Q2 2021 Ocugen Inc Earnings Call
[music].
Good morning, and welcome to the oxygen 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 would now turn the conference over to Ken and Chesty head of Investor Relations and communications for oxygen you may begin.
Thank you operator, I'd like to welcome you to our conference call with me today is <unk>, Chairman and CEO, Dr. Shai <unk>, who will provide a business update and our financial officer, Chief Financial Officer, and head of corporate development Foundry Subramanian, who will provide a financial update.
Earlier. This morning, we issued a press release, including a business update and second quarter 2021 financial results. We encourage listeners to review the press release, which is available on our website at www Dot Aki Jim 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 oxygen web site 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.
<unk> related to the ongoing COVID-19, pandemic uncertainty regarding whether and when we will be able to submit a biologics license application from <unk> to the FDA and whether and when we will receive regulatory approvals for <unk> in the United States 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, 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 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 most annuity.
Thank you Ken Good morning, everyone and thank you for joining and we hope you and your families are safe and well.
We're now more than 18 months into coronavirus pandemic, and we share the concerns of our public health officials of the risks and challenges.
In spite of mutating wireless.
The headlines speak every day.
<unk>, Washington, or many regions in the United States and we now have a pandemic.
Vaccinated debt represents the vast majority of new cases searching through North America. It is really difficult to hear accounts of people in the hospital and realizing too late that the vaccine and debt taken well known precautions could potentially have prevented serious illness and debt. The same holds true for our friends in the market last week.
Blink Health agency of Canada to reported but almost 85% of recent reported COVID-19 cases across Canada are among those were unvaccinated.
Every day my leadership team and I, along with the staff at oxygen discuss outlook and potential contributions to the broader public health agenda and the fight against COVID-19 yesterday as I stated on our last call with you. Our Hearts go to those who have lost loved ones.
I've been personally touched due to this wireless and our thoughts are also with the health care workers public health officials and scientists are working every day to bring this pandemic back under control today I would like to provide you an update on occupancy humans in conjunction with our co development partner.
Correct.
<unk> for the second quarter, we continue to believe that correct scene, if approved would be a critical edition to our national Arsenal to fight this pandemic and we believe that our efforts during the second quarter represent important steps for <unk>.
Forward to bringing <unk> into North America.
All of this would not be possible with total collaboration with lot of biotech as you know these past months continue to be trying times for India. The demand for vaccines is great.
And they have continuously been working to deliver for India and the 16 other countries in which <unk> has been authorized and approved for use for their work in partnership we see thank you.
On this slide.
We have summarized the major events that have transpired over the second quarter of 2021.
In June oxygen enter into an amendment to our agreement with biotech that expanded our ability to develop manufacture and commercialize <unk> into Canada. In addition to our existing rights in the United States.
That growth followed up with the discussions with health, Canada free Shields, and led to our ability to file a regulatory submission under the interim order, which was transitioned into a new drug submission for COVID-19, we're extremely pleased that this was accomplished in such short order, especially from the Urgencies increasing in Canada now.
That review has topic, we are ready to answer their questions and we've worked with them throughout their review. It is important to note that op unit loads and affiliate <unk> in Canada to help facilitate the submission and interaction with health, Canada discipline will be responsible for the development and potential commercialization of <unk> in Canada.
Next I will discuss our engagement in the United States as we stated in early June the U S food and drug administration directed us to submit a biological licensing application.
BLA for <unk> vaccine the data requirements for coaxial are still being evaluated while we anticipate a need for an additional clinical trial, we're confident in our ability to navigate and address the fda's process and requirements.
Our partner product biotech posted compelling phase III clinical data in early July.
Which are being evaluated for peer reviewed publication of these data show that <unk> demonstrated an overall efficacy against COVID-19 at 77, 8% and 93, 4% again a severe disease.
Really impressive is that this phase III clinical trial was the first 1 to evaluate the efficacy of our COVID-19 vaccine against the Delta radiant within a controlled setting.
In fact, the majority of the symptomatic cases identified in aggregate in the vaccine and control arms in the phase III clinical trial, where COVID-19 variants.
The majority of which were identified to be Delta Radiant B 160, 672 data showed coaxial achieving the 65, 2% efficacy rate against the Delta variant data from Covid cases demonstrated lowered our load at least 104, less and vaccinated individuals compared to placebo group.
Showing potential for less transmission of the disease by individuals who receive collapsing. Furthermore, the data showed an efficacy against <unk>.
A symptomatic disease at 63, 6%, suggesting the potential of the vaccine to reduce debt symptomatic spread of the disease.
Finally, the readout of the safety data demonstrated that only 12, 4% of participants in both the treatment and control zone control arms of the clinical trial reported an adverse EBIT.
Half a percent of participants reported as severe disease severe.
<unk> at growth Stevens.
The totality of this data latest 2 important points, which make me optimistic both co vaccine serving a critical role in North America.
These data on Delta are very suggestive that correction is a valuable tool in our fight against this wireless now, especially with this variant not dominating this fourth we are experiencing.
This is a point, we have been communicating to stakeholders, including FDA and health Canada.
Because this vaccine trains the immune system to attack the whole COVID-19 wireless based on multi antigens, including the spike a nucleocapsid protein <unk> has the potential to be effective against multiple variants and reduce the possibility of mutant <unk> escape.
We recognize that this COVID-19 pandemic will continue to be a long term challenge to our healthcare system and society and such a multi pronged ability to attack. The wireless so effectively has the potential to bring flexibility into our public health strategies, providing <unk> vaccine as an option, which is built on traditional platform.
Similar to polio vaccine, which has an established efficacy and safety record may benefit many annex vaccinated individuals and result in significant benefit to public health.
On a final note about our progress for <unk> vaccine in June oxygen selected jubilant, Hollister, which is the amount of contract manufacturing organization to be our partner for Codexis to prepare for potential commercial manufacturing in North America.
Technology transfer from bottled biotech to jubilant has also been initiated.
And as you saw back in March we hired GP GAAP real as our head of manufacturing and supply chain, which is now building out the team experienced in drug substance and drug product management logistics and packaging and procurement.
This team is absolutely focused on co vaccine that will house Appalachian responsibilities for our entire portfolio of assets.
This rounds out our update on correcting now I'd like to turn our attention to our outlet portfolio.
We remain on track to initiate our first gene therapy phase 2 clinical trial for our Q4 hundred later this year. These trials will be targeting to specific general types rhodopsin and <unk> currently our toxicology studies are progressing well with the readouts forthcoming.
All of these will support an A&D debt.
Anticipate being filed in the fourth quarter.
This has been a busy quarter with much going on behind the scenes to advanced <unk> and our ocular portfolio and there is much more ahead I will now turn the call over to Sanjay to provide our second quarter 2021 financial update Sanjay.
Thank you sugar and good morning, everyone.
I will now provide an overview of key financial results for the second quarter of this year.
We ended the quarter with cash cash equivalents and restricted cash totaling $115.8 million as of June 32021, compared to $24.2 million on hand as of December 31, 2020.
Our research and development expenses for the quarter ended June 32021 were $18.9 million.
Compared to $1.6 million for the second quarter ended June 32020, R&D expenses for the quarter ended June 32021 included $15 million of expense related to the upfront payment made to <unk> biotech for rights to <unk> in Canada.
General and administrative expenses for the quarter ended June 32021 were $6.8 million compared.
Compared to $1.8 million from the previous year's second quarter ended June 32020.
The increase was primarily driven by a $1.5 million increase in noncash stock based compensation expense approximately $2 million of proxy solicitation costs incurred for our stockholder meetings and an increase in infrastructure costs to support the continued growth of the organization.
Net loss was $26 million or 13 net loss per share for the quarter ended June 32021, compared to a net loss of $16.2 million.
Our <unk> 19 net loss per share for the previous years quarter ended June 32020.
Finally, we are very pleased with our inclusion into the Russell 3000 index assets with 2000 index. It's a demonstration of the growing value of oxygen and we are happy to be part of this important benchmark that concludes my report.
Thank you Sanjay with that we'll open up the call for questions operator.
As a reminder, if you'd like to ask a question simply press star 1 on your telephone keypad.
Our first question comes from the line of Ken with Mackie. Please go ahead.
Go ahead, Chris.
Oh I'm sorry.
No there'll pronouncing my name Yeah. Thank you Sandra.
So.
Let's start with <unk>.
Canadian approval review.
Do you have a good understanding.
At this point.
What other data theyre going to need and just any estimate.
How long do you think the review might taken when the authorization might be granted.
We have submitted.
All the data.
What is needed from submission.
So the Canadian submission K and again on the specific timeline and the approval of block we can't give you that at this stage.
All I can say is it's under active review by Health Canada.
As we get questions literally 2 restaurants them very promptly and deployed any information they need.
Okay, and then maybe let's switch them too.
The U S from the FDA.
In terms of the.
Additional study can you give us.
Oh.
A review of what the design of that study might look like.
Again, we are in discussions with them.
Continuously and.
As soon as we reach an agreement.
On the equipments for the BLA and the additional studies, we need we'll be updating the markets.
Okay.
Is there a X.
Cash.
In terms of timing when you might start to be in position to start that study.
From.
Our resource perspective, and from marketing perspective.
We'll be ready to start the study this year.
Yes.
Okay.
So.
Okay, Great and then let's switch then let's go ahead and ship to the.
So gene therapy.
<unk>.
So.
Ed.
Sort of.
Can you give us.
An estimate of when you may complete the.
<unk> talks and what do you anticipate youll be able to say about those results.
Yes.
Yes, the DLP toxicity and spreading data.
And the next few months we.
We are on target to <unk>.
Hello, Randy by the end of the year as planned.
Once again as the Readouts from Mount prior to filing the NDA will be happy to share that news with the markets.
And currently everything is on target.
Okay, alright, great to hear that Okay, let me jump back in queue.
Yes.
Thanks.
Yes.
Your next question comes from the line of Robert Leboyer with Noble capital.
Good morning first question is on the submission of the data from for publication from the Phase III.
Could you.
Give any details about the type of publication, whether it's general interest like the new England journal or something more specific like in immunology journal and what the timing might be.
Again.
The obligation the broth biotech or partners or directly daily.
Once again, it's going to be 1 of the key medical journals.
<unk>.
So they are directly dealing with them.
Okay.
And as soon as we know more update to share.
Okay and in terms of the FDA and the BLA submission.
Can you elaborate at all on the type of study that might be needed in terms of its size scope.
Or any of the economy.
Is it.
Too early to determine those things or are there any details that you can share.
Ed This is unfortunately I cannot share any details.
Once again as soon as we reach an agreement on the path.
We'll be happy to provide update to the markets at that time.
Okay. Thank you very much.
And your question comes from the line of Sao Paulo, with pharma with H C. Wainwright.
Thank you this is our care from hit to render it.
Good morning, Sean current Sanjay.
Good morning market running archaic.
Couple of.
Great questions.
So I understand you're in discussions with the Canadian regulatory authority.
So.
Assuming.
The real growth.
Simon you have a successful.
As a result.
In terms of commercialization do you.
How does this work do they have to.
The approved by individual provinces or is this a federal program.
Indeed.
Canadian geography.
No actually this is a health Canada. So they gave approval for Canada.
Yes.
Once you get the approval.
Yes, it's across Canada.
Okay.
Okay. So you don't need to go across.
Then.
In terms of.
Discussions with the FDA.
Okay.
Are you planning to meet with them further before your submission and what's the trigger point.
For your submission.
Looks like you have most of the data with you at this point right.
Yes, we have most of the data from our phase III clinical trial, including all the manufacturing.
We are aware.
Discussing the regulatory path from the BLA what is required.
Any additional studies and that's the part is as soon as we finalize those as I mentioned before I mean, we have resources to initiate as soon as we reach an agreement with FDA and we'll work on them. Our goal is to efficiently conduct those studies if needed.
And do the filings for the BLA.
Okay, and then talking about resources.
As you stated in your prepared remarks Bert has.
Gordon it's collapsing crude in 16 different countries.
Including India I would think.
What's what's their capacity and do they have enough capacity.
To manufacture.
The product at least initially.
For Canada, and the U S.
Yes, but what has been the <unk>.
Partners working extremely hard.
Every month the capacities are moving up.
<unk> publicly stated.
They're going to target more than half a billion doses per year debt capacity and they're hopeful to get there from the next few months. So therefore.
We are optimistic we'll get water was a place we need from North American market.
Perfect. Thank.
Thank you Jim.
Thank you all right. Thank you. Thank you.
Your next question comes from the line of Chris <unk> with Cantor Fitzgerald.
Hi, Good morning, everyone. Thanks for taking my question I'm not sure if youre going to be able to answer. This 1 but just wanted to ask for U S trial.
A lot of talk right now about booster vaccines as well so can you speak to whether your discussions with the agency are focusing on Vaccinating people for the first time or if you're also planning to look at kovacs from perhaps as a potential booster for those here that have received 1 of the other vas.
It seems that an EUA.
Good question, Yes, we will be looking into all of those options Kristen.
As you know there is a.
Many many of the vaccinated too they can get infected and they'll be looking for bolsters from the future. So we will be looking into all potential options and unmet medical needs in the U S including children.
We are carefully evaluating and conducting the clinical trials whatever is needed to support the market.
Okay. Thanks for that and wanted to ask if you could please discuss how you believe the efficacy of co vaccine specifically against the Delta Varian has compared to some of the other current vaccines, where there are data available at this point and then also wanted to hear your thoughts about.
Some of the emerging variants beyond Delta. Thank you.
Yeah, I think the 1 thing I want to make it very clear.
Correct.
Only product.
Which is data from control phase III clinical trial.
On efficacy on Delta variant, which show a 65, 2%.
And some of the data probably youre seeing is.
Neutralization data coming from surveillance.
But again.
It's the only vaccine with controlled clinical trials.
So that's really important to note.
The second question.
Can you repeat your second lien exposure it gets the English interesting yes.
Yeah of course I just wanted to ask what your thoughts are about emerging variants beyond delta on kind of how youre thinking about the.
What day in the next 6 months from now.
Debt.
And again.
We are seeing emerging variance.
Uh huh.
Every day every few months it will probably so this is going to continue and if you look at the data generated with co vaccine.
And the clinical trial too.
As we stated majority of the cases.
Our from variants. So it sure solid efficacy overall, 78% inclusion of all of those variants. So thats really important this vaccine is built on broad spectrum.
Non wireless so you have multi antigenic approach you give a broad protection of cellular and humoral responses. Therefore, we believe this has potential to address even emerging future variance. So thats why its important to how this kind of a vaccine as an option in our toolkit so that.
You are not looking at evaluation by itself like spiked based vaccines.
A broad protective vaccine, which can work for longer term.
Okay. Thanks, and then the last question I have for you is maybe if you could just walk through the experience with <unk> in India I think the last earnings call you hosted a day.
Definitely a different situation in terms of the number of cases and it seems to be getting somewhat under control at least from where we were a couple of months ago. So I wanted to ask generally speaking how the experience there and kind of help you think about the efficacy enrollment kovacs broadly speaking and if you have.
Any thoughts you could share from your partners generally about what they are hearing out there again about people who have received kovacs and thanks again for taking the question.
Thank you Justin yes, they have an amazing journey again.
And last day.
<unk>.
Administered over 50 million doses of <unk> in India.
And then it is also public.
Government report coming out of the government.
Or between 5 to 6 million.
Subject to the initial surveillance data coming out on both correction Blue Shield in the report clearly stated they don't have it.
Related to blood clots, which is really important so the vaccine has shown to be effective and safe and they continue to increase their capacity and continue to meet the demand and trying to support the public health agenda in India.
Okay.
Okay, and you have a follow up from the line of <unk> with Chardan.
Hi, yes, so CRISPR Sanjay.
Operating expense going forward.
Strip out the 1 time expenses from R&D.
SG&A.
Is $4 million a quarter for each of those are reasonable assumptions for the next several quarters or is that too aggressive.
Well I think of the G&A side that would be Lindsay aggressive.
Because we are we just had another 1 time is related to the shareholder expenses from.
Non cash expenses related stock based compensation that really impacted that Kay.
But on the R&D side as you know we are definitely <unk>.
Investing more in our ocular programs and of course <unk> is a huge component of it. So there of course, we had a 1 time related to the to the Canadian rights, which of course will not be incurred again.
But there is there are other items that we are.
Anticipating in terms of procuring at risk in terms to get ready for the commercialization in the Canada or the U S and so with regard to that I think it should be.
You should factor.
Little bit of a growth coming in from the general expenses for R&D as we bolster our teams and invest in programs and then there will be these.
These 1 off expenses related to preparations for the vaccine, including any potential clinical trials as they emerge.
Decisions from discussions with FDA.
Yes. It is thank you.
Sure.
And at this time I will turn the call back over to Ken and chassis for closing comments.
That basically thank you, ladies and gentlemen for participation in the joining US. This concludes today's conference you may disconnect. Your lines at this time and thank you for your participation and have a wonderful day.
[music].
Okay.
[music].