Q4 2020 Ocugen Inc Earnings Call
Good morning, and welcome to the Aki Joint Conference call.
At this time all participants are in a listen only mode.
A question and answer session will follow the presentation.
If anyone should require operator assistance during the conference. Please press Star then zero on your telephone keypad.
Please note this conference is being recorded.
I will now turn the conference over to Lisa Dissenter, Vice President of integrated Communications at Lavoy Hill's science to introduce the oxygen team you may begin.
Thank you operator I'd like to welcome you to our conference call with me today are Archie just chairman and CEO, Joshua Shanker of masonry and our CFO and head of corporate development Sanjay Shukla Romanian earlier. This morning oxygen issued a press release, including a business update.
In full year 'twenty 'twenty financial results, we encourage listeners to review the press release, which is available on the oxygen website at www dot oxygen Dot Com. This call is also being recorded and a replay will be available on the investors section of the oxygen website.
For approximately 45 days before we begin our formal comments I'll remind you that various remarks, we make today constitute forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties.
We may in some cases use terms such as predicts beliefs potential proposed continue estimates anticipates expects plans intends may could might will should or other words.
They convey uncertainty of future events or outcomes to identify these forward looking statements such forward looking statements include information about qualitative assessments, especially on.
Oh data potential benefits expectations for clinical trials and the anticipated timing of clinical trial, Readouts regulatory submissions and regulatory authorizations or approvals. This information involves risks and uncertainties that could cause actual results to differ materially.
<unk> from those expressed or implied by such statements risks and uncertainties include among other things the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints commencement and or completion dates for clinical trials.
Tories submission date regulatory approval dates and or launch dates as well as risks associated with preliminary and interim data, including the possibility of unfavorable on new clinical trial data and further analyses of existing clinical trial data the risk for clinical.
Trial data are subject to differing interpretations and assessments, including during the peer review publication process in the scientific community generally and by regulatory authorities, whether in one data from Barack Biotechs clinical trials will be published in scientific Journal publications.
And if so when and what what modifications whether the U S food and drug administration. The FDA will be satisfied with the design of average outs from preclinical and clinical studies of Covance, and which had been conducted by Barack biotech in India, whether and when any.
Biologics license and or emergency use authorization applications may be filed in the United States for Copaxone, whether and when any such applications. Maybe you proof by the F. D. A decisions by the F D a impacting labeling manufacturing processes safety and or other matter.
So that could affect the availability or commercial potential of colfax and in the United States, including development of products or therapies by other companies. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission S E C.
<unk> the risk factors described in the section entitled Risk factors in the quarterly and annual reports that we file with the SEC, except as required by law, we assume no obligation to update forward looking statements contained in this press release, whether as a result of new information future events.
Or otherwise after the date of this webcast you should read carefully the risks and uncertainties described in today's press release as well as the risk factors included in our filings with the SEC note that we intend to file our form 10-K with the SEC Tomorrow any information we provide on this call on.
For <unk> call is provided only as of the day of this call March 18th 2021, and we undertake no obligation to update any forward looking statements as we make may make on this call on account of new information future events or otherwise I will now turn the call over to <unk> Chairman.
And CEO Doctor Shanghai mercenary.
Thank you Lisa good morning, everyone and thank you for joining since this time last year, when we hadn't grasp the full impact on the pandemic and what it would mean in our daily lives. We at origin have made it on a personal mission to be part of the solution to help and COVID-19.
Through our partnership with current biotech a leading vaccine Delta Burbidge from India, we are working to potentially bring that COVID-19 vaccine Lexie.
Steve.
Coaxial was developed in partnership between the government of India embark biotech and was granted approval for emergency use authorization by the Indian authorities and he's currently part of the largest vaccine distribution program in the world.
Several million people have received this vaccine in India.
It has an excellent safety track record to date, leading journals, such as nature and lancet published a rigorous scientific research conducted uncle waxy to date, which includes preclinical and human phase one and for each student.
<unk> provides an excellent opportunity for oxygen to enter the infectious disease market.
Is different from other COVID-19 vaccine options currently authorized for emergency use in the United States. These.
These vaccines are you on mute mrna on air.
On the wireless technology.
Accident utilizes a traditional approach as an advanced stage hold for young inactivated vaccine using day Vero cell manufacturing platform.
This is the same technology that has been successful in producing the polio vaccine for infants globally for decades.
And are a key differentiator is that correction induces the immune system to target the whole wireless, which we believe reduces the possibility of mutant widest escape.
The other currently available options in the United States target just the spike antigen to elicit an antibody response, but correction has been shown to induce immune responses against multiple tumor antigens, including the spike protein receptor binding domain and the nucleocapsid protein after Sars Covid two wireless.
Along with the strong cellular responses.
In fact data demonstrating <unk> ability to neutralize that U K variant of SAR School too was published recently on pause.
Data front on March two we announced on the go vaccine once for him to the 81% effective in an interim analysis of the phase III clinical trial of nearly 26000 participants in India not only did go vaccine demonstrate the high clinical efficacy trend.
Again as to COVID-19, but it also showed significant immunogenicity against the rapidly emerging U K variant and has potential to be effective against other emerging variance to.
The interim analysis included a preliminary review of the safety database with short severe serious and medically attended adverse events occur at low levels and were balanced between vaccines and placebo groups.
The phase III trial, which is being conducted by part biotech but resulted in the final efficacy analysis at one two day confirmed cases.
Currently three UAS for the other COVID-19 vaccine products.
Rates do not authorized to use in children under age 60.
<unk> phase II results cover adolescents ages 12, plus.
There are over 16 million children in the U S. Between the ages of 12, and 16 and most of them must attend Middle School High School we.
We are planning to use our existing data to potentially covered this age group.
Uhm offering a potential significant immediate benefit to vaccinate children.
We will consider initiating U S clinical trials of vaccine in additional patient populations, including pediatric and high risk studies.
Oxygen is in active discussions with the FDA to continue to develop the regulatory pathway for <unk>.
In candidate applications.
Based on our discussions we are planning to file that application in April on additional efficacy and safety data from phase III clinical trial.
We're also in discussions with BARDA, the biomedical advanced research and development authority regarding their role and procuring medical countermeasures on the strategic National stockpile.
With regard to manufacturing under our agreement with spark biotic they will supply the initial doses in the United States Upon U S approval.
We had already working with an EBITDA accrued local Seattle, we established release testing of the product for the U S market overall, we're aiming to make 200 million doses available this year to support the U S. COVID-19 immunization program.
We are in discussions with potential U S manufacturers and planning to work with bottles biotech on technology transfer once the initial doses are supplied.
Importantly, co vaccine offers additional benefits for stockpiling story and distribution.
Because it will be shipped in a ready to use liquid formulation will be able to use existing vaccine supply chain channels.
Collecting has an expected shelf life of up to two years in a normal refrigerator temperature and up for three months at room temperature.
In summary, we are excited to collaborate with dark biotech Donald vaccine vaccine candidate for the U S market on.
Management team as well as the vaccine scientific advisory Board and highly expedient vaccine advisors. We have assembled at origin have a strong relationship with the leadership on par with biotech is collaboration Leverages <unk> vaccine expertise and R&D manufacturing regulatory and commercialization capabilities.
Steve.
Under the terms of the agreement oxygen and how the U S rights to the vaccine candidate and who will be responsible for clinical development regulatory approval.
Including the UAE and commercialization in the United States and will retain 45 per cent of the net profit.
Now the shift our discussion to ophthalmology pipeline, we are on track to enter the clinic with our first for gene therapy candidate for Q4 hundred.
Based on over Marty for gene therapy platform, which provides the potential to address multiple diseases with one product we are planning to file an IND.
To initiate two phase two clinical trials later this year for gene mutation associated signal excuses.
In February we announced that the European Commission granted orphan medicinal product designation for our Q4 hundred for retinitis Pigmentosa and Leber congenital amaurosis, which we believe further supports the potential of our modified for gene therapy platform to treat many.
Good day.
Caesars.
Retinal diseases associated with retinitis Pigmentosa and leber congenital amaurosis diseases are caused by mutations in over 170 <unk>.
And it is impractical to dose therapies.
Specific to EG.
All Q4 hundred a single product has potential to treat both RP and SBA, including all the integrations.
Associated with 175 genes.
On the manufacturing site for our Q4 hundred were completed our 200 lever commercial scale up process.
Finally, the development of our novel Biologic program on Q2 hundred and gene therapy candidate <unk> for 10.
Are both progressing well and we are on track to be in the clinic for both programs next year.
Since October Forest last year, we have raised gross proceeds of around $39 billion through offerings of common stock.
Now we have a healthy balance sheet.
We plan to continue to raise capital as needed to fund our vaccine development in ophthalmology pipeline.
We're also seeking potential funding.
From the U S government for coaxial mint and supply.
We made strong progress during 2020 toward our goals of developing a differentiated vaccine to save lives from COVID-19, and developing gene therapies for blindness diseases.
We look forward to continuing our momentum in 2021 with the planned U S rollout of go vaccine as well as filing an IND for our Q4 hundred to move our profit gene therapy program into the clinic.
Now turn the call over to Sanjay to provide our year end 2020 financial update on Jay.
Thank you, Sean and good morning, everyone.
As <unk> mentioned before 2020 has been a very eventful year for oxygen and broadens our mission to cure blindness diseases and save lights from COVID-19.
During 2020, we also took the necessary steps to clean our capital structure and risk capital in a prudent and pragmatic manner.
I will now provide an overview of key financial results for 2020.
We ended the year with cash cash equivalents and restricted cash totaling $24 2 million on December 31, 2020, compared to $7 6 million as of the year end 2019 since.
Since the beginning of this year, we have raised an additional $28 million on gross proceeds and as of February 28 2021.
We had an estimated $46 6 million of cash cash equivalents and restricted.
Cash extending our runway to over 12 months.
Our research and development expenses for the year ended December 31, 2020 were $6 4 million compared to $8 $1 million for the year ended December 31, 2019. The decrease was primarily due to the discontinuation of the <unk> 310 program in 2019, partially offset by an increase of <unk> <unk>.
Severance related charges in 2020.
General and administrative expenses for the year ended December 31, 2020 was $8 million compared.
Compared to $6 1 million for the year ended December 31 2019.
The increase was primarily driven by an increase in insurance premiums and employee related expenses in 2020.
Net loss attributable to common stockholders was $34 4 million or <unk> 31.
Net loss per share for the year ended December 31, 2020, compared to a net loss of $20 2 million or.
Or $1 46 net loss per share for the year ended December 31 2019.
As you are aware, we have a special meeting of stockholders scheduled to reconvene on April 14 at <unk> am Eastern time.
The meeting originally convened on March 16th the Joan to this date as we did not received sufficient votes in favor of the proposal to approve and adopt an amendment to the certificate of incorporation to increase the number of authorized shares of common stock from 200 million to $295 million.
At the meeting held a few days ago, an overwhelming majority of holders rewarded wanted in favor of this proposal.
But it needs to receive the approval of a majority of our outstanding shares as a day.
Record date in order to be adopted we.
We need your continued support to get additional awards to approve the proposal.
We would like to remind stockholders of the importance of this proposal and request all stockholders of record on the record date of February 11, 2021 to vote in favor.
A decision not toward has the same effect as award against the proposal.
The increase in authorized shares is critical for the long term success of the company.
It is important to recruit and retain the key talent needed to advance our business.
As we grow as a company we need to have the ability.
To access the financial markets quickly and strategically and having available chairs, which enabled us to do so.
Without an increase in a number of authorized shares.
Unable to execute strategic transactions that would accelerate our progress towards achieving our mission and potentially expanding our scope and influence.
Thank you for those who have voted or plan to award in favor of the proposal. We appreciate your continued support of occupants mission to serve patients.
But that we will open up the call for questions operator.
Ladies and gentlemen, if you'd like to ask a question at this time. Please press. The Star then the number one key on your Touchtone telephone.
To withdraw your question press the pound key.
Again Thats Star then one if you'd like to ask a question at this time please.
Please standby, while we compile the Q&A roster.
Our first question comes from Keay <unk> with Chardan.
Yes, thanks, good morning.
I'm wondering if you can tell us to what extent you can.
Hum.
Flavor, if you will of the discussions with the FDA regarding EUA.
Obviously, the phase III data.
Ben.
Presented.
Top line at least.
What more.
As the agency, telling you you need two.
To provide to them.
So good question I think yes, we are in discussions we believe we have a regulatory pathway.
We have to get additional data just less other companies one of them agent safety additional safety after a booster dose and obviously if you look at the bar with biotech. They got two interim analysis and one final analysis. So we believe when we go to the second interim.
Safety data is available illiquid data that should be sufficient to submit that UA just as other companies have done so that's where we are.
That process. So we are anticipating it will to get that required data by sometime in April.
So thats why we are seeing with targeting <unk> in April.
Okay great.
If if.
Required to do some additional clinical study evaluation and the U S are you currently.
Preparing at least in terms of our planning exercise.
On trying to line up.
From an activity like that.
So actually yes based on the need for this vaccine and the under emergency use authorization.
Our team in the Advisory Board everybody believes strongly I think there is a pretty good chance that you know we can apply for you. A however, we always prepared for clinical trials as we outlined and we are planning to conduct pediatric clinical trials on additional trials on the high risk.
And so that we are already planning.
Okay, Great. Let me ask for one more on the manufacturing side.
In order to meet the volume goals that you laid out there.
In your discussions with potential.
Okay.
Most are you finding that.
Beyond technical capabilities.
They actually would have the <unk>.
Open space to be able to.
Engage.
With you and brought on.
On the technology side, and then actually have the capacity to two per.
Produce and your target volumes this year.
Yes.
Good question Keith Yes, we are.
Just as anybody else in the ALDA vaccines for players, we're working with the government and we are having discussions with the <unk>.
Most of the U S.
Obviously, we are making progress on that.
And then we will let the market and we have this plan is finalized.
And I'll, let you guys do correct in all day in each of doses.
As I mentioned before they're going to come from Barth biotech upon EUA approval and for the first leg of the face transition we have engaged the U S. CLO, which is approved by FDA to do as it relates to testing. So the initial doses will be released under oxygen control.
<unk> done by U S VA Proto lab here in Pennsylvania.
So that's already ongoing.
Right.
Okay.
Let me get back in queue, but thank you.
Okay.
Our next question comes from Jake <unk> with Roth Capital Partners.
Hey, guys. Thanks for the update.
One quick question, so you've communicated that cobalt from Citibank.
Dan It is multiple Nick Wang from Covid.
For example.
Thank you Paul and welcome everybody.
Thank you Paul.
Reported in a better place on population growth.
Thanks, Ed.
Got it in for Ben I think Anthony Thanks items by the administration that same day.
So it doesn't get into the back into the classroom. So just curious how much data you actually have installed on specifically.
And then age 12 and above.
That enrolled into the phase III study and how important that number will be for negotiations and then the second part regarding that is that.
But that.
Is getting relative way about the variance that Minto mine guidance line negotiations.
Hi, Lee.
Absolute LOE consider a quick clinical data on to kind of guide potential appetite for.
Yeah.
Yeah, so moving but I think the line will not put it for you, but I think I got it one is first question is.
The 12, plus age group on the second one is related to variance.
No.
Discussions with the government and then on what Youre hearing from upside. So we do have data from 12, plus as I mentioned before at least 16, plus volume kids, but mostly in Middle School and high School day.
They would be.
No.
Really the.
Target for this vaccine because there is a significant unmet need currently there is one vaccine, which is 16 plus all of the <unk> and other two are 18, plus so this is really important I think.
We really have to get the kids into the classroom just like.
Vitamin administration staging and upon approval, we'll be able to deploy those doses again, we got tens of millions as we mentioned from from.
From our contractual obligation with Florida, they're going to supply and our goal is to at least you don't get those kids on those vaccinations.
The data, we have been able to get the UAE.
And the second step is on the variance we did.
Published the data our collaborator on the UK variant data looks.
Pretty promising.
And no reduction in closing antibodies and based on that we believe based on the how this vaccine is delta.
We believe it will be potentially effective against other variants do so obviously when you have a broad vaccine like this even though there are other.
So players in the U S. We believe.
This will have its advantages and it's much needed in the Arsenal, if we need to do additional studies as a booster dose two other vaccine <unk>, we'd be happy to do that.
To get this going so that in our go leads this vaccine can protect and the slowdown or minimize our prevent wireless scape and control the pandemic, we'll do everything we can.
Ladies vaccine.
Thanks Shankar.
Our next question comes from volume Buccola ROM accounts with HC Wainwright.
Thank you. This is RK from H C. Wainwright, good morning, shrunk or items Sanjay.
On quite a few of my questions have been.
Answered already but I have a couple of them.
Regarding the phase III.
Data on the complete analysis of the phase III data.
Do you do you have an idea of in biotech.
Biotech.
It would be able to release that.
Yeah, we are anticipating the next day drum to come out sometime in April.
And as.
As soon as it comes out the release and.
We're going to.
Get all the information and get ready for EUA submission. So we're anticipating that in April.
Sorry, so in April.
Another interim on the final analysis.
Is that right. The yeah. The final analysis from Paulo again and on the second interim you have to get certain number of cases and the final analysis when you get to 130.
And so they are anticipating for some time.
April the second interim and then based on the effective day rates on how they're getting with no more than they're going to be able to get the final 30 number but we believe by the time they get the second interim we should have adequate data on.
The efficacy <unk> safety.
So does the FDA would require.
Yeah.
Final analysis data or once you get in April is sufficient.
For book, the pediatric population right, so pediatric 1200 above as well as the adult population.
To file for the EUA.
Yeah. So I think EBITDA has once again the efficacy endpoint is one one we believe with that.
The already robust interim look it looks good and so if it follows and we believe it will follow the similar trend.
So that should be sufficient but on the safety side there is a requirement.
Do you need to get certain data.
This big data beyond the booster dose for a certain number of participants.
Participants on the clinical trial. So we believe by the time they get back that safety data will be available that's important.
And also you know.
This is getting massive organizations in India.
<unk> already dosed millions of participants.
<unk> expense.
The National Immunization program.
And any data we can get from that.
We are closely working with our partner and I think they said the government is supporting them and they will be happy to support that.
Good day and on package.
Perfect and then one last question from me is on the on the stockpiling part of the conversations.
Have you initiated that or do you need to wait for the U S. EU to be completed and approved before getting into a discussion regarding stockpiling.
We're already having discussions with BARDA.
And so we are in active discussions right now and.
And then we'll continue those.
Perfect. Thank you gentlemen talk to you soon.
Thank you okay.
Thank you okay.
Our next question comes from Kristen <unk> with Cantor Fitzgerald.
Hi, everybody. This is Blake on for Chris then I have two questions for you guys.
Recent surveys in the U S shown that more than 30% of Americans are choosing not to receive the vaccine once they become eligible for many reasons have you on your partner brought thought about different ways you could educate the general population in the U S on ways that kovacs and differentiate us from any other vaccines that are currently on.
A market, particularly as it relates to safety and mechanism.
Yeah, I mean, we're already.
Educating and then a differentiating it's a vulnerability on vaccine it give us a broad spectrum.
Humira as well as cellular responses and this is made with a similar platform technology that they're known for decades and up on your vaccine is being made so we will definitely do whatever we can to educate the public on.
On the safety aspects on the coverage aspect on radio.
Aspects and also this could be an ideal vaccine for all children, that's really important.
We as a company are willing to do any additional studies would need to do because our goal is really focus on the children make sure.
We can really get them back to school and what our we can contribute to create like a day.
Most to normal life, and so that's really important for us and we're going to work.
With FDA and worked with the government what are we can do to help out to control. This pandemic, we're willing to do.
Okay, and one more quick one if I may I know, we've talked a lot about.
The phase III data and how they kind of interact with the new variants that are kind of coming out.
But if you if you have any other color to add on.
Okay.
So back then in the context of these other variants and have you noticed or have you has your partner noticed any.
Initial trends in the data having to do with circulating variants that maybe you haven't mentioned and also you mentioned.
Kind of a real kind of an approximate number or the number of people who are <unk>.
Currently been vaccinated with Kovacs in India are you kind of able to give any more specifics on that total number of people that have been vaccinated at this point.
Yeah, so coming to the variance yeah, we have data on the published.
On.
On the UK vary on the data looks good on Theres no election, neutralizing antibody effect again in the way of conducting these studies.
Conducting really appropriate studies, how it should be done.
Non engineered wireless actually taking the total streams from the patients who are infected and then conduct a mineral pleasant antibody studies. So that's appropriate for you do it and so with that respect they got solid data on UK variant.
Also anticipating data and a similar studies from other variants, including Brazil. The Brazil, one is important because if you look at the New York.
Recently, there is a mutation <unk> hundred $40 for Kate.
That is very prevalent in Brazil too.
And I think the cases in New York austerity.
Very rapidly and there's a pretty significant percentage I think over 20% if I saw last week.
Which is which has a <unk> hundred 80 book Irradiant. So we are anticipating data.
By the time, we get the data from other analysis from park biotech next month and they are also anticipating variant data as soon as we get that we are planning to submit all of that information as a part of for the U S.
Okay. That's that's really great. Thank you very much.
Okay. Thank you.
That concludes today's question and answer session I'd like to turn the call back to Lisa Dicenzo for closing remarks.
Thanks to everyone for taking time to join this call. This morning, we are dedicated to for selling the unmet need of saving lives from COVID-19, and fulfilling patient needs by bringing to market transformative therapies for <unk> line of diseases, we look forward to providing further updates in the coming months.
Thank you.
Thank you.
Ladies and gentlemen. This concludes today's conference you may disconnect. Your lines at this time. Thank you for your participation and have a wonderful day.
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