Q1 2021 Ocugen Inc Earnings Call
Yes.
Good morning, and welcome to the oxygen conference call at the.
This time all participants are in listen only mode. A question and answer session will follow the presentation.
If anyone should require operator assistance during the conference. Please.
The press Star zero on your telephone keypad.
Please note. This conference is being recorded I would now like to turn the conference over to Lisa just sensor Vice President of integrated Communications and.
Lavoy health science to introduce the occupants team you may begin.
Thank you operator, I'd like to welcome you to our conference call with me today are our kitchens, chairman and CEO Doctor, Shanghai, and moved scenario and our CFO and head of corporate development Sanjay separate mania.
Earlier this morning on could you and issued a press release, including a business update and first quarter 2021 financial results. We encourage listeners to review of the press release, which is available on the on kitchen website at Www Dot oxygen dotcom on this call is also being.
The 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. The various remarks, we make today constitute forward looking statements within the meaning of the private securities litigation risk.
Form act of 1995, which are subject to risks and uncertainties. We may in some cases use terms such as predicts believes potential proposed continue estimates anticipates expects plans intends may could.
Right, well should or other words, the convey uncertainty of future events or outcomes to identify these forward looking statements such forward looking statements include information about qualitative assessments of available data potential benefits expectations.
The clinical trials and anticipated timing of clinical trial, readouts regulatory submissions and regulatory authorizations or approvals.
This information and involves risks and uncertainties that could cause actual results to differ materially 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.
Hated clinical endpoints commencement and completion dates or clip for clinical trials regulatory submission dates regulatory approval dates and door launch dates as well as risks associated with preliminary in the interim data, including the possibility of favorites.
The new unfavorable new clinical trial data and further analyses of existing clinical trial data. The rest of the clinical trial data are subject to differing interpretations and assessments, including during the peer reviewed publication process in the scientific community generally.
And by regulatory authorities, whether and when data from Barack Biotechs clinical trials will be published and scientific journal publications, and if so when and with what modifications and whether the U S food and drug administration. The F. D. A will be satisfied with the design and.
The results from preclinical and clinical studies of Carfax, and which are being conducted by per rack biotech any of the India.
And when any biologics license and or emergency use authorization of applications may be filed in the United States for co vaccine, whether and when any such applications may be approved by the F. D. A.
Sessions, but the F D a impacting labeling and manufacturing processes safety and other matters that could affect the availability or commercial potential of co vaccine 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. The S. C C, including the risk factors described in the section entitled Risk factors in the quarterly and annual reports that we filed with the SEC you should read carefully the risks and uncertainties.
Ascribed in todays press release as well as the risk factors included in our filings with the SEC note that we intend to file our form 10-Q with the SEC today.
Any information we provide on this conference call is provided only as of the date of this call may seven and 2021 and except as required by law, we undertake no obligation to update any forward looking statements.
We make on this call on account of new information future events or otherwise I'm on.
Now I'll turn the call over to Archie Jones, Chairman and CEO, Dr Shankar and lose scenario.
Thank you Lisa good morning, everyone and thank you for joining.
That is not the day that goes by without us witnessing the devastation caused by the kernel, whereas pinned on it.
As you all know India is currently experiencing one of the divorce spikes seen but any country since the pandemic began.
Over the last two weeks COVID-19 has claimed about 120 lives every hour on an average in India and the secondly on devastating COVID-19 infections or.
Our Hearts go out to the people of India and those working on the front lines to bring this table outbreak under control.
Also of sincerely appreciate the work done by caregivers and Jews governments, including the U S government and everyone who is helping.
On a co development partner for <unk> vaccine.
The objective has been ramping up production to meet the demands of the vaccines and India.
And navigating these extreme conditions to scale of production and increased supply.
It's encouraging to note as Dr. Anthony Faraci director of and my E I'd and the Chief Medical advisor to the President mentioned last week studies of convalescent Sera of coax and recipients have phone that collection and effectively used the latest the b 1617 and variant on India.
Double mutant stream of the Corona awareness.
However, it is concerning that the according to the World Health organization. The video has been detected and 17 countries, including the U S. We.
The continued to strongly believe that it is critical to add correct and automation of Arsenal to fight this pandemic.
We are encouraged by our announcements earlier this week the collection of demand stated potentially affecting the nice taking the strength.
And keep idioms of source go too that you gave it yet which is the 117 and the Indian double of Adient, B 1617, and Brazilian P. Do variant the 112 week too.
And just seeing the whole of COVID-19 wireless based on multi antigens, including the spike and nuclear capsid proteins coaxial and potential effectiveness against the multiple radiance and reduces the possibility of mutant weighted escape.
This is an important differentiator from currently available and vaccines and the U S, which only address the spike protein cortex and illustrates the broad spectrum immune response of 98, 3% sort of conversion by stimulating both the Cumulus and.
And so a little of responses against multiple widen protein correct and could be and more powerful GAAP on that.
And it's more likely to remain effective as the wireless continues to mutate.
And they can get the strong booster vaccine option, even for those who have already taken one of those other vaccines.
And and the recently shared second on the interim results of the Phase III clinical trial correct me if demand stays at 78% all on efficacy and 100% and severe COVID-19 disease, including hospitalizations.
Quebec City and continues to show strong results in all of the studies conducted to date the oxygen teams of rigid a comprehensive drug master file and the FDA and these pre bidding the EUA application. The current crisis and India is hampering some of the data collection and enforced by the co development partner part of the buyer.
And the thing is the result, finalizing out of you application is taking longer than anticipated despite of the humanitarian crisis, and India bottomed biotech and oxygen are working tirelessly and diligently to complete the EUA application and we hope to file at the FDA as soon as practicable.
Meanwhile.
We are highly and collaborated with discussions with the EBITDA we have.
We also signed up with an FDA approved lab or at least testing of the vaccine upon authorization and we are actively working on security and contract manufacturing partners and the U S.
We're also in discussions and the biomedical advanced research and development of authority of BARDA regarding the purchase commitment once authorized under EUA. We're planning for the pediatric study and kids six months and older. Because we believe coax and has a very strong safety profile and the.
It is based on the traditional vaccine technology platform.
We believe the correct and can help during the course of this pandemic by preventing severe COVID-19 disease, including hospitalizations and sort of less significantly limit the spread of the symptomatic COVID-19 infections based on efficacy shown to date.
Now the shift to an update on our ophthalmology pipeline yes.
Yesterday, the preclinical results of our novel Biologic candidate <unk> 200 were presented at the Association for research and vision and Ophthalmology 2021 annual meeting the.
Because of the study was to evaluate efficacy of <unk> 200, and in vitro and in vivo models for ocular neo vascular diseases of the 200 of juice, new restaurant of the nation and damage to the retina and demonstrated the compatible or slightly improved activity to <unk>.
And in animal disease model.
200 of transferring from started fusion protein demand strength at potential to treat diabetic macular edema, diabetic retinopathy and wet age related macular degeneration.
We are planning the initiation of phase one two clinical trial for <unk> 200, and next year.
We remain on track to initiate a parcel of gene therapy, and I just want to clinical trial for up to 400 later this year. The toxicology studies are progressing growth.
We have completed.
Manufacturing of 200 liter scale to support clinical studies, we're also planning to initiate the phase one two clinical trial for our Q4 of them for dry age related macular degeneration next year.
Late last month.
On the closing of it and just stood direct offering the healthcare focused institutional investors and <unk>.
<unk> gross proceeds of $100 million.
And we intend to use the net proceeds from the offering for the general corporate purposes capital expenditures and working capital expenses the.
The capital raises this year and significantly strengthened our balance sheet and position us well to develop on programs and build our team.
In summary, we're working diligently to bring <unk> vaccine the U S market the planned filing of our application and eventually and BLA or biologics licensing application.
We're continuing to expand our team the highly talented individuals to support our growth.
And also planning to move our lead ophthalmology gene therapy product candidate on Q4 hundred and to the clinic later this year.
And the ability to raise additional capital as needed we have the resources to continue driving on vaccine and ophthalmology pipeline forward and anticipate strong momentum across our pipeline for the remainder of this year I will now turn the call over to Sanjay to provide on first quarter 2021 financial.
The big Sanjay.
Thank you chunk of and good morning, everyone. We have made significant strides and the first quarter of this year, particularly and working to bring the vaccine to the U S market and the submission of a comprehensive drug master file with the FDA.
I will now provide an overview of key financial results for the first quarter of this year.
We ended the quarter with cash cash equivalents and restricted cash totaling $44 9 million as of March 31, 2021, compared to $24 2 million as of December 31, and 2020 in.
In April 2021, you raised an additional $100 million and gross proceeds with a registered direct offering.
Our research and development expenses for the quarter ended March 31, 2021 were $2 9 million compared to $1 7 million for the three months ended March 31, 2020. The increase was primarily related to the toxicology studies for all of our all Q4 hundred program and the development activities.
Vaccine.
General and administrative expenses for the quarter ended March 31, 2020, one were $4 $2 million compared to $2 $3 million from the three months ended March 31, and 2020. The increase was primarily driven by proxy solicitation cost and go to obtain the increase and authorized shares of our common stock.
The net loss was $7 $1 million on <unk> net loss per share for the quarter ended March 31, and 2021 compared to a net loss of $3 9 million or seven and net loss per share for the quarter ended March 31 2020.
The recently terminated the Neocart asset purchase agreement the medevac and are currently evaluating other options, including potentially developing the asset ourself as always we continue to evaluate the market for potential assets to invest license or partner, we will update you with any development on this from.
And in the near future.
The debt, we will open up the call for questions operator.
If you would like to ask and audio question. Please press star one on your telephone keypad again, the star one to ask and audio question.
Your first question comes from the line of Keith Mckey with charting.
Good morning.
So a couple of questions about the vaccine.
Shane you mentioned.
Yeah go ahead.
Good morning.
Can you hear us.
We kind of given the K.
Okay. Please press star one.
Operator looks okay.
Got disconnected.
The next question, we can come back the K.
Okay. Your line is open.
Hello.
Hello.
You bet.
I can hear you can you hear me yes.
Yes, yes, now we can hear you. Thanks, Scott good morning, Okay, Yeah, but I don't know what happened there with the thanks.
Couple of questions about the the vaccine of Shaker you mentioned.
Some of some some some delays due to the activity that's happening and India.
Do you have a sense of when you might be able to complete the EUA filing the application application.
Oh, yeah, yeah the.
Stay tuned and all we're working very hard with the.
Partners.
At Bald biotech and it's taking longer than anticipated and we had.
Planning to complete the U application and the.
Thanks.
Okay and in your initial discussions with the FDA would of the said if anything about wanting to see vaccine data for U S patients before allowing them to move forward.
Not to date.
Okay.
Alright, very good that's all I have let me get back on queue.
Thank you okay. Thank you.
I would like to ask a question. Please press star one.
The next question comes from the line of Gela.
<unk> <unk> with Roth capital.
Good morning, guys. Thanks for the update of a couple quick ones for you I think the first one is just and you know additional info on what where we need it from the folks and India to kind of finalize the EU application like what that assets are you missing the lap of masonite mapping and you're waiting for.
But as you know this is a very large clinical trial.
And the.
At the conclusion of the interim phase two and then the second interim.
The interim results from the phase three clinical trial.
Do you have to pull all of the data together.
And this amount of effort and.
And in the middle of the pandemic, obviously this crisis and India has caused some delays.
And so just as everybody is submitted there is large amount of safety database you have to pull together.
Okay.
Efficacy, that's what they're working on.
Okay. So you do need some and some safety and some efficacy data that you're waiting on and then the follow up question is regarding the master fall and I know you've submitted it but I was just wondering you know when you anticipate getting from feedback from the FDA and when you do get the feedback are you kind of communicated publicly.
Again and.
And again.
The normal course of business and the Dia communications and it.
And depending on if it's of feedback concerning you know there are some anticipated the questions or clarifications needed and that's the reason and all we.
The collaboratively working with the FDA. So we can incorporate anything else any information additional information and the U and that's the plan and obviously, we may not be going into already dense.
Understood and then just the last one year volume pass with the continued execution on the ophthalmology pipeline and sellers. Just wondering if you can provide just a little bit more granularity as to what needs to be complete and cause. It's nice that you do have capital the kind of support from the dose afterwards, but just any detail on it.
Now what's needed for the next steps for <unk> 400, and I keep the 200.
Yes, so occupy 100 and as I stated, we have successfully completed manufacturing at the 200 liter scale.
Potentially of commercial scale.
And so the next step is for the preclinical toxicology studies are in progress.
As soon as we complete those studies, we get the reports and be ready to find the A&D.
Which is the and we are anticipating to find the later part of this year.
Okay. Thanks, Shankar and congrats again on all of the progress.
Thank you Bob for the question.
Your next question comes from the line of Robert Leboyer with the noble capital.
Good morning.
Good morning, how are you doing I'm doing well thanks, Mike.
My question has to do with the emergence of use application and when you. When you expect to hear and answer back from the FDA is positive what would that mean in terms of rollout and how would it fit with the current vaccination programs.
Yes.
Again, it'll be we're anticipating it's going to be a similar process to other companies.
After we filed the emergency use authorization application typically agency it takes two to four weeks.
And to make a decision and have a meeting with the ACA IP and.
And after that we will be ready to roll out of the vaccine just as all of the companies have prepared.
Okay, great. Thank you very much.
Thank you.
Your next question comes from the line of Carla.
On Macau with T H H C Wainwright.
Thank you of this is RK from H C Wainwright.
Good morning.
Jeff just for my Edification.
If you could.
Please help us try and.
Try to distinguish between the two.
The filing of the master file on.
And what you'll need to do in terms of the.
The emergency use application.
What are the differences there in terms of data in terms of.
You know what else you need to be providing.
Yes.
So we are following FDA guidance on.
You at four include vaccines, so based on the guidance.
Master file is the.
Plus debt to include all preclinical manufacturing and any other data prior to phase III. So that it gives us an opportunity for FDA to review and provide physicians comments price.
Prior to filing of UAE, So thats the process, we had completed and.
File of us quite extensive.
And the second step is filing the emergency use authorization.
Vacation and just as other companies have done so those are the two of them so that obligation and how.
The primarily.
The second interim analysis up to the point under 2000 patients what we have announced before sales.
The safety efficacy and.
<unk> the new.
Video and data, which is coming out which will be part of the application.
Really good so obviously going into the SKU.
And it is already in the reported up it looks at the data. So do you still have to sit down with the FDA.
For the pre EUA and discussion and.
And is that on.
And that discussion will happen.
Before you also have another discussion with the BARDA.
These two are separate and discussions on.
How should we think about.
Timing of all of this.
And in the course of getting <unk> and into.
Of the hands of BARDA.
Yes, the FDA process at the similar process to other companies.
Sure.
And.
We're collaborating and working with them, we're continuously communicating with them.
And so obviously, we will be notifying them and communications.
And when we are filing the UA.
And the.
The conversation on the communications those of different from BARDA and BARDA.
The independent.
And obviously working with the BARDA of administration.
So those discussions are ongoing.
So that like in parallel and obviously the market linked.
Okay.
Last question from me.
With with all of the.
All of the entities that are being spent on <unk> and I'm trying to get the correction.
Across the finish line.
How are you.
Uh huh.
How are you on your resources.
To not only get collection through but also.
For phase one dose.
Clinical trials and get started on all of your 400 early next year.
Yeah. So the.
We are actually we are.
Also announced we are also increasing our internal resources, we got a also a good size external team of.
The demand for solid experts supporting coax and development, including and on future clinical trials plans and everything else and addition to that internally we are beefing up the team the recently announced of.
We hired the senior vice president of manufacturing and supply chain.
Tremendous experience from vaccines and gene therapy expertise and the highly regarded person and the industry and so we're billing of very strong manufacturing team under him and similarly, we're going to beef up other functional areas and the organization as we continue to grow this year.
And that's going to support as you've stated starting with the Rockies 400 gene therapy program, which we plan to file the IND.
And part of the year and initiate the clinical trials plus all of the ophthalmology programs with.
The planning to initiate.
As you stated for based on on the clinical trials and comparison, our Q4 hundred 14 gene therapy as well as on Q2 hundred and we'll be supporting them.
And of the resources.
Every day.
Thank you. Thank you Shanker and best Sunday and talk to you soon.
Thank you. Thank you again.
Our next question comes from the line of Kristen <unk> with Cantor Fitzgerald.
And good morning, everyone. Good morning, Thanks for taking the questions. The first one I have is in regardless of the potential usage of kovacs and as a booster have you considered what work our understanding would need to go into the to determine when somebody should receive this and the number of doses.
And then how are you and your partners thinking about tracking the long term durability of kovacs and as all of the company. Just generally speaking are trying to determine how often these boosters will be needed.
Okay. So on.
And separate the two questions the booster studies again.
We are.
We're still preparing the protocols typically.
You have to wait for any bolsters.
For the required and the coax in case, you know we're doing the bolster after 28 based on the first dose. Similarly, if you.
Do you want to space them out for other racks and he's at least a month or more.
And that could be to be determined our clinical team headed by Dr. Bruce Forest and expert in this field and the we're going to make those of editions and the upcoming months before we filed the protocol with FDA.
And the second parties and all of you going to monitor of long term debt.
Our ability I think of our partners have already published extensive data I think and the lancet.
The lancet and others and we're continuing to monitor and the long term durability of this vaccine and typically what is important and fees I think of the missing piece people have to understand it's not just the safety and efficacy of efficacy the.
But the one time.
And you're remembering as a part of the face of clinical trial and it is really important to measure the restaurants at 10 of the responses and T cell responses and.
And that's what they're doing.
And to you on.
Thank you and then just to go off of <unk> question, how should we be thinking about the near term spending projections, including your comments about expanding the head count as well as planning of pediatric study and evaluating some of these booster.
Sure Joe Studies.
Thank you for the.
So kristi and good question. So the obviously raised some capital that he recently both in the first quarter as well as end of last month of the $100 million our deal. So the debt we have a very strong balance sheet, we have been hiring many people over the last.
A few months.
And we have bolstered the team quite a bit book on the vaccine side as well as on the ophthalmology side. So the activities are progressing well on that front and with all of this capital that is really that's more than sufficient for us to do kind of.
Put in place any of the clinical plans for pediatric study as well.
Continuing on with out of original plans on the ocular program. So we feel this is at this point and time very confident that is of sufficient for all of our program and plans.
And as well as our hiring plans.
Thank you so much and then my last question is whether you anticipate any issues related to the current travel ban to India as it relates to manufacturing inspection or anything else regarding that partnership.
Yeah the.
The travel ban again Christina.
And the monitoring just as any other country.
And as breakouts are going to come up across the globe.
And again, we cannot anticipate how long it's going to last.
And as far as of any potential inspections and all agencies of conducting.
And these days and until the inspections. So they have some flexibility on that.
Great. Thanks, so much everybody.
Thank you.
You do have a follow up question from the line of Zynga.
<unk> with Roth capital.
Hey, guys just wanted to do a quick follow up on something that of Jacob.
Chris and his question I was just wondering for I D.
Yeah. This is gonna be coming of a day initial doses of critical Lindsay from Barbara is that still the plan or are you now considering you have the name Mr. Jonathan has come from the U S matter of fact.
That is still the clients like the.
While we are in parallel and working with the U S contract manufacturing.
Yeah.
This concludes the question session for today I would now like to turn the conference back to Lisa for any additional or closing remarks.
Thanks to everyone for taking the time to join this call. This morning, we are dedicated to help save lives from COVID-19 by bringing <unk> into the U S market and develop gene therapies to cure blindness diseases, we look forward to providing further updates in the coming months. Thank you.
Thank you for participating on today's conference call, Ladies and gentlemen. This concludes today's conference you may now disconnect. Your lines at this time. Thank you for your participation and have a wonderful day.