Q4 2024 Lineage Cell Therapeutics Inc Earnings Call

March 10, 2025

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Thank you for attending by mining is yourself and I will be your country operator today.

This time I would like to welcome everyone to the nine H Shah Therapeutics fourth quarter and full year 2024 conference call. At this time all participants are in listen only mode and audio webcast of this call is available on the investors section of <unk> website at Ww.

<unk> nine <unk> dot com.

This call is subject to copyright and is the appropriate the outline H and recordings reproduction or transmission of this call without the express written consent of line HR strictly prohibited.

Thank you. Bye-bye.

[inaudible]

Rochelle: Thank you for standing by. My name is Rocell and I will be your conference operator today.

Hone: Minder today's call is being recorded I would now like to introduce your host for today's call <unk> Hone head of Investor Relations at lineage missed hone. Please go ahead.

Speaker Change: At this time, I would like to welcome everyone to the Lineage Cell Therapeutics 4th quarter and full year 2024 conference call. At this time, all participants are in listen only mode. An audio webcast of this call is available on the investor assertion of Lineages website at www.lineagecell.com

Speaker Change: Thank you Michelle good afternoon, and thank you for joining US a press release reporting our fourth quarter and full year 2024 financial results was issued earlier today March 10, 2025 and can be found on the investors section of our website.

Speaker Change: This call is subject to copyright and is the property of Lineage and recordings, reproductions or transmissions of this call without expressed written consent of Lineage are strictly prohibited. As a reminder, the base call is being recorded. I would now like to introduce your host for today's call, Ioana Hone, Head of Investor Relations at Lineage. Miss Hone, please go ahead.

Speaker Change: Please note that today's remarks and responses to your questions reflect management's views as of today only and will contain forward looking statements within the meaning of federal securities laws.

Speaker Change: Statements made during this discussion that are not statements of historical fact should be considered forward looking statements, which are subject to significant risks and uncertainties. The company's actual results or performance may differ materially from the expectations indicated by such forward looking statements for a discussion of certain factors that could.

Ioana Hone: Thank you, Rachelle. Good afternoon and thank you for joining us. A press release reporting our fourth quarter and full year 2024 financial results was issued earlier today, March 10, 2025, and can be found on the investor's section of our website.

Speaker Change: Cause the company's results or performance to differ we refer you to the forward looking statements section in today's press release and in the company's SEC filings, including its most recent annual report on Form 10-K.

Speaker Change: Please note that today's remarks and responses to your questions reflect management's views as of today only, and will contain forward-looking statements within the meeting of federal

Speaker Change: We caution you not to place undue reliance on any forward looking statements, which speak only as of today and are qualified by the cautionary statements and risk factors described in our SEC filings with US today are Brian Culley, Our Chief Executive Officer, and Jill how our Chief Financial Officer, I'll now hand, the call over to Brian.

Speaker Change: Statements made during this discussion that are not statements of historical fact should be considered forward-looking statements, which are subject to significant risk and uncertainties. The company's actual results or performance may differ materially from the expectations indicated by such forward-looking statements.

Speaker Change: Thank you Juan and good afternoon, everyone. We appreciate you taking the time to join us on the call.

Speaker Change: for a discussion of certain factors that could cause the company's results or performance to differ. We refer you to the Forward-looking Statement Sections in today's press release and in the company's SEC filings, including its most recent annual report on form 10K.

Speaker Change: There are three topics, which I plan to cover today will start with an update on offer Jim and some recent developments in the field of RPE transplants, which we think reflects favorably on our program.

Speaker Change: Then I'll transition to scalable GMP manufacturing, which is a topic of rising importance to the cell therapy field.

Speaker Change: We caution you not to place undue reliance on any forward-looking statements which speak only as of today and are qualified by the cautionary statements and risk factors described

Speaker Change: And it'll provide a few words on our in house program will be C. One and our recently initiated spinal cord trial doesn't plans for the future.

Speaker Change: As most of you know our lead candidate offered for patients with dry AMD with geographic atrophy, an allogeneic cell transplants comprised of RPE cells.

Speaker Change: Thank you Juan and good afternoon, everyone. We appreciate you taking the time to join us on the call.

Speaker Change: There are three topics, which I plan to cover today I will start with an update on our project and some recent developments in the field of transplant, which we think reflects favorably on our program.

Speaker Change: <unk> delivered a suspension to the sub retinal space and a onetime surgical procedure.

Speaker Change: It is currently in a phase Iia study called the Galette studies, that's being managed by our partners Roche and Genentech.

Speaker Change: Then I'll transition to scalable GMP manufacturing, which is a topic of rising importance to the cell therapy field.

Speaker Change: We believe the ongoing glut study is progressing well. This is an open label study with 90 day primary or secondary endpoints and it has been enrolling for nearly two years. So we believe that a sufficient amount of data should have been collected and reviewed by now for which to make a decision on whether or not to continue to invest.

Speaker Change: I'll provide a few words on our in house program will be C. One and our recently initiated spinal cord trial doesn't plans for the future.

Speaker Change: As most of you know our lead candidate for patients with dry AMD with geographic atrophy is an allogeneic cell transplants comprised of RPE cells.

Speaker Change: In this program.

Speaker Change: This is relevant because Roche recently underwent a comprehensive review of its pipeline during which they trimmed nearly 30% of their development programs, including some partnered cell therapy programs.

Speaker Change: Our Virginia delivered as a suspension to the sub retinal space and a one time a surgical procedure.

Speaker Change: It's currently in a phase Iia study called the Dilip study, that's being managed by our partners Roche and Genentech.

Speaker Change: We were not affected by those pipeline reductions and instead, we've observed since that time, what appears to be an increase in opportune activity in the past year.

Speaker Change: We believe the ongoing <unk> study is progressing well. This is an open label study with 90 day primary or secondary endpoints and it has been enrolling for nearly two years. So we believe that a sufficient amount of data should have been collected and reviewed by now for which to make a decision on whether or not to continue investing.

Speaker Change: For example, about a year after the trial began Roche and Genentech entered into an additional agreement with lineage to provide services for things like manufacturing training and long term follow up of our phase one two a patients.

Speaker Change: In this program.

Speaker Change: They continue to open clinical sites in the ongoing study and they recently sought and obtained our met designation for origin.

Speaker Change: To be clear that lineage has not received any interim data for roche's ongoing phase III trial, we do not know when any such data will be made available, but these actions by our partners appear to us more likely than not to reflect these moving in a positive direction.

Speaker Change: We were not affected by those pipeline reductions and instead, we've observed since that time, what appears to be an increase in opportune activity in the past year.

Speaker Change: I will add that our ryzen confidence is reflected in certain actions that we're taking such as structuring warrants around a positive opportunity clinical milestone.

Speaker Change: Which if it occurs would accelerate the maturity date of those warrants.

Speaker Change: They continue to open clinical sites in the ongoing study and they recently sought and obtained orphan designation for <unk>.

Speaker Change: If the share price exceeds the warrant strike price at that time that could provide us with an additional $36 million of capital.

Speaker Change: I want to be clear that lineage has not received any interim data from Roche as ongoing phase Iia trial, and we do not know when any such data will be made available, but these actions by our partners appear to us more likely than not to reflect things moving in a positive direction.

Speaker Change: We did this in part to reduced concerns about a post event financing overhang, something which is often associated with major clinical announcements.

Speaker Change: We continue to be unable to guide to the timing of any phase Iia updates from Genentech, and we don't yet know the process by which findings from the glut study will become available, but I do want to remind everyone that a decision to advance to a next study could happen at any time.

Speaker Change: I will add that our ryzen confidence is reflected in certain actions that we're taking such as structuring warrants around a positive opportunity clinical milestone, which if it occurs would accelerate the maturity date of those words.

Speaker Change: There is no regulatory requirement that we are aware of which requires genentech to complete enrollment in the ongoing study or to announce galette data before launching a controlled study.

Speaker Change: If the share price exceeds the warrant strike price at that time that could provide us with an additional $36 million of capital.

Speaker Change: We did this in part to reduced concerns about a post event financing overhang, something which is often associated with major clinical announcements.

Speaker Change: Even if genetic wanted to keep the glut study highlights confidential from competitors. They still would be required to post a new clinical trial on political trials dot Gov, which would trigger acceleration of the maturity date of the warrants.

Speaker Change: Well, we all eagerly await information from the ongoing phase Iia trial. There are two things in the meantime, which I'd like to highlight for you today.

Speaker Change: There is no regulatory requirement that we are aware of which requires genentech to complete enrollment in the ongoing study.

Speaker Change: The first is that we have learned that Roche and Genentech plan to provide a three year clinical update from the phase Iia trial, which lineage conducted.

Speaker Change: Or to announce we'll let data before launching a controlled study.

Speaker Change: For those of you who recall the two year update at last year's retinal cell and gene therapy innovation summit.

Speaker Change: Even if genetic wanted to keep the galette study highlights confidential from competitors. They still would be required to post a new clinical trial on clinical trials dot Gov, which would trigger acceleration of the maturity date of the warrants.

Speaker Change: <unk> reported changes to key anatomical structures.

Speaker Change: And more importantly average games to be CVA of five to seven letters, which persisted for two years.

Speaker Change: Well, we all eagerly await information from the ongoing phase Iia trial. There are two things in the meantime, which I'd like to highlight for you today.

Speaker Change: I'm not able to provide the details about the forthcoming three year data, but genentech have reviewed the anatomical and functional benefits, which were reported at two years and I can report today that those benefits have indeed continued to persist for another consecutive year.

Speaker Change: The first is that we have learned that Roche and Genentech plan to provide a three year clinical update from the phase Iia trial, which lineage conducted.

Speaker Change: For those of you who recall that two year update at last year's retinal cell and gene therapy innovation summit.

Speaker Change: To date five patients from the lineage phase Iia trial have demonstrated durable anatomical and functional improvements and I'll remind everyone that these effects have not been shown to occur spontaneously.

Speaker Change: Genentech reported changes to key anatomical structures and.

Speaker Change: And more importantly average gains to be CVA of 5% to seven letters, which persisted for two years.

Speaker Change: Observing vision games lasting for three years, despite dry AMD being a degenerative and irreversible disease is to us indicative of a powerful and durable treatment effect, one which may prove in future clinical trials to be superior to currently available therapies because patients on those.

Speaker Change: <unk> continued to lose vision.

Speaker Change: One need look no farther than the 211 G. A patients who were treated as part of the fixed set of cop, one phase III studies and reported in the lancet in 2023, where the mean vision change on that best available therapy was a loss of eight benign letters.

Speaker Change: Observing vision gains lasting for three years, despite dry AMD being a degenerative and irreversible disease is to us indicative of a powerful and durable treatment effect, one which may prove in future clinical trials to be superior to currently available therapies because patients on those.

Speaker Change: And the untreated patient control Similarly lost seven letters.

Speaker Change: More recently a.

Speaker Change: Long term study of more than 18000 people with dry AMD and who did not develop neovascular AMD during the observation period.

Speaker Change: <unk> continue to lose vision.

Speaker Change: Experienced b CVA losses of 12 letters at 36 months.

Speaker Change: One look no further than the 211 gea patients who were treated as part of the fixed set of Compline phase III studies and reported in the lancet in 2023, where the mean revision change on that best available therapy was a loss of eight benign letters.

Speaker Change: Minimum the cohort of the oldest patients with moderate vision loss at baseline or moderate vision, rather at baseline. The mean loss was 20 letters.

Speaker Change: Based on the information I shared today about mean be CVA of those opportunity patients remaining above baseline at three years.

Speaker Change: And the untreated patient control Similarly lost seven letters.

Speaker Change: More recently, a long term study of more than 18000 people with dry AMD and who did not develop neovascular AMD during the observation period experienced the CVA losses of 12 letters at 36 months.

The performance to date between opportunity anti complement or a opportune in an untreated control.

Speaker Change: It's not just that patient vision is moving in opposite directions.

Speaker Change: That delta is getting wider over time.

Among the cohort of the oldest patients with moderate vision loss at baseline or moderate vision, rather at baseline. The mean loss was 20 letters.

Speaker Change: The second opportunity item I wanted to highlight some recent news emerging from competing RPE companies, which I think is extremely positive for us.

Speaker Change: Based on the information I shared today about <unk> of those opportunities patients remaining above baseline at three years.

First.

Speaker Change: A small U S based company, which uses RPE cells, which they sourced from cadavers recently reported gains envision at 12 months using their approach.

Speaker Change: The performance to date between opportunity anti complement or a opportune in an untreated control it.

Speaker Change: Second a different small competitor this one based outside of the U S, but using a cell line as a source of RPE.

Speaker Change: It's not just that patient vision is moving in opposite directions.

Speaker Change: <unk> to share data from their RPE program at the ARVO conference in May we've seen some of their topline data and it is both positive and consistent with our original findings.

Speaker Change: That delta is getting wider over time.

Speaker Change: The second opportunity item I wanted to highlight some recent news emerging from competing RPE companies, which I think is extremely positive for us.

Speaker Change: And then third according to a recent news article.

Speaker Change: Astellas is RPE therapy is quote very close to proof of concept results.

Speaker Change: First.

Speaker Change: A small U S based company, which uses RPE cells, which they sourced from cadavers recently reported gains envision at 12 months using their approach.

Speaker Change: We haven't seen their data, but we assume it will be positive or we don't think this program would be highlighted by their chief strategy Officer.

Speaker Change: Second a different small competitor this one based outside of the U S, but using a cell line as a source of RPE.

Speaker Change: If you're surprised that I would highlight our competitors in such a positive way it's.

Speaker Change: <unk> shared data from their RPE program at the ARVO conference in May we've seen some of their topline data and it is both positive and consistent with our original findings.

Speaker Change: It's because we're working with a completely new modality and it's normal for people to be unconvinced by a relatively small number of patients, especially when we're all making claims about uncommonly positive clinical outcomes.

Speaker Change: And then third according to a recent news article Astellas is RPE therapy is quote very close to proof of concept results.

Speaker Change: But every time a company independently reports positive data from an RPE transplant and those data points get aggregated it can become a powerful endorsement of our mechanism and that conviction to this approach.

Speaker Change: We haven't seen their data, but we assume it will be positive or we don't think this program would be highlighted by their chief strategy Officer.

Speaker Change: If you're surprised that I would highlight our competitors in such a positive way.

Speaker Change: At this point there are four and probably soon there will be five independent reports a functional games from an RPE transplant.

Speaker Change: Because we're working with a completely new modality and it's normal for people to be unconvinced by a relatively small number of patients, especially when we're all making claims about uncommonly positive clinical outcomes.

Speaker Change: From among those companies investors will presumably tried to sort out which among us is best positioned to win the large addressable market.

And given everything that is required to successfully manufacture and commercialize an allogeneic cell therapy product for such a large patient population.

Speaker Change: Every time, a company independently reported positive data from an RPE transplant and those data points get aggregated it can become a powerful endorsement of our mechanism and that conviction to this approach.

Speaker Change: I feel confident that the combination of lineage as manufacturing process.

Speaker Change: Genentech's development strategy and Roche is a commercialization partner for.

Speaker Change: At this point, therefore, and probably soon there will be five independent reports a functional games from an RPE trailing cleared.

Speaker Change: <unk> us with a triumvirate of advantages over these other programs.

From among those companies investors will presumably tried to sort out which among us is best positioned to win the large addressable market.

Speaker Change: And while we wait for the story to play out.

Other programs May also provide our shareholders with validating endorsements that we're on the right track.

Speaker Change: And given everything that is required to successfully manufacture and commercialize an allogeneic cell therapy product for such a large patient population.

Speaker Change: This topic actually leads nicely into my discussion of scalable cell therapy manufacturing.

Speaker Change: Really it's just been making investments of time and capital into our manufacturing capability for many years, which has generated new intellectual property, but perhaps more importantly, but helped us achieve specific and measurable milestones in that area.

Speaker Change: I feel confident that the combination of lineage as manufacturing process.

Speaker Change: <unk> development strategy and Roche as the commercialization partner provides us with a triumvirate of advantages over these other programs.

Speaker Change: I think we're all aware that unlike five years ago exceptional clinical data is no longer sufficient to drive high valuations.

Speaker Change: And while we wait for the story to play out. These other programs May also provide our shareholders with validating endorsements that we're on the right track.

Speaker Change: In connection with increased awareness of modern cell therapy practices.

Speaker Change: Customers have learned much from the crowded into undifferentiated car T space and increasingly appreciate that if you don't have a credible path to commercial scale manufacturing and maybe you really don't have a viable product candidate.

Speaker Change: This topic actually leads nicely into my discussion of scalable cell therapy manufacturing.

Speaker Change: When he has just been making investments of time and capital into our manufacturing capability for many years, which has generated new intellectual property, but perhaps more importantly, it has helped us achieve specific and measurable milestones in that area.

Speaker Change: And that concern is especially true for allogeneic cell therapy programs because the main reason allogeneic is attractive.

Speaker Change: I think we're all aware that unlike five years ago exceptional clinical data is no longer sufficient to drive high valuations.

Speaker Change: It's supposed to offer affordable production of consistent material.

Speaker Change: But that is not the definition of alginate alginate just means the cells are sourced from a donor instead of from the patient.

Speaker Change: In connection with increased awareness of modern cell therapy practices.

Allogeneic should not the extent expanded to assume affordable production or immediate use products.

Speaker Change: <unk> have learned much from the crowded and undifferentiated car T space and increasingly appreciate that if you don't have a credible path to commercial scale manufacturing than maybe you really don't have a viable product candidate.

Speaker Change: In some cases allogeneic might only mean, a donor provides a single source or a single dose of a therapy.

Speaker Change: And that concern is especially true for allogeneic cell therapy programs because the main reason allogeneic is attractive.

Speaker Change: Such is the case for an organ transplant.

Speaker Change: In better instances companies might be generating 10, or 100, or maybe up to a thousand doses of their therapy from a bag of donated blood.

Speaker Change: It's supposed to offer affordable production of consistent material.

Speaker Change: But while those programs are allogeneic by definition, they aren't maximally, reducing the cost of production.

Speaker Change: But that is not the definition of alginate alginate just means the sales are sourced from a donor instead of from the patients.

Speaker Change: Term allogeneic should not the extent expanded to assume affordable production or immediate use products.

Speaker Change: I'll review.

Speaker Change: Is it you're not actually delivering on the benefits of an allogeneic therapy unless your production system can deliver millions of doses.

Speaker Change: Some cases allogeneic might only mean, a donor provides a single source or a single dose of a therapy.

Speaker Change: And that's where we're working to establish a leading position in pallet generic process development production and scale.

Speaker Change: Such is the case for an organ transplant.

Speaker Change: In better instances companies might be generating 10 to 100 or maybe up to 1000 doses of their therapy from a bag of donated blood.

Speaker Change: I wanted to explain why we believe this is a credible path.

Speaker Change: Given the large patient population, we've always known that offer gen would require a commercially viable manufacturing platform. So for years, we've invested heavily in process development and other cell therapy manufacturing capabilities.

Speaker Change: But while those programs are allogeneic by definition, they arent maximally, reducing the cost of production.

Speaker Change: I'll review.

Speaker Change: But those investments do not need to be limited only to opportunity.

Speaker Change: Is that youre not actually delivering on the benefit of an allogeneic therapy unless your production system can deliver millions of doses.

Speaker Change: In many cases the methods trade secrets insights and Knowhow, we have acquired can be.

Speaker Change: And that's where we're working to establish a leading position in balance generic process development production and scale.

Speaker Change: And in some cases already has been applied to our other programs.

Speaker Change: In this way overtime, we are enabling lineage to develop multiple programs each possessing the necessary diad of clinical evidence and commercially viable production.

Speaker Change: I wanted to explain why we believe this is a credible path.

Speaker Change: Given the large patient population, we've always known that opportunity would require a commercially viable manufacturing platform. So for years, we have invested heavily in process development and other cell therapy manufacturing capabilities.

Speaker Change: The main reason I speak on the topic. So often is that when I look at the cell therapy landscape, especially at the non cancer allogeneic field I can only find vague and aspirational statements about stable cell banks are theoretical projections about manufacturing scale I have not yet found evidence that these companies have produced their drug product.

Speaker Change: But those investments do not need to be limited only to opportunities.

Speaker Change: In many cases the methods trade secrets insights and Knowhow, we have acquired can be and in some cases already has been applied to our other programs.

Speaker Change: By a scalable process in a GMP environment.

Speaker Change: In this way overtime, we are enabling lineage to develop multiple programs each possessing the necessary Diane of clinical evidence and commercially viable production.

Speaker Change: While they may be allogeneic by definition, they haven't yet shown a believable line of sight to the primary reason for pursuing an allogeneic approach, which is a large scale production capability.

Speaker Change: The main reason I speak on the topic. So often is it when I look at the cell therapy landscape, especially at the non cancer allogeneic field. Thank you.

Speaker Change: And in our view if you can't deliver on large scale production, you arent going to be able to affordably address a large patient population.

Speaker Change: Can only find big an aspirational statements about stable cell banks are theoretical projections about manufacturing scale I have not yet found evidence that these companies have produced their drug product by a scalable process in a GMP environment.

Speaker Change: So what we've been working on is to become the first company to reduced to practice, a clear and convincing case of a scalable GMP production process.

Speaker Change: We believe doing this will set a high bar for allogeneic economics tell make lineage and attractive company and partner.

Speaker Change: They may be allogeneic by definition, they haven't yet shown a believable line of sight to the primary reason for pursuing an allogeneic approach, which is a large scale production capability.

Speaker Change: To explain in detail what this looks like if.

Speaker Change: If you were to generate 100 vials of a master cell bank and a G. M T lab and randomly select one of those vials to manufacture another 100 vials of a working cell bank and then he randomly select one of those files to make 100 vials of your products.

Speaker Change: And in our view if you can't deliver on large scale production, you arent going to be able to affordably address a large patient population.

Speaker Change: So what we've been working on is to become the first company to reduced to practice, a clear and convincing case of its scalable GMP production process.

Speaker Change: You will have credibly demonstrated that you have reduced to practice a production capability of 1 million lives.

Speaker Change: We believe doing this will set a high bar for allogeneic economics make lineage and attractive company and partner.

Speaker Change: We don't believe any of the allogeneic companies. We monitor has achieved this milestone.

Speaker Change: Yet we believe it is a necessary component to commercial success in a large market indications. So we are focusing on this goal.

Speaker Change: To explain in detail what this looks like.

Speaker Change: If you were to generate 100 vials of a master cell bank and a GMP lab and randomly select one of those vials to manufacture another 100 vials of a working cell bank and then he randomly select one of those files to make 100 miles of your product.

Speaker Change: Way to capitalize further on our investments in opportune.

Speaker Change: It helps differentiate us from our peers in this area.

Speaker Change: The next and thirdly, I'll briefly comment on our second clinical stage Allogeneic program O P. C. One.

Speaker Change: You will have credibly demonstrated that you have reduced to practice a production capability of 1 million lives.

Speaker Change: You might have seen this program highlighted on C. N N back in January and if not the interview we did with Sanjay Gupta is still available on our website.

Speaker Change: We don't believe any of the allogeneic companies. We monitor has achieved this milestone.

Speaker Change: Let me see one is designed to help increase recovery and mobility for people, who have suffered from a spinal cord injury.

Speaker Change: Yet we believe it is a necessary component to commercial success in a large market indications. So we are focusing on this goal as well.

Speaker Change: [laughter].

Speaker Change: It is comprised of a population of the mylan generating cells of the spinal cord.

Way to capitalize further on our investments and opportunities.

Speaker Change: And these cells help control the messages between your brain and your muscles.

Speaker Change: And help differentiate us from our peers in this area.

Speaker Change: Our approach to addressing paralysis due to spinal cord injuries to manufacture replacement cells of the spinal cord and deliver them right to the site of injury, which is basically the same approach that produce successful outcomes to date in dry AMD.

Speaker Change: The next and thirdly, I'll briefly comment on our second clinical stage Allogeneic program OTC one.

Speaker Change: You might have seen this program highlighted on CNN back in January and if not the interview we did with Sanjay Gupta is still available on our website.

Speaker Change: Let me see one has been tested in 30 individuals with severe spinal cord injuries and while the long term safety and efficacy data. We have collected so far is promising and merits further investigation.

Speaker Change: <unk> is designed to help increase recovery and mobility for people, who have suffered from a spinal cord injury.

Speaker Change: It is.

Speaker Change: Is that the population of the Mylan generating sales of the spinal cord.

Speaker Change: This wasn't acquired program and we have two areas of improvement we'd like to complete before we would feel ready to move OTC one into a later stage trial.

Speaker Change: Sales helped control the messages between your brand and your muscles.

Speaker Change: Our approach to addressing paralysis due to spinal cord injuries to manufacture replacement cells of the spinal cord and deliver them bright to the site of injury, which is basically the same approach that produce successful outcomes to date in dry AMD.

The first area of improvement is delivery.

Speaker Change: We recently began a small clinical study called the dose study.

Speaker Change: To test the safety and performance of a novel delivery device.

Speaker Change: We believe the device we are testing in this study will be superior to the original delivery system into waves.

Speaker Change: <unk> has been tested in 30 individuals with severe spinal cord injuries and while the long term safety and efficacy data. We have collected so far is promising and merits further investigation.

Speaker Change: First.

Speaker Change: It's easier to use and deploy to clinical sites.

Speaker Change: More importantly, the new device allows a dose of cells to be administered to patients over four to five minutes without stopping the patients respiration.

Speaker Change: This wasn't acquired program and we have two areas of improvement we'd like to complete before we would feel ready to move <unk> into a later stage trial.

Speaker Change: Previously it was necessary to stop ventilation when you delivered the cells. So this is a significant enhancement to the procedure.

Speaker Change: The first area of improvement is delivery.

Speaker Change: We recently began a small clinical study called the dose study.

Speaker Change: In addition to the safety and the performance of the new device. We also will be collecting functional assessments on all patients, which gives us the opportunity to investigate any signals of efficacy that may arise.

Speaker Change: To test the safety and performance of a novel delivery device.

Speaker Change: We believe the device we are testing in this study will be superior to the original delivery system in two ways first.

Speaker Change: That is important because this study will be the first time <unk> is administered to patients with a chronic spinal cord injury, which represents an additional and larger patient population for this experimental therapy.

It's easier to use and deploy to clinical sites.

Speaker Change: And more importantly, the new device allows a dose of cells to be administered to patients over four to five minutes without stopping the patients respiration.

Speaker Change: The first site for.

Speaker Change: This clinical study is just down the road at UC, San Diego Health and patient enrollment is expected to commence next quarter.

Speaker Change: Previously it was necessary to stop ventilation when you delivered the cells. So this is a significant enhancement to the procedure.

Speaker Change: The second area of obesity, one improvement as our new manufacturing process, which actually has two sub parts.

Speaker Change: We first applied lessons from our origin program to increase the scale purity and control of the sales we make.

Speaker Change: And second we developed a new immediate use formulation, which eliminates the lengthy dose preparation steps that were required in prior studies.

Speaker Change: That is important because this study will be the first time <unk> is administered patients with a chronic spinal cord injury, which represents an additional and larger patient population for this experimental therapy.

Speaker Change: Subject to clearing the subject to obtaining clearance from FDA, we plan to introduce the cells. We make from this improved process and the new formulation into the dose trial.

The first site for this clinical study is just down the road at UC, San Diego Health and patient enrollment is expected to commence next quarter.

Speaker Change: In parallel with these two ongoing enhancements to the <unk> program. We also are working on the design of a larger trial with a focus on collecting more sensitive and clinically relevant endpoints, which we think will help overcome the complexity of data capture in this patient population.

Speaker Change: The second area of obesity, one improvement as our new manufacturing process, which actually has two sub parts.

Speaker Change: We first applied lessons from our origin program to increase the scale parity in control of the sales we made in.

Speaker Change: When all three of these necessary activities have been concluded the design of the device and the cells. We believe we either alone or with a future partner will be in a position to conduct a larger clinical trial of obesity one.

Speaker Change: Second we developed a new immediate use formulation, which eliminates the lengthy dose preparation steps that were required in prior studies.

Speaker Change: Subject to declaring subject to obtaining clearance from FDA, we plan to introduce the sales we make from this improved process and the new formulation into the dose trial.

Speaker Change: And I should add that we still plan to apply for a certain political grant as soon as they began accepting applications, which serve as indicated will occur this spring.

Speaker Change: In parallel with these two ongoing enhancements to the <unk>. One program. We also are working on the design of a larger trial with a focus on collecting more sensitive and clinically relevant endpoints, which we think will help overcome the complexity of data capture in this patient population.

Speaker Change: Last comment I wanted to make before we review our financials as if we don't often highlight individual patent issuances, but just so that you are aware, we have continued to add value to our patent portfolio.

Speaker Change: For example earlier this year to additional opportune patents issued which included claims covering certain aspects of how we manufacture ourselves.

Speaker Change: Some of the discoveries we make we patent while others, we intentionally routine as trade secrets, but overall, we aim to increase our proprietary position for <unk> in all of our development programs in the best possible way.

Speaker Change: And I should add that we still plan to apply for a certain political grant as soon as they begin accepting applications, which serve as indicated will occur this spring.

Speaker Change: With that I will turn things over to Jill for a review of our financials. Thanks.

Speaker Change: Last comment I want to make before we review our financials as if we do often highlight individual patent issuances, but just so that you are aware, we have continued to add value to our patent portfolio.

Jill: Thanks, Brian and good afternoon, everyone.

Jill: As of the date of this filing our overall cash position is expected to support our current planned operations into Q1 of 2027, our runway has been meaningfully extended following our November 2024 registered direct offering and as of December 31, 2024, we're reporting year end cash cash equivalents and.

Speaker Change: Example, earlier this year to additional operation patents issued which included claims covering certain aspects of how we manufacture ourselves.

Jill: [noise] marketable securities of $47 $8 million.

Jill: Whether with the approximately $5 5 million in net proceeds which we received from the second closing of this offering that occurred in January. This supports our current run rate guidance of approximately two years from now.

Jill: Thanks, Brian and good afternoon, everyone.

Jill: Importantly, the November financing incorporated a milestone milestone warrants with a mechanism to accelerate maturity, which means lineage may be able to access an additional 36 million in funding if the clinical milestone is achieved and the stock is above 91 cents.

Jill: We implemented this financing strategy because we believe it go no go decision.

Jill: <unk> Securities of $47 8 million together with the approximately $5 5 million in net proceeds which we received from the second closing of this offering that occurred in January. This supports our current run rate guidance of approximately two years from now.

Jill: I wish to publicly disclose their intent to run a controlled clinical trial opportunities with a major event for lineage and for opportunities probability of success.

Jill: Our strategy was to not only secure immediate capital, but to also create an opportunity for future capital, which again is contingent in part upon the success.

Jill: Importantly, the November financing incorporated a milestone milestone warrant with a mechanism to accelerate maturity, which means lineage may be able to access an additional $36 million in funding. The clinical milestone is achieved and the stock is above 91.

Jill: The successful advancement of African.

Jill: Alongside this recent financing activity, we will continue to balance between our costs and investment of capital as we work towards other potential sources of funding such as milestone payments. We are eligible for under the Roche Genentech collaboration program grants and our additional business development transactions.

Jill: We implemented this financing strategy because we believe it go no go decision by Roche publicly disclosed our intent to run a controlled clinical trial opportunities with a major event for lineage and for opportunities probability of success.

Jill: I will review, our fourth quarter operating results.

Jill: Our revenue was generated primarily from collaboration revenue royalties and other revenues.

Jill: Our strategy was to not only secure immediate capital, but to also create an opportunity for future capital, which again is contingent in part upon the success.

Jill: Total revenues for the fourth quarter were approximately $2 9 million a net increase of <unk> 8 million as compared to $2 1 million for the same period in 2023.

Jill: The successful advancement of opportunity.

Jill: Alongside this recent financing activity, we will continue to balance between our costs and investment of capital as they work towards the other potential sources of funding such as milestone payments. We are eligible for under the Roche Genentech collaboration program grants and our additional business development transactions.

Jill: The increase was primarily driven by more collaboration revenue recognized from deferred revenue under the collaboration and license agreement with Roche.

Jill: Operating expenses are comprised of research and development expenses and general and administrative expenses.

Jill: Total operating expenses for the fourth quarter were $7 8 million a decrease of <unk> 4 million as compared to $8 2 million for the same period in 2023.

Jill: Next I will review, our fourth quarter operating results.

Jill: Our revenue was generated primarily from collaboration revenue royalties and other revenues.

Jill: Total revenues for the fourth quarter were approximately $2 9 million a net increase of <unk> 8 million.

Jill: R&D expenses for the fourth quarter were $3 4 million a decrease of <unk> 5 million as compared to $3 9 million for the same period in 2023 and.

Jill: As compared to $2 1 million for the same period in 2023.

Jill: And that decrease was primarily driven by a decrease of $1 2 million.

Jill: The increase was primarily driven by more collaboration revenue recognized from deferred revenue under the collaboration and license agreement with Roche.

Jill: R O P C. One program expenses, and two and <unk> 2 million for other research and development programs, partially offset by an increase in <unk> 4 million for our operating program expenses and <unk> 5 million for our preclinical programs.

Jill: Operating expenses are comprised of research and development expenses and general and administrative expenses totaled.

Jill: Total operating expenses for the fourth quarter were $7 8 million a decrease of <unk> 4 million as compared to $8 2 million for the same period in 2023.

Jill: G&A expenses for the fourth quarter of $4 4 million were primarily in line with expenses for the same period in 2023.

Jill: R&D expenses for the fourth quarter were $3 4 million a decrease of <unk> 5 million as compared to $3 9 million for the same period in 2023 the.

Jill: Loss from operations for the fourth quarter was $5 1 million, a decrease of $1.3 million as compared to $6 4 million for the same period in 2023.

Jill: The net decrease was primarily driven by a decrease of $1 2 million.

Jill: Other income expenses for the fourth quarter, reflecting other income of $1 8 million compared to other income of 1.6 planes for the same period in 2023.

Jill: For our <unk> program expenses, and $2 2 million for other research and development programs, partially offset by an increase in <unk> 4 million for our operating program expenses and <unk> 5 million for our preclinical program.

Jill: The net increase was primarily driven by changes in fair value of warrant liability.

Jill: And the offset by exchange rate fluctuations related to lineage as international subsidiaries and certain warrant related transaction costs incurred as part of the November 2020 for financing.

Jill: G&A expenses for the fourth quarter of $4 4 million were primarily in line with expenses for the same period in 2023.

Jill: The net loss attributable to lineage for the fourth quarter was $3 3 million or two cents per share compared to a net loss of $4 8 million or <unk> <unk> per share for the same period in 2023.

Jill: Loss from operations for the fourth quarter was $5 1 million a decrease of $1 3 million as compared to $6 4 million for the same period in 2023.

Jill: Next I will review our full year operating results.

Jill: Other income and expenses for the fourth quarter reflected other income of $1 8 million compared to other income of one 6 million for the same period in 2023. The net increase was primarily driven by changes in fair value of warrant liability largely offset by exchange rate fluctuations related to lineage as international subsidiaries and certain warrant related trans.

Jill: Total revenues for the year were $5 9 million, a net increase of <unk> 6 million as compared to $8 9 million for the same period in 2023.

Jill: Increase was primarily driven by more collaboration revenue recognized from deferred revenue under the collaboration and license agreement with Roche total operating expenses were $31 million, a decrease of $2 7 million as compared to $33 7 million for the same period in 2023.

Jill: Action costs incurred as part of the November 2020 for financing.

Jill: The net loss attributable to lineage for the fourth quarter was $3 3 million or <unk> <unk> per share compared to a net loss of $4 8 million or <unk> <unk> per share for the same period in 2023.

Jill: R&D expenses were $12 five nine a decrease of $3 2 million as compared to $15 7 million for the same period in 2023. The decrease was primarily driven by $2 7 million for obesity, one program expenses $1 1 million for our preclinical and other research and development programs. These decreases were primarily offset five points.

Jill: Next I will review our full year operating results.

Total revenues for the year were $5 9 million, a net increase of <unk> 6 million as compared to $8 9 million for the same period in 2023 the.

Jill: The increase was primarily driven by more collaboration revenue recognized from deferred revenue under the collaboration and license agreement with Roche total operating expenses were $31 million, a decrease of $2 7 million as compared to $33 7 million for the same period in 2023.

Jill: 6 million for our option program.

Jill: G&A expenses were $18 2 million, an increase of approximately $2 9 million as compared to $17 3 million for the same period in 2023.

Jill: Increase was primarily driven by <unk> 6 million for stock based compensation expense and <unk> 4 million for personnel costs, partially offset by an overall decrease in cost incurred for services provided by third parties.

Jill: R&D expenses were $12 5 million, a decrease of $3 2 million as compared to $15 7 million for the same period in 2023. The decrease was primarily driven by $2 7 million for our <unk> program expenses $1 1 million for our preclinical and other research and development programs. These decreases were primarily offset by.

Jill: Loss from operations were $21 5 million, a decrease of $3 2 million as compared to $24 7 million for the same period in 2023.

Jill: Other income and expenses reflected in other income of $2 9 million compared to other income of $1 5 million for the same period in 2023. The net increase of $1 4 million was primarily driven by changes in the fair value of warrant liability exchange rate fluctuations related to lineage as international subsidiaries and fair market value changes in marketable.

Jill: $6 million for our operating program.

Jill: G&A expenses were $18 2 million, an increase of approximately $1 9 million as compared to $17 3 million for the same period in 2023. The net increase was primarily driven by <unk> 6 million for stock based compensation expense and <unk>.

Jill: $4 million for personnel costs, partially offset by an overall decrease in cost incurred for services provided by third parties.

Jill: Equity Securities. This increase in other income was partially offset by certain warrant related transaction cost incurred as part of the November 2020 for financing as long as the nonrecurring prior year employee retention credit.

Jill: Loss from operations were $21 5 million, a decrease of $3 2 million as compared to $24 7 million for the same period in 2023.

Jill: And net loss attributable to lineage was $18 6 million or nine cents per share compared to a net loss of $21 5 million or 12 cents per share for 2023.

Brian Culley: And with that I'll hand, the call back to Brian.

Brian Culley: Great. Thanks, Joe So I will summarize by saying first that we remain confident in the potential for opera, Jim to drive positive clinical outcomes and dry AMD and we feel the independent evidence generated from other RPE transplant trials supports and elevates that belief.

Jill: Securities. This increase in other income was partially offset by certain warrant related transaction cost incurred as part of the November 2020 for financing as well as the nonrecurring prior year employee retention credit.

Brian Culley: Second we are planning for success by seeking to capitalize on our historic investments in cell manufacturing and use those investments as a foundation from which additional programs can be advanced into and through clinical trials.

Brian: Net loss attributable to lineage was $18 6 million or <unk> <unk> per share compared to a net loss of $21 5 million or 12 cents per share for 2023, and with that I'll hand, the call back to Brian.

Brian Culley: Third we are steadily advancing OTC, one toward a larger clinical trial in spinal cord injury, while ensuring first that the necessary attributes for that program to be successful are in place.

Brian: Great. Thanks, Joe So I will summarize by saying first that we remain confident in the potential for <unk> to drive positive clinical outcomes and dry AMD and we feel the independent evidence generated from other RPE transplant trials supports and elevates that belief.

Brian Culley: We very much appreciate your support and belief in our vision and with that operator, we are ready to take some analysts' questions.

Brian Culley: I would like to remind everyone that in order to ask a question Press Star then the number one on your telephone keypad.

Brian: Second we are planning for success by seeking to capitalize on our historic investments in cell manufacturing and use those investments as a foundation from which additional programs can be advanced into and through clinical trials.

Speaker Change: Well pause for just a moment to compile the Q&A roster.

Speaker Change: Your first question comes from the line of Jack <unk> with Baird. Please go ahead.

Brian: Third we are steadily advancing what we see one toward a larger clinical trial in spinal cord injury, while ensuring the necessary attributes for that program to be successful or in place.

Speaker Change: Great. Thank you so much for taking the questions and congratulations on all the progress.

Speaker Change: The first one I wanted to ask on offer Jane was around the competitive landscape. It seems like there are a lot of players that are making advances in the field.

Brian: We very much appreciate your support and belief in our vision and with that operator, we are ready to take some analyst questions.

Speaker Change: You mentioned on the call a few different pieces of differentiation as it relates to offer Jim but what are you doing as a team to protect your market leadership here as it relates to RPE cell replacements, and then a quick follow up on the offer gen.

Speaker Change: I would like to remind everyone that in order to ask a question Press Star then the number one on your telephone keypad, we won't clash for just a moment to compile the Q&A roster.

Speaker Change: Do you see the updated three year data that was alluded to on the call and then I just have one more follow up after that as well. Thanks so much.

Speaker Change: Your first question comes from the line of Jack <unk> with Baird. Please go ahead.

Speaker Change: Thank you Jack ultimately a product development is intended to be Oh.

Jack: Great. Thank you so much for taking the questions and congratulations on all the progress I guess the first one I wanted to ask on all Virgin was around the competitive landscape. It seems like there are a lot of players that are making advances in the field.

Speaker Change: The means by which revenues are captured so I think what I said in my opening remarks is really the crux of it whether there's one company working on RPE transplants or 50 companies is is not as important as whether you are putting in.

Speaker Change: You mentioned on the call a few different pieces of differentiation as it relates to all Virgin, but what are you doing as a team to protect your market leadership here are as it relates to RPE cell replacement and then.

Jack: Follow up on all Virgin.

Jack: When might you see the updated three year data that was alluded to on the call and then I just have one more follow up after that as well. Thank you so much.

Speaker Change: Place all of the right and necessary attributes for success.

Speaker Change: I use the word triumvirate and I really think that the triumvirate of the lineage manufacturing the genentech product development capabilities, and then Roche as a leader in ophthalmology is a commercialization partner.

Jack: Thank you Jack.

Jack: Ultimately.

Jack: Product development is intended to be.

Jack: The means by which revenues are captured so I think what I said in my opening remarks is really the crux of it whether there's one company working on RPE transplants or 50 companies.

Speaker Change: Puts us you know far and ahead in a better position.

Anyone else.

Speaker Change: I think it's an open question in the field still as to how differentiated different programs ultimately can be and that differentiation would presumably need to be demonstrated in a clinical setting I find that to be a fascinating question, but there is no answer we have seen cases, where.

Jack: Is is not as important as whether you are putting in place all of the right and necessary attributes for success.

Jack: I used the word triumvirate and I really think that the triumvirate of the lineage manufacturing the genentech product development capabilities, and then Roche as a leader in ophthalmology is a commercialization partner puts us.

Speaker Change: Are the companies that failed to advance them, but it's sometimes unclear why they have left.

Speaker Change: <unk> left the the area. So we find a lot more to be happy about when we see these independent examples validating a novel mechanism like the one that we have but I really don't lose any sleep worrying that.

Jack: Far and ahead in a better position than anyone else.

Jack: I think it's an open question in the field still as to how differentiated different programs ultimately can be.

Speaker Change: You know these other organizations are going to be more well prepared the lineage is to be able to make and sell this product through the various alliances and relationships that we have in place.

Jack: And that differentiation would presumably need to be demonstrated in a clinical setting.

Jack: Find out to be a fascinating question, but there is no answer we have seen cases, where.

Jack: The companies have failed to advance, but its sometimes unclear why they have left.

Speaker Change: Yeah.

Speaker Change: Got it and then just very briefly do you have any additional time line as it relates to some of your operation data and then I wanted to ask a bigger picture.

Jack: Left the area. So we find a lot more to be happy about when we see these independent examples validating a novel mechanism like the one that we have but I really don't lose any sleep worrying that.

Speaker Change: How do you think about the positive early results from not only opportunity is in RPE cell replacement therapy, but now we're seeing I think you call. It four to five companies in the RPE cells place space.

Jack: These other organizations are going to be more well prepared the lineage is to be able to make and sell this product through the various <unk>.

Speaker Change: Enacted modality for solid replacement, how do you see that winning.

Speaker Change: Moving across the broader lineage story.

Speaker Change: Do you think of as the RPE cells.

Speaker Change: A concept for obesity, one and thanks for all the permits all one.

Jack: Alliances and relationships that we have in place.

Jack: Well, thanks, Jack Yeah. So for the three year data those inquiries can be directed to genentech they get to decide.

Jack: Got it and then just very briefly is do you have any additional time line as it relates to the three year average and data and then I wanted to ask a bigger picture.

Jack: Which events and conferences and they selected a lot of different ones over the years that we've been involved with them. So we don't have today, an announcement or a disclosure about where they would be announcing that information only that they intend to however, I hope it does not go unnoticed.

Jack: How do you think about the positive early results from not only off Virginia RPE cell replacement therapy, but now we're seeing I think you quoted four to five companies of RPE cells place.

Speaker Change: Hey, these guys are in.

Speaker Change: Active modality for cell replacement, how do you see that leading bringing across the broader lineage story.

Jack: That I did say that the effects continued to persist. So yeah, we'll be sure to make sure that everyone is aware that if we or genentech are making announcement, which is the normal course of events that you would be in your everyone would be aware of that.

Speaker Change: Where do you think of as the RPE cells of a proof of concept for obvious you wanted thanks for all the programs.

Speaker Change: Thanks, Jack Yeah, so for the three year data.

Speaker Change: Those inquiries can be directed to genentech they get to decide.

Speaker Change: Which events and conferences and they selected a lot of different ones over the years that we've been involved with them. So we don't have today, an announcement or a disclosure about where they would be announcing that information only that they intend to.

Jack: The second one with respect to modality.

Jack: I I think that.

Jack: There's a conflation in the minds of many people.

Jack: That cell therapy is synonymous with car T.

Jack: And while car T is certainly revolutionize the therapies and in oncology there are almost countless numbers of programs that are in our view sometimes poorly differentiated.

However, I hope it does not go unnoticed that I did say that the effects continue to persist so.

Speaker Change: We'll be sure to make sure that everyone is aware that if we or genentech.

Speaker Change: Make an announcement, which is the normal course of events that you would be in your everyone would be aware of that.

And we really think that the growth opportunity is not in oncology, but in all of the other areas that you might call non college. So these would be the most obvious places where cell transplantation kind of lends itself. So our P E transplants four or five.

Speaker Change: The second one with respect to modality.

Speaker Change: I think that.

Speaker Change: Theres a conflation in the minds of many people.

Speaker Change: That cell therapy is synonymous with car T.

Speaker Change: And while Turkey is certainly revolutionize the therapies in oncology there are almost countless numbers of programs that are in our view sometimes poorly differentiated.

Jack: Companies and there's probably a bunch of academic initiatives out there as well spinal cord injury has long been one of the premier choices in terms of suitability between the mechanism and the condition.

Jack: We're very proud to have <unk>.

Speaker Change: And we really think that the growth opportunity is not in oncology, but in all of the other areas that you might call non call Agee. So these would be the most obvious places where cell transplantation kind of lends itself. So RPE transplants for $5.

The most advanced cell transplant program in that indication.

Jack: Of the others that you might find going out into this growth area would be Parkinson's. So Bayer just announced that they were going to move from a phase one two a phase three.

Jack: One diabetes attracted a great amount of attention for our neighbors at Sana. We also and there are other companies have the initiatives in our auditory neurons. There are hundreds of different types of cells in the human body clearly not all of them is suitable as a cell.

Speaker Change: Companies and there's probably a bunch of academic initiatives out there as well as spinal cord injury has long been one of the premier choices in terms of suitability between the mechanism and the condition.

And we're very proud to have.

The most advanced cell transplant program in that indication.

Jack: <unk> medicine, so to speak but the ones that I've mentioned here on the call today, certainly are and I think they're getting a lot of attention for the companies that are working in this space. So we see it as the real exciting side of cell therapy versus car T for US car T has been a wonderful validation.

Speaker Change: The others that you might find going out into this.

Speaker Change: Area would be Parkinson's Bayer just announced that they were going to move from a phase one into a phase III type one diabetes attracted a great amount of attention for our neighbors at Sana.

Jack: <unk> of what is possible and now companies like lineage and others are looking at some of these large fields, where small molecules and antibodies have left some opportunity on the table.

Speaker Change: We also and there are other companies have initiatives in auditory neurons. There are hundreds of different types of cells in the human body clearly not all of them is suitable as a cell transplant medicine, so to speak but the ones that I've mentioned here on the call today, certainly are and I think they're getting a lot of.

Jack: And I think that there is increasingly going to be excitement and a higher belief system in the use of complex cells as solutions for diseases or conditions, which have not been fully solved by small molecules or antibodies.

Speaker Change: Attention for the companies that are working in this space. So we see it as the real exciting side of cell therapy versus car T. For US car T has been a wonderful validation of what is possible and now companies like lineage and others are looking at some of these large fields, where small mall.

Speaker Change: Well, it's great to see the Gras concept and congratulations again on all the progress. Thanks, so much.

Question.

Speaker Change: Comes from the line of Joel Thank goodness with H C. Wainwright. Please go ahead.

Speaker Change: <unk> and antibodies have left some opportunity on the table.

Speaker Change: Hey, guys. Good afternoon. Thanks for taking the question. So a couple of questions on salt on O. P. C. One. Please so first I guess, they're all logistics questions.

Speaker Change: And I think that there is increasingly going to be excitement and a higher belief system in the use of complex cells as solutions for diseases and conditions, which have not been fully solved by small molecules or antibodies.

Speaker Change: I'm, assuming you're using the same centers that used in phase one two way and just curious is there a certain percentage of new centers, where the surgeons have gone through the the updated training.

Speaker Change: Well, it's great to see the growing proof of concept and congratulations again on all the progress. Thanks, so much.

Speaker Change: Thank you Joe we will have a peak a combination of new sites and experience.

Speaker Change: Question.

Comes from the line of Joe Fund Ganesh with H C. Wainwright. Please go ahead.

Speaker Change: The first site that UC San Diego.

Speaker Change: Is is attractive to us because we do have some dose prep work that needs to get done and they have the right facilities for that as additional sites to come on those will turn up on our clinical trials dot Gov, posting which is already available and so you'll be able to see.

Hey, guys. Good afternoon. Thanks for taking the question. So a couple of question on Salt on obesity. One. Please so first I guess, they're all logistics questions.

Speaker Change: The sites as they as they come on board.

Speaker Change: No that's great and just as a side to that how far ahead to say, even appearing on clinical trials Gov with the training have occurred and then my second question was.

Speaker Change: Thank you Joe we will have.

Speaker Change: At peak, the combination of new sites and experienced sites.

Speaker Change: The first site that UC San Diego.

Speaker Change: No.

Speaker Change: It is attractive to us because we do have some dose prep work that needs to get done and they have the right facilities for that as additional sites to come on those will turn up on our clinical trials dot Gov, posting which is already available and so youll be able to see.

Speaker Change: From the time of the phase one two way, which was a while ago can you describe any changes in the logistics and being able to get patients to the surgical suite faster or any other components that have improved.

Speaker Change: Yes. Thank you with respect to training there are a lot of different kinds of training. This protocol training for the labs CRO their surgical training the surgeons, there's even training for transportation.

Speaker Change: The sites as they as they come onboard.

Speaker Change: No that's great and just as a side to that how far ahead to say, even appearing on clinical trials Gov with the training has occurred and then my second question was you know.

Speaker Change: And management of the drug.

Speaker Change: [laughter].

Speaker Change: When all of that work is complete and then you have a site initiation visits than you're actively enrolling patients. So what you find is there is a.

From the time of the phase one two way, which was a while ago can you describe any changes in the logistics of it and being able to get patients to the surgical suite faster or any other components that have improved.

Speaker Change: Long continuum from beginning to end as states go through all of these stage gates and.

Speaker Change: And you may have multiple sites indifferent points, along that continuum at any one time.

Speaker Change: Yes. Thank you with respect to training there are a lot of different kinds of training.

Speaker Change: With respect to the prior study we absolutely.

Speaker Change: This protocol training for the labs, the CRO their surgical training for the surgeons, there's even training for transportation.

Speaker Change: Saw opportunities to learn from.

Speaker Change: The prior trial and to look for best practices and in fact that was one of the reasons why we wanted to develop a immediate use formulation.

Speaker Change: And management of the drug.

[laughter].

Speaker Change: When all of that work is complete and then you have a site initiation visits than you are actively enrolling patients. So what you find is there is a.

Speaker Change: Because the original use of this therapy.

Speaker Change: A long continuum from beginning to end as sites go through all of these stage gates and.

Speaker Change: <unk> literally hours of preparing yourselves, Washington, playing them et cetera.

Speaker Change: And you may have multiple sites.

Speaker Change: Rather than the formulation, which we developed which.

Speaker Change: In different points, along that continuum at any one time.

Speaker Change: Which is immediate use.

Speaker Change: So there are places that we think will.

With respect to the prior study.

Speaker Change: Ease the burden.

Speaker Change: We absolutely.

Speaker Change: We saw opportunities to learn from.

Speaker Change: For both the patient the caregiver the provider.

Speaker Change: The prior trial and to look for best practices and in fact that was one of the reasons why we wanted to develop a immediate use formulation.

Speaker Change: Even the study coordinators and also also sponsor.

Speaker Change:

Speaker Change: But at the end of the day you know there certainly are some unavoidable activities of getting everyone in for all of their assessments within the appropriate windows and all the other things that are required to execute high quality clinical trial.

Speaker Change: Because the original use of this therapy.

Speaker Change: Included literally hours of preparing the cells, Washington plating them et cetera.

Speaker Change: Rather than the formulation, which we developed which is immediate use.

Got it thank you Brian.

Speaker Change: So there are places that we think will.

Speaker Change: Thank you. Your next question comes from the line of Michael Lewis.

Speaker Change: Ease the burden.

Michael Lewis: With vaccines.

Speaker Change: For both the patient and caregiver the provider.

Speaker Change: Go ahead.

Speaker Change: Hey, guys. Thank you so much for taking my questions today.

Speaker Change: Even the study coordinators and also assess sponsor.

Speaker Change: Hum.

Speaker Change: I guess, just what was the dose study.

Speaker Change: But at the end of the day, there certainly are some unavoidable activities of getting everyone and for all of their assessments within the appropriate windows and all the other things that are required to execute our high quality clinical trials.

Speaker Change: Well S. T. I want you to prove the device safety in either of the settings burst and kind of like a safety run in portion of the study before you can open it up to fully enroll across all the plant sites or can you just start off pretty much from the get go.

Speaker Change: Got it thank you Brian.

Speaker Change: Yeah.

Michael Lewis: Thank you Michael there there is it's a great question.

Speaker Change: Thank you. Our next question comes from the line of Mike.

Michael Lewis: And there is a a staging.

Speaker Change: <unk> with Maxim Group. Please go ahead.

Michael Lewis: The process So F D a.

Speaker Change: Hey, guys. Thank you so much for taking my questions today.

Michael Lewis: Really did us a favor by encouraging us to enroll a.

Speaker Change:

Speaker Change: So I guess just on the dose study.

Michael Lewis: Chronic patients in this study, but they did also want to put some appropriate safety measures in place. So the first several patients.

Speaker Change: Well S. T. I want you to prove the device safety in either of the settings first and kind of like a safety running portions of the study before you can open it up to fully enroll across all the plant sites or can you just start off pretty much from the get go.

Michael Lewis: In the study will have thoracic injuries. So they would be from T. One T 10, that's your thoracic range and Theres a hierarchy of of the if you're familiar with the Asian spinal injury Association or Asia.

Speaker Change: Thank you Michael there is it's a great question.

Speaker Change: And there is a a staging.

Michael Lewis: International standards for how you classify neurological spinal cord injuries and the short hand of that is H, a H b H C M, which is a I S. A S b.

Speaker Change: Process, So F D a.

Speaker Change: Really did us a favor by encouraging us to enroll.

So a I S. A would be you've got a no function or sensation below the level of injury.

Speaker Change: Chronic patients in this study, but they did also want to put some appropriate safety measures in place. So the first several patients.

Michael Lewis: So you have the least amount to lose in that situation.

Speaker Change: In the study we will have thoracic injuries. So they would be from tier one tier 10, that's your thoracic range.

Michael Lewis: So we would start with a thoracic patient of is a.

Michael Lewis: And then we would work our way up into our open enrollment I think around patient four.

Speaker Change: And there is a hierarchy of IFF.

Speaker Change: If you're familiar with the agent spinal injury Association or Asia.

Michael Lewis: Alright, thanks for that.

Speaker Change: The international standard for how you classify neurological spinal cord injuries and the short hand of that is H, a H b H C.

Speaker Change: And then just in terms of your capital plans right you have strengthened your balance sheet a bit are there any plans to accelerate the work on.

Speaker Change: Which is EASA.

At all or do you find it more prudent to maintain more of a steady approach given that we still face some market uncertainty.

Speaker Change: So AI is a would be you've got no function or sensation below the level of injury.

Speaker Change: So you have the least amount to lose in that situation.

Speaker Change: I've noticed the market uncertainty for certain so residents absolutely is still an important program for US we continue to work with the University of Michigan as well as internally on that program. It didn't get a lot of airtime in my prepared remarks, only for the sake of time not because.

Speaker Change: So we would start with a thoracic patients of <unk> eight.

Speaker Change: And then we would work our way up into our open.

Speaker Change: Open enrollment I think around patient four.

Speaker Change: Alright, thanks for that.

And then just in terms of your capital plans right you have strengthened your balance sheet a bit are there any plans to accelerate the work on its dominance at all or do you find it more prudent to maintain more of a steady approach given that we still face some market uncertainty.

Speaker Change: There's anything new or different with it.

Speaker Change: I think the organization's management prides itself on being extremely prudent and insisting upon our return on the capital, which we invest into our programs. So I think that it is the case that this is not and has not been for years, the kind of environment, where companies can go as fast as they are.

Speaker Change: I've noticed the market uncertainty for certain.

Speaker Change: So residents absolutely is still an important program for US we continue to work with the University of Michigan as well as internally on that program. It didn't get a lot of air time in my prepared remarks, only for the sake of time.

Speaker Change: Possibly can.

Speaker Change: And I think we're seeing a lot of penalties being paid for companies that did that instead, we are very careful about.

Speaker Change: The investment decisions that we make and we also are aware that we might have a much more attractive cost of capital in the future. When offer Gen is a little bit more advanced and that will make our our ability to accelerate development of all of the other programs a little more attractive to our investors. So we really try to.

Speaker Change: Not because there's anything new or different with it.

Speaker Change: I think the organization's management prides itself on being extremely prudent and insisting upon our return on capital, which we invest into our programs. So I think that it is the case that this is not and has not been for years, the kind of environment, where companies can go as fast as they are.

Speaker Change: To strike, an appropriate balance considering macro micro sector internal and all the other factors that one might imagine in order to try to maximize the investment opportunity for our shareholders over long periods of time.

Speaker Change: Possibly can.

Speaker Change: And I think we're seeing a lot of penalty is being paid for companies that did that instead, we are very careful about.

The investment decisions that we make and we also are aware that we might have a much more attractive cost of capital in the future when opportune as a little bit more advanced and that will make our ability to accelerate development of other programs a little more attractive to our investors. So we really try to.

Brian Culley: Alright, Thank you very much Brian I appreciate your color on the matter.

Speaker Change: Mike.

Speaker Change: Your next question comes from the line of Mike Danny when it rallied securities. Please go ahead.

Mike Danny: Oh, yes, good afternoon team congrats on the progress and thanks for taking our question. So Brian appreciate your mapping the development stage drug there. So some of the Bureau RPE program looks like.

Couple are coming at a rule.

Mike Danny: So I think to my two data could you touch on where we are with maybe some of these programs in terms of.

Mike Danny: Manufacturing.

Brian: Alright, Thank you very much Brian I appreciate your color on the matter.

Mike Danny: The source material cell line process development and scale up GMP grade material.

Speaker Change: Mike.

Speaker Change: Your next question comes from the line of Miami, One Penny when it rallied securities. Please go ahead.

Speaker Change: Might be a bit to the best took their knowledge and is there any direct comparison on what number of cells that are needed across the programs to kind of get to that therapeutic effect.

Speaker Change: Yes, good afternoon team congrats on the progress and thanks for taking our question. So Brian I. Appreciate your mapping the development stage progress of some of the peer RPE program looks like.

Speaker Change: We're starting to see that some of these programs and then I do have a follow up.

Speaker Change: Thank you my own with respect to the number of cells. I think most companies are operating anywhere from maybe 25 or 50000 up to 200000 and I think that has to do with our surface area calculation. These cells tend to.

Speaker Change: People are coming at ARVO.

Speaker Change: So make tremendous data could you touch on where we are with maybe some of these programs in terms of.

Speaker Change: Manufacturing.

Speaker Change: But the source material cell line process development and scale up you have to be great. Thank you.

Speaker Change: They're adherent tonight, they they they tend to form very organized our structures.

Speaker Change: Might be a bit to the best of your knowledge and is there any direct comparison on what number of cells that are needed across the programs to kind of get to that therapeutic effect.

<unk> as they are administered to the sub retinal space.

Speaker Change: With respect to the manufacturing by other companies.

Speaker Change: We're starting to see that some of these programs and then I do have a follow up.

Speaker Change: Thank you my own.

Speaker Change: I very much wish that I had some specific information about their capabilities, because I would probably aimed to contrast, it with our own capabilities in that regard.

Speaker Change: With respect to the number of cells I think most companies are operating anywhere from maybe 25 or 50000 up to 200000, and I think that has to do with our surface area calculation.

Speaker Change: I have said before that we are on a feeder free system other than the fill finish it's a closed system thousands of doses per batch I don't know where other companies or other than one company that sources their material from.

Speaker Change: Wells tend to.

Speaker Change: They are adherent Tonight.

Speaker Change: Tend to form very organized structures.

As they are administered to the sub retinal space.

Speaker Change: With respect to the manufacturing by other companies.

Cadavers, so I don't know that that is necessarily a commercially viable source because passage in mature cells.

Speaker Change: Very much wish that I had some specific information about their capabilities, because I would probably aimed to contrast, it with our own capabilities in that regard.

Is is not something that one can do endlessly the way that our pluripotent stem cells can be passage endlessly.

Speaker Change: I have said before that we are on a feeder free system other than the fill finish it's a closed system thousands of doses per batch.

Speaker Change: I also look at the Astellas program, obviously that is a very well funded.

Speaker Change: Global organization, However, I think there I N D opened in 2010, so they have been working for a very long time.

Speaker Change: I don't know where other companies or other than one company that sources their material from cadavers.

Speaker Change: We do get the impression that that will have some results announced soon so perhaps there will be an opportunity to get some insights into their manufacturing capabilities, but I think that even at current process scale and current non optimized capabilities that lineage is probably setting the bar and I hope to be able.

Speaker Change: I don't know that that is necessarily a commercially viable source because passage in the <unk>.

Speaker Change: Sure cells.

Speaker Change: Is not something that one can do endlessly the way that our pluripotent stem cell can be passage endlessly.

Speaker Change: I also look at the Astellas program, obviously that is a very well funded.

Speaker Change: Well to not only say more about our capabilities in the near future, but also find some insights about the competitors' capabilities, which perhaps will only highlight that we believe we have the most promising opportunity in this particular approach.

Speaker Change: Global organization, However, I think their IND opened in 2010, so they have been working for a very long time.

Speaker Change: We do get the impression that that will have some results announced soon so perhaps there will be an opportunity to get some insights into their manufacturing capabilities.

No that's super helpful.

Speaker Change: The follow up.

Yes, sorry.

Speaker Change: Link that even at current process scale and current non optimized capabilities that lineage is probably setting the bar and I hope to be able to not only say more about our capabilities in the near future, but also find some insights.

Speaker Change: Yes, Thank you, Brian and just to follow up on that comment you made about the controlled study which are good periodically be run in parallel to the study.

Speaker Change: Is there any insight you may have on the kind of patient exposure and what efficacy endpoints could makes sense given obviously, the very large <unk> BCP a treatment effect that you get for this modality.

Speaker Change: <unk> about the competitors' capabilities, which perhaps will only highlight that we believe we have the most promising opportunity in this particular approach.

Speaker Change: And I'm not sure and again, if there's anything to glean, but other programs. There's one more that had a designation like yours.

Speaker Change: Super housekeeping follow up.

Speaker Change: Yes, all right and just can.

Speaker Change: But I assume you are in the lead and whatever we learned about the next steps on Bush is going to be what others will follow.

Speaker Change: Yes, Thank you, Brian and just to follow up on that comment you made about the control study, which could theoretically be run in parallel to that.

Speaker Change: But that was kind of my question. Thanks, Thanks again for taking my question.

Speaker Change: In that study.

Yeah. Thank you for the Mt.

Speaker Change: Is there any insight you may have on the kind of patient exposure.

Speaker Change: Do you know that some of the reports I've seen from others.

Speaker Change: <unk> could make sense, given obviously, the very large <unk> treatment effect that you get to this modality.

Speaker Change: Indicate pretty significant improvements in B C V a.

Speaker Change: One hypothesis is that those companies have in fact learned from our experience and are taking great care to deliver the cells right across the G. Eight that of course was one of our important findings.

Speaker Change: And not sure and again, if there is anything to glean with other programs. There's one more that has <unk> designation like yours.

Speaker Change: But I assume you are in the lead and whatever we learned about the next step from Roche is going to be what others will follow.

Speaker Change: So it is possible that that they are seeing absolute values at clinically relevant time points.

Speaker Change: But that was kind of my question. Thanks, Thanks again.

Speaker Change: Yeah.

Speaker Change: Yeah. Thank you for that amount.

Speaker Change: Our.

Speaker Change: Even greater than the ones that we have reported in our study.

Speaker Change: Do know that some of the reports I've seen from others in.

Speaker Change: Simply attributable bought too.

Speaker Change: Indicate pretty significant improvements in BC VA.

Speaker Change: Learning from our experience in delivering the cells in exactly the the ideal location.

Speaker Change: Which is terrific because it would suggest to me that the ongoing surgical optimization study, which genentech is conducting.

Speaker Change: Holds the promise of potentially having even better results than we have already reported in our phase one.

Speaker Change: So it is possible that.

Speaker Change: That they are seeing absolute values at clinically relevant time points.

Speaker Change: I have no specific knowledge of that happening at this time.

Speaker Change: Ever it would seem to be plausible given what others have reported with their own approaches.

Speaker Change: Or even.

Speaker Change: Even greater than the ones that we have reported in our study.

Speaker Change: Attributable bought too.

Speaker Change: So I do think that there are opportunities here for this treatment, especially because it is novel.

Speaker Change: Learning from our experience in delivering the cells in exactly the the ideal location.

Speaker Change: To improve which is quite frankly, a normal story line for a new technology that it gets better over time, so I would be hopeful that that would be the case here.

Speaker Change: Which is terrific because it would suggest to me that the ongoing surgical optimization study, which genentech is conducting.

Speaker Change: Holds the promise of potentially having even better results than we have already reported in our phase one I have no specific knowledge of that happening at this time.

Speaker Change: But again Genentech is specifically conducting a surgical optimization study to explore various ways method, it's equipment to deliver cells to the sub retinal space.

However, it would seem to be plausible given what others have reported with their own approaches.

Speaker Change: But because the clinical effects, which lineage have reported do not ever happened spontaneously.

Speaker Change: So I do think that there are opportunities here for this treatment, especially because it is novel.

Speaker Change: One would reasonably assume that genentech would be able to see signals of efficacy in the ongoing study and thereby make some decisions about how important this program is or is not to them.

Speaker Change: To improve which is quite frankly, a normal story line for a new technology that it gets better over time, so I would be hopeful that that would be the case here.

Speaker Change: With respect to the size of the study.

Speaker Change: But again Genentech is specifically conducting a surgical optimization study to explore various ways methods equipment to deliver cells to the sub retinal space.

Speaker Change: I don't know that surgical optimization ever truly and there are probably people still trying to make lasik surgery better even today. So I would imagine that as this technology continues some version of surgical optimization might continue forever. So I don't know that they're necessarily is a discrete and statistically.

Speaker Change: But because the clinical effects, which lineage have reported do not ever happened spontaneously.

Speaker Change: Would reasonably assume that <unk> would be able to see signals of efficacy in the ongoing study and thereby make some decisions about how important this program is or is not to them.

Speaker Change: Powered and point associated with the ongoing <unk> study.

Speaker Change: Which is why I elected to make the point that.

Speaker Change: A decision to advance into a controlled study could occur at any time and it doesn't necessarily have to be tied to the conclusion or any particular follow up period of the ongoing <unk> study and in fact, we intentionally designed the warrants in the financing to be tied to that.

Speaker Change: With respect to the size of the study.

Milestone for exactly that reason.

Michael Lewis: Makes sense. Thank you Brian.

Speaker Change: <unk> end point associated with the ongoing <unk> study.

Speaker Change: Thank you very much.

Speaker Change: Your next question comes from the line of Oh break Louie for with Craig Hallum. Please go ahead.

Speaker Change: Which is why I elected to make the point that.

Speaker Change: Hi, Brian.

Speaker Change: I was interested in your comment about the potential for Roche to start a new control study and I guess at any time in the absence of a data disclosure.

Speaker Change: Was wondering would there be anything on your end required to prepare for that possibility, perhaps on the manufacturing side of things or anything else.

Speaker Change: Millstone for exactly that reason.

Speaker Change: Yeah.

Speaker Change: We maintain a very clear wall between our public information and the information that lineage may come into possession of.

Speaker Change: Makes sense. Thank you Brian.

Speaker Change: Thank you very much.

Speaker Change: Your next question comes from the line of Oh, Great Louie.

Speaker Change: So I really don't have any particular item to point to and in fact, I struggled to sort of hypothesize, what one might look at I suppose in.

Speaker Change: With Craig Hallum. Please go ahead.

Great Louie: Hi, Brian.

Great Louie: I was interested in your comment about the potential for Roche to start a new control study and I guess at any time in the absence of a data disclosure. So I was wondering would there be anything on your end required to prepare for that possibility, perhaps on the manufacturing side of things or anything else.

Speaker Change: In some cell therapy applications, having sufficient material might be an indicator of what our partner is aiming to do them.

Speaker Change: But as I've shared a couple of times our production levels are already so high that we do not have a shortage, we don't need to do anything in particular.

Great Louie: Okay.

Great Louie: We maintain a very clear wall between our public information and information that lineage may come into possession of.

Speaker Change: With respect to our our product to scale our process scale in order to adequately supply even the largest of clinical trials. So I think all of those decisions will ultimately up to be up to our partners in our partners' hands and we will you know just.

Great Louie: So I really don't have any particular item to point to and in fact, I struggled to sort of hypothesize, what one might look at.

Great Louie: I suppose.

Speaker Change: In some cell therapy applications, having sufficient material might be an indicator of.

Speaker Change: Collaborate and cooperate with them at a at any point that is in furtherance of the opportune program.

Great Louie: What our partner is aiming to do.

Great Louie: But as I've shared a couple of times our production levels are already so high that we do not have a shortage, we don't need to do anything in particular with respect to our our product scale our process scale.

Speaker Change: Okay, Alright got it sounds like you have plenty of RPT.

Speaker Change: RPE cells on hand.

Speaker Change: Maybe just one more question I was interested in the impairment that you mentioned earlier of the AR.

Speaker Change: Great, great, a or b or a complete or incomplete injury, you and I was wondering if there were any differences between the responses in these type of acute patients in the prior studies.

Great Louie: In order to adequately supply even the largest of clinical trials. So I think all of those decisions will ultimately up to be up to our partners in our partners' hands.

Speaker Change: And if there were any other features that you think might make chronic patients are good candidates for O P C.

Great Louie: And we will just collaborate and cooperate with them yet at any point that is in furtherance of the opportune program.

Speaker Change: And thank you for that question. The prior work included only five patients with thoracic injury, but 25 patients with cervical injuries.

Great Louie: Okay, Alright got it sounds like you have plenty of.

Speaker Change: RPE cells on hand.

Speaker Change: So the comparisons that we will be making or probably more likely to be interesting on the cervical side.

Speaker Change: Maybe just one more question I was interested in the impairment that you mentioned earlier.

Speaker Change: Yeah, great, great, a or b or a complete or incomplete injury and I was wondering if there were any differences between the responses in these type of acute patients and the prior studies.

Speaker Change: But at the same time this study is.

Speaker Change: Intended to be a safety and performance study of a device and delivery.

Speaker Change: And if there are any other features that you think might make chronic patients are good candidates for OTC.

Speaker Change: And the follow up periods and spinal cord injury can be quite long.

Speaker Change: So given the size of the study the period of follow up and the objective. The primary endpoint objective of this study.

Speaker Change: Thank you for that question.

Speaker Change: The prior work included only five patients with thoracic injury, but 25 patients with cervical injuries. So the comparisons that we will be making.

Speaker Change: We don't really know what a meta analysis or what sort of predictive outcomes, we might be anticipating.

Speaker Change: <unk> are probably more likely to be interesting on the cervical side.

Speaker Change: But to the extent that chronic patients.

Speaker Change: They have never been treated.

Speaker Change: But at the same time this study is.

Speaker Change: With O P. C. One there certainly are many people in the field who are not intimidated.

Speaker Change: Intended to be a safety and performance study of a device and delivery.

Speaker Change: By the presence of the of the scar and old injuries and these individuals and we would be among them believes that the the plasticity in the regenerative capability of the spinal cord, even after many years can be reengage and restored.

Speaker Change: The follow up periods and spinal cord injury can be quite long.

Speaker Change: So given the size of the study.

The period of follow up and the objective the primary endpoint objective of this study.

Speaker Change: We don't really know what a meta analysis or what sort of predictive outcomes, we might be anticipating.

Speaker Change: Perhaps not completely but I believe even partially could be extremely clinically relevant to individuals who have lost their their motor control. So we are very excited to see <unk> go into chronic patients for the first time, because unlike sub acute patients where you really don't know.

Speaker Change: But to the extent that chronic patients.

Speaker Change: I have never been treated.

Speaker Change: With OTC one there certainly are many people in the field who are not intimidated.

Speaker Change: By the presence of the scar and old injuries and these individuals and we would be among them believe that the the plasticity in the regenerative capability.

Speaker Change: What the recovery journey for any individual patient is likely to be although I will say that the field is getting better at predicting that but a chronic patient who has plateaued.

Speaker Change: For many years.

Speaker Change: The spinal cord, even after many years can be reengage and restored.

Speaker Change: Might be more easy to provide a signal after therapy. If they in fact have some sort of change in their performance status. So I think what's attractive about chronic is not just that there are larger numbers of patients, who perhaps might be easier to enroll because they have already.

Speaker Change: Perhaps not completely but I believe even partially could be extremely clinically relevant to individuals who have lost their motor control. So we are very excited to see <unk> go into chronic patients for the first time, because unlike sub acute patients where you really don't know.

Speaker Change: It's been stable and are not coming off of a very acute injury, but also because of their baseline should be stable until it changes to baseline might be more easily attributed to our intervention.

Speaker Change: What the recovery journey for any individual patient is likely to be although I will say that the field is getting better at predicting that.

Speaker Change: But a chronic patient who has plateaued.

Speaker Change: For many years.

Speaker Change: Okay I see alright, thank you for taking my questions today.

Albert: Thank you Albert.

Albert: Your final question comes from the line of Shannon action with Raymond James. Please go ahead.

Shannon Action: Hey, Brian.

Speaker Change: Can you provide some additional thoughts on the ability to use dose does a bridge to the new formulation of <unk>, one and maybe what comparability studies remain from the new production process, maybe speech here.

Speaker Change: It's been stable.

Speaker Change: And are not coming off of a very acute injury, but also because of their baseline should be stable until it changes to baseline might be more easily attributed to our intervention.

Speaker Change: Confidence in being able to include the new formulation and the current R&D. Thanks.

Speaker Change: Okay I see.

Speaker Change: Yeah excellent question and thoughtful question, Sean we have manufactured L. P. C. One with our improved process and we have conducted substantially all of the comparability testing that we intend to do.

Speaker Change: Alright, Thank you for taking my questions.

Speaker Change: Thank you Albert.

Speaker Change: Your final question comes from the line of Shannon Passion with Raymond James. Please go ahead.

Speaker Change: So which includes in vivo efficacy studies.

Shannon Passion: Hey, Brian.

Shannon Passion: Can you provide some additional thoughts on the ability to use dose does a bridge to the new formulation of <unk> and maybe what comparability studies remain from the new production process, maybe speech here.

Speaker Change: Importantly for everyone listening, it's very important that the process does not change the potency or efficacy of these cells and so the comparability testing would include.

Shannon Passion: Confidence in being able to include the new formulation and the current <unk>.

Speaker Change: All of the customary features of identity and other characterizations of the cells potency of the cells, including an in vivo study bioinformatics analysis of the cells.

Speaker Change: Yeah excellent question and thoughtful question, Sean we have manufactured LPC, one with our improved process and we have conducted substantially all of the comparability testing that we intend to do.

Speaker Change: We are substantially complete, but we did strategically prefer to have the IMD process for dosed.

Speaker Change: So which includes in vivo efficacy studies importantly for everyone listening.

Speaker Change: Be completed.

Speaker Change: It has been so that we could get the study up and going and then as a second phase introduce all of the data for the new cells to FDA for their review and appended into the the dose study and that way, we didn't want to give them both.

Speaker Change: It's very important that the process does not change the potency or efficacy of these cells and so the comparability testing would include.

Speaker Change: All of the customary features of identity and other characterizations of the cells potency of the cells, including an in vivo study bioinformatics analysis of the cells.

Speaker Change: [laughter] a.

Speaker Change: A new device and new cell process.

Speaker Change: Do you think about we thought that would be more efficient.

Speaker Change: We are substantially complete, but we did strategically prefer to have the IMD process for dosed.

Speaker Change: [noise] excuse me in hindsight.

Speaker Change: It still took a long time to review, but I think that's okay. I think staging it in the way that we have it makes sense I cannot say today, whether the new cell process will be introduced into the scope of the six to 10 dosed patients or if we will append a small number of patients to the end.

Speaker Change: <unk> completed.

Speaker Change: It has been so that we could get the study up and going and then.

Speaker Change: As a second phase introduce all of the data for the new cells to FDA for their review and appended into the dose study and that way, we didn't want to give them both.

Speaker Change: Have dosed, but our current thought is that we would use the forthcoming sites and the currently activated sites to be the sites that are also utilizing the new formulation of the cells. So.

Speaker Change: A new device and new cell process.

Speaker Change: To think about we thought that would be more efficient.

Speaker Change: [noise] excuse me in hindsight it still took a long time to review, but I think that's okay. I think staging it in the way that we have it makes sense I cannot say today, whether the new cell process will be introduced into the scope of the six to 10 dosed patients or if.

Speaker Change: So I think one of the things that we would like to do is actually get some of that information out and perhaps that can aid with some investor comfort.

Speaker Change: I seeing how the new process compares to the old process, because we do think that it is a much better way of making the cells that would come about better control and that it is going to be deemed by US initially is comparable and we expect the FDA will find that same conclusion.

Speaker Change: We will append, a small number of patients to the end of dose, but our current thought is that we would use the forthcoming sites and the currently activated sites to be.

Speaker Change: Understood. Thank you.

Speaker Change: Thank you very much Chuck.

Speaker Change: Rates that are also utilizing the new formulation of the cells. So I think one of the things that we would like to do is actually get some of that information out and perhaps that can aid with some investor comfort by seeing how the new process compares to the old process. Because we do think that it is much better way of May.

Speaker Change: That ends our Q&A session I will now turn the call back over to Brian Colley for closing remarks, Mr. Cody. Please go ahead.

Speaker Change: Great. Thank you everyone. We hope this was helpful and we'll look forward to having you back soon for our Q1 2025, calling me.

Speaker Change: The cells that we gotten bounce better control and that it is.

Speaker Change: Ladies and gentlemen that concludes today's call. Thank you all for joining you may now disconnect.

Speaker Change: We're going to be deemed by US initially is comparable and we expect the FDA will find that same conclusion.

Speaker Change: Understood. Thank you.

Speaker Change: Thank you very much.

Speaker Change: That ends our Q&A session I will now turn the call back over to Brian Colley for closing remarks, Mr. Colby. Please go ahead.

Speaker Change: Great. Thank you everyone. We hope this was helpful and we'll look forward to having you back soon for our Q1 2025 call it mix.

Speaker Change: Ladies and gentlemen that concludes today's call. Thank you all for joining you may now disconnect.

Speaker Change: [music].

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