Q4 2024 Ocugen Inc Earnings Call
All participants lines are in listen only mode.
Following the Speakers' commentary there will be a question and answer session.
Speaker Change: I will now turn the call over to Tiffany Hamilton outages.
Tiffany Hamilton: Head of corporate Communications you may begin.
Tiffany Hamilton: Good morning and welcome to Ocugen's fourth quarter and full year 2024 financial results and business update. Please note that this call is being recorded at this time. All participant lines are in listen-only mode.
Speaker Change: Thank you operator, and good morning, everyone. Joining me on today's call and webcast with Dr. Shotgun Musarri occupants, Chairman CEO and co founder who will provide a business update and an overview of our clinical and operational progress for mesh from Johnson, our Chief Accounting officer, who will provide more detail on our financial results.
Tiffany Hamilton: Following the speaker's commentary, there will be a question and answer session.
Tiffany Hamilton: I will now turn the call over to Tiffany Hamilton, Ocugen's Head of Corporate Communications. You may begin. Thank you, operator, and good morning, everyone.
Speaker Change: And Dr. Houma Kumar Chief Medical Officer will be available to answer questions. Following the presentation.
Tiffany Hamilton: Joining me on today's call and webcast is Dr. Shankar Musunuri, Ocugen's chairman, CEO, and co-founder, who will provide a business update and an overview of our clinical and operational progress. Ramesh Ramachandran, our chief accounting officer, will provide more detail on our financial results. And Dr. Huma Qamar, chief medical officer, will be available to answer questions following the presentation.
Speaker Change: This morning, we issued a press release detailing associated business and operational highlights for the fourth quarter and full year of 2024.
Speaker Change: We encourage listeners to review the press release, which is available on our website at <unk> Dot com.
Speaker Change: Call is being recorded and a replay with the accompanying slide presentation will be available on the investors section of the oxygen website for approximately 45 days.
Tiffany Hamilton: This morning we issued a press release detailing associated business and operational highlights for the fourth quarter and full year of 2024. We encourage listeners to review the press release, which is available on our website at ocugen.com.
Speaker Change: This presentation contains forward looking statements within the meaning of the private Securities Litigation Reform Act of 1095, 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.
Tiffany Hamilton: This call is being recorded and a replay with the accompanying slide presentation will be available on the Investor section of the Ocugen website for approximately 45 days.
Speaker Change: <unk> may could might will should or other words that convey uncertainty of future events or outcomes to identify these forward looking statements.
Tiffany Hamilton: This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainty. We may, in some cases, use terms such as predicts, believes, potential, proposed, continue, estimates, anticipate, expects, plan, intend, may, could, might, will, should, or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements include but are not limited to statements regarding our preclinical and clinical development activities and related anticipated development timelines. 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.
Speaker Change: Such statements include but are not limited to statements regarding our preclinical and clinical development activities and related anticipated development timeline such.
Speaker Change: 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.
Speaker Change: 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 our quarterly and annual reports that we file with the SEC.
Speaker Change: Any forward looking statements that we make in this presentation speak only as of the date 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.
Tiffany Hamilton: 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. Any forward-looking statements that we make in this presentation speak only as of the date of this presentation, except as required by law.
Speaker Change: Finally occupants annual report on Form 10-K, covering 2024 will be filed today.
Speaker Change: I will now turn the call over to Dr. <unk> scenario.
Speaker Change: Thank you Tiffany and thank you all for joining us today.
Tiffany Hamilton: 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.
Speaker Change: Eager to share the ongoing progress upward Marvell, Martha gene therapy platform across all three clinical programs.
Speaker Change: It was especially exciting to announce last week that we would.
Tiffany Hamilton: Finally, Ocugen's annual report on Form 10-K, covering 2024, will be filed today.
Speaker Change: Alignment with the FDA to move forward with the phase II <unk> III.
Shankar Musunuri: I will now turn the call over to Dr. Musunuri. Thank you, Tiffany, and thank you all for joining us today. We are eager to share the ongoing progress of our novel modifier gene therapy platform across all three clinical programs. It was especially exciting to announce last week that we reached an alignment with the FDA to move forward with a Phase II-III pivotal confirmatory trial for RQ410ST-BLA targeting Stargardt disease, making it possible to potentially expedite our clinical development timeline by two to three years, which is expected to save significant costs in addressing disease burden even sooner than anticipated.
Speaker Change: From a two week trial for <unk> <unk>, it's D b elite targeting targeted disease, making it possible to potentially expedite.
Speaker Change: From development timeline by two to three years, which is expected to see significant cost and addressing disease burden even sooner than anticipated.
Speaker Change: Important news also brings us closer to our goal of three potential delays in the next three years.
Speaker Change: Q4 hundred in 2026.
Speaker Change: Do you put an S T in 2027, and our Q4 10 in 2028.
Speaker Change: We know this is a bold ambition, but I'm confident that we have with the strategic scientific expertise along with an unrelenting commitment to patients to deliver on our commitment.
Shankar Musunuri: This important news also brings us closer to our goal of three potential BLA's in the next three years. RQ400 in 2026, RQ410ST in 2027, and RQ410 in 2028. We know this is a bold ambition, but I'm confident that we have the strategic and scientific expertise, along with an unrelenting commitment to patients to deliver on our commitment.
Speaker Change: During 2024, we continuously advanced.
Speaker Change: Our programs in line with enrollment and dosing timelines and are continuing to drive the product pipeline forward in 2025.
Speaker Change: Throughout <unk>, we are providing data to validate our revolutionary platform.
Speaker Change: To support our efforts in the clinic, we secured 65 million in equity and debt financings in the second half of 2024.
Shankar Musunuri: During 2024, we continuously advanced. Our programs in line with enrollment and dosing timelines and are continuing to drive the product pipeline forward in 2025. Throughout development, we are providing data to validate our revolutionary platform.
Speaker Change: Extensive cash runway into the first quarter of 2026.
Speaker Change: Let's discuss our Q4 hundred our lead candidate in more detail.
Speaker Change: Natus Pigmentosa FX 300000 people in the U S and EU combined and 1.6 million globally.
Shankar Musunuri: To support our efforts in the clinic, we secured $65 million in equity and debt financings in the second half of 2024 that extends cash runway into the first quarter of 2026.
Speaker Change: Can be associated with mutations in more than 100 genes with only one product on the market.
Speaker Change: This 1% to 2% of patient population you can see the EBIT for.
Shankar Musunuri: Let's discuss RQ400, our lead candidate, in more detail. Retinitis pigmentosa affects 300,000 people in the U.S. and E.U. combined and 1.6 million globally, and is associated with mutations in more than 100 genes.
Speaker Change: Our Q4 hundred to meet a tremendous unmet medical need and potentially capture all the market share.
Speaker Change: Jean agnostic mechanism of action.
Speaker Change: In February the European Commission provided a positive opinion.
Speaker Change: The European Medicines Agency's EMA committee for advanced therapies.
Shankar Musunuri: With only one product on the market that addresses 1-2% of patient population, you can see the ability for RQ400 to meet a tremendous unmet medical need and potentially capture all the market share through its gene-agnostic mechanism of action.
Speaker Change: Our Q4 hundred advanced therapy medicinal product a T M B classification.
Speaker Change: At D&B classification is granted to medicines that can offer groundbreaking opportunities for the treatment of disease and accelerates the regulatory review timeline of this potential onetime gene therapy for life.
Shankar Musunuri: In February, the European Commission provided a positive opinion from the European Medicines Agency's EMA Committee for Advanced Therapies for OCU-400 Advanced Therapy Medicinal Product ATMP Classification. ATMP classification is granted to medicines that can offer groundbreaking opportunities for the treatment of disease and accelerates the regulatory review timeline of this potential on-time gene therapy for life. Additionally, this classification allows Ocugen to interact with EMA more frequently for scientific advice and protocol assessment.
Speaker Change: Currently this classification allows oxygen to interact with the EMA more frequently for scientific advice and protocol assistance.
Speaker Change: In January we announced positive two year safety and efficacy data from our Q4 hundred phase one two clinical trial that demonstrated a clinically meaningful improvement of two land game.
Speaker Change: 10 letters on the E D D R S chalk and low luminescence.
Speaker Change: Equity Olympia.
Speaker Change: In treated eyes, when compared to untreated fellow eyes. This treatment effect was statistically significant with a P value of 0.00 files in all subjects, regardless of mutation at two years, demonstrating the long term durability for our Q4 hundred.
Shankar Musunuri: In January, we announced positive two-year safety and efficacy data from the RQ400 Phase I-II clinical trial that demonstrated clinically meaningful improvement of two-line gain, 10 letters on the ETDRS chart, in low luminescence visual equity, LLVA. in treated eyes when compared to untreated fellow. This treatment effect was statistically significant, with a p-value of 0.005 in all subjects, regardless of mutation at two years, demonstrating the long-term durability for RQ400. These two-year LLVA findings, which are the most sensitive measure of visual function, are consistent with the results observed at one year.
Speaker Change: These do you view your findings, which are the most sensitive measure of visual function are consistent with the results observed at one year.
Speaker Change: The phase III study spanning one New York will enroll 150 participants divided into two sturdy pumps 75 participants with a rope gene mutations and scientific participants what gene agnostic in each arm first bench will be randomized in a two to one ratio to receive either treatment.
Speaker Change: <unk>.
Speaker Change: Which is 2.5 times 10 to the 10 largest part of our Q4 hundred remain in an untreated control group respectively.
Shankar Musunuri: The Phase 3 study, spanning one year, will enroll 150 participants divided into two study arms, 75 participants with the row gene mutations and 75 participants who are gene agnostic. In each arm, participants will be randomized in a two to one ratio to receive either treatment. which is 2.5 times 10 to the 10 VG per I of RQ for 100 or remain in an untreated control group, respectively. We're actively enrolling patients in the U.S. and Canada in the Phase 3 Limelight clinical trial of RQ400 and intend to complete enrollment in the first half of 2025 to remain on track to meet BLA and MAA filings targets mid-2026.
We're actively enrolling patients.
In the U S and Canada, and the phase III limelight clinical trial of <unk> 400, and intend to complete enrollment in the first half of 295 do remain on track to meet to BLA and MAA filings targets mid 2026.
Speaker Change: Next up is our Q4 dynasty.
Speaker Change: No approved treatment options available for patients it's target disease 100000 patients in the U S and Europe combined are desperate for an answer.
Speaker Change: All Q4 hundred.
Speaker Change: S T with a single sub retinal injection as potential to treat sagar in all a busy year for associated retinopathy and in the fourth quarter received orphan medicinal product designation from the EMA for the treatment of a b C F or associated retinopathy.
Shankar Musunuri: Next up is Ocufort and ST. With no approved treatments, options available for patients with Stargardt disease, 100,000 patients in the U.S. and Europe combined are desperate for an answer. Acu400-410ST with a single subretinal injection has potential to treat Stargardt and all ABCA4-associated retinopathies and in the fourth quarter received orphan medicinal product designation from the EMA for the treatment of ABCA4-associated retinopathies. Earlier this week, we announced that OCU-410ST also received ATMP classification along with OCU-410, which is a critical step to potentially address these severely unmet medical needs in the very near future. Six-month data from phase one of the RQ410SD Guardian trial demonstrated clinically meaningful two-line, 10-letter improvement in visual function measured by best-corrected visual equity, BCVA, which is statistically significant with a p-value of 0.02 in treated eyes.
Speaker Change: Earlier this week, we announced the docking for dynasty also received a D&B classification, along with our Q4 10, which is a critical step to potentially address these severely unmet medical needs.
Speaker Change: The very near future.
Speaker Change: Six month data from page one after our Q4 time SD Guardian trial.
Speaker Change: Demonstrated clinically meaningful to line 10 electric improvement in visual function measured by best corrected visual equity BCP V, which is statistically significant with a P value of 0.0 to in treated eyes.
Speaker Change: Percent of Evaluable treated eyes demand stated stabilization or improvement in visual function.
Speaker Change: There was 52% slower trophic lesion growth in Aki for Dennis D featured ice versus untreated fellow eyes upper single injection at six months and seven patients.
Speaker Change: 103% slower retrofit.
Shankar Musunuri: 100% of evaluable treated eyes demonstrated stabilization or improvement in visual function. There was 52% slower atrophic lesion growth in Ocu410ST treated eyes versus untreated fellow eyes after single injection at six months in seven patients and 103% slower atrophic. lesion growth in treated eyes versus untreated fellow eyes at 12 months in two patients. OcuFOT-NST maintains a favorable safety and tolerability profile with no serious adverse events, including no cases of ischemic optic neuropathy, vasculitis. intraocular inflammation. endothalamitis or choroidal neovascularization and no adverse events of special interest.
Speaker Change: Lesion growth in treated eyes versus untreated fellow eyes at 12 months and to patients.
Speaker Change: Q4 dynasty maintain.
Speaker Change: <unk> maintains a favorable safety and tolerability profile with <unk>.
Speaker Change: No serious adverse events, including no case itself can.
Speaker Change: Can make optic neuropathy vasculitis.
Speaker Change: Intra ocular inflammation.
Speaker Change: Endo problem like this are choroidal, Neovascular nation, and no adverse events of special interest.
Speaker Change: The phase III pivotal confirmatory trial of Aki Fortinet steep will randomize 51 subjects 34 of whom will receive a single sub retinal 200, microliter injection of Aki for Tennessee at the concentration of one five times 10 to 11.
Speaker Change: Genomes Vg per ml.
Speaker Change: In the eye with the worst vision equity and 17 of whom I'm, So an untreated controls.
Shankar Musunuri: The Phase 2-3 Pivotal Conformatory Trial of RQ410ST will randomize 51 subjects. 34 of whom will receive a single subretinal 200 microliter injection of RQ-410ST at a concentration of 1.5 x 10 to the 11 vector genomes VG per ml in the eye with the worst visual equity, and 17 of whom will serve an untreated control. The primary endpoint in the clinical trial is changing atrophic lesion site. The secondary endpoints include visual equity as measured by best-corrected visual equity. and LLVA compete on Tweeted competition. One-year data will be utilized for the BLA filing. We plan to initiate the Phase II-III study mid-2025 and are targeting BLA submission by 2027.
Speaker Change: The primary endpoint in the clinical trial is change in retrofit collision sites.
Speaker Change: The secondary endpoint include regional equity as measured by best corrected visual acuity.
Speaker Change: And L. L V compared to untreated controls one new data will be utilized for the BLA filing.
Speaker Change: We plan to initiate the phase two three study mid 2025 and are targeting BLA submission by 2027.
Speaker Change: Now, let's move on to our developments and occupancy which is specifically designed to address multiple pathways implicated in the pathogenesis of dry age related macular degeneration AMD.
Speaker Change: AMD and offer a distinct advantage or current treatment options are target only one pathway a comprehensive system.
Speaker Change: Currently.
Speaker Change: Treatment options require frequent <unk> injections about six to 12 doses per ear.
Shankar Musunuri: Now let's move on to our developments in OCU410, which is specifically designed to address multiple pathways implicated in the pathogenesis of triagelated macular degeneration, DAMD, and offer a distinct advantage over current treatment options that target only one pathway, the complement system. Currently FDA-approved treatment options require frequent intravitreal injections, about 6 to 12 doses per year, and are accompanied by various safety considerations. For example, roughly 12% of patients develop Witt-Mackler degeneration following treatment.
Speaker Change: Accompanied by various safety considerations.
Speaker Change: For example, roughly 12% of patients develop wet macular degeneration. Following treatment is also important to note. There are no approved therapies for geographic atrophy G E and <unk>.
Speaker Change: Rob.
Speaker Change: Our Q4 time has the potential to regulate all four pathways related to disease progression lipid metabolic inflammation oxidative stress and activation of the complement system, thereby addressing the underlying causes of this disease.
Shankar Musunuri: It is also important to note there are no approved therapies for geographic atrophy, GA, in Europe. Ocufortin has the potential to regulate all four pathways related to disease progression, lipid metabolism, inflammation, oxidative stress, and activation of the complement system, thereby addressing the underlying causes of this disease. Approximately 2 to 3 million patients in the US and EU and 8 million patients globally suffer from GA, advanced form of DAMD. Preliminary nine-month data of Ocufortin showed clinically meaningful two-line a ten-letter improvement in visual function, LLBA, and treated eyes compared to untreated eyes in the phase one portion of the trial.
Speaker Change: Approximately two to 3 million patients in U S and EU and 8 million patients globally suffer from G advanced form a D. A M D.
Speaker Change: Preliminary nine month data of occupancy and showed clinically meaningful to line.
Speaker Change: What kind of lift or improvement in visual function, a little bit in future lies compared to untreated eyes in the phase one portion of the trial.
Speaker Change: Subject sure considerably slower lesion growth, 44% from baseline and treated eyes versus untreated fellow eyes at nine months and follow up data from the phase one study.
Speaker Change: Brazil ration of retinal tissue at nine months at all lesions of treated eyes with a single injection of our Q4 came in phase one compared favorably to published data on our leading FDA approved complement inhibitor given monthly or every other month at the same time points.
Shankar Musunuri: Subjects showed considerably slower lesion growth, 44% from baseline in treated eyes versus untreated fellow eyes at nine months, and follow-up data from the Phase I study. Preservation of retinal tissue at nine months at our GA lesions are treatedized with a single injection of RQ-410 in phase one, compared favorably to published data on the leading FDA approved complement inhibitor given monthly or every other month at the same time point.
In the phase II study, the safety and efficacy of our coupon 10 in patients with D. A secondary to a D. A M. D will be assessed 51 patients were randomized one to one to one into either of two treatment groups.
Speaker Change: Liam or high dose or a control group.
Speaker Change: And the treatment group subjects received a single sub retinal 200 Microliter administration.
Shankar Musunuri: In the phase 2 study, the safety and efficacy of RQ410 in patients with GA secondary to D-AMD will be assessed. 51 patients were randomized, one to one to one, into either of two treatment groups, medium or high dose, or a control group. In the treatment group, subjects received a single subretinal, 200 microliter administration of 5 times, 5 times 10 to the 10 vector genomes or VGs per mil, which is a medium dose, or 1.5 times 10 to the 11 VGs per mil, high dose, while the control group remained untreated. This week, the DSMB convened and reviewed the safety and tolerability profile of an additional 15 subjects from the phase two portion of the study.
Five times five times 10 to the 10 vector genomes or reduce per mill, which is a medium dose or 1.5 times 10 to the 11 reduce personnel idose.
Speaker Change: The control group remained on treatment.
Speaker Change: This week, the DSM be convened and reviewed the safety and Tolerability profile of an additional 15 subjects from the phase II portion of the study.
Speaker Change: No serious.
Speaker Change: Adverse events related to Aki for 10, I've been reported to date, and all 60 subjects, including phase one.
Speaker Change: Unlike currently available treatments for G H.
Speaker Change: No case itself stomach optic neuropathy vasculitis intra ocular inflammation.
Speaker Change: In the broader.
Speaker Change: Our choroidal Neovascular innovation and no adverse events of special interest.
Shankar Musunuri: No serious. adverse events related to Octu410 have been reported to date in all 60 subjects, including phase one. Unlike currently available treatments for GA, there were no cases of ischemic optic neuropathy, vasculitis, intraocular inflammation, endothelmitis or choroidal neovascularization, and no adverse events of special interest.
Speaker Change: Interim clinical data from the Armada clinical trial.
Speaker Change: Available in the second half of 'twenty to 'twenty five this data will help us design, a future pivotal confirmatory phase III study planned for 2026 and enable our potential BLA and MAA filings as soon as 2028.
Speaker Change: Given the multi functional effect of our modified gene therapy, the profound unmet medical need limited treatment options and the fact that it is designed as a one and done treatment. We believe our Q4 10 can be a potential gold standard for treating G eight worldwide.
Shankar Musunuri: Interim clinical data from the Armada clinical trial will be available in the second half of 2025. This data will help us design a future pivotal confirmatory phase 3 study planned for 2026 and enable our potential BLA and MAA filings as soon as 2028. Given the multifunctional effect of our modified gene therapy, the profound unmet medical need, limited treatment options, and the fact that it is designed as a one-and-done treatment, we believe RQ410 can be a potential gold standard for treating GA worldwide.
Lastly, I would like to call attention to our biologic candidate nomination vaccines platform. After 200 more into the clinic and patients are currently being dosed in phase one clinical trial for diabetic macular edema DMA <unk> 200 has the potential to change the treatment landscape for <unk>.
Speaker Change: Diabetic retinopathy.
Speaker Change: Macular degeneration, but AMD with its unique mechanism of action.
Shankar Musunuri: Lastly, I would like to call attention to our Biologic Candidate and Annihilation Vaccines platform. Opioid 200 moved into the clinic and patients are currently being dosed in phase one clinical trial for diabetic macular edema, DME. Opioid 200 has the potential to change the treatment landscape for DME, diabetic retinopathy, and macular degeneration, VET-AMD, with its unique mechanism of action. Binding the active component, thumbstatin, to integrin receptors that play a crucial role in disease pathogenesis and holds the promise to benefit all DMA patients, including the 30 to 40 percent of patients who do not respond to current anti-VEGF therapies.
Speaker Change: Binding the active component some statin.
Speaker Change: Integrin receptors that play a crucial role in disease pathogenesis and holds the promise to benefit all DMD patients, including the 30% to 40% of patients who do not respond to current anti VEGF therapies.
Speaker Change: The <unk> 200 phase one clinical trial is a multi center open label dose escalation study to assess drug safety and <unk> injection and three cohorts logos.
Speaker Change: 0.0 to five milligrams medium dose 0.05 milligrams and a high dose <unk> one milligram.
Speaker Change: All subjects will receive a total of control to improve it'll injections of <unk> 206 weeks apart.
Shankar Musunuri: The RQ-200 Phase 1 clinical trial is a multi-center, open-label, dose-escalation study to assess drug safety via intravitreal injection in three cohorts, low-dose. 0.025 milligrams, medium dose 0.05 milligrams, and a high dose 0.1 milligram. All subjects will receive a total of two intravitreal injections of Ocu-200 six weeks apart. Patients' follow-up will take place up to three months after the last injection.
Speaker Change: Patient follow up will take place up to three months after the last injection.
Speaker Change: <unk> 12 million people in the United States 130 million people worldwide are affected by DMA, Dr or wet AMD.
Speaker Change: The investigational new drug IND.
Speaker Change: Application for our Q4 hundred okay.
Speaker Change: Companys inhaled mucosal vaccine for COVID-19 was cleared by the F D. A.
The National Institute of allergy and infectious diseases, and my AI D. Part of the National Institute of Health is expected to sponsor and conduct the phase one trial to assess the safety Tolerability and Immunogenicity for Q4 hundred administered where two different droughts emulation into the lungs and intranasal.
Shankar Musunuri: Approximately 12 million people in the United States, 130 million people worldwide are affected by DME, DR, or VET-AMD.
Shankar Musunuri: The investigational new drug, IND, application for Ocu-500, the company's inhaled mucosal vaccine for COVID-19, was cleared by the FDA. The National Institute of Allergy and Infectious Diseases, NIAID, part of the National Institute of Health, is expected to sponsor and conduct the phase one trial to assess the safety, tolerability and immunogenicity for Q400 administered via two different routes. Annihilation into the lungs and intranasally as a spray. The Phase I trial will enroll 80 adult subjects aged 18 to 64 years. 40 subjects will be assigned to the low-dose group and 40 subjects will be assigned to the high-dose group.
Speaker Change: <unk> is a spray.
Speaker Change: The phase one trial will enroll 80 subjects, aged 18 to 64 years.
Speaker Change: 40 subjects will be assigned to the low dose group and 40 subjects will be assigned to the high dose group.
Speaker Change: Within each group 20 subjects will receive the emulation farm up the vaccine and the other 20 subjects will receive the intranasal form the primary aim of the study is to determine safety was secondary and exploratory endpoints include antibody production systemic as well as mucosal and the number of breakthrough Covid nine.
Speaker Change: <unk> infections.
<unk> hundred is based on a novel <unk> Z.
Shankar Musunuri: Within each group, 20 subjects will receive the emulation form of the vaccine and the other 20 subjects will receive the intranasal form. The primary aim of the study is to determine safety, while secondary and exploratory endpoints include antibody production, systemic as well as mucosal, and the number of breakthrough COVID-19 infections. Octave 500 is based on a novel chimpanzee adeno vector. Chad 36 Technology. Earlier clinical studies to prevent COVID-19 that employed a similar technology administered where inhalation demonstrated increased mucosal and systemic antibodies and a durable immune response up to one year using one-fifth the dose compared to the same vaccine administered in trauma.
Speaker Change: Victor.
Speaker Change: Chad 36 technology.
Speaker Change: Earlier clinical studies to prevent COVID-19 that employed a similar technology administer emulation demonstrated increased mucosal and systemic antibodies and the durable immune response up to one year using one pick the dose compared to the same vaccine administered intramuscularly.
Speaker Change: The phase one clinical trial is anticipated to start in the second quarter of 295.
Speaker Change: I'll now turn the call over to remain ramachandra to provide the financial update.
Ramachandra: Thank you Sean and good morning, everyone. I will now provide an overview of the key financial results for the fourth quarter and full year of 2024.
Ramachandra: Our research and development expenses for the quarter ended December 31, $2024, $8 3 million compared to $1 seven 8 million for the fourth quarter of 2023.
Shankar Musunuri: The phase one clinical trial is anticipated to start in the second quarter of 2025.
Ramesh Ramachandran: I'll now turn the call over to Ramesh Ramachandran to provide the financial update. Ramesh. Thank you, Shankar, and good morning, everyone.
Ramachandra: The full year ended December 31st 2024.
Ramesh Ramachandran: I will now provide an overview of the key financial results for the fourth quarter and full year of 2024. Our research and development expenses for the quarter ended December 31st, 2024, at $8.3 million compared to $7.8 million for the fourth quarter of 2023. For the full year ended December 31st, 2024, research and development expenses were $32.1 million compared to $39.6 million for the year ended December 31st, 2023.
Ramachandra: Search and development expenses were $1 $32 1 million compared to $39 6 million for the year ended December 31st 2023.
Ramachandra: General and administrative expenses for the fourth quarter ended December 31 2024.
Ramachandra: $6 3 million compared to $1 $5 2 million for the fourth quarter of 2023.
Speaker Change: General and administrative expenses for the year ended December 31st Sprint at 94.
Speaker Change: Dollar $26 7 million compared to $1 32.0 million for the year ended December 31st 2023.
Ramesh Ramachandran: General and administrative expenses for the fourth quarter end at December 31st, 2024, where $6.3 million compared to $5.2 million for the fourth quarter of 2024. General and Administrative Expenses for the Year Ended December 31, 2024 were $26.7 million compared to $32.0 million for the Year Ended December 31, 2023.
Speaker Change: Net loss was approximately $13 9 million or 0.05.
Speaker Change: Net loss per share for the quarter ended December 31st 2024, compared to a net loss of approximately $11 million of 0.04 cent per share net loss for the fourth quarter 2023.
Speaker Change: Full year net loss was 54 1 million.
Ramesh Ramachandran: Net loss was approximately $13.9 million or 0.05 cent net loss per share for the quarter ended December 31st, 2024 compared to a net loss of approximately $11 million or 0.04 cent per share net loss for the fourth quarter 2023. Full-year net loss was $54.1 million or $0.20 net loss per share compared to a net loss of $63.1 million for the full year 2023 or $0.26 net loss per share.
Speaker Change: 0.2 thousand <unk> net loss per share compared to a net loss of <unk>.
Speaker Change: $63 1 million, but the full year $2023 zero point in 2006, and net loss per share our.
Speaker Change: Our cash and restricted cash totaled $1 $58 8 million as of December 31, 2024, compared to $39 5 million as of year ended December 31st 2023.
Speaker Change: We expect that our cash and restricted cash will enable us to fund operations into the fourth quarter of 2026 as always we are proactively exploring shareholder friendly opportunities to increase our working capital, including partnerships that will drive long term strategy for our scientific platforms.
Ramesh Ramachandran: Our cash and restricted cash total $58.8 million as of December 31st, 2024, compared to $39.5 million as of year ended December 31st, 2023. We expect that our cash and restricted cash will enable us to fund operations into the first quarter of 2022.
Speaker Change: That concludes my update for the quarter definitely back to you.
Speaker Change: Thank you very much we will now open the call for questions.
Speaker Change: Greater.
Speaker Change: We will now begin the question and answer session. If you have dialed in I would like to ask a question. Please press star one on your telephone keypad to raise your hand and joined the queue.
Ramesh Ramachandran: As always, we are proactively exploring shareholder-friendly opportunities to increase our working capital, including partnerships that will drive long-term strategy for our scientific platform. That concludes my update for the quarter.
Speaker Change: I would like to withdraw your question simply press Star one again.
Tiffany Hamilton: Tiffany, back to you. Thank you, Ramesh.
Speaker Change: Yeah.
Speaker Change: Our first question comes from the line of Michael part of it.
Tiffany Hamilton: We will now open the call for questions. Operator. We will now begin the question and answer session.
Speaker Change: From Maxim Group. Please go ahead.
Michael: Hi, there. Thank you guys. So much for taking my questions that I congrats on all the good progress.
Operator: If you have dialed in and would like to ask a question, please press star 1 on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press star 1 again.
Speaker Change: Thank you.
Michael: Hey, I guess.
First off thinking about a more of a housekeeping question when thinking about your runway.
Michael: Does this factor in for potentially newly launching studies like the <unk>.
Michael Kronovich: Our first question comes from the line of Michael Kronovich from Maxim Group.
Michael: Q4, 10 SP phase two three.
Shankar Musunuri: Please go ahead. Hi there, thank you guys so much for taking my questions today, congrats on all the good progress. So, I guess... First off, thinking about a more of a housekeeping question, when thinking about your runaway, does this factor in for potentially newly launching studies like the OCU410SP Phase 2-3? Yes Michael, it's already budgeted.
Michael: Yes, Michael it's already budget yet.
Michael: Alright, and then I guess in terms of the.
Michael: The <unk> program right given idea of when we could expect to see data start to emerge from that phase one and then what sort of efficacy endpoints are being evaluated just given that it is a phase one study.
Michael: Good morning last two months of interest good morning. Thank you for the question.
Huma Qamar: All right. And then I guess in terms of the DME program, right, do you have an idea of when we could expect to see data start to emerge from that phase one? And then what sort of efficacy endpoints are being evaluated, just given that it is a phase one study?
Speaker Change: Actually we are looking at the safety and efficacy are reported okay 200 towards the end of this year.
Speaker Change: And as we are assessing the safety of a unilateral until the actual administration of bucket 200. It also looking at the exploratory end points of a B C. D E and the doors responsive. Okay. 200. However, we are also looking at the secondary endpoints of our Q2 hundred mm antibody formation and.
Huma Qamar: Good morning. I'll ask Huma to address this. Good morning. Thank you for the question. Actually, we are looking at the safety and efficacy report of RQ200 towards the end of this year. And as we are assessing the safety of unilateral intravitreal administration of RQ200, we're also looking at the exploratory endpoints of BCVA and the dose response of RQ200. However, we are also looking at the secondary endpoints of RQ200 antibody formation and PK of RQ200 as well.
Speaker Change: The PK of Aki 200, that's about.
Speaker Change: Okay. Thank you and then just.
Speaker Change: One more for me I'll hop back into the queue.
Speaker Change: For <unk> 500, right now that's really hasn't been much of us.
Speaker Change: Core program lately, but just perhaps have you heard anything regarding funding availability for that phase one.
Speaker Change: Just given that the recent uncertainty around funding we've heard of NIH.
Michael Kronovich: Okay, thank you.
Michael Kronovich: And then just one more from me and I'll hop back into the queue.
Speaker Change: Yes, Michael that I already had meetings with us after our Anda approval.
Michael Kronovich: Just for OCU 500, right, I know this really hasn't been much of a Core Program lately, but just perhaps, have you heard anything regarding funding availability for that Phase I, just given that the recent uncertainty around funding we've heard of at NIH? Thank you. Yes, Michael, the NIAID had meetings with us after our IND approval, and they're still stating they're on track to initiate. All right. Thank you very much for the additional clarity. And once again, congrats on all the progress. Thank you.
Speaker Change: The there's still.
Speaker Change: Stating that on track.
Speaker Change: To initiate the phase one.
Speaker Change: Alright, Thank you very much for the additional clarity and once again congrats on all the progress.
Speaker Change: Thank you.
Speaker Change: Our next question comes from the line of swam Pakula mccahon.
Speaker Change: <unk>. Please go ahead.
Speaker Change: Thank you good morning, shrunk or Houma and Tiffany.
Speaker Change: Couple of quick questions from me.
Speaker Change: Shankar are you suddenly have met an aggressive target for your team.
Speaker Change: <unk> three BLA starting next year.
Speaker Change: So what gives you and your team confidence that you could add to this.
Swayampakula Ramakanth: Our next question comes from the line of Swayampakula Ramakanth from H.C. Baybright. Please go ahead. Thank you. Good morning, Shankar, Huma, and Tiffany. A couple of quick questions from me.
Speaker Change: And as investors, what should we be watching out.
Speaker Change: Do you want to see our progress towards this goal.
Speaker Change: Cool.
Shankar Musunuri: So Shankar, you certainly have made an aggressive target for your team of filing three BLA's starting next year. So what gives you and your team confidence that you could achieve this? And as investors, what should we be watching out to see your progress towards this goal? Yeah, good morning. Okay, good question. I mean, investors need to look at our track record. We started most of the gene therapy programs getting into the clinic late 21, 22. And today we are in the beginning of 25. And we have all three programs running from all cylinders. So our track record speaks for itself.
Speaker Change: Yeah. Good morning, Okay. Good question.
Speaker Change: I mean, the investors need to look at our track record.
Speaker Change: We started most of the gene therapy programs getting into the clinic late 'twenty, one 'twenty two and today, we are in the beginning of 'twenty five and we have all three programs running from all cylinders. So our track record speaks for itself.
Speaker Change: So the goodies.
Speaker Change: Once again.
Speaker Change: D a.
Speaker Change: For allowing us to knock off the phase III and the ability to convert the existing phase two clinical trial into phase three confirmatory pivotal trial for BLA for startup disease, It's a significant unmet medical need and that naturally line stop and so we are estimating if it's time to trial mid this year about nine months of recruitment.
Shankar Musunuri: And so the goal is, once again, thanks to FDA for allowing us to knock off the phase 3 and ability to convert existing phase 2 clinical trial into phase 2, 3 confirmatory total trial for BLA, Stargardt disease. It's a significant medical need. And that naturally lines up. I mean, so we are estimating if we start the trial mid this year, about nine months of recruitment. And then it's a one year follow up that will put us into 27. And so that should be reasonably targeted for BLA.
And then it's a one year follow up that would put us into 'twenty seven and so that that should be reasonably targeted for BLA.
Speaker Change: Similarly, the getting into occupancy at 10, we recently announced a month ago, but our recruitment.
Speaker Change: This completed in our phase two clinical trial for <unk> targeting geographic atrophy. So that means our phase two will be completed.
Speaker Change: By early next year, our interim data.
Speaker Change: Which is coming out in the second half of this year.
Shankar Musunuri: Similarly, getting into RQ410, we recently announced a month ago that our recruitment is completed in our Phase 2 clinical trial for RK410 targeting geographic atrophy. So that means our Phase 2 will be completed by early next year. Our interim data which is coming out in the second half of this year will allow us to start having conversations and discussions with the FDA as well as EMA on phase three clinical design. So we are hopeful to initiate that next year. Once again, that will have a one year duration. And GA is relatively easier to recruit compared to orphan diseases such as RP and Stargardt.
Speaker Change: Allow us to start having conversations and discussions with FDA as well as EMEA on phase three clinical design.
Speaker Change: So we are hopeful to initiate the next year once again that will have a one year duration and G is really literally easier to recruit compared to orphan diseases, such as RP and Starbucks and we were inundated with patients during our phase two clinical trial with so many patients reaching out to us therefore that gives us.
Speaker Change: Prudence, we can complete the clinical trial, including recruitment of his start in 'twenty six we can relatively.
Speaker Change: Relatively it get it done by 28 and that can be lined up for BLA and so that's why I think these timelines are reasonable so starting next year RP.
Swayampakula Ramakanth: And we are inundated with patients during our phase two clinical trial. We have so many patients reaching out. Therefore, that gives us confidence we can complete the clinical trial, including recruitment. If you start in 26, we can relatively get it done by 28, and that can be lined up for BLA. And so that's why I think these timelines are reasonable. So starting next year, RP, retinitis pigmentosa, RQ400, and 2027 is going to be RQ410, disease. And 2028, we're targeting BLA for OcuFort and geographic. Perfect. Thank you for that.
Speaker Change: Can I just remembered as Archie for 102 hundred 27 is going to be occupied dynasties target disease, and 2028, we're targeting BLA for occupancy and geographic atrophy.
Speaker Change: Perfect. Thank you for that.
Speaker Change: And so we were just talking about short term for G E.
Speaker Change: So we know that there are two approved therapies for this indication.
Speaker Change: So given that.
Speaker Change: How easy would it be.
Speaker Change: Two covenants, both physicians and patients.
Speaker Change: Two to initiate therapy on <unk>.
Speaker Change: Our Q4, then is considering the price point difference.
Huma Qamar: So we are just talking about 410 for GA. So we know that there are two approved therapies for this indication. So given that, how easy would it be to convince both physicians and patients, you know, to initiate therapy on Ocu410 as considering, you know, the price point difference? Go ahead. So I'll, RK, thank you for the question.
Jim: Go ahead Jim.
Jim: Okay. Thank you for the question I'll provide the clinical aspect and isolate Kemper County, Pennsylvania, but so in terms of one of the things I wanted to mention here is that you completed recruitment ahead of time for GM because there was a.
Jim: Huge you know a number of requests from the patients who have already got some full rate and either way and in fact, they live on the waiting list and we had a certain number to the crude for our phase III in terms of whatever the approved therapies right. Now are there, particularly are the competitors are the first and foremost in terms of the clinicians.
Huma Qamar: I'll provide the clinical aspect and the price point, Shankar can provide the input. So in terms of one of the things I wanted to mention here is that we completed recruitment ahead of time for GA because there was a huge, you know, number of requests from the patients who have already got SyphoRe and IsoRe. In fact, they were on the waiting list and we had a certain number to recruit for our phase three. In terms of whatever the approved therapies right now are there, particularly with competitors, the first and the foremost, in terms of the clinicians, the safety and tolerability profile of those products are concerning and 12% of, you know, the patients are progressing to the VET-AMG.
Jim: The safety and Tolerability profile of those products are concerning and 12% of our you know what the patients are progressing to the vet A&D.
Jim: In terms of the safety and Tolerability profile of rocket 410.
Jim: That gives us extreme confidence that there were no serious adverse events like CMV and ischemic optic neuropathy and Dr. Myers and escalators, which are the hallmarks of currently approved products also our protocol had included the washout period for those two.
Huma Qamar: In terms of the safety and tolerability profile of OcuPore 10, that gives us extreme confidence that there were no serious adverse events like CNV and ischemic optic neuropathy and ductal miters and vasculitis, which are the hallmarks of currently the approved products. Also, our protocol had included the washout period for those two approved products as well for a three month period. So in terms of recruitment and in terms of the safety and tolerability and efficacy profile, we are not only seeing differences or improvements in the structural as well as the functional outcomes and in Europe, there is no approved product.
Jim: As well our parts.
Jim: Three months period, so in terms of recruitment and in terms of the safety and Tolerability and efficacy profile are we are not only seeing differences are improvements and be structural as well as a functional outcomes and in Europe. There is no. Other products. The most majority of those are you know physicians because of the compliance issues of six to 12 injections per year and safety.
Speaker Change: Concentrations are not really prescribing and also the patients are reluctant to do that as you see the H block onset is 60 years of age and older and in terms of the price point I would like chunk or is a top tier. Thank you Omar so RK from a price point perspective.
Huma Qamar: So most majority of the physicians, because of the compliance issues of six to 12 injections per year and safety considerations are not really prescribing. And also the patients are reluctant to do that. As you see, the age being onset is 60 years of age and older.
Speaker Change: As we stated U S itself has more than a million patients with a late a D. A M D, which is geographic atrophy and most of these patients.
Speaker Change: Get a potentially funded by CMS.
Speaker Change: So we need to start working with them, obviously as a as an organization.
Shankar Musunuri: And in terms of the price point, I would let Shankar add his thoughts here. Thank you, Huma. So Arki, from the price point perspective, as we stated, US itself has more than a million patients with a late DAMD, which is geographic atrophy. And most of these patients... get potentially funded by CMF. So we need to start working with them. Obviously, as a as an organization, we are very mindful. We're watching other gene therapies, how they are getting priced. And unfortunately, in the marketplace, there are gene therapy products either today, either they're targeting very complex diseases or they're going after ultra rare diseases or they're going after diseases that already have a solution in the marketplace, which is not an unmet medical need.
Speaker Change: We are really mindful, we're watching other gene therapies, how theyre getting priced.
Speaker Change: Unfortunately in the marketplace. There are gene therapy products, either today or they're targeting very complex diseases are theyre going after ultra rare diseases or they're going after diseases that already have a solution in the marketplace, which is not an unmet medical need it's a it's a using scientific platform AAV vector for <unk>.
Speaker Change: Or something to replace like one and done and stopped taking multiple injections of biologicals are certain treatments. So definitely we need to consider all the price points and when you have a huge population like this number.
Speaker Change: Number one the pricing should be reasonable and so a one and done treatment. So even the patients are mostly in sixty's or seventy's, they're still how.
Shankar Musunuri: It's a it's a using scientific platform, a vector to deliver something to replace like one and done instead of taking multiple injections of biologicals or certain treatments. So definitely we need to consider all the price points. And when you have a huge population like this, number one, the pricing should be reasonable and it's a one and done treatment. So even the patients are mostly in 60s or 70s, they still have, you know, many, many years of quality of life years, you know, remaining for them. So we'll do the appropriate pharmacoeconomic analysis and we will price it fairly so that, you know, our goal is to make sure the payers can reimburse it and and the patients who really need the product.
Speaker Change: Many many years of quality of life years Oh.
Speaker Change: Meaning for them. So we'll do the appropriate pulmicort economic analysis, and we will price at a fairly so that you know our goal is to make sure the payers can reimburse it and in the patients who really need the product they get it our goal is to provide market access. So we're going to work on every day.
Speaker Change: And our perspective to make sure our patients get our product.
Speaker Change: Who need them.
Speaker Change: Thank you and thank you for that so last question from me on <unk>.
Speaker Change: 400.
Speaker Change: The first program with a phase three study in progress.
Speaker Change: Additional data should we expect.
Shankar Musunuri: They get it.
Speaker Change: From the phase one two study.
Shankar Musunuri: Our goal is to provide market access. So we're going to work on every effort in our perspective to make sure our patients get our product. We need. Thank you.
Speaker Change: Between now and.
Speaker Change: Filing of BLA next year.
Swayampakula Ramakanth: Thank you for that.
Speaker Change: So as we have recently updated on our.
Swayampakula Ramakanth: So, last question from me on OCU-400, with the Phase 3 program, with the Phase 3 study in progress, what additional data should we expect from the Phase 1-2 study, you know, between now and... in the planning of your BLA next year. So as we have recently updated on our durability profile as well as safety, so safety will continue to be there. That's a commitment. that we have made. So also on the efficacy functional endpoints, we will continue to report the parameters accordingly, LLVA and other functional parameters as they become.
Speaker Change: Durability profile as well as safety so safety will continue to be there that's our commitment.
So also on the efficacy functional end points, we will continue to report it nanometer it accordingly.
Speaker Change: And.
Speaker Change: Apparently does as they become available.
Speaker Change: The data we.
Speaker Change: Recently announced at the two year durability that's important.
Speaker Change: Not only.
Speaker Change: From payer perspective, too so we'll definitely have three year data at the time of filing next year.
Speaker Change: Perfect.
Speaker Change: Thanks, Thanks for taking all my questions.
Speaker Change: Thank you.
Swayampakula Ramakanth: Okay, the LLVA data we recently announced at the two-year durability, that's important, not only from payer perspective too, so we'll definitely have three-year data at the time of Perfect.
Speaker Change: Question comes from the line of Robert Leboyer from Noble capital markets. Please go ahead.
Speaker Change: Good morning, and congratulations on all the progress.
Speaker Change: It has to do with both.
Speaker Change: Oh, So U 500.
Swayampakula Ramakanth: Thanks for taking all my questions. Thank you.
Speaker Change: And whether there will be any grant revenue to the company associated with the phase one trial.
Speaker Change: Yeah, as we've stated publicly.
Robert Leboyer: Question comes from the line of Robert LeBoyer from Noble Capital Markets. Please, go ahead. Good morning and congratulations on all the progress.
Speaker Change: <unk> is sponsoring this program.
Speaker Change: We have completed our obligations from a company perspective.
Speaker Change: We are responsible for.
Shankar Musunuri: OCU 500, and whether there will be any grant revenue to the company associated with the Phase 1 trial. Yeah, as we stated publicly, MIAAD is sponsoring this program. And we have completed our obligations from company perspective. We are responsible for develop doing all the preclinical work and manufacturing. and filing the IND, getting it approved and clear to FDA and then transferred to them. So we've done our part and they're supposed to fund the Phase 1 clinical program and take it to the next level.
Speaker Change: Develop doing all the preclinical work in manufacturing.
Speaker Change: The filing date and they get it and get the approval and clear Bret D. And then transfer it to them. So we've done our part and they're supposed to fund the phase one clinical program and take it to the next level.
Speaker Change: Okay, we'll we'll.
Speaker Change: We will be funding.
Speaker Change: <unk> recorded as revenue by the company or will this just be.
Speaker Change: Something where you turn it over to the.
Speaker Change: The agency and they run the trial.
Speaker Change: Yeah, we will be turning over to the agency on the trial.
Speaker Change: Okay. Thank you.
Robert Leboyer: Okay, will the funding... be recorded as revenue by the company, or will this just be something where you turn it over to the agency as they run the trial? Yeah, we'll be turning over to the agency there on the... Okay, thank you.
Speaker Change: Our next question comes from the line of the meal.
Speaker Change: From charges.
Speaker Change: Go ahead.
Speaker Change: Hey, good morning, guys. Congrats on all the progress.
Speaker Change: Couple of questions on some form 10 S T.
Speaker Change: First what is your manufacturing strategy for four tenants and do you plan on using the commercial grade product for the phase II III study.
Speaker Change: Good question Daniel.
Daniil Gataulin: Our next question comes from the line of Daniil Gataulin from Chardin, please go ahead. Hey, good morning, guys. Congrats on all the progress.
Speaker Change: We have already made.
Speaker Change: At a commercial scale introduced into our phase one.
Speaker Change: And at the same scale would be used for phase three.
Shankar Musunuri: A couple questions on 410ST. First, what is your manufacturing strategy for 410ST, and do you plan on using the commercial-grade product for the Phase II-III study? Good question, Daniil. We already made, at a commercial scale, introduced into our Phase 1, and the same scale will be used for Phase 2-3. We'll follow the similar pattern like we're doing for RP. For RP, we are introducing two commercial scale lots in our pivotal trial. We'll do the same thing for SD program, which is consistent. And the FDA agreed with our strategy and we're moving forward. Okay, got it.
Speaker Change: We will follow the similar pattern like we're doing for RP.
Speaker Change: For RP.
Speaker Change: Were introducing two commercials get lots in our pivotal trial will do the same thing for SD program, which is consistent and our and M D.
Speaker Change: Agreed.
Speaker Change: Strategy and we're moving forward with that.
Speaker Change: Okay got it and in terms of the sites for the study are you looking at both the summit.
Speaker Change: Ex U S sites, and what proportion of each geography, we're using both.
Speaker Change: I mean, there's nobody to sites, except for Canada of course, I mean, we do have sites set up in Canada for retinitis Pigmentosa.
Speaker Change: If necessary, we will activate the sites for saga.
Shankar Musunuri: And in terms of the sites for this data, are you looking at both the S and XUS sites? And what are the proportions of each if you're using both? And there is no ex-U.S. sites except for Canada, of course. I mean, we do have sites set up in Canada for retinitis pigmentosa. If necessary, we'll we'll activate those sites for Stargardt. But based on the patient population, we only need 51 patients. I think Huma and our team are comfortable that they can get those patients in the U.S. very quickly. Got it.
Speaker Change: But based on the patient population, we only need 51 patients.
Humor: Humor and her team are comfortable that they can get those patients in the U S. They could do.
Humor: Got it okay. Thank you very much where they can the question.
Humor: Thank you.
Dr. Shankar: This concludes the Q&A portion I will now turn the call back over to chairman and CEO and co founder Dr. Shankar listen only.
Dr. Shankar: Thank you operator, we appreciate the continued interest in the enrollment of our key stakeholders as we move forward with our transformation initiatives, we look forward to ear off significant catalyst.
Daniil Gataulin: Okay, thank you very much for taking the question.
Dr. Shankar: I heard are ahead as we establish origin as a pioneering biotechnology leader in gene therapies for blindness diseases.
Operator: This concludes the Q&A portion.
Shankar Musunuri: I will now turn the call back over to Chairman, CEO, and Co-Founder, Dr. Shankar Musunuri. Thank you, operator. We appreciate the continued interest and involvement of our key stakeholders as we move forward with our transformative initiatives. We look forward to a year of significant catalysis. ahead as we establish Ocugen as the pioneering biotechnology leader in gene therapies for blindness.
Dr. Shankar: Have a great day.
Shankar Musunuri: Have a great day. Thank you for watching!