Q1 2022 Ocugen Inc Earnings Call

Good morning, and welcome. Thank you.

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.

<unk> on your telephone keypad.

Please note this conference is being recorded.

I will now turn the conference over to Kim and Chelsie.

As with Investor Relations and communications for oxygen you may begin.

Thank you operator, I would like to welcome you to our conference call with me today, our oxygen chairman and CEO and co founder Dr. <unk>, who will provide a business update and our chief.

Accounting officer, and senior Vice President of Finance, Jessica Crespo, who will provide a financial update.

Earlier. This morning, we issued a press release, including a business update and first quarter financial results for 2022, we encourage listeners to review the press release, which is available on our website at www Dot <unk> Dot com.

This call is also being recorded and a replay along with accompanying slides will be available on the investors section of the oxygen 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 results to 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 whether and when we will.

Be able to submit a biologics license application for <unk> to the FDA and whether and when we will receive regulatory approvals for <unk> in the U S, Canada or Mexico. These.

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 the quarterly and annual reports that we file with the SEC you should read carefully the risks and uncertainties described in today's press release as well as the risk factors included in our.

Our filings with the SEC finally, our 10-Q will be filed soon after today's call.

I will now turn the call over to <unk>, Chairman CEO and co founder Dr. Shankar missionary.

Thank you Ken.

Good morning, everyone and thank you for joining we hope you and your families are safe and well.

We are here today to review for you. The most recent activities and events that took place over the first quarter of 2022, along with providing a financial update.

<unk> value proposition of courageous innovation comes from the diversity within our pipeline.

Brink's multitude of opportunities to develop new medicines and EC states the options are either limited or nonexistent.

In the long run oxygen, Texas is connected to our ability to bring innovative and meaningful medicines that generated significant value for patients and society.

We are being forward looking and our approaches with <unk> using this particular time to enhance our clinical development program.

At the World vaccine Congress in late April speakers, all agreed that public health strategies.

And more vaccine options are needed.

And as typical in the pandemic the same sense change that landscape again all of this still needs.

Demand that our nation needs vaccines that go beyond the spike protein and attack the other targets such as the N proteins that the long term durability.

<unk> ability and the broader immune response, maybe important for realizing that bolster strategy for annual vaccinations people want options for vaccinating themselves the children, including vaccines based on a traditional platform.

Clearly have a role to play.

And we are pressing forward to fulfill our commitment.

And our funding focus blindness diseases is becoming clearer, especially with a wider network and recognizes pigmentosa a disease for which there are no medicines to block disease progression no cures and limited treatment to help manage some months tragic journey that leads to blindness.

The oxygen team continues to charge ahead and over the course of the past quarter. We are seeing great progress mixed in with the challenges that are characteristic of the life Sciences business I'm, especially confident that the team is well situated to advance our restaurants.

This slide contains important opportunities we see ahead of collapsing.

But before I get to those opportunities I'm going to address how we are working through some obvious headwinds.

The work.

Health organization announced it wanted our partner <unk>.

To address deficiencies found in the manufacturing facility used hurco vaccine, which led us to temporarily pause the dosing of subjects in our phase two three study.

<unk> zero zero to the FDA subsequently placed 30 on clinical cohort.

Under the backdrop, there are some important facts to share.

First <unk>.

<unk> affirmed that the available data indicate co vaccine is effective in most safety concerns exist second we have provided information to the FDA and are working towards resolving this issue. So that we can resume that clinical trial.

Even so we have not stopped finding opportunities to commercialize <unk> vaccine and we recently added Mexico is a part of what is known as the oxygen territory.

This was made possible because of the strong relationship we have with bottled biotech who shares our object use with the Mexican government to fight COVID-19, with this contract amendment, we have expanded our commercial footprint.

I will cover all of the North America.

<unk> already has an emergency use authorization in Mexico for adults and application for pediatric use 18, each group is under review.

We are currently working on commercializing the vaccine in Mexico.

Now, let's turn to modify your gene therapy program.

Central to <unk> research and development on inherited retinal diseases for which there are no options and only one gene therapy modality exists.

Our modified gene therapy, Unlike traditional gene therapy as shown in preclinical models to ethic directly it yourself genes.

Nuclear hormone receptors.

The charts.

<unk>. These in the charts modulate gene activity and maintains homeostasis.

<unk> networks are not functioning properly. This unbalanced state can lead to disease for oxygen that the family of inherited retinal diseases that cause blindness.

Modifier of gene therapies, when influencing and HRS can dissolve disease progression FX disease onset or how disease present in the body like blindness diseases associated with <unk>.

<unk> III rhodopsin mutations other mutations.

Our phase one two safety and efficacy clinical trial for our Q4 hundred targeting retinitis pigmentosa associated with gene mutations and Mark to EBIT and adoption is ongoing.

I'm very pleased to say that we dosed our second patient this week this.

This is a significant accomplishment and another way to therapeutic category because for the first time, we're evaluating this Marty prior gene therapy concept that adoption mutation in the ophthalmology space.

By the end of the study we will collect data from 18 patients, which will constitute three cohorts of three different doses before moving onto the phase III clinical trial.

If successful this therapy has the potential to treat many mutations under RP. Currently RP has about 150 mutations about 2 million people globally struggle with this blindness diseases.

Additionally, no therapies exists today to rescue them from disease progression. So our sense of urgency for is skewing one site is critical.

Our next candidate our Q4 10 has IND, enabling studies underway to support future phase one two clinical trial targeting dry age related macular degeneration.

Finally, our novel Biologic, all Q2 hundred and transferring tons stacked in fusion protein that has the potential to count those.

Macular edema.

Retinopathy and wet age related macular degeneration is progressing well with IND, enabling activities to support future phase one two clinical trial.

We hope to move both <unk> and rocket 200 to clinic next year.

In summary, despite the headwinds we have a plan to move quickly on a coax in clinical trials that are required for a BLA submission. We will continue to provide updates on these clinical clients.

What's important to remember is that the strength of our pipeline. These funding that delivers innovation, we're exploring especially in our modified gene therapy platform and our novel biologic today.

We are looking for new therapies, such as our Q4 hundred 410, and 200 agonist the multitude of blindness diseases, but we also have our sights set on other disease states that could benefit from this modality.

Overall, we have made significant progress this quarter and we remain confident in the long term opportunities and growth that we believe our pipeline to unlock.

<unk> and shareholders I'm very proud of our team that is solely dedicated with the focus on patients.

I will now turn the call over to Jeff to provide our first quarter 2022 financial update Jess.

Thank you Chuck and good morning, everyone I will now provide an overview of our key financial results for the first quarter of 2022.

Our research and development expenses for the three months ended March 31 2020.

Of our $7 $9 million compared to $2 $9 million for the quarter ended March 31 2021.

Increase is attributed to our continued investment in our development activities for <unk> and our ophthalmology portfolio, which includes the initiation of clinical trials as well as an increase in R&D headcount to support these programs.

General and administrative expenses for the three months ended March 31, 2022 were $10 1 million compared to $4 2 million for the three months ended March 31 2021.

The increase in general and administrative expenses relates to increased infrastructure costs to support the growth of our organization.

Net loss was approximately $18 million or nine net loss per share for the quarter ended March 31 2022.

Compared to a net loss of approximately $7 million or <unk> <unk> net loss per share for the same quarter of 2021.

Our cash cash equivalents and restricted cash totaled $129 9 million as of March 31.

2022, compared to $95 1 million as of year end December 31 2021.

That concludes my update back to you Ken.

Thank you Jess.

We will open up the call for questions operator.

Thank you.

As a reminder.

You will need to breakfast star one on your telephone.

A question for Paul.

Again to ask a question star one.

On your telephone keypad.

While we compile the Q&A roster.

Our first question comes from the line of Ben.

From Roth Capital Partners. Your line is open.

Good morning, Thanks for taking my questions and congrats on the.

First question for me is just about callbacks.

Any update on the conversation around access in Mexico, and then have those conversations manufactured by the company in Shanghai.

So your question is that an impact on Mexico.

The duvernay to finding partners as they have announced they are working on corrective actions and.

Following up on the facility upgrades whatever is required.

They're going to simply work on fixing them and an interim obviously, we're in parallel discussions with Mexican government, we have just initiated and.

But commercializing the vaccine there. So it is going to take some time and we are hopeful by the time we.

We are dominant we have some positive news on the Mexican side on the commercialization. We believe our partners are going to come through and are going to support us.

And as I, just stated as I mentioned in the.

My conversations before.

<unk> chosen those states. This vaccine is safe and effective and Theres no issues related to the safety of the vaccine.

Okay.

When you think about Q4 hundred you mentioned the second patient had been dosed and so I just wanted to know is the second patient is also being Duncan.

The first patients or are you moving up again.

Yes.

Great News this week, we dose the second patient.

<unk>.

This is a process with the gene therapy clinical trial I mean, obviously, we have to finish three patients.

Per dose, we had low mid and high and once we are done with the third patient in the first cohort.

Then.

As usual you have to have the SMB as safety Board has to meet and do they have to look at the data and they have to do against Signup too good to the next dose. So we are getting a lot of interest in this clinical trial as you know there are many patients struggle with these diseases and we're really pleased with the progress to date.

And then the last one is about <unk> 10 in 200.

You plan to have the IMD.

Be submitted next year and half the programs in the clinic or are you anticipating just happened.

But did it next year and then.

Now I suppose potentially having all three programs in the clinic.

By 2020 for a game that we anticipate having sui ophthalmology.

By the end of 2023.

We are planning to have all three ophthalmology programs in the clinic next year.

Perfect. Thank you congrats metric background.

Yes.

Exactly.

Thank you.

Our next question comes from the line of Danielle.

From Chardan your line is open.

Hi, good morning.

For taking the questions.

That's something our progress.

You mentioned for <unk>.

That you are working on finalizing additional studies required for the BLA.

In addition to the immune bridging study what are the ones, we think will be required.

So typically.

Even though our partners agenda at a significant data set elsewhere.

According to FDA requires.

The data U S demographic.

Typical and so we anticipate we have to conduct those studies currently we're trying to finalize the protocols with the FDA. In addition to that as the market is going to shift towards.

That's what everybody is anticipating the booster doses. So we are going to evaluate in the current study update any gaps related to bolster dose and we're going to also introduce that.

Evaluation and the upcoming studies.

As a safety trial with impact are separating the <unk> <unk> whatever is required safety is a must and Louis demographic. We are committed to conducting that so we are also evaluating bolster our strategy because that's what he is going to be in the future as we are anticipating annual boosters.

A few years to control included.

So we will be conducting those studies do after we get an agreement with FDA.

Okay got it. Thank you and then a quick one on <unk> for 100, you mentioned that there is high interest in the study so.

In terms of enrollment.

Patients lined up already for the second liens.

Sorry cohorts I mean, it's just a matter of waiting.

<unk> reviews and between the cohorts.

And then yes, there is a lot of interest we have.

Over five sites actually lined up within the U S.

And different geographies. So it's convenient for patients and then obviously the process.

It takes a little time, because after each cohort even if the second cohort two upper sentimental patient you have to wait.

There is a certain period of two to four weeks and typically <unk>.

Gene therapy companies go through this and they need to make sure everything is okay. We've got the SMB. Then you go to the second and third patients and you have to follow the process, even though we have a lot of interest many of these sites.

Investigators see these patients.

We have to wait for the process to go through but we are confident as we announced before we will complete our enrollment this year that's the plan.

Okay, I couldnt congrats again.

Okay. Thank you.

Yes.

Thank you operator for your question.

Again to ask a question.

One on your telephone.

Our next question comes from Goldman Sachs.

Your line is open.

This is RK from Hudson and good morning.

<unk> current Jessica Thanks for taking my questions.

And our Q4 hundred just just to make sure I understand it correctly.

No.

DSM B look.

Our done only after the first patient in each cohort so.

But between the second and third correct. So you basically can recruit.

Patient number two ambition number three within each cohort right.

Waiting for any additional looks correct.

That's accurate, yes, and then after the cohort dumped again you have to wait for the second sentimental.

Yes.

Okay and then.

Furthermore, the study to complete.

What works.

What's the.

And what is that amount of time.

You will be following up.

Each cohort so by the time they are the studies would you have.

Close to eight years' worth of.

Data from each cohort.

That's right.

So the study is designed with some clinical trial start, though so we have a follow up for one year duration.

Envisioned and we'll be following up on the safety. It was three months. In addition to that we have multiple observation endpoints.

We'll be following up on the patients.

We'll be providing updates to the market.

It's one year or so.

Alright fantastic so by the time the study is done.

Package, both on the safety and efficacy.

Even though it's on their phase one study.

Yes. It is.

<unk> phase one too because that's okay.

Okay.

And then switching topics Hunter correct Sam.

What's there.

<unk>.

What's what's the situation in Canada, So where exactly is the application at this point.

Or do they also have questions on the ambulatory is talking about in terms of manufacturing.

Is that causing any delays in that.

So Ken.

Canadian Indias of the new drug submission reviews ongoing.

And.

As we get questions, we're addressing them.

And I don't have a definitive timeline on that I mean the.

Obviously.

This is a new drug submission process like BLA in the U S. They don't have emergency authorization process.

Anymore any longer so.

Currently we are responding to them as we get questions. So if that had any changes to that or.

<unk> will be updating the markets.

Very good.

Thanks for taking my questions.

Thank you. Thank you.

Again, if you would like to ask a question press the star one on your telephone.

Okay.

We have a question for.

Thank you Ron.

Your line is open.

Okay.

Good morning.

Sean could you just mentioned that in Canada.

They no longer have that UA process, but.

From my best of my understanding the application was submitted in time should be considered under the EUA could you comment on that please.

No actually last year, when we submitted the.

Application, Canada was transitioning into neurotic submission process.

We actually submitted it jumped that timeline.

Sometime I think at the end of summer and beginning of fall and so what they did.

<unk> is actually to the full filing and transition into Mds.

So it is.

It is correct to assume that it is not being concerned the UA in Canada.

Yes, it's not an answer for you and kind of that Youre right.

Thank you so much.

Thank you. Thank you.

There are no further questions at this time I will turn the call back over to Kevin.

Thank you and thank you to everyone who joined US for this call today, we look forward to providing further updates to you in the coming months and we hope you have a great day. Thank you. Thank you.

This concludes today's conference call. Thank you for participating you may now disconnect.

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