Good morning, and welcome to the Opigen Conference Call. At this time, all participants are in listen only mode. A question and answer session will follow the presentation. Please note this conference is being recorded. I would now like to turn the conference over to Lisa DeCenza, Vice President of Integrated Communications at Lavoie Health Science To introduce the Ocugen's team, you may begin.
Thank you, operator. I'd like to welcome you to our conference call. With me today are Ocugen's Chairman and CEO, Doctor. Shankar Musaneri and our CFO and Head of Corporate Development, Sanjay Subramanian. Earlier this morning, Ocugen issued a press release, including a business update And Q1 2021 Financial Results, we encourage listeners to review the press release, which is available on the Ocugen website at www.ocogen.com.
This call is also being recorded and a replay will be available on the Investors section I'll remind you that various remarks we make today constitute forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as predicts, believes, potential, proposed, continue, Estimates, anticipates, expects, plans, intends, may, could, might, will, Should or other words that convey uncertainty of future events or outcomes to identify these forward looking statements. Such forward looking statements include information about qualitative assessments of available data, potential benefits, Expectations for clinical trials and anticipated timing of clinical trial readouts, regulatory submissions and regulatory authorizations or approvals. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, The uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, Commencement and or completion dates for clinical trials, regulatory submission dates, Regulatory approval dates and or launch dates as well as risks associated with preliminary and interim data, including the possibility of favorable new clinical trial data and further analyses of existing clinical The risk to clinical trial data are subject to differing interpretations and assessments, including during the peer review slash Publication process in the scientific community generally and by regulatory authorities whether and when data from Bharat Biotech's Clinical trials will be published in scientific journal publications and if so, when and with what modifications, Whether the U.
S. Food and Drug Administration, the FDA, will be satisfied with the design of end results From preclinical and clinical studies of Covaxin, which have been conducted by Bharat Biotech in India, Whether and when any biologics license and or emergency use authorization applications may be filed in the United These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission, the SEC, 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 filings with the SEC. Note that we intend to file our Form 10 Q with the SEC today. Any information we provide on this conference call To update any forward looking statements we make on this call on account of new information, future events or otherwise, I will now turn the call over to Ocugen's Chairman and CEO, Doctor.
Shankar Musanuri.
Thank you, Lisa. Good morning, everyone, and thank you for joining. There is not a day that goes by without us witnessing the devastation Caused by the coronavirus pandemic. As you all know, India is currently experiencing one of the worst spikes seen by any country since the pandemic began. Over the last two weeks, COVID-nineteen has climbed about 120 lives Every hour on an average in India is the second wave of devastating COVID-nineteen infections.
Our hearts go out to the people of India and those working on front lines to bring this terrible outbreak under control. We also sincerely appreciate the work done by caregivers, NGOs, governments, including the U. S. Government and everyone who is helping. Our co development partner for co vaccine, Bharat Biotech, has been ramping up production to meet the demand for the vaccines in India.
They are navigating these extreme conditions to scale up production and increase supply. It is encouraging to note As Doctor. Anthony Fauci, Director of NIAID and the Chief Medical Advisor to the President mentioned last week, studies of Convulsant Sarah of COVAXIN recipients have found that COVAXIN effectively neutralizes the B.1617 variant or Indian double mutant strain of the coronavirus. However, it is concerning that according to the World Health Organization, The variant has been detected in 17 countries, including the U. S.
We continue to strongly believe that it is critical to add COVAXIN to our national Personnel to fight this pandemic. We are encouraged by our announcement earlier this week that Covaxin demonstrated Potential effectiveness against 3 key variants of SARS CoV-two, the U. K. Variant, which is B117 The Indian double variant B1617 and Brazilian P2 variant B11282. By addressing the whole COVID-nineteen virus based on multi antigens, including the spike and nuclear capsid proteins, Covaxin's potential effectiveness By stimulating both, humoral and cellular responses against multiple viral protein, Covaxin could be a more powerful weapon That is more likely to remain effective as the virus continues to mutate, making it a strong booster vaccine option even for those who have already taken one of those other vaccines.
In the recently shared second interim results of the Phase 3 clinical trial, Covaxin demonstrated 78% overall efficacy and 100% in severe COVID-nineteen disease, including hospitalizations. Covaxin continues to show strong results in all the studies conducted to date. The Ocugen team submitted a comprehensive drug master file With the FDA and is preparing the EUA application, the current crisis in India is hampering some of the data collection efforts by our co development partner, Bharat Biotech. As a result, finalizing our EUA application is taking longer than anticipated. Despite the humanitarian crisis in India, Bharat Biotech and Ocugen are working tirelessly and diligently to complete the EUA application, And we hope to file it with the FDA as soon as practicable.
Meanwhile, we are having collaborative discussions with the FDA. We have also signed up with an FDA approved lab for release testing of the vaccine upon authorization, and we are actively working on Contract Manufacturing Partners in the U. S. We're also in discussions with the Biomedical Advanced Research and Development Authority, BARDA, Regarding the purchase commitment, once authorized under EUA, we are planning for a pediatric study in kids 6 months and older because we believe COVAXIN has a very strong safety profile as it is Based on a traditional vaccine technology platform, we believe that COVAXIN can help change the course of this pandemic By preventing severe COVID-nineteen disease, including hospitalizations, as well as significantly limit the spread of asymptomatic COVID-nineteen infections based on efficacy shown to date. Now To shift to an update on our ophthalmology pipeline.
Yesterday, preclinical results of our novel biologic candidate, ORQ200 were presented at the Association For Research in Vision and Ophthalmology 2021 Annual Meeting. The purpose of this study was to evaluate efficacy of ORQ-two hundred in in vitro and in vivo models for ocular neovascular diseases. RP200 reduced neovascularization and damage to retina and demonstrated comparable or slightly improved activity to eflibercept in an animal disease model. FUC200, a transferrin tomstatin Fusion Protein demonstrated potential to treat diabetic macular edema, diabetic retinopathy And wet age related macular degeneration, we are planning the initiation of Phase III clinical trial for ORQ200 next year. We remain on track to initiate our 1st gene therapy Phase III clinical trial for ORQ400 later this year.
The toxicology studies are progressing well. We have completed manufacturing a 200 liter scale to support clinical studies. We are also planning to initiate a Phase III clinical trial for OQ410 for dry age related macular degeneration next year. Late last month, we announced closing of a registered direct offering with the healthcare focused institutional investors and raised Gross proceeds of $100,000,000 We intend to use the net proceeds from the offering for general corporate purposes, Capital expenditures and working capital expenses. The capital raises this year have significantly strengthened Our balance sheet and position us well to develop our programs and build our team.
In summary, we're working Diligently to bring Covaxin to the U. S. Market with the planned filing of our EUA application and eventually a BLA biological licensing application. We are continuing to expand our team with We are also planning to move our lead ophthalmology gene therapy product Candidate, Ocu400, into the clinic later this year. With the ability to raise additional capital as needed, We have the resources to continue driving our vaccine and ophthalmology pipelines forward and anticipate strong momentum across our pipeline for the remainder of this year.
I will now turn the call over to Sanjay to provide our Q1 2021 financial update. Sanjay? Thank you, Shankar,
and good morning, everyone. We have made significant strides in the Q1 of this year,
particularly in working to bring Covaxin to the U. S. Market
With the submission of our comprehensive DrugMaster file with the FDA, I will now provide an overview of key financial
results Q1 of this year.
We ended the quarter with cash, cash equivalents and restricted cash totaling $44,900,000 As of March 31, 2021, compared to $24,200,000 as of December 31, 2020. In April 2021, we raised an additional $100,000,000 in gross proceeds with our registered direct offering. Our research and development expenses for the quarter ended March 31, 2021 were $2,900,000 compared to $1,700,000 for the 3 months ended March 31, 2020. The increase was primarily related to the toxicology studies for our Au Q400 program The development activities for Covaxin, general and administrative expenses for the quarter ended March 31, 2021 Were $4,200,000 compared to $2,300,000 for the 3 months ended March 31, 2020. The increase was primarily driven by proxy solicitation costs incurred to obtain the increase in authorized shares of our common stock.
Net loss was $7,100,000 or $0.04 net loss per share for the quarter ended March 31, 2021 compared to a net
loss $3,900,000
or $0.07 net loss per share for the quarter ended March 31, 2020. We recently terminated the Neocart asset purchase agreement with MediVate and are currently evaluating other options, including potentially developing the asset ourselves. As always, we continue to evaluate the market for potential assets to invest, License or partner, we will update you with any developments on this front in the near future. With that, we will open up the call for questions.
Your first question comes from the line of Keay Nakae with Chardan.
Good morning. So a couple of questions about
Kay, can you hear us? We can't hear you, Kay.
Kay, please press star 1.
Operator, looks like he
got disconnected.
We go to the next question, we can come back to Kay.
Okay, your line is open.
Hello? Hello? Hey, can you hear me back?
I can hear you. Can you hear me?
Yes. Yes. Now we can hear
you. Thanks, Kate. Good morning.
Okay. Yes, I don't know what happened there, but thanks. Couple of questions about the vaccine. Shanker, you mentioned some delays due to the activity that's happening in India. In India, do you have a sense of when you might be able to complete the EUA filing
Okay. As I stated, we're working very hard with our partners At Bardock Biotech, and it's taking longer than anticipated. We are planning to still complete the EU application in the upcoming weeks.
Okay. And in your initial discussions with the FDA, what have they said, If anything about wanting to see vaccine data for U. S. Patients before Okay. All right.
Very good. That's all I have.
Let me get back in queue. Thanks. Thank you, Kate. Thank you.
Your next question comes from the line of Zegda Jala with Roth Capital.
Good morning, guys. Thanks for the update. Just have a couple of quick ones for you. I think the first one is just Additional info on what's really needed from the folks in India to kind of finalize the EU application, like what data sets are you missing or what information
Zigba, as you know, this is a very large clinical trial. And at the conclusion of the interim Phase 2, I mean the 2nd interim results For the Phase 3 clinical trial, we have to pull all the data together. It's an enormous amount of effort. And in the middle of the pandemic, Obviously, this crisis in India has caused some delays. So just as everybody has submitted, there is a large amount of safety database we have to Together
along with efficacy.
That's what they're working on.
Okay. So you do need some safety and then Some efficacy data that you're waiting on. And then the follow-up question is regarding the master fall. I know you've submitted it, but I was just wondering When you anticipate getting some feedback from the FDA and when you do get that feedback, are you going to communicate it publicly?
Again, it's again, the normal course of business in Depending on if it's a feedback concerning, there are some anticipatory questions or clarifications needed, That's the reason we are collaboratively working with FDA, so we can incorporate anything else, any information additional information in the UA. That's the plan. And obviously, we may not be going into all the details.
Understood. And then just the last one, you're really impressed with the continued execution on the ophthalmology pipeline. And so I was just wondering if you can provide just a little bit more granularity as to what Needs to be completed because it's nice that you do have capital to kind of support some of those efforts, but just any detail as to what's needed for the next steps for
We'll be ready to file the IND, which is and we are anticipating to file that later part of this year.
Perfect. Thanks Shankar and congrats again on all the progress.
Thank you.
Thanks, Jaika. Thanks for the questions.
Your next question comes from the line of Robert Laboya with Noble Capital.
Good morning. I
Good morning. How are you doing?
I'm doing well. Thanks. My question has to do with the emergency use application And when you expect to hear an answer back from the FDA, if positive, what would that mean in terms of roll And how would it fit with the current vaccination programs?
Yes. Again, it will be we're anticipating it's going to be similar It's going to be similar process to other companies. After we filed the emergency use authorization application, Typically, agency takes 3 to 4 weeks to make a decision and have a meeting with ACIP. And after that, We will be ready to roll out the vaccine just as other companies have prepared.
Okay, great. Thank you very much.
Thank you.
Your next question comes from the line of Swakkala Ramakanth with THHC Wainwright.
Thank you. This is RK from H. C. Wainwright.
Good morning.
Just for my edification, if you could, Please help us try to distinguish between the filing of the master file and What you'll need to do in terms of the emergency use application, what are the differences there In terms of like data, in terms of what else you need to be providing?
Yes. So we are following FDA guidance on EUA for acute vaccines. So based on the guidance, Master File is a first step to include all preclinical manufacturing and any other data prior to Phase 3, So that it gives an opportunity for FDA to review and provide suggestions, comments prior to filing a UA. So that's the process we have completed and our
Just as
other companies have done. So those are the 2. So that application will have primarily the 2nd interim Analysis up to that point, 127 patients, what we have announced before, safety, efficacy, including The new variant data which is coming out, which will be part of that application.
Very good. So, obviously, Going into this, FDA has already reviewed quite a bit of your data. So do you still have to sit down with the FDA For a pre EUA discussion
and
that discussion will happen Before you also have another discussion with
Ibarra, these 2 are separate discussions and how should
We think about timing of all this in the course of getting, COVAXIN into the hands of BARDA.
Yes. With the FDA process, it's a similar process to other companies. We are We're collaboratively working with them. We're continuously communicating with them. And so obviously, We will be notifying them in communications when we are filing the UA.
And That conversation, that communication, those are different from BARDA. BARDA is independent and obviously working with the BARDA administration. So
Okay. Last question from me. With all that All the energies that are being spent on Covaxin and trying to get the Covaxin across the finish line, How are you on your resources To not only get COVAXIN through, but also to get 4 Phase 1, 2 Clinical trials get started on Opdiv 4 100 early next year.
Yes. So We are actually we also announced we are also increasing our internal resources. We got also A good sized exnal team of a team of solid experts supporting coaxing development, Including future clinical trial plans and everything else. In addition to that, internally, we're beeping up the team. We recently announced we hired the Senior Vice Manufacturing and supply chain.
There's tremendous experience from vaccines and gene therapy expertise and a very highly regarded person in the industry. And so we're building a very strong manufacturing team under him. And similarly, we're going to beef up other functional areas in the organization As we continue to grow this year and that's going to support, as you stated, starting with our AQ-four 100 gene therapy program, which we're planning to file the IND Later part of the year and initiate clinical trials, plus all other ophthalmology programs, we're planning to initiate, as you stated, 4 Phase 1 to clinical trials and comprising ARQ400, ARQ410 gene therapy as well as ARQ200 and we'll be supporting them. We are reaping up the resources Every day.
Thank you.
Thank you, Shankar and best friend. Talk to you soon.
Thank you. Thank you, Otke.
Our next question comes from the line of Kristin Kluska with Cantor Fitzgerald.
Good morning. Thanks for taking the questions. The first one I have is in regards to the potential usage of Covaxin as Booster, have you considered what work or understanding would need to go into this to determine when somebody should receive this And the number of doses and then how are you and your partners thinking about tracking the long term durability of Covaxin as All of the companies, just generally speaking, are trying to determine how often these boosters will be needed.
Okay. So, I'll Separate the two questions. The poster studies again, we are still preparing the protocols. Typically, you have to wait for any posters for the required. Then the co vaccine case, we're doing the poster After 28 days after the first dose.
Similarly, if you want to space them out for other vaccinees at least a month or more And that to be determined. Our clinical team headed by Doctor. Bruce Forrest, an expert in this field. And we're going to make those additions in the upcoming months before we file the protocol with FDA. And the second part is, are you going to monitor long term durability?
I think our partners have already Published extensive data, I think, in Lancet and others, and they're continuing to monitor the long term durability of this vaccine. Typically, what is important is, I think, the missing piece people have to understand, it's not just the safety and efficacy. Efficacy is At one time, you're measuring as a part of the Phase 3 clinical trial and it's really important to measure responses, tiller responses and T cell responses. And that's what you're going to get the durability on.
Thank you. And then, just to go off of RK's question, how should we be thinking about the near term Bending projections, including your comments about expanding the headcount as well as planning a pediatric
So, Kristin, good question. So, we obviously raised some capital very recently, both in Q1 as
well as end of last month with the $100,000,000 RDO. So with that, we have a very strong balance sheet. We have been hiring many people over the last few months, And we have bolstered our team quite a bit, both on the vaccine side as well as on the ophthalmology side. So the activities are progressing well on that front. And with all of this capital that is raised, it's more than sufficient for us to kind of put in place Any of the clinical plans for pediatric study as well as continuing on with our original And as well as hiring plans.
Thank you so much. And then my last question is whether you anticipate any Issues related to the current travel ban to India as it relates to manufacturing, inspection or anything else regarding that partnership?
Yes. The travel ban, again, Christine, we're closely monitoring, just as any other country, These breakouts are going to come up across the globe. And again, we cannot anticipate how long it's going to last. And as far as any potential inspections and all, agencies are conducting these days digital inspections. So they have some flexibility on that.
Great. Thanks so much everybody.
Thank you.
Hey, guys. Just wanted to do a quick follow-up on something that was triggered by Kristen's question. We're just wondering For the doses that are going to be coming over the initial doses, particularly from Bharat, is that still the plan? Why are you now considering having the initial doses come from the U. S.
Manufacturer?
That is still the plan, Zygda, While we are in parallel working with the U. S. Contract manufacturing.
Thanks to everyone for taking the time to join this call this morning. We are dedicated to help save lives from COVID-nineteen by bringing COVAX into the U. S. Market and develop gene therapies to cure blindness diseases. We look forward to providing further updates in the coming months.
Thank you.
Thank you for participating in today's conference call. Ladies and gentlemen, this concludes today's conference. You may now disconnect your lines at this time. Thank you for your participation and have a wonderful day.