in messenger RNA therapeutics.
John one incorporating the immune stimulating cells cytokine IL 12 is the first investigational product on this platform and is currently being evaluated in the phase two of ovation two study.
I can say unequivocally that the pace of study enrollment has allowed us for a look at some encouraging albeit early data.
Among advanced ovarian cancer patients Dr. Vorst, we'll be discussing this more in a few minutes.
And then a further adaptation of our technology, our unique understanding of plasmid vector construction provides the basis for our next generation vaccine platform that we call Pliocene.
So it is seen as a proprietary approach to DNA plasmid based vaccine and in its current iteration and design with multiple viral antigens within immune modifier.
Like Sonic cytokine IL 12, all delivered within a single plasmid vectors.
We believe that this approach nucleic acid vaccine design holds the promise of clinical and technical advancements over the highly efficacious and very impressive new generation of mrna vaccines and we'll talk more about this in a few minutes.
Driving our research is an outstanding group of scientists that have recently been reinforced with individuals with advanced knowledge in molecular biology, and immunology and vaccine development.
We continue to build relationships with development partners and vector construction analytical method development and supply chain capability, we have improved our capacity to produce high volumes of research quantities of vaccine prototypes for a proof of concept work.
In addition, as you know from our press releases, we have assembled a vaccine advisory board comprised of highly recognized researchers along with.
Our new board members, whose experience and backgrounds will provide new and enabling perspectives on our work.
To date in 2021, we've taken advantage of favorable market conditions to raise more than $60 million and equity capital with the most recent raise of almost $14 million completed in early April.
Our cash position was additionally, improve with the sale of $2 million of our New Jersey net operating losses.
We further strengthened our balance sheet with a new $10 million loan facility with Silicon Valley Bank, which allowed us to repay 6 million of much higher interest venture that Jeff will provide more details.
Regarding this financing.
And.
And in hit during his comments, but bottom line.
Is that are we have smartly strengthen their balance sheet with investor friendly straight common stock deals and non dilutive financings all of which provide a cash runway comfortably through 'twenty 'twenty four that assumes of course, our current spending projections.
That's a period of time sufficient to reach a number of important development milestones, including progression free survival data from the ovation two phase III study.
And proof of concept from our vaccine initiative.
Now before asking Dr. Borys to give you his perspective on the ovation two study I want to remind you that the subject of the trial is gen. One.
Gen. One is our DNA based immuno oncology candidate and as I mentioned its foundation is therapy class. Unlike viral delivery systems that can only be administered once because of the immune response to the delivery system itself. Gen. One is not the subject of neutralizing activity and even if an individual's immune system.
This ability to dose repeatedly makes gen. One.
Our unique formulation of IL 12, an ideal candidate for study in oncology.
To date more than 100 ovarian cancer patients have been treated with gen. One in our clinical trials.
The results so far demonstrate excellent safety and recently published clinical data supported by translational data that clearly show activation of a significant dose dependent innate and adaptive immune response and remodeling of the immune microenvironment to pro immune.
So just let me cab show that a little bit the way I like to characterize gen ones observed mechanism, it's like taking one foot off the immune systems break.
And putting the other foot squarely on the immune systems gas pedal.
So with that as kind of a descriptor I'm going to turn the call over to Nick Force for an overview of Gen. One and our ovation clinical program John.
Nick I'm sorry, Thank you very much Mike.
Our ovation two study is an open label randomized phase II study in treatment naive advanced ovarian cancer patients. This is a subset of patients whose tumor burden is too great for immediate surgical intervention ovation. Two combines gen. One with standard of care chemotherapy and our study half of the chemotherapy.
Gen. One is giving before surgery and the other half is given after surgery. The purpose of this approach is to shrink the tumor as much as possible to make the surgeons job as easy as possible usually in about half of the cases, the surgeon is able to remove all the visible tumor when gen. One is added to the chemo.
Therapy than the surgeon is able to remove all of the tumor and about 80% of the cases. This is good news for our patients. Following the surgery patients are given the other half of the chemotherapy plus or minus to gen. One in order to address any remaining disease. The study's primary objective is to see if gen. One can delay any return.
Of the cancer. This is called progression free survival. The ovation. Two study is designed to see if we can delay the return by at least 30%. The statistical language is that the study is designed with an 80% confidence interval for an observed progression free survival hazard ratio of 0.75, which mean.
And approximately 33% improvement in risk for cancer progression.
We are now closing in on 60% of the projected 110 patients have been or are being enrolled in this study in July following a preplanned interim safety review of 55 asked treated patients. The data is the data safety monitoring board or DSM be unanimously recommended that the study.
Continue treating patients with a dose of 100 milligrams per meter squared the DSM be further determined that safety is satisfactory with no dose limiting toxicities reported.
During this pre planned review, we also reported interim clinical data from the first 36 patients who are integral de bulking surgery. The data showed that 20 patients were treated with gen. One at a dose of 100 milligrams per meter squared plus the neo adjuvant chemotherapy with 16 out of 20 patients.
80%, having no residual disease or are zero and our zero is good news for the patients and suggested an improved survival outcome.
16 patients were treated with chemotherapy only with nine out of those 16 patients or 56%, having no residual disease, a favorable comparison for gen. One when.
When we look at these ongoing findings and the published results from our ovation. One study there is consistency in our data and we show that Gen. One is working because of higher doses patients do better in terms of resection rates and chemotherapy response scores in other words, our patients are doing better than the control group at <unk>.
<unk> at higher doses do better than those at lower doses to good indicators of strong treatment activity.
As I review 2021 has definitely been a Europe progress for Gen, one and the ovation program and.
In February the FDA awarded <unk> fast track designation for Gen. One. This designation is a recognition that gen. One as a potentially important therapy in patients with ovarian cancer in March one of the most important scientific meetings on women's cancer annual meeting of the society of gynecological.
<unk> accepted for presentation. The ovation two study that other so that other physicians and researchers can get acquainted with our work.
And last week, perhaps our most important scientific milestone this year was having the findings of our ovation. One study published in the prestigious peer reviewed journals from the American Association for cancer Research. This publication is open access and can be downloaded by anyone interested in reading at the current version is in man.
Script form while the nicely typeset form will be available in a few weeks you can find the link to it on the <unk> website.
Key finding of this published study is that Gen. One can be safely administered in combination with chemotherapy in newly diagnosed patients with advanced ovarian cancer.
Patients receiving gen. One at higher doses did better and we also show that Gen. One activating the immune system against the cancer.
During this time the lead medical researchers of the gynecological oncology group contacted us to discuss our partnership with Celsius for developing Gen. One in ovarian cancer working together, we have developed plans to collect molecular profile of patients enrolled in our ovation two study to help understand who would benefit.
Most from Gen. One this may result in a future amendment of our study, which would focus our research on the patients with the greatest likelihood of treatment success.
The second quarter of our ovation two investigators continue to work through the pandemic and to recruit patients collect data getting us to the point, where we now have a robust base of data.
Which we will be using for future designs. We also held two data safety management more board meetings to ensure the safety of Gen. One and to keep a careful watch on the integrity of the study itself to date. The ovation. Two study is experiencing good enrollment and we are seeing consistent efficacy as we did.
Patient one with manageable safety at a dose that is clearly impacting ovarian tumors with that overview I'll turn it back over to Michael.
Okay. Thank you Nick Great overview as usual I, just thought I would just like to make a comment about the G O G on the guidance.
Logical oncology group represents over 200 of the most important investigational sites for ovarian cancer in the United States and some some of the.
Institutions outside of the United States their interest in our trial as a.
Yeah, quite humbling and I think very important.
As we continue our work so your interaction with them is very important to the company. We thank you for that.
Now I'd like to turn to our <unk> initiative.
Of course, we Havent working hypothesis I'd like to share that with you. It's that the DNA plasma has the potential to be superior to an mrna vaccine and a number of very important ways that I'd like to share those with you.
Plasmid comprised of multiple antigens reduces the possibility that evolving virus variants will escape vaccine dependent immunity think covid 19, the D variant for champions.
A DNA based vaccine allows for a longer more durable response longer activity, meaning production of the antigens and accompanying cytokine may potentially improve memory T cell vaccination activation.
A DNA based vaccine that co expresses the cytokine IL 12 may induce a better quality of immune response and last but not least.
Formulated DNA based vaccine will have improved stability had better working temperatures as shown in actual use in our immunotherapy product channel one.
Yeah.
Are these we believe are important advantages now onto our progress on port potential advantages.
On the progress of our scientists have successfully produced the family of vaccine vectors. They verify their composition and formulated these factors with a proprietary with our proprietary non viral delivery systems and.
In addition, they have demonstrated expression of our S. One and M antigens and of IL 12, cytokine by Elisa RTC Peach, PCR and Western Blot analysis, following transfection and cell culture systems.
Immunization of mice with one or more of these factors resulted in the production of immunoglobulin G antibodies and cytotoxic T cells response to.
Specific.
Uh huh.
Spike antigen of the co op.
The Sars Covid two virus.
Parallel in vivo studies are in progress to optimize vector composition.
Delivery route dosing and dosing frequencies and production of neutralizing antibodies.
Hopefully and I'd say our work.
I'm quite confident that we'll be able to present some of these data at upcoming scientific conferences. Later. This fall, we look forward to doing that and sharing that information with you our investors.
So you may be asking yourself why now you know we pose this question at our last conference why now since the current mrna vaccines are so highly effective.
Another question might be a what what are our chances for commercial success. These two fundamental questions have three answers I'd like to share with you first our immediate goal is to validate our vector in delivery technology in preclinical studies using the current mrna vaccines as comparator.
Once we have demonstrated our hypothesis that our hypothesis has proven should there be a commercial possibility. We will seek development partners for Covid 19 clinical trials SEC.
Second and I and even more importantly to our strategy once our hypothesis has been demonstrated.
Once it's been proven.
We will begin development of vaccines to address a broad range of other infectious viral agents.
And third as I have said before we may be on the verge of a potential breakthrough combining antigen with IL 12 has the potential to.
To be both prophylactic and therapeutic.
The development of a vaccine technology that could head that has the potential to be truly therapeutic a therapeutic vaccine. If you will could revolutionize our approach to infectious disease.
Thats. The same we are very excited about the Pliocene platform managed prospect prospects and look forward to continuing our research and reporting our developments to you.
Now before turning the call over to Jeff I want to raise an important issue that has intensified during this year's proxy season with respect to many many shareholders not voting their shares.
And this is an important issue and that's why I want to share with you. During this call I'm not talking about voting for or against a management proposal.
I'm talking about simply voting.
As you know, we had to adjourn and reschedule our annual shareholder meeting to a later date to allow our proxy solicitors, along with Jeff tempt to them, an allo and me to bring in enough votes to obtain a quorum.
And we're not the only company to have the journal's annual meeting a quick Google search finds that many companies resetting their annual meeting dates in order to muster a quorum.
This challenge of securing a quorum was a first for US this year and is largely due to a confluence of circumstances.
Data show that on average only 32% of retail shareholders cast their ballots for shareholder meetings and this percentage is even lower for small cap firms like Celsius.
However, under stock exchange rules banks brokers and other holders of record who can aggregate client shares in street name typically a discretionary really hot.
They have their discretionary authority to vote those shares on routine proposals in the absence of voting instructions from beneficial owners and they have done so for as long as I recall in the past.
However, this year.
Many online brokers, such as Charles Schwab and its affiliate TD Ameritrade have declined to exercise its discretionary option and.
Interpreting a federal rule rule.
The rule 2251 is prohibited of this practice when in fact, the real estates that broker may exercise its discretionary votes for routine matters in the absence of shareholder proxy instructions.
Charles Schwab.
Which had a policy of voting for discretionary items in the same proportion as customer proxies that were actually submitted.
Wired TD Ameritrade earlier this year concentrating retail investors at essentially one brokerage house compounding the problem robinhood.
Also declines to vote shares held by customers on discretionary items.
Needless to say.
For companies with large retail holdings like sell Xian is difficult to get 50% of shares voted in order to reach a quorum.
Okay.
So where do we go from here Your company has decided Celsius decided to bring attention to this problem and push for a solution.
Perhaps starting with making sure that brokers are interpreting interpreting rules to 251 properly.
We're in the process of moving forward with a plan that will hopefully.
Returned brokerages to their press past practices.
But also we'd like to improve our engagement with individual investors as a part of our strategy first.
We need to identify who has the authority to clarify the rules language and cut through the finger pointing between the various organizations in the administrative bureaucracy a stock exchange governance. This I can tell you is a challenge.
Finding who will step up to the plate for interpretation is not easy, but we will look for fine we'll find the means to do so.
In parallel we're working to create grassroots supports for the correct interpretation because there are many parties that may be adversely impacted aside from the issuers, including investment banks law firms auditors and proxy solicitors.
We're in contact with a lobbyist who is engaged by the National Investor Relations Institute and the society for corporate governance, which comprised of corporate secretaries.
We're also investigating ways to improve direct retail engagement via new service offerings, such as phone apps as well as to lower the threshold for what constitutes a quorum.
Which would have to be a formerly voted on by investors.
I'd like to say, we certainly should not be doing this it's a an extraordinary use of our time, but bottom line is the companies, including Celsius spend.
Spending way too much time and money on proxy solution system solicitation.
Then forced in to doing this.
The lack of participation from investors and voting is discouraging.
As you know one share one vote, a central tenet of corporate governance.
And let's not lose sight of when investors are voting on.
Is oftentimes proxy proposals are necessary to facilitate company's future success.
Chelsea and is passionate about this initiative, we value our investors and impress upon them that Theyre disinterest may impact human health.
As we work to advance the development of life saving therapeutics.
So with that now I'd like to turn the call over to Jeff Jeff. Thank you Michael.
Details of <unk> second quarter 2021 financial results are included in the press release, we issued this morning and in our form 10-Q, which we filed today before the market opened the company ended the second quarter of 2021 was $64.5 million in cash and investment securities restricted cash and accrued interest receivable.
Included in this amount is $1.85 million in net cash proceeds received in may from the sale of approximately $2 million of our unused New Jersey net operating losses over the past three years, we have raised nearly $15 million from the sale of these Nols, which is equivalent to nearly a four.
Full year's operating expenses without any dilution to our investors and.
And we have an additional $5 million of unused New Jersey Nols available to the company for sale between 2022 and.
In 2024 at current spending levels, we have sufficient cash to fund operations through 2024, and as Michael said these funds provide a runway to see us through several important value, creating milestones. Let me now turn to a review of the second quarter and the first half.
2021 financial results for the quarter ended June 32021, <unk> reported a net loss of $5.4 million or <unk> <unk> per share. This compares with a net loss of $5.3 million or <unk> 18 per share for the quarter ended June 32020.
Operating expenses.
Were $5.2 million for the current quarter, which is up $300000 or 6% from operating expenses of $4.9 million for the second quarter of last year, breaking this down by line item research and development expenses, they were $2.6 million for the second quarter of 2021, and this compares to 3 million.
A year ago, a decrease of 16% clinical trial costs for the phase III Optima study decreased to $200000 compared to 600000 in the prior year quarter R&D and <unk>.
Costs associated with the development of Gen. One to support the ovation two study as well as the <unk> DNA vaccine technology platform increased to $1.4 million from $900000 in the prior year quarter other costs related to the company's clinical development programs decreased by about half a million dollars due to lower regulatory.
Tori and manufacturing costs related to the Thermodox program.
General and administrative expenses were $2.6 million for the second quarter. This year compared with $1.9 million for the second quarter last year. The $700000 increase is primarily attributable to higher noncash stock compensation expense.
$100000, an increase in professional fees of $400000 and an increase in premiums on our director and officers insurance of 100000.
In June 2021, the company entered into a new $10 million loan facility with Silicon Valley Bank and use $6 million of the facility to retire all outstanding indebtedness with Horizon Technology Finance Corporation, we recognized $200000 loss for the debt extinguishment.
So LCI and incurred interest expense of $200000 during the second quarter of this year largely in line with the 300000 in the comparable prior year period, both related to horizon interest. This new loan facility provides five months of operating runway at.
At a very low cost of capital the new loan carries an interest rate of 3%, which compares to an interest rate close to 10% when the previous venture debt with horizon.
On a year to year on a year to date basis net cash used for operating activities was $7.3 million, which compares to $7.9 million in the first half of 2020. This.
This is in line with our projected cash utilization for 2021 of approximately $17 million or an average of $4 million to $5 million per quarter cash provided by financing activities was close to $55 million. During the first six months of 2021, resulting from equity offerings in January and <unk>.
April and proceeds from the Silicon Valley Bank loan facility and the sale of art in New Jersey.
I'd now like to turn the call back over to Mike. Thanks, Jeff could view quick overview.
I want to close our prepared remarks today by underscoring that we believe that Chelsea on holds great potential.
To benefit patients in need and to create value for our shareholders.
We have a highly capable team of researchers and clinicians who are committed to bringing life saving medicines to market.
When we look ahead to our anticipated complement accomplishments it's helpful to remind you.
Of all of the assets that reside within <unk>.
We have a versatile technology platform.
More than one versatile technology platforms in the exciting area of nucleic acid medicines.
Our competency spanned the scope of what is required to rigorously evaluate drug candidates.
Our relationship with regulatory authorities in both in.
In the United States and outside the United States are exemplary.
And with smart spending great science, and prudent cash management, we have sufficient capital to deliver on our timelines and support our promises.
Before we open the call to your questions I want to mention that we will be presenting at the H C. Wainwright Global investment conference being held virtually this year.
<unk> September 13th and 15th.
Plan to present that hold one on one meetings at the investment conference. We look forward to your participation in meeting you virtually.
So now with that overview of our business and financials, we'd like to open the call to questions.
Before I turn it over to the operator are we do have a writing question that I think I'll address upfront.
The question is where do we stand with our breakthrough status application.
For Gen one in ovarian cancer.
All this good question and we've gone and we've addressed that I believe before but I think we probably have some more detail to share with you.
While we submitted briefing document to the FDA outlining our intention to submit for breakthrough status and a preliminary meeting to a screening group. While the result of that meeting was.
Very very strong encouragement from FDA to continue our clinical research or clinical review evaluation of Gen. One in newly diagnosed ovarian cancer patients.
They were very complimentary of the primary endpoints in our trial design.
But they indicated to us that we may not have enough data for Europe proper review for breakthrough.
And for breakthrough designation.
We then took the additional step to compare the single arm data.
Two a synthetic control arm, we thought the us.
<unk> R patients treated in the phase one study.
With patients in control arms, or who would have otherwise qualified for our study.
Matching them to the to the treatment patients in our phase one study might provide the FDA with enough assurances that what we were seeing was not random.
We reached we did submit a breakthrough therapy application on that basis again.
Very likely conversation with the agency.
A very strong endorsement of our work in ovarian cancer, but theyre concerned that a synthetic control arm not yet validated might not be the best way to evaluate our proposal for breakthrough consideration. They did encourage us to come back when we had more data from the <unk>.
<unk> two study, which you know includes randomized patients in the meantime, they suggested to us that.
Apply for fast track designation, having many of the same advantages.
This breakthrough designation.
Is it I guess is impactful with the investment community, but from a practical standpoint breakthrough status gives it I mean.
Fast track status gives us quite a few advantages with the agency and.
We submitted an application for.
For a fast track status. It was approved in short time.
We announced that once we had the approval not too long ago.
In the meantime, it's our intention.
Is FDA suggested and once we have some additional data.
And we're getting close.
But additional data from the phase II study, we will consolidate that with the phase one data and reapply for breakthrough status.
So with that operator, I think we can go onto our questions from the attendees.
Attendees meeting attendees.
Thank you and if you would like to ask a question. Please signal by pressing star one on your telephone keypad.
If you are using a speaker phone. Please make sure. Your mute function is turned off to allow your signal to reach our equipment.
Again star one to ask a question and we'll pause for just a moment to allow everyone an opportunity to signal.
And our first question comes from Kumar Raj Shah with Brookline capital markets. Please go ahead.
Hi.
Good morning, Thanks for taking my questions and also congratulations on all the progress.
So with regards to the gentleman over here and try as you know with the <unk>.
Let me go he started placing our game.
Well I'll tell you our thoughts.
You know the putative enrollment and in bump up the number of sites on board.
Where do we stand with regard to the dock.
Yes, so I think.
<unk> is probably the best person to answer this question I'd just like the proceeded with we've been in the business of running clinical trials now together as a team here for sure for some 10.11 years and I would just characterize the enthusiasm among our investigators is as good as it gets that.
Being said Nick.
Could the trial sites and what our expectations are.
Yeah. Thank you very much for your question.
It is clear that the pandemic has impacted everyone, including cancer research in cancer patients.
We saw an increase in our patient enrollment for example in June and I think it was a result of the pandemic easing and patients going back for their checkups and follow ups.
It looks like to be maybe tightening again, but we hold regular conference calls with all our <unk> as a matter of fact I had one yesterday to review of the current situation and we're all doing our best to continue enrolment. Luckily we don't have too much competition from other studies. So a lot of focus is on.
The ovation two study in terms of our sites we have over 22.
Two sites I believe are recruiting patients at the moment in both our north.
In both U S and Canada. Our most recent site opening was in Albuquerque, New Mexico and they are currently screening a number of patients. There. So we're going to continue working hard through the pandemic and hopefully we will meet all our objectives and timelines for getting the patients.
Okay, and with regard to the bank Levy Arctic investigator sponsored trials.
How much involvement and does sell somehow them.
Thank you Yannick.
Yeah. So this is in terms of the study that we're working with Oxford University in England. We've worked very closely with the with the study team. We were involved in the study protocol design.
Were obviously supplying the product that we're supplying.
<unk>.
Consulting on any issues of safety so I'm.
I'm not sure if they've enrolled their first patient yet, but theres certainly open for enrollment at the moment.
I'd like to add a little bit more to that if you don't mind Kumar so.
Celsius has decided to focus the majority of its energy on immuno oncology.
Immunology and vaccines, we've recently announced that we've established a subsidiary in Zug, Switzerland, and placing all of our intellectual property assets for Thermodox Enzo.
Along with we have a managing director one of our board members are physician Andreas Force.
<unk> has been named our managing director.
He is working directly and so as not to.
Distract the the Celsius team from our immuno oncology and our immunology vaccine programs.
The.
Management of these relationships and support for <unk>.
The.
Clinical trials will be coming through <unk> and through our managing director and transform <unk>.
I'd just say one more thing so we do have a small budget to support these activities.
While we want to be sure that it is unless there is a reason to do so.
We're seeing a you know a significant.
The reason to do so we don't expect our support for the Thermodox.
Activities to have any significant impact on our cash position.
Okay great.
With regard to the vaccines that will maintain about multiple antigens using multiple R&D Jones.
So with some other companies what we have seen your stock.
Mike will teach us.
They are seeing comparatively lower neutralizing antibodies a comeback this income 90.10.
What has been your experience are high in the preclinical model and maybe you can provide us some art work delays unexpectedly.
So Chris shade are you in a position to answer that question. Please.
So kumar thank you for that question.
Yes, it's still in the process of.
Our competition of vaccines.
And we have seen.
In response to multiple antigens.
You haven't gotten to a point of.
Protection neutralization assays.
With respect to wants to be known.
You know raise where people are using some.
It's a plasmid iron bridge that lowered the expression of second antigen.
Hum.
Unit vaccines.
Its approach.
Using a Chinese people have shown multiple HIV antigen express as well. So you know you haven't gotten to that point yet.
Concrete.
We should be able to demonstrate benefit.
Okay, great. Thank you so much.
Okay.
Thank you.
Thank you we have no additional questions at this time I'll turn the call back over to Mr. <unk> for closing remarks.
Well. Thank you very much and thank you all for your time. This morning, we certainly do appreciate your interest in Celsius.
I want you know we are we are we.
We enjoy speaking with our.
Investors and we look forward to your participation.
<unk> you.
Do you have any.
Other shareholders that you communicate with we encourage you to.
Ask them to join US in these conference calls are going to find a way to reach out to the.
Investors to increase participation.
And so with that I'd like to say that at <unk>, we continue to be driven by our commitment to bring new medicines to patients in need.
And this is exemplified by our work and our talented scientists and clinicians and technical staff.
We look forward to keeping you appraised of our progress in throughout the year.
We will be bringing you up to speed if any events that are important outside of the regular quarterly meetings, you can count on us to make sure that you have the information.
So with that we are.
Hope you have a reason to participate in the upcoming H C.
Right Virtual conference.
And if not we will be speaking to you again, when we report on our 2021 third quarter financial results in November have a great rest of your day. Thank you again.
And this concludes today's call. Thank you all for your participation you may now disconnect.