Q2 2020 Ocugen Inc Earnings Call
Ladies and gentlemen, today's conference is scheduled to begin shortly please continue to standby. Thank you for your patience.
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This time all participants are in listen only mode. A question and answer session will follow the presentation.
Anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.
Please note this conference is being recorded.
I'll now turn the conference over to lease at the Sun.
<unk> President of integrated Communications Lovely health science to introduce occupancy.
You may begin.
Thank you operator, I'd like to welcome you to our conference call with me today are our kitchen, chairman and CEO Dr. Shaker machinery, our CFO Sanjay separate money and are acting CMO and chair of the scientific Advisory Board.
Dr Mohamad Genia.
Earlier. This morning are teaching issued a press release, including a business update and Q2 2020 financially we felt.
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 that's true 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 pursuant to the safe Harbor provisions of the private Securities Litigation Reform Act of 1995, including statements related to our business strategy.
Gee.
Q2 results of operations and financial position, our ability to raise capital I turn to acceptable to us our perspective products product approval research development costs timing and likelihood of success and plans and objectives of.
Management for future operations.
These forward looking statements are subject to risks and uncertainties that may cause actual results to differ materially from our expectations and for pets and can be identified by words, such as anticipate elite cotton. Please continue could.
As to me expects intend in other words of similar meaning.
Any such forward looking statements are not guarantees of future performance 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 FCC note that our 10-Q was filed this morning.
Any information we provide on this conference call. It's provided only as of today. This call August 14th 2020, and we undertake no obligation to update any forward looking statements. We may make on this call on account of new information future events or.
Otherwise.
I'll now turn the call over to our kitchens, chairman and CEO Dr. Shanker with scenario.
Thank you Lisa.
Good morning, everyone and thank you for joining us this morning.
Very excited about the progress we have made this quarter. Despite the challenges of the global and to make.
Your work today will not translate to kind of beach the potential to Q linguistic Hughes.
Oh for gene therapy product candidate arc Usone hundred would it need it's been Tulsa is on track to enter the clinic.
<unk> problems on page one two trials into next year I.
Our second gene therapy product book, you Fortune dry age related macular degeneration, no plus novel Biologic Monkey 200, the major retinal diseases are on track.
Clinic 2022.
Our business strategy of diversifying or part of the purchase.
Sure portfolio diversification and reduce risk was shown to be prudent and in June and we decided to discontinue history trial walk at 300, Arkla graft versus host disease.
Preplanned interim compensates analysis indicated the trial is unlikely to meet its co primary endpoints upon completion.
As a result, we seized elephant talk you 300.
And initiated the workforce reduction is it possible for shift in focus towards the money for your gene therapy platform and novel Biologics program.
We've been added resources needed in the coming here just want to go to strengthen our R&D and clinical development groups and support all four line short to midterm goals of any shooting for early stage clinical trials. We can the next one to two years.
We're successful and raising capital door ATM programs Jacksonville Rumsey into first quarter of two Btwenty. One we will continue to raise capital to support our short and don't value creation goes but on a patient isn't as transformers.
Today, we will provide an update on our progress as we drive our product like going forward.
And he will then share my like how for second quarter 2020 financial results, if one of the Qs T I.
Our management team and advisors are dedicated to creating long term value for all shareholders as evidenced by the appointment of Dr. mom month, Jimmy on that's trade off older No scientific Advisory Board.
Attracting top talent to drive product don't meet your do smaller.
Dr Junior isn't ophthalmologist, but if not specialist and inherited retinal disease ex book with over 20 years experience ophthalmology and gene and cell therapies. His deep experience in ophthalmology gene therapy will be instrumental.
As we advance or breakthrough warrants player gene therapy platform into the clinic next year. He is also offering tremendous support dr., Jim as an acting Chief Medical officer.
Continued to be very excited about mortified, you've got a big blocks.
Which has the potential to treat everybody else inherited retinal diseases.
Single gene therapy product one of the biggest advantages upward monastery of gene therapy platform is that has the potential to eliminate the need for individual gene replacement gene editing strategies and be therefore be highly differentiated from professional gene therapy Idcs.
Last month, we were granted our tour de orphan drug designation Rocky for hungry.
Treatment talk through litigation associated it nobody can be duty.
The real mutation is part of the notice pigment those ARPU agrees genetic disorders that didn't want a breakdown and it also sounds into retina and can lead to visual impairment and blindness.
This is one of the more common mutations we can look class accounting for approximately 12% don't renewed its been dose of <unk> in the United States, adding to the orphan drug designation rock you 400 for NRT and ship to 90 mutation associated that nobody generation the older.
For all gene mutation associated no degeneration further supports our opinions breakthrough Martin could you that'd be blackstone's provincial to treat multiple bind species is the single product.
This week, we announced the seat dogs.
So would it be orphan drug designation for our Q4 hundred NPD seeks be gene mutation, resulting in brick notice pigmentosa and autosomal dominant.
Congenital stationary night blindness.
For orphan designations for a single gene therapy product.
Q4 hundred distinct and ophthalmology space.
And we are excited about taking just program into clinic next year for patients want in desperate need of rescue from blindness diseases.
In order to there's no degeneration suggest that Tonight is pigmentosa effect or 1.5 million people worldwide.
450 gene mutations have been identified.
Associated with good news Pigmentosa and this number represents only 60% of that had noticed pigmentosa patient population.
The remaining 40% of these features cannot be genetically diagnosed make it difficult. There don't up you would you will treatments. We believe are smart grid gene therapy has the potential to eliminate the need for developing more than under 50, and you would your production and provide one treatment options. All these patients.
This month, Oh, Chief Scientific officer, Dr., Russell ball or move them, but I like a breakthrough Marta Snchez gene therapy platform as a part of the next generation therapy seminar at this year's Lord Orphan Drug Congress, Let's say conference on August 24.
We will also be providing updates for investor conferences in the U.S. and that you'd better be conference in Europe in September and October.
Oh strategic partnership. It's comes you know bio one of them solidifies our plans to enter the clinic and the next year for the don't talk lumpy 400.
Well the manufacturing activities are going well and that's blind, including scaling up to 200 leader batch size funnel blind phase one two trials.
Our plan to scale up manufacturing to commercial levels at this time minimal just the risk of product inconsistency in future.
Got a consistency is extremely critical for any gene therapy product.
We're on track with our R&D, enabling GLP toxicology studies.
Well, we're very happy that the progress on this program and very excited to enter.
So the clinic next year as planned.
For Q2 hundred we anticipate that bria, Indeed meeting if be later this year for this novel biologic for the treatment of major retinal diseases, including diabetic macular edema diabetic neuropathy and.
Age related macular degeneration.
We're also planning to secure manufacturing partner.
Soon.
For walk you portend.
To treat dry age related macular degeneration, we had a planning to meet the if the doing capital from exterior to agree on board, Matt I, Indeed, namely studies and early stage clinical trials.
Before I turn the cool call well, what the Sanjay I just want to mention our continued commitment to will shift numbers as we drive the development or product pipeline and our deep commitment to patients by addressing read and under certain blindness diseases gene therapy novel Biologics.
I'll now turn the call over to Sungy to persuade or second quarter 2020 financial Center.
Thank you Chuck.
Good morning, everyone as shrunken mentioned before the second quarter has been very eventful quarter, well oxygen and strengthens our mission to double up gene therapies to cure blindness diseases.
I'll now provide an overview of key financial results for the second quarter up this year.
We ended the quarter on June 30, 2020, the cash cash equivalents and district, and cash totaling $15.1 million compared to $7.6 million as appeal than 2019.
The increase in cash extended runway well into the fourth quarter of 2021.
The second quarter of this year, we recorded revenues of $43000 pursuant to a collaboration agreement that I'd blade Inc. with respect to the development of a delayed corporate 19 testing kits.
This time, we do not expect this agreement to be significant jockeys in overall business, but we will update the market as things develop.
Our research and development expenses for the three months ended June 30, 20, $21.6 million compared to $1.2 million, but a three month ended June 32019.
The increase was primarily due to severance related costs, partially offset by the reimbursement pursuant to the collaboration agreement the deadly.
General and administrative expenses for the three month ended June 30, 20, $21.8 million compared to $1.1 million for the three month ended June 32019.
Defense was driven by the increase in public company insurance expense and severance related costs.
Net loss was $3.6 million or 19 cents loss per share for the three months ended June 30, 2020 compared to a net loss of $3.5 million are 58 cents loss per share for the three months ended June 30 29 team.
We ended the quarter with 135 million shares outstanding.
April we completed an amendment and exchange of the CD theme warrants for 21.9 million shares of common stock and non interest bearing unsecured notes a $5.6 million.
Today. The company has made prepayments of $3.1 million on the unsecured notes from proceeds received under the May 2020, and June 2020 ATM.
At the minor the warrant amendment, an exchange hub address the overhang in our capital structure and be currently do not have any of the premerger financing warrants outstanding.
But that we will open up the call for questions.
Operator.
Ladies and gentlemen to ask a question you'll need a press star one on your telephone to.
Let's roll your question press the pound key.
Please standby and while we compile the Q on a roster.
Again, ladies and gentlemen data Star then one to ask a question.
Our first question comes from key Mccain with Chardan. Your line is no.
Yes. Thank you two questions for you.
One.
Do you anticipate the publication of any additional preclinical data and in any.
Journals during the second half the year.
[noise] any additional data could you repeat the question okay.
Yep publication of any preclinical data.
On a hockey 400.
Yes.
Or any of your gene buff modifier Uh huh.
Checked out yet.
Good question. Okay. Currently on it you know we're doing.
Oh this year are based on the agreement with each would that be created meeting.
Excuse me note I, India, enabling studies.
Started a of GLP toxicology studies.
And obviously some of the work is getting done and the interim off any talks information they available in the first half of next year.
Okay great.
And to what extent is co bid.
Impacting your ability to get that Oh, hi, Andy talks.
Work John.
Pre ideas task force.
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Okay I'm sorry, you Love your line is very clear could you please repeat efficiently.
Sure can you hear me better now.
Yes, yes, there yes.
My question was to what extent is filled with 19 impacting your ability to complete the pre <unk> detox work.
Actually so far no we don't have any impact because of 90.
And Oh studies.
I'm going as planned.
Okay, and the fact that.
And so I know its busy developing their own Uh huh.
First Kirby to vaccine that that's not impact can you on the manufacturing side at all.
It's a great question HM Okay. Yeah. There they are both front end a they're very busy. However, there's this strong commitment toward program. The video data to support doesn't there, they're continuing to support us not including as I mentioned in mind.
I'll just earlier now they're trying to scale up the process to 200 their scale, which is a commercial scale to minimize any risk on the CMC and manufacturing site. So we have a complete supporting cooperation sequencing.
Okay very good that's all I know.
Thank you thank you Dave.
Thank you as a reminder, ladies and gentlemen, better Star then one to ask a question.
Our next question comes from so no mccolo wrong calls when bar. Your line is now open.
Thank you.
Good morning sunk on something to Miss him.
Oh, Yeah could you speak little lower.
So all but now.
That's fine.
Thank you.
This this is all came from Pennsylvania side.
A couple of quick questions.
Well in general.
Turning to that's my disappointment are sufficient.
What percentage.
<unk>.
And now to me in the.
The patients.
And Uh Huh. This incident, we identified or do you.
<unk> to do some kind of.
So I'm kind of a diagnostic conversations before you then fill them into New York and books.
Yeah. Good question marketed.
On the prevalence rates in on this is a again.
It's about lets been thousand patients in the U.S.
And all the clinical trials.
This we have to do the Juno type thing and I will also ask a doctor generic or acting CEO movies on the call to sort of that or you know at justice.
Junior.
Yes, thanks banker.
That's really quite saying all so we definitely need to you know slices based on prior to enrollment and all clinical trial and.
Okay, Denver, and you know procedure done right now and gene therapy trials and.
Were definitely very talking to do that with all clinical investigators the are things to do that and so this will give part of the process regarding the prevalence a chance I mentioned already diseases, but as you know.
So that's one of the most common inherited retinal diseases.
Yeah, so rare.
You know a whole ferreri now offering not great Coleman.
All right along.
Our flight regarding the in our two east three wells, which which is one of them he sells the humidifiers.
Vis vis vis genetic mutation have different clinical labs is only one to one of them is nothing like the statement also but the other clinical disease implicated was this gene mutation and that's the whole notion about.
Oh for on a problem. This is well flying on won't quantify multi records.
Diseases for your questions in fiscal but our E or it must've been it's also you can see Gulf around one two person all well just almost dominant life fitness, though.
So thank you limits for that type of concern yet or are they benefit plus.
Currently available and validated or no need to do some work to.
Good luck of on the day before.
Before flying.
Youre, yes couldn't in political.
One moment Guinea, yes, yes, no. These are standard testing and all day asking for facing with American visas or.
You had been Bonnie now four years bike now close to 20 plus years even earlier.
Just anecdotally indication. So you take blood samples you know you send it to a genetic latching onto look I'd be making sense all the chromosomes in all correctly <unk> well. This is well established for the beat it has been a long before and better formula one commercial product can be I, you know affordable therapy.
So where are you going to seems procedure nothing different than what could be used before and all the other cancer trial, we're going to typing.
So.
Mm Hmm, though I know you're planning to do the poor programs up and running equipment over the next to no yet and Uh huh.
HM.
In general to walk into the design of this phase one studies and also also to think about HM development plans.
Well it means or programs that you want them.
But going.
So for a month or so.
Yeah, Yeah. Good question, Okay, and briefly explain high levels in Americas denier didn't Arden.
The gene therapy program says as we outlined in our deck, they're planning to initiate to Pablo phase one trials.
And again based on the guidance would be a and agreement on these are meant to be small you're talking about nine patients in each trial with the sequel horse.
For one year study because you have to monitor the patient safety for one year.
Along with exploration points, and then you're going to pick one of them to finalize and move into phase three.
And then our Q2 hundred and Rocky for 10 again, you know if these are targeting major written as they see this.
And at the first one two programs will now obviously not more patients then our Q4 hundred.
And well, Mike you want to Adam.
Yeah, absolutely not I think as Shankar.
Although more highlights so for the off Q4 hundred which is a unique that Jim what a fire platform technology and how you got as far as you know when the first again, which will be the safety you know multi ascending dose trial.
And that's was at the end the health authority or acquire.
Oh product.
With that although to be done gene therapy will be mckesson.
Rebuilds low mid cycle.
Right.
Okay.
Oh.
And then we will have you know and had been data.
Yeah.
Ladies and well look out well I.
Okay.
HM Okay, we will look at two different mutations and first Friday.
Yeah.
All right first one will be.
Our in our two really Asia otherwise.
Yeah.
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It will be the first.
Yes.
Shifting to the.
To honor, which is.
ER.
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We'll go out we will be part.
Right.
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Indication.
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And then for Congress anyhow.
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<unk>.
Thank you.
Thank you very much sometimes sometimes and so.
Thank you okay. Okay.
Thank you and our last question comes from Kristen Coskey with Cantor Fitzgerald. Your line is now open.
Hi, Good morning, everybody hope, you're all doing well, maybe just a follow up from one of our case question given up 400 pipeline focuses on patients with very prevalent read what are you doing now to try to low key you know where some of these patients could be for the trial and also what are your broad.
On genetic testing effort in general given day, given the marketing of looks Turner and also the increased number of clinical trials focusing on RP page.
Dr. Junya go ahead.
Yes, the looking only got thanks for your question Great question.
So we definitely are playing out to build you know our off patient registry and a one of our plan is.
Working all with the center of excellence in the country and I've only lasting also in Europe and as you know for this kind of patients you know almost no feragen. So you see the senior general restaurant clinic, but it's more specialized.
Uh huh.
Generation three we are working all was Oh Hello.
Okay.
In Europe.
You have the volume.
<unk>, which will be partner was.
Right.
Did you know groundwork there on that.
Okay.
And so we will continue.
No.
Further.
Oh regarding all de icing on the strategy for at least evolving.
That will be one off you know.
All right.
Bye.
Three working on with the level of like I said earlier the clinical that you did also was you'd be at the group, which we are.
A very close you know.
[laughter], who is going to work with other foundation anything else.
Pardon me anyway.
Okay, and although you know on game has their own Virgin Street for <unk> I suppose this month one off the areas.
Very carefully.
And we started the work that we will continue to know where you know work on Betsy.
Okay, great. Thank you very much.
Thank you for <unk>.
Thank you ladies and gentlemen. This concludes our question answer session I would now like to turn the call back over to loosens up for any concluding remarks.
Thanks to everyone for taking the time to join the call. This morning were dedicated to filling significant patient needs by bringing to market transformative therapies for blindness diseases. We look forward to providing further updates in the coming months. Thank you.
Thank you ladies and gentlemen. This concludes today's conference call. You may disconnect. Your lines at this time. Thank you for your participation and have a wonderful day.
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