REGENXBIO Inc. Q2 FY2021 Earnings Call

Good afternoon, and thank you for joining us today. With us are Ken Mills, REGENXBIO's President and Chief Executive Officer; Dr. Steve Pakola, our Chief Medical Officer; and Vit Vasista, our Chief Financial Officer. Earlier this afternoon, REGENXBIO released financial and operating results for the second quarter ended June 30, 2021. The press release reporting our financial results is available on our website at www.REGENXBIO.com. Today's conference call will include forward-looking statements regarding our financial outlook in addition to regulatory and product development plans. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted and can be identified by words such as expect, plan, will, may, anticipate, believe, should, intend, and other words of similar meaning. Any such forward-looking statements are not guarantees of future performance and involve certain risks and uncertainties. These risks are described in the Risk Factors and the management's Discussion and Analysis sections of REGENXBIO's Annual Report on Form 10-K for the full year ended December 31, 2020, and comparable risk factors sections of REGENXBIO's quarterly reports on Form 10-Q, which are on file with the Securities and Exchange Commission and available on the SEC's website. Any information we provide on this conference call is provided only as of the date of this call, August 9, 2021, and we undertake no obligation to update any forward-looking statements we may make on this call on account of new information, future events, or otherwise. Please be advised that today's call is being recorded and webcast. In addition, any unaudited or pro forma financial information that may be provided is preliminary and does not purport to project financial positions or operating results of the Company. Actual results may differ materially. I would now like to turn the call over to Ken Mills.

Thank you, Patrick. Good afternoon, everyone. Thanks for joining us. I hope you're all having a safe and nice summer. On today's call, we'll begin with a recap of recent business highlights. Steve will provide an update on our clinical programs and Vit will provide an overview of financial results for the second quarter of 2021. At the end of the call, we'll open the line for questions. I'm pleased to report that 2021 has been productive for REGENXBIO. We've made important progress across our clinical development program and anticipate a busy second half of 2021. Our dedicated team remains focused on bringing the therapeutic potential of our pipeline programs to patients in need and we look forward to continuing our leadership in AAV-based gene therapy development and manufacturing. Our focus this year continues to be on execution across our pipeline programs. Our clinical programs evaluating RGX-314 for the treatment of wet AMD and diabetic retinopathy have expanded and continue to be on track. The first trial in our pivotal program evaluating subretinal delivery of RGX-314 in patients with wet AMD, ATMOSPHERE, continues to enroll patients, and our second pivotal trial is expected to initiate in the fourth quarter of 2021. In addition, we continue to advance our two Phase II trials evaluating the suprachoroidal delivery of RGX-314, using the SCS Microinjector. The first interim data from Cohort 1 of AAVIATE, our Phase II trial in wet AMD, will be presented at the Retina Society 54 Annual Scientific Meeting that begins in September in Chicago, Illinois. We're on track to report the initial data in diabetic retinopathy later this year in the fourth quarter. For RGX-121, our one-time gene therapy for the treatment of MPS II or Hunter Syndrome, we were pleased to share additional positive interim data from our clinical program at ASGCT in May. We continue to drive this program forward, enrolling additional patients at a higher dose and enrolling pediatric patients over the age of five years. And finally, our work on RGX-202 also continues. We now expect to file an IND for the treatment of Duchenne Muscular Dystrophy by the end of this year. I will now turn the call over to Steve for an even more detailed clinical and regulatory update.

Thanks, Ken. As Ken mentioned, our pivotal program evaluating the subretinal delivery of RGX-314 for the treatment of wet AMD continues to be on track. We are enrolling patients in the ATMOSPHERE, the first of two planned pivotal trials expected to support a BLA in 2024. As a reminder, ATMOSPHERE is expected to enroll approximately 300 patients and evaluates RGX-314 compared to repeated ranibizumab intraocular injections, a standard treatment option for patients with wet AMD. We also expect to initiate the second of two randomized well-controlled clinical trials as part of our pivotal program in the fourth quarter of 2021, and we look forward to sharing additional details. Beyond our pivotal program for RGX-314, we've made progress in our two Phase II trials evaluating RGX-314 when delivered to the suprachoroidal space. We have completed dosing of patients in the third cohort of our Phase II trial for the treatment of wet AMD known as AAVIATE. This is the cohort of patients that received the same dose of RGX-314 as patients in the second cohort, which is 5E11 genome copies per eye, but the patients in the third cohort are neutralizing antibody positive at entry. This may provide us additional information about the effects of RGX-314 in NAV-positive patients, potentially broadening the patient population that could be treated with this in-office delivery approach. I am pleased to announce that we plan to present initial data from Cohort 1 at the lower dose of 2.5E11 GC per eye at the Retina Society 54 Annual Scientific Meeting, which runs from September 29 to October 2. Additionally, we plan to report initial data from Cohort 2 in the fourth quarter of 2021. For ALTITUDE, our Phase II trial to evaluate RGX-314 seuprachoroidal delivery in patients with diabetic retinopathy, we have completed enrollment of Cohort 1 and we expect to report initial data in the fourth quarter of 2021. We have also begun enrolling patients in Cohort 2 at a higher dose and are pleased to announce that we will be expanding into a third cohort of patients in this trial. As with AAVIATE, Cohort 3 of ALTITUDE will evaluate efficacy, safety, and tolerability in up to 20 patients who are NAV positive. And the same dose evaluated in Cohort 2 will be evaluated in Cohort 3. As in previous cohorts, patients will not receive prophylactic immune-suppressive corticosteroid therapy before or after administration of RGX-314. In addition, we are making great strides in our rare disease portfolio and are well-positioned to provide key clinical updates in the second half of 2021 and beyond. From our ongoing Phase I/II trial of RGX-121 in MPS II patients up to five years old, we were pleased to share additional positive interim data from Cohorts 1 and 2 at ASGCT in mid-May. As reported RGX-121 continued to be well tolerated with no drug-related serious adverse events. Biomarkers and measures of neurodevelopmental function indicated CNS activity following RGX-121 administration with continued evidence of systemic enzyme expression and biomarker activity observed. We also began dosing patients in Cohort 3 at an increased dose level of 2E11 GC per gram brain mass in the second quarter of 2021. We continue to enroll patients in this cohort. Our Phase I/II trial of RGX-121 for the treatment of MPS II in pediatric patients over the age of five years old also continues to enroll patients, and we look forward to keeping you updated across both of our RGX-121 Phase I/II trials. Enrollment is ongoing in Cohort 2 of our Phase I/II trial of RGX-111 for the treatment of MPS I at a dose of 5E10 GC per gram brain mass as we are focused on realizing the therapeutic potential of RGX-111 for MPS I patients in need. Our team is preparing to submit the IND for RGX-202, a potential one-time gene therapy for the treatment of Duchenne. We plan to submit this IND package by the end of 2021. Lastly, we remain on track to provide program updates for RGX-181 for the treatment of CLN2 disease and RGX-381 for the treatment of ocular manifestations of CLN2 disease by the end of 2021. Our team has made significant progress in the first half of this year and we look forward to driving this momentum throughout the second half of 2021. With that, I turn the call back over to Ken.

Thanks for the great overview, Steve. I'm excited to share just a few more business updates. In July, we officially moved into our new headquarters in Rockville, Maryland. It's been tremendous to watch this lab and office space come online and I'm glad to have our team move into this space. The headquarters include the cGMP facility, which is expected to allow for the production of NAV vectors at scales up to 2,000 liters, and we're focused on integrating our capabilities to ensure adequate supply is available across all of our programs. We anticipate that the manufacturing facility in this space will be fully operational starting in the first half of 2022. Our proprietary NAV Technology Platform also continues to be the foundation of the development of gene therapies outside of the walls of REGENXBIO. Our licensee partners have made significant advancements in their respective programs utilizing NAV AAV delivery, with several in late stages of development. Our partners at Novartis have reported they treated more than 1,400 patients with intravenous Zolgensma, which uses the NAV AAV9 for the treatment of SMA. We've also been pleased to see the initiation of Novartis' new pivotal study of intrathecal delivery in patients with Type II SMA. In addition, Ultragenyx recently reported plans to begin dosing patients in two pivotal studies for DTX301 for the treatment of OTC deficiency, and DTX401 for the treatment of GSD Ia. We also note the re-initiation by Astellas of the pivotal trial for AT132 for the treatment of X-linked myotubular myopathy. All of these candidates use our NAV AAV8 vector. Corlieve Therapeutics is a company that we helped form in 2020, and in June 2021, Corlieve announced a definitive agreement for uniQure to acquire Corlieve and its lead program for the treatment of temporal lobe epilepsy, now known as AMT-260, that utilizes REGENXBIO's NAV AAV9 vector. This transaction closed in July of 2021 under the license and collaboration agreement. REGENXBIO received equity in Corlieve and is eligible to receive milestones as well as royalties on net sales of AMT-260. As a result of the acquisition, REGENXBIO receives a portion of the EUR46.3 million in upfront cash uniQure paid to acquire Corlieve and is eligible to receive a portion of over EUR200 million in additional milestones that may be paid to Corlieve shareholders by uniQure. We look forward to the continued collaboration with all of our licensee partners to bring AAV gene therapies forward, using our proprietary NAV Technology Platform to patients in need. With that, I'd like to turn the call over to Vit for a review of our financials.

Thank you, Ken. REGENXBIO ended the quarter on June 30, 2021, with cash, cash equivalents, and marketable securities totaling $593 million compared to $522.5 million as of December 31, 2020. The increase was primarily due to the $216.1 million of aggregate net proceeds received from our follow-on public offering of common stock completed in January 2021, including the full exercise of the underwriters' option to purchase additional shares in connection with the offering. The increase was partially offset by net cash used in operating activities of $71 million, cash used to purchase property and equipment of $50.9 million, and Zolgensma royalties paid to Healthcare Royalty Management of $22 million during the six months ended June 30, 2021. Based on our current operating plan, we expect the balance in cash, cash equivalents, and marketable securities of $593 million as of June 30, 2021, to fund our operations, including the completion of our internal manufacturing capabilities and clinical advancement of our private candidates into the second half of 2023. With that, I will turn the call back to Ken to provide final thoughts.

Thanks, Vit. The hard work, experience, and commitment of our entire team has enabled significant progress across our entire gene therapy portfolio. We're focused on building on our momentum from the first half of 2021 to execute on clinical and preclinical development for the remainder of this year and beyond. With that, we'll open up the call operator for questions.

Your first question comes from Geoff Meacham from BofA. Your line is now open.

Hey, guys. This is Alec on for Geoff. Thanks for taking our questions. Just a few from us. Since Cohort 1 from the suprachoroidal study is comparable in terms of the dose level to Cohort 5 in the subretinal study, could you just remind me of the thought process behind starting at this dose and whether the bioavailability is expected to be comparable between the two administrative techniques, or could it maybe be a little bit less just in terms of expectations for the data? And then as a follow-up to that, I'm just trying to frame the update at the conference in terms of the length of the follow-up, is it safe to say that it could be somewhere in the six-month range, given the study opened about a year ago? Obviously, maybe not enough to reach the 40-week BCVA endpoint. And then, just lastly, a quick one. Do you think it would be appropriate to apply read-through to what we might see in the DR update in 4Q, given its obviously different patient populations? Thanks.

Thanks, Alec. Steve, would you like to handle this?

Sure, great. Thanks, Alec, for those questions. So, why start Cohort 1 dose level with suprachoroidal with the same GC per eye that we had in our Phase I/II Cohort 5? Basically, we had the benefit of a full dose range that we had gone through with the subretinal delivery plus the overall preclinical package, including GLP tox studies where we had the ability to start that high and also to be able to go higher. So we felt that it was important to already, right out of the gate, start with the dose where there could be equipoise of actually being able to look for some type of pharmacodynamic signal. To your second question of how might we think of that translating, I think the reality is these are, and we've always said this, these are different routes of administration. Fortunately, we chose suprachoroidal because like subretinal it allows us to administer locally, where we're unlike with intravitreal administration, we can give that dose where it spreads close to the target retinal tissue. But it is a different route, where you get a broader spread than say the more intense transduction in a smaller area that you expect with subretinal delivery. So, it's really hard, Alec, to say more than that, and that's why we do the dose-rangings with a different route of administration. But here we have the benefit, because of all the experience we have, to be able to start a little higher. As far as the data that we're going to be able to look at Retina Society and what we're going to be able to come out, again very consistent with what we've said from the beginning, where in the wet AMD disease setting, we've always felt, even in our subretinal Phase I/II study and we've signaled the same in our suprachoroidal wet AMD study AAV8 that six months is a more fulsome time point to really evaluate the key biomarkers that we care about, including functional outcome. So, the typical outcome measures that we've talked about in the past and that we have experience looking at, at six months are what we're going to look for and what we'll be able to present at Retina Society. Your question on diabetic retinopathy, yes, you're spot on. That's a different patient population. However, we do have the body of evidence across many different anti-VEGF repeated injection programs that have looked at treatment of different patient populations, including diabetic retinopathy, as well as wet AMD, where there is the general belief of a range of doses that has effect in one disease setting of VEGF driven retinopathies that by targeting anti-VEGF with similar doses in other VEGF driven retinopathies that you have the potential to detect a signal. It's just in that patient population where the signal is something different, albeit just as important. It's just that in diabetic retinopathy, we have the ability to look at the severity of the underlying diabetic retinopathy and actually grade that and actually see can we improve the diabetic retinopathy severity with one-time administration in the office with RGX-314.

Operator?

The next question comes from the line of Gena Wang from Barclays. Your line is now open.

Thank you. I have one question with three parts on RGX-314 suprachoroidal programs. The first one is a clarifying question. Across all the cohorts in AAVIATE and ALTITUDE trials, is the volume the same for each injection? And my second question is for AAVIATE Cohort 1 data at the Retina Society, should we expect meaningful information from the extra relief? And also for the full presentation, will you include the protein level in addition to visual acuity, retinal thickness, and injection frequency data? And third, the last part of the question is, you started Cohort 3 for both AAVIATE and ALTITUDE, any concerns on safety since you increased the concentration? And also, any concern on efficacy since you enroll the patients with existing neutralizing antibody?

Hi Gena, this is Ken. I'll start and then maybe Steve can provide more details if necessary. Regarding the volume question, thank you for your inquiries. The standard volume for the suprachoroidal device we've chosen for delivering RGX-314 is 100 microliters, which is what we've used in the initial cohorts of both studies. During the dose escalation in the AAVIATE study, the first change involved increasing from 2.5E11 to 5E11, and we transitioned from a single injection of 100 microliters to two separate injections in one visit. In this case, we injected into two different sites, effectively administering 200 microliters to those patients. As we proceed with ALTITUDE, we have standardized on the 100-microliter volume for higher concentrations, and we plan to continue this in Cohorts 3 and future cohorts. On the data, I caught the tail end of your question, possibly not the beginning. We are about a month away from presenting data with investigators at the Retina Society meeting. Our approach here is similar to or identical to what we've done with our subretinal data, where we present a comprehensive package of information from the study. Steve mentioned in response to Alec's question that we have typically used a six-month cut-off as an important time point for collecting various measures. The measurements we are taking are consistent with past studies, including safety. Regarding the functional outcome Steve mentioned related to protein levels, we haven't conducted a data cut yet, but we will be transitioning into that in the next 30 to 60 days to prepare for the announcement. We are gathering as much data as possible for that podium presentation based on what we have from the clinical study. The final question was about Cohort 3, specifically on safety and efficacy. Steve, would you like to add anything?

Yes, I can jump in there. Hi, Gena. Yes, so the aspect of increased concentration by being able to go to a single 100 microliter injection that Ken referred to that we're able to do in Cohort 3 of AAVIATE and also in Cohort 2 and Cohort 3, Cohort 2 and Cohort 3 of ALTITUDE, whether we have any safety concerns there, we felt comfortable to advance to using that higher concentration in both NAV negative, but then also NAV positive patients based on the data we have. And also the higher concentration data that we have from our preclinical package that was included in our IND, and all of that was what made us feel comfortable to go there. Your second related question was, what about efficacy issues of evaluating NAV positive patients as we're doing now in both AAVIATE and we'll be doing in ALTITUDE? Here, this is why we do these cohorts, here again, from the beginning, even before starting the initial cohorts, in NAV negative patients, our plan had always been and we'd always communicated that we were going step-wise first looking in NAV negative patients, and these were the first-ever studies looking at suprachoroidal gene therapy. But now that we have done that at two different doses in the wet AMD population, that's what gave us the comfort to advance there. And this is why we're so excited to make these significant milestones for this space to not only be able to assess NAV negative patients, but also to look at both safety and efficacy in patients who are NAV positive.

Okay. Next question comes from the line of Dane Leone from Raymond James. Your line is now open.

Thank you for taking the questions. I guess, first question for me, when do you think you would consider getting a bilateral study for RGX-314, either suprachoroidal or in the subretinal procedure? And then, secondly, can you maybe give some color in terms of the IND around DMD? If there is, what I think originally, you had that slated to begin in the mid-part of the year. It's now back towards the latter part of the year. Any color there would be appreciated as well. Thank you.

Sure, Dane. I'll address the second part of your question regarding RGX-202. We are currently working on the IND deliverables required to finalize and initiate the process. At the beginning of the year, we indicated that we expected to have everything ready by mid-year, but we are now projecting it to be pushed to the fourth quarter of this year. However, there have been no significant changes to our internal processes concerning the IND filing and starting the study. It's just a minor adjustment to our original timeline based on the work that has been completed. For the bilateral consideration, I'll have Steve provide some insights.

Sure. Hi, Dane. It's a good question. It's actually one we get anecdotally, not surprisingly from, for example, patients in our Phase I/II subretinal study, who have had good success with treatment in one eye and an interest in 'wouldn't this be great if I could have both my eyes treated'. So, I'll take each route separately. For subretinal delivery, the benefit of all the experience that we have here, both in terms of the relative immune-privileged status of the subretinal space and also the precedent of let's turn a bilateral administration, it does make sense that going forward, we would consider the potential to treat the fellow eye of patients who had one eye treated as a study eye in our trial. So, we haven't announced plans there, but that is something that we think makes a lot of sense from a clinical development standpoint. And also, of course, in the real world going forward to fully realize the value proposition for RGX-314 gene therapy treatment. For suprachoroidal delivery, as we've often said, that's in much earlier innings in terms of evaluation. So first things first, we evaluate how a study eye treatment goes in terms of safety and efficacy, and overall tolerability, and based on the results that we see there and the accumulated data also that we have from subretinal as of that time point, we would also be in a better position to evaluate treatment of the fellow eye of study patients.

Okay. Next question comes from the line of Mani Foroohar from SVB Leerink. Your line is now open.

Hey, good afternoon. This is Rick on the line for Mani. Congrats on all the progress. And just two questions from us. First, yes, so the data in the Hunter program has been pretty impressive to date. I was hoping you could just share some of your most recent thoughts on the pathway to approval here? And if you can comment specifically on approvable endpoints in Hunter Syndrome and expectations for a single-arm registrational trial versus placebo-controlled? And then the second question is just around financials. I know the cGMP Facility is expected to be fully operational during the first half of 2022. If you could just elaborate on some of the expected changes in distribution of CapEx versus OpEx as the facility is completed? And if we should expect any meaningful increases in spend as the vector manufacturing scales up?

Thanks, Rick. I’ll begin with the first question. Regarding Hunter Syndrome, we have been encouraged by the initial study results. The first two doses have indicated changes in biochemistry suggesting that the gene therapy is functioning as intended and is moving towards having a significant impact on the children. We aim to align these findings with functional and clinical assessment data, which historically take longer to validate. From Cohorts 1 and 2, we have gathered meaningful insights linking early biochemical changes to longer-term progress in assessments. Our plan is to present this evidence to all stakeholders, including regulators, to demonstrate the relationship between early biochemical changes and long-term clinical outcomes. We are also increasing the dosage, which we believe will further enhance our strategy, as we expect an increased dose effect while maintaining a favorable safety profile. In any rare disease program, we are patient in gathering all the data, but our team is focused on accelerating the pathway to meet this significant unmet need. We will rely heavily on early biomarker evidence to support the clinical outcomes we seek for these children and their families, which regulators should also expect. On the financial side, I will start. Vit, if you would like to add anything, we have ongoing capital expenditures this year. Once the manufacturing suite is operational, we will complete that phase of investment. Over the next several months and into the middle of next year, we will introduce additional programs, including RGX-202, and expand our RGX-314 program with more dose levels and a new study. Operationally, the demand for GMP space will continue to grow. We anticipate a reduction in CapEx moving from 2021 to 2022 and beyond, especially regarding the GMP facility, while we expect a steady increase in operational expenses associated with our growing clinical study platform, particularly for DMD and later stages of RGX-314 with more patients in the upcoming pivotal trial and potentially new programs as well. Anything you’d like to add, Vit?

Yes, thank you, Rick. We anticipate that from a capital expenditure perspective, there will be continued spending to finalize the manufacturing suite, with much of the work in 2022 primarily focused on that suite. Additionally, we expect a shift in operational expenses as we move from relying on external contract manufacturers to bringing more processes in-house once our facility is operational. Given the increased demand for drug products in the clinical stages, we believe these costs will be somewhat higher than what we currently forecast.

Okay. Next question comes from the line of Matthew Harrison from Morgan Stanley. Your line is now open.

Hey, Greg. Good afternoon. I have a couple of follow-up questions. One is about RGX-314 and the other is about Hunter. Regarding Hunter, could you help us understand how you view your gene therapy program in comparison to some of the antibodies in development, particularly those that seem to cross the blood-brain barrier more effectively? How do you see the GAG reductions contrasting between these two treatment approaches, and what are your thoughts on the competitive landscape for development? Secondly, on RGX-314, there have been many inquiries. I was really hoping you could share your thoughts on the cohorts; since we're only seeing data from the first dose, will we need to wait for all three cohorts to be completed, or could promising data from the first cohort allow for a quicker advancement? Could you outline the scenarios for how you might proceed based on the initial data we’re expecting?

Yes, Matthew. Thank you for your question. We have consistently demonstrated our commitment to being disciplined and focused on achieving a solid pharmacological understanding of our product candidates. This includes a treatment candidate using a new route of administration. We have tested five different doses with our subretinal route to assess safety, pharmacology, and functional clinical responses, leading us to a well-informed decision about advancing to pivotal phase studies. We intend to apply the same disciplined approach to the suprachoroidal route, although we are starting with a foundational pharmacological understanding that we can relate to our subretinal experiences, particularly in terms of safety, where we already have evidence. We are beginning with higher dose levels and plan to continue escalating doses based on our preclinical data and overall clinical understanding. The critical point is that we will determine the speed of our progression based on the comprehensive data from the cohorts we intend to enroll and escalate. We seek to establish a dose response curve before progressing to later stages of development for any route of administration and candidate profile. Discussions with regulators, such as the FDA, suggest that more data is beneficial, especially when considering populations in the hundreds of thousands or millions. In contrast, rare or ultra-rare diseases may require different considerations. We are encouraged that our enrollment is on track, including the expansion of our Phase II studies into higher doses for NAV-positive patients. We expect to report initial data at the six-month mark for Cohort 1 in AAVIATE and anticipate rapid follow-ons for additional cohorts due to this enrollment expansion. We will continue to share important data at relevant time points as we receive it, ensuring that we have sufficient information to inform our decisions about the next steps for our programs, particularly for wet AMD and diabetic retinopathy. Regarding the Hunter program, we are enthusiastic about the interest in lysosomal storage diseases. There is currently a lack of treatment addressing the central nervous system issues faced by affected children, even though there are enzyme replacement therapies for systemic symptoms. Our unique gene therapy approach can be described as an inside-out approach. Changes in biomarkers and biochemistry in the cerebrospinal fluid of children indicate that our treatment is effectively transducing and expressing protein within cells, which is critical to addressing the underlying problem. We have observed meaningful correlations between biochemical changes and our gene therapy effects, and we have characterized various substrates related to these intracellular changes. Other treatment methods may demonstrate biochemical changes, but they operate differently and often rely on mechanisms outside the cells. While we focus on our area of expertise, we believe that our one-time gene therapy treatment, which shows preclinical and clinical evidence of meaningful changes, signifies that the gene has successfully entered brain cells. This data represents a significant milestone in tackling important diseases, and we are eager to support it with clinical evidence as we move forward, particularly for conditions like Hunter Syndrome.

Okay. Your next question comes from the line of Esther Rajavelu from UBS. Your line is now open.

Thank you for taking my question. I apologize for missing the queue earlier; I was jumping between calls. Can you help us understand how widely suprachoroidal delivery is currently used and in what context, as well as the economics of suprachoroidal delivery compared to intravitreal for ophthalmologists? I also have one other follow-up question.

Yes, I can. I’ll address the first part of your question. The suprachoroidal space, particularly in relation to delivery methods beyond gene therapy, has seen significant use through Clearside and their SCS Microinjector. They have treated over 1,000 eyes, primarily with a steroid called triamcinolone for non-infectious uveitis, although it has applications in other treatment areas as well. Due to their solid track record regarding safety, tolerability, and ease of administration, they're continuing to collaborate with companies like Bausch on their lead program. This partnership is one of the reasons we selected Clearside as we aim to utilize the most clinically validated device for administering infusions to the suprachoroidal space in our one-time office-based gene therapy approach. We are enthusiastic about moving forward with this method, as Clearside and their partners have demonstrated great feasibility in administering RGX-314 with the SCS Microinjector. This approach offers the advantage of not requiring an operating room, which makes it simple and straightforward for specialized retinal surgeons to perform in-office. We are excited to keep progressing with suprachoroidal delivery. However, we still need to determine whether neutralizing antibody status will play a significant role in expanding the use of this injection method. Ken, do you have anything to add regarding the latter part of that question?

No, Steve. Just that we're not prognosticating on pricing of suprachoroidal right now. We're initiating our first in-human investigation of what we think is an exciting round of administration and approach, and have the opportunity to evaluate that and take inventory of it, look more to the future to talk about next steps of the program, and ultimately, happy to have conversations about commercialization of this high-potential approach.

Okay, there are no further questions. At this time, I will turn it over back to Mr. Ken Mills for any closing remarks.

Thanks, operator. And thanks, everyone, for participating today. For those of you who are still hanging on, I'd say we had an exciting quarter. We have three data updates that we've communicated between now and the end of the year, starting with Retina Society, then Cohort 2 wet AMD, and diabetic retinopathy Cohort 1, between now and the end of the year for RGX-314, an IND filing for our DMD program, and more updates on RGX-121. Looking to continue to chart a course for how that program moves forward. So, thanks for the great questions. We touched on a lot of these topics, emphasized that the first half of this year has been a great period of execution for the Company, and looking forward to more updates for the rest of the year. Have a good afternoon.

This concludes today's conference call. Thank you for participating. You may now disconnect.