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More durable and reliable progress. Good stuff. ARVO a month from now! 23-27 April.
https://www.arvo.org/annual-meeting/
https://www.businesswire.com/news/home/20230306005224/en/RG6501-OpRegen®-Phase-12a-Results-to-Be-Featured-at-2023-Association-for-Research-in-Vision-and-Ophthalmology-ARVO-Annual-Meeting-in-Presentation-by-Eyal-Banin-M.D.-Ph.D.
CARLSBAD, Calif.--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that results from imaging analyses of structural changes in addition to visual data from a Phase 1/2a clinical study of RG6501 (OpRegen), will be presented at the 2023 Association for Research in Vision and Ophthalmology Annual Meeting (ARVO 2023). The meeting will be held April 23 – 27, 2023 at the Ernest N. Morial Convention Center in New Orleans, LA. The presentation, “Exploratory optical coherence tomography (OCT) analysis in patients with geographic atrophy (GA) treated by OpRegen: Results from the Phase 1/2a trial” will be featured as part of the Paper Session, on April 25, 2023 between 12:30 PM to 12:45 PM MDT, by Eyal Banin, M.D., Ph.D., Director, Center for Retinal and Macular Degenerations (CRMD), Department of Ophthalmology at Hadassah-Hebrew University Medical Center (presentation number 2826, session number 331). RG6501 (OpRegen) is a retinal pigment epithelium cell transplant therapy currently in development for the treatment of geographic atrophy secondary to age-related macular degeneration (AMD). It is being developed under an exclusive worldwide collaboration between Lineage, Roche and Genentech, a member of the Roche Group, and is currently being evaluated in a Phase 2a clinical study in patients with geographic atrophy secondary to age-related macular degeneration (ClinicalTrials.gov Identifier: NCT05626114).
https://hadassah-hospital.org/doctor/eyal-banin.htm
NEWS -- Q4 2022 Lineage Cell Therapeutics Inc Earnings Call
Participants
Brian M. Culley; CEO, President & Director; Lineage Cell Therapeutics, Inc.
Gary S. Hogge; SVP of Clinical & Medical Affairs; Lineage Cell Therapeutics, Inc.
Ioana C. Hone; Director of IR; Lineage Cell Therapeutics, Inc.
Jill Ann Howe; CFO & Principal Financial and Accounting Officer; Lineage Cell Therapeutics, Inc.
Jack Kilgannon Allen; Senior Research Analyst; Robert W. Baird & Co. Incorporated, Research Division
Joanne Lee
Joseph Pantginis; Director of Research & MD of Equity Research; H.C. Wainwright & Co, LLC, Research Division
Kristen Brianne Kluska; Analyst; Cantor Fitzgerald & Co., Research Division
William McKinnie Wood; Research Analyst; B. Riley Securities, Inc., Research Division
Presentation
Operator
Welcome to the Lineage Cell Therapeutics Fourth Quarter and Full Year 2022 Conference Call. (Operator Instructions) An audio webcast of this call is available on the Investors section of Lineage's website at www.lineagecell.com.
This call is subject to copyright and is property of Lineage. And recordings, reproductions or transmission of this call without the expressed written consent of Lineage are strictly prohibited. As a reminder, today's call is being recorded.
I would now like to introduce to you your host for today's call, Ioana Hone, Head of Investor Relations at Lineage. Ms. Hone, please go ahead.
Ioana C. Hone
Thanks, Mandeep. Good afternoon, and thank you for joining us.
A press release reporting our fourth quarter and full year 2022 financial results was issued earlier today, March 9, 2023, 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 fact should be considered forward-looking statements, which are subject to significant risks and uncertainties. The company's actual results or performance may differ materially from the expectations indicated by such forward-looking statements. For a discussion of certain factors that could cause the company's results or performance to differ, we refer you to the forward-looking statements section in today's press release and in the company's SEC filings, including its most recent annual report on Form 10-K. We caution you not to place undue reliance on any forward-looking statements which speak only as of today and are qualified by the cautionary statements and risk factors described in our SEC filings.
With us today are Brian Culley, our Chief Executive Officer; Jill Howe, our Chief Financial Officer; and Gary Hogge, our Senior Vice President of Clinical and Medical Affairs.
With that, I'd like to turn the call over to Brian.
Brian M. Culley
Thank you, Ioana, and good afternoon, everyone. Welcome to our full year 2022 call. We appreciate you joining us today.
2022 was another challenging year for biotech companies, but I think it was an exceptional one for Lineage. We worked successfully alongside Roche and Genentech to prepare OpRegen for its next clinical trial, and that trial is now open and enrolling new patients.
With the positive tailwinds from the OpRegen program in place, we made bold but financially responsible moves to expand our pipeline, adding a photoreceptor program, which capitalizes on our experience and success in ophthalmology and by adding an auditory neuron program, which is the first time we've shown that we can not only improve upon existing assets, but also create them from scratch in our R&D labs, vastly reducing any third-party financial obligations from these in-house product candidates.
2022 also marked a year of important and successful clinical and regulatory execution for the Lineage team as we advanced our clinical programs along their respective developmental pathways.
I realize this is a 2022 recap call, but I know a lot of investor attention is presently focused on the dry AMD landscape. So I thought that would be a better way to use my opening remarks.
Last month, FDA approved a complement inhibitor to treat dry AMD. And with this approval, the FDA has set a precedent that anatomical change in the form of photoreceptor preservation is an approvable endpoint in this condition. We believe this is an enormous regulatory decision for us because the data we have collected to date with OpRegen and its ability to improve outer retinal structure and either halt or even reverse the progression of GA is far greater than what has been demonstrated by either of the leading complement inhibitors.
Critics sometimes say that we've only shown these results in a small number of patients, but I will remind them that we are seeing changes which do not occur spontaneously, and we're reporting these via multiple independently verified analyses using objectively captured anatomical images. So on this basis, we believe these early and exceptional results are likely to be repeated in larger studies.
When I look at the error bars surrounding the point estimates on the Phase III trial for the complement inhibitor, which recently gained FDA approval for which only a small reduction in GA growth is provided, I think it's highly likely that all 5 OpRegen patients, which Roche and Genentech reported on at the ARVO Annual Meeting last year have shown greater reductions to the area of GA than all of the more than 1,200 patients treated in the clinical trials, which supported that drug's approval.
Furthermore, we have demonstrated not only anatomical changes but also functional improvements to patients' vision with an average of 7.6 letters gained among all Cohort 4 patients and increasing to 12.8 letters gained among the 5 patients who received extensive coverage of OpRegen cells across their GA and who additionally exhibited outer retinal structure improvements measured 12 months following transplant in our Phase I/IIa study.
Recently, a number of outlets have been reporting that a different complement inhibitor can provide functional benefits to vision. The evidence which that company provided was a post hoc exploratory analysis, which is something my former colleague likes to call drawing the target around the arrows after they're fired. This selective data cuts sought to make the case that patients on treatment were less likely to lose 15 letters at 12 months than patients on placebo.
Despite this data similarly being in a very small number of patients, representing only 5 to 10 patients of all patients treated on that trial, it actually was quite well received by the investment community. And for this reason, I will again draw the comparison that OpRegen data, which was reported at ARVO by Roche and Genentech showed 25% of patients in Cohort 4 gained at least 15 letters. They didn't avoid loss. They gained vision. So we're talking about comparisons, which are as large as a 30-letter delta between these approaches.
Obviously, it's a huge benefit for patients and the medical community to finally have something which may help some patients with their condition, but it appears to us that there is a tremendous amount of clinical benefit, which could still be provided. Benefits which monthly injections of complement inhibitors have not shown. It's very important for our results to continue being presented at major medical meetings and help the medical and investor communities become aware of the efficacy, safety and other attributes of our product candidate profile.
One of the additional potential advantages of the OpRegen product profile is in dosing and administration. OpRegen treatment involves a single 30-minute procedure rather than giving patients an injection every month or 2, year after year with all the compliance issues, which accompany it. For this reason, we often are asked how long our treatment lasts. But we don't yet know because we haven't reached a clear terminus or an indication of the benefit tapering.
I've mentioned on prior calls, that we have patient data going out as long as 5 years in some cases, including our very first patient with structural improvement who after 4 years has lost 30 letters in her untreated eye, which, by the way, was her better performing eye at baseline. But she was still 3 letters higher than her baseline level of visual acuity in her OpRegen-treated eye. Again, that's data coming 4 years post treatment in a disease which is widely viewed as inevitably progressive.
Long-term follow-up from the Phase I/IIa study is still ongoing, which allows us to continue to monitor evidence of the duration of treatment effect. And there may be more to come from deeper imaging analyses as well. Next month, some of that data from our Phase I/IIa trial will be made available at the 2023 ARVO Annual Meeting on April 25. That will be presented by Dr. Eyal Banin on behalf of Roche and Genentech. And as always, data updates are important disclosures, and we look forward to this next one happening in just a few weeks.
Meanwhile, we're excited about the ongoing Phase IIa study, which Roche and Genentech has launched to evaluate the safety and efficacy of OpRegen as well as certain delivery techniques. It is difficult to predict when that trial will have data available because it has an enrollment range of 30 to 60 patients. But regardless, the primary and secondary outcome measures for that study will all occur at 90 days. So the primary observation period is very brief compared to what we usually expect from dry AMD studies.
Genentech has disclosed 2 enrolling clinical sites so far in Cincinnati and Sacramento, both of whom participated in our Phase I/IIa study. Dr. Christopher Riemann, the PI from the Cincinnati Eye Institute is a former Lineage site PI who treated one of the original retinal restoration patients, and we appreciate his and Dr. Telander's continued participation in the OpRegen trial, and we expect more sites will be coming online this year.
Moving next to our spinal cord program. You'll recall that a lot of our work last year focused on activities to support regulatory interactions for OPC1, which we successfully completed as planned. Our response to an RMAT interaction with a comprehensive data package was submitted to FDA to support the use of the new delivery device, along with a clinical protocol synopsis for the small safety study we plan to conduct in sub-acute and chronic patients, and which I've discussed previously on several occasions.
We have been in active dialogue with FDA and have been responding to additional requests for information following our initial RMAT package submission. We anticipate another formal interaction to occur with FDA in the second quarter, a Type B meeting, which we hope will support submission of our planned IND amendment in the second half of this year. Assuming the necessary clearances are received, our plan is to initiate the open-label device safety clinical study known as the DOSED study in 5 to 10 patients with either subacute or chronic injuries as soon as we're able.
We also remain in frequent contact with the California Institute for Regenerative Medicine, and we continue to plan to apply for a grant to support the device safety study. As most of you are aware, CIRM guidelines state that an applicant must provide communication from FDA indicating that it's safe to proceed with a proposed clinical trial protocol. So therefore, the timing of the submission of our grant application will be contingent on and subsequent to receipt of FDA clearance to initiate the dose study.
For VAC2, we submitted our pre-IND meeting package as planned, actually a little bit earlier than we planned and have already received feedback from FDA. Our emphasis in the pre-IND package was to understand the FDA's view of our production process and the analytical methods, which we propose to use to manufacture and characterize our clinical material. Their feedback was generally positive and provided us with a clear and actionable path to an IND submission.
Any future IND filing would naturally be expected to include supporting clinical data from the Phase I study of VAC2 conducted by Cancer Research UK. We currently are still awaiting those data and were recently informed by Cancer Research UK that it's expected to be available during the second quarter of 2023. This data would be an important component of any potential IND so we will be in a better position to update you on our VAC plans at that time. In the meantime, we will continue to monitor the changing landscape of DC vaccine product candidates and their evolving clinical data.
We've also continued to engage in manufacturing and preclinical activities for our 2 new cell transplant programs in hearing loss and vision disorders, both of which were publicly launched last year. Initial preclinical studies from our photoreceptor program are currently ongoing, and we hope to be able to present top line preclinical data once the appropriate patent submissions have been made and as data become available.
Last month, we also announced the initiation of preclinical testing with our auditory neuron program in a collaboration with the University of Michigan with initial preclinical data anticipated to be available later this year. I'd like to remind everyone that Lineage's hearing loss program didn't even exist at the beginning of last year, and yet we've already started in vivo preclinical studies. Notably, we've been able to advance this program to that stage while spending less than $1 million of our R&D budget. We believe that speed and return on our R&D investment dollars are illustrative of the efficiency and versatility of the Lineage platform.
We showed the ability to advance from a little more than a product concept then develop new differentiation methods to generate intellectual property and execute on the manufacture of a specific cell type, then proceed into in vivo testing in less than 12 months and with an investment of less than $1 million. When we compare the money and time we invested to move a new program from concept into in vivo testing against the industry norms for a small molecule making the same journey, we find striking differences in the return on invested capital. And as we continue to improve our capabilities and our homegrown programs advance further, I think it will become increasingly apparent that the Lineage platform has tremendous untapped potential.
Our goal will be to unlock that value in the months and years ahead, both internally and through partnerships while still maintaining a prudent financial balance between the exciting progress occurring with OpRegen and our expansion activities with our pipeline.
This brings me next to a few comments about our most recent business development transaction. As you know from prior calls, I have said that we are emphasizing business development, and that includes in-licensing, out-licensing and joint development projects. Our most recent deal is an option agreement with Eterna Therapeutics, which gives us an affordable way to gain access to several new technologies, which fit within our overall strategic approach. These staged investments in technologies are intended to provide us with certain advantages and help set the foundation for the type of company we aim to become.
Because our confidence in the future success of OpRegen has increased upon the recent regulatory precedent set by FDA in dry AMD, we believe this is the right time to apply our technology in other areas. That is where the Eterna deal fits into our overall strategy. It provides us with an opportunity to gain experience in 3 new areas: gene editing, hypoimmunity and induced pluripotent stem cells or iPSCs. These 3 complement and are expected to bolster our in-house manufacturing and directed differentiation capabilities.
Gene editing offers us an opportunity to modify the behavior and functionality of cells and engineer new features before they are transplanted. This ex vivo editing allows us to fully characterize an edited cell line prior to it being administered to a patient. In some cases, we may look to add genes and thereby add functionality, while in other cases, we may look to delete genes, which may help with the tolerability or the durability of a transplant. Editing also gives us a competitive edge because it makes our products difficult to copy, and it may give them better clinical outcomes.
As we explained in the press release announcing the Eterna agreement, we will be utilizing a B2M deficient cell line, which is a feature associated with lower chances of transplant rejection. We don't see hypoimmunity as relevant to our existing programs because we've never received a reported rejection of our OpRegen or OPC1 cells and that's going out as long as 10 years in patients with spinal cord injury or as long as 5 years in patients with dry AMD. But the eye and spinal cord are known to be tolerant locations for cell transplants. If we want to expand our technology to other areas of the body, we need to consider whether hypoimmunity could be beneficial and ensure that all of our product candidates have an appropriate and suitable commercial product profile. We think hypoimmunity could be an interesting feature for potential new product candidates.
The third new aspect of this deal is the use of an iPSC line. We already have intellectual property for certain platform inventions and uses of iPSC cells, but exercising this option could lead to our first product candidate built from day 1 on an iPSC cell line. We know from experience that the quality and performance of iPSC lines can vary widely, and we'll be keen to see how these cells behave in our hands. Regardless, experience with both iPSC and ES lines is rare and we'll give Lineage yet another point of differentiation compared to the competition.
Overall, we're very excited about this deal because we believe it provides us with access to multiple new technologies but with a relatively modest cost structure. We anticipate providing updates under this collaboration later this year.
Overall, while many cell therapy and gene-editing companies struggled badly last year, reducing headcounts and/or deprioritizing programs, we broadened our pipeline and advanced each of our 5 programs. We made a number of key hires and expanded our research space in both California and Israel, but we did this with very responsible and stepwise investments to help ensure we have capital to reach additional milestones and important events.
I believe the company made exceptional progress in 2022 and our efforts during 2023 will remain focused on the further progression of our allogeneic cell therapy programs, making responsible investments in disease settings where we believe we can have a meaningful impact and the continued prioritization of both new and existing collaborations, all and each in support of our overarching vision of building Lineage into a leading cell therapy company.
With that, I'll now hand the call over to Jill for a discussion of our financials.
Jill Ann Howe
Thanks, Brian, and good afternoon, everyone.
Beginning with our balance sheet, I believe we continue to be efficient with our spending and are well capitalized to conduct the near-term activities, which Brian just outlined. Our reported cash, cash equivalents and marketable securities as of December 31, 2022, totaled $57.9 million, which is expected to support our planned operations into Q3 of 2024. Please note, this does not account for any of the Roche Genentech milestones, which we may receive nor for any business development or grant revenues, which we may receive during this same period.
Let me start with an overview of our fourth quarter 2022 operating results. Our revenue is generated primarily from licensing fees, collaboration revenues, royalties and research grants. Total revenues for the fourth quarter were approximately $1.9 million, a net increase of $0.7 million as compared to $1.2 million for the same period in 2021. The increase was driven by the recognition of deferred collaboration revenues in connection with the Roche agreement, which we entered into in 2021.
Operating expenses are comprised of research and development expenses and general and administrative expenses. Total operating expense for the fourth quarter were $8.5 million, a decrease of $20.7 million as compared to $29.2 million for the same period in 2021. The overall decrease was almost entirely driven by a decrease in R&D expense due to the Roche collaboration. R&D expenses for the fourth quarter were $4.1 million, a decrease of $20.7 million as compared to $24.8 million for the same period in 2021. The decrease was substantially driven by the prior year $21 million accrual for financial obligations payable to the IIA and Hadasit in connection with the $50 million upfront payment received in early 2022 under the Roche collaboration. This decrease was partially offset by $0.1 million and $0.2 million in new expenses to support the development of the photoreceptor and auditory neuron cell therapy programs, respectively.
G&A expenses for the fourth quarter were $4.3 million, a decrease of $0.1 million as compared to $4.4 million for the same period in 2021. The decrease was driven by a $0.4 million in legal and litigation expenses. Loss from operations for the fourth quarter were $6.6 million. This is due to a decrease of $21.6 million as compared to $28.2 million for the same period in 2021, principally owing to Roche collaboration-related expense accruals of $21 million, as I had previously mentioned.
Other income for the fourth quarter was $0.3 million compared to other income of $0.2 million for the same period in 2021. This variance was primarily related to the change in the value of marketable equity securities as well as exchange rate fluctuations related to our international subsidiaries for the applicable period. The net loss for the fourth quarter was $6.4 million or $0.03 per share compared to a net loss of $29 million or $0.17 per share for the same period in 2021.
Now let me move on to our full year 2022 operating results. Revenues for the full year were $14.7 million. This represents an increase of $10.4 million compared to $4.3 million for the same period in 2021. Again, the increase is primarily related to revenues recognized from the $50 million upfront payment from the Roche collaboration. Total operating expense for the year was $36.5 million, a decrease of $15.6 million as compared to the $52.1 million for the same period in 2021.
Total R&D expense for the year was $14 million, a decrease of $19.9 million as compared to $33.9 million for the same period in 2021. The decrease was substantially driven by the prior year $21 million accrual for financial obligations payable to the IIA and Hadasit. This decrease was partially offset by $0.7 million and $0.5 million in R&D spending on the new auditory neuron and photoreceptor cell therapy programs, respectively.
Total G&A expenses for the year were $22.5 million. This is an increase of approximately $4.3 million as compared to $18.2 million for the same period in 2021. The increase was primarily attributable to $2.1 million in litigation and legal expenses, $1.3 million in salaries and related benefit fees and $0.9 million in share-based compensation expenses.
Losses from operations for the year were $22.5 million, a decrease of $26.7 million as compared to $49.2 million for the same period in 2021. Other income and expenses for the year netted an expense of $3.3 million compared to other income of $5.9 million for the same period in 2021. The net variance was primarily related to a prior year gain on sale of marketable equity securities as well as exchange rate fluctuations related to our international subsidiaries for the applicable period.
The net loss for the year was $26.3 million or $0.15 per share compared to a net loss of $43 million or $0.26 per share for 2021. Overall, we intend to maintain the same spending discipline that we have adhered to for years and which has served us well in the past. The biotech markets continue to face uncertainty, so we believe that maintaining discipline with our spending will continue to allow us to maintain our plan to reach meaningful milestones and create value for shareholders from our investments in our programs.
Now let me hand the call back to Brian.
Brian M. Culley
Great. Thanks, Jill.
Circling back to the beginning of this call, I continue to think that Lineage is doing quite well in an otherwise strained environment for the biotech industry. We have been hitting our milestones and advancing our programs in a responsible and positive way. And I expect Jill and I will continue to apply the same financial discipline to our programs this coming year.
Our approach helped us land a valuable collaboration with Roche, and I believe it will continue to be an important attribute during 2023. And further out, as our programs demonstrate success in the clinic or in preclinical testing and potentially attract additional, nondilutive support, I believe, we'll have opportunities to accelerate our work across a number of parallel paths.
Broadly speaking, a few things we'll be working on this year and which you may want to watch for updates on include additional data from the completed Phase I/IIa trial of OpRegen, which we expect next month; additional regulatory progress with OPC1, which we will conduct during the second quarter of this year and which will support OPC1 returning to clinical testing. And we'll be doing our part to support the manufacturing and Phase IIa study of OpRegen being conducted by Roche and Genentech, the results of which we believe could be a seminal event, not only for Lineage but also for the entire GA field.
In addition, we've planted a few seeds to prepare for the future, including our new preclinical programs and the Eterna option deal which gives us affordable access to new technology, which we can combine with our existing capabilities and the furtherance of our goal of using the transplant of whole cells to change the course of disease in new and exciting ways.
And with that, Mandeep, we are ready to respond to any analyst questions that there may be.
Question and Answer Session
Operator
(Operator Instructions) Our first question comes from the line of Jack Allen from Baird.
Jack Kilgannon Allen
Great. Congratulations to the team on all the progress made over the course of the quarter. Brian, you did a great job laying out some of your thoughts around the recent news in geographic atrophy, but I was wondering if you could dive a little bit more deeply into some of the conversations you have with your partner Roche on the heels of this announcement. Any sense as to how soon we could see data? I know you did make a comment as you said earlier, but I'd love to hear any more feedback from the ground there? And then I have one quick follow-up as well.
Brian M. Culley
Yes. Thanks, Jack, for the question. The shortest possible answer is no, nothing to add. The biggest challenge, I think, is the enrollment range being 30 to 60, makes it really difficult to say when, where and how the public disclosure of data will occur, whether it will come in pieces or major medical meetings and so forth. But I do suspect that as we get closer to that event for those events, that we might be in an opportunity to provide more clarity and expectation around it.
Jack Kilgannon Allen
Great. Great. And then my other question, a little bit out of the box here. I'm not sure if you've seen the news coming from some of the medical suppliers here. But it's been hard to get your hands on nonhuman primates or at least it could become more pressing to get your hands on non-human primates given some of the updates from some of the players in the space. I was wondering if you had any comment as it relates to your preclinical activities and the use of these valuable research assets and how you're factoring that into the timelines there?
Brian M. Culley
It's a great question. Part of the answer is that we do not do any nonhuman primate testing. So we haven't -- we're not susceptible to a supply challenge. But by chance, I was looking early this morning at a similar company's slide deck and noticed that they were reporting a lot of data in NHP. And it occurred to me, I wonder if that is an issue for them. It's not for us. I don't know how others are managing it, but we have, ever since COVID began, we have worked to ensure that our supply chains are in good order, and we benefit by being a multinational company in that way. But specifically to NHPs, we don't have any clinical -- excuse me, any preclinical activity utilizing that particular species.
Jack Kilgannon Allen
Great. I congratulate you again on all the progress made over the course of the quarter.
Operator
Our next question comes from the line of Mayank Mamtani from B. Riley Securities.
William McKinnie Wood
This is William Wood on Mayank Mamtani. Congratulations, Brian, to you and the team, really excited to see all the progress you've been making and looking forward to the upcoming work. A couple of questions here from us. We're excited, obviously, to see that you've got the upcoming OpRegen data at ARVO in April. Would be -- I know you've touched on this already a little bit, but it would be great to hear what we might be able to see as far as new or incremental maybe surrounding or remind us how your OTT anatomical results tend to correlate with visual acuity given pretty long follow-up that you've had now all treatment. And then also to clarify, have you or your partner Roche seen the value of cutting BCVA data in terms of a rate of vision loss by greater than 15 letters or 3 lines?
Brian M. Culley
I appreciate the questions, William. I'm going to hand off to Gary to speak to those. Thank you.
Gary S. Hogge
Yes. So obviously, there's a lot of new and buzz around the BCVA and cutting it -- looking at 3-line loss over time. The good thing is that we examine it closely throughout and in the Cohort 4, which is the optical population that is involved in those studies, we haven't had a 3-line loss in any of our Cohort 4 patients. So that's certainly something to be intrigued about. Smaller numbers we know, but it looks like we've maintained those visual improvements that we've observed over time we reported out.
And the data coming up at ARVO, we'll focus on looking at different analysis of the OCT assessment. And how quickly those changes occur and how they tie into the visual acuity improvements, particularly in those patients that showed signs of outer retinal structural improvement. And so we're very excited to have this data, again, presented by an entirely independent analysis.
William McKinnie Wood
I appreciate that extra color there. And then also just to clarify, do you know the timing of the release of ARVO abstracts and then whether you expect that the abstract presenter may comment on the Phase II enrollment status since there is a meaningful overlap in trial sites there?
Gary S. Hogge
Yes. So as per the ARVO website, it will be available sometime in early March, so perhaps in the next week or 2. With regards to Dr. Banin and his ability to comment on the future or the ongoing study that is conducted by Genentech and Roche, I don't think he'll be able to offer any additional comments at this time.
Brian M. Culley
And William, I'm going to add here. I don't think I'm putting Roche on the spot. But as a general matter, when we were running the Phase I/IIa, these were the first 24 people on the planet to ever receive this experimental therapy. Now that there is a basket of safety and efficacy data available, it makes me think that the conversation between a prospective patient on the clinical trial and their doctor might go a little differently because they could actually show some results that are available in the public domain. So I am hopeful, although I have no specific information because the trial is just underway, but I'm hopeful that enrollment will go faster than it was when we were running it.
William McKinnie Wood
Got it. That's really helpful. And then one last one, switching gears. In regard to your ANP1, there's obviously been a number of players in the hearing space, a lot of them incorporating Intratympanic administration. Just curious what your plans are on delivering the cells into the inner ear. I know you mentioned that it could be a good combo for cochlear implants, but I don't think you're going to be limiting to that. Maybe just walk us through your plans there.
Brian M. Culley
Yes. So I think what the right way for me to describe is that we have a lot of good ideas, but they need to be tested. And so we're not today in a position to say a whole lot more about an intended patient population or exactly what the right clinical application will be. There are many causes of hearing loss. We're going to follow the data that's collected. And right now, we're just at the very earliest stages of that process. So it's difficult, but I think as we reject some hypotheses, reject some options and begin to narrow down what we think is the best approach, that will be something we'll look forward to sharing when we are able to do so and feel confident in that information.
Operator
Our next question comes from the line of Kristen Kluska from Cantor Fitzgerald.
Kristen Brianne Kluska
So we've talked a lot about how a GA approval in general, could help to better educate the market. But perhaps I'll ask you the question from a different direction. How do you think that the emergence of these commercial complement inhibitors can help frame eligible patients by the time OpRegen potentially reaches the market? So I know you've shown that if patients are perhaps too far along towards legal blind status, they may not be eligible. So do you think that patients should they be compliant on these complement inhibitors could become eligible given there's at least some slowing of the progression?
Brian M. Culley
I love it. We have a market leader that is going to condition a market to accept a new therapy in an environment where there are no approved therapies today. And I think there are a couple of places where that could be beneficial. There are technologies out there that are helping people to identify this disease earlier. So I think we're going to see an increase in the prevalence through identification of patients. And I think most companies with these therapies in development are thinking that earlier patients are sort of more suited for therapy. And I also think that the aging population is going to increase the incidence of the condition.
So if you imagine that when my dad was first diagnosed with dry AMD that he would have been told, "We're sorry, there's nothing we can do for you, Mr. Culley." But now, he would be brought in. He would have a specific caregiver. Presumably he would be on therapy. And now he's a little bit of a captured population.
So if you come along with the second, third or fourth treatment in a disease setting, you benefit from the precedent and the awareness of an educated patient population. So I would not feel so positively about it if we had a MeToo therapy. But because our therapy is so wildly different, and I'm hopeful we'll continue to look so different in terms of its product profile, I think that it's actually a big positive for us.
Kristen Brianne Kluska
Okay. And given the data here and of course, the validation from Genentech and Roche, I'm wondering how you're thinking about this pathway with some of your earlier candidates as you start to do some work here? So do you like potentially establishing some proof-of-concept data in-house before potentially seeking partnerships similar to what you saw here? And then can you detail for us some of the preclinical work that you're intending to conduct near term?
Brian M. Culley
So with respect to the strategic component of your question, which has to do with partnering, I think the answer is that it very much depends on the cost of development that you're facing, your probability of success, the macroeconomic business environment you're in, your cost of capital, all of these factors are sort of fun decisions that companies with multiple assets get to make.
So we don't have a priority, a plan to either partner or not partner any of our assets. We look at them as assets that have optionality and flexibility. We just try and make them as valuable as possible so that if we do elect to enter into a partnership that we can find that partnership to be financially rewarding and strategically valuable. And that means partnering with people who have high capabilities and are going to increase the probability of success.
I do think from an approach that the success that we've had so far and we will continue with the OpRegen program does create a certain amount of a halo effect on other assets. Clearly, we are working with different cell types, and so there's not a perfect apples-to-apples comparison. But conceptually, the notion that cells are capable of doing things that are beyond the reach of small molecules is a notion that we think is being borne out in the setting of dry AMD, and we believe will be applicable in other settings.
And I could refer to this morning there was a trial that was unsuccessful in the setting of spinal cord injury utilizing a particular scaffold. There were no biologics involved. It was just pure scaffold. Unfortunately for patients, that was not a study that was successful. But again, to me, that is another reminder in the field that sometimes the standard or expected approaches just aren't quite strong enough when the condition is very severe as in the case of cells that are dying off that goes far beyond a single pathway and getting to the level of the entire cell or the cell has been destroyed through an accident or some sort of trauma such as the case of spinal cord injury.
Kristen Brianne Kluska
Thank you, Brian. Looking forward to seeing the data in a few weeks.
Operator
Our next question comes from the line of Joe Pantginis from H.C. Wainwright.
Joseph Pantginis
So Brian, I wanted to focus on your 2 leading regulatory discussions, and I'll start with VAC2 if you don't mind. So obviously, you talked about the pre-IND discussions right now are surrounding production processes as well as characterization of the cells. So I was curious how do those processes differ, if any, from what CRUK is doing?
Brian M. Culley
Thank you, Joe, for that question. I would say that the similarities in the process, they exist, but one of the reasons that we exercise the option is that we saw an opportunity to improve upon those processes. I want to be really clear for everyone listening that each cell type that we try to manufacture demands and requires its own unique set of steps. So we do not have a one-size-fits-all differentiation secret sauce that we apply to different cell types. It really is a laborious effort to figure out how to get these cells to behave in the way that we want so that we're only manufacturing the cells which we desire to be used in the clinic.
So in the setting of the DCs, which we manufacture, we've made great strides in improving the characterization of those cells and some of that data and information has been provided to FDA so that they can see what we would plan to use going forward.
So there definitely are some differences relative to what we were making -- or excuse me, what was being used by CRUK. But at the end of the day, there are release criteria and properties that are consistent across the material. So it's not like it's a different cell type that would necessarily lead to large differences in clinical behavior. We really have been satisfied with the clinical performance. We're looking more to how we can optimize it, how can we scale and get better production costs and make it more affordable and allogeneic off-the-shelf option for patients and how can we increase the potency, perhaps lower the dose. These are all things that we are working on to see if we can improve a product profile in what is otherwise very much a challenging clinical setting.
Joseph Pantginis
That's really helpful. And then just switching over to OPC1. I was hoping to get even some broad strokes at the minimum, the types of questions that have been going back and forth between you and the FDA and how that's translated into what your wish list looks like going into the Type B meeting?
Brian M. Culley
That's a great question. I would say the vast majority of the content in the materials that we've been sharing with the FDA and the questions they've been coming back with have to do with the new device. This is a device that has not been used before for this purpose. And so they have a lot of questions about how it will be used and how it will perform.
What provides us with some comfort and confidence is that the components that actually go into or touch the patient are the same. The cells that are being used are the same as before. The needle is the same type of needle. Everything that's different with the Neurgain device is actually external to the patient.
So I think from a performance perspective, I feel confident that we will have a good outcome from this study. But nevertheless, the FDA is going to be prudent and want to understand how do all these manipulators work, how do they attach, what happens in a fail situation? What's the worst case scenario? Very standard types of information-seeking questions that we've been getting. And I'll ask Gary if there's anything that he -- that comes to mind that he'd like to add to that question, Joe.
Gary S. Hogge
Yes. Just to add that there's nothing unexpected, but many of these are first time in human use when they assembled together as an entire component. And so they want a demonstration of if you pass the cell through, is it still viable and potent ones that goes through the needle and syringe. Are the components -- what's the pH of the components, what's the software look like? They are all questions that we've got to address. Many of them involve very complex detailed reports and analysis, and that's what the back-and-forth questions have been. Nothing unexpected, but many -- much of it takes time.
Operator
Our final question comes from the line of Jason McCarthy from Maxim Group.
Joanne Lee
This is Joanne Lee on the call for Jason. Just 2 around OpRegen. My first one is regarding the recent approval from Apellis, which we noticed was purely based on disease trajectory with no benefit on visual acuity. Now that we've seen a willingness from the FDA to prove based solely on structural changes in geographic atrophy, does the upcoming data at ARVO take a greater importance for OpRegen? And how does this impact the importance of also demonstrating functional benefit in patients with GA?
Brian M. Culley
Thank you for the question, Joanne. I think that the ARVO data is going to be important because there will be parts of that data that have not been shared before. And we're working with a product candidate that is being discussed as being capable of creating anatomical changes far beyond that of the leading candidate and the more recently approved complement inhibitor. So I think any new data on our approach is definitely meaningful to the field.
With respect to the second part of your question, how does it change the calculus on function? I think it's notable that the data from that recently approved asset essentially proves with statistical significance that they do not affect the visual field. So I think that the opportunity to provide a greater clinical benefit in patients is sitting there for the taking for whichever approach and whichever company can find it because the standard of care clearly has -- unquestionably has no effect on visual function. So I see that as a great opportunity, and I think that we are one of the most important contenders to grab that opportunity.
Joanne Lee
Got it. I appreciate the details. And then just given the differences in mechanism behind complement inhibition and retinal restoration, how would you expect a one-and-done treatment like OpRegen could fit in with complement targeting drugs like Empaveli and others. Would this be something patients could perhaps take and then afterwards on a follow-up receive complement inhibition to further prevent damage? Curious to see how you'd imagine OpRegen could be positioned in the treatment landscape?
Brian M. Culley
I imagine myself as a patient looking at 2 product profiles, one that requires a monthly or every other month injection in the eye. And I'm an elderly individual who has difficulty getting to a clinic 6 to 12 times a year and comparing that with a onetime procedure approximately 30 minutes, and I'm awake for it with multiple years, maybe a lifetime of benefit. So I think the product profile just screams preference, but I'm going to invite Dr. Hogge to add to my thoughts.
Gary S. Hogge
I think there's 2 ways you can look at it and both favor, hopefully, patient outcome. OpRegen potentially be used first and then follow up with a complement inhibitor. So if you take care of rest of GA (inaudible) RPE and keep the photoreceptors healthy. And then given it is an aged eye, then complement inhibition may further set up opportunities to succeed and be established for long-term benefit.
Alternately, if you keep complement inhibition first, decreased inflammatory cascade is ongoing, put in OpRegen cells, and they may be even more likely to succeed. But bottom line, the earlier intervention -- the early identification of a much larger patient pool will help both patients and physicians treating them.
Brian M. Culley
Thank you, Joanne. I'm going to actually combine your question a little bit with the question that we got from Kristen Kluska from Cantor because one of the sort of fun ways I think about the complement inhibitor is that it's sort of like one of those tower defense video games where it's slowing a process. So you can imagine there will be more patients in the hot zone, the addressable zone that could be treated by us. So in terms of the utility of OpRegen if a complement inhibitor becomes established, I think, again, you could see a greater number of patients that exist in that addressable patient population spectrum because some of the very early individuals with dry AMD who get on to complement inhibition, if, in fact, they are on for years and there's 20% or so less progression, they might still be within an addressable profile for our product at some point in the future.
Joanne Lee
Great. Appreciate the additional color. Congratulations on all the progress, and we'll be looking forward to the data at ARVO.
Operator
I would now like to turn the call over to Brian Culley for closing remarks.
Brian M. Culley
Well, thank you, everyone. We absolutely and sincerely appreciate your support of Lineage as we look to position ourselves as a leader in cell therapy and cell transplant medicine. Thank you very much for joining the call today, and have a great rest of your week.
Operator
Thank you, ladies and gentlemen. This does conclude today's call. Thank you for your participation. You may now disconnect.
NEWS -- RG6501 (OpRegen®) Phase 1/2a Results to Be Featured at 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in Presentation by Eyal Banin, M.D., Ph.D.
CARLSBAD, Calif., March 06, 2023--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that results from imaging analyses of structural changes in addition to visual data from a Phase 1/2a clinical study of RG6501 (OpRegen), will be presented at the 2023 Association for Research in Vision and Ophthalmology Annual Meeting (ARVO 2023). The meeting will be held April 23 – 27, 2023 at the Ernest N. Morial Convention Center in New Orleans, LA. The presentation, "Exploratory optical coherence tomography (OCT) analysis in patients with geographic atrophy (GA) treated by OpRegen: Results from the Phase 1/2a trial" will be featured as part of the Paper Session, on April 25, 2023 between 12:30 PM to 12:45 PM MDT, by Eyal Banin, M.D., Ph.D., Director, Center for Retinal and Macular Degenerations (CRMD), Department of Ophthalmology at Hadassah-Hebrew University Medical Center (presentation number 2826, session number 331). RG6501 (OpRegen) is a retinal pigment epithelium cell transplant therapy currently in development for the treatment of geographic atrophy secondary to age-related macular degeneration (AMD). It is being developed under an exclusive worldwide collaboration between Lineage, Roche and Genentech, a member of the Roche Group, and is currently being evaluated in a Phase 2a clinical study in patients with geographic atrophy secondary to age-related macular degeneration (ClinicalTrials.gov Identifier: NCT05626114).
The Association for Research in Vision and Ophthalmology, Inc. (ARVO) was founded in 1928 in Washington, DC by a group of 73 ophthalmologists. ARVO is the largest and most respected eye and vision research organization in the world. ARVO members include nearly 11,000 researchers from over 75 countries. ARVO advances research worldwide into understanding the visual system and preventing, treating and curing its disorders. For more information, please visit https://www.arvo.org/ or follow the association on Twitter @ARVOInfo.
About Geographic Atrophy
Geographic atrophy (GA) is an advanced form of age-related macular degeneration (AMD) characterized by severe loss of visual function. GA is a leading cause of adult blindness in the developed world, affecting at least 5 million people globally. There are two forms of advanced AMD: neovascular AMD and GA. GA and neovascular AMD can occur simultaneously in the same eye, and patients treated for neovascular AMD may still go on to develop GA. GA typically affects both eyes.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230306005224/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
NEWS -- Lineage Cell Therapeutics to Report Fourth Quarter and Full Year 2022 Financial Results and Provide Business Update on March 9, 2023
CARLSBAD, Calif., March 02, 2023--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that it will report its fourth quarter and full year 2022 financial and operating results on Thursday, March 9, 2023, following the close of the U.S. financial markets. Lineage management will also host a conference call and webcast on Thursday, March 9, 2023, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its fourth quarter and full year 2022 financial and operating results and to provide a business update.
Interested parties may access the conference call on March 9th, 2023, by dialing (800) 715-9871 from the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through March 16, 2023, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 5707771.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230302005045/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://r@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
NEWS -- Lineage Enters Into Option and License Agreement With Eterna Therapeutics to Develop Hypoimmune Pluripotent Cell Lines for Multiple Neurology Indications
CARLSBAD, Calif., February 22, 2023--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies to replace and restore specific cell types of the human body, today announced that it has entered into an exclusive option and license agreement (the "Agreement") with Eterna Therapeutics Inc. ("Eterna") for the development of novel beta 2 microglobulin (B2M)-deficient induced pluripotent stem cell (iPSC) lines, which Lineage will evaluate for development into differentiated cell transplant therapies. The new cell lines to be developed by Eterna will support the potential creation of additional product candidates at Lineage, specifically for the treatment of certain central nervous system (CNS) disorders and other neurology indications. Eterna is the exclusive licensee of the key intellectual property underlying this collaboration from its discovery partner Factor Bioscience.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230222005324/en/
"This agreement provides the opportunity to combine insights obtained from our dry age-related macular degeneration program with new tools, to broaden the scope of our technology and may help deliver solutions for a wider range of diseases. The engineering of desirable properties into cell lines can also lead to treatments that are highly differentiated from our competitors," stated Brian M. Culley, Lineage’s CEO. "The initial cell lines we envision bringing into the clinic through this agreement will utilize proprietary mRNA-based gene-editing technology developed by Eterna’s CEO, Dr. Matt Angel. It is natural that we would look to introduce aspects of gene editing, hypoimmunity, and additional pluripotent cell lines alongside our existing directed differentiation capabilities in the furtherance of our overall goal of becoming a comprehensive leader in cell therapy."
Under the Agreement, Eterna plans to conduct certain gene-editing activities and provide materials to Lineage for evaluation. The Agreement provides Lineage an option to obtain an exclusive license to utilize and sublicense the novel gene-edited cell lines for preclinical, clinical, and commercial purposes in the field of CNS diseases. A feature of the starting cell line is the targeted deletion of the B2M gene, which is designed to reduce the immunogenicity of product candidates derived from the lines by inhibiting rejection by CD8+ T cells. Lineage expects this attribute will expand the edited cell lines’ overall utility, including for non-immune privileged or non-human leukocyte antigen (HLA) matched indications. Additional planned gene edits may further differentiate the cell line from others currently in use by competitors. Financial terms were not disclosed.
"The cell therapy expertise demonstrated by Lineage makes them an attractive partner to deploy our mRNA cell engineering platform for the generation of novel gene-edited iPSC lines for neurological applications," said Matt Angel, Ph.D., CEO of Eterna. "At Eterna, we have expertise in creating gene-edited iPSC lines using our extensively patented mRNA cell engineering technologies. We look forward to collaborating with the Lineage team on this project and working with them to develop these powerful tools for the generation of new, intelligently-engineered cell therapy product candidates in the CNS space."
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on Twitter @LineageCell.
About Eterna Therapeutics Inc.
Eterna Therapeutics is a preclinical-stage biotechnology company committed to realizing the potential of mRNA cell engineering to provide patients with transformational new medicines. Eterna has in-licensed a portfolio of over 100 patents covering key mRNA cell engineering technologies, including technologies for mRNA cell reprogramming, mRNA gene editing, the NoveSlice™ and UltraSlice™ gene-editing proteins, and the ToRNAdo™ mRNA delivery system from Factor Bioscience. NoveSlice™, UltraSlice™, and ToRNAdo™ are trademarks of Factor Bioscience. For more information, please visit https://www.eternatx.com.
About Factor Bioscience Inc.
Founded in 2011, Factor Bioscience develops technologies for engineering cells to advance the study and treatment of disease. Factor’s gene-editing technologies enable the precise deletion, insertion, and repair of DNA sequences in living cells to correct disease-causing mutations, make cells resistant to infection and degenerative disease, modulate the expression of immunoregulatory proteins to enable the generation of durable allogeneic cell therapies, and engineer immune cells to more effectively fight cancer. Factor’s cell-reprogramming technologies enable the generation of clonal lines of pluripotent stem cells that can be expanded and differentiated into any desired cell type for the development of regenerative cell therapies. For more information, visit https://www.factorbio.com.
Lineage Cell Therapeutics Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "aim," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to: our plans to develop new cell lines into differentiated cell transplant therapies and potential product candidates, and the potential indications thereof, including as a result of the Agreement with Eterna; our expectations regarding the utility of edited cell lines, the effect of such cells lines on our overall technology, and any related clinical activities; our ability to differentiate a cell line from those of competitors, to broaden our overall capabilities, to deliver solutions for a wider range of diseases, and to develop treatments that are differentiated from our competitors as a result of the Agreement. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that Lineage or Eterna may fail to fully perform under the Agreement or that Lineage, in its sole discretion, may elect not to exercise its option under the Agreement; that the potential benefits of the Agreement, including the potential development of new cell lines into new product candidates may not be realized; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230222005324/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Thanks for posting this Paulness…missed it in my email inbox.
NEWS -- Lineage Provides Update on Auditory Neuronal Cell Transplant Program for the Treatment of Hearing Loss
CARLSBAD, Calif., February 08, 2023--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today provided an update on its auditory neuronal cell therapy program (ANP1), for the treatment of hearing loss, with an initial focus on auditory neuropathy spectrum disorders. Preclinical testing of ANP1 has begun through a collaboration with the University of Michigan and Yehoash Raphael, Ph.D., The R. Jamison and Betty Williams Professor of Otolaryngology, Department of Otolaryngology-Head and Neck Surgery and Lab Director at the University of Michigan Kresge Hearing Research Institute. Dr. Raphael will serve as Principal Investigator and direct initial preclinical testing in collaboration with the company. Hearing loss is a significant unmet medical need, and by 2050, nearly 2.5 billion people are estimated to be impacted by listening impairments across the globe.
"ANP1 is an internally-developed program and which we believe is illustrative of the efficiency and versatility of our technology," stated Brian Culley, Lineage CEO. "In less than one year, we created new methods of differentiation which successfully advanced a new product candidate from the concept stage to the successful manufacture of a discrete cell type at clinically testable scale. Along the way, we generated new intellectual property and advanced that product candidate into preclinical testing. This new pipeline program was created with less than $1.0 million of investment from our R&D budget and without the use of third party grants or intellectual property. This efficiency comes in part from the extensive experience we gained from our prior development of other cell types. With each new cell type we derive, our in-house expertise grows and we elucidate some of the secrets of differentiation kinetics across various lineages. Moreover, because our pipeline assets are pre-validated, meaning they are specific cell types known to perform defined tasks in the human body, we mitigate certain risks and inefficiencies of working on targets with low clinical relevance. We believe our insights and capabilities provide us with a leading position in the cell transplant space."
Dr. Raphael added, "Patients with sensorineural hearing loss due to absence of auditory neurons cannot benefit from cochlear implants. Despite extensive efforts using traditional molecular approaches or more recently, gene therapy, there still are no FDA-approved pharmacological options for these patients. ANP1 takes a different approach: it targets the auditory nerve with an allogeneic population of replacement cells to replace the missing auditory neurons. This offers a novel and potentially more clinically measurable effect than narrow and targeted methods. Rather than changing just one gene or one pathway, replacing the entire cell may be more broadly applicable across a large number of patients. There are many questions to answer, and I am excited to be working with Lineage on this bold new initiative for the potential betterment of the hearing in patients with auditory neuropathies."
Dr. Raphael is an expert in hearing loss research whose interests include inner ear biology, protection and regeneration, gene therapy, genetic deafness and stem cell therapy. Research interests in his lab include repair and regeneration in the inner ear, tissue engineering technologies as applied to the cochlea and vestibular organs, and hereditary deafness. Dr. Raphael is the recipient of numerous awards and honors and has published extensively in the area of hearing loss, with more than 200 publications.
Auditory neuropathy is a challenging hearing disorder in which the inner ear successfully detects sound but has a problem with sending signals from the ear to the brain, currently accounting for approximately 10% of cases of sensorineural hearing loss (SNHL) in children. Current state of the art medical knowledge suggests that auditory neuropathies play a substantial role in hearing impairments and deafness. Hearing depends on a series of complex steps that change sound waves in the air into electrical signals. The auditory nerve then carries these signals to the brain. Auditory neuropathy can be caused by a number of factors including damage to the auditory neurons or loss of these neurons. Researchers are still seeking effective treatments for those affected with auditory neuropathy.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "aim," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to: the potential use of ANP1 for the treatment of hearing loss; the broad potential for Lineage’s regenerative medicine platform and Lineage’s ability to advance and expand the same, including Lineage’s ability to manufacture new specific and differentiated cell types on anticipated timelines and budgets; and the potential for Lineage’s investigational allogeneic cell therapies to generate clinical outcomes beyond the reach of traditional methods and provide safe and effective treatment for multiple, diverse serious or life threatening conditions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: unexpected safety or efficacy data observed during preclinical trials; changes in expected or existing competition; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
Disclaimer: Title provided for identification purposes only. The views and opinions expressed are those of the individual only and do not necessarily reflect the positions of the University of Michigan.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230208005248/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
NEWS -- Lineage to Present at BTIG Ophthalmology Day and the Cantor Fitzgerald Medical & Aesthetic Dermatology, Ophthalmology & MedTech Conference
Fireside Chat with BTIG Research Scheduled for November 29, 2022 at 12:00pm Eastern
Panel Hosted by Cantor Research Scheduled for December 8, 2022 at 1:45pm Eastern
CARLSBAD, Calif., November 29, 2022--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that Brian M. Culley, Lineage’s Chief Executive Officer, will present at the BTIG Virtual Ophthalmology Day, on November 29, 2022 at 12:00pm Eastern Time, in a fireside chat hosted by Yun Zhong, Ph.D., Director, Biotech Equity Research at BTIG. Mr. Culley will also be presenting at Cantor Fitzgerald’s Medical & Aesthetic Dermatology, Ophthalmology & MedTech Conference on December 8, 2022 at 1:45pm Eastern as part of the "Ophthalmology Panel, Vision For The Future: Dry AMD, Other Greenfield Opportunities, and Late-Stage Stories To Shake Things Up". The panel will be hosted by Jennifer Kim, Vice President, Equity Research at Cantor Fitzgerald, and the conference is taking place at the Fontainebleau Miami Beach hotel, December 7-8, 2022.
"I look forward to the opportunity to discuss the evolving landscape in dry AMD, a disease for which there are currently no FDA-approved therapies and which has attracted significant investor attention as of late," stated Brian M. Culley, Lineage CEO. "Atrophic AMD is a progressive disease that if left untreated can ultimately rob a person of their vision. It is increasingly positive for patients that new potential therapies for dry AMD are attracting mainstream interest, and I am excited at how a cell transplant approach can be more prominently featured in such conversations."
BTIG’s Virtual Ophthalmology Day 2022 is exploring emerging innovation in ophthalmology and is being hosted by BTIG, a global financial services firm specializing in institutional trading, investment banking, research, and related brokerage services. BTIG’s Corporate Access program hosts client events across the consumer, digital assets, energy and infrastructure, financials, healthcare, real estate and technology sectors. To join the conference, please email info@btig.com.
The Cantor Medical & Aesthetic Dermatology, Ophthalmology & MedTech conference will feature one-on-ones with leading companies in the Medical & Aesthetic Dermatology, Ophthalmology & MedTech industries, as well as key opinion leaders in the dermatology and ophthalmology space. To join the conference and for more information, please contact your Cantor representative.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "aim," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to: investor attention in the dry AMD landscape or mainstream interest in potential dry AMD therapies, and the impacts these may have on patients with, or potential therapies for, dry AMD and the role that cell transplant therapies may have in the treatment of dry AMD moving forward; and the potential benefits of treatment with OpRegen. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that potential treatments for dry AMD, including OpRegen, may not prove to be successful in clinical trials be and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20221128005145/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
NEWS -- Lineage Announces Launch of Phase 2a Study by Genentech of RG6501 (OpRegen®) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
CARLSBAD, Calif., November 28, 2022--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that its partner Genentech, a member of the Roche Group, has launched a Phase 2a, multicenter, open-label, single arm clinical study of RG6501 (OpRegen), a retinal pigment epithelial cell therapy. The study is intended to optimize subretinal surgical delivery and evaluate the safety and activity of OpRegen in approximately 30, and up to 60 patients with geographic atrophy (GA) secondary to age-related macular degeneration. The primary objectives of the study are to evaluate (i) the proportion of patients with subretinal surgical delivery of OpRegen to target regions under the retina, and (ii) to evaluate the safety of subretinal surgical delivery of OpRegen as measured by the incidence and severity of procedure-related adverse events at 3 months following surgery. A key secondary objective is to evaluate the proportion of patients with qualitative improvement in retinal structure, as determined by Optical Coherence Tomography (SD-OCT) imaging, within 3 months following surgery. RG6501 (OpRegen) is currently being developed under an exclusive worldwide collaboration between Lineage, Roche and Genentech.
"In our Phase 1/2a clinical trial, RG6501 (OpRegen) demonstrated the potential to slow, stop, or reverse the progression of GA in patients with GA. These results can be maintained beyond one year following a one-time, approximately 30-minute outpatient procedure," stated Brian M. Culley, Lineage CEO. "We are excited that Roche and Genentech are advancing the OpRegen program in a larger clinical study and will seek not only to optimize and potentially improve its delivery, but also confirm safety and activity of OpRegen in this patient population. We expect the findings from this Phase 2a study will be highly informative and may increase the probability of success in any future larger, comparative trials."
"We are excited for the launch of this Phase 2a study, where one of the key objectives is to optimize the delivery of OpRegen to achieve the best outcomes," stated Seppi Lin, Vice President of OMNI Early Clinical Development at Genentech. "This study will provide key insights for the future development of the OpRegen program. Geographic Atrophy (GA) secondary to AMD is a disease area of high unmet need with no approved therapies, and we are committed to developing effective and innovative medicines for patients with serious eye diseases."
About the Phase 2a Study
The planned Phase 2a clinical study is a multicenter, open-label, single arm study to optimize subretinal surgical delivery and to evaluate the safety and activity of OpRegen in patients with GA secondary to AMD. Approximately 30 and up to 60 patients may be enrolled across multiple sites and will receive OpRegen administered as a single subretinal injection to one eye with impaired vision. Study treatment will consist of a single subretinal injection of OpRegen at a dose of up to approximately 200,000 cells delivered to target areas of GA in the study eye.
The primary objectives of the study are to evaluate (i) the proportion of patients with subretinal surgical delivery of OpRegen to target regions under the retina, and (ii) to evaluate the safety of subretinal surgical delivery of OpRegen as measured by the incidence and severity of procedure-related adverse events at 3 months following surgery. A key secondary objective is to evaluate the proportion of patients with qualitative improvement in retinal structure, as determined by SD-OCT imaging within 3 months following surgery.
About Geographic Atrophy
Geographic atrophy (GA) is an advanced form of age-related macular degeneration (AMD) characterized by severe loss of visual function. GA is a leading cause of adult blindness in the developed world, affecting at least 5 million people globally. There are two forms of advanced AMD: neovascular AMD and GA. GA and neovascular AMD can occur simultaneously in the same eye, and patients treated for neovascular AMD may still go on to develop GA. GA typically affects both eyes. There are currently no U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) approved treatment options available for patients with GA.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "aim," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to: our collaboration and license agreement with Roche and Genentech and the timing of anticipated FDA interactions; the potential of RG6501 (OpRegen) to be a safe, effective and durable, one-time treatment for geographic atrophy secondary to age related macular degeneration; the significance of this Phase 2a study, including the potential that it will be informative or increase the potential of success in future larger, comparative trials; and preclinical activities, clinical trials, and clinical data updates related to our programs. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; that competing alternative therapies may adversely impact the commercial potential of OpRegen; that Roche and Genentech may not successfully advance OpRegen or be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20221128005217/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
NEWS -- Lineage Cell Therapeutics Reports Third Quarter 2022 Financial Results and Provides Business Update
Follow link for full Press Release:
https://finance.yahoo.com/news/lineage-cell-therapeutics-reports-third-210500032.html
NEWS -- Lineage Cell Therapeutics to Report Third Quarter 2022 Financial Results and Provide Business Update on November 10, 2022
CARLSBAD, Calif., November 03, 2022--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that it will report its third quarter 2022 financial and operating results on Thursday, November 10, 2022, following the close of the U.S. financial markets. Lineage management will also host a conference call and webcast on Thursday, November 10, 2022, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its third quarter 2022 financial and operating results and to provide a business update.
Interested parties may access the conference call by dialing (800) 715-9871 from the U.S. and Canada and should request the "Lineage Cell Therapeutics Call" or provide conference ID number 5262180. A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through November 17, 2022, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 5262180.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20221103005165/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
…and ‘Howe’! <3 <3 <3
Massive applause to building the dream team!
NEWS -- Lineage Cell Therapeutics Appoints Jill Howe as Chief Financial Officer
CARLSBAD, Calif., October 31, 2022--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that Jill Howe will join as the Company’s Chief Financial Officer, effective November 14, 2022. Ms. Howe brings more than 20 years of significant strategic, financial, and operational experience to Lineage, with an emphasis on capital strategy, corporate finance, treasury management, global infrastructure, and operational excellence. Ms. Howe has successfully built biotechnology organizations and implemented operational infrastructures alongside the execution of over $1.66 billion of capital raising transactions and will bring extensive strategic experience to the role. Most recently, Ms. Howe was Chief Financial Officer of DTx Pharma, and prior to that, was Vice President of Finance and Treasurer at Gossamer Bio, Inc., serving an integral role in the company’s initial public offering (IPO) and concurrent listing on the Nasdaq Global Select Market, various follow-on and debt deals, and overseeing all aspects of finance and accounting operations globally.
"Jill is a wonderful addition to our executive team as we work to establish Lineage as a leader in cell therapy and cell transplant medicine," stated Brian M. Culley, Lineage CEO. "She is a successful executive with an extensive track record of execution in capital raising, strategic financial management, global expansion, and support, as well as mergers & acquisitions, and reflects the newest expansion of our team. Our continued growth will allow Lineage to exhibit greater productivity and increase the breadth of what we are able to accomplish in the months and years ahead."
Ms. Howe most recently served as Chief Financial Officer of DTx Pharma, a biotechnology company creating novel RNA-based therapeutics to treat the genetic drivers of disease. From 2018 to 2021, she served as Vice President of Finance and Treasurer for Gossamer Bio, Inc. (NASDAQ: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, where she managed all aspects of finance operations, accounting, and global IT and real estate efforts, including the building-out of world-class labs and office space. She also served as a Board member of all Irish and Luxembourg subsidiaries of Gossamer Bio. From 2016 through 2017 she served as Controller & Director of Finance at Amplyx Pharmaceuticals, Inc., a company dedicated to the development of therapies for debilitating and life-threatening diseases that affect people with compromised immune systems, which was subsequently acquired by Pfizer, Inc. From 2013 to 2016 she served as Controller & Director of Finance at Receptos, Inc. (NASDAQ: RCPT), which was subsequently acquired by Celgene, Inc. for more than $7 billion. Prior to that, from 2006 to 2013 she worked in various accounting roles, leading up to Director of Finance, at Somaxon Pharmaceuticals, Inc. (NASDAQ: SOMX), which was acquired by Pernix in 2012. Ms. Howe earned her Bachelor of Arts in Accounting from San Diego State University and serves on the Board of Directors of various nonprofit, private and public biotechnology companies. In 2022, Ms. Howe won the 2022 CFO of the Year Award in the small business category from the San Diego Business Journal and was specifically recognized for her leadership in building and managing successful financial teams, laying the groundwork for success, and as a San Diegan, for contributions to the community through her local charity work.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "aim," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to: Ms. Howe’s employment with Lineage and the anticipated or implied benefits thereof to Lineage and Lineage’s continued growth and ability to exhibit greater productivity in the future. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20221031005220/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
NEWS -- Lineage Announces Notice of Allowance of Two Patents Covering Processes for Manufacturing Allogeneic Oligodendrocyte Progenitor and Retinal Pigmented Epithelium Cells
CARLSBAD, Calif., October 10, 2022--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance to grant a patent for the Company’s U.S. patent application No. 16/750,975, entitled "Dorsally-Derived Oligodendrocyte Progenitor Cells From Human Pluripotent Stem Cells," with claims covering proprietary manufacturing processes developed by Lineage for its oligodendrocyte progenitor cell therapy candidate (OPC1) for the treatment of spinal cord injury (SCI). The patent, which is expected to be issued in the coming months, would have a term that would expire no earlier than 2040. Additionally, the Company announced that the European Patent Office (EPO) has issued a notice of Intention to Grant a patent for Lineage’s patent application entitled "Preparation of Retinal Pigment Epithelium Cells," (European Patent Application 16753990.7).
"These new patents highlight our ability to generate differentiated cell types from undifferentiated pluripotent cells and are valuable outputs from our platform. The production of specific cell lineages in a controlled and reproducible manner, on platforms which can support large-scale clinical trials, provide us with an important competitive advantage," stated Brian M. Culley, Lineage CEO. "In addition to extending the patent coverage of our assets, new IP can also permit us to protect our programs without relying on patents licensed or obtained from third parties, which may reduce or eliminate payments to such third parties and retain more value for Lineage."
Lineage aims to provide cell-based therapeutic benefits to patients by replacing cells lost due to disease, aging, or in the case of spinal cord injury, a traumatic event. The Company currently is focused on preparing for a planned interaction with the U.S. Food and Drug Administration (FDA) this quarter to discuss its OPC1 Investigational New Drug (IND) amendment submission, which would enable the clinical performance and safety testing of an improved delivery system to administer OPC1 in both acute and chronic spinal cord injury patients. In support of the Company’s planned regulatory interactions, most of the verification and validation activities for this novel parenchymal spinal delivery system and its preclinical testing have been completed, with additional preclinical activities also near completion.
About OPC1
OPC1 is an oligodendrocyte progenitor cell (OPC) transplant therapy designed to provide clinically meaningful improvements to motor recovery in individuals with acute spinal cord injuries (SCI). OPCs are naturally occurring precursors to the cells which provide electrical insulation for nerve axons in the form of a myelin sheath. SCI occurs when the spinal cord is subjected to a severe crush or contusion injury and typically results in severe functional impairment, including limb paralysis, aberrant pain signaling, and loss of bladder control and other body functions. There are approximately 18,000 new spinal cord injuries annually in the U.S. and there currently are no FDA-approved drugs specifically for the treatment of SCI. The OPC1 program has been partially funded by a $14.3 million grant from the California Institute for Regenerative Medicine. OPC1 has received Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug designation from the U.S. Food and Drug Administration (FDA).
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform, Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion-dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "aim," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to the issuance of patents within the coming months and their terms for expiration; the potential value and benefits of these patents; any potential competitive advantages of our cell production capabilities; our ability to reduce or eliminate third-party payments through the development of new intellectual property; our collaboration and license agreement with Roche and Genentech and the timing of anticipated FDA interactions, preclinical activities, clinical trials, and clinical data updates related to our programs. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that patents we expect to be issued may not be issued as soon as expected or at all, or if issued, may expire earlier than expected; that potential benefits of newly developed intellectual property to the Company may not be realized as quickly as expected or at all; that we may need to allocate our cash to unexpected events and expenses causing us to use our cash more quickly than expected; that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; that competing alternative therapies may adversely impact the commercial potential of OpRegen; that Roche and Genentech may not successfully advance OpRegen or be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction; that we may not establish new partnerships or expand existing collaborations; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20221010005173/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
NEWS -- Lineage to Present at Alliance for Regenerative Medicine 2022 Cell & Gene Meeting on the Mesa
CARLSBAD, Calif., October 04, 2022--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that Brian M. Culley, Lineage’s Chief Executive Officer, will present at the Alliance for Regenerative Medicine 2022 Cell & Gene Meeting on the Mesa, on October 12th, 2022 at 2:15pm PT / 5:15pm ET at the Park Hyatt Aviara, Carlsbad, CA. Virtual meeting attendance is available and includes a livestream of Lineage’s presentation and the ability to view all conference sessions on-demand. Interested parties can visit the 2022 Cell & Gene Meeting on the Mesa website for full information on the conference, including registration.
The Cell & Gene Meeting on the Mesa is the sector’s foremost annual conference bringing together senior executives and top decision-makers in the industry to advance cutting-edge research into cures. Tackling the commercialization hurdles facing the cell and gene therapy sector today, this meeting covers a wide range of topics from clinical trial design to alternative payment models to scale-up and supply chain platforms for advanced therapies. The program features expert-led panels, extensive partnering capabilities, exclusive networking opportunities, and dedicated presentations by the leading publicly traded and privately held companies in the space. This conference enables key partnerships through more than 3,000 one-on-one meetings while highlighting the significant clinical and commercial progress in the field.
About the Alliance for Regenerative Medicine
The Alliance for Regenerative Medicine (ARM) is the leading international advocacy organization dedicated to realizing the promise of regenerative medicines and advanced therapies. ARM promotes legislative, regulatory, reimbursement and manufacturing initiatives to advance this innovative and transformative sector, which includes cell therapies, gene therapies and tissue-engineered therapies. In its 13-year history, ARM has become the global voice of the sector, representing the interests of 450+ members worldwide, including small and large companies, academic research institutions, major medical centers and patient groups.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20221004005157/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
NEWS -- Lineage Establishes New R&D Facility in U.S. and Expands Current GMP Manufacturing Facility in Israel
Expansions Expected to Support Process Development and Production of Current and Future Cell Transplant Programs
CARLSBAD, Calif., October 03, 2022--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today the opening of a new research and development (R&D) facility in Carlsbad, California, and the expansion of its Good Manufacturing Practice (GMP) manufacturing facility based in Jerusalem, Israel. Lineage’s new Carlsbad facility will broaden the Company’s R&D capabilities in the U.S. and support the development of current and future allogeneic cell transplant programs. The expansion of Lineage’s Israel-based facility will increase the Company’s infrastructure, including development and optimization of larger-scale clinical manufacturing processes, and continued execution under its ongoing collaboration with Roche and Genentech for RG6501 (OpRegen®), a retinal pigment epithelium cell replacement therapy which has completed enrollment in a Phase 1/2a clinical trial for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
"We have elected to increase our R&D footprint at our existing GMP manufacturing facility and establish a new R&D facility in Carlsbad, California," stated Brian M. Culley, Lineage CEO. "These steps will permit us to expand our process development and analytical testing capabilities and conduct exploratory work on future programs, whether owned by us or our current or future partners. This move also is expected to reduce our reliance on certain vendors, which may reduce costs and risks of timeline uncertainty or supply chain disruption. The additional capacity also can help us become an even more capable partner in prospective alliances for new products and allow us to explore additional uses for our current cell transplant programs."
Mr. Culley added, "Challenges in the biotech sector are unlikely to persist indefinitely. We believe it is important to take steps, even in this environment, to be positioned for a future recovery. The modest investments we are making today, partially offset by the termination of the lease for our research facility in Alameda, California in January of next year, will help centralize our operations and put us in a position of greater readiness for future success."
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "aim," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to: the potential benefits of the new and expanded facilities to the Company and its operations, including the broadening of the Company’s R&D capabilities, increasing development and optimization of larger-scale clinical manufacturing processes, the expansion of the Company’s process development and analytical testing capabilities and ability to conduct exploratory work on future programs, the increase in the Company’s manufacturing facilities, the decreased reliance on certain vendors, the reduction in costs and risks of timeline uncertainty and supply chain disruption, and the improvement in the Company’s position of greater readiness for future success. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that potential benefits of the new and expanded facilities to the Company and its operations may not be realized as quickly as expected or at all; that we may need to allocate our cash to unexpected events and expenses causing us to use our cash more quickly than expected; that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; that competing alternative therapies may adversely impact the commercial potential of OpRegen; that Roche and Genentech may not successfully advance OpRegen or be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction; that we may not establish new partnerships or expand existing collaborations; that we do not successfully broaden awareness of our mission or accomplishments; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20221003005286/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Our partners @Roche & @Genentech are at the forefront of advancing new treatments for #DryAMD and other eye diseases.
— Lineage Cell Therapeutics (@LineageCell) August 24, 2022
Learn how regenerative cell therapies like RG6501 (#OpRegen) are being developed to restore #VisionLoss: https://t.co/npllWs3Vvv
NEWS -- Lineage to Present at H.C. Wainwright & Co. 2nd Annual Virtual Ophthalmology Conference
CARLSBAD, Calif., August 15, 2022--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today Brian M. Culley, Lineage’s Chief Executive Officer, will present at the H.C. Wainwright 2nd Annual Ophthalmology Virtual Conference, in a fireside chat hosted by Joseph Pantginis, Ph.D., Director of Research; Managing Director, Equity Research, H. C. Wainwright & Co. LLC. The fireside chat will be available to investors on demand, starting on August 17th, 2022 at 7am ET.
Interested parties can register to view on-demand replay on the Events and Presentations section of Lineage’s website. Additional videos are available on the Media page of the Lineage website.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220815005164/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Russo Partners – Media Relations
Nic Johnson or David Schull
mailto://Nic.johnson@russopartnersllc.com
mailto://David.schull@russopartnersllc.com
(212) 845-4242
NEWS -- Lineage Cell Therapeutics, Inc. (LCTX) Q2 2022 Earnings Call Transcript
By Motley Fool Transcribing - Aug 12, 2022 at 2:31AM
Q2 2022 Earnings Call
Aug 11, 2022, 4:30 p.m. ET
Contents:
Prepared Remarks
Questions and Answers
Call Participants
Prepared Remarks:
Operator
Welcome to the Lineage Cell Therapeutics second quarter 2022 conference call. [Operator instructions] An audio webcast of this call is available on the investors section of Lineage website at www.lineagecell.com. This call is subject to copyright and is the property of Lineage. And recordings, reproductions or transmission of this call without the expressed 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 conference, Ioana Hone, head of investor relations at Lineage. Ms. Hone, Please go ahead.
Ioana Hone -- Head of Investor Relations
Thank you, Brianna. Good afternoon and thank you for joining us. A press release reporting our second quarter 2022 financial results was issued earlier today, August 11, 2022, 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 fact should be considered forward-looking statements, which are subject to significant risks and uncertainties. The company's actual results or performance may differ materially from the expectations indicated by such forward-looking statements. For a discussion of certain factors that could cause the company's results or performance to differ, we refer you to the forward-looking statements section in today's press release and in the company's SEC filings, including its most recent annual report on Form 10-K and its subsequent quarterly reports on Form 10-Q. We caution you not to place undue reliance on any forward-looking statements, which speak only as of today and are qualified by the cautionary statements and risk factors described in our SEC filings.
With us today are Brian Culley, our chief executive officer and interim chief financial officer, and Gary Hogge, our senior vice president of clinical and medical affairs. Brian will provide some prepared remarks, and then he and Gary will be available for questions from analysts. With that, I'd like to turn the call over to Brian.
Brian Culley -- Chief Executive Officer and Interim Chief Financial Officer
Thanks, Hone, and good afternoon, everyone. We appreciate you joining us on the call today. As you know, I currently am serving on an interim basis as the company's CFO. Several weeks ago, we initiated a nationwide CFO search with an accomplished recruiting firm, and we already are connected to some great candidates.
So I'm hopeful we'll have that position fill soon, and we will update you accordingly. Before I provide the business update today and identify a few events you can look forward to. I typically like to start off with a few general comments about the biotech environment and in particular, where I see Lineage within the field of cell therapy. Along those lines, one notable and recent event was yet another non-cancer cell therapy company, catching the attention of a much larger acquirer.
In this case, I'm, of course, referring to the acquisition of ViaCyte by Vertex. Although many investors focus on the oncology side of cell therapy and indeed, that is where cell therapy has established its strongest foothold. Additional success continues to occur among non-cancer cell therapy companies, such as through the acquisitions of Sema, BlueRock, most recently ViaCyte. And I would also include the partnership which we struck with Roche and Genentech as another significant event for the field of cell transplant medicine.
Reflecting positively on both IPS and ES companies and especially compared to some of the setbacks we've seen with certain mesenchymal or undifferentiated cell therapy companies. And as this field matures and more and more clinical data are generated, it increasingly appears that cell transplants when deployed in the right setting with the right delivery tools have the potential to become an important new branch of medicine. For this reason and others, Lineage will continue to try and position ourselves as a leader in this space through the combination of internal and partnered product development efforts. Thinking next about where Lineage sits within this emerging and promising field as a business and as an investment, I believe we continue to be in an environment where companies with three key characteristics may be in a better position than others to create value in the coming months and years.
Those three characteristics are, one, having multiple years of cash. Two, having deals with big pharma companies. And three, having diversification through a portfolio of assets, preferably clinical-stage assets because those typically offer shorter timelines to approval than do preclinical ones. In those three features, cash, validation and a pipeline are attributes of Lineage, which I believe put us in a strong position to attract shareholder interest in the months and years ahead, and I'd like to touch on each of them briefly today.
Starting with cash, it is clear that the biotech industry continues to be in a period of uncertainty and volatility. And for this reason, we have persisted with our disciplined use of capital. As of the end of the second quarter, we had a projected cash runway of at least two years. I will add that those two years do not include any cash milestones from the Roche agreement, which we may receive during that period.
This runway also does not include any revenues from business development deals, although we are putting greater efforts behind that area as well. As noted in today's press release, we expanded one of our existing agreements last quarter and have initiated multiple discussions for additional corporate alliances, which might help fund or otherwise enhance our assets. And as you know, we continue to be in close contact with SERM and intend to see grant support for the OPC1 program. We may consider SERM support for other programs as well.
So as I have said before and can reiterate again today, we believe Lineage continues to be in a period of good financial health, which allows us to focus on creating value across the spectrum of short, medium and most importantly, long-term time frames. With respect to the second attribute, validation from big pharma, everyone by now is aware of the alliance we entered into with Roche and Genentech last year for the development of OpRegen for dry-AMD with GA or as it is now called by Roche, RG6501. Although we're not able to share specifics, we're extremely pleased with the progress of OpRegen development since entering our collaboration with Roche and Genentech and the resources, which have been allocated to its furtherance. Most of the details are internal to the two companies, but I am able to say that during the second quarter, we made progress across all of the primary functional areas, including clinical, regulatory and manufacturing technology transfer activities, which are reflected in the additional $4.1 million of revenue recognized in the second quarter.
Lineage successfully completed additional manufacturing runs of OpRegen, along with their associated CMC activities. We continued with the planned technology transfer activities and held a series of joint advisory and separately joint manufacturing committee meetings, which are collaborative forums for discussion and planning for the next steps for OpRegen and its related activities. Long-term follow-up of patients from the phase 1-2A clinical study, which Lineage conducted is also ongoing. And most notably, those enrolled patients are still doing well, which supports the multiyear durability of a treatment effect with operegen.
Bolstered by the compelling body of data, which we generated from OpRegen in an early clinical trial, we will continue to work closely with the teams at Roche and Genentech to offer our support and experience and advance OpRegen ever closer to later-stage trials. We believe the results we have observed to date with OpRegen compare favorably against the various efforts focused on complement inhibition, which require a lifetime of frequent dosing, offer only a modest effect on GA progression and to our knowledge, have no or a minimal effect or benefit on visual acuity. For these reasons and many others, we're excited about generating further clinical data from this program as soon as possible. And thirdly, with respect to the diversification, which our promising and recently expanded pipeline offers to investors, the team made excellent progress in multiple areas with a particular focus on advancing certain clinical and regulatory steps, which are not only necessary to support any future trials, but also reduce risk across our portfolio.
In particular, efforts were made to prepare for regulatory interactions for both our OPC1 and VAC2 programs, which are necessary to support their next phases of clinical testing and spinal cord injury and oncology, respectively. And we also continue to engage in manufacturing and preclinical activities for our newly launched cell transplant programs for hearing loss and vision disorders. I'll add that activities which will support our regulatory interactions for OPC1 are nearing completion, which I believe is a positive reflection of our efforts to reduce cell therapy development timelines. Our new thaw and inject formulation of OPC1, which we manufactured via an improved and larger scale process has been undergoing preclinical testing, and I'm pleased to share today for the first time that our OPC1 cells from the improved formulation and process have successfully demonstrated functional recovery in a clinically relevant animal model for spinal cord injury, including improvement in gate coordination and motor performance, along with cell engraftment, which manifests as a reduction of the area of cavitation in the spinal cord.
These findings are consistent with prior data generated from a less efficient and lower scale manufacturing process, so we are delighted that our new and improved process has performed as intended in these studies. We expect that these results will be submitted and available for publication and review. In conjunction with our efforts on the cell side, the other cell side, we have been working on an improved delivery system for OPC1. We believe the novel delivery system, which we licensed from near gain will offer a safer and easier-to-use method for delivering OPC1, and I'm able to share today that most of the verification and validation activities for this delivery system, including its preclinical testing in support of a regulatory submission have been completed, which moves us closer to our goal of filing an IND amendment and testing the DFD clinically.
With both the cell and delivery activities making excellent progress this past quarter, we have reengaged with the California Institute of Regenerative Medicine, or CIRM, to open discussions about providing some financial support for this trial. We also have been reengaging with various industry and caregiver groups such as Spinal Cord Outcomes Partnership Endeavor, and American Spinal Injury Association, as well as with the contemporary thought leadership in spinal cord injuries and with prior study participants. Everything seems to be coming together nicely for the OPC1 program, which I will remind you, will include for the first time administering OPC1 to patients with chronic spinal cord injuries, not just sub-acute injuries in our planned clinical trial to evaluate the safety and performance of the novel delivery device. As OPC1 gets increasingly closer to returning to clinical testing, it's worth remembering why we are so excited to continue this program.
Now, I won't repeat my usual comments about the enormous unmet medical need or the absence of any approved treatments but refer you instead to prior clinical data. The full study results from the 25 patients enrolled in the Phase 1-2A clinical study in sub-acute cervical spinal cord injury were recently published in the Journal of Neurosurgery Spine. In that publication, it was reported that OPC1 demonstrated an excellent safety profile and at one year post treatment, 96% of patients had recovered one or more levels of neurological function on at least one side of their body compared to an expected control rate of approximately 68% according to CSL. In addition, 32% of patients in that study recovered two or more levels of neurological function on at least one side of their body, which again is higher than what Steeves and Llull would have anticipated.
For these reasons and because there were many lessons learned from the initial trial of OPC1, which we aim to incorporate into the next study, we are very excited to put OPC1 back into clinical testing and evaluate the potential for our replace and restore technology to provide outsized clinical outcomes in spinal cord injury, not unlike our experience to date with the restoration of retinal tissue observed with OpRegen in the setting of dry-AMD. Moving next to our VAC2 program. We have similarly continued to make progress toward an IND submission in preparation for potential U.S. clinical testing next year.
I'd like to remind everyone first that Cancer Research U.K. continues to follow patients in the phase one clinical study of VAC2 in non-small cell lung cancer, and the public release of clinical study results is entirely subject to their discretion and control. However, our team has received all the necessary clinical information, which is required to support the regulatory interactions which we are working toward in the U.S. Depending on the outcome from those FDA interactions, we would be permitted to conduct clinical testing of VAC2 at U.S.
Centers for the first time. As we work toward those FDA interactions, I can update you today to share the following technology transfer of the VAC2 program from Cancer Research U.K. to Lineage, the Lineage team engaged in efforts to optimize the manufacturing process. The manufacturing team was able to successfully increase the production scale to a level compatible with early stage testing while also significantly reducing our cost of goods.
I will add that part of the reduction in the cost of goods was due to scale, but a large amount of that reduction was attributable to new methods of production, which we deploy. The team also made marked improvements in the purity and functionality of the product candidate reflected in surface marker expression and in vitro functionality tests. I want to diverge for just a moment to highlight something, which I think has gone under the radar for some time. These manufacturing achievements, which I'm describing today reflect the third time for which Lineage's manufacturing team was able to meet ambitious production goals, goals which were unattainable by multiple prior sponsors and contract manufacturers.
Manufacturing specific cell populations in a reproducible and consistent manner is extremely difficult. And doing so using a process that can not only support initial clinical testing, but also have a line of sight on to a commercial platform is something we've done twice. First with OpRegen, then again with OPC1, and now we've nearly accomplished the third time with our dendritic cell program. I don't think we get full credit for our manufacturing capabilities today, but I do think awareness is rising about how the manufacturing portion of cell therapy product development is so critical and how doing it well can greatly reduce development cycles and avoid regulatory delays, the likes of which we have seen at some other companies.
But I also believe that with additional time and success, the capabilities and know-how of the Lineage's manufacturing team will be more fully appreciated. Returning back to our pipeline programs. I'll conclude by adding that we also have continued to advance our auditory neuron and photoreceptor programs. They both are proceeding through the required preclinical development manufacturing activities, which are necessary to support initial clinical testing.
And as we generate data or have other interesting events, which we can share with you, you can expect updates from time to time on those two programs. Overall, our efforts at this time remain focused on conducting our share of the OpRegen development activities, as well as successfully completing a diverse set of regulatory preclinical and clinical events for our pipeline. Events, which will provide not only clarity on our development time lines, but also help de-risk and increase the value of our various assets. And because we're doing this work among the tailwinds of multiple years of cash, a big pharma partnership and a diverse set of unique yet related cell therapy assets, I'm encouraged by what the future may hold for Lineage.
A handful of specific goals and objectives, which I'd like to invite you to be aware of include a planned interaction with the FDA in Q4, where we intend to discuss our OPC1 IND amendment submission to enable the clinical performance and safety testing of the novel delivery system in acute and chronic spinal cord injury patients. Second, a pre-IND regulatory interaction with the FDA also in Q4 to seek feedback on a VAC2 CMC nonclinical and clinical package to support U.S. clinical development. Third, evaluation of new partnership opportunities and/or expansion of existing collaborations, you saw recently that we are successful in expanding an existing collaboration with ABM for our HyStem technology and that we continue to work with our partner, Immunomic Therapeutics.
But we also would like to enter into additional alliances with larger economic benefits to Lineage and are aggressively seeking to identify opportunities to enter into such corporate alliances and help advance our assets. Fourth, we intend to submit a grant application to SERM for the continued support of the clinical development of OPC1. And fifth, we intend to generate preclinical data to support a pre-IND meeting with the FDA for our new auditory neuron program. We, of course, have other goals, but the ones that I've highlighted today, in particular, will provide additional regulatory and spending clarity and potential de-risking of our programs.
We believe that execution of these goals will continue to demonstrate our ability to successfully advance novel cell therapy product candidates. OK. With that, let me put on my interim CFO hat and turn next to our financial results. With respect to our balance sheet, we continue to be in a comfortable position as we expect to have more than two years of liquidity, not accounting for any of the Roche and Genentech milestones, which we may receive in the next two years nor for any business development or grant revenues, which we may receive.
Our reported cash, cash equivalents and marketable securities as of Q2 totaled approximately $72 million. In comparison, our normalized net operational spending for the past two years was between $20 million and $25 million. So even though we likely will see that amount be closer to $30 million this year, we have more than doubled that amount in the bank and can continue to just focus on running the business. Total revenues for the second quarter were approximately $4.6 million, an increase of $4 million, representing an increase of over 700% compared to the same period in 2021.
The increase was due primarily to licensing fees in connection with the Roche collaboration agreement and reflecting our share of collaboration responsibilities. The largest portion of the activity attributed to this revenue was OpRegen manufacturing costs, but also include personnel, materials and clinical consulting expenses. As you may recall, we received a $50 million upfront payment from Roche in January on a cash basis, but on a GAAP basis, we are recognizing that $50 million over time as opposed to a point in time and utilizing an input method of costs incurred over total estimated costs to complete our performance obligations. The accounting recognition for the Roche upfront payment generally resembles a percent complete methodology but is a reflection of our proportional contribution and may vary from quarter to quarter.
Overall, our revenue recognition for the second quarter was largely in line with our expectations. Total operating expenses for the second quarter were approximately $8.6 million, an increase of approximately $1.1 million compared to the same period in 2021. The increase was a result of increased R&D spending of approximately $400,000, primarily related to development activities in our new auditory neuron and photoreceptor cell therapy programs, as well as an increase in OpRegen related expenses to support the Roche collaboration. Furthermore, G&A expenses were up by approximately $700,000, mostly related to higher stock-based compensation and payroll and related benefits expense.
Our loss from operations for the second quarter was approximately $4.2 million, a decrease of $2 million compared to the same period in 2021, resulting from the aforementioned $4 million increase in revenues and offset with a $1.1 million increase in operating expenses. The net loss attributable to Lineage for the second quarter was $6.8 million or $0.04 per share. And as we always say at this point in the call, it's important to remember that the variance between our loss from operations and our overall net loss is impacted by changes in the value of our investments, as well as by foreign currency exchange rate fluctuations related to our international subsidiaries. While these nonoperational fluctuations are important, we tend to utilize loss from operations as a more relevant measurement with regard to our clinical programs.
Turning to the balance sheet. We reported cash and cash equivalents and marketable securities of approximately $72 million as of quarter end. And additionally, as disclosed as a subsequent event in our recently filed 10-Q, during July, we also received approximately $0.9 million in net proceeds from a warrant exercise at our subsidiary in Israel. As I mentioned earlier, we anticipate a modest increase in our normalized net spending this year compared to the prior year because our programs increased in number and continue to advance toward their next clinical trials.
And we have certain performance obligations under the Roche agreement such as supplying OpRegen cells for the next clinical trial. But as I also noted earlier, we estimate our net operational spend for 2022 on a normalized basis will be less than $30 million. Overall, we intend to maintain the same spending discipline that we have adhered to so far and which has served us well in the past. We believe that this spending discipline, alongside our cash balance puts us in a good position to create value for shareholders from our investments.
Our guiding principle at Lineage is to advance the emerging technology of cell transplant medicine and to show the potential for those transplants to outperform traditional approaches by providing the product attributes and rigorous clinical testing necessary to achieve commercially successful medicines in areas of high unmet need. To that end, we believe we have not only generated evocative data from our current clinical programs, but also have the opportunity to do so with our earlier stage initiatives. We've made significant investments in and improvements to areas such as production, scale, purity and delivery of our differentiated cells, which, overall, we believe, is a proven path to creating best-in-class products for end users and strong competitive advantages to protect lineages and our current and potential partner sales over the long term. We also are working hard to identify and execute on measures which can reduce cell therapy development timelines, which we believe is a new area of opportunity in this young field.
Wrapping up, as I speak with you today, we are confident in our cash position, our corporate alliances and our diverse portfolio of assets from which we can seek to optimize an attractive mix of development partnerships and internally developed programs. There is a lot to like about where we are today and much to anticipate from us in the coming weeks, months and years. We sincerely appreciate your support as we continue to position Lineage to become a leader in cell therapy and cell transplant medicine. And with that, operator, we are ready to respond to any questions from research analysts, which may be incoming.
Questions & Answers:
Operator
[Operator instructions] Your first question comes from Mayank Mamtani with B. Riley Securities. Your line is now open.
William Wood -- B. Riley Securities -- Analyst
Thank you so much. This is William Wood on for Mamtani. Brian, congratulations to you and the Lineage team for another very productive quarter. Just a couple of questions from us here.
So just thinking about OPC1, maybe even in terms of OpRegen, where it sometimes takes a little bit longer for the sales to get in and really do what they're supposed to do and to really get the results you're looking for, obviously, already shown very nice results with OPC1 at one year. Just curious about some of the longer-term data for efficacy, potentially maintenance or even improvements or alternatively degradation of the recovery for our OPC1 treated from the side star or potentially even from earlier trials. Is that the recovery is maintained? And extra color, that would be great.
Brian Culley -- Chief Executive Officer and Interim Chief Financial Officer
Yes. So I'll invite Gary Hogge to comment. I think I'll just preface by saying it's a question we all have. I mean, how durable are these cells.
They continue to persist in patients. And so, potentially, they will essentially outlive the people that they are transplanted into. But Gary could be a little more specific about how long we monitor patients and how long we've seen these kinds of benefits.
Gary Hogge -- Senior Vice President of Clinical and Medical Affairs
Yes, sure. Thanks, Brian. So William, what we've observed to date is that the cells appear to persist at the site of administration so they don't migrate anywhere, they stay where they were put. And all systems on the MRI findings to date would say that they're durable up to the length of follow-up, which is greater than 10 years in some patients at this point.
So as we complete some of the additional animal models and look for the durability response in the animals, we didn't think that that will follow through with our individual patients. And one thing they were doing shortly is there'll be a management looking at the MRI finding, specifically to show that those improvements from the site of administration are maintained for a period of time. As Brian said, sometimes the patients with rehab also continued to improve, even if they don't necessarily gain multiple levels on the different assessments, but individual ability to move fingers or digits or risks can definitely improve quality of life. So we're also looking at being able to publish some of those data.
William Wood -- B. Riley Securities -- Analyst
Also curious, you've discussed a lot with potential partnerships or collaborations. I'm just curious where you've seen the most interest as far as from external programs looking at your specific internal programs, even considering also there's the most interesting manufacturing side of things? And then maybe kind of in addition to that, if there is a scenario where you potentially see sort of your manufacturing side spin out from the clinical development side or something to that degree? Just any extra information there.
Brian Culley -- Chief Executive Officer and Interim Chief Financial Officer
Yes. So as you know, I can't comment specifically on any discussions or any specific companies. What I'm able to say is that we are aware in particular, in an environment like we're in right now in biotech that there's trends benefit if you have a platform technology of working with multiple corporate partnerships because you're able to just conduct so much more, many more shots on goal, so much more productivity when you've got multiple parties working. The challenge for any company is if you have choices deciding how to sort of divide up a large either intellectual property estate or different parts of technology and sometimes parts of the technology overlap.
For example, there may be certain applications of intellectual property with respect to a manufacturing process, which we could deploy across related indications. And so, sometimes, you have to make decisions about how you're going to kind of divide up the pie if you have the opportunity to make those choices. So we're really keen to accelerate our product development because we obviously cannot manage 5 simultaneous pivotal trials. So we're really supportive and interested in business development.
Generally, with respect to more strategic considerations like manufacturing, I can't imagine scenarios where utilizing our manufacturing expertise could be valuable to our company. But I want to caution everyone that that does not mean turning into a lower-margin manufacturing CRO business. We'll always want to have a meaningful piece of the upside for any program. So I want to be clear that our jobs here involve creating value and sometimes that might mean you go in an unexpected direction in order to create that value, and that's OK.
But I do think that we recognize that our contribution and getting the best economics from any future deal is going to be driven by having a lot of value behind our contribution and not I would say, diminishing it or allowing us to get into relationships where we're not going to be paid a fair value for our contribution. So I recognize that that is very sort of a generic sort of response for reasons that you're already aware of. But nonetheless, these are the realities of how we view our business and what we have to offer.
William Wood -- B. Riley Securities -- Analyst
Yeah. No, that's. It's very helpful. I think I'll leave it there.
I appreciate it, Brian. Congratulations again to you and the team and, yes, congratulations.
Operator
Your next question comes from Kristen Kluska with Cantor Fitzgerald. Your line is now open.
Rick Miller -- Cantor Fitzgerald -- Analyst
Good afternoon. This is Rick for Kristen. We have two for you here. In the photoreceptor program, with the caveat that, of course, is in preclinical development still ongoing.
Are you thinking about -- how are you thinking about potential learning that might be carried over from the OpRegen program in terms of delivery and the importance of covering affected areas of tissue in the ophthalmology space?
Brian Culley -- Chief Executive Officer and Interim Chief Financial Officer
Yes. I mean, I think one of the nice things about introducing another ophthalmology program is that there is much that we can learn, and we already have very established relationships in that space. So it was an easier area for us to get into. But let me again invite Gary to address some more specifics to your question.
Gary Hogge -- Senior Vice President of Clinical and Medical Affairs
Sure. So Rick, one thing is we've certainly got the experts in retinal physiology and disease cause disease at the back and call at this point is they're very engaged with the OpRegen data. So one thing we learned from OpRegen is delivery, delivery, delivery is critical. If you make the cells in the and they are the most functional, they will do their job as intended.
So the key alarms that would be early intervention, appropriate delivery in an area that is targeted to make a difference. So there are a number of diseases that impact the photoreceptors as you can imagine, and we're certainly open to considering all of those.
Rick Miller -- Cantor Fitzgerald -- Analyst
OK. And maybe just one more. Looking ahead to regulatory interactions around OPC1, how are you thinking about how the preclinical activities that you mentioned could fit into the meeting? What do you believe regulators are looking for here?
Brian Culley -- Chief Executive Officer and Interim Chief Financial Officer
Well, it's a tough question because it's sort of a moving answer. I think the FDA has been evolving in its own state of maturation in the field of cell and gene therapy. For example, I think that FDA has been increasingly interested in functional assay data from cell therapy manufacturers just to provide one example. We do know that they wanted to see specific to the OPC1 program, information about the device before they reviewed the information about the new process that we are utilizing.
So we're going to follow a sequential path there that they've outlined for us. But this is, I won't say, new territory, but there are not a large number of precedents for delivering cells like this to the spinal cord. So it's difficult for us to know and that, in fact, is part of the reason why we're trying to be comprehensive with our submission and get the agency as much information as we think they're looking for so that we can have some positive outcomes in an area which is breaking some new ground.
Rick Miller -- Cantor Fitzgerald -- Analyst
That's great. Thank you very much.
Operator
Your next question comes from Joe Pantginis with H.C. Wainwright. Your line is now open.
Joe Pantginis -- H.C. Wainwright -- Analyst
Hey, everybody, good afternoon. Thanks for taking the question. If you don't mind, I'd like to ask CFO, Brian, a question first. I appreciate that you give the guidance about a little under $30 million or so for net spent this year.
But I was curious more specifically about the G&A line. That line tends to be a little choppy. Obviously, there are some noncash items that are included there. But I guess I would ask the question this way.
Either does this quarter -- or I'm sorry, the second quarter number represent a baseline. Or how should we sort of view that with regard to the current rightsizing of the company's FTEs?
Brian Culley -- Chief Executive Officer and Interim Chief Financial Officer
As you know, this is my second tour of duty as an interim CFO. So of course, I'm not prepared to answer that question. So G&A was up only about $700,000, a lot of that is in fact, related to personnel. I am aware that many companies have been laying people off and that we are a bit of a salmon going in the opposite direction.
That's wonderful. I mean, that reflects that we're confident that we have the capital to be able to expand sensibly in this environment. And I also believe that we have a wonderful choices out there attributable to the fact that some very high-caliber companies are laying people off. And those people are going to be increasingly interested in a company like Lineage that has capital and some validation from big pharma, etc.
So I think that you could consider it to be more of a new baseline rather than a stand-alone one-off increase in the quarter because a lot of it is connected to personnel and we want to keep those personnel, but I think that's great. Change through growth and adding people is also going to turn into greater productivity and the breadth of what we're able to accomplish. So I'm really happy with where we've come in and our continued disciplined use of capital, and I'm particularly excited about some of the new hires that we've made and some of the candidates that we're continue looking at.
Joe Pantginis -- H.C. Wainwright -- Analyst
And then, I guess, my next question, I mean, it's surrounding Roche, and I know a lot of the details around my question are in the weeds of the confidential documents, but I guess I'll ask it this way. How far will you be taking? Or what do you feel you could share with us with regard to what your remaining responsibilities are with regard to manufacturing and CMC?
Brian Culley -- Chief Executive Officer and Interim Chief Financial Officer
So you're correct. The weeds are, in some places, so I think that they're redacting that information. So I'm not able to say really anything beyond what I shared today. Primarily, our contributions are around manufacturing for the next clinical study, completing the phase 1-2A study, which we already completed enrollment for, but we have to follow up patients.
And we have sorted additional contributions largely in the form of sort of advisory I'd characterize them as advisory contributions. So it's really difficult for me to say anything more than that. However, as we do get closer and as some of the public information does get released, it will be easier for us to be able to either connect some dots or be able to make some explicit statements about the program, it's timeline, revenue recognition and everything in between those two.
Joe Pantginis -- H.C. Wainwright -- Analyst
And then my last question is more of a pie in the sky question because, look, you're very fortunate to have a strong cash balance, especially in this environment. And I'll preface my question by saying, obviously, you have a lot going on. So but with that said, would you be considering at any point? Or are you even bothering to look at any potential technologies or assets to bring in that might be complementary because of the depressed valuations that are out there?
Brian Culley -- Chief Executive Officer and Interim Chief Financial Officer
I think the right answer is always yes. I think that in some environments, you're in a stronger position to be able to consider that. If you got a high equity price and a lot of capital, but I think the reality is that we are always looking at ways that we can accelerate the development of our programs. Are we spending more time thinking about those opportunities than we were one year ago? Yes.
We hired some additional personnel in business development and licensing, and that's one of their areas effort, but I would not say that we have an explicit campaign with narrow search criteria and an engaged investment bank to work on a project that would be beyond the scope of what we're doing. But when the phone rings and people want to talk about alliances, we always pick up and sometimes we're the ones that are dialing. So the answer is yes, but I also don't want to make more of it than our normal course of business, looking for ways that we can add or enhance to our business.
Joe Pantginis -- H.C. Wainwright -- Analyst
Got it. Thank you, Brian.
Operator
Your next question comes from Jason McCarthy with Maxim Group. Your line is now open.
Jason McCarthy -- Maxim Group -- Analyst
Hey, Brian, thanks for taking the questions. Two questions, and specific around VAC2 and one more broadly. But for VAC2, can you give us a sense of when we could see the Cancer Research U.K. phase one data in lung? Is that going to be this year? And how is that data going to be used to present to regulators for development in the U.S.? And my second question is more broadly, you had mentioned the Vertex ViaCyte acquisition.
But can you talk just a little bit about what we see is essentially most big pharmas and big biotech are now aligned or aligning themselves with cell therapy non-oncology initiatives?
Brian Culley -- Chief Executive Officer and Interim Chief Financial Officer
So question one is like itself a two-parter when VAC2 and then how would we use it. So I'll do Part 1. So it's up to Cancer Research U.K. and I'll just be very direct that one of the factors that led us to exercising our option to bring that program back was that we felt that it would move quicker in lineages hands than where it was.
So we don't know when that data will be available or published or presented. It's not our decision and it's not under our control. But when it does become available, we certainly will want to share it with everyone. And then, I'll hand off to Gary for how the information that we have collected can be useful to a U.S. filing.
Gary Hogge -- Senior Vice President of Clinical and Medical Affairs
Yes. So one thing to keep in mind is that the endpoints, as he's shown on clintrials.gov are primarily safety at 5 years and signs of immune effector efficacy at two years. The last patient came on in February of this year. So that patient will take two years until February of 2024.
So we've got a ways to go for that patient, hopefully, because they continue to do well. We have the complete annual safety update. There are no untoward unexpected adverse events or serious adverse events, it's behaved as expected. Everything has been mild and well tolerated.
And so, those safety data will contribute to our regulatory submissions and discussions with the agency. And again, we're focused on the FDA, but there are other regulatory bodies that we'd like to essentially consider as well.
Brian Culley -- Chief Executive Officer and Interim Chief Financial Officer
And then returning back to your second question. This is a really exciting time in cell therapy because I think what we're seeing, and it would be a debated point. But my view of what we're seeing is that as data continues to be generated, the most promising data in my mind is emerging in the area of differentiated cell types going after areas like Type 1 diabetes and Parkinson's. It's not with the undifferentiated "Adult cells", the mesenchymal cells from adipose or umbilical cell.
I think what's exciting in the seat that I sit in at Lineage and is shared with some of the companies that you have in mind when you're asking this question, are these non-oncology, so i.e., non-T cell non NK cell. Specific differentiated cell types that are used much like a bone marrow transplant. You are just manufacturing the cell type. The cell has a specific function.
You deliver it, you have to have a solution for how it can remain durable and not be rejected. But if the cells are there and they're functional, they may be able to provide that normal natural biological function that is somehow lost under certain conditions like dry-AMD with GA or Parkinson's disease or diabetes. And I agree with you entirely that it seems that more and more interest is being reflected by the international big pharma community, and they are sometimes making baby steps, sometimes making massive bites, but there does seem to be a trend in this direction, which I think is incredibly exciting because it is still a relatively early technology and early technologies get better with time. And so, I think you're going to see explosive growth in this field.
I've been saying that for a couple of years. And I think there's increasingly evidence to support that. And it will just be a question of how high is the ceiling on this. And I believe it's very high indeed.
Jason McCarthy -- Maxim Group -- Analyst
Great. Thank you for taking my questions.
Operator
[Operator signoff]
Duration: 0 minutes
Call participants:
Ioana Hone -- Head of Investor Relations
Brian Culley -- Chief Executive Officer and Interim Chief Financial Officer
William Wood -- B. Riley Securities -- Analyst
Gary Hogge -- Senior Vice President of Clinical and Medical Affairs
Rick Miller -- Cantor Fitzgerald -- Analyst
Joe Pantginis -- H.C. Wainwright -- Analyst
Jason McCarthy -- Maxim Group -- Analyst
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NEWS -- Lineage Cell Therapeutics to Report Second Quarter 2022 Financial Results and Provide Business Update on August 11, 2022
CARLSBAD, Calif., August 04, 2022--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that it will report its second quarter 2022 financial and operating results on Thursday, August 11, 2022, following the close of the U.S. financial markets. Lineage management will also host a conference call and webcast on Thursday, August 11, 2022, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its second quarter 2022 financial and operating results and to provide a business update.
Interested parties may access the conference call by dialing (800) 715-9871 from the U.S. and Canada and (646) 307-1952 from elsewhere outside the U.S. and Canada and should request the "Lineage Cell Therapeutics Call" or provide conference ID number 6448886. A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through August 18, 2022, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 6448886.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 1/2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, which is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy, and (v) PNC1, a photoreceptor neural cell therapy for the treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220804005025/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Russo Partners – Media Relations
Nic Johnson or David Schull
mailto://Nic.johnson@russopartnersllc.com
mailto://David.schull@russopartnersllc.com
(212) 845-4242
B.Riley Financial Thinks Lineage Cell Therapeutics’ Stock is Going to Recover
Source: TipRanks
B.Riley Financial analyst Mayank Mamtani initiated coverage with a Buy rating on Lineage Cell Therapeutics (LCTX – Research Report) today and set a price target of $4.00. The company's shares closed last Monday at $1.30, close to its 52-week low of $1.10. According to TipRanks.com, Mamtani has currently 0 stars on a ranking scale of 0-5 stars, with an average return of -31.4% and a 20.7% success rate. Mamtani covers the Healthcare sector, focusing on stocks such as Arrowhead Pharmaceuticals, Spectrum Pharmaceuticals, and Madrigal Pharmaceuticals. Currently, the analyst consensus on Lineage Cell Therapeutics is a Strong Buy with an average price target of $6.00, which is a 334.
https://www.tipranks.com/news/blurbs/b-riley-financial-thinks-lineage-cell-therapeutics-stock-is-going-to-recover?utm_source=advfn.com&utm_medium=referral
Consistently advancing. Solid groundwork.
NEWS -- Lineage Broadens Collaboration With Advanced BioMatrix for HyStem® Cell Drug Delivery Technology
CARLSBAD, Calif., June 02, 2022--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that it has expanded its existing collaboration with Advanced BioMatrix, a division of BICO Group AB (STO: BICO), for Lineage’s HyStem cell/drug delivery technology. Under the expanded collaboration, Advanced BioMatrix will broaden its current focus of manufacturing and supplying R&D-grade HyStem to the research community to include the development, supply and/or licensing of clinical/commercial GMP- (Good Manufacturing Practice) grade material for its customers. The amended agreement increases the milestone payments and royalty percentages due to Lineage upon ABM reaching certain development milestones and/or product sales.
"We are pleased to broaden the scope of our agreement with Advanced BioMatrix and the opportunity to include the commercial supply of clinical-grade HyStem as part of ABM’s biomaterials & bioprinting portfolio which is widely available to the cell therapy product development community," stated Brian M. Culley, Lineage CEO. "We have decided this year to place a greater emphasis on business development and licensing and we believe the decision to broaden our partnership with ABM is an example of our ability to rapidly monetize prior investments in our technology platform and its related intellectual property. Alongside our prioritized assets, other assets which are not core to our cell transplant platform can create new opportunities for cash flow and support our development pipeline. Our strategy is to identify and pursue opportunities to unlock value from our business and to utilize capital from these corporate alliances to advance our novel cell therapy programs."
"The mission of Advanced BioMatrix is to enable the future of life-saving treatments, and the HyStem technology can now be more fully utilized as a tool towards accomplishing this mission," added Bowman Bagley, Advanced BioMatrix CEO.
HyStem is a patented hydrogel which mimics naturally occurring extracellular matrix, the structural network of molecules surrounding cells in organs and tissues and essential to cellular function and tissue structure. HyStem biomaterial has been shown to support cellular attachment and survival as well as compatibility with a wide variety of cells and tissue types including brain, bone, skin, cartilage, vascular and heart tissues.
About Advanced BioMatrix, Inc.
Advanced BioMatrix, a San Diego based leader in the life science of three dimensional (3D) applications for tissue culture, cell assay, bioprinting and cell proliferation, was acquired by BICO Group AB in September 2021. BICO is a publicly traded bioconvergence company that designs and supplies technologies and services to enhance biology research. Advanced BioMatrix has been manufacturing and delivering high quality products for research uses and applications for over 10 years and continues to add several innovative new products each year that provide research tools for our customers worldwide. Advanced BioMatrix develops new products and technologies directly and also collaborates with many research institutes, universities and life science companies.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 1/2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, which is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "aim," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to: the collaboration and license agreement with Roche and Genentech; the power and efficiency of Lineage’s platform and its competitive advantages; the potential future achievements of Lineage’s clinical and preclinical programs; and plans and expectations of Lineage’s products in development. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the risk that Advanced BioMatrix may not be successful in maintaining or expanding its market for HyStem; risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220602005379/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Solebury Trout IR
Justin Frantz
(mailto://jfrantz@soleburytrout.com)
(617) 221-9100
Russo Partners – Media Relations
Nic Johnson or David Schull
mailto://Nic.johnson@russopartnersllc.com
mailto://David.schull@russopartnersllc.com
(212) 845-4242
Lineage Cell Therapeutics Reports First Quarter 2022 Financial Results and Provides Business Update
The primary objective of the study was to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment- emergent adverse events. Secondary objectives are to evaluate the potential activity of OpRegen by assessing changes in visual function and retinal structure. The primary objective and the secondary objectives were assessed at 12 months following OpRegen subretinal delivery (“Month 12”) and subjects are followed for up to five years.
Summary of Safety Results (data cutoff: January 18, 2022)
? All 24 treated patients reported at least one adverse event (“AE”) and at least one ocular AE.
? The majority of AEs reported with OpRegen were mild (Cohorts 1-3, 87%; Cohort 4, 93%), and the immunosuppressive regimen was well tolerated.
? The ocular AEs reported with OpRegen were mainly related to the surgical procedures used for subretinal delivery, with the most common being conjunctival hemorrhage/hyperemia (n=17) and epiretinal membrane (n=16).
? One patient discontinued the study due to an AE that was determined unrelated to treatment.
? No cases of rejection following OpRegen subretinal delivery have been reported.
? No acute or delayed intraocular inflammation, or sustained intraocular pressure increase following OpRegen subretinal delivery has been observed.
-2-
Summary of Activity Results (data cutoff: January 18, 2022)
? Preliminary evidence of improvement in visual function using the Early Treatment Diabetic Retinopathy Study (“ETDRS”) assessment of BCVA:
? Cohort 4 subjects (n=12) had an average 7.6 letter gain in the study (treated) eye and an average 1.7 letter gain in the fellow (untreated) eye at Month 12 compared to baseline. Cohorts 1-3 subjects (n=11) had an average 4.7 letter gain in the study eye and an average 6.0 letter gain in the fellow eye at Month 12 compared to baseline.
? Three subjects in Cohort 4, or 25% of Cohort 4, and one subject in Cohorts 1-3 had a 15 letter or greater gain in the study eye at Month 12 compared to baseline. None of the fellow (untreated) eyes had a 15 letter or greater gain.
? Five Cohort 4 subjects with OpRegen delivered to most or all of the GA area, including the fovea, had greater gains in visual function at Month 12 (average 12.8 letter gain) as compared with subjects who did not receive OpRegen in a similar manner to most or all of the GA area, with evidence for regions of apparent improvement of outer retinal structure as assessed by spectral domain optical coherence tomography (“SD-OCT”).
? SD-OCT imaging analysis of all subjects is ongoing.
These data support the potential for OpRegen to slow, stop, or reverse disease progression in GA. Further assessment of the optimal disease stage for intervention, surgical procedure for subretinal delivery, and target delivery location of OpRegen in a larger, controlled clinical study is needed to confirm these preliminary findings.
NEWS -- Lineage Cell Therapeutics to Report First Quarter 2022 Financial Results and Provide Business Update on May 12, 2022
CARLSBAD, Calif., May 05, 2022--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that it will report its first quarter 2022 financial and operating results on Thursday, May 12, 2022, following the close of the U.S. financial markets. Lineage management will also host a conference call and webcast on Thursday, May 12, 2022, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its first quarter 2022 financial and operating results and to provide a business update.
Interested parties may access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through May 20, 2022, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and Canada and entering conference ID number 1875641.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 1/2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, which is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy, and (v) PNC1, a photoreceptor neural cell therapy for the treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220505005147/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Solebury Trout IR
Justin Frantz
(mailto://jfrantz@soleburytrout.com )
(617) 221-9100
Russo Partners – Media Relations
Nic Johnson or David Schull
mailto://Nic.johnson@russopartnersllc.com
mailto://David.schull@russopartnersllc.com
(212) 845-4242
That is why I load on every big dip. I loaded large at $1.18 and some at $1.20. LCTX
Lineage Cell Therapeutics (LCTX) Received its Third Buy in a Row
Source: TipRanks
After Maxim Group and Noble Financial gave Lineage Cell Therapeutics (NYSE MKT: LCTX) a Buy rating last month, the company received another Buy, this time from H.C. Wainwright. Analyst Joseph Pantginis reiterated a Buy rating on Lineage Cell Therapeutics today and set a price target of $7.00. The company's shares closed last Monday at $1.20, close to its 52-week low of $1.13. According to TipRanks.com, Pantginis is currently ranked with 0 stars on a 0-5 stars ranking scale, with an average return of -28.4% and a 17.7% success rate. Pantginis covers the Healthcare sector, focusing on stocks such as Applied Genetic Technologies, Actinium Pharmaceuticals, and Checkpoint Therapeutics.
https://www.tipranks.com/news/blurbs/lineage-cell-therapeutics-lctx-received-its-third-buy-in-a-row-3?utm_source=advfn.com&utm_medium=referral
NEWS -- RG6501 (OpRegen®) Phase 1/2a Clinical Results Support the Potential for OpRegen to Slow, Stop or Reverse Disease Progression in Geographic Atrophy Secondary to Age-Related Macular Degeneration
Great loading zone approaching here!! Such a solid company in my opinion!! LCTX
NEWS -- Lineage to Present at B. Riley Securities 2022 Neuro & Ophthalmology Virtual Investor Conference on April 27, 2022
Fireside Chat with B. Riley Research Analyst Scheduled for 3:30pm Eastern Time
Topics Will Include Two New Cell Therapy Programs Launched Following Roche and Genentech Partnership for RG6501 (OpRegen®) Program
CARLSBAD, Calif., April 26, 2022--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today Brian M. Culley, Lineage’s Chief Executive Officer, will present at the B. Riley Securities 2022 Neuro & Ophthalmology Virtual Investor Conference, in a fireside chat hosted by Mayank Mamtani, Managing Director, Senior Biotech Research Analyst and Group Head of Healthcare Research at B. Riley Securities, on Wednesday April 27th, 2022 at 3:30pm EST.
Interested parties can register to view both the live event and replay on the Events and Presentations section of Lineage’s website. Additional videos are available on the Media page of the Lineage website.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, which is now being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy, and (v) PNC1, a photoreceptor neural cell therapy for the treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220426005359/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Solebury Trout IR
Mike Biega
(mailto://Mbiega@soleburytrout.com)
(617) 221-9660
|Russo Partners – Media Relations
Nic Johnson or David Schull
mailto://Nic.johnson@russopartnersllc.com
mailto://David.schull@russopartnersllc.com
(212) 845-4242
NEWS -- Lineage Announces a Fifth Cell Therapy Program: Allogeneic Photoreceptor Transplants for the Treatment of Diseases Which May Lead to Blindness
Dynamic Culturing Process Developed by Lineage Offers Path to Clinical- and Industrial-Scale Production of Photoreceptors
Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced a new cell therapy development program: photoreceptor neural cell (PNC) transplants for the treatment of vision loss due to photoreceptor dysfunction or damage. Similar to the company’s recently announced pipeline expansion into auditory neurons for the treatment of hearing loss, Lineage has filed for intellectual property protection covering the composition and methods for generating PNCs. Based on recent in vivo data generated using the company’s PNCs, these cells may be capable of forming reconstructed retina with high survivability and neural connectivity to surrounding functional layers. Notably, Lineage has demonstrated feasibility which could support a large-scale method for producing both types of photoreceptors, known as rods and cones.
“It is natural that, on the heels of the announcement of our alliance with Roche and Genentech for our RPE cell therapy, a deal worth up to $670 million dollars plus double-digit royalties if certain development, approval, and sales milestones are achieved and other conditions are met, that we also would pursue treatments for vision loss through the other major cell type of the retina, the photoreceptors,” stated Brian Culley, Lineage’s CEO. “Our fundamental technology and accumulated know-how give us the opportunity to make many different cell types, and we have demonstrated our ability to create new programs rapidly and efficiently in two distinct areas, expanding our cell therapy pipeline to five separate preclinical and clinical programs, while still maintaining what we believe is an appropriate and responsible rate of investment for a company of our size. This latest program is part of our long-term planning for clinical and commercial success and serves as another example of the capability of our technology platform. We believe our ability to, in just a matter of months, advance from a product concept to generating new intellectual property and manufacturing the desired cell types, is illustrative of the power and efficiency of our platform. We believe the combination of our capital discipline and current balance sheet will support multiple years of further progress, during which we anticipate reaching achievements with each of our clinical and preclinical programs.”
Dr. Rami Skaliter, who leads the manufacturing function for Lineage, added, “I’m exceptionally proud of the team’s success at overcoming obstacles related to the limited scale of photoreceptor production. Building upon our experience with other cell lineages, we have developed intellectual property, and filed for patent protections, on a manufacturing process which is compatible with large-scale production of photoreceptors in a closed system, improvements which could enable industrial manufacturing. We believe this accomplishment will provide new opportunities for clinical, and ultimately commercial, production of photoreceptors in areas of large unmet need such as Retinitis Pigmentosa, Stargardt’s Macular Dystrophy, and retinal detachments, either independently or through strategic alliances.”
As part of a scientific collaboration with Professors Benjamin Reubinoff, M.D., Ph.D. and Eyal Banin, M.D., Ph.D., of the Hadassah-Hebrew University Medical Center, the differentiation of pluripotent cells into photoreceptors with clinically compatible characteristics was established utilizing a novel differentiation protocol which generated positive identity of key markers of both rods and cones photoreceptor populations. The data generated by the company further demonstrated that a single cell suspension of photoreceptor precursor cells has the potential to survive and mature post-transplantation in a rodent model of retinal degeneration.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include five allogeneic (“off-the-shelf”) product candidates: (i) OpRegen, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, which is now being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy, and (v) PNC1, a photoreceptor neural cell therapy for the treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “aim,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to (i) the potential amount of payments to Lineage under the alliance with Hoffman-La Roche Ltd. (“Roche”) and Genentech, Inc., (ii) the potential for new opportunities for clinical, and ultimately commercial, production of photoreceptors in areas of large unmet need, (iii) Lineage’s position to become a leader in the emerging field of regenerative medicine and anti-aging technology, and (iv) future areas of potential treatment using PNC transplant. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the risk that competing alternative therapies may adversely impact the commercial potential of OpRegen, which could materially adversely affect the payments payable to Lineage under the Roche/Genentech collaboration and license agreement, the risk that Roche/Genentech may not be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction; the risk that Lineage might not succeed in developing products and technologies that are useful in medicine and demonstrate the requisite safety and efficacy to achieve regulatory approval in accordance with its projected timing, or at all; the risk that Lineage’s intellectual property may be insufficient to protect its assets; risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220425005336/en/
Contacts:
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Solebury Trout IR
Mike Biega
(mailto://Mbiega@soleburytrout.com)
(617) 221-9660
Russo Partners – Media Relations
Nic Johnson or David Schull
mailto://Nic.johnson@russopartnersllc.com
mailto://David.schull@russopartnersllc.com
(212) 845-4242
NEWS -- Lineage and Cancer Research UK Announce Completion of Patient Enrollment in Phase 1 Clinical Study of VAC2 for the Treatment of Non-small Cell Lung Cancer
CARLSBAD, Calif., April 13, 2022--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that Cancer Research UK recently completed patient enrollment in the ongoing Phase 1 clinical trial of VAC2, an allogeneic cancer vaccine product candidate, for the treatment of non-small cell lung cancer ("NSCLC"). Under the terms of an existing agreement, Cancer Research UK will complete the ongoing clinical trial and Lineage has now assumed responsibility for further clinical development of the VAC2 product candidate and any future development opportunities derived from the VAC platform.
"We are pleased that Cancer Research UK has successfully completed patient enrollment in the VAC2 Phase 1 clinical study and overcame substantial challenges stemming from the COVID pandemic. We look forward to initial clinical results from this study being available later this year," stated Brian M. Culley, Lineage CEO. "Clinical data previously collected by Cancer Research UK demonstrated peripheral immunogenicity in patients with NSCLC treated with VAC2, providing support to the underlying mechanism of using allogeneic dendritic cells to present tumor-associated antigens to the body’s immune system. Simultaneous with Cancer Research UK efforts to complete enrollment in the current study, the focus at Lineage has been on making improvements and modernizations to the VAC manufacturing process, an approach which we similarly employed in the development of OpRegen. We believe our focus on manufacturing will help prepare VAC2 for additional clinical trials and provide a competitive advantage for any future VAC programs which we advance, either alone or through alliances. With Cancer Research UK having completed enrollment of the current study, the team at Lineage also has begun work towards the submission of an Investigational New Drug Application for clinical testing of VAC2 in the U.S., which we anticipate submitting to the FDA later this year."
Dr. Nigel Blackburn, Director of Cancer Research UK’s Centre for Drug Development, added: "We are delighted to see that this innovative VAC2 program has reached such an important milestone in its development and are extremely proud to have played an important role in establishing its tolerability in lung cancer patients. We look forward to seeing Lineage advance VAC2 under their leadership in the future."
About VAC2
VAC2 is an allogeneic, or non-patient specific "off-the-shelf," cancer vaccine product candidate designed to stimulate patient immune responses to an antigen commonly expressed in cancerous cells but not in normal adult cells. VAC2, which is produced from a pluripotent cell technology using a directed differentiation method, is comprised of a population of nonproliferating mature dendritic cells. As the most potent type of antigen presenting cell in the body, dendritic cells instruct the body’s immune system to attack and eliminate harmful pathogens and unwanted cells. Because the tumor antigen is loaded exogenously into the dendritic cells prior to administration, VAC2 is a platform technology that could be modified to carry selected antigens, including patient-specific tumor neo-antigens or viral antigens. VAC2 is currently being tested in a Phase 1 study in adult patients with NSCLC in the advanced and adjuvant settings (NCT03371485), conducted by Cancer Research UK.
About Cancer Research UK’s Centre for Drug Development
Cancer Research UK has an impressive record of developing novel treatments for cancer. The Cancer Research UK Centre for Drug Development has been pioneering the development of new cancer treatments for 25 years, taking over 140 potential new anti-cancer agents into clinical trials in patients. It currently has a portfolio of 21 new anti-cancer agents in preclinical development, Phase I or early Phase II clinical trials. Six of these new agents have made it to market including temozolomide for brain cancer, abiraterone for prostate cancer and rucaparib for ovarian cancer. Two other drugs are in late development Phase III trials.
About Cancer Research UK’s Commercial Partnerships Team
Cancer Research UK is the world’s leading cancer charity dedicated to saving lives through research. Cancer Research UK’s specialist Commercial Partnerships Team works closely with leading international cancer scientists and their institutes to protect intellectual property arising from their research and to establish links with commercial partners. Cancer Research UK’s commercial activity operates through Cancer Research Technology Ltd., a wholly owned subsidiary of Cancer Research UK. It is the legal entity which pursues drug discovery research in themed alliance partnerships and delivers varied commercial partnering arrangements.
About Cancer Research UK
NEWS -- Lineage to Present at the NobleCon18 Investor Conference on April 20, 2022
CARLSBAD, Calif., April 11, 2022--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that Brian M. Culley, the Company’s Chief Executive Officer, will be presenting at NobleCon18 - Noble Capital Markets’ Eighteenth Annual Investor Conference on April 20th, 2022 at 4:30pm ET in Seminole Ballroom A. NobleCon18 is taking place at the Hard Rock Hotel & Casino in Hollywood, Florida, April 19th – 21st, 2022.
An archived webcast of the corporate presentation will be available starting April 21st, 2022 on the Events and Presentations page of the Lineage website, and as part of a complete catalog of presentations available on the conference website: https://www.nobleconference.com and on Channelchek https://www.channelchek.com, the investor portal created by Noble Capital Markets. Additional videos are available on the Media page of the Lineage website.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include four allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, which is now being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer and (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy. For more information, please visit https://www.lineagecell.com or follow the Company on Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220411005035/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Solebury Trout IR
Mike Biega
(mailto://Mbiega@soleburytrout.com)
(617) 221-9660
Russo Partners – Media Relations
Nic Johnson or David Schull
mailto://Nic.johnson@russopartnersllc.com
mailto://David.schull@russopartnersllc.com
(212) 845-4242
NEWS -- Lineage to Present at the 2022 Virtual Growth Conference Presented by Maxim Group LLC on March 28, 2022
CARLSBAD, Calif., March 24, 2022--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that Brian M. Culley, the Company’s Chief Executive Officer, will be presenting at the 022 Virtual Growth Conference, presented by Maxim Group LLC and hosted by M-Vest. Mr. Culley will be participating in an "Ophthalmology Panel" hosted by Jason McCarthy, Ph.D., Senior Managing Director, Biotechnology, on March 28th, 2022 at 10am ET / 7am PT. Mr. Culley will also provide a corporate overview which will be available to investors on demand, starting on Monday March 28th, 2022.
The live panel and on-demand presentation will be available to registered users directly through the M-Vest platform: https://m-vest.com/events/2022-virtual-growth-conference. Registration is required for conference participation. An archived webcast of the corporate presentation will also be available on the Events and Presentations page of the Lineage website. Additional videos are available on the Media page of the Lineage website.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include four allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, which is now being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer and (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy. For more information, please visit https://www.lineagecell.com or follow the Company on Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220324005234/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Solebury Trout IR
Mike Biega
(mailto://Mbiega@soleburytrout.com)
(617) 221-9660
Russo Partners – Media Relations
Nic Johnson or David Schull
mailto://Nic.johnson@russopartnersllc.com
mailto://David.schull@russopartnersllc.com
(212) 845-4242
NEWS -- Lineage Announces Pipeline Expansion to Include Auditory Neuronal Cell Therapy for Treatment of Hearing Loss
NEWS -- RG6501 (OpRegen®) Full Phase 1/2a Results to Be Featured at 2022 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in Presentation by Allen C. Ho, M.D., FACS
CARLSBAD, Calif., March 14, 2022--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that full results from a Phase 1/2a clinical study of RG6501 (OpRegen®), a retinal pigment epithelium cell transplant therapy currently in development for the treatment of dry age-related macular degeneration (AMD), will be presented at the 2022 Association for Research in Vision and Ophthalmology Annual Meeting (ARVO 2022) (https://www.arvo.org/annual-meeting/), to be held May 1 – 4, 2022 at the Colorado Convention Center in Denver, CO. The presentation, "Safety and Efficacy of a Phase 1/2a Clinical Trial of Transplanted Allogeneic Retinal Pigmented Epithelium (RPE, OpRegen) Cells in Advanced Dry Age-Related Macular Degeneration (AMD)" will be featured as part of the Retinal Prostheses and Transplantation Session, on May 2, 2022 between 3:00 PM to 5:00 PM MDT, by Allen C. Ho, M.D., FACS, Wills Eye Hospital Attending Surgeon and Director of Retina Research, Professor of Ophthalmology, Thomas Jefferson University, Mid Atlantic Retina and President, The Retina Society (abstract number 3714956). RG6501 (OpRegen) is currently being developed under an exclusive worldwide collaboration between Lineage, Roche and Genentech, a member of the Roche Group.
The Association for Research in Vision and Ophthalmology, Inc. (ARVO) was founded in 1928 in Washington, DC, by a group of 73 ophthalmologists. ARVO is the largest and most respected eye and vision research organization in the world. ARVO members include nearly 11,000 researchers from over 75 countries. ARVO advances research worldwide into understanding the visual system and preventing, treating and curing its disorders. For more information, please visit https://www.arvo.org/ or follow the association on Twitter @ARVOInfo.
About OpRegen
OpRegen® is a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, being developed under a worldwide collaboration between Lineage, Roche and Genentech, a member of the Roche Group. The Phase 1/2a open-label, dose escalation safety and efficacy study evaluated a single injection of human retinal pigment epithelium cells derived from an established pluripotent cell line and transplanted subretinally in patients with advanced dry AMD with GA and enrolled 24 patients into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with a best corrected visual acuity (BCVA) of 20/200 or worse. The fourth cohort enrolled 12 better vision patients (BCVA from 20/65 to 20/250 with smaller mean areas of GA). Cohort 4 also included patients treated with a new "thaw-and-inject" formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study was to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment emergent adverse events. Secondary objectives are to evaluate the preliminary efficacy of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance. OpRegen has been well tolerated to date and there have been no new, unexpected ocular or systemic adverse events or serious adverse events related to OpRegen or study procedures that have not been previously reported.
About Dry AMD
Dry age-related macular degeneration (AMD) is a leading cause of adult blindness in the developed world. There are two forms of AMD: wet AMD and dry AMD. Dry AMD is the more common of the two types, accounting for approximately 85-90% of cases. Wet AMD is the less common of the two types, accounting for approximately 10-15% of cases. Global sales of the two leading wet AMD therapies were in excess of $10 billion in 2019. Nearly all cases of wet AMD begin as dry AMD. Dry AMD typically affects both eyes. There are currently no U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) approved treatment options available for patients with dry AMD.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer. For more information, please visit https://www.lineagecell.com or follow the Company on Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220314005160/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
mailto://ir@lineagecell.com
(442) 287-8963
Solebury Trout IR
Mike Biega
mailto://Mbiega@soleburytrout.com
(617) 221-9660
Russo Partners – Media Relations
Nic Johnson or David Schull
mailto://Nic.johnson@russopartnersllc.com
mailto://David.schull@russopartnersllc.com
(212) 845-4242
Lineage Cell Therapeutics GAAP EPS of -$0.17 misses by $0.12, revenue of $1.2M beats by $0.56M
Source: Seeking Alpha
To read the full story on Seeking Alpha, click here.
https://investor.lineagecell.com/static-files/fad7b70b-0a51-44a0-af60-cb0005f0a19c
Plenty of reading material.
NEWS -- Lineage Cell Therapeutics to Report Fourth Quarter and Full Year 2021 Financial Results and Provide Business Update on March 10, 2022
CARLSBAD, Calif., March 01, 2022--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that it will report its fourth quarter and full year 2021 financial and operating results on Thursday, March 10, 2022, following the close of the U.S. financial markets. Lineage management will also host a conference call and webcast on Thursday, March 10, 2022, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its fourth quarter and full year 2021 financial and operating results and to provide a business update.
Interested parties may access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section (https://investor.lineagecell.com/events-and-presentations/upcoming-events) of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through March 18, 2022, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and Canada and entering conference ID number 7718167.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, which is now being developed (https://investor.lineagecell.com/news-releases/news-release-details/lineage-establishes-exclusive-worldwide-collaboration-genentech) under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer. For more information, please visit https://www.lineagecell.com or follow the Company on Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220301005049/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Solebury Trout IR
Mike Biega
(mailto://Mbiega@soleburytrout.com)
(617) 221-9660
Russo Partners – Media Relations
Nic Johnson or David Schull
mailto://Nic.johnson@russopartnersllc.com
mailto://David.schull@russopartnersllc.com
(212) 845-4242
Might as well at these prices! Crazy Oversold! IMO.
BlackRock continues to add to its holdings of LCTX.
NOVEMBER 2021: 8,551,700 shares
Now FEB 2022: 10,008,510 shares
Guess I might as well add some more too.
NEWS -- Lineage to Present at B. Riley Securities 2022 Virtual Oncology Conference on January 27, 2022
Fireside Chat with B. Riley Research Scheduled for 2:00pm Eastern
Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that Brian M. Culley, Lineage’s Chief Executive Officer, will present at the B. Riley Securities 2022 Virtual Oncology Conference, in a fireside chat hosted by Mayank Mamtani, Managing Director, Senior Biotech Research Analyst and Group Head of Healthcare Research at B. Riley Securities.
Mr. Culley will provide an update on Lineage’s cell therapy pipeline, including an outline of the clinical development plans for its OPC1 program for the treatment of spinal cord injury and VAC2 for the treatment of solid tumors. Lineage recently received a $50 million upfront payment from Genentech, a member of the Roche Group, under the Company’s exclusive worldwide collaboration for the development and commercialization of OpRegen®, an RPE cell therapy for the treatment of ocular disorders. Lineage plans to use a portion of the payment to help support the advancement of its OPC1 and VAC programs noted above, as well as the expansion of its regenerative medicine platform into new disease settings which are yet to be disclosed.
Interested parties can register to view both the live event and replay on the Events and Presentations section of Lineage’s website. Additional videos are available on the Media page of the Lineage website.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, which is now being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer. For more information, please visit https://www.lineagecell.com or follow the Company on Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “aim,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to the collaboration and license agreement with Roche and Genentech and activities expected to occur under the collaboration and license agreement, the upfront, milestone and royalty consideration payable to Lineage and Lineage’s planned use of proceeds therefrom, the potential benefits of treatment with OpRegen, and Lineage’s plans to advance its spinal cord injury and oncology programs and announce new disease settings where it plans to deploy its technology. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including the risk that competing alternative therapies may adversely impact the commercial potential of OpRegen, which could materially adversely affect the milestone and royalty payments payable to Lineage under the collaboration and license agreement, the risk that Roche and Genentech may not be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction, and risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220124005033/en/
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Solebury Trout IR
Mike Biega
(mailto://Mbiega@soleburytrout.com)
(617) 221-9660
Russo Partners – Media Relations
Nic Johnson or David Schull
mailto://Nic.johnson@russopartnersllc.com
mailto://David.schull@russopartnersllc.com
(212) 845-4242
NEWS -- Lineage Cell Therapeutics to Present at H.C. Wainwright Bioconnect Virtual Conference
CARLSBAD, Calif., January 04, 2022--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, announced today that Brian M. Culley, Chief Executive Officer will be presenting at the H.C. Wainwright Bioconnect Virtual Conference (https://hcwevents.com/bioconnect/). The corporate presentation will be available to investors on demand, starting on January 10, 2022 at 7:00am ET on the Events and Presentations section of Lineage’s website (https://investor.lineagecell.com/events-and-presentations/upcoming-events).
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, which is now being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer. For more information, please visit https://www.lineagecell.com or follow the Company on Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220104005219/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Solebury Trout IR
Mike Biega
(mailto://Mbiega@soleburytrout.com)
(617) 221-9660
Russo Partners – Media Relations
Nic Johnson or David Schull
mailto://Nic.johnson@russopartnersllc.com
mailto://David.schull@russopartnersllc.com
(212) 845-4242
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