Q3 2025 Lineage Cell Therapeutics Inc Earnings Call
Welcome to the lineage saw Therapeutics third quarter 2025 conference call. At this time. All participants are in a listen-only mode. An audio webcast of this call is available on the investor section of lineages website at www.lineage.com. This call is subject to copyright and is the property of lineage and the 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. I would now like to introduce your host, for today's call Ayanna hon, head of investor relations at lineage Miss Holmes.
Please go ahead.
Thank you, Angela.
Good afternoon and thank you for joining us.
A press release.
Reporting our third.
2025 and can be found on the investors section of our website. 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.
Statements made during this discussion that are not statements of historical facts. 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 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, 10 K. And in subsequent SEC filings, 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 are Brian Cully, our chief executive officer and Jill, how our Chief Financial Officer. I'll now hand the call over to Brian.
Thank you, Ana. Good afternoon, everyone. We appreciate you taking the time to join us on the call today.
I'll begin with a update on our lead program offering then review our progress against the 5 strategic goals, which I outlined for you. Last quarter.
In addition, I'll provide some insights on our pipeline strategy before concluding with some information.
On our eyelids cells.
And I will hand the call to jail for a review of our financials before taking questions from our analysts.
I want to begin with an update on operation because there have been some very exciting advancements in the ongoing. Phase 2A, collect study or pleased to update you that Janet is continuing to expand the retinol community's exposure and experience with opportunity.
In particular, Genentech opened 2 new clinical sites last month, and 5 new clinical sites were opened during the prior quarter.
Overall 8 clinical sites have been opened in just the past 6 months. Bringing us to a total of 15 unique locations.
In comparison.
Genentech opened only 1 new site in all of 2024. So we take this site expansion to be a positive sign.
As a reminder, we don't have full visibility into the glass study enrollment or its findings, but the study has been running for more than 2 years and it is an open label trial for which all primary and secondary outcome, measures are captured at 90 days.
Given that there has been abundant time for Genentech to collect outcomes data in year 1 and they more than doubled the number of sites in year 2 we interpret this acceleration of their clinical efforts to be a positive signal for the future of this program.
Clinical sites is.
Of course, just 1 element.
To our belief that things are going well for operation.
Technology.
For example.
Since the study began jentech reported its own 24 and 6. Uh excuse me, 36 months analyses from the lineage phase 12a trial.
That data showed that as a group patients, who received a 1-time dose of opportun rpe cells across large areas of their GA enjoyed improvements in retinal structure. Consistent and durable increases in visual Acuity and an acceptable, safety profile.
These are remarkable clinical findings because patients with GA. Don't selfheal
And earlier this year.
These outcomes were independently validated by similar reports coming from three other groups, each using their own version of an RPE suspension.
1 of those competing entities is a multinational pharmaceutical company which we believe further supports the commercial potential of our cell transplant approach.
As a further, reminder.
A year ago, rosh was streamlining, its Pipeline and eliminated a set of development programs.
With quote, best-in-class potential.
Around the same time, row elected to seek and successfully received our mat designation for oportun.
And more recently genetic shared that they would be evaluating 2. Next Generation delivery devices.
Acquired specifically for the opportunity program and which have the potential to not only improve the safety and success of the cell transplant procedure, but may also offer a significant competitive advantage over companies that lack. Both, this specialized equipment and the extensive delivery experience of our partner row.
When you aggregate.
All of these public.
That I did not list all of them today.
But I hope you will appreciate why we are bullish on the future of operation to treat GA patients and why we are taking steps to try to repeat the success with other cell types.
So given what appears to be a steadily growing list of asymmetrically positive indicators for the successful advancement of opportunity into a controlled clinical trial. And while still noting the ultimate
Decision to advance the program is solely with our partners Roshan Genentech. We have increasingly been thinking about how we can create value from the clinical Technical and financial success.
That we're anticipating from opportunity.
With that in mind, I will turn next to some statements I made on our prior quarterly call to get a scorecard on how we've been doing.
Last quarter I outlined 5 areas of focus through the end of this year. And I'm pleased to report that we have already successfully delivered on several of those strategic initiatives. And we still have nearly 2 months to go.
Our first goal was to enter into deals, which partly or completely fund existing product candidates.
We accomplished this goal through the partnership. We announced with William de menthe. Investor wdi which is expected to fund up to 12 million dollars in research and collaboration costs. For all planned pre-clinical development of resonance. Our first internally developed cell transplant program for the treatment of hearing loss.
residents was an important test for our business model because it shows that we could conceive of
manufacturer a new cell-based product candidate.
generate new intellectual property and Advance it into initial, preclinical testing, in approximately 1 year and with the modest initial investment
And soon thereafter we signed a collaboration agreement with wdi which is a world-leading hearing Healthcare Company, securing external funding leading to an IND or CTA. If the data supports it,
And also provides access to technology, expertise in a network of hearing Health leaders.
We and wdi also have preserved, the right to enter into a future clinical. Andor commercial deal with a Pharma partner.
If such an opportunity does arise.
I believe this collaboration was an important demonstration of the speed efficiency and return on investment that the lineage platform can provide and provides evidence to support our strategy of replicating. Our, our opportunity and success with other cell transplant programs
In addition to funding existing assets.
Our second goal was creating new assets which could attract external funding or collaborations.
Our expectation, is that we would then disclose our next intended indication before our next quarterly call.
Our third goal was to capitalize on.
We Believe.
Could solve issues which impede others programs from success.
Our new initiative in islet cell production is an example of how we're trying to meet this goal. Specifically
We're looking to tackle the major limitations in production scale which must be solved in order to have a commercially viable cell therapy product for Type 1 diabetes.
If we are successful with this initiative, our Innovations could be applicable to other programs.
Potentially opening the door to conditions, previously, thought to be too big, and too expensive to address with cell therapy.
At scale, affordability is in fact, the entire point of allogenic off-the-shelf product development, so achieving this goal would Mark a crucial moment for the field.
Our fourth goal was to obtain a serum, Clint 2, Grant which we applied for earlier this year.
Serum has employed a new review process and our understanding of that process is that only 7 applications were Advanced out of an initial larger pool of candidates.
We were among those 7 finalists.
Since that selection to the final 7, we have answered a series of questions from the grants working group, but we have not received a grant score or any indication of whether we ultimately will receive a grant or not.
however, we believe the finalists will be voted on at
serm icoc meeting on December 11th.
Therefore assuming serm maintains its planned timing and we have interpreted their uh, plans correctly. We should know our status toward meeting our fourth goal in about 4 or 5 weeks.
And by the way,
if we do receive certain funding, it would provide a very nice non-dilutive offset of up to approximately 7 million from the ongoing dose study of OPC 1 for spinal cord injury.
The last of the 5 goals I outlined for the quarter was to complete activities, leading to Milestone revenues from our partnership with rosh and zhinantech.
As you already know, I cannot speak to our Milestones or their amounts until such time as they are met.
But it remains an important activity, it is a top priority and I am pleased with our progress related to this effort.
As a final Point most of the goals we have focused on are tied in some way to an expansion of our business. For example expanding the scope of the OPC 1 Study via serum Grant or expanding the output of new apps from our in-house manufacturing platform.
These are intentional moves by us.
Because they reflect the convergence of 3. Key factors 1, the reduction to practice of our high-scale GMP banking system which we announced a few months ago.
2, the emergence of a more favorable biotech Market, which has improved the cost of capital from which we can fund judicious and stepwise expansion.
And 3 the belief that the Arjun program will continue to advance under our roast Chen and Tech Alliance and provide us with the credibility confidence and capital to take our platform further than where it.
We have been eagerly awaiting a time when this accumulation of factors would align and permit us to elevate. Lineages growth, trajectory we believe this momentum began in the second half of this year and expected to continue during 2026.
I should add at this point that while we aim in time to create a basket of cell therapy assets, some of which we might choose to develop internally and some of which we might partner, I have been asked on occasion how we as a
small company which has long demonstrated, such fiscal discipline. How would we manage a larger portfolio?
The answer is clear our core technology. Our platform generates assets, which share essential traits in common,
Traits occur early enough in a project that they're not dependent on us. Having a huge body of disease specific expertise.
Our technology is based foremost on the directed differentiation of pluripotent cells into discrete and scalable cell types of the human body. And while each product candidate is, of course, intended, for a different condition and each cell line, behaves in a unique manner, the early and necessary steps of process development control scale and Purity are largely common features in the way we apply them.
Is necessary to succeed or without requiring. An excessive amount of capital investment.
and by adapting or initiating each program on the same process development modality,
we are generating more shots on goal per dollar invested.
Platform expansion as a convenient transition point.
I'll turn lastly to an explanation of our recently revealed eyelet cell initiative.
The human body is comprised of about 200 discrete cell types, and because pluripotent cells can become any of those 200 cell types. We have many choices about where to deploy our resources into new product candidates.
When we were nearly 100% focused on operating this selection process was largely running in the background.
Our initial pilot effort from the strategy was our program and auditory neurons because we knew auditory neurons represented a high quality opportunity.
And based on our recent collaboration with wdi that has proven to be true.
But there are many other cell types, we could tackle. And as opposition's future brightened, we have increasingly emphasized and acted on our plans to repeat our opinion success.
To that end. We hired a former venture capitalist who built for us a proprietary opportunity tracker.
The basic idea for that tracker is that you Matrix? Each of your product opportunities against dozens of product characteristics, such as the addressable Market, the quality of translational models and many other aspects
Including, of course, our proprietary manufacturing insights.
And from the thousands of data points.
Which are generated.
We can identify our best potential Returns on investments.
One of the top outputs from this proprietary process was the opportunity for us to enter the type 1 diabetes space.
Our work identified three main obstacles preventing cell transplantation from providing a commercially feasible functional cure for type 1 diabetes patients.
The first of these was the mechanism.
but multiple companies have since shown that indeed an eyelet cell transplant can achieve insulin Independence for patients
The second obstacle is a need for Lifetime immune suppression, which is not a commercially feasible solution for the vast majority of patients.
Several attempts to eliminate the need for immunosuppression have been explored. This is capsules or droplets but we find the recent evidence from genetically edited hypo cells to be the most attractive approach 1, which has created a line of sight on breaching that second obstacle.
That leaves only the third major hurdle, which is production scale.
Cadavers are not a sustainable or stable source of eyelet cells.
But pluripotent cells are sell renewing.
So they can solve those deficiencies.
However, while a single poly potent cell can give rise to thousands of rpe cells in our system.
You can only get a dozen or so eyelet cells from each per potent, sell that you start with.
And because the anticipated dose levels are as high as a billion cells per patient. You're not really a commercially viable product until and unless you can overcome the biological ceiling imposed by the generally accepted differentiation processes that exist today.
I obviously cannot go into detail for competitive reasons, but the gist of the matter is that we have conducted some early work that suggests we may be able to increase our already large-scale production process by many thousands-fold.
If we are successful, this could increase our relevance in the race, to develop a functional cure for type 1, diabetes.
Our initial goal for this program is to demonstrate our capability with 1 of our proprietary and best behaving cell lines.
This initial work is ongoing and intended to lead to a go no-go decision on further development which we will expect to occur next quarter.
If the initial work with an internal cell line is successful.
We believe it could accelerate partnership conversations for this program.
And in parallel with any such talks, we would also seek to demonstrate system compatibility with a hypo team, cell line, either internally or externally sourced, which would be a more suitable line from which to support a clinical campaign.
And depending of course on the results and feedback we collect along the way. We may elect to do this work for a partner or retain the product internally for a longer period.
So to summarize.
we believe we can reach an initial feasibility decision on this t1d initiative with a modest investment and just a few more months of work,
Which we can apply.
To improve the efficiency of our existing programs.
So, with that, I'll turn things over to Jill for a review of our financials.
Thanks Brian and good afternoon everyone.
As of September 30th 2025 our overall cash position was 40.5 Million. This amount is expected to support our planned operations into Q2 of 2027, which is 1 quarter longer than we got it to on our last call.
The biggest contributor to the longer Runway. We are reporting today is Cash. We have already received from our new alliance with wdi. This we also continue to pursue other sources of funding like the storm grants.
To support the dose study and Milestone payments. We are eligible for under the row. Genentech collaboration agreement as well as any additional Partnerships, which we may elect to enter into in the future.
Separately a large additional source of potential cash is the approximately 37 million of Warrant Capital? We may receive if Roshan Genentech publicly disclosed their intent to Advanced operation and to a clinical trial with the comparator arm and our investors exercise, their warrants in cash.
Now, let me review our third quarter results.
Our revenue is generated primarily from collaboration Revenue royalties and other revenues. Total revenues were 3.7 million. A decrease of approximately 0.1 million as compared to 3.8 million for the same period in 2024. The decreases primarily driven by lower royalty revenue and other service revenues recognized as 3 million partially offset by more collaboration revenues of 0.2 million.
Our operating expenses are primarily comprised of R&D and Gen X expenses. Total operating expenses for the third quarter. Were 7.5 million a decrease of 0.1 million as compared to 7.6 million for the same period in 2024.
Our R&D expenses were 3.3 million and increase of 0.1 million as compared to 3.2 million substance period in 2024.
The net increase was primarily driven by 0.2 million for our OPC 1 program, 0.4 million for our pre-clinical programs and other undisclosed programs partially offset 5.5 million for our opportunity program.
Our GNA expenses were 4.2 million. A decrease of 0.2 million is compared to 4.4 million for the same period in 2024. This decreases primarily attributable to stock based compensation expenses and services provided by Third parties?
We lost some operations with $3.8 million, which was in line with the comparative prior period.
Um loss other income expenses, reflected other expenses of 26 million compared to other income of 0.8 million for the same period in 2024. The change was largely attributable to the non-cash quarterly fair value remeasurement of the foreign liabilities of 26.66 million compared primarily due to change in our share price as compared to the prior year and point 2 million for exchange rate. Fluctuations related to lineages International City areas
The net loss was 29.8 million or 13 cents per share compared to a net loss of 3 million or 2 cents per share for the same period in 2024. The change was primarily driven by the aforementioned warrant liability.
Our financial results continue to reflect our ongoing dedication to responsible fiscal management and we remain focused on balancing. Our cost of capital with the Investments, we make to grow and strengthen our Pipelines.
So with that, I'll hand the call back to Brian.
Thanks Jill. So I will quickly summarize by repeating 2 key themes. First we remain confident in the potential for opportunity to drive positive, clinical outcomes and dry AMD. And we are encouraged by our partners signs of commitment to the program.
We also believe the independent evidence generated by others. Rpe cell transplant. Trials, supports and elevates our place and restore philosophy.
Second, we're preparing for a successful future by making new investments in our cell transplant platforms and using our recent manufacturing innovations as a foundation from which additional pipeline programs can be advanced either via.
Partnerships or independently.
We believe our approach offers powerful optionality, which we consider essential for a company at our stage of growth and development.
We appreciate your support and belief in our vision and with that, operator, we are ready to take anyone's questions.
Thank you. We will now begin the question and answer session if you have dialed in and would like to ask a question. Please press star 1 on your telephone keypad to raise your hand and join the queue. If you would like to redo your questions and could press star 1 again, thank you. And your first question comes from the line of mayank magnani with B Riley Securities. Your line is now, open.
Hi, yes, thanks. Sorry for the pause there. Uh, this is William on, for mayank, uh, congratulations on a very nice quarter, uh, a couple from us if we met, um, just kind of curious. Um, in terms of your, uh, the considerations for your, uh, eyelet sell program. You mentioned that those sort of, uh, go no go decision in the works, you know? I was consider, uh, Curious. What the internal considerations are incorporated into that for uh on how to move forward. Um and then um,
I'm just also kind of curious in terms of, uh, Partnerships. You obviously mentioned the William deont collaboration. Um, how should we think you, how should we be thinking about and, uh, additional Partnerships? Um, are you still looking to extend additional collaborations or, um, sort of what's the ballpark or the goalposts internal goal that you're looking for, um, to complete and, and and whether it's based on sort of capital or or capacity-wise.
Program. Um,
due to the biological ceiling which exists in differentiation protocols today.
The um opportunity to really step function change the the the process by which you differentiate is probably fairly limited and and probably not a solution that that would lead to the kind of scale that we're talking about.
but,
If you can start with a much larger number of cells that biological ceiling becomes less relevant. So our efforts are aimed at some of the earliest steps.
So that by the time you get to the later steps which are let's say capped
You're already on track for the kinds of output that you need to get. So it at the end of the day, it's a mathematical formula where you start with let's say 100 trillion cells per year and you need to work backwards through various size of vessels. How long does it take to turn around a batch of product? And ultimately all the way back to the earliest steps? And if you do not maximize the earliest steps, sufficiently
You will never reach the kind of output that is required to have a commercially viable product. You would perhaps create an interesting Niche product but that's not really our objective here.
So we have a lot of experience with this part of the process development activity and so we are working on some uh fairly straightforward efforts and if we can knock down the barriers in the earliest steps, we think that that provides a credible line of sight to conduct the same activities with some other cell lines at potential Partners could have or be able to do it with our own cell line and be able to just continue on the process. Obviously, we are not saying that we can or need to in the initial days.
Show someone that we can make a hundred trillion cells but rather we want to show the modality. The platform has that capability and then of course, there's risk inherent in actually reducing that fully to practice but
That is.
Partnered all the time. In this industry, people people partner pre-clinical programs or Phase 1 programs. Not knowing if they will ever ever generate revenues so it's analogous to that. It just happens to have an emphasis in the early stage scale.
The second question you asked was regarding Partnerships. So you know, I'm very proud of the team for identifying demant as a bit of an atypical partner for us. However, their ideal for us because of their hearing expertise. Um we don't have an OP priori objective to find atypical Partnerships. Um nor do we oppose them, um, you know, they must be fit for purpose.
Because we lack hearing loss, expertise William de menthe. Invest is a terrific choice for us.
It gets partnered or not has many inputs 1 of those. Inputs certainly is, what is the cost and what is the risk and and and when would it be appreciated by the investment Community versus being appreciated by a partner? Um, that's not a question that we can really answer because it depends in large part on our cost of capital. So if we have an unattractive, share price, it makes sense to rely on Partners to advance programs. If we have a more reasonable share price, we have the lovely opportunity to hold on to things a little bit longer, create more value. So it really comes back ultimately to the business of value creation, and value creation per share. So there are other factors that, you know, I I can, I won't go into them. But but ultimately all of the factors come together and we then make an assessment of whether now is the right time to do a partnership and with whom
Got it. That's very helpful. Thank you. Brian. Uh, 1 more, if I may just briefly on OPC 1. Congratulations on the on your first, uh, SBI patient being dosed. Um, I was just curious, um, based on sort of, if the, the patient, uh, is affected. Say, in this case, from T1, to T10, uh, I believe originally at least pre-clinical the OPC 1, uh, or opcs in general could migrate approximately about 5 centimeters and so, just thinking about the the span of injury there, um, even if it's, uh, originally at a single site is there.
Potential here for OPC 1 to be administered. Uh or dosed at multiple sites to achieve greater coverage along the spinal cord.
Your your question is correct. The first patient was a thoracic injury patient. Um, we have in Prior cases
had patients that received cells in 2 separate locations during the same surgery, so I would describe it as saying, approximately, half the dose was administered on 1 side of the lesion and the other the remainder of the dose was delivered on the other side of the lesions. So you're asking a very interesting question? Can you, can you deliver multiple doses? Multiple locations. The short answer is. Yes. Is there benefit from redosing down the road? We don't know the answer to that yet.
But we have what we consider to be a very strong safety profile for OPC 1. So it would be something that we would like to investigate. And we know of no reason why 1 could not receive uh multiple doses of the of the product. Even at the even at the full dose of 20 million cells.
Got it. Thanks Brian. Congratulations again and we'll hop back to the queue.
Your next question comes from the line of
K with HC way, right? Your line is now open.
Hey everybody. Good afternoon. Thanks for taking the question.
Sir Grant. Um, whether it's 7 million or what have you, I wanted to Simply ask um based on your commentary how you feel the additional funding might expand or accelerate the program?
Uh, thanks Joe. Um so yeah, we don't know if we will get, we don't know final amount because the way that the funding works is there's a bit of a bring down exercise where they uh check on your budget to make sure it aligns with your original application. Nothing significant has changed but in the
Ideal case for us. Uh, we would be somewhere, you know, maybe just a little north of 7 million. Um, this would accomplish multiple things for us.
Uh the first is that we would feel uh emboldened to expand the number of sites and be more aggressive about recruiting patients. Um, because we have both acute and chronic injury patients, that will be enrolled. Acute, injury patients are harder to find because you have a window where they are uh, eligible for your trial. So you it's good to
Cast a wide net.
Cash that we would, otherwise plan to spend on this trial. So it's a very nice pickup but just to be clear, if anyone who's listening is not certain about this, uh, serum does not hand you a check for the full amount. It is essentially a reimbursement. So there's a delay and a Stager, but you are, if you conduct all the activities and the program continues, you are likely to collect the full amount of the, uh, of the grant over the multi-year period.
That's very helpful. Thank you for that. Um, next question a bit of housekeeping, housekeeping, probably, a little rhetorical, uh, for Jill. Um, with regard to your cash Runway. Um, are any of the rosh Milestones or Beyond included in that Runway or it's basically uh, you'll update when they happen?
Yeah, that's right Joe. So it's not included.
We are able to achieve those milestones and they get added into our exist, our on our forward, Runway, excuse me.
Perfect. And then Brian. My last question is really about your longer term business model. Um, you obviously have a foundational platform with all of the different, um, sell directions, you can take here. So
Looking deep into the future and I know this is, uh, difficult. Can you tell us how? Or, you know, why or why not lineage could become a tool or sell services company as part of its approach?
I hope we never do uh, is my answer. Um, the problem is that, I think, um, it remains difficult to do the work that we do. Um, we have the lovely advantage of of having been around and involved in this, in this technology for over 20 years. Uh, so I think we've gotten quite good at it. But nevertheless, it's difficult to price the development of the the recipe by which you, uh, develop.
Sell because you don't know how long it's going to take. So, it's not a a easily, it's not a widget that you can easily price, um, the other, uh, factor with respect to sort of behaving like a cdmo, is it? Uh, those margins tend to be unattractive to me. Um, I want through our Partnerships to have significant ownership in the upside. Um, we're not particularly interested in in doing fee for service work. We do have an exquisitely, well-trained team, but we also have a small facility so we don't really have the capacity to do that. There are some scenarios that I think are worth considering, which are, uh, whether we have some intellectual property or some other technology that perhaps an alliance with 1 of those cdmos would make sense, especially in areas that we have deemed, not to be of interest to us, because there are plenty of people who are working on self therapy programs that we wouldn't touch.
You know, the fact that they have raised capital and and perhaps some of that Capital could find its way to flow back to lineage would be fantastic. So, you know, do we have formulation technology or storage technology or process technology? Um, and could that be utilized by others in sort of a multi-handler do that by by separating by getting a big return on investment. IE separating the amount of money required to launch a new program from the amount of money we get from a partnership. And and I think that both the rosh agreement and the wdi Agreements are really good examples of that are upfront or are reimbursed amount is greater than the amount that we put into to invent these things. So I I think it
If we can continue to find those opportunities, um we will be less reliant on the capital markets than perhaps we would if we did not conduct those uh, strategies.
Rate really appreciate that uh and Sarah as well as all the others. Thanks a lot.
Thank you, Jill.
Your next question comes from the line of
Jack Allen from Barrett. You mean, uh, your line is now open.
Hi. Uh, this is Charlie on for Jack. Thank you for taking our questions. Um, so just to start with the dose study. Uh, could you remind us of any interpatient stagger requirements there how quickly you could do patients and what sort of data set you envision collecting, uh, before announcing initial data, as well as? Uh, with this first chronic patient? Could you let us know when they were dose and how we should think about the stability of their motor function prior to doing? Uh thanks and then I have a follow-up afterwards
So the dose study does have a Stager. Um, the first patient was a thoracic AJ and the next patient will be a thoracic HB. And then, the third patient will be thoracic, A or B. And then we can do our first cervical patient. Um, and, and those steps that I outlined can be either chronic or Subacute, um, at that point.
We then go into open enrollment.
For an additional 2 to, uh, 6 patients.
The um data set. Um we have already provided initial data we have shared that the new device had performed a delivered. The cells in its intended way. Um and that is the primary objective of this study was to assess the safety and performance. However I recognize that the investment Community is, you know, more intrigued by the possibility of seeing some functional Improvement in patients especially chronic patients. And I think that's the right thing to be excited about.
The, um, the status of the patient, the stability of the patient is not known to me, um, but in any case, the patient was dosed on July 30th. So approximately 2 months ago. So we would assume that that would be too soon to report on any sort of functional changes that they might, uh, be experiencing
If they are experiencing any at all, um, and that is because there can be some variability even among chronic injury patients and we would not want to get ahead of the story and I would point no further than the opportune program. When we first identified retinol restoration, we didn't go public for 9 months because it was such an extraordinary claim. Frankly, we needed to make sure we had a lot of independent and blinded reviews of that data before we went out to speak about it and and by doing so, we were able to speak quite credibly about it. We would imagine the same approach with respect to the dose study, so we will continue to watch the this patient. Um, there is a stagger, the patients go approximately a month and they have to pull together your dsmb, uh, and then they go through the review before you get cleared. Um, so what I, what I really can only say about the patient at this point is that there have been no significant.
Safety events and uh, that's through the first 60 days following the treatment, so that's great. And the device seemed to work the way it was intended. So that's great. Um, and we will continue and, you know, I think it's really more of a 2026 story for this trial.
Wonderful, thank you for the color there and uh, helping to unpack that multifaceted question. Um, for the follow-up uh, just curious.
Excuse me, on the upper gen uh program. Um have you has row? Given you a sense for the degree of follow-up? They'd like to see from patients treated in the gallette study, prior to moving into a pivotal trial. And is there any kind of description of a data package? They're working toward that we should keep in mind and that will do it for us. Thank you.
Sesame's.
Our uh, through 90 days. So the 2 primary areas and the secondary assessment occur within uh 90 days. So um, now that that is not inclusive of, you know, longer term functional data. So those data of course, do get collected. Those patients are on study for for years, but the initial questions that should be framing decisions. Occur, very rapidly. So that's in part why? We're so encouraged by seeing the expansion and the continuation of this of this program is that if it were a disaster presumably that would be quite easy to know. Um, but we do not know what the plans are for the data package and it's probably worth reminding. Everyone that this is not a conventional Phase 2 study.
Um, there is no prespecified endpoint. It is not a responders analysis. The way that we often see Phase 2 responders analysis. This is surgical optimization
Or when it will occur, we just know that it's an end point. That is difficult to miss.
It occurs very rapidly and there seemed to be a lot of um activities which I outlined on the call today, that would suggest that things are going well. So we're hopeful that, uh, we're correct in interpreting these events. And that, um, you know, at some point in the future, we will all learn the very specific answer to your question.
I would add to that that this is a new technology um, optimization surgical optimization. Presumably could continue for many, many years. That would not be unusual to me in any way but at some point saying that you feel comfortable enough to continue development because there's a clock, ticking of course, there are some competitors and you know, there are hope for revenues out there. So, you know, I think that there is tension between optimizing to Perfection which is an unrealistic goal in the short term and moving forward into, you know, aggressive development. And I trust that our partners who have been so profoundly successful in Ophthalmology, product development, know exactly what they are doing. And I have no problem saying they surely know better about how to do this than we do. So we believe the asset is in the very best and most capable hands possible. And if through their work they are ultimately increasing the future Peak sale.
Of this product. If they are increasing the probability of success of this product, then we are quite comfortable, waiting for their timelines to hit, so that we can all enjoy success.
Wonderful makes a lot of sense. Thanks so much for the thorough answer. Brian.
Your next.
Fight, uh, Partners your line is now open.
Great thanks. This is crazy man. Um just uh quickly on upper Jen are there any conferences where you think the next data update could be presented, or have you spoken to janete cro on their intention of presenting more data?
Discussions about upcoming presentations. And you know, we share content at some point, uh, before but with respect to what I believe you're really aiming at which is the, uh, which is, you know, a disclosure of full galette data or at least some form of glet data. Uh, we do not know their plans and so we, we, we just like, you look at the calendar and we just imagine different events and forums where that could occur, but we don't know. Uh, it could be something that spontaneously comes out at Hawk.
A farm a day and Opthalmology day a random day Monday. Like we just don't know.
got it and maybe on the serum Grant, um,
I guess what happens if you don't get certain funding, uh how does that impact your program?
To go through the effort to put together a really fantastic application. It's probably a phone call to really try to understand why. Because we feel like the fit for this.
Program is right in the center of the bullseye for serums Mission. Um but ultimately it changes very little. The program will continue. We will continue to find and identify patients. We need to demonstrate that this new device is adequate and sufficient to support a larger trial. We need to bridge in the new cells that we have prepared and tested. And all of that work will continue. We would just regret that we were not successful.
In security.
Um, external and and very good cost of capital support for the program, and the way that we've envisioned it for so long.
The runway, by the way, that we described does not include any serum dollars. So, you know, potentially there would be a pickup depending on uh, how close to the edges. We are on a on a quarter there.
Great. Thank you very much for taking my questions. Thank you Boris.
Your next question comes from the line of shun mutant with Raymond James, your line is now open.
The dose study maybe remind us of the safety waiting period and uh progress you're making in terms of identifying patients uh to be treated. Thanks.
Thanks Sean. Yeah. The
Nav was that we could accelerate things by um, not having the new cells, be a separate study. So our strategy is to have the cells introduced, uh, more or less at the end of the dose study. Uh, does that mean that the dose study gets larger? Not necessarily. It depends on the next part of your question, which is the FDA dialogue.
Have been preparing the package to take all of that information to FDA so that we could find out what it uh you know what, what exactly the path will need to be. Um so potentially they the agency would say you can introduce these cells into the dose study in the last you know 4 or 5 patients, the last 1 or 2 patients. Maybe they'll ask us to add 4 or 5 patients at the end, but we're trying to accelerate and compress timelines by not doing it as a separate campaign.
Um, with respect to the, uh, the the, uh, the gating of patients and the waiting period. Uh, I think I mentioned before, it's, it's, it's about a month. But then you've got this sort of
Practical reality of assembling, you know, collecting your data preparing, your data, assembling it for your data, safety monitoring board, getting them to discuss and say everything is okay. And then going back to your sites and saying it's it's okay to go. I I mean, on average, it's hard for me to estimate because we don't have a lot of experience running spinal cord trials. The the prior data was collected by others but I would estimate that the turnaround time would be uh quarterly because you've got the explicit stagger and then you've got the implied stagger um but it also will be a function of additional sites. So you know, 1 of the convenient uh nuances of what we've done here is we wanted to start slowly because we wanted to make sure that the new device was going well. And we also had to start slowly because we had a Stager, but conveniently we've been waiting for a serum output so serums not funding any of this currently. So, just at the time that we would hope to be getting out of a Stager and opening more sites.
Sites. Uh, we may be having partial reimbursement from serum, so the it all sort of is, you know, coming together in the most economically feasible way. Um, and I think that that makes sense for for where we are as a business. And as I said before around, you know, around our our cost of capital. So you can expect to see more activity with the study. You can expect us to see having that FDA engagement and you can expect to hear more detail from us on timing as we secure that timing and information from f.
Understood. Thanks Brian.
Your next question.
Hello, your line is now open.
Hi. Um, I noticed that Rosh highlights the Opera Gen program in an investor event they held in September and discussed these new devices that they acquired for the procedure. Can you just give us some more color around the capability of these devices?
I'd be happy to there. Are 2 basic ways.
To access the subretinal space.
And everyone should be reminded that you must deliver the opportunity cells to the subretinal space. These these cells are not working at Big distances. They are a transplant. So they have to go where the rpe cells belong.
And you can go through the front of the eye, which is trans vitriol.
Or there's a newer technology or newer method, which is super Coral, which goes around and accesses the subretinal space from the the back of the eye. So front door or back door, um, each of those devices that, uh, Rose described on their their recent, uh, Farm a day or, or Opthalmology day. I don't recall, which, uh, each of those is a Next Generation version. So the trans vitriol is an improved version of
What is off-the-shelf and the supercarro is also an improved version of the the technology that we first demonstrated in these patients in our Phase 1 study that we uh acquired a license to uh gyroscope That Was Then acquired by Novartis. So they have trade-offs, the front of the eye and the back of the eye are just different. We do not know and I I don't know if Roche and Genentech have decided but we do not know as lineage, which of the 2 is superior. 1 is very straightforward. You can see everything you're doing. It's very off-the-shelf.
Requires some specialized training and some specialized tools, but it may have some advantages. Um, ultimately we're going to have to wait and see what kind of information from these devices comes from it. And I, I do want to caution everyone that there's no guarantee that our partners are going to tell us all what they found. Um, you know, when I look at some of the competitor data, I feel that they are advantaged in a way because we at lineage showed them where to put the cells.
Uh so if you go around telling everyone every piece of data that you discover in a way you can be enabling your competitors. So it's very important because the the warrant the 37 million dollars of of Warrant Capital that you'll described that was intentionally designed with Milestone language that did not uh that was uncoupled from specific devices or data presentations. It's simply and solely required, our partners to disclose their intent, to run a controlled or comparative armed study. So it's it's some of a lower bar, but it was intentionally written that way to capture the possibility that
They might say that they're going forward and not tell everyone why, but that's okay. We still would stand to, um, you know, interpret that as a very big positive, but of course, we're hopeful that they will, you know, be comfortable, sharing everything that they like. And I think given that at 1 of those conferences, um, you know, the global franchise
Said that they wanted.
Pioneer innovation in Vision restoration um in in the context of of words talking about going Beyond compliment, uh, I I think that they're going to find some interesting things. I think they're going to be proud. I think they're going to want to show off.
And I think that'll be great for us in our shareholders.
Great. Thank you.
Thank you, Albert.
There are no further questions. I will not turn the call back over to Mr. Brian, Kelly for closing remarks,
I think it's
it's a bit Misfortune a bit of Misfortune that there's a lot of, um, you know, discouraging news around selling gene therapy. You know, we've all seen the news from teada and Galapagos and Novo. Um, I think it's important to keep in mind that uh, lineage is not doing a togus carti. Um, what we are doing is quite different and the criticisms that maybe levied against certain kinds of cell therapy, may not be entirely applicable to what we're doing. So, I invite everyone to go deeper and really consider how we are distinguishing ourselves through manufacturing and our basic approach of developing allogenic off-the-shelf self transplants. Uh, and then, uh, please contact us. If you have any questions, we're uh, really happy about how things are going. Thanks for your attention.
Ladies and gentlemen, that concludes today's call, thank you all for joining. You may now disconnect