Lineage Cell Therapeutics Inc. Q1 2023 Earnings Call

Speaker 2: only mode.

Speaker 2: An audio webcast of this call is available on the investor's section of Lineage's website at www.lineagecell.com.

Speaker 2: This call is subject to copyright and is the property of Lineage and recordings, reproductions, or transmissions of this call without the express written consent of Lineage are strictly prohibited. As a reminder, today's call is being recorded.

Speaker 2: I would now like to introduce your host for today's call, Iwana Home, Head of Investor Relations at Lineage. Ms. Home, please go ahead.

Speaker 3: Thank you, Abby. Good afternoon and thank you for joining us. A press release reporting our first quarter 2023 financial results was issued earlier today, May 11, 2023, and can be found on the Investor section of our website. Please note that today's remarks and responses to your questions.

Speaker 3: reflect management's views as of today only, and will contain forward-looking statements within the meaning of federal securities laws. 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.

Speaker 3: 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 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.

Speaker 3: including its most recent annual report on Form 10K. We caution you not to place under 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, our Brian Cully, our Chief Executive Officer.

Speaker 3: Jill Howe, our Chief Financial Officer, and Gary Hoag, our Senior Vice President of Clinical and Medical Affairs.

Speaker 3: With that, I'd like to turn the call over to Brian .

Speaker 4: Thank you, I want to get up to noon everyone. We appreciate you taking the time to join us today.

Speaker 4: Our most recent quarterly call was just two months ago, but I'm happy to report today on additional and fairly exciting progress which has occurred since then. The most significant event of the past two months was the Arvo Annual Meeting held in New Orleans, where Dr. A. Albanyne, one of the investigators involved with the initial Phase 1-2-A trial of operagen,

Speaker 4: performed on data collected in our study.

Speaker 4: To be clear, these were new, independently generated analyses conducted by GenNTEX, MAST, Expert, Greater. And while the data support and reinforce our original findings, as well as the substudy findings made by the Diohaney Image Research Lab, these were novel analyses and results. And while the data support and reinforce our original findings made by the Diohaney Image Research Lab, these were novel analyses and results.

Speaker 4: which Liniache had not previously reported.

Speaker 4: We have previously reported and presented on unique clinical findings among some of our cohort-4 patients, including areas of GA being smaller at 12 months than at baseline, and increases in patient visual function at 12 months, which occurred notably among the five patients who received extensive coverage of operagen.

Speaker 4: across their area of GA. But Genentech took these data analyses even further, using proprietary technology and imaging expertise, and they were able to generate new analyses from the raw data and images.

Speaker 4: These additional results support what Linneys had reported previously, including structural and functional improvement in a disease previously thought to be inevitably progressive.

Speaker 4: Genentech showed new findings supporting the observation that extensive placement of operogen cells across the area of GA appeared a result in the best clinical outcome seen in clinical trials to date.

Speaker 4: As well as continued evidence that transplant of operagen cells may result in a multi-year treatment effect from a single dose.

Speaker 4: We believe these findings compare favorably versus the burden of someone typically elderly and with very poor vision, seeking out a monthly or even every other monthly injection of a complement inhibitor.

Speaker 4: licensed vitriol retinal surgeon is capable of performing using standard instrumentation.

Speaker 4: And these outcomes occurred five out of five times when operogen was placed extensively across the area of GA.

Speaker 4: Additionally, something which I believe has continued to be overlooked. In the evidence Genentech presented, which showed a patient who no longer had features of CERORA near the border of their GA following treatment with operagen.

Speaker 4: I'll remind you that Cirora is an area of complete RPE and outer reticle atrophy, which essentially means the complete loss of photoreceptors and the essential supporting RPE.

Speaker 4: I'd also like to point out that thousands of patients have completed clinical trials for the two leading complement inhibitors, but despite recent reports from extensive subgroup analyses of those data.

Speaker 4: I'm not aware of even a single case of CERO resolution among them.

Speaker 4: Well, lineage may not have yet as many data points as the competition.

Speaker 4: But even setting aside the vision gains we report in patients who should be losing vision.

Speaker 4: We are reporting much larger anatomical changes in the competition, and we're using objectively collected methods on anatomical features unaffected by patient effort.

Speaker 4: So I believe these direct comparisons and questions about relative value are completely valid.

Speaker 4: We welcome these comparisons, especially as the OPPERGEN program advances through the clinic.

Speaker 4: As a reminder, the primary and secondary endpoints for the ongoing study occur just 90 days post-treatment.

Speaker 4: which means these data are detectable and collected nine months earlier than the more common 12-month treatment outcomes.

Speaker 4: Before moving on, I'd just like to convey my appreciation to our partners, Rosamson and Entex, for enthusiastically supporting our desire to have these new data presented at ARVO. Their retinal tissue segmentation algorithm and additional resources, which they deployed, give us further conviction in our cell transplant approach. Thank you.

Speaker 4: and reflect the insights and expertise which we were counting on when entering into the license agreement for the development and commercialization of operative, from which I'll remind you we're eligible to receive up to $620 million in additional payments as well as double digit royalties.

Speaker 4: In the meantime, we'll closely monitor the establishment and size of the dry AMD commercial market.

Speaker 4: While lineage does not have a commercial product today, we believe the recent approval of psychvovery and reported $5.9 billion acquisition by a cellist of a similar compliment inhibitor asset.

Speaker 4: will not only help create, engage, and informed physician and patient populations.

Speaker 4: But also set the stage for potential next-generation products like Operagen by verifying expectations of a multi-billion dollar commercial market, which is comprised of patients eager to find effective interventions for their

Speaker 4: Moving next to our OPC-1 program, which is intended to help patients recover more fully from a spinal cord injury, our recent focus has been on completing the requisite regulatory interactions to support the initiation of the dose trial, which is a 6-10 patient safety study of a new spinal cord cell delivery system.

Speaker 4: As you'll recall, we previously held an R-MAT meeting with FDA to discuss the use of the new delivery device. Along with the device information, we included a protocol synopsis for the clinical safety study we planned to conduct in sub-tute and chronic SEI patients. That R-MAT interaction was followed by a request from lineage for a type B meeting to discuss specific items which would be included in an IND amendment. Unexpectedly, the FDA noted in response to our report that their response is from that meeting.

Speaker 4: would not be available until the last week of June , which is approximately eight weeks later, than we'd expected for a type-by-meeting request.

Speaker 4: I want to provide some comfort to our knowledge. This later than expected meeting date is in no way a reflection on the OPC-1 program.

Speaker 4: The FDA explained that the delay was due to time constraints among certain essential staff members necessary for our topics. So we find this to be unfortunate but not entirely surprising given the deluge of cell and gene therapy programs currently in development. Nevertheless, after the type B meeting is held this summer, we will be able to provide

Speaker 4: I do have three additional updates on OPC-1 today. The first is that we strengthen our intellectual property position through a patent which was granted for claims covering manufacturing processes which lineage developed. That patent has claims which expire no earlier than 2040 providing us with a long period of protection for this program. Second, I want to provide an update on our announcement regarding the creation of the first annual spinal cord injury investor symposium, a conference which lineage will be presenting this year alongside the Christopher and Dana Reeve Foundation.

Speaker 4: and which will be held the last week of June at the Sanford Consortium for Regenerative Mence in LaHoya, California.

Speaker 4: We created this event to increase engagement between industry and patients in the patient advocacy community, which in our experience can help inform and improve the product development process.

Speaker 4: The REVE Foundation is a recognized leader in the field of spinal cord injury and we're proud to have them as a partner as we advocate for those affected by paralysis. We aim to increase disease awareness.

Speaker 4: Elevated the probability of success for product development, and promote clinical trial participation by focusing on topics such as patient appropriate endpoints and the benefits of partnerships among in-between for-profit and nonprofit organizations. The most notably, two days ago we announced that we'd received an education grant from the California Institute for Regents.

Speaker 4: ever supported by SIRM and we're grateful to the agency for its continued commitment to spinal cord injury.

Speaker 4: As I have shared before, we still expect to approach SIRM about a clinical trial grant to support the dose clinical study, but that step is normally performed after the IND amendment has been submitted.

Speaker 4: So third and lastly for OPC 1 today, I just want to convey my appreciation to all the members of Team Lineage, both in Karlsbad and Israel, as well as any investors who participated in the Wings for Life World Run last weekend.

Speaker 4: The world runs an important and global fundraiser for SDI research and embodies the importance of broad-based collaboration, which as I just explained, we believe is core to successful product development in this condition. Moving along, I have just a few more updates to share for back two. As you know from our previous discussions regarding the pre-I&D written feedback we received,

Speaker 4: small cell lung cancer.

Speaker 4: We've been waiting for that data to arrive and I'm happy to share today that we received some key updates and now expect the complete data package to arrive next quarter.

Speaker 4: I have stated previously that we believe strategic alliances offer us the best mix of risk and reward for the VAC platform, and our BD team has several exploratory discussions ongoing for VAC2 and the VAC platform more generally.

Speaker 4: While there can be no assurance that any development partnerships we're exploring will come through for a wish. Our preference for the VAC program is to de-risk it through one or more alliances rather than proceeding independently, and the BD team will continue to work on this initiative.

Speaker 4: There also have been some encouraging clinical results reported in the neoantigen vaccine space lately.

Speaker 4: So we intend to continue to monitor this landscape closely because doing so will better inform our corporate strategy and help us determine the best development path for back to or any other platform programs which we may pursue through academic or corporate partnerships.

Speaker 4: For ANP1, which is our transplant program for hearing loss, we have a number of different

Speaker 4: The preclinical testing is ongoing through a collaboration with the University of Michigan.

Speaker 4: Our initial objectives from this collaboration are to determine the preferred location for the cell transplants and to determine how long the cells can survive after transplantation.

Speaker 4: Last week, I was provided with the first ever images generated from that preclinical work. And in fact, I'll see if we can post one of those images to our Twitter account after this call. I think it's kind of a cool thing to see. I was excited to see the early data because as you will recall, our hearing loss program didn't even exist at the beginning of last year. But yet, our hearing losses created a form of Tekin command gap which was realized in the last year and a half, followed by a massive decrease in hearing death rates and preliminary death rates between 2013 and 2019. And finally, I think the most exciting thing this fall is that even with the strongest

Speaker 4: we already have our first preclinical data emerging.

Speaker 4: We developed a differentiation method, filed intellectual property, and proceeded into in vivo testing in less than 12 months, and with a commitment of less than $1 million per-unit dollars. And frankly, I think one of the key advantages for lineage, in what continues to be a difficult environment for small biotech companies, is that our core technology offers us the ability to make tremendous progress without also having to make tremendous expenditures. Our discipline spending and efficient use of R&D dollars is a foundation which Jill and I believe is appropriate for our stage of development, and which can help us bridge to important events and opportunities which lie ahead.

Speaker 4: such as completing enrollment and reporting data from the ongoing phase 2 trial of operative, the initiation and conduct of clinical trials for OPC-1, and progress in partnerships which we pursue across other areas of our business. As a final but actually quite important note,

Speaker 4: I'm also happy to report that based on preliminary estimates of market cap cutoff, we anticipate lineage will be added into the Russell 3000 and the Russell micro cap indices this summer. An inclusion which may help to expand investor awareness.

Speaker 4: increase institutional ownership, and provide additional liquidity in our stock. With that, I will now hand the call over to Jill for a discussion of our financials.

Speaker 5: Thanks, Brian , and good afternoon everyone.

Beginning with our balance sheet, I believe we continue to be efficient with our spending and our well-capitalized to conduct linear term activities which Brian just outlined.

Our reported cash, cash equivalents, and marketable securities as of March 31, 2023, holds $46.8 million, which is expected to support our current planned operations in July 16th, 2022.

Please note, this does not account for any of the roasts and antichmilestone payments, nor for any business development or grant revenues, which we may receive during the same period. Now let me review our first quarter operating results.

A revenue is generated primarily from licensing fees, royalties, collaboration revenues, and research grants.

Total revenues for the first quarter were approximately $2.4 million, a decrease of $2.8 million as compared to $5.2 million for the same period in 2022. This decrease was driven by lower collaboration and licensing revenues in conjunction with the Roche Agreement. Thanks to the

Our operating expenses are comprised of research and development and general and administrative expenses. Total operating expenses for the first quarter were 8.9 million, a decrease of 2.5 million as compared to 11.4 million for the same period in 2022.

R&D expenses for the first quarter were $4.2 million, an increase of $1.2 million as compared to $3 million for the same period in 2022.

The increase is primarily driven by a half million of nonclinical related expenses to support the OBC-1 program and point two million in the OPPOGIM program expenses to support the Roche collaboration. Another point four and point two million of the increase was related to R&D spending on the auditory neuron and voter receptor programs respectively. The program was related to R&D spending on the auditory neuron and voter receptor programs

Gena expenses for the first quarter were 4.7 million, a decrease of 3.7 million is compared to 8.4 million for the same period in 2022. The decrease is primarily driven by the 3.5 million in lower litigation and legal expenses related to the serious litigation settlement that was accrued in the prior year and 0.2 million and lower expenses.

value of our marketable equity securities, enters from our marketable debt securities, and are receivable for the Employee Retention Credit Program partially offset by exchange rate fluctuations related to our international subsidiaries.

The net loss for the first quarter was $4.4 million, or $0.03 per share, compared to a net loss of $7.1 million, or $0.04 per share, for the same period in 2022.

Now, let me hand the call back to Brian . Thanks, Jill. I continue to believe Linnie is making good decisions in a challenging biotech environment. We've been conservative and disciplined with our spending and we're advancing our programs in a responsible way. Our collaboration with Genentech and Roche is progressing extremely well and one of the many things will be excited to work on this year will be continuing to support Genentech and Roche in the further clinical development of opergents for the treatment of dry MD with geographic atrophy.

As always, we sincerely appreciate your support of the company as we look to position lineage to become a leader in cell therapy and cell transplant medicine.

And with that operator, we are ready to respond and do any endless questions. This time, I would like to begin our question and answer session. If you would like to ask a question, press store 1 on your telephone keypad.

If you would like to withdraw your question, again, press star 1 on your telephone keypad.

We'll pause for just a moment to compile the Q&A roster. Your first question comes from the line of Jack Allen from Bayard. Your line is open. Your line is open.

Awesome. Thank you so much for taking the questions and congratulations to the team on the progress made throughout the quarter. I'll kick things off with a question on the OPR-GYN program. I realize that the clinical study right now is being run by Roche, but I was wondering if you had any comments as opposed to getting data readout from that 2A study. You do reference the rather rapid time point here with the...

and you got both of them. Dosing is underway in the study, which is confirmable by the fact that at Roche's quarterly update, we have been moved to a phase two program. They only do that after first patient has been initiated. So.

We've got three sites open right now, more sites are expected, but there are two variables that are very hard for us to provide the firm answer on when data be expected. One is that the study could enroll anywhere from 30 to 60 patients.

This is a surgical optimization study, so you can imagine that if there is a variable which is tested and it looks interesting, they may continue to investigate that variable to see if they can squeeze out some more benefit or ease of use.

So we don't know how many patients will be defining the end of enrollment. The other part of the question is whether what we're looking for is full data, such as what might be publicized or at a major medical meeting, versus top-line data. My view is that while subject matter experts surely would like to see B-scans and OCT images, there are no evidence for rule google

The main question I believe that is out there is whether Roche will be able to observe and report the same kind of data as lineage has and Will you find that to be satisfying in 30 patients and 10 patients and five patients and just one patient? So it's very difficult for us to say exactly when the data

will arrive, but we do have this one advantage that is quite meaningful, which is we're going to be getting our data approximately nine months sooner than you might expect because they are both anatomical primary and secondary endpoints. With respect to milestones, the milestones are redacted for competitive reasons.

whether there was a milestone in connection with the current study and we haven't reported one and what you can take from that is that there was not a milestone and that is because that surgical optimization study which is running right now was not originally contemplated when we entered into the deal. So we're very happy that the optimization study is being done. It gives us...

proceed with this study after the deal was already determined, i.e. the milestones were already a place where they belong. So hopefully that is as much of an answer as I can provide on data on milestones and hopefully that can provide at least some insight as to the information that we've been able to provide to date. Great, great. Thank you so much for that, Collier. And then maybe just one very brief follow-up.

I know you had very strong efficacy in the cohort 4 data once you had realized that you had to fully cover the lesion.

The question would be, do you get the sense from Roche as to whether they're looking to optimize efficacy here or could it be that they're also looking to optimize safety? How do you think about their their relative, I guess, objectives with this study?

Yeah, Jack, we think the answer is both. Obviously, cover as much of the area of GA as possible because that's where the efficacy and effect were observed and how best to safely do that. And certainly the group at Roche and many of their social experts are some of the foremost in the world and as Brian alluded to, they may have some ideas on how better to approach both the front of the IPPD retinotomy as well as perhaps other delivery routes. So we await those data and that may be involved in whether it's 30 or...

So obviously with the ARVO data, pictures speak volumes. So I'm just curious, seeing these new imaging analyses and being able to see better coverage, et cetera. Do you think that will impact any of the plans moving forward with regard to still assessing various delivery techniques?

The number one, Ophthalmology Company in the world is to rely on their judgment on those decisions. So, this is a new technology. We have five of potentially the best ever clinical outcomes that you can get in this disease setting, but it's still five. So, is there room for improvement through different approaches, methods?

safety, ease of use, all of these things will really be data-driven decisions, but data-driven decisions that are inextricably linked to Roche's ophthalmology experience.

With respect to OPC1 and the wish list, the device that we are proposing to use has advantages that feel very obvious to us in terms of the ease of use and potentially the safety, maybe even spilling over into efficacy. So in a way that everyone has offered an option for mental health systems to conform with

we'd like to get a green light to be able to deploy that device. It does look like a device that could be used at many more centers than the original method of delivering cells, which required a lot of scaffolding and equipment and the handling and construction of that equipment. So in terms of...

ease of use and deployability, we'd really like to get a green light there. We have not yet taken the new process by which we manufacture the cells and presented that comparability data to FDA because we're doing these things sequentially.

That may help us just be able to continue on under the current I&D, for example. But the agency is aware that we have developed a new process and they know that when we have completed our comparability testing and we are in a position to do so, we will bring all of that data to them. So.

Step one is a clean bill of health to be able to initiate the dose study. And then step two will be to get the cell data in front of the agency. And then longer term we have some really interesting ideas around assessment tools and endpoints. So that would be for a future conversation.

Awesome, thanks for the color Brian . Thank you Jill. Your next question comes from the line of Kristen Kluska from cancer your line is open. Hi good afternoon everybody thanks so much for taking the questions and congrats on these recent data.

The field is really moving towards appreciating and recognizing the advantages related to looking at OCT specifically for GA.

Well, I'm, thank you, Chris, and I appreciate that question. I'm not a doctor, so I use really simple ideas. I feel like it's sort of like the difference between an X-ray and an MRI. OCT gives you almost histological levels of observation, and I think there's been a trend.

toward that as a very informative tool, I in fact had a physician say to me that he doesn't need to see his patients. He can just see the OCT images and knows what to do next. But Gary, do you have anything to add? We might have some additional insights on kind of the state of the art with his imaging technologies. I think this is the statement from A.O. which they consider the gold standard for evaluating the bus to yours.

and the academic efforts, the FDA will also come around. Thank you. And then specifically to this analysis that was reported at ARVO, can you maybe give us a little bit color of understanding why these analyses were conducted to begin with? It seems that before you reported this data,

be the first part is just understanding why they did these studies and then the second part is if they've communicated if anything based off of these studies has changed how they've thought about looking at this ongoing 2a study. I'll take Chris and I'll preface for Gary and just say that I...

While I wish it weren't the case, the reality is the data which are reported from lineage are going to be viewed differently than data which are reported from Roche. So the reason why I've gone to great lengths, the emphasize that these are new analyses, that they hadn't been seen before.

The reinforced art finding is because I'm quite aware that hearing it from Roche can easily mean a lot more to one's evaluation of the data than just hearing it from Lineage team. But Gary, perhaps you could speak a little more specifically to person's question. Yeah, I think Roche looked at this.

sub-study conducted by Doheny, some of the additional analyses by Brandon Lujan and Jordi Moniz and others, and they certainly believed it because that's why they did the deal. But the thought is, is there a way that a much larger pivotal registration study on a global basis......

that you can look at a standardized way to assess the progression or redression of the area of atrophy. And there are certain methodologies that they would appear to be exploring to automate this process and make it reproducible across multiple central reading sites.

Thanks. And then just last question I have for you is based off of all the feedback you're hearing now that the first drug has been officially launched, do you think that having an approved treatment is going to change how physicians and patient appetite to getting diagnosed earlier and doing more routine testing in this landscape? I mean, we often hear from KOLs that even if patients are aware that they could be at risk or there's an indication, they just don't frankly want to know a whole lot about it if there's nothing that a doctor can offer them and now that narrative has changed.

are creative of patients and so you end up with a much more mature and established market landscape than if you're going in there and trying to say to someone who five years ago was told there's nothing I can do for you and now all of a sudden there is an effective therapy

if they don't happen to see your commercial on TV, they're never going to go see their doctor because they don't think there's anything they can do. So I absolutely feel very strongly that it is better for this space, better for these patients, to become smarter about their disease and the education that will occur with the conversations that they have with their physicians. And I can tell you anecdotally through a conversation I had with one surgeon that he has patients coming in off the street.

with printouts of press releases about the recently approved agent and they want it. So I think we've always known that vision is important and now we may have a convergence of that desire for an intervention with the presence of an intervention, which as Roger Bannister said many years ago famously, À prémoile de l'eau...

and educated patient population.

Abby, I think Christian asked to be answer offline, so if we have any others, please let me know.

Your next question comes from the line of Mayok Manteni from B. Riley. Your line is open. Good afternoon. This is Yuan for Mayok. Thank you for taking our questions. Great to see the data update at ARWOL. First, could you maybe discuss if Roche is or has plans to incorporate the ARWOL findings of relying more on OCT during the analysis for their standoff and the

Got it. And our second question is, can you provide any extra color on the MRI findings in your upcoming publication and how this were incorporated into your learnings for your novel delivery system? Yeah, the MRI findings, which you're referring to as a forthcoming publication...

a cavity or a vacancy in the area of injury and that can lead to complication. And of course you cannot conduct an electrical impulse across a gap. So the MRI is a wonderful tool for observing the presence or absence of a cavity and in particular the presence or absence of a cavity.

present, the patient has a cavity or not, and we want to report these data because the rate of cavitation, i.e. the frequency of an open area or a gap in the spinal cord was vastly reduced following administration of OPC1.

So, that is an important and notable finding which speaks to durability of the cells and also provides some very good information for long-term follow-up of the durability of our cells which, again, we see quite easily in the setting of the eye because we have such good access and we're able to replicate that work.

in the spinal cord through the use of an MRI. God, it's sex-phased and helpful, Connor. You bet. Thank you very much. Your final question comes from the line of Michael Okumich from Maxim Group. Your line is open.

Hey guys, thank you for taking the question and congrats on the progress.

So, I guess to start off, you touched on how activity in the space surrounding geographic atrophy highlights the value of the OPERAGIM program, in particular the 5.9 billion acquisition

are the magnitude of effects on the anatomical side, which is vastly greater. You can see from the complement inhibition, what you can imagine is the best possible effect. And it's not a smaller area of GA. These areas of GA always get larger. So on the anatomical side, number one, we've got wonderful data that suggests that we are far beyond the complement inhibitors. Number two, we have an effect on visual acuity.

And I referred the extensive data analysis, the post-clock analyses that are being done, which I feel in many cases are highly selective and are an attempt to find evidence of functional improvement, which in this case would be less loss of vision.

That's not what we have seen. We have seen gains of vision. Now I recognize that vision is assessed with a more variable tool compared to the anatomical changes, but nevertheless the differences between catastrophic vision, I.E. losing 15 letters, or let's see extraordinary gain of 15, 20, 25 letters.

That is such a large difference that I feel it is notable and worthy of some You know some great consideration and then thirdly is the administration Again, we're talking about elderly people who are being asked with despite their extremely poor vision

to get to a clinic, to get an injection. If they want the best effect, they need to have that injection every month. If they want to forfeit a little bit of the already small benefit, then they go every other month. So I really feel like compared to a one-time therapy, we have the triple benefit of a large anatomical effect, a large functional benefit,

and a single administration. And I really think that that is just a much better product profile because when you get down to it, products are driven through sales, through the sales rep and the physician excitement and interest. And it all has to be detailed off of a package insert, which means it all has to be backed up by your data.

All right, thank you. And just to follow up on that point, I'd like to see if you could.

how you envision if the data holds up with what we've seen so far, Opragen and the complement inhibitors fitting into the treatment flow. Would you expect this to be something where, you know, both therapies could be used in tandem, either, you know.

complement to slow down the progression and then you get operaGen to reverse and restore or do you believe that based on the current data at least it's efficient enough that this is something that would potentially you know be a replacement or a competitive offering? Thank you for the clarification. I believe if our data holds up it would be an easy decision whether you're on a complement inhibitor or not to switch to a one-time surgical intervention which holds the promise of halting the expansion of your GA and providing you with a benefit vision in the near term, but I also don't think that it has to be exclusive. Gary, I know you've had some conversations with docs about this and perhaps you can add for Michael.

your thoughts on how these products could be used together or in different sequences? Yes, we've had hypotheses from our scientific study committee and others to suggest it could be used either way. You could try to tamp down the inflammation with the complement inhibitor and then come on with Oprigen. We move to the next part, called TMFA, and we're going to move out but pretty soon start

Or, alternatively, you could put in fresh, healthy RPE cells in Oprigen and then follow that up with a complement inhibitor to help address the patient's own RPE that are still sick and aging.

So, we can see either scenario coming through, ultimately the controlled randomized studies of Obrigin will dictate how it's ultimately used.

And Michael, I'll add a curious point for you because I have a kid of video game playing age that I like to think about the complement inhibitors similar to a tower defense video game where you are using an agent that is going to slow down the disease process.

To my mind, that will create a pooling, a clogging, a greater number of patients in an addressable zone for treatment for Opragen. Because if you're slowing the progression of GA as more and more people demographically are getting into a treatment, the beginning, the early phase of treatment, you're going

But they stay there longer because they've got, let's say, 20% slower growth. You will mathematically end up with more people in a treatment paradigm opportunity for offergen. Thank you. One last one for me and then I'll hop back in the queue. I just like to ask on the, um...

one of your preclinical programs. Can you talk about the role of the B2M deficiency in your collaboration with turnip for CNS disorders?

Absolutely, I'm glad you asked. We don't always have time to put everything into these calls or press releases, but the ETERNA collaboration is an option agreement which is part of a seed planting process. A company that believes it's going to be successful with its lead...

of your cells or perhaps some additional properties of your cells. So this is the convergence of engineering and biology.

Eterna has a very suitable ex vivo editing technology. We do not need to get involved in the assessment of the ex vivo editing technology.

In vivo editors because we're able to develop lines and then test the material before it goes into patients. So we can rely on any number of alternate editing technologies.

B2M and specifically dealing with the MHC class 1 proteins is of course around rejection. Now we've never had a report of rejection of ourselves across any of our programs, but we have interest in a number of other areas and applications of our technology and gaining experience.

there are a number of them that are relevant. HLAG, HLAE, CD47, there are a bunch of things that different companies are doing and we actually benefit from watching and reading their data to see what seems to be encouraging or seems to be less encouraging. So we don't have anything to say other than generally we are interested in...

do so, and that would, of course, include specific applications of future cell types. All right. Thank you very much for that, Brian . And again, congrats on the progress. Thank you. There are no further questions at this time. Mr. Brian Kelly, I turn the call back over to you. Thank you, Anna. Thank you, everyone, for joining today, and we will look at the next

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