Q3 2022 Ocugen Inc Earnings Call
Good morning, and welcome to the Aki Gen third quarter, 2022 business update and financial results call.
At this time all participants are in a listen only mode. A question and answer session will follow the presentation. If you should require operator assistance. Please press star zero on your telephone keypad. Please note. This call is being recorded.
I will now I'll turn the call over to Tiffany Hamilton, Aki Jin head of corporate communications.
Thank you Angela joining me today are oxygen chairman CEO and co founder Dr. Shankar from scenario will provide a business update and our chief accounting Officer, and senior Vice President of Finance, Jessica Crespo will.
We will provide more update on our financial results.
Earlier. This morning, we issued a press release detailing business activity for Q3 2022, we encourage listeners to review the press release, which is available on our website at oxygen Dot com.
This call is being recorded and a replay along with the accompanying slide presentation will be available on the investors section of the website for approximately 45 days.
This presentation contains forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995, which are based on the beliefs and assumptions of the opportunity incorporated and on information currently available to management.
All statements contained in this presentation other than statements of historical fact are forward looking statements. We may in some cases. These terms such as predicts believe potential proposed continue estimate anticipates expects plans intends may could might well should or other words to convey.
Uncertainty of future events or outcomes, but agenda by these forward looking statements.
Such statements are subject to numerous important factors risks and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission SEC.
Including the risk factors described in the section entitled Risk factors in our quarterly and annual report that we filed with the SEC.
Forward looking statements that we make in this presentation speak only as of this stage of this presentation, except as required by law, we assume no obligation to update forward looking statements contained in this presentation, whether as a result of new information future events or otherwise after the date of this presentation.
Finally, I'll get in the third quarter 10-Q will be filed soon after today's call I will now turn the call the doctor listener.
Thank you Tiffany good morning, and thank you for joining our call.
I'm very proud of the important accomplishments, we achieved in the third quarter with continuous innovation is the driving force behind it.
We do.
Gently progressing there were some gene therapies, Unfortunately broader nodal plant expansion.
<unk> program, which now includes a unique mucosal vaccine for arc.
<unk> hundred for COVID-19.
We had also very enthusiastic about the potential for modified gene therapy platform that we shared in more detail.
American Academy.
Allergy conference in Chicago.
R&D day last week.
The oxygen team continues to charge ahead establish ourselves as a fully integrated patient centric biotech company.
As we meet our clinical and regulatory milestones I'm, especially confident with the team as well.
To drive sign new directions, and break new ground for patients who have no effective therapeutic options and people want choice and the fight against COVID-19.
Good day.
To provide updates on our vaccine gene and cell therapy programs.
I'd like to start with Aqua jumps vaccine program.
With 19 remains persistent.
And the world critically needs more effective and safe vaccine options.
We are realizing some of the limitations of vaccines currently available.
I did state in terms of their durability and capability to reduce transmission.
Up until now much of the attention has been on reducing hospitalization rates, but we need to think much more broadly and consider one.
New variants will close.
And what is required to police the unique challenges that this next phase of COVID-19 will bring.
As I alluded to earlier in September we announced our licensing agreement with Washington University to develop manufacture and commercialize its proprietary mucosal vaccine in the United States, Japan and Europe .
I'll give you 100 has the potential to generate rapid local community and the newest Mt.
And lungs.
Sorry go to <unk> and in fact the morning.
We believe that the mucosal vaccine can help reduce the transmission rates by generating neutralizing ITG mucosal Iga and T cell responses. This approach represents a potential universal bolster regardless of previous COVID-19 vaccination.
Intend to work closely with the U S government agencies.
Pandemic preparedness, and the regulatory pathway and the initiation of clinical trials.
Additionally, we are addressing the public's need but a more durable immune response to COVID-19 with continued development of our candidate vaccine <unk>.
Enrollment was completed and dosing continues in the phase II III mineral bridging and broadening clinical trial with topline data expected in early 2023.
We are encouraged that no safety concerns have been identified in the trial to date.
Part of the technology transfer, we successfully completed the demonstration patch Jumblatt Alastair.
We will have the ability to move forward once oral health optimization concerns with our partner have been resolved.
Now moving on to our gene therapy programs.
I could do is deeply committed to our core technology focused on inherited retinal diseases, along with other blindness diseases affecting larger patient populations.
We're making progress in our weitzel Werent retinitis Pigmentosa, a disease for which there is no cure no.
It makes sense to block disease progression and limited treatments to help manage the patient strategy journey.
Ultimately leads to blindness.
Independent data safety monitoring Board completed a review of safety data number of subjects enrolled in cohort two for the <unk> 400 phase one two clinical trials.
It is pigmentosa and recommended proceeding to enroll subjects in cohort three.
We have dosed the first patient and the company expects to complete the cohort three enrollment by the end of the year.
By the end of the Phase one two study data will be collected and analyzed from those RFP in LCA patients before initiating the phase III efficacy trial.
Currently <unk> is associated with mutations in more than 100 genes affecting approximately 2 million people globally.
The current study will start enrolling patients with the leber congenital amaurosis or LCA Sep 290 mutations MTA is a rare eye disease associated with mutations in more than 25 genes.
Our Q4, Tom also leveraging our modified gene therapy platform is being developed to.
Utilize the nuclear hormone receptor gene wrote off of the treatment of dry age related macular degeneration.
AMD, which affects approximately nine to 10 million Americans alone.
This quarter, we are announcing the addition of our Q4 SD the potentially treat <unk> disease, an orphan disease.
Mr Gate, along with dry AMD.
It is fully completed cgmp manufacturing in support of clinical trials and are currently conducting IND, enabling studies.
Oxygen is planning to file IND applications to initiate phase II clinical trials for both these programs in Q2 2023.
Another product modality and the retinal disease space is based on a novel fusion protein.
<unk> 200 is designed to treat diseases, such as diabetes, macular edema, diabetic retinopathy and wet AMD.
He's currently executing IMD, enabling studies and is planning to submit an IND application in the first quarter of 2023 to initiate a phase one trial targeting the Amit.
Regarding our reasonably do some therapies in May we expanded our pipeline to cell therapy in orthopedics with Neocart.
<unk> shows potential to accelerate geely and reduce the rebuilding damaged knee cartilage and limiting the progression of osteoarthritis.
<unk> is working with the FDA to complete the phase III protocol.
Development and is building its own manufacturing suites to prepared for the study.
Earlier this year, the FDA granted regenerate medicine advanced therapy, or <unk> designation the neocart.
We paid a full thickness lesions of the knee cartilage in adults.
Our ambitious clinical agenda, and the rigor and clinical development advanced our pipeline is reflective of our culture of continuous innovation.
Relentless in our pursuit towards our long term goals and reaching the patients who can potentially benefit from our diverse pipeline.
I'll now turn the call suggests to provide our third quarter 2022 financial results.
Thank you Sean and good morning, everyone I'll now provide an overview of the key financial results for the third quarter 2022 or.
Our research and development expenses for the three months ended September 32022 were $15 6 million compared to $6 $8 million for the three months ended September 32021.
The increase in research and development is primarily driven by costs incurred to execute on our clinical trials.
General and administrative expenses for the three months ended September 32022 were $7 5 million compared.
Compared to $4 $5 million for the third quarter of 2021.
Our net loss was approximately $21 9 million or 10 net loss per share for the third quarter of 2022.
Compared to a net loss of approximately $10 8 million or five net loss per share for the third quarter of 2021.
Our cash cash equivalents and restricted cash totaled $101 6 million as of September 32022, compared to $95 1 million as of yearend December 31 2021.
We are focused on efficiently managing and prioritizing the use of our capital our plans to work with the U S government agencies for support and funding of our COVID-19 vaccine program has allowed us to extend our cash runway into the fourth quarter of 2023.
That concludes my update for the quarter Tiffany back to you.
Okay, Thanks, Chad and with that we will open the call for questions Angela.
At this time, if you would like to ask a question. Please press star followed by the one on your telephone keypad.
Your first question comes from the line of Jennifer Kim with Cantor Fitzgerald.
Your line is open.
Hey, everyone. Congrats on the quarter and thanks for taking our questions I have a few here. The first is I think you mentioned that the R&D cost reflects the cost incurred for clinical trials, but I'm. Just wondering how should we think about those opex numbers going forward in terms of where G&A and R&D are at for the quarter.
And I know that you said that you are building manufacturing sites to prepare for for Neocart and overall expansion. My second question is just the topline results from the phase two three for connection can you walk us through what the next steps and the timeline for those steps would look like in terms of your discussions with agencies and.
The potential for conducting an adult safety trial et cetera.
Yes, Jennifer good morning, Thank you.
Just answer the first question sure Jennifer I'll do the second one yeah. So with regards to the cost on a go forward basis I think this quarter is probably a decent proxy for our go forward expenses.
Looking at R&D and G&A.
And the second question is related to.
Neocart.
Internal.
Could you repeat your second Michigan.
Yeah sure it's for the Phase III <unk> III data for connection can you walk us through sort of what the next steps would look like after the topline data and the timeline for that in terms of your discussions and where you should.
Well go next.
Yes, yes, so the top line data as we stated we have completed enrollment.
We are currently going through.
The data analysis operate done with.
Collecting all the samples from the patients after the second dose.
And we are anticipating to.
Clearly the top line results early next year.
And then the study will get completed obviously as we mentioned before.
The data will also.
Give us some direction.
Dosing patients who have taken mrna before that means in addition to new patients. We also had modernizations, because it's really difficult to enroll 100% new patients at this stage.
Pandemic is.
And therefore, we are going to get data bolster data on patients who took environment without a vaccine and so based on that once again, we are already working with the FDA on the next safety protocol, which we believe may be needed for the U S.
Safety study.
U S demographics for BLA, but however, based on the booster data showed a lot of light into how we move forward because we believe correct and can make it.
Good bolster.
Brian immune response.
For people, who took somewhat of an issue.
Which is only based on spine.
Okay. That's very helpful and if I could squeeze one more question as you expand to include LCA patients.
And you're Lucky 400 trial are you expanding at the cohort three dose and then how many patient LCA patients with them we need it.
To then support.
Moving into phase III.
Yeah.
Yes.
That's a good question. So yes, that's the plan just like you stated our abilities to go with the most tolerable dose.
And there will be recruiting three patients.
Alright, thanks, guys.
Thank you.
Your next question comes from the line of Robert Leboyer with Noble capital.
Your line is open.
Good morning.
I had a question on Neocart and if there are any time frames that you can give us as to finalizing the phase III protocol or starting the clinical trials.
Yes currently Robert.
We are still the two steps to it one is.
Getting your protocol finalized with FDA, we've been working with them. It takes some time.
The second step most important step I think that I think we know we'll get that squared off.
Next few months.
Most weight lifting is our manufacturing.
Because cell therapy is almost like a personalized medicine, you don't need large manufacturing facilities, but you do need highly scientific.
Small facilities, it's very complex science that we can manage with good control. So thats why the oxygen is committed to build our own facilities and our R&D expansion, but actually preparing those facilities. So that's the rate limiting one is getting FDA approval.
Protocol agreement the second most important step is getting our efficiency is ready for this and we are anticipating those facilities already by the end of next year.
Okay, Great. That's very helpful. Thank you.
Your next question comes from the line of Danielle <unk> with Chardan.
Your line is I'm sorry, good morning.
Okay.
Thank you for taking my question.
A couple of shares so with two vaccines in the pipeline and the collapse in <unk> 100.
What is your strategy for them.
Working together, you're looking at the most in complementary.
Just wanted to see what the big pictures for both of them.
Yeah, absolutely so occupy hundred obviously mucosal vaccine is really needed irrespective of what Youre vaccinated.
So Dr.
We have the control of the transmission rate I mean, thats really important otherwise, whereas you'll continue to mutate.
All of the experts in the field believe you really needed something nucor's on vaccine.
Maybe you can stop the entry of wireless so I think that's going to be good for the long term too.
Our <unk> offers a broad immune response, I mean, ideally if everyone gets correcting and establishing a broad immune response, so adoptive immunity. So.
Youll, how ability to fight off and our emerging radiance potentially and then you take.
Mucosal vaccine as a bolster.
Which is inhaled or intranasal would youll be very convenient even for kids and the long term and it's also easier to make this vaccine is based on have nowhere electro platform. So as the new idioms come in on annual basis, its easy to produce this vaccine compared to or inaccurate or <unk>.
Well respected.
So that's the missing feature.
Obviously.
It's really need it.
The vaccine is the great great needs right now will depend on market is growing.
Okay got it that was helpful.
Another one on <unk> 400, or are you still guiding to report initial data by mid 'twenty three and if so what are some of the key metric that we should be.
Paying particular attention to.
Yes, I mean, we will continue to monitor the data and our goal is to.
Give some data reach by mid next year.
As we mentioned before.
Phase one two clinical trial the primary endpoint is safety.
Furthermore, we are monitoring it.
Efficacy based on observational endpoints in each mutation.
I have a different endpoint going into phase III. So that's the reason they're multiple observation endpoints looking at.
And broadly a functional.
As well as structural endpoint structural means under OCD and we're looking at the structure of the retina.
Is there any stabilization of it.
Regeneration.
So blazing a signal is really important in these patients right.
<unk> from the generation.
And so you are looking at structural aspects and functional aspects of it.
You can get.
Like I say dmitry are looking at mobility.
Some of those data will be we're hoping to release by mid next year.
Got it thank you very much.
Your next question comes from the line of Jonathan Aschoff with Roth Capital Partners. Your line is open.
Alright, Thanks, guys and good morning, My one question is on Kodak's and to what extent.
Or actually I'm, sorry, it's an Oc U 500 or to what extent do you think that someone's meat.
Vaccination status prior to getting 500 might allow them to neutralize.
What's on that adenovirus and make it not really that effective.
Good morning, Jonathan.
I think when you give me a golden vaccines typically.
System is primed it is really important.
No most of Americans are primed with a modern it so they have two shots framed.
Mucosal vaccine dose.
So our goal is to really target.
As a universal booster vaccine, that's all potential targets and.
And people who are vaccinated before it's really important that prime before they get the mucosal vaccine at least the data is pointing out.
You get the full benefit.
Okay. Thank you.
Your next question comes from the line of.
<unk> <unk> with Mizuho Securities. Your line is open.
Hi, guys. Thanks for taking my question.
Just curious.
Let's see.
You know what.
With vaccination essentially I guess moving from government pay chief commercial pay just wondering Holly Hewitt.
You guys are thinking about the role for both.
<unk> action and I guess, ultimately Ocu 500. Thanks.
Yes.
I think you have seen that at all.
Some of.
Competitors vaccine players have announced their pricing and some of them want to prejudice or 100 Bucks a dose that anticipating more into private market.
Sure.
So the coax in all followed the traditional path somebody wants to take it to the.
Primary cities, which should be a very good parameters in this vaccine as well as bolster however.
However, with the mucosal vaccine that has a lot of emphasis.
From all the way from governmental agencies to all the experts in the field. They are supporting it they are really worried about.
<unk>.
Significant limitations coming up if you don't control the transmission.
And therefore.
The great need for it and we're working with government agencies, we believe something novel light deck something to control the transmission because in our largest democracies I mean, the countries out there, including India and China launched equals on vaccines and we are really behind it I think it's time.
We're hoping a government will step up after the elections and support development of mucosal vaccine.
Which is occupy 100 and we believe.
For that something like that to control the transmission, where everyone agrees the pseudo government support that's what we believe and eventually that may become private too.
In future years, but at least in the short term we believe government.
So it really supports nuclear vaccine.
Okay.
And just following up on your comment about.
The OCC from the 500 being authorized in China, and India can you give us a sense of how effective that is in those country and whether it's broadly used.
Thanks.
Yes in India, I mean, the data is public mobile.
While the company self publish some of the data coming out of the clinical trials.
Obviously in India. The just launched it in the phase III data looks good compared to co vaccine head to head and they showed good.
Not only <unk> zones of mucosal.
Immunogen, Inc. Response, they also stated in our latest.
Hello.
Emerging variants are variance of concerned today, which is our existing <unk>.
And from.
The other vaccine in China, which is emulation vaccine is widely rolled out in fact.
There is some public information out there.
As of last week.
<unk> rolled it out for many many large cities in China.
So we don't know the delays, but there.
At least publicly available data looks good.
So both of them are pointing out Nichols vaccines may be very beneficial to control the spend to make in transmission.
There are no further questions at this time. This concludes the Q&A portion I will now turn the call back over to chairman and CEO and co founder.
Doctor Shankar.
Most scenarios.
Thank you Angela I would like to conclude the call with some additional parting thoughts we have shown remarkable progress to achieve our original creating a fully integrated patient centric biotechnology company that targets unmet medical needs and in fact public health.
Finding this out last week during our R&D day that between 2023 and 2027, we're targeting BLA filings and product launches in each of the next five years, reflecting what we mean by creditors simulation.
We believe our gene therapies have potential to bring significant value to our patients and shareholders as discussed at the R&D day.
We have to prioritize our resources on gene therapies was seeking partnership with the government agencies for vaccines to support public health in the short term.
Once we start getting data next year on gene therapies.
Hello oxygen to potentially form partnerships outside of U S to support our growth and the long term, we will continue to strengthen our pipeline to become leaders in disease areas. We are present and continue to offer hope for patients across the globe. Thank.
Thank you for joining us today.
And everyone have a great day.
This concludes today's call you may now disconnect.
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