Q2 2020 Lineage Cell Therapeutics Inc Earnings Call
[music].
Welcome to delineate cell therapeutics second quarter, So many Chinese conference call.
This time, all participants are in listen only mode.
I'd a webcast of today's call is available on the Investor section.
<unk> website at Www dot lineage cells dotcom.
This call is subject to copyright and is the property, you'll see any age hey recordings reproduction or transmission of the school. We don't expressed written consent Oh maneesh are strictly prohibited.
As a reminder to the east coast being recorded.
Oh, no likes to introduce your host for today's call in French you want to home director of Investor Relations that they need each Michelle. Please go ahead.
I think that you know good afternoon, and thank you for joining US a press release reporting our second quarter 2020 financial results was issued earlier today August six 2020 and can be found on the Investor section of our website. Please note that today's conference call and webcast will contain forward looking statements.
Within the meeting a federal securities laws, including statements regarding our strategy goal product candidates clinical trials financing and cost savings matters.
Such statements are subject to significant risks and uncertainties, including those described in our press release issued on August six 2020, and our most recent form 10-K and 10-Q filing.
Actual results or performance may differ materially from the expectations indicated by are forward looking statements do those risks and uncertainties. We caution you not to place undue reliance on any of the forward looking statements, which speak only as of today.
Joining us today, our Chief Executive Officer, Brian Colley, Our Chief Financial Officer, Brandi Roberts, and our senior Vice President clinical in Medical Affairs, Gary Hoak. The executives will provide prepared remarks, then take questions from analysts with that I'd like to turn the call over to Brian Colley our CEO.
Thank you want a good afternoon, everyone. We appreciate you joining us on a quarterly call today.
This past quarter was extremely productive for the company and on today's call.
Turning to review the most important milestones we reached with each of our three clinical stage cell therapy programs.
After I provide these program updates Randy will review, our financial spend will summarize some upcoming events, which shareholders can look forward to minimal open up line for analyst questions.
You start with offer Jim or product candidate to treat dry A.M.D. with geographic atrophy.
Dry AMD de with GE is one of the leading causes of vision loss in the world and we estimate there between one or 2 million people in the U.S. suffering from the advanced form of the condition, which is the initial for we hope to treat.
But diseases caused by the slow progressive loss of specialized red cells.
And our approach to treating dry Andy is to grow and transplant brand new Brett the cells to replace the ones, which are dysfunctional dying or have already died off. This program is currently enrolling patients in a phase one two way clinical trial at five active centers.
Because there are no FDA approved therapies to treat dry M.D., we believe the commercial opportunity for a new treatment is incredibly attractive.
And we recently announced a discovery, which we believe distinguishes our program substantially from the competition and positions us as the most promising dry AMD de therapeutic currently in development.
I make this strong statement because in June we reported evidence of what is potentially the first known report its finding of retinal tissue restoration in a patient receiving a transplant RP east cells.
This finding is unprecedented because humans lack the ability to re grow or repair retinal tissue. So most companies are simply trying to slow the retail disease progression.
Well our data supports the view the dry AMD d. is not in irreversible degenerative condition, which only gets worse overtime.
I believe we're the only company to report in a clinical setting that some portion of disease retinal tissue may actually be recoverable in dry AMD patients.
Patient, we treated with our opportune cells had a trophy and stage disease get showed substantial restoration of retinal tissue within the previous area of GA.
Specifically the area GA assessed at nine months was approximately 25% smaller than the patients baseline prior to treatment.
These findings were initially observed by an independent external advisor using multiple imaging technologies and were subsequently confirmed by the reading center and additional experts in the field of retinal imaging.
We also recently hosted a call with real experts to review these results in detail.
Theres a replay of that call on our website, which I strongly recommend checking out.
Oh, we're currently conducting a third independent review of these findings as well as going back to determine whether it appears in any of our previously treated patients.
And we plan to submit these data in a case report manuscripts for scientific peer review when these analyses are complete.
One reason these data are so exciting to us is that clinical trial setting.
You ordinarily would compare one group of treated eyes against a group of untreated dies and determine whether the area of atrophy in the treated eyes grew more slowly because slower growth is a positive outcome in the study.
But what we've shown is that it's possible to not simply slow the growth rate, but actually reverse it and restore retinal structure to a normal appearance and architecture, which from a statistical perspective makes it much easier to see differences between treated on treated groups. Because you know the untreated group will only get.
Worse over time.
In contrast, it's a few of the GE used in your treated group get smaller than you're really pulling down the average growth rate of your experimental arm and instilling an incredible amount of statistical power into your trial. So this is sort of like comparing to race cars that are headed toward a cliff and the clip in this.
Case would be blindness, everyone wants to find a way to make one of the cars from slower.
And in our case, we have a car which went in reverse so it's pretty easy to tell which car you want to be sitting.
Overall this potential may mean that we can run a smaller faster trial, while still maintaining tremendous power in our analysis. So this is why it's so important for us to try and repeat this finding and demonstrate per second time that retinal restoration as possible and at what we are seeing is a realism.
One of the long held promise of cell therapy.
For this reason, we're looking forward to seeing whether a different patient we treated just a couple of months ago becomes that valuable second example, or or maybe one of the next couple of patients we treat we'll provide that evidence.
Despite our excitement we have to remain patient because these areas of GA do grow very slowly and there's nothing we can do to accelerate the amount of time. It takes to show differences in grocery we simply have to wait until enough time has passed to see if the GE has gotten smaller instead of getting larger.
But that's certainly could be an exciting announcement, if we observe it and again have a confirmed by external experts.
Now in addition to the retinal restoration discovery, we also have observed additional benefits and some of our patients on this trial. Those include increases in visual acuity reductions in the rate of growth of GE.
And increases in patient reading speed.
We believe the body of evidence, which we're collecting will support a new paradigm for how to approach the treatment of trying a d. and one that no other company as shown evidence for.
Our primary objective to show that directed differentiation and transplant RP cells can provide clinically meaningful outcomes in this disease.
Oh by the way I should mention that I know lot of people are no. Following this emerging story. So I should explain that despite a large number of dry AMD de suffers in this country. It is still difficult to enroll patients onto clinical trials. There are many reasons for this including the challenges of identifying what are typically elderly volunteers who.
Still have meaningful vision, they need to sign up for an elective surgery meet the enrollment criteria and be comfortable with a large number of doctor visits despite whatever regional co bid restrictions they may be subject to let asking a lot of people, but from time to time, obviously, we do fine candidates, who meet our criteria and then you get successfully enrolled on.
And treated on our trial.
Fortunately as our data set has grown and matured and seek to get the treatment is increasingly known to the positions enrollment might get a little bit easier going forward. Because these retinal specialists are able to express more confidence and enthusiasm in the potential benefits from treatment, but to be fair cobot, it's still a hurdle.
For this study as as it is for many other studies as well.
But to help boost the process. We recently opened a fifth active site in the U.S. and we're hoping that we soon can get another one or two patients from our sites.
Located in L.A., Cincinnati or Philadelphia.
As a reminder, about this trial, we've had three surgical experiences with the gyroscope therapeutics five 10-K approved orbit STS device, that's the tool, which we used to administer the cells into the sub retinal space.
This device can provide us with a meaningful competitive advantage in administering sells to the subretinal space, but we still want to confirm the early promising results that we've seen we would like to confirm that with another two or three patients.
Once those final patients have been dose using the device, which should occur in the next month or two that will conclude before bit portion of the study going if everything goes well we would plan to conclude enrollment in the phase one two a study around that time.
And move into a follow up phase, which would include interactions with various regulatory authorities like the FDA.
And entering into more advanced partnership discussions.
So overall things are trending positively for our dry AMD program.
Because we'll continue to be on collecting additional patient data.
Repeating the restoration binding, which I described in completing the orbit valuations days, which altogether will help director clinical regulatory and partnership strategies.
In terms of the next data update.
On the option program.
Aside from updates for announcements, we could make at any time on retinal restoration.
We also plan to provide an overall update at the upcoming A.O. Virtual conference in the second week of November.
In the past we've had a very good reception from these presentations and we will have more to say about her plans in our presentations as that meeting date approaches.
Moving next to back this is our allogeneic or off the shelf dendritic cell cancer vaccine.
This product candidate is comprised of mature dendritic cells, which we manufacture from established don't lines.
Load with a tumor specific marker to instruct the body's immune system to attack and eliminate cancer cells.
Hi, educating your T cells to seek out and destroy cancer cells back to acts like a highly trained booster for your immune system.
During the second quarter, we elected to conduct an early exercise our option to the back program from our development partner cancer Research UK.
She our UK has been and continues to conduct a phase one clinical trial of back to in patients with non small cell lung cancer.
But after reviewing data from the first for patients treated in the study it was clear to us that back to dendritic cells to it in fact provide targeted education of T cells, and that's a signal, which we were seeking and it was apparent in multiple assay systems.
So the signal was also present in an earlier totally gets version to back to note is that one and then even earlier investigator sponsored study. So the ongoing back to trial was confirmatory of these positive earlier findings and gave us confidence the mechanism was being preserved when moving from an autologous.
Setting into an allogeneic setting and this is important because only an allogeneic platform can provide cost and manufacturing advantages, which have limited the autologous dendritic vaccines.
An additional reason for the early exercise of the back option was to send it to our in house experts and cell therapy manufacturing.
So that they could begin work immediately on necessary production enhancements.
Although see our UK collected some valuable clinical data they did not have in house expertise in pluripotent cell guided differentiation. So they could not develop necessary improvements to the manufacturing process. So in order to fully exploit the potential of the back platform, we need to modernize its just like we did.
With a written the program successfully.
That's all explain in a moment just like we're doing currently with our spinal cord program.
But the first provide an example of how we're now able to expand the back platform from when it was being managed by see our UK.
We recently started looking into using the fact platform to create a corona virus vaccine.
This is possible because one of the hallmarks of the back platform is generating high levels of CD for positive and Cdeight positive T cells and most patients.
T cells are required for the memory facts long term vaccine.
If you've been following the literature on Kogut vaccines I'm sure you've seen that while the early days were focused on generating antibodies. There's more recently been an increased focus on the importance of engaging the adaptive immune system and specifically the patients T cell response.
There clearly are many vaccine approaches being pursued today.
Really no way to predict what kind and form immunological stimulus will work best in various genetic or professional populations. So we have submitted a provisional patent application for our approach and are now in the process of submitting proposals for external grant support from both us and international.
Funding organizations.
We're also unsuccessful with our first application to serve as we're many other companies, but we recently research received a response from BARDA inviting us to a meeting this month under what they call their Corona watch program, where we will be able to discuss our proposal and plans efforts.
This is encouraging to us because BARDA reported that they received more than 3500 meeting request, but his deep granted only approximately 400 of those meetings. So 3500 meeting request and 400 invitations for these meetings.
No because most of these cobot funding pools didn't even exist a few months ago Theres really no way for us to estimate our chances of success in obtaining a cold and related grant from BARDA or from anywhere else, but we're going to press on and we'll do our best obviously to be successful with this effort in identifying some external.
Funding support for that initiative.
I should add here that.
Among any and all of our current or future vac product candidates and that's for either cancer or of infectious disease.
The mean differences among them are the antigen are in a sequence, which we insert into the dendritic cells. The dendritic cells are identical sequence that we put in there the signal or message that differs and that's what defines these products.
Well that means that many of these manufacturing improvements, which we have begun working on they are identical across the oncology and infectious disease programs, which means that any funding we received or investments we make ourselves into the back platform are effectively multiply because they advance steps which are common.
Both the oncology and infectious disease platforms, and all of the product candidates, which currently or me in the future reside there again.
So even though lineage now has control of the back to program.
Seer UK is still responsible for collecting data on the current patients as well as dosing two additional patients in the ongoing study.
We now have begun to explore additional oncology applications, which we internally call back 345.
As well as additional infectious disease applications as I mentioned a moment ago.
And importantly, now that we are in charge and responsible for the back program. We also are in a position to explore business development opportunities with companies in the immuno oncology space, where we would provide access to our dendritic cell platform as a delivery tool for someone else's antigens.
It could help us generate a whole pipeline of different product candidates with various expression cassettes targeting many different types of cancers.
Feel that the product platform nature of that will enable us to engage in new and exciting partnering discussions and become much more prominent player in immuno oncology field, especially as we validate immature the production process scale and other important commercial attributes of that.
We also are in process of hiring new but the new position that we created a vice president of oncology that would be someone to lead the development of not only back to but also the expansion of oncology pipeline, which of course can help with both partnering efforts as well as internal development programs.
The last thing I'd like to add on the back program is it sometimes we get questions about the limitations of using dendritic cells for tumor therapy.
Important to understand that first generation efforts were largely monotherapy approaches in heavily pre treated patients and that is not where the fields has remained.
Of course aware of the history and we're encouraged by more recent and we believe far more relevant work, suggesting that combination approaches with checkpoint inhibitors or even chemotherapy as well as second generation technologies like our allogeneic Dcs and neo antigens may offer more promising clinical outcomes.
And this is exactly where lineage intends to position ourselves as a second generation alternative in a combination setting with the added benefits of being allogeneic and adaptable across many different combinations of potential antigens. So this is still in somewhat of the early stages, but it is something you can look.
40 hearing more about from us as we continue through the year.
Thirdly, moving next to LPC. One this is our clinical stage programs are spinal cord injury. This past quarter, we announced that manufacturing has been completely transfer to our facility in Israel, where the key process improvements have been developed and implemented.
We also strengthened our patent position in order to protect this new LPC, one process, the product and compositions and methods abuse and as you described earlier, it's vital that we also modernized this production process to enable a later stage clinical trial, and ultimately commercialization and I'm very proud to share that my expectations and then exceed.
By our CMC team working on this project.
They generated new cgmp master and working sell banks, which ensures consistent batches are produced state improve the production process to achieve greater efficiency and higher quality control, making it compatible with larger scale manufacturing and be a late readiness.
They introduced new in process controls and release testing updating them to be more compatible with current and expected future regulatory guidelines and they're on track to initiate GMP production in early 2021 to support the clinical efforts.
Looking ahead, they also little bit developing a song and inject formulation like we have for opportune while in parallel the product development team will be evaluating superior delivery tools, which altogether will enable an easier surgical procedure and faster enrollment in the next clinical trial.
All of this work will lead us them to an arm out meeting with FDA, which were planning for sometime around the end of this year or early next year and once all of these commercially enabling improvements, which we're working on are in place manufacturing side of the LPC. One program will have caught up with the impressive clinical data side and I.
I believe that we'll open up new opportunities to evaluate consider strategic alliances just as we're doing with oxygen and are planning to do with back.
Overall, our approach with LPC, one is intended to replicate our development strategy for option in which we seek not only to provide cell based regenerative benefits, but also commercially relevant solutions with competitive advantages in areas like scale up production costs and delivery techniques.
Lastly, I just want to add today that I'm approaching my two year anniversary here at lineage and I'm extremely thankful to this team for successfully implementing so many changes in such a short timeframe as you can tell from our three clinical stage programs, we have adopted a model of taking exciting.
Early stage clinical data specifically from cell therapy programs, which are addressing high unmet needs along with low competition.
Then, we enhance and modernize their manufacturing processes to make them capable of supporting later stage trials and ultimately commercialization.
And then after modernizing the production process, we will move these products into later stage trials either on our own or in most cases collaboration with a larger partner and because the power of our directed differentiation platform is the ability to manufacture many different cell types, we have an opportunity through this strategy to provide.
Our shareholders with long term growth and sustainability ideally while also relying on non equity dilutive funding and frankly on that point I'm pleased to remind you that lineage has not needed to conduct a traditional equity financing for almost three years, yet we have made tremendous progress progress with our programs and our pipeline in that same period.
And as Brad you will explain in just a moment. We believe we'll continue to have access to capital, which will permit us to continue with this approach.
So in conclusion, if you look carefully at how we have advanced our programs and the decisions, which we've made.
Steps that we have taken such as creating three dimensional art T cell production, which now accounts in the billions of cells per batch or acquiring the rights to RPC, one from a serious and bringing to bear our manufacturing expertise or more recently exercising the back option early so that we could expand the cancer and infectious disease pro.
Grams off a single platform all of these steps fit into a larger strategy of creating value by converting early and exciting science, it's a compelling and rigorous clinical data and manufacturing capabilities, which then attract the attention in support of investors and major pharmaceutical companies and ideally doing so without diluting shareholders.
On attractive prices.
So with those program updates complete I'll now hand things over to Brandy. Two please review our financials and discuss some additional plans that we have for this year.
Thank you, Brian I'll start off with the statement of operations for the second quarter of Twentytwenty.
Total revenues for the second quarter of Twentytwenty were $400000, a decrease of $400000 as compared to $800000 for the same period last year as discussed on prior calls we expect our revenues to be lower than historical levels. As they are now generated primarily from our <unk> origin related grant and right.
He is from the licenses of patent.
Operating expenses are comprised of research and development expenses and general and administrative expenses.
Total operating expenses for the second quarter of Twentytwenty were approximately $6.7 million, a decrease of $4.8 million as compared to $11.5 million for the same period in 2019.
R&D expenses for the second quarter, Twentytwenty were $2.8 million, a decrease of $2.4 million as compared to $5.2 million for the same period last year.
The overall reduction was primarily related to a decrease of $1.7 million in Oregon, and other ups or make application expenses, which was primarily related to a reduced level of manufacturing activity in the second quarter of this year as compared to the same period last year.
Additionally, there was a 700000 dollar reduction and OPGC one expenses.
I merely related to a decrease in development activities and twentytwenty as compared to 2019 when technology transfer was a heavy focus with OVC one coming in house with the serious acquisition.
DNA expenses for the second quarter of Twentytwenty were $3.9 million, a decrease of $2.4 million as compared to $6.3 million for the same period last year.
The decrease was primarily attributable to the following reductions $1.6 million in a serious related expenses.
$200000 and each of these expenses compensation accounting and Investor and public relations and $100000 and these expenses travel red and consulting.
These decreases were offset by a 200000 dollar increase related to the cessation of shared services reimbursements.
Our loss from operations for the second quarter of Twentytwenty was $6.4 million, a reduction of $4.4 million as compared to $10.8 million for the same period in 2019.
Other expense net for the second quarter of Twentytwenty reflected other expense net of $100000 compared to other expense net of $20.5 million for the same period in 2019.
The variance was primarily related to changes in the value of equity method investments and marketable equity securities for the applicable period as well as foreign currency translation adjustments related to lineages international subsidiaries.
The value of lineages oncocyte shares decreased by $21.4 million in the second quarter of 2019, which contributed greatly to the overall balance and other expense net for that period.
Our net loss attributable to lineage for the second quarter of Twentytwenty was $6.5 million or four cents per share as compared to a net loss attributable to lineage of $30 million or 20 cents per share for the same period in 2019.
I'll focus my next remarks around cash management.
As of June Thirtyth, Twentytwenty cash cash equivalents and marketable securities totaled $20.3 million.
Additionally, the value of our note receivable due from driven essence as of this date was valued at $24.4 million.
The maturity date of that note is August thirtyth. So unless you have in essence completes an IPO of at least $50 million and the next 24 days. The total amount of $24.6 million of principal and interest will become due and payable in cash later this month.
Cash management continues to be a priority at lineage I'm happy to report that net cash used in operating activities in the second quarter of Twentytwenty was $700000 lower than the first quarter of Twentytwenty and that net cash used in operating activities for the first six months of Twentytwenty was $9.7 million lower than the.
Same period in 2019.
It has been a primary goal for us to substantially reduce our operating expenses from historical levels, but do so while advancing our programs in an efficient manner.
As Brian has discussed operating during the covert 19 pandemic has been a challenge, but we have worked to keep our clinical programs moving forward, while keeping a very careful eye on expenses.
We continue to look for ways to reduce our spend.
As an example, we've been working to reduce our corporate footprints in the San Francisco area. Since we've reduced headcount, we don't need as much space and the second quarter, we entered into a sub leased for 10000 square feet of our main building and this will help us reduce our overall facility related expenses.
We're currently evaluating additional opportunities that could reduce our facilities Ben further.
In general our second quarter cash activity was inline with our expectations.
Original 2020, net operational spend budget was $16 million and as discussed last quarter, we anticipate a modest increase from that position during the remainder of the year primarily related to the early exercise of our option with cancer Research UK.
Our plans for the development of a vaccine against Sars koby to another corona viruses and delays caused by cobot 19 to our average and clinical trial.
We continue to evaluate our assets and fund our operations by selling portions of our marketable securities during the second quarter.
We sold about 2.4 million shares of August say common stock at an average price of $2.53 a share for gross proceeds of $6.1 million and we continue to hold approximately 3.6 million shares of Oncotype stock that was valued at $6.8 million as of August 4th Twentytwenty.
Our ownership in August site is now at about 5.4%.
As Brian mentioned it has been almost three years. Since this company has done a traditional equity financing we have been able to successfully fund the transition of this company into an emerging leader in the cell therapy space.
Not through dilutive financings, but instead with a combination of smart, but aggressive expense reductions and timely sales of our investments.
We are committed to demonstrating the power of our cell technology to treat various diseases and conditions.
As Brian discussed, we now have a case of retinal restoration, which to our knowledge has never been reported before this is extremely exciting over the course of the next few months, Brian and I will be expanding our breadth of investor and analyst outrage and following our next operates in data released at a Oh, we expect to advance the partnering discuss.
Since we have already been having with leading pharmaceutical companies and explore options for funding in the next clinical trial with only a few patients to enroll in our current study now is the time to get more people interested in our story. We are excited about the future not only for operation, but for OPGC, one and the VAT platform as well with that I'll turn the call back to.
Ryan.
Thanks, Randy So moving next to seems to look forward to in the remainder of this year our goal as always we'll be to continue advancing our clinical programs, but specifically there are five things we plan to emphasize which include two data update so first.
We will meet this month with BARDA to discuss our proposal for non dilutive funding for krona virus vaccine candidate.
We secondly plan to report initial back to clinical data from patients treated in the ongoing phase one trial run by cancer Research UK.
We expect to complete patient enrollment in the U.S. with the gyroscope orbit, STS and our new thought and injected formulation and the ongoing phase one two a clinical trial of oxygen for the treatment of try amdy with GA.
We plan to present, new and accumulated oxygen data at the eight Oh annual meeting the second week of November.
And we expect to meet with U.S. FDIC to discuss the further development of the LPC. One program now that we have advanced manufacturing to a much more mature status.
You'll also see us participating more at various events as we increase our engagement with the investment medical communities through virtual participation of medical and healthcare conferences as well as participating in things like podcast interviews and similar communication channels. So that we can be sure to reach a broad audience with our progress and achievement so with that.
I again, we'd like to thank you for joining us on the call today, an operator the team here is ready for any analyst questions.
Right. So as a reminder.
So the question you will need to press star one on your telephone through is all your questions press the pound key against that is star one on your telephone.
We do have a question on acute from Joe Thank goodness from H.C. Wainwright your normalized.
Everyone. Thanks for taking the question Hope you are all doing well a couple of questions. If you don't mind, Brian first real nice to hear about the back update with regard to your upcoming BARDA meeting and I guess during your prepared comments you just touched upon this I was hoping you might diving a little more regarding your specific car.
And so when you look at the media today and everything focusing on antibodies, but why is the vac approach might be a little differentiated with regard to its T cell generating properties.
Yeah. So thank you for that question Joel.
Yeah. So I think there has been a an evolution in the thinking in the early days, that's funny to say early days, because they're not long ago, but everyone is focused on appropriately I'm sure focused on.
The the immediate response your antibody generation neutralizing antibodies and and then as time has gone on and we've learned a little bit more about the virus I think the preponderance of the content. That's out there seems to have migrated more and more toward the discussion around T cells in the roll the T cells and finding buyers.
None of this is new to an immunologist.
But you know, there's 300 million amateur immunologist out there now and so.
For us it it was an interesting idea early on to use the back platform because the vac platform relies on the power of the dendritic cells to deliver a message to the immune system, so, whereas many many that.
Seen approaches which exist today.
Rely on the immune system to just naturally pick up antigens and hope that they get presented the right way in the message gets delivered we sort of skip that first step we force the message right first we get to choose the message that we think is important and there's been a lot of work it's already determine what parts of the virus are the most important the most antigenic. So we go.
A choose which part of the virus is the most important signal and then we pre package that into the dendritic cells, which is the body's very best communicator of four in material to the immune system and so we've already picked the best.
Antigen and then we package it into the dendritic cell and and we put it into the patients and we can tell from our efforts in oncology. The patients immune systems are recognizing this information that were packaging and it's making it into the T cell and it's being amplified so when thinking about.
Treating across various vaccine or really any kind of vaccine.
Being able to affirmatively select the antigen that you think is the most important and then skipping that first step two to hopefully ensure that you're getting a nice fidelity of message to the immune system and the knowing apriori from experienced clinical experience and other studies that we've been able to do that with other antigens.
To US you have to try that right. It's just it's so logical to US no. There are definitely challenges there challenges that all of us have with respect to mass production and distribution and testing and these are all roads that are just certain degree being travelled by many companies today, but we were very pleased.
That are that the one of our whenever applications. This one in particular the BARDA application.
Did at least get picked up make it through their first past filter and I think I had shared that the numbers. There you know there's only had a.
Something north of 400 of these meetings at a 3500 applications.
So I think it's encouraging it doesn't mean anything but at the same time, it's quite encouraging that we were able to have enough of a proposal to make it passed that first pass.
And you know we're going to press on and you know, we're fortunate with either BARDA or someone else that we can.
Find a fine supporters and champions for our approach that say that hey. This this is something that we need to do because we have no ability to predict which companies approach on care, how big they are theres no real way to predict who's going to be successful and there may be sub populations. There maybe you know a professional.
No.
Populations like healthcare workers that are more suitable for our approach.
You know, we're not going to try and be conclusive about that we want to see if we can get past step one which is to find some external support for our work. So that we can validate that our approach is worth a much higher levels investment going forward I hope I hope that addresses the question well enough.
No. It certainly does thank you for that and then my last question is if you don't mind I'm just wanted to switch back to the opera Gen data. So after the striking restoration data that you announced I guess I.
I would look at it this way what kind of feedback have you been getting from the field and how has that evolves from physicians in looking at that restoration data and I guess I would say its semi facetiously, saying look I mean are dr., saying are they looking at it cautiously right now, saying this is an end of one or they you know is it a lot.
On the continue on that says look you're just not expected to see this kind of data, but we'd love to see a few more patients are sort of where does it stand on the continuum right now.
Sure. That's that's a great question because it's it's often make some version of the Joe could you could you could show 100 cases of this and investors would say well you haven't shown me 101 cases, so there's always sort of you know this eagerness to have more.
The difference between zero and one we think is extraordinary.
But there's still a big gap between one and two you know people always want to have some skepticism and think it's an outlier and I think what is typical of something like this is that you. The folks that are most easily convinced tend more commonly to be the experts right. It's the people who understand what the images are.
Going.
You have a frame of reference to appreciate what you've done so if I sit down with a a generalist investor I sit down with a retinal expert and I show them, what we have it as far easier to get the retina expert excited about what we have because they have an appropriate context or framework to evaluate.
We have a.
A large database of historical evidence of what can and cannot happen in the back of the eye, whereas the generalist has a great difficulty with that so I think that there's there's a continuum here that as more and more evidence for our approach whether that includes retinal restoration or not I mean, we were doing great even before we now.
Retinal restoration I mean, we're seeing things happening in the Guy that we're very excited about the restoration is like you know eight feet of frosting on a on a six inch key so we're really happy about what we've seen but I do think that there's going to be.
Hopefully not to gradual but somewhat of a gradual continuum through your experts in imaging out to your retinal surgeons as as the publications and things get get out there are more widely disseminated and then out to your ophthalmologists and then as you know you kind of make your make your way through and as more and more evidence is.
Filed on it becomes easier easier to pass through that way so.
Short answer to your question is yes, everyone would like to see it happened. The second time, we think we know what was special about this patient and we think we can reproduce suit, but as I described in the presentation. It's challenging because it does take you know maybe as early as six but more commonly nine or even 12 months before you can see.
And in some of this because these things are growing so slowly in the back of the guy, but I just want to emphasize for everyone is listening it's not like a cut that can heal.
These these are unit directional lesions they only get bigger so the fact that we were able to make one of them become smaller and show normal retinal architecture, what's really exciting people understand those images. So we're just going to keep trying to generate more and more evidence of it and.
Those dominoes should start falling at some point.
Fantastic I really appreciate all the extra color Brian.
Thanks, Joe Thanks for the questions.
Next one on the line is the loan from Raymond James fewer it all lives.
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Hey, guys. This is following through on for Dane. Thanks for taking our question just one from us.
On the ill update for opera Jan can you just given a little bit more color on what we should expect and I mean, how much more fault, we could see thank you.
Yeah, Let me. Thank you for the question, let me insight Gary hoax into the discussion to talk about what we think we'll be presenting at A.O.
Yes, thanks for the question.
The so the show will be the second week of November.
Unfortunately in virtual meeting, but that's actually not about thinking that the presentation will live on for a longer time afterwards.
But the goal would be to present all the orbit patients have you been enrolled by that point.
As well as the three additional court for patients that were treated the traditional route as well as the safety profile for up to five years for early as patients. So it'll be accumulated data for all patients and any data we have up to that essentially the week before a.
Great. Thanks.
Well.
I'm showing no further question at this time I would like to turn the conference back to Mr., Brian colleagues for on for any closing remarks.
Well thanks, everyone again I appreciate you joining us obviously excited about our plans I think we've got a lot look forward to this year. We appreciate the shareholder support and we'll continue to position lineage to be a successful leader in cell therapy and cell transplant medicine. Thank you and have a great afternoon everyone.
Ladies and gentlemen, this concludes todays conference call you may now disconnect.
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