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Lineage Cell Therapeutics, Inc. (LCTX -1.04%)
Q2 2021 Earnings Call
Aug 12, 2021, 4:30 p.m. ET


  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:


Welcome to the Lineage Cell Therapeutics second-quarter 2021 conference call. At this time, all participants are in a listen-only mode. An audio webcast of this call is available on the Investors section of the Lineage website at www.lineagecell.com. This call is subject to copyright and is the property of Lineage and recordings, reproductions or transmissions 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, director of investor relations at Lineage. Ms. Hone, please go ahead.

Ioana Hone -- Director of Investor Relations

Good afternoon, and thank you for joining us. A press release reporting our second-quarter 2021 financial results was issued earlier today, August 12, 2021, and can be found on the Investors section of our website. Please note that today's discussion will contain forward-looking statements within the meaning of federal securities laws, including statements regarding our strategy, goals, product candidates, clinical trials, data announcements and updates, anticipated regulatory meetings and interactions, planned manufacturing improvements, financing, cash management and runway, anticipated collaboration opportunities and benefits and commercial potential. 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.

Actual results or performance may differ materially from the expectations indicated by our forward-looking statements due to known and unknown risks and uncertainties. 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 in our filings with the SEC, including in our quarterly report on Form 10-Q filed today, August 12, and our annual report on Form 10-K for the year ended December 31, 2020. Presenting today is Brian Culley, our chief executive officer; and Kevin Cook, our chief financial officer. Brian and Kevin will provide some prepared remarks, then take questions from analysts.

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

Brian Culley -- Chief Executive Officer

Thanks, Ioana, and good afternoon, everyone. We always appreciate you joining us on our quarterly calls. The Lineage team continued to execute on its aggressive business plan, making significant operational and clinical progress during the second quarter. Most notably, we delivered additional positive clinical data from our OpRegen program to treat dry age-related macular degeneration with geographic atrophy.

We made substantial progress moving our spinal cord injury program toward further clinical testing. We generated revenue from the first milestone payment under our new VAC-based cancer alliance, and we even monetized some of our noncore assets. I'm also very happy that we have strengthened our leadership team through the appointment of Kevin Cook as our new chief financial officer. And as Ioana just mentioned, Kevin is joining me on the call today, and I appreciate the immediate impact he's had on our organization.

As I say each call, Lineage is pioneering a new branch of medicine. Our approach is to manufacture differentiated cell types and transplant those cells into the body to restore or improve function, which has been lost due to injury or disease. Simply put, we believe that if retina cells or spinal cord cells are dying off or dysfunctional, you need to replace those specific types of cells. This regenerative medicine platform which we own is both broad and powerful, not only for the value of our current indications but also because our self-transplant approach might someday be applicable to a large number of different cell types and address many different unmet needs.

Manufacturing different cell types and demonstrating their safe use in clinical trials so that they can be commercialized and reach patients is vital to our long-term goal of becoming the leading cell therapy company. All of our cell therapy programs use cells, which we manufacture from NIH-approved cell lines, which were established and characterized decades ago. Because our cells are clearly potent and have never been differentiated, they can surpass the Hayflick limit, a principal of cellular agent. The Hayflick limit states that a normal human cell can only replicate 40 to 60 times before it breaks down by a programmed cell death.

The cells manufactured from our pluripotent cell lines can be replicated far above the ceiling. Simply put, this means we can generate enough material to supply even the largest commercial markets without ever sourcing new material or changing our starting material. That's very different from what some of the competing allogeneic companies do with adult cells or mesenchymal cells. When you start with mesenchymal cells or adult cells, there is a limit to how many times you can divide them before you have to obtain new starting material.

I don't believe the advantages which Lineage enjoys in this area are fully appreciated yet, but as our programs continue to advance through clinical trials and show additional promise, I believe people will start to ask increasingly detailed questions about the limits of various approaches and discover that our endless supply of cells provides us with an advantage over companies which have to change their starting material, every 10, 100 or even 1,000 patients. Using the same starting cell line for the entire lifetime of a program should provide Lineage with fewer regulatory complications, superior quality control, and, of course, lower lifetime costs of manufacturing. These advantages of our true off-the-shelf platform are even greater when compared to autologous or individual patient-specific approaches where a therapy is created for just a single person. Every bit as important as cost-effective scale-up, our approach also avoids the risk of genetic manipulation, which many of you will certainly have noticed, recently has reemerged in the news due to serious unexpected safety issues associated with certain gene therapies and ophthalmology clinical trials.

Instead of manipulating the genome and potentially causing changes, which we can't track or control, we utilize directed guided differentiation to manufacture ourselves. With directly guided differentiation, we harnessed the natural steps in the developmental pathway in order to manufacture only our desired cell types. We never modify the genome as part of our manufacturing process because it simply isn't necessary. Our cells are tested to ensure they have the attributes needed to perform the job of the cells they are replacing without changing their genome in uncontrollable ways.

And to date, we have never documented a single case of rejection of our cells from any of our patients even up to five years after treatment. These advantages help establish our belief that our technology platform has potential not only in the indications we currently are pursuing, which are valuable in their own right, but also may produce additional product candidates beyond dry-AMD, spinal cord injury, and cancer. And as we continue to generate encouraging data on both the safety and efficacy of our three current cell transplants, will consider opportunities to investigate new applications of our technology and potentially address new or related diseases, either on our own or through strategic alliances. I now will turn to doing a quick review of our recent accomplishments and set some expectations for the remainder of this year.

I will, as usual, begin with OpRegen, our lead product candidate intended to treat dry-AMD with GA, a disease with no FDA-approved treatments. Our approach to treating this disease is to transplant healthy new retina cells to replace or support the ones that have died off or are dysfunctional. Replacing the entire cell avoids risks and limitations inherent in approaches that just target a single pathway, which may prove to be the wrong pathway or approaches that target a certain mutation, which might only be relevant to a small subset of patients. I've said many times that we believe our approach may be able not only to slow the disease process but may even be able to halt or reverse it.

And we now have evidence of this claim occurring in multiple patients. We also believe that OpRegen, which currently is contemplated as a one-time treatment performed in about 30 minutes under local anesthesia, has an enormous advantage in terms of compliance and convenience over traditional drugs being developed by competitors that require monthly or semi-monthly injections. Since the beginning of the phase 1/2a clinical trial for OpRegen, we have provided a cascade of positive updates from its use. We believe our data set has improved with each update as the amount of evidence has grown and more and more times lapsed from the date of treatment, and we intend to continue providing these interim updates moving forward.

In fact, our next update, showing with at least nine months of follow-up on all treated patients, is expected later this quarter. As I just mentioned, we have reported three separate cases of retinal tissue restoration in dry-AMD patients treated with OpRegen. And specifically, what this means is that outer retinal layer restoration has been observed using clinical, high-resolution optical coherent tomography or OCT and this was evidenced by the presence of new areas of RPE monolayer with overlying ellipsoid zone, external limiting membrane, and outer nuclear layer, which were not present at the time of baseline assessment. These findings suggest integration of the new RPE cells, the OpRegen therapy, integration with functional photoreceptors in areas that previously showed no presence of any of these cells.

And remarkably, these outcomes occurred in three out of the four patients who received their dose of OpRegen throughout the atrophic area rather than placing the cells away from or even adjacent to the atrophic area. None of the other 20 patients received cells in this manner. So, we believe the correct way to measure our event rate for this finding is three out of four patients demonstrated restoration or 75%. And of course, the higher your event rate, the easier it is to demonstrate statistical significance in the context of a clinical trial.

Now, the totality of these findings supports the view that atrophic AMD is not an irreversible degenerative condition and that some portion of diseased retinal tissue may be recoverable if the right intervention is used. And to our knowledge, despite many hundreds of patients with dry-AMD and GA having been treated in clinical trials by different sponsors, Lineage is the only company that has shown even a single case of retinal tissue restoration, and that we have three cases, each one adding durability with each passing day. In light of these unprecedented findings, we hosted a call with therapeutic area experts to discuss the results in detail, and we really encourage those who have not listened to this replay of the call to do so by visiting the events & presentations section of our website. In addition to retinal restoration, which is an anatomical observation, we also have seen functional improvements in the majority of treated patients' eyes with 83% of all cohort 4 patients continuing to exhibit stable or improved, Best Corrected Visual Acuity or BCVA, at least six months post treatment.

Meanwhile, visual acuity declined or worsened in the majority of the patients' untreated eyes. And to further support the anatomical restoration data and the visual acuity data we have collected, we also have reported that we now have microperimetry data collected at the year 2 and year 3 post-treatment study visits of one of our restoration patients and which indicated improvements in the patient's ability to discern different intensities of light. This patient also experienced clinically significant improvement in visual acuity for more than two years, at one point, gaining 12 letters on an early treatment diabetic retinopathy scale or ETDRS scale, the standard assessment measurement tool. Altogether, the data set we are collecting includes both functional and anatomical evidence, which further reinforces our belief that a suspension of OpRegen RPE cells can generate clinically meaningful outcomes in patients with dry-AMD with GA and particularly in those with earlier-stage atrophic disease.

Now for those of you for whom the subtleties of the details of OCT imaging and ETDRS scores is a little too technical, we would also just invite you to visit our website and watch the two patient testimonials we recently posted. We've realized that there is a lot of attention on competitors' attempts to slow the growth of atrophy. But despite hundreds of treated patients, those approaches have failed to report both a structural and functional benefit to patients' vision. In contrast, we have patients in our trial who have not simply slowed the growth of GA, but actually reversed it and have benefited from an improvement in their vision at the same time.

Looking ahead for the promising OpRegen program, in addition to the regular updates that we provide, we plan to provide additional updates at important medical conferences this year, including the 54th Annual Retinal Society Scientific Meeting, which takes place in Chicago, September 29 through October 2, as well as at the 2021 Annual Academy of Ophthalmology Annual Meeting, the largest ophthalmology meeting in the world, which takes place in New Orleans, November 12 through the 15th. We also are working with our advisors in preparation for a meeting with the FDA in the fourth quarter of this year, where we intend to discuss our proposed next steps for further clinical development of OpRegen. Overall, the data we have generated to date reinforces our belief that RPE cell transplants can provide outcomes beyond the reach of traditional pharmaceutical approaches, which are limited to a subset of biological pathways and which may fail to provide the maximum restorative benefit available to patients. We continue to work to position OpRegen RPE transplants as the best available option in the race to address the large unmet medical need in dry-AMD with GA.

Now, moving next to OPC1, our allogeneic cell transplant program to treat spinal cord injuries. OPC1 is a one-time administration of specialized spinal cord cells called oligodendrocyte progenitors, which are delivered directly into the area of injury and a spinal cord patient. Spinal cord injuries can lead to paralysis and loss of motor and sensory functions, and the lifetime cost of care for an SCI patient has been estimated to be as high as $5 million. But like dry-AMD, there currently are no FDA-approved treatments for spinal cord injury.

Because the material used in the prior clinical trial of OPC1 by a different sponsor was not manufactured through a process compatible with late-stage clinical and commercial development, the Lineage team needed to develop a new manufacturing process, which led successfully to significant improvements in the production, quality, and scale of OPC1. These are improvements which we expect will enhance the commercial viability of a future approved product. We also developed a new thaw-and-inject formulation, simplifying logistics and enabling investigational use broadly at any spinal cord treatment center, which we expect will help accelerate enrollment for late-stage clinical trials. And specifically, this new formulation will allow us to eliminate the dose preparation steps and the need for a specialized facility and trained staff, which will reduce overall logistics of preparation from several hours in a lab to just a few minutes in the OR and reduce costs by approximately 90%.

This new process, which we developed, has been established into our in-house GMP facility at a scale necessary to support the next clinical trial phase, and we are working through the steps to increase our production scale to eventually support commercial operations. In parallel with this work, we are focused on completing our manufacturing comparability plan, which is intended to demonstrate that our new process has maintained the same safety and activity attributes as the material which was previously cleared by FDA for clinical use. At the same time that we are fulfilling these FDA requirements to introduce our new manufacturing process into the next phase of clinical development, we plan to initiate an interim clinical safety study of a new delivery device through our collaboration with Neurgain Technologies. The Neurgain Parenchymal Spinal Delivery or PSD system is expected to reduce a significant technical hurdle to conducting any larger scale clinical trials because it has been designed to allow for the administration of cells to the spinal cord without stopping the patient's respiration, and it can accommodate our new thaw-and-inject formulation.

We currently are conducting preclinical studies in a large animal model to validate this device, and we intend to submit an amendment to our investigational new drug or IND application for OPC1 in the fourth quarter of this year to initiate a clinical safety study in SCI patients. And we have already received feedback from FDA in June 20 -- in June of this year under the Regenerative Medicine Advanced Therapy or RMAT program for such a study. And as an added benefit from that FDA interaction, we learned that in addition to patients with sub-acute injuries, which are the patient characteristics treated previously, we anticipate that patients with chronic spinal cord injury also will be eligible for enrollment in the safety study. This larger patient population will not only provide safety and device performance data across a broader range of patients and injury types, but also may aid enrollment because chronic patients are generally easier to identify and enroll than patients who would need to have had an injury within a few weeks or months prior.

Overall, these data will be more informative to the program and support further product and device development. Testing this new delivery system in a small study will simplify the design and execution of a subsequent controlled study, introducing OPC1 manufactured with our new process. There are few options for SCI patients to enroll in clinical trials. So, we believe this is an important program for the entire field of spinal cord injury, and we will be working closely with the SCI community to launch it on a successful trajectory.

Now, thirdly, I will move to VAC2, our investigational off-the-shelf dendritic cell cancer vaccine. VAC2, as many of you will recall, is comprised of mature dendritic cells, which we manufacture from proprietary and established cell banks, which are then loaded with a tumor-specific target or an antigen to instruct, enhance, and deploy the body's immune system about which cells it should attack and eliminate. Last year, we exercised our option with Cancer Research U.K. to bring the VAC immuno-oncology platform in-house.

And not long thereafter, we reported encouraging preliminary phase 1 clinical results in non-small cell lung cancer patients and in which VAC2 demonstrated potent induction of immune responses, providing us with additional mechanistic validation and reinforcing data obtained in the autologous VAC1 clinical trials conducted previously. Our partner, Cancer Research U.K., is responsible for this study. And with enrollment impacted by COVID restrictions across the U.K., they are still working on enrolling the final patient into this study. But following completion of enrollment, we anticipate additional clinical data from this study will be available and reported.

Meanwhile, our focus is on making improvements in modernizations to the VAC manufacturing process, which will help prepare VAC2 for further trials and provide competitive advantages for any future VAC programs we may design and advance. This manufacturing-focused investment is fairly similar to what we did successfully with both OpRegen and OPC1, and is very core to the highest competencies at Lineage. As part of the manufacturing enhancement process, we aim to enhance the flexibility of the VAC platform because one could theoretically insert any antigen into our dendritic cells, and we believe the VAC platform is capable of, therefore, producing nearly a limitless number of product candidates with each one being distinguished by the specific antigen, which the dendritic cells are carrying to the patient's immune system. So, this opens up a large number of potential corporate partnerships by allowing us to use our dendritic cells as carriers for other companies' antigens, and while simultaneously retaining the option to advance our own carefully selected antigens.

As an example of us implementing that exact strategy. In April, we announced our first collaboration for our VAC platform with Immunomic Therapeutics, or ITI, with whom we're collaborating to generate a novel product candidate derived from our VAC platform and targeting a proprietary antigen construct provided by ITI, and this would be for the treatment of glioblastoma multiforme. As of early August, we have already achieved the first technical milestone under this agreement, which triggered a payment to Lineage of $0.5 million and allows us to continue working toward the achievement of subsequent milestones, which, by the way, includes another $1.5 million, which we are working to receive within the next year. This illustrative collaboration represents the first of many partnerships we hope to enter into with our VAC platform, and we believe it helps to further validate VAC, not only as a promising new therapeutic vaccine platform but also as an engine for partnering.

The early success demonstrated in our first ITI collaboration provides real-world validation of this approach, and our plan is to leverage our technology to generate additional VAC-derived cell therapies for our pipeline and capitalize on the strength of Lineage's recent manufacturing and cell transplant accomplishments. These alliances can diversify our oncology pipeline across more programs and provide new opportunities for success without the financial burden of independent development. And I'll continue with the theme of corporate partnering and add that in June, we announced an option agreement with Amasa Therapeutics, a privately held biopharmaceutical company for our HyStem technology and for the development and commercialization of therapies for local treatment of solid tumors. We believe that many tissue engineering and regenerative cell-based therapies will require the delivery of therapeutic cells in a matrix or a scaffold for accurate placement, retention, and engraftment.

And through this agreement, we have an opportunity to provide Amasa with access to our clinical-grade HyStem material to support the development of oncology-related products. Alongside a previously announced deal with Advanced BioMatrix, this deal represents the second HyStem related transaction we have entered into over the past two years. As many of you will recall, Lineage has an extensive intellectual property portfolio, and from it we will continue to seek opportunities to unlock value from our non-core assets. In June, we reported that we have been added to both the Russell 3000 Index, as well as the Russell Microcap Index.

These additions reflect the continued progress we have made in establishing ourselves as a leader in cell therapy and regenerative medicine and should help us benefit from the tremendous growth that we foresee in the field of cell therapy. Our addition to the Russell indexes can expand awareness of our corporate mission and objectives among a broader audience of investors and could help drive an increase in the liquidity of our stock, enhancing our own internal market awareness efforts. Overall, I believe we have continued to execute and generate valuable progress advancing all three of our clinical programs and further strengthening the company's capabilities. So with that, I'm happy to now turn the financial section over to our new CFO, Kevin Cook.

Kevin brings Lineage more than 20 years of significant strategic financial and operational experience, and he has executed over $30 billion of capital raising and corporate development transactions, and Kevin will walk you through the financial update before joining me for our Q&A session.

Kevin Cook -- Chief Financial Officer

Thank you, Brian, and good afternoon, everyone. I'm excited to be here, and I look forward to connecting with many of you more closely in the months ahead. In the meantime, let's talk about some of our recent financial results. Total revenues for the second quarter were approximately $500,000, a $100,000 increase from the same period in 2020.

The increase was due primarily to a $200,000 increase in booked collaboration revenues from the new Immunomic Therapeutics' Licensing Agreement, plus a $100,000 increase in royalties, offset by a reduction in grant revenues resulting from the completion of NIH grant activities in the prior year. Total operating expenses for the second quarter of 2021 were approximately $7.5 million, an increase of approximately $800,000 as compared to the same period in 2020. The increase was primarily related to an increase in general and administrative expenses due to higher investor relations expenses, Asterias merger-related expenses, and other legal costs. Our loss from operations for the second quarter was approximately $7.1 million, an increase of $700,000 as compared to the same period in 2020.

This increase was mostly due to higher G&A expenses incurred in the second quarter of 2021. The net loss to Lineage for the second quarter of 2021 was $4.8 million or $0.03 per share as compared to $6.5 million net loss or $0.04 per share for the same period in 2020. It's important to remind investors that the variance between our loss from operations and our overall net loss is impacted by changes in the value of our investments in OncoCyte and Hadasit, as well as foreign currency exchange rate fluctuations related to Lineage's international subsidiaries. Additionally, in the second quarter, we recognized a gain of $0.5 million related to the extinguishment of debt for our Paycheck Protection Program loan, which was forgiven in full.

While these nonoperational fluctuations are important, we tend to utilize loss from operations as a more relevant measure of performance with regards to moving our clinical programs forward. Turning to the balance sheet. The company ended the quarter with approximately $68.7 million in cash, cash equivalents, and marketable securities. Accordingly, we continue to feel that our liquidity level provides us flexibility and funding to reach additional value-creating milestones in the months and years ahead.

That wraps up the financial section. So, I thank you for your time, and we'll now turn the call back over to Brian.

Brian Culley -- Chief Executive Officer

Thanks, Kevin. We believe that the field of cell therapy is poised for explosive growth and that scalable allogeneic or off-the-shelf approaches have the ability to provide significant commercial advantages over autologous or patient-derived methods. And Lineage's objective is to be positioned for the rapid growth of this emerging branch of medicine by providing evidence that off-the-shelf cells can generate safety and efficacy data in large commercial opportunities where small molecules have not succeeded. Some of the events and milestones, which shareholders can look forward to include with respect to the OpRegen program, the presentation of additional interim data from the Phase 1/2a study, which is anticipated during this quarter and the next quarter of this year.

We also plan to meet with FDA to discuss further clinical development, and that is anticipated in the fourth quarter of this year. With respect to the OPC1 program in spinal cord injury, we will be evaluating the Neurgain PSD device in both preclinical and then clinical testing. We are conducting GMP production of OPC1 via an improved manufacturing process and we'll be conducting release testing to support a late-stage clinical trial, and we have an FDA interaction to discuss manufacturing improvements, which is anticipated around the end of this year or maybe early next year. And then just to wrap up again on the VAC program.

We're looking for the completion of enrollment in the ongoing phase 1 study in non-small cell lung cancer and then, of course, reporting results from that study. And we will continue to evaluate new opportunities for VAC product candidates based either on internally identified or partnered tumor antigens. And overall, we will look -- continue to look and evaluate partnership opportunities and ways to expand either existing collaborations or identification of nuke collaborations to fully enjoy the benefits of our platform. Here at Lineage, we're immensely proud to have the opportunity and responsibility to advance this new and exciting branch of medicine, and we aim to make a profound impact on the millions of people who serve our inspiration.

So, for those of you who would like to understand better about what it means on a personal level, I really encourage you to check out the media section of our website where you can hear directly from the same patients that we aim to help. So, thank you very much for joining us this afternoon. We appreciate your support as we position Lineage to become a leader in cell therapy and transplant medicine. And with that, operator, we are definitely ready to respond to any analyst questions which we may have.

Questions & Answers:


[Operator instructions] For our first question, we have Kristen Kluska from Cantor Fitzgerald. Your line is open.

Kristen Kluska -- Cantor Fitzgerald -- Analyst

Hi. Good afternoon, everyone. Thanks for taking my question.

Brian Culley -- Chief Executive Officer

Hi, Kristen.

Kristen Kluska -- Cantor Fitzgerald -- Analyst

The first one I have -- hey. The first one I have is on OPC1. So, with your recent announcement that chronic spinal cord injury patients will be eligible for enrollment in the study. Could you discuss if there will be any different clinical parameters in measuring the effect for these patients? Or perhaps what would be considered a meaningful result for them? And then how do you anticipate the inclusion of these patients could change the addressable market opportunity? 

Brian Culley -- Chief Executive Officer

Thank you, Kristen, for the question. So, the study that we will -- that we're planning to conduct next in -- for OPC1 is the device study. And so the objective of that study is to demonstrate not just the safety of that device, but its ability to be able to successfully deliver cells into the correct location, the spinal cord. We intend to collect some efficacy data in that study, but that's not the purpose of the study.

So, it won't be large enough to have a lot of statistical findings. But what I like in particular about the design and the inclusion of chronic patients is that chronic patients have typically plateaued. You don't often see meaningful spontaneous recovery in a chronic patient. So, we have what I think is a very asymmetric setup to this study.

Ostensibly, we're there to make sure that we can deliver the cells to the right place in the spinal cord. However, if we see some sort of signal in even a non-statistical signal in a chronic patient, I think that opens up an incredible new and exciting area for us, which would certainly have a large impact on the addressable commercial opportunity because our current expectation for this therapy is that you would want to administer it between 21 and 42 days after an injury. But if we can have some benefit, even a small benefit in patients that were injured three months ago, three years ago, 33 years ago. Now you get to not just include the incidence of a condition, but also the prevalence of the condition.

So it would be multiples larger if we were able to treat and provide a benefit to chronic patients. But the real advantage for us on its face is that we can -- we are just trying to make sure that the new system is effective and safe at delivering the cells and that we can do that in a chronic patient because it really is more of an anatomical question that we're getting an answer to rather than an efficacy question. Does that make sense?

Kristen Kluska -- Cantor Fitzgerald -- Analyst

Yes, it does. Thank you for that. And then on OpRegen, one of the potential benefits you've cited outside of efficacy and safety is on durability and convenience as this treatment doesn't entail frequent injections we've seen for other trials. So, I wanted to ask how long you intend to follow up with these patients in cohort 4 to determine how long the effects could be maintained in order to determine if future procedures will be needed on a couple of years basis? Or do you think this is really going to have to be evaluated more on an individual patient basis?

Brian Culley -- Chief Executive Officer

So, what we plan to do with the current protocol is follow these patients for five years. If we decide to make a change at some point in the future and follow them for longer, that -- that's fine. I think we would like to eventually answer the question as to what is the mean length of benefit? How durable is the therapy? And when you do get out to five years, you're kind of assuming it's lifetime. But at present, we would follow these patients for five years.

We don't -- that obviously is not a clinically fungible period of time from which to build a study for the purposes of approval. So thankfully, the FDA has conveyed to a number of sponsors that a 12-month observation period would be appropriate in the setting of dry AMD. So, we intend to continue to collect anatomical and functional data on patients, which started monthly and then it's going through quarterly and eventually to become an annual assessment but ultimately reaching out for five years. But we don't intend to use five years as a clinical trial endpoint, I would expect completely that we would follow the standard path of a 12-month observation period.

So, we'll collect the data. I expect that we'll continue to report that long-term data, but for people who are wondering which data point they should pay the most attention to the six-month and 12-month data points are the ones that are the most well established as being relevant to a regulatory process. 

Kristen Kluska -- Cantor Fitzgerald -- Analyst

Thank you. And just on that note, now that you've observed a number of patients beyond six months, and you have long-term follow-up for many others. Were there any other important takeaways or observations that you think will be important as you look to meet with the FDA to discuss the next steps around this program? I know, of course, you've highlighted the placement of the cells and the importance there and how this has translated for the cases of retinal tissue restoration. But anything else, you know, that you found to be notable?

Brian Culley -- Chief Executive Officer

Yeah. You mentioned placement, I think that's really important. The other one that I think is very important is how you image the patients. So, the traditional way, which I think is going away is to use FAF, which is sort of like an aerial picture.

The future and certainly, our intended future is to use OCT because you're getting a cross-section. You can see all of the layers almost at the level of histology. You can see the cross-section. So, for us, having the ability to deliver tissue and be looking to measure the functional activity of that tissue in areas where it wasn't present, you actually can't see that using FAF.

We cannot see that using FAF because our cells do not fluoresce under FAF. So, we feel that we are in a -- we are aligned with the future and it's not a distant future. This is more present, but we are aligned with the future of how to measure and evaluate geographic atrophy and that would be to use optical coherence tomography or OCT rather than FAF. So, that's an important consideration for us going forward.

And I think where it's most striking is some data. We have one slide that we shared not too long ago, where it shows about a 30% benefit for a patient. It reduces their area of atrophy by about 30% when you look at it using FAF. But again, that's sort of imperfect aerial view.

When you look at the same patient at the same time points using OCT, you can see that their area of atrophy is unchanged. That's 100% as a stopping a ceasing of growth of atrophy. So, clearly, there's more information to be learned from using OCT. So, I think placement of cells and I think that the measurement tool, the assessment tool are really important ones.

Other ones like the frequency of assessment, some of the characteristics of patients, those are a little bit more straightforward and conventional.

Kristen Kluska -- Cantor Fitzgerald -- Analyst

Great. Thank you, Brian.

Brian Culley -- Chief Executive Officer

You bet. Thank you, Kristen.


Next question, we have Joe Pantginis from H.C. Wainwright. Your line is open. 

Joe Pantginis -- H.C. Wainwright & Co. -- Analyst

Hey, guys. Good afternoon. Thanks for taking the question. I got a couple of questions on OpRegen and a shorter question on VAC2.

So first, on OpRegen, I guess I wanted to focus on, do you have some feedback you can provide as to, you know, KOL feedback or physician feedback that you've had now that you have three patients that have shown, you know, restoration, which has been unheard of up until this point, you know, that you're using for feedback ahead of your upcoming FDA meeting, and this is beyond, say, the physicians that you've had on your recent KOL events? And then secondly, with regard to OpRegen. I guess, you know, as you're looking to your FDA meeting, you know, your wish list what kind of endpoints are you looking for for a primary endpoint. You know, there's been a lot of evolution from the FDA with regard to ocular endpoints. You know, you mentioned microperimetry before the FDA is focusing on that more and more, say, versus BCVA, which has been in a lot of the wet AMD study.

So how do you think it might play out? Or what's your wish list around that?

Brian Culley -- Chief Executive Officer

Great. Hi, Joe, and thank you for the question. So, with respect to therapeutic area experts and their input, we've been delighted with what we have heard. And in some cases, it's sort of extraordinary comments.

We're not planning to build a meeting package for FDA around their extraordinary comments. We'll build that around the data. But the benefit for us is that this is heavily anatomical data. So, going in and bringing visual acuity data or patient-reported outcomes data.

That's fine. That's useful and informative, but everybody knows that those assessments, the tools, and how they're collected, they tend to be a little bit more subjective. But anatomy does not change, you know, but for the fact that you've got this right in the back of your eye getting bigger, you can take images, collect images and you can line them up exactly the same based on where vessels are and you can really see these changes. And so you're able to separate from some of the, let's say, placebo effects of clinical assessments or separate away from some of the more subjective factors.

You know, you've got one data collector who, you know, lets the patient lean forward a few inches when they're reading the eye chart. You're not allowed to do that. So, you know, it can be difficult to get really clean data when you have some of these subjective assessments, which is what puts us in such a good place with respect to going to the FDA with an emphasis around retinal restoration because it's an anatomical observation for which the individual has no ability to influence. You cannot regenerate retinal tissue by wishing for it, playing forward, etc.

So, I think that although we have heard some really wonderful, I'm reluctant to even restate some of them because they're almost too much to believe. But I think that although we've heard some really wonderful comments from some thought leaders in the field, in particular, ones who have been very close to the data and been able to really dig into it, we won't rely on that for the discussions with FDA. We will rely on just the pure observations. there was ELM here.

There wasn't ELM six months ago. Where did that come from? What happened six months ago, that was our intervention. So, I don't feel that we need to rely on some of that. That is the result of the data that they saw.

So, we'll let the data do the work for us. With respect to the endpoint, I kind of touched on it a little bit in that answer. I think the Division Director in Ophthalmology has been quite clear that that changes in the growth rate of geographic atrophy would be an approvable endpoint. I saw a competitor recently, had a special protocol assessment conducted that would suggest to me that the FDA is supportive of that anatomical endpoint on its face, it might be viewed as a secondary marker of efficacy, but it's also inevitable.

If that area of atrophy gets really big, you will lose your vision. So, I think that being able to use an anatomical endpoint is where we want to be. I do not want to use visual acuity. And to my mind, visual acuity is this amazing secondary endpoint that might give us overwhelming commercial power if we have evidence of a benefit and vision or no loss of vision compared to a control arm.

That is an extremely powerful talking point for commercializing an asset, if that's included in the package insert. But I think that our probability of clinical success and regulatory approval is really going to be driven more by our ability to halt or even reverse the growth of these atrophies. And so that's where I want us to be, and I think that's the best place for us to be. And it's funny for me to say that because 12 months ago, I had to be very vague about it.

I couldn't tell you if I thought we would be a GA story or a visual acuity story because we didn't have enough data. We have enough data now that it's very easy to say we want to be a GA growth inhibition story with the added benefit of being able to look at a functional improvement for the patient or absence of loss for the patient, either of which would be something that I have not seen the competition be able to deliver yet.

Joe Pantginis -- H.C. Wainwright & Co. -- Analyst

No, no, I really appreciate that, and it's been nice to see the evolution of these answers. And I said my question on VAC2 would be a little bit shorter because I think you might be a little circumspect with regard to your answer. Obviously, as you alluded to in your prepared comments and in prior calls, this really is a platform type of technology. So I guess I wanted -- and you've already shown your ability to attract business development activities.

So I guess with that said, I know you can't be qualitative. Can you -- I'm sorry, you can't quantify per se, but maybe some qualitative type comments as to any potential in -- additional inbounds you've been having on the platform.

Brian Culley -- Chief Executive Officer

I will be evasive about that only because I prefer -- you can always be close to deals and sometimes they can go away. So we will communicate any additional VAC2 deals after they are signed. But I think it represents a very compelling growth area, not only because it's oncology for which there's a lot more precedent in cell therapy and a lot of activity and interest and investor enthusiasm. I mean oncology, there are a lot of reasons why that's an attractive area for us.

But also because it does allow -- as I said in my previous remarks, it does allow us to be able to increase our development pipeline by fractional ownership or partial ownership or joint ownership or even majority ownership with a bunch of other companies because there are literally billions of potential antigens. And one of the great challenges in our field is trying to figure out which antigens would actually be the ones that are most selective and the most antigenic and so forth and their whole companies built around trying to figure out what's a good thing to stick in front of the patient's immune system to get a response. So, our ability to use the dendritic cells as carriers. I'm delighted that we have the first case of this that we've got a partner that -- from which we are generating revenues and delivering against that partnership.

And I would be really happy to have a bunch of those. So it's not the No. 1 priority at the company by any means, but it is a really exciting area of growth where we can capitalize on prior investments to spin out a flywheel style, a bunch of new programs. And maybe the others will do the development, maybe we'll do the development.

I don't know. I'd love to see a combination of different structures. You can even create a whole new company just around the oncology side of what we do. So really, the sky is the limit, comes out of the conversations that we have with various parties.

Joe Pantginis -- H.C. Wainwright & Co. -- Analyst

Look, I really appreciate the color despite yourself described evasiveness, Brian. But thanks a lot. I appreciate it.

Kevin Cook -- Chief Financial Officer

Thank you for the space, Joe. Thank you.


Next question, sir. We have Dane Leone from RJF. Your line is open.

Dane Leone -- Raymond James -- Analyst

Hi. Thanks for taking the questions and congrats on the progress. Just one question for me. Could you just maybe detail what the interactions with the FDA have been around OpRegen and what the next meeting is planned for and what's going to be discussed in that meeting? Thank you. 

Brian Culley -- Chief Executive Officer

Yeah, of course, Dane, thanks for the question. There haven't been many. The interactions that occurred shortly after I joined the company, tended to be protocol amendments. We introduced the new thaw-and-inject formulation.

We introduced the Orbit subretinal delivery system into the protocol. So, we've not had a formal end of phase 2 meeting. So that's something for everyone to look forward to, and it's planned for Q4 of this year because it would be the first time that we would have frank discussions around endpoints, study design, etc. So, the phase 1/2a study, which has now completed enrollment is essentially a trigger to go on to this next higher level of discussion.

So that's where we are. And I think it's actually a pretty important event because it will speak to what the questions are that we will ask next from a regulatory perspective. And of course, from that, the size of the study, the cost of the study, the duration of the study, the importance and significance of the study, all of that will precipitate out of that meeting, right? I hope it will. So, it's an important meeting for us to look forward to and prepared for.

Dane Leone -- Raymond James -- Analyst

And is that -- sorry, one follow-up. Is that meeting has a set date as of now?

Brian Culley -- Chief Executive Officer

We have not called the meeting, and we have not set what category. I'm sure you're familiar, there's type A, B, C. There's different categories under which you can request meetings. That is work that is ongoing.

We're preparing our side before we set our gate. But we would -- presumably, once we have a meeting confirmed and on the calendar, we would presumably make everyone aware of when that will occur so that people can anticipate that we would have some follow-up from minutes, etc., from that meeting.

Dane Leone -- Raymond James -- Analyst

OK. So, as it stands now, 4Q is your internal target, not something actually on the calendar with that yet.

Brian Culley -- Chief Executive Officer

That is correct. And as you know, maybe some listeners don't know, there's also a waiting period between when you request the meeting and when the meeting is actually granted. It can be 30, 60 days. It can be -- in between that, it really varies according to a number of different parameters, I won't go into, but just so that people know you don't just pick up the phone and say, "Hey, can I come and see you tomorrow over lunch?"

Dane Leone -- Raymond James -- Analyst

Perfect. Thank you so much.

Brian Culley -- Chief Executive Officer

You bet. Thank you, Dane.


I am having no further questions at this time. I would now like to turn the conference back to Mr. Brian Culley for closing remarks.

Brian Culley -- Chief Executive Officer

Well, thank you, and thank you, everyone, for joining. I think we had a great quarter. I'm very happy about it. I'm excited about rejoining in our next quarterly update.

In the meantime, we'll get back to work and keep opening the company forward. Thank you all very much, and enjoy your afternoon and evening.


[Operator signoff]

Duration: 53 minutes

Call participants:

Ioana Hone -- Director of Investor Relations

Brian Culley -- Chief Executive Officer

Kevin Cook -- Chief Financial Officer

Kristen Kluska -- Cantor Fitzgerald -- Analyst

Joe Pantginis -- H.C. Wainwright & Co. -- Analyst

Dane Leone -- Raymond James -- Analyst

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