Q3 2021 Ocugen Inc Earnings Call
Good morning, and welcome to the Aki Gen 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 zero on your telephone keypad. Please note. This conference is being recorded I will now turn the conference.
Average kin and Chalsty head of Investor Relations and communications for oxygen.
May begin.
Thank you operator, I'd like to welcome you to our conference call with me today are <unk>, Chairman CEO and co founder Dr. Shankar amongst jewelry, who will provide a business update and our chief financial officer, and head of corporate development, Sanjay Superman, who will provide a financial update.
Earlier. This morning, we issued a press release, including a business update and third quarter 2021 financial results. We encourage listeners to review the press release, which is available on our website at www dot oxygen dot com.
This call is also being recorded and a replay along with the accompanying slide presentation will be available on the investors section of the <unk> website for approximately 45 days.
As always we need to advise you that this call will contain forward looking statements such forward looking statements are subject to risks and uncertainties that could cause actual events or actual results to deliver differ materially from expectations, including among other things the uncertainties inherent in.
Research and development of our product candidates risks to our business related to the ongoing COVID-19 pandemic uncertainty regarding.
Regarding the whether the FDA will grant us emergency use authorization for <unk> in.
<unk> 2018, and when we will be able to submit a biologics license application for kovach sent to the FDA and whether and when we will receive regulatory approvals for authorizations for <unk> in the U S or Canada.
These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission, including the risk factors described in the section entitled Risk factors in our quarterly and annual reports that we file with the SEC.
You should read carefully the risks and uncertainties described in today's press release and accompanying slide presentation 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.
I'll now turn the call over to <unk>, Chairman and CEO, Dr. Shankar move similarly.
Thank you Ken Good morning, everyone and thank you for joining and we hope you and your families are safe and well.
Today, we are here to review in rapid succession of milestones from this company I feel privileged to lead.
It reminds me of the same.
MS Margaret Mead Court network.
A small group of thoughtful commentary citizens can change the warm indeed, it's the only thing that <unk> has.
These words remind me.
One year ago oxygen was less than 20 individuals. We all had a vision to bring new therapies that could tackle serious diseases and bring new options for people wanting to choice.
We have completed three quarters of 2021, and our oxygen family has grown significantly committed to bringing <unk> BBB, one slide to our COVID-19 vaccine candidate to the United States and Canada, along with our lead candidate for blindness diseases, Our Q4 hundred which is a part of our modifier.
Our gene therapy platform.
Today's update is a result of their hard work along with the efforts of our global partners product biotech and casino bio <unk>.
Thank you all for your contributions.
This slide outlines the major events that transpired over the recent months, including the third quarter of 2021.
We want to congratulate our partners at modest biotech for securing an emergency use listings for <unk> by the World Health organization. This is exciting news thats, a tremendous accomplishment and a critical validate or for broadening the global portfolio of COVID-19 vaccines and <unk>.
Noticed by the regulatory authorities around the world.
Closer to home oxygen took significant steps to progress collecting BBB, one five to the U S food and drug administration.
Last week, we submitted <unk> vaccine for emergency use authorization from the FDA for use among those aged two to 18 years.
We believe there is a significant unmet need within this age group.
Knowing that there is a lack of choice for different vaccines within the U S market.
Particularly in ages two to five there is currently no approved option. We believe the data as we top lined on our Friday call November 5th press release make it compelling efficacy and safety case to the agency and we look forward to furthering our discussions with them.
And in mid October we filed an investigational new drug application to support the initiation of the phase III immuno bridging study between the U S population and the results of Biotechs phase III clinical trial involving nearly 25800 participants.
This phase III bridging trial is being conducted in support of an upcoming BLA.
Our trial has designation acute 002 and will involve a few hundred subjects that primary objective will be to compare neutralizing titers between the U S based participants who get to doses of <unk> to those who got two doses in the phase III efficacy.
Trial in India.
Secondary objectives include measuring the immunogenicity of two doses of <unk> vaccine over time in those who are of each between 18 and 65 in those over the age of 65 as well as determining its immuno broadening effect, including indoors, who previously.
MS. Li received an mrna vaccine such a broadening effect could include antibody responses against multiple antigens, such as spike and nucleocapsid protein.
We're also preparing for the possibility of conducting a CFT bridging trial.
Finally, we are hearing from many people about their interest in participating in this clinical trial if approved.
We're really appreciative of their passion and after disease June for further development.
To the north our engagement with health, Canada continues and responses to deficiencies noted are being prepared as a reminder, we have played for approval under the interim order and our application was automatically transport to a new drug submission process.
I now want to update you on our progress with our modified gene therapy program.
I am pleased to announce that yesterday oxygen filed an investigational new drug application for our Q4 hundred our lead candidate and the Monitory <unk> gene therapy platform for the treatment of retinitis pigmentosa, resulting from genetic mutations.
<unk> <unk> rhodopsin.
This is a proposed safety and dose finding phase one two clinical trial involving a small number of patients.
We have already successfully completed manufacturing at commercial scale.
At 200 liter scale to support clinical studies.
As part of the clinical trial patients will be absorbed post dose, but at least 12 months from their occupy 100 could more entry of phase III clinical trial evaluating its ability to address multiple inherited retinal disease mutations.
This is the beginning of a new journey one started by our partner Dr. Rodino Haider from Harvard Medical School, and we look forward to sharing the progress of our trial if approved throughout 2022.
Following close behind our Q4 hundred is our next candidate our Q4 10.
IND, enabling preclinical studies have started to support a future phase one two clinical trial of.
<unk> is designed to address dry age related macular degeneration.
Most prevalent chronic form of AMB accounting for approximately 90% of total AMD cases, and is characterized by slow progressive dysfunction of the retinal pigment epithelium photoreceptor loss and retinal degeneration.
About 150 million people suffering from dry AMD and on the award and no treatment options available. There is significant unmet medical need preclinical data recently presented at the dry AMD Therapeutics conference in October suggest that our Q4 plays a role in that.
Genes associated with dry AMD dial up overtime, and we will continue to explore this area throughout 2022.
We are pleased to share that in order to support the manufacturing of our Q4 10, we have expanded our arrangement with <unk>.
To be our partner responsible for our chemistry manufacturing and controls development and manufacturing.
Dave will now support the CMC development and manufacturing for both the occupy 100 and occupy 10 programs I.
Our agreement with Casino <unk> was amended in September to add this program.
Rounding out.
Our ocular portfolio occupy 200 hour.
For income stack in fusion protein is still progressing well we are on track with our preclinical activities to explore further how it can help those with diabetes.
<unk> diabetic retinopathy and wet age related macular degeneration.
With our Q4 hundred moving into clinic.
And <unk>.
200, continuing that IMD, enabling studies, our focus on ocular therapies remains very strong.
This indeed has been a busy quarter with much going onto advanced correcting and our ocular portfolio and there is much more ahead.
I will now turn the call over to Sanjay to provide our third quarter 2021 financial update Sanjay.
Thank you Chuck and good morning, everyone.
I will now provide an overview of key results for the third quarter of this year.
Our research and development expenses for the quarter ended September 32021 were $6 3 million compared to $1 5 million.
The third quarter ended September 32020.
The increase is primarily driven by production development and regulatory activities, all Q4 hundred preclinical activities as well as employee related expenses due to an increase in R&D headcount.
General and administrative expenses for the quarter ended September 32021 were $4 5 million compared to $1 7 million for the third quarter ended September 32020.
Our increase in general and administrative expenses relates to increased infrastructure costs to support the growth of the organization.
Net loss was $10 8 million or.
<unk> net loss per share for the quarter ended September 32021, compared to a net loss of $10 5 million or <unk> <unk> net loss per share for the previous year's quarter ended September 32020, which included a $7 million write off of an asset held for sale.
We ended the quarter with cash cash equivalents and restricted cash totaling $107 5 million as of September 32021, compared to $24 2 million.
As of December 31, 2020 that concludes my update that you can.
Thank you Sanjay and with that we will open the call for questions operator.
At this time, if you would like to ask a question. Please press Star then the number one on your telephone keypad again Thats Star then the number one.
I ask a question.
Your first question comes from the line of Ken.
<unk> <unk> with Chardan.
Good morning.
Couple questions for you.
Good morning.
Yes.
The first question relates to timing for the adult population in the U S. So as you convince the bridging study.
And hopefully that will set you up to file.
In the middle of next year, so should.
Should we think about possible approval and.
Q1 of 'twenty, three is that kind of an appropriate way to look at the timing.
Yes.
Follow the path of regulatory pathway and other completed followed.
We believe.
Agency loans or consumer fast track for US we were planning to initiate that.
At the right timing and so based on that we're planning to file the BLA in the second half of next year.
So sometime.
In 2023.
Yes, it must have if.
If we do get the fast track designation.
It seems to be reasonable.
Okay, Great and then.
Under your agreement with <unk>.
Under a scenario, where the U S. We'd like to purchase <unk>.
Our vaccines to help distribute O U S again because of this.
Many attractive.
Characteristics.
His broad precluded from selling vaccine to the U S for that purpose and you exclusively.
Have the right.
So the vaccine to the U S government.
Any purposes.
Yes, we have rights in the U S and Canada and any procurement from U S government, yes, they have to go through.
Okay great.
And then for the most recent EUA filing for the pediatric.
Given that Youre running the bridging study for adults how do we think about whether you'll need to run a bridging study for pediatrics as well before you could give in terms of approval.
This is again, we have filed emergency use authorization.
As we outlined in the 2% to five age group. Currently there are no authorized vaccines are approved vaccines and there is a significant unmet medical need and those things will be.
Considered play for emergency use authorization. So thats. The reason based on compelling data we have in the pediatric population.
Decided that the American kids do need a choice and we thought in the 2% to 18 each group. That's the data we have from our pediatric population from what partners. We filed in the U S. It is purely based on unmet medical need.
Okay and then.
Just two more questions one.
For Canada.
Should we think about the potential timing there to get a potential.
Approval.
Having filed in Q3.
No.
Sure.
Cool.
Anticipating accrual review again.
First half 'twenty through 'twenty, two I'm, sorry, or maybe mid 'twenty two.
Timing for that.
That potential approval.
Okay.
I think the process for Canada again it as.
As we stated.
That is no.
Excellent of emergency use authorization, but Scott interim order it expired and the file got into.
NDS, which is new drug submission process.
And typically it does take some time and I cannot comment on actual regulatory time.
Exact date. However, we are closely working with health, Canada review process and addressing any questions come up on the way.
Okay and then.
<unk> on the following four Aki 400, nice to see those programs will be entering the clinic.
On the end of the year. So that's great. That's all I have.
Thank you thank you Ken.
Your next question is from Zach Butler with Roth capital.
Good morning, Thanks for taking my question Congrats Rafal.
Okay.
A couple of quick questions for me in the first half.
Just on the pediatric <unk> I was just curious you with any here.
Any kind of update.
Update on an acceptance at the EUA before a decision is made.
Next our feedback from the FDA will be.
Whether or not it is that <unk> expect something within a weaker Q1.
Good morning.
Again.
<unk>.
The review process.
The accepted for review so the processes ongoing.
So when we get updates when appropriate updates to the market at this time I cant comment anymore.
Okay.
Not expecting to get better about the acceptance or anything like that prior to an update on what that not adding <unk> is approved.
Typically the EUA goes through the process.
Based on the process.
Three companies have done typically it goes to outcome before it gets any margin.
And so thats a typical process so.
We're working with the agency on that.
Our remarks from here I know you said.
For Health, Canada U.
You can let me comment on the timing of anything but I think you also said that you haven't gotten any questions or comments from them is that correct.
Can you repeat the question.
Sorry, what health, Canada, obviously, saying that so far after your submission we haven't gotten back any questions. I'll follow up are you having had to submit additional information or anything like that just waiting to hear back from them.
But this is a normal course of business review process.
Any NDA resubmission and the regulatory agencies in the companies.
The actual process respond back and forth.
And so that's again normal course of business Thats, what we are dealing with kindergarten.
Okay. So you have had some back of the swap with that and then the next one here is just about the potential to expand <unk> Barrett I know I think you have the opportunity to detail a lot more territory, but I was just wondering what it is that you need to see before you make the decision and ticket is down.
So just just to make sure I understood. Your question correctly, you're asking about our opportunity to expand our territory rights with Florida.
For other agents.
What would be the.
No.
On the catalyst for that.
Yet.
Again, those options are open and again, we're really focusing on the U S and Canada at this stage.
Again, we'll keep those options open with our partners.
Okay, and then moving on to our Q4 hundred really excited to see that in the R&D get submitted I was just curious as to.
Any update about the study design, what we might see any kind of clinical update Brian thanks on that program.
Yes.
A&D gets accepted and goes through the process.
We will be launching the information into clinical trials stock out.
And that.
That will help.
All the stakeholders.
Potential patients and everybody else.
And again this is going to be a small trial just as other orphan designation trials in the retinal space.
Okay.
And at that point.
You maintained quite Ken I was just wondering where you are in terms of development if container doing anything right now Ken are you doing.
And the enabling studies were in the process.
Yes.
As started working on the development.
For 400.
So we do have a roadmap from the FDA on occupancy.
And currently the team is.
In the process of executing those plans.
Okay. Thanks for the update.
Thank you Dave.
Your next question is from Robert Leboyer with.
Global capital.
Good morning good.
Good morning, Hi.
Congratulations on the results on all the progress you've made in the last quarter.
Michael Your question is.
To do with the <unk>.
Booster shots and the durability of <unk>.
And whether there is data that might show any need or.
Lack of need to have a booster shot six months or 12 months after vaccination.
And I also was wondering if there was any data.
To show or any discussion of the.
Using kovacs in following one of the messenger RNA vaccines to give broader protection or any benefits that one might have there.
So Robert first question is.
The longevity effect.
Again, our partners are.
Generating some data and the data is available it will be published.
And but however.
The data to date clearly short of one thing scientifically people have to discuss more about cellular responses. The T cell response, which creates a memory.
And that's all you got the long protection with any vaccine.
Our partners have shown in the published.
Articles in the political journalist medical journals.
Vaccine elicits strong tailor responses.
So that means potential memory and you should get loan protection.
Again, when they generate more data, we're going to continue to share that with the market.
Question is people have been vaccinated with mrna vaccines are we going to generate the data.
The answer is yes, our clinical trial, which we did file the IND.
The immuno bridging trial doesn't exclude anybody who took mrna vaccines and flagged. It does include <unk>.
People, who have taken mrna vaccines with the cash.
It has to be at least six months earlier. So those people will be included in our clinical trial and we're going to generate the data in those subjects.
Great. Thank you very much.
Yeah.
Thank you Rob.
I'm sorry. Your next question is from Sean Lee with HC Wainwright.
Good morning, guys and thanks for taking my questions.
My name is on the <unk>.
<unk> agreement with buyer right. So does that cover potential commercial supply if you're EUA for pediatric population is approved.
How much supply would you have access to and.
Also in terms of the tech.
Tech transfer to <unk>, what's the progress on <unk>.
The timeline on that.
Yes.
The UA.
Supply agreement does include illiquid dose as Sean and our partner ourselves significantly increase that capacity.
This year.
And also.
So they don't how many restrictions for expert so we will be.
Adequate supply of water is needed post EUA in the U S and as far as the technology transfer is concerned it Julian Hollister the program is going well and.
We are anticipating completion of Istar.
Establishing back including closest foundations in the first half of next year. So that we can switch the supply. So initial part of the supply. Thus include even we did see a product from <unk>.
Biotech partners. It will include U S packaging and testing from U S release site, which have been established.
Once the transfer is completed next year would you need additional CMC validation for the FDA to.
So that the clinical batches of commercial batches.
Yes, that's a normal part of the process. When you add additional sites you always have to show the compatibility and that will be the product process.
Alright.
My next question is on the <unk>.
Q4, 10, and so on.
You showed some pretty good preclinical results from that program back in October I was wondering what's the development timeline on that and when can we expect tactical into the clinic.
Is it related to <unk>.
Yes.
Yes no.
Then.
Yes, that's one again, we have a roadmap from FDA we.
We have to follow the typical process as other gene therapy product like we did for 400.
So the two steps, which are really important to get to file the IND for that one is.
Developing and manufacturing the product.
And second part.
These are preclinical toxicology studies.
As we agreed with the FDA.
Again this is a big program it goes too.
And a large populations, unlike 400, which targets.
Rare diseases therefore.
And therefore.
The workload this is little little it'll take a little longer.
From preclinical Tox perspective.
Thing else and therefore, we are typically working on it.
Again.
I mean I would.
At least we have a road map from EBITDA and we're going to execute it and our goal is to put that in the clinic in next 12 to 18 months.
Great. That's all I have thanks for the additional clarity.
Thank you Sean.
At this time there are no additional questions I would like to turn it back over to Ken for closing remarks.
Alright, Thank you very much and thanks, everybody for taking the time to join this call. This morning, we look forward to providing further updates in the coming months and we thank you for your time.
Thank you ladies and gentlemen. This concludes today's conference call. You May now disconnect. Your lines at this time. Thank you for your participation and have a wonderful day.
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