Q4 2023 Ocugen Inc Earnings Call
[music].
Good morning, and welcome to <unk> business update with certain financial for the year ending 2023.
Please note that this call is being recorded at this time.
All participant lines are in listen only mode.
Following the Speakers' commentary there will be a question and answer session.
I will now turn the call already deepening Hamilton <unk> head of Communications you may begin.
Hamilton: Thank you operator.
Hamilton: Joining me today is <unk>, chairman CEO and co founder Dr. Shawcor mercenary will provide a business update Michael.
Michael: Michael Breininger corporate controller is also on the call and will provide certain financial for the year ending 2023.
Michael: Finally, Zumba Kumar Chief Medical Officer will be available to answer questions during the Q&A.
Michael: This morning, we issued a press release detailing business and operational highlights for the year ending 2023.
Michael: We encourage listeners to review the press release, which is available on our website at <unk> Dot com.
Michael: This call is being recorded and a replay with the accompanying slide presentation will be available on the investors section of the oxygen web site for approximately 45 days.
This presentation contains forward looking statements within the meaning of the private Securities Litigation Reform Act.
Michael: Of 1995, which are subject to risks and uncertainties.
Michael: We may in some cases use terms such as predict believe potential proposals continue estimates anticipates expects plans intends may could might will should or other word second day uncertainty of future events or outcomes to identify these forward looking statements.
Michael: Such statements include but are not limited to statements regarding our clinical development activities and related anticipated timeline such.
Such statements are subject to numerous important factors risks and uncertainties and may cause actual events or results to differ materially from our current expectations.
Michael: Other risks and uncertainties are more fully described in our periodic filings with Securities and Exchange Commission at V C.
Michael: <unk> the risk factors described in the section entitled Risk factors in any annual reports that we file with the SEC.
Michael: Any forward looking statements that we make this presentation speak only as of the date of this presentation.
Michael: Except as required by law, we assume no obligation to update forward looking statements contained in this presentation, whether as a result of new information future events or otherwise after the date of this presentation.
Finally, our annual report on Form 10-K expected to be filed no later than April 16 2024.
Speaker Change: I will now turn the call over to Dr loose jewelry.
Speaker Change: Thank you Tiffany good morning, and thank you all for joining US today looking back at 2023, our team's unwavering dedication.
Tiffany J. Hamilton: The stage for transformation 2024, and our Marty for a gene therapy programs for brand new species.
Tiffany: The strides we have made a mark just in time.
Tiffany: Only personal.
Tiffany: Only personal.
Tiffany: And by the significant benefit.
Tiffany: Our therapies and potentially offer to patients.
Allow me to briefly share an inspiring account justifies the core of our model.
Tiffany: Greatest simulation from a patient in the occupancy 100 phase one two trial for ignite as Pigmentosa, a genetic disorder that decreased retinal cells and ethics approximately 100000 people in the U S and one 6 million people worldwide, a 60 year old patient began experience.
Tiffany: The onset of RP in his forties as the disease progresses and his vision worsen.
Tiffany: Increasingly turn to his livelihood.
Tiffany: Due to fundamental independently.
Tiffany: Before joining go trial, you're faced with future dominated by visual impairment.
Tiffany: And all available treatment options. This driving has proven to be a life altering experience not just for him but also for his family.
Tiffany: Following his treatment if Q4 hundred 84, so gradual restoration site industry July as a matter of fact, you shape that he is dosed I was.
Tiffany: One of the two and now it is better than the untreated eyes.
Tiffany: It's getting to no patients like these.
Tiffany: Hitting the re award stories fortified our resolve for board motivation to Delaware safe and effective therapies are significantly underserved diseases.
Tiffany: For reference we have also posted distribution video in the previous section of our corporate website.
Tiffany: As we review our 2023 milestones we have thrown off having achieved recognition from the FDA and other agencies in total areas.
Tiffany: I will touch upon our vaccines and cell therapy platforms.
Tiffany: On the vaccine development from our teams diligently pursued a moderate <unk>.
Tiffany: Revenues.
Tiffany: Culminated in a collaboration with the NIH carpet my age to include occupy hundreds and the project Nextgen initiate your desk the therapeutic potential of.
Tiffany: Several early stage vaccine candidates.
In combating COVID-19.
The initial commitment to cover costs for early stage vaccine candidates.
Tiffany: Strategic leap forward.
Tiffany: To address this public health impact with the minimal financially.
Tiffany: On our shareholders.
Tiffany: In addition, our state of the art Cgmp facility innovations.
Tiffany: You did last year.
Tiffany: For the production of Neocart phase III ready <unk> <unk> cell therapy platform.
Tiffany: This asset promote predecessor presented us with valuable opportunities after thoroughly evaluating compatibility with RP against existing pipeline and R&D expertise.
Tiffany: Knowledge, our responsibility for future patients eagerly waiting.
Great.
Tiffany: On the cell therapy market points to reach 8 billion by 2028, and an encouraging ridiculous landscape. We're now strategically evaluating alternatives to ensure neocart.
Tiffany: It's on track to maximize value for patients and shareholders.
Tiffany: Before I get into the modified gene therapy update I'd like to take a moment to discuss the broader landscape of the gene therapy market.
Tiffany: <unk> position within it.
Tiffany: We believe that in therapy market is on the cusp of a significant transformation.
Tiffany: Current market economics indicate a growing interest in <unk> and cell therapies.
Tiffany: Goodbye technological advancement increased investment and clinical activity and a supportive regulatory environment.
Tiffany: Monday transaction within the past year <unk>.
Tiffany: Our need for gene therapies industry analysts predict that the global gene therapy market is expected to surpass $30 billion by the end of the decade.
This image growth prediction is driven by unmet medical needs of growing pillar millions of patients globally suffering from diseases.
Tiffany: Until recently were unsuitable.
Tiffany: Last year, we achieved alignment from the FDA on the design aspect.
Tiffany: Our Q4 hundred phase III study.
Tiffany: As we prepare to initiate our pivotal occupy 100 phase III clinical trial I'd like to emphasize that we will be the only gene therapy basically drawn with the broad honoree designation.
Tiffany: The MBS alignment on our trial design.
Tiffany: <unk> hundred is rooted in compelling positive preliminary safety and it results demonstrated in the phase one two trial last year multi luminance mobility testing MLM D luminescence vision, it could be a little bit.
Tiffany: And best corrected visual acuity <unk> efficacy measurements patients, leaving the fleet in each category of these measurements bezels indicated improvement our preservation and ice compared with our Q4 hundred vessels from our understanding of the June agnostic mechanism of action.
Tiffany: But we are not the proposed phase III study for amputation. The MBA has included luminescence dependent navigation assessment.
Tiffany: D and E and measure of functional vision changes in patients with inhibitors. They see this as the primary endpoint.
A multi center randomized 150 patient phase III study will feature two arms.
Tiffany: Drew and gene agnostic.
Tiffany: <unk> 75 patients each arm.
Tiffany: In each of the sides of it.
Tiffany: This expense will be randomized two to one.
Tiffany: The treatment group.
Tiffany: And untreated control group.
Upon receiving approval from the FDA, we anticipate initiating a phase III trial for patients with <unk> Rd.
Tiffany: Our collaborator.
Tiffany: Alright.
Conversations with FDA to advance <unk> 400 to phase III and from the acute need for therapies with RP patients and our clinical data potential to foster a transformative impact.
Tiffany: Now.
On to occupy.
Occupancy finished.
Tiffany: The current treatment landscape, our book geographic atrophy G a staggered basis.
Streamline imaging.
Tiffany: The estimated 1 million patient gea market in the U S. Thompson momentum with recent drug approvals. However, these treatment options have significant limitations at the required multiple injections per year impacting patient claims and only target one pathway contributing to G. H.
Tiffany: Q4, 10 regulate multiple pathways and reward with the disease.
Tiffany: <unk> lipid metabolic inflammation oxidative stress membrane attack complex complement.
Tiffany: And has the potential to provide treatment for life.
Tiffany: Currently there.
Tiffany: There is no approved treatment for people linguists targeted disease, an orphan blindness disease that affects approximately 40000 people in the U S alone.
In the first quarter of 2024, we have completed dosing of cohort one in both.
Tiffany: Q4 10.
Tiffany: Marvel and argue for Tennessee Guardian patient two clinical trials.
Tiffany: Data and safety monitoring board.
Tiffany: <unk> for the SSD clinical trial determine the safety and Tolerability profile for Akio portal SD is favorable and approved to proceed to dosing with the medium dose of Q4, Tennessee in the dose escalation for Delta.
Tiffany: The FDA orphan drug designation for <unk> or an extra day last year further underscores our commitment to blindness conditions.
That requires ongoing treatment with high unmet medical need collaborations with the Premier retinal surgery Center.
Tiffany: I have been pivotal in bolstering our patient recruitment efforts and deepening our understanding.
Tiffany: With the maturing pipeline of clinical progress opportunities positioned at the forefront of this we're doing gene therapy market.
Tiffany: The army and orphan drug designations granted to our gene therapy programs demonstrate our potential to lead in this area.
Tiffany: Based on the patient as Tony from what occupy 100.
Tiffany: We're not only making headway, but already making a meaningful difference.
Tiffany: Our estimated those at origin is to Delta and Delaware.
Therapies to patients battling conditions that impact quality of life and functional independence.
Tiffany: So in February 2034, commercial cases, we shared or expected pathway for the market approval of Aki 400.
Tiffany: This was navigators critical faces and ensure we deliver on our long term strategy. We recently announced the appointment of Dr. Michael Moore, as our Chief Medical Officer.
Tiffany: Dr. <unk> extensive experience and contributions to date and our previous role as our head of clinical development and clinical operations are pivotal to our team.
Tiffany: Expertise and foundational lot of jiff oxygen Marty for a gene therapy platform will be instrumental to the success of our clinical programs.
Tiffany: I will now.
Tiffany: Turn the call over to Mike Berninger.
Michael Breininger: Controller to provide financials Mike.
Michael Breininger: Thank you sugar.
Michael Breininger: In our press release. This morning, we noted that we will restate our consolidated financial statements as of and for the year ended December 31, 2022 in connection with the filing of our 2023 and Form 10-K similar.
Michael Breininger: Similarly, the company will include restated unaudited financial information for the first three quarters of 2023 and 2022.
Michael Breininger: <unk> errors and each of the restated periods relates to the Companys noncash accounting for the estimated cost and one of its collaboration arrangements.
Over the company does not expect the errors to result in any impact on its cash position cash runway or financial projections.
Michael Breininger: <unk> cash cash equivalents and investments totaled $39 million.
Michael Breininger: As of December 31, 2023, compared to $90 9 million as of December 31, 2022.
Michael Breininger: We expect our current cash cash equivalents and investments will enable us to fund operations in the fourth quarter into the fourth quarter of 2024.
I'll now turn the call over to the operator for questions.
None: Thank you. So far is now open for your questions to ask a question at this time. Please press star followed by the number one on your telephone keypad, we'll pause for just a moment to compile the Q&A roster.
Operator: Your first question comes from the line of swam Pakula Romcom with H C. Wainwright Your line is open.
Speaker Change: Thank you and good morning for sugar.
Speaker Change:
Speaker Change: Sure.
Speaker Change: On the occupancy from that program.
Speaker Change: And when should we expect.
Speaker Change: Next the clinical update.
Speaker Change: And.
Speaker Change: Also.
Speaker Change: What else needs to be.
Completed.
Speaker Change: Before.
Speaker Change: You can get.
Speaker Change: The phase III program started.
Speaker Change: Alright, good morning I'll, let.
Mark answer the question go ahead.
Mark: Thank you Chuck and thank you for the question.
Mark: So far all capable hundreds one session studies completed the enrollment.
None: Red Tonight is linked to the patients and.
None: <unk> 12.
None: We will be periodically providing the updates as they come up we have completed the enrollment for already anticipate Mitchell.
None: Portion of the study.
None: Okay.
None: Are you expecting us to are you talking about phase III.
None: Yes, what's what else needs to get done for that.
Okay for phase III, we are actively working with the FCA.
None: Dr. Andrew <unk>.
None: We have been booking rates will agree with the FDA and are grateful for their support of the FDA alignment Jaafar clinical protocol.
None: All goes well, we will be commencing our study in April.
None: Best of luck.
None: Good.
None: And then regarding.
None: <unk>.
None: The.
None: Uh huh.
None: Okay.
<unk> safety monitoring board.
None: Our growing you to move to the next dose level and 410 S T.
None: So at this point, how many patients would be entering into the next phase.
None: Of that dose evaluation and also.
None: Right.
None: Okay.
None: Would you be releasing any of the data from the initial cohorts are.
None: Do this at a time when you have enough data from multiple cohorts.
None: So that's a good question, but we are moving towards the median dose cohort.
None: The phase one portion of the study the treatment redesign just because it was escalation portion will be will be enrolling three patients.
None: In there as well as when it after that there will be a high dose cohort.
None: Three as well and from there we are planning to update periodically on the safety updates preliminary safety updates. After he sold once we have the <unk> from the high dose cohort at <unk> the dose escalation portion of the study.
None: Thank you very much.
None: And then last question from me is on the Neocart.
None: So based on your comments it looks like you are ready in terms of.
None: Manufacturing part of.
None: Manufacturing the product needed for this study.
None: What else is needed to get started.
None: In your conversations with potential collaborators.
None: What.
None: What are they looking for.
So that.
None: You can move the conversation to the next level.
None: Great question.
The facility is already and we have learned from FDA to move into phase III or matches information everything you said I mean, obviously this is a.
None: Phase III is it.
None: <unk> study and take some recruitment time, so that is the capital mix might need it. So thats exactly what we are working with some potential partners to make sure. We got the funding to continue the clinical trials because once we started we need to make sure we have adequate funding support.
None: So we can finish it.
None: Very good. Thank you very much for taking all my questions.
None: Okay.
None: Okay.
Speaker Change: Our next question comes from the line of Dan Neanderthal Lean with Chardan capital markets. Your line is open.
Speaker Change: Okay.
Speaker Change: Hey, good morning, guys. Thank you for taking the question congrats on the progress.
Speaker Change: And on the phase III <unk> hundred trial.
Speaker Change: Is there a minimum number of mutations that you will need to be looking at.
Speaker Change: You bet.
Speaker Change: <unk> to gain abroad mutation agnostic label.
Speaker Change: Yeah.
None: So I will take that question and the answer is no.
None: We are alluding the Joplin in one arm and then the other gene agnostic or maybe we will have 75 patients 70 functions in rhodopsin arm 75, and gene agnostic approach 50 being in the active arm and 25 in the crucial.
None: Okay and internally do you do.
None: Are you guiding on how many gymnastics RFP Gen acoustics patients here I'll be looking at.
So we are not thats exactly what we have the broader indications for our products. So that is we are addressing the patients' unmet medical need here and we are opening this phase III trial.
None: To actually validate our novel modified gene therapy.
None: Got it alright, thank you.
Yes.
Okay.
None: This concludes the Q&A portion.
None: I will now turn the call back over to Dr. Shankar machinery.
Shankar Musunuri: Thank you.
Shankar Musunuri: As we close today's session I wanted to highlight our 2023 journey and our 24 strategy our focus on patients as manifested in numerous regulatory milestones and advancements in our gene therapy pipeline with rocket 400 program on the <unk> Phase III trial in line with the 2026 BLA approval target timeline.
Shankar Musunuri: And the completion of first cohort dosing in our <unk> and importantly, the trials, we stand at an exciting adventure of clinical progress and potential of.
Shankar Musunuri: Gene therapy markets dynamic growth and our strategic position within its signal of future right the opportunity.
And while we continue to advance the pipeline. We also continue to pursue partnership opportunities for up to 400.
Shankar Musunuri: I want to thank all our stakeholders for their continued trust and support we entered this year with great momentum and clear objectives, driven by a mission to bring game changing.
Shankar Musunuri: Gene and cell therapies, and vaccines to market and working even harder to provide access to patients globally. Thanks again, everyone have a great day.
None: Ladies and gentlemen. This concludes today's conference call you may now disconnect.
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Good morning, and welcome to <unk> business update with certain financial for the year ending 2023.
None: Please note that this call is being recorded at this time.
None: All participant lines are in listen only mode.
None: Following the speakers from <unk>, there will be a question and answer session.
None: I will now turn the call over to Tiffany Hamilton.
Tiffany J. Hamilton: Okay, James head of Communications you may begin.
Tiffany J. Hamilton: Thank you operator.
James: Joining me today is <unk>, chairman CEO and co founder Dr. <unk> will provide a business update Michael.
James: Michael Breuninger corporate controller is also on the call and will provide certain financial for the year ending 2023.
Speaker Change: Finally, Dr. Lu Kumar Chief Medical Officer will be available to answer questions during the Q&A.
Speaker Change: This morning, we issued a press release detailing business and operational highlights for the year ending 2023.
Speaker Change: We encourage listeners to review the press release, which is available on our website at Aqua agenda.
Speaker Change: This call is being recorded and a propane company slide presentation will be available on the Investor section of the <unk> website for approximately 45 days.
Speaker Change: This presentation contains forward looking statements within the meaning of the private Securities Litigation Reform Act.
Speaker Change: Of 1995, which are subject to risks and uncertainties.
Speaker Change: We may in some cases use terms such as predict believes potential proposed continue estimate anticipates expects plans intends may could might will should other words that convey uncertainty of future events or outcomes to identify these forward looking statements.
Speaker Change: Such statements include but are not limited to statements regarding our clinical development activities and related anticipated timelines.
Speaker Change: Such statements are subject to numerous important factors risks and uncertainties and may cause actual events or results to differ materially from our current expectations.
Other risks and uncertainties are more fully described in our periodic filings with Securities and Exchange Commission as each day.
Speaker Change: <unk> the risk factors described in the section entitled Risk factors and.
Speaker Change: Any 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.
Speaker Change: Finally, our annual report on Form 10-K, we expect it to be filed no later than April 16 2021.
Dr. unknown: I will now turn the call over to Dr. <unk>.
Dr.: Thank you Tiffany good morning, and thank you all for joining US today looking back at 2023, our team's unwavering dedication.
Dr. <unk>: At this stage, but our transformation 2024, and modify our gene therapy programs for blindness diseases.
None: The strides we have made a modest employment and profoundly personal.
None: By the significant benefits of <unk>.
None: Our therapies and potentially offer to patients.
None: Hello me to briefly share an inspiring account that justifies the core of our model.
None: <unk> simulation from a patient that occupy 100 phase one two trial for ignite as Pigmentosa.
None: Genetic disorder that degrade signals sales and FX approximately 100000 people in the U S and one 6 million people or white Ah.
None: The 60 year old patient begin experiencing the onset of our fleet in his forties as disease progresses and his vision worsened.
None: Increasingly tightened his livelihood and his ability to function independently.
None: Before joining <unk> trial, you're faced with future dominated by visual impairment with no available treatment options. This trial has proven to be a life altering experience not just for him but also for his family.
None: The year following his treatment with anti <unk> 480 reports a gradual restoration of site industry July as a matter of fact, you shape that is dosed.
None: One of the two and now it is better than the untreated eyes.
None: It's getting to know fragrance like these and hitting their real world series.
None: Fortified our resolve but bold innovation, Delaware safe and effective therapies are significantly underserved diseases.
None: We also posted this patient video and patients section of our corporate website.
None: As with EUR 2023 miles. So we are trough, having achieved recognition from the FDA and other agencies in total area.
None: I will touch upon our vaccines and cell therapies.
None: On the vaccine development front, our teams diligently pursued of bundling funding avenues as culminated in a collaboration with the NIH.
None: Profit my age to include occupy 100, and the project initiated.
None: That's the therapeutic potential of several early stage vaccine candidates and combating COVID-19.
<unk> commitment to cover costs for early stage vaccine candidates is a strategic leap forward.
None: With us to address this public health imperative with the minimal essentially match and our shareholders.
In addition, our Saratoga, obviously GMP facility renovations were completed last year.
The production of Neocart to our phase III ready <unk> reasonably a cell therapy platform.
Acquiring this asset promote predecessor presented us with invaluable opportunities after thoroughly evaluating its compatibility with RP against existing pipeline and R&D expertise.
None: Knowledge, our responsibility future patients eagerly waiting.
None: They bring it.
None: With the cell therapy market poised to reach it.
None: Billion by 2028, and as our aging regulatory landscape, we have now strategically evaluating alternate Joseph ensure neocart stolen by states on track to maximize value for patients and shareholders.
None: Before I get into the modified gene therapy update I'd like to take a moment to discuss the broader landscape of the gene therapy market and <unk> position within it.
None: We believe that in therapy market is on the customer of a significant transformation.
None: Current market economics indicated growing entrust agenda and cell therapy cleared by technological advancement increased investment and clinical activity and a supportive regulatory environment.
None: Ameren they transact within the past year symbolized appeal and need for gene therapies industry analysts project that global gene therapy market is expected to surpass $30 billion by the end of the decade.
None: The immense growth prediction is driven by unmet medical needs a growing pool of millions of patients globally suffering from diseases that until recently where on triple.
None: Last year, we achieved alignment from the FDA on the design aspects of Q4 hundred phase III study.
None: As we prepare to initiate our pivotal occupy 100 phase III clinical trial I'd like to emphasize that we will be the only gene therapy phase III trial with a broad offering designation.
None: The MBA Glenmont on our phase II trial design for <unk> hundred is looked at and compelling.
None: Preliminary safety and efficacy results demonstrated in the phase one two trial last year, multi luminance multitasking MLM D luminescence visual it could be a little bit in best corrected visual equity BCB on efficacy measurements of patients receiving the treatment in each category.
None: Eight of these measurements business indicated improvement, our preservation and ice futures with arguable hundreds.
None: There is a phone our understanding of the June agnostic mechanism of action.
None: The design of the proposed phase III study for RP patients. The FDA has included luminescence dependent navigation assessment.
None: <unk> and <unk>.
Our measure of functional vision genius in patients with inherited retinal diseases and the primary endpoint.
None: The upcoming multi center randomized 150 patient safety study will feature two arms.
None: Drew and gene agnostic with up to 75 patients in each arm.
None: In each arm of this document parts French will be randomized two to one.
The treatment group.
None: And untreated control group.
None: On receiving approval from the FDA, we anticipate initiating the phase III trial for patients with RP.
None: Our collaborator.
None: Alright.
Collaborator: Conversations with FDA to advance our Q4 hundred to phase III.
Collaborator: On the acute need for therapies with RP patients and our clinical data has potential to foster a transformative impact.
Now.
Collaborator: Onto occupy 10 and occupancy finished.
Collaborator: The current treatment landscape or both geographic atrophy G. A staggered BCS is extremely limited.
Collaborator: The estimated 1 million patient gea market U S. Thompson momentum with recent drug approvals over these treatment options have significant limitations and the required multiple injections per year impacting patient compliance and only target one pathway contributing to G. <unk>.
Collaborator: Q4, 10, regulate multiple pathways and Lord with disease, including lipid metabolic inflammation oxidative stress and membrane attack complex complement.
Collaborator: And has the potential to blade onetime treatment.
Collaborator: Presently there is no approved treatment for people living with target diseases, and orphan quaintness disease that affects approximately 40000 people in the U S alone.
Collaborator: And the first quarter of 2024, we have completed dosing of cohort one book.
Collaborator: Our Q4 10.
Collaborator: And our Q4, Tennessee Guardian phase one two clinical trials, the data and safety monitoring board for the.
Akio potent SD clinical trial enrollment for the safety and Tolerability profile for Akio portal SD is favorable and approved to proceed to dosing with the medium dose of <unk> four Tennessee in the dose escalation phase of the Chile.
Collaborator: The FDA orphan designation for occupancy and equity last year further underscores our commitment to blindness condition.
Collaborator: That requires ongoing treatment with high unmet medical need collaborations with the Premier retinal surgery center across the U S. I've been pivotal in bolstering our patient recruitment efforts and deepening our understanding.
Collaborator: With the maturing pipeline of clinical progress opportunities positioned at the forefront of this we're doing gene therapy market.
MBA are Matt and orphan drug designation granted to our gene therapy programs demonstrate our potential to lead in this area.
Collaborator: Based on the testimony from all occupy 100 clinical trial, we are not only making headway, but already making a meaningful difference.
Collaborator: Our ultimate goal at <unk> is to develop and deliver safe and effective therapies to patients battling conditions that impact quality of life and functional independence.
At our February 2034, clinical showcase we shared or expected pathways for the market approval of occupancy 400.
Collaborator: To help us navigate this critical phase and ensure we deliver on our long term strategy, we recently announced the appointment.
Collaborator: I presume Omar so chief Medical Officer.
Collaborator: Dr. <unk> extensive experience and contributions to date and our previous role as the head of clinical development and clinical operations are pivotal to our team.
Collaborator: <unk> expertise and functional largest oxygen smarter gene therapy platform will be instrumental to the success of our clinical programs.
I will now.
Collaborator: <unk> worked with Mike Springer, our corporate controller to provide financials Mike.
Michael Breininger: Thank you sugar in our press release. This morning, we noted that we will restate our consolidated.
Michael Breininger: As of and for the year ended December 31 2022.
Michael Breininger: In connection with the filing of our 2023 Form 10-K.
Michael Breininger: <unk>. The company will include restated unaudited financial information for the first three quarters of 2023 and 2022.
Michael Breininger: We identified errors in each of the restated periods related to the Companys noncash accounting or the estimated costs and one of its collaboration arrangements. However.
However, the company does not expect tariffs if any impact on its cash position cash runway or financial projections.
Michael Breininger: <unk> cash cash equivalents and investments totaled $39 5 million as of December 31, 2023, compared to $90 9 million as of December 31, 2022.
Michael Breininger: We expect our current cash cash equivalents and investments will enable us to fund operations in the fourth quarter into the fourth quarter of 2024.
None: I'll now turn the call over to the operator for questions.
Thank you.
None: Now open for your questions to ask a question. This time. Please press star followed by the number one on your telephone keypad.
None: Just a moment to compile the Q&A roster.
None: Your first question comes from the line of swam Pakula Rakesh with H C. Wainwright Your line is open.
Rakesh: Thank you good morning.
Rakesh: Shankar.
Rakesh: Sure.
Swayampakula Ramakanth: On the Akio 400 program.
Rakesh: When should we expect to hear at next clinical update.
Rakesh: And.
Rakesh: Also.
Rakesh: What else needs to be.
Rakesh: <unk>.
Rakesh: Before you can get.
Rakesh: The phase III program started.
Rakesh: Alright, good morning, I will let the Kumar answer the question go ahead.
Kumar: Thank you Thiago. Thank you for the question so.
Kumar: So for rocket 400 phase one study we have completed enrollment.
Kumar: Retinitis pigmentosa patients.
Kumar: E.
Kumar: LTE as well.
Kumar: We will be periodically providing the updates.
Kumar: As they come but we have completed the enrollment for a rich largest sequential guide.
Ocean off the study.
Kumar: Okay.
None: Are you expecting us to.
Talking about phase III.
None: Both ways to get done for that.
Okay for phase III, we are actively working with FCA.
None: They are and what they do.
None: We have been booking rates will agree with the FDA and are grateful for the support on the FDA lightly Jaafar clinical protocol.
None: If all goes well, we will be commencing our study.
None: Paul.
Richard Best of luck.
None: Good.
None: And then regarding.
Hey.
None: Yeah.
None: Sure.
None: The.
The data safety monitoring board.
None: Our growing you to move to the next dose level and 410 S T.
None: So at this point, how many patients would would be entering into the next phase.
None: Of that dose evaluation and also.
None: Hum.
None: Would you be releasing any of the data from the initial cohorts are.
None: To do this at a time when you have enough data from multiple cohorts.
So that's a good question, but we are moving towards the medium dose, which is cohort two at phase one portion of the study the trigger three design, which is the dose escalation portion of that will be enrolling patients in there as well as when it after that there will be a high dose cohort with three.
None: Three as well and from there we are.
None: Hi to update periodically on the safety updates feed into the safety updates after day one.
None: <unk> from the high dose cohort at the dose escalation.
None: <unk> portion of the study.
None: Thanks, Thank you very much.
And then last question from.