Q1 2025 REGENXBIO Inc Earnings Call
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Operator: Welcome, everyone, to the first quarter 2025 Regenxbio Earnings Conference call. At this time, all participants are in a listen-only mode.
Welcome everyone to the first quarter 2025 genetics bio <unk> earnings conference call. At this time all participants are also the only mode.
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As a reminder, this call maybe recorded.
Patrick Christmas: At this time, I'd like to turn the conference over to Patrick Christmas, Chief Legal Officer of Regenxbio. Please go ahead. Good afternoon, and thank you for joining us today.
At this time I'd like to turn the conference over to Patrick Christmas Chief Legal Officer of Virgin next bio. Please go ahead.
Speaker Change: Good afternoon, and thank you for joining us today earlier. This afternoon organics bio released financial and operating results for the first quarter ended March 31st 2025.
Patrick Christmas: Earlier this afternoon, Regenxbio released financial and operating results for the first quarter ended March 31st, 2025. The press release is available on our website at www.regenxbio.com.
Speaker Change: Press release is available on our website at Www Dot Regina spinal dot com.
Patrick Christmas: 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.
Speaker Change: 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.
Speaker Change: Believe should intend and other words of similar meaning.
Speaker Change: 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 section of <unk> annual report on Form 10-K for the full year ended December 31 2020.
Patrick Christmas: These risks are described in the Risk Factors in the Management, Discussion, and Analysis section of Regenxbio's annual report on Form 10-K for the full year ended December 31, 2021. and Comparable Factors sections of Regenixbio's quarterly reports on Form 10-Q, which are on file with the Securities and Exchange Commission and available on the SEC's website.
Speaker Change: And comparable risk factors sections of <unk> quarterly reports on Form 10-Q, which are on file with Securities and Exchange Commission and available on the Sec's website.
Patrick Christmas: Any information we provide on this conference call is provided only as of the date of this call, May 12, 2025, and we undertake no obligations 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.
Speaker Change: Any information we provide on this conference call is provided only as of the date of this call May 12, 2025, and we undertake no obligations to update any forward looking statements. We may make on this call on account of new information future events or otherwise.
Speaker Change: 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.
Patrick Christmas: 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.
Curran Simpson: I'll now turn the call to Curran Simpson, President and CEO of Regenxbio. Curran? Thank you, Patrick, and thank you, everyone, for joining us today. We've had an impressive start to the year at Regenxbio and are in store for an exciting remainder of 2025. Today you will hear about our strong late-stage clinical progress. sets us up to potentially bring multiple first or best-in-class gene therapies to patients over the coming years.
Current Simpson: Now I'll turn the call to current Simpson, President and CEO of Virginia by out correctly.
Speaker Change: Thank you Patrick and thank you everyone for joining us today.
Speaker Change: We've had an impressive start to the year at <unk> bio and are in store for an exciting remainder of 2025.
Speaker Change: Today, you will hear about our strong late stage clinical progress, which sets us up to potentially bring multiple first or best in class gene therapies to patients over the coming years.
Curran Simpson: We will also discuss other key elements that we believe position us to successfully transition to commercial stage, including our U.S.-based, in-house, commercial-ready manufacturing and broad potential to secure non-dilutive funds.
Speaker Change: We will also discuss other key elements that we believe position us to successfully transition to commercial stage, including our U S base in house commercial ready manufacturing and broad potential to secure non dilutive funding.
Curran Simpson: With me on today's call are Dr. Steve Pakola, our Chief Medical Officer, and Mitch Chan, our Chief Financial Officer. I'll start with a review of recent business highlights, then turn it over to Stephen Mitch for clinical and financial updates.
Speaker Change: With me on today's call are Dr. Steve Nicola, our Chief Medical Officer, and MS Chan, our Chief Financial Officer.
Speaker Change: I'll start with a review of recent business highlights then turn it over to Stephen Mitch for clinical and financial updates.
Curran Simpson: Then I'll have a few closing remarks before opening the call for Q&A.
Speaker Change: Then I'll have a few closing remarks before opening the call for Q&A.
Curran Simpson: Starting with our most advanced program, RGX-121, or Chlamydzogene Lenparbovac, the potential first gene therapy and one-time treatment for MPS2 or Hunter syndrome, a devastating disease that affects approximately 2,000 patients worldwide. Any day now we expect the FDA acceptance of the BLA, which we submitted under the Accelerated Approval Pathway in March 2025. RGX 121 remains on track for potential FDA approval in the second half of this year.
Speaker Change: Okay.
Speaker Change: Starting with our most advanced program, <unk> 121, or <unk> gene land Parvo back.
Speaker Change: The potential first gene therapy, and one time treatment for MPS II or Hunter syndrome.
Speaker Change: Devastating disease that affects approximately 2000 patients worldwide.
Speaker Change: Any day now we expect the FDA acceptance of the BLA, which we submitted under the accelerated approval pathway in March 2025.
Speaker Change: <unk> hundred 21 remains on track for a potential FDA approval in the second half of this year.
Curran Simpson: Earlier this year, we established a key strategic partnership with Nippon Shinyaku to commercialize our neurodegenerative franchise, including RGX-121 and RGX-111 for severe MTS1, and commercial preparations are progressing well. Together with Nippon, our goal is to deliver RGX 121 to patients beginning in the first half of 2026.
Speaker Change: Earlier this year, we established a key strategic partnership with <unk> to commercialize our neuro degenerative franchise, including <unk> 121, and <unk> 111 for severe MTS one.
Speaker Change: And commercial preparations are progressing well.
Speaker Change: Together with Nippon our goal is to deliver <unk> hundred 21 to patients beginning in the first half of 2026.
Curran Simpson: Accelerating quickly, right behind RGX 121, is RGX 202, our next generation candidate for Duchenne Muscular Dysfunction. I am pleased to report that our pivotal study continues advancing rapidly. We have surpassed 50% enrollment for our Pivotal data set. We're seeing increased interest and enthusiasm from the patient community about RGX202 and its differentiated profile, and we remain on track to submit a BLA in mid-2026 and seize our unique second-to-market or fast-follower opportunity in Duchenne. Positive input from our growing investigator community supports our belief that RGX2 has the potential to be a preferred and differentiated treatment option. It's important to keep in mind that, one, RGX202 is the only investigational next-generation DMD gene therapy in pivotal study and the only investigational therapy with both robust microdistrophin and functional data available.
Speaker Change: Accelerating quickly right behind <unk> hundred 21, <unk> 202, our next generation candidate for Duchenne muscular dystrophy.
Speaker Change: I am pleased to report that our pivotal study continues advancing rapidly.
Speaker Change: We have surpassed 50% enrollment for our pivotal dataset.
Speaker Change: We're seeing increased interest and enthusiasm from the patient community about <unk> and its differentiated profile and we remain on track to submit a BLA in mid 2026 and sees our unique secondary market, our fast follower opportunity in Duchenne.
Speaker Change: Positive input from our growing investigator community supports our belief that <unk> has the potential to be a preferred and differentiated treatment option.
Speaker Change: It's important to keep in mind that one RG X. Two two is the only investigational next generation DMD gene therapy in pivotal study and the only investigational therapy with both robust micro dystrophin and functional data available.
Curran Simpson: Regenx 202 has the potential to be approved for patients aged 1 to 3 who currently have no access to gene therapy. And last, DMD represents a large addressable market. With over half of the prevalent DMD population projected to remain untreated as of 2027. The expected year of RGX202's commercial launch.
Speaker Change: <unk> <unk> has the potential to be approved for patients aged one to three who currently have no access to gene therapy.
Speaker Change: And last DMD represents a large addressable market.
Speaker Change: With over half of the prevalent DMD population projected to remain untreated as of 2027.
Speaker Change: The expected year of Rdx <unk> commercial launch.
Curran Simpson: Given our strong and rapid clinical progress, conviction in our differentiated profile, and in recognition of the ongoing unmet need, We will begin producing RGX202 commercial supply at our Manufacturing Innovation Center here in Rockville, Maryland in the third quarter of this year. With full clinical and planned confirmatory supply already in hand, we will build commercial inventory to be prepared for a smooth launch and meet patient needs immediately upon the potential approval of RGX202. As a reminder, our Manufacturing Innovation Center is a state-of-the-art integrated GMP facility. that can produce up to 2,500 doses of RGX202 annually. Enough to treat approximately one-fifth of the estimated North American DMD population.
Speaker Change: Given our strong and rapid clinical progress conviction in our differentiated profile and a recognition of the ongoing unmet need.
Speaker Change: We will begin producing rdx tool to commercial supply at our manufacturing innovation center here in Rockville, Maryland in the third quarter of this year.
Speaker Change: With full clinical and planned confirmatory supply already in hand.
Speaker Change: We will build commercial inventory to be prepared for a smooth launch and meet patient needs immediately upon the potential approval of <unk>.
Speaker Change: As a reminder, our manufacturing innovation center is a state of the art integrated GMP facility.
Speaker Change: That can produce up to 2500 doses of <unk> 202 annually.
Speaker Change: And that's to treat approximately one fifth of the estimated north American DMD population.
Curran Simpson: all while delivering industry leading purity levels in Duchenne with over 80% full caps.
Speaker Change: All while delivering industry, leading purity levels in duchenne with over 80% forecast.
Curran Simpson: We look forward to sharing additional Phase I-II functional data for RGX202 in the first half of this year as we aggressively advance towards commercialization.
Speaker Change: We look forward to sharing additional phase one two functional data for Rdx 202 in the first half of this year as we aggressively advance towards commercialization.
Curran Simpson: Moving to our retinal programs, we continue to work closely with our partner AbbVie to progress ABBV-RGX314 or Serabgine Lumparupu. 314 is advancing in two pivotal studies for subretinal wet AMD, one phase two study for supercoroidal wet AMD, and preparations for a pivotal program are underway in diabetic retinopathy, or DR, using supercoroidal delivery.
Speaker Change: Moving to our retinal programs, we continue to work closely with our partner Abbvie to progress.
Speaker Change: <unk> hundred 14, our Surat gene lung power OPEC.
Speaker Change: 300, <unk> is advancing in two pivotal studies for sub retinal wet AMD.
Speaker Change: One phase III study for Super cried, a wet AMD and preparations for a pivotal program are underway in diabetic retinopathy or Dr. Using super parietal delivery.
Curran Simpson: We remain on track to be the first gene therapy on the market for wet AMD with a product that has demonstrated compelling durability and strong patient impact. Both WETA-AMD and DR represent large, multi-billion dollar commercial opportunities, and we believe 314 has the potential to preserve vision and serve as a meaningful alternative to today's standard of care. In summary, we remain excited for and are well positioned to deliver on the opportunities ahead of us.
Speaker Change: We remain on track to be the first gene therapy on the market for wet AMD with a product that has demonstrated compelling durability and strong patient interest.
Speaker Change: Both wet AMD and Dr represent large multibillion dollar commercial opportunities and we believe <unk> has the potential to preserve vision and serve as a meaningful alternative to today's standard of care.
Speaker Change: In summary, we remain excited for and are well positioned to deliver on the opportunities ahead of us.
Stephen Pakola: With that, I would like to now turn the call over to Steve for an update on our clinical programs. Steve? Thank you, Curran. I'll start with RGX202, a potential one-time gene therapy for the treatment. RGX202 uses the NAV-AV8 vector and is the only microdystrophin construct to include the C-terminal domain, a key element of naturally occurring dystrophin critical to protecting muscle from contraction-induced damage. This novel construct, combined with the highest purity levels in the field, make 202 a potential best-in-class gene therapy for Duchenne. As Curran mentioned, I'm pleased to share that today we announced the pivotal phase of the Affinity Duchenne trial is beyond 50% enrolled.
Steve Nicola: With that I would like to now turn the call over to Steve for an update on our clinical programs Steve.
Speaker Change: Karen.
Steve Nicola: I'll start with <unk>, a potential onetime gene therapy for the treatment of Duchenne.
Steve Nicola: <unk> 202 uses the NAV <unk> vector and its the only micro dystrophin construct to include the C terminal domain.
Steve Nicola: Element of naturally occurring dystrophin critical to protecting muscle from contraction induced statement.
Steve Nicola: This novel construct combined with the highest purity levels in the field make 202, a potential best in class gene therapy for Duchenne.
Steve Nicola: As Kurt mentioned I am pleased to share that today, we announced that pivotal phase of the affinity Duchenne trial is beyond 50% enrolled.
Stephen Pakola: Our accumulating Phase 1-2 results are showing impressive evidence of differentiation on safety, biomarkers, and functional outcomes. This is driving increased excitement throughout the Duchenne. giving us further confidence as we move toward our target of completing pivotal enrollment in the second half of this year. This trial is enrolling ambulatory patients age 1 and above, generating data where limited results are available. Based on the clinical profile and in partnership with our investigators, we expanded the inclusion criteria to a broader range of experts. Additional trial sites continue opening in the U.S. and Canada, and we are making great strides in our pivotal strategy to enroll across a wider age group.
Steve Nicola: Our accumulating phase <unk> results are showing the impressive evidence of differentiation on safety.
Steve Nicola: So marker and functional outcome.
Steve Nicola: This is driving increased excitement throughout the duchenne community, giving us further confidence as we move toward our target of completing enrollment in the second half of this year.
Steve Nicola: This trial is enrolling ambulatory patients age one and above generating data were limited results exist for Duchenne gene therapies.
Steve Nicola: Based on the clinical profile and in partnership with our investigators we expanded the inclusion criteria to a broader range of exon mutation.
Steve Nicola: Additional trial sites continue opening in the U S and Canada, and we're making great strides in our pivotal strategy to enroll across a wider age range with an aim to secure a broad label supported by a clear and robust product profile.
Stephen Pakola: with an aim to secure a broad label supported by a clear and robust product profile. In November, we reported positive safety and efficacy data from the Phase 1-2 study, including positive functional outcomes from the first five participants. at nine and 12 months. These results presented last November showed 202 recipients exceeded external natural history controls and established benchmarks for clinical outcomes. Specifically, we observed functional improvements in all five evaluated patients, including those at dose level two, consistent, robust expression, transduction, and localization of our differentiated 202 microdistrophin in muscle with all participants above 10% expression. We have also seen a favorable safety profile with no serious adverse events or AEs of special interest.
Steve Nicola: In November we reported positive safety and efficacy data from the phase one two study, including positive functional outcomes from the first five participants at 9% and 12 months.
Steve Nicola: These results presented last November showed 202 recipients exceeded external natural history controls and establish benchmarks for clinical outcomes.
Steve Nicola: Specifically, we observe functional improvements in all five evaluated patients, including those at dose level two.
Steve Nicola: Consistent robust expression traded deduction and localization.
Steve Nicola: <unk> of our differentiated 202 micro dystrophin in muscle with all participants above 10% expression.
Steve Nicola: We have also seen a favorable safety profile with no serious adverse events or aes of special interest.
Stephen Pakola: Building on this data in March at the 2025 MDA Conference. We presented new biomarker data from two patients. including the first data from our cohort of patients under four years. This patient, age 3 at dosing, had a microdystrophin expression level of 122% of control. Patients age 1 to 3 represent a significant portion of the prevalent Duchenne population, yet this group has no access to approved gene pairs. Overall, the Phase 1-2 data show consistent microdischarfen expression in all 12 patients spanning all age Functional Improvements, and Evidence of Altering the Trajectory of Disease, and a Favorable Safety Profile.
Steve Nicola: Building on this data in March at the 2025 MDA Conference.
Steve Nicola: We presented new biomarker data from two patients.
Steve Nicola: <unk> the first data from our cohort of patients under four years of age.
Steve Nicola: This patient <unk> III dosing at a micro dystrophin expression level of 122% of control.
Steve Nicola: Patients aged one to three represent a significant portion of the prevalent Duchenne population yet. This group has no access to approved gene therapy.
Steve Nicola: Overall, the phase one two data showed consistent micro dystrophin expression in all 12 patients spanning all age groups functional improvements and evidence of altering the trajectory of disease and a favorable safety profile.
Stephen Pakola: As the program advances, we expect an increased focus on the dose level 2 cohort as these patients receive the commercial dose level. We look forward to sharing additional data from the Phase I-II study in the first half of this year.
As the program advances, we expect an increased focus on the dose level two cohorts. These patients received the commercial dose level.
Steve Nicola: We look forward to sharing additional data from the phase <unk> study in the first half of this year.
Stephen Pakola: Now on to our Retina Franchise 314. which is being developed in collaboration with AbbVie to treat wet AMD and diabetic retinopathy or DR. I'll start with 314 for DR being evaluated in the Phase 2 Altitude Trial using in-office supercorroidal testing. Like what AMD, DR is a progressive disease that causes vision loss and ultimately blindness if not treated appropriately.
Steve Nicola: Now onto our retina franchise, $3 14, which is being developed in collaboration with Abbvie to treat wet AMD and diabetic retinopathy or Dr.
Speaker Change: I'll start with 314 for Dr being evaluated in the phase II <unk> trial using in office Super Choroidal delivery.
Speaker Change: Like what AMD, Dr is a progressive disease that causes vision loss and ultimately blindness, if not treated appropriately.
Stephen Pakola: As we've shared, we completed our end of phase two meeting with the FDA in the fourth quarter of last year and are actively working with AbbVie on plans for our phase three clinical program that would support global regulatory pilot. We look forward to sharing more on that program as preparations progress.
Speaker Change: As we've shared we completed our end of phase II meeting with the FDA in the fourth quarter of last year and are actively working with Abbvie on plans for our phase III clinical program that would support global regulatory filings.
Speaker Change: We look forward to sharing more on that program as preparations progress.
Stephen Pakola: In WET-AMD, we are evaluating 314 via two different delivery forms, subretinal and supracaroidal. Within subretinal, we have two ongoing physical trials, Atmosphere and Ascent, in the US, Europe, and Germany. These trials continue to progress well. As we've announced in January, enrollment of both pivotal trials is expected to complete this year, and we expect to share top-line data in 2026.
Speaker Change: In wet AMD, we are evaluating $3 14.
Speaker Change: Two different delivery forms sub.
Speaker Change: Brighton and Super Choroidal.
Speaker Change: Within <unk>, we have two ongoing pivotal trial atmosphere in ascent in the U S Europe and Japan.
Speaker Change: These trials continue to progress well as we've announced in January enrollment of both pivotal trials is expected to complete this year and we expect to share top line data in 2026.
Stephen Pakola: 314 is on track to be the first gene therapy on the market for wet AM. and is poised to deliver a compelling product profile based on the impressive safety and durability seen in our Phase 1-2a trial. In this trial, 314 achieved meaningful reduction in treatment burden and sustained treatment effect through four years. Overall, we remain encouraged by the ongoing progress with 314.
Speaker Change: 314 is on track to be the first gene therapy on the market for wet AMD.
And is poised to deliver a compelling product profile based on the impressive safety and durability seen in our phase <unk> trial.
Speaker Change: In this trial 314 achieved meaningful reduction in treatment burden and sustained treatment effect three or four years.
Speaker Change: Overall, we remain encouraged by the ongoing progress with $3 14.
Stephen Pakola: I'd like to particularly highlight the differentiated safety profile observed in our in-office supercoroidal program. This is particularly notable in the setting of short course seven week prophylactic steroid eye drops, a significantly shorter regimen than those used in other gene therapy trials. This continues to support the potential of 314 as a meaningful treatment option for patients and physicians.
Speaker Change: I'd like to particularly highlight the differentiated safety profile observed in our in office Super Choroidal program.
Speaker Change: This is particularly notable in the setting of short course, seven week prophylactic steroid eyedrops are significantly shorter regimen than those used in other gene therapy trials.
Speaker Change: This continues to support the potential of $3 14 is a meaningful treatment option for patients and physicians.
Stephen Pakola: Finally, turning to our MPS program. It's an incredibly exciting time for Regenxbio in the Hunter Syndrome community with the recent submission of our BLA for RGX 121. This filing is supported by data from the CAMPSITE trial, which met its primary pivotal endpoint with high statistical success. In addition, we previously reported that 80% of pivotal dose patients either discontinued enzyme replacement therapy or remain treatment-naive, along with evidence of neurodevelopment improvement.
Speaker Change: Finally, turning to our NPS program.
Speaker Change: Incredibly exciting time for regenerative bio and the Hunter syndrome community with the recent submission of our BLA for <unk> 121.
Speaker Change: This filing is supported by data from the <unk> trial, which met its primary pivotal endpoint with high statistical significance and.
Speaker Change: In addition, we previously reported that 80% of pivotal dose patients either discontinued enzyme replacement therapy or remain treatment naive.
Speaker Change: Along with evidence of neuro development improvement sustained fruit for years post dosing.
Stephen Pakola: Staying for 4 years post-pandemic. 121 represents a potential significant advancement, not only improving patient outcomes, but also improving the daily lives. As a one-time gene therapy, 121 has the potential to achieve these benefits. While also reducing the treatment burden and the significant amount of time families spend getting weekly enzyme replacement therapy. We look forward to an anticipated FDA approval decision in the second half of 2025.
Speaker Change: 121 represents a potential significant advancement not only improving patient outcomes, but also improving the daily lives of patients and families.
Speaker Change: As a onetime gene therapy 121 has the potential to achieve these benefits while also reducing the treatment burden and the significant amount of time families spend getting weekly enzyme replacement therapy.
Speaker Change: We look forward to an anticipated FDA approval decision in the second half of 2025.
Stephen Pakola: To conclude, we are making significant progress with data updates and trial progression across all programs in our pipeline.
Speaker Change: To conclude we are making significant progress with data updates and trial progression across all programs in our pipeline.
Stephen Pakola: I'd like to thank all of the patients, families, clinicians, and patient advocacy representatives who have been involved in and supported all of these trials.
Speaker Change: I'd like to thank all of the patients families clinicians and patient advocacy representatives.
Speaker Change: <unk> been involved in and supported all of these trials.
Mitch Chan: With that, I'll turn the call over to Mitch to review our financial guidance. Thank you, Steve. Regenxbio ended the quarter on March 31, 2025, with cash, cash equivalent and marketable securities of $272 million, compared to $245 million as of December 31, 2024. The increase was primarily driven by the $110 million upfront payment received under the Nippon-Shinjuku collaboration and was partially offset by cash used to fund the operating activities during the first quarter of 2025. R&D expenses were $53 million for the quarter ended March 31, 2025, compared to $54.8 million for the quarter ended March 31, 2024.
Speaker Change: With that I'll turn the call over to Mitch to review our financial guidance Mitch.
Mitch: Thank you Steve.
Mitch: <unk> ended the quarter on March 31, 2025, with cash cash equivalents and marketable securities of $272 million.
Mitch: Compared to $245 million as of December 31, 2024.
Mitch: The increase was primarily driven by the $110 million upfront payment received under the Newpage conducted collaboration and was partially offset by cash used to fund operating activities. During the first quarter of 2025.
Mitch: R&D expenses were $53 million for the quarter ended March 31, 2025, compared to $54 8 million for the quarter ended March 31 2024.
Mitch Chan: The decrease was primarily due to clinical trial expenses for RGX 314 and RGX 202.
Mitch: Decrease was primarily due to clinical trial expenses for RPX grew one four and <unk> 202.
Mitch Chan: We expect the balancing cash, cash equivalent and marketable securities of $272 million as of March 31st, 2025 to fund our operations into the second half of 2020. This cash runway guidance is based on the company's current operational plans and excludes the impact of any future potential royalty income associated with RGX-121. If we include additional non-dilutive financing, we expect the cash framework to potentially extend well beyond 2026. For instance, some examples of our non-diluted financing options include development and sales milestone, reversion of our royalty income, and the potential sale of our Priority Review Voucher, or RGX 121, if approved, which has recently sold for at least $150 million.
Mitch: We expect the balance in cash cash equivalents and marketable securities of $270 2 million at March 31, 2025% to fund our operations into the second half of 2026 <unk>.
Mitch: This cash runway guidance is based on the company's current operational plan and excludes the impact of any future potential royalty income associated with RPX 121.
Mitch: If we include additional non dilutive financing, we expect the cash runway to potentially extend well beyond 2026.
Mitch: For instance.
Mitch: Some examples are non dilutive financing options include development and sales milestone reversion of our royalty income and the potential sale of our priority review voucher or <unk> 121, if approved which has recently sold for at least $150 million.
Mitch Chan: Collectively, we have many non-dilutive financing optionalities that could extend our cash runway well beyond the second half of 2020.
Mitch: Collectively we have many non dilutive financing optionality that could extend our cash runway well beyond the second half of 2026.
Curran Simpson: With that, I turn the call back to Curran to provide final thoughts. Thanks, Mitch. As you heard today, there's tremendous momentum and strong execution across our pipeline to advance our programs towards key milestones. To recap, We have submitted our first BLA and our partnership with Nippon Shinyaku for our MPS programs is off to a strong start. We look forward to a potential FDA approval of RGX 121 this year. The pivotal study of RGX202 is moving rapidly. and we believe remains well positioned to potentially serve as the next and preferred gene therapy in Duchenne. We are planning for success and will initiate commercial supply manufacturing in the coming months in anticipation of a 2027 commercial launch.
Mitch: With that I turn the call back to current to provide final thoughts.
Current Simpson: Thanks Mitch.
Current Simpson: As you heard today, there is tremendous momentum and strong execution across our pipeline to advance our programs towards key milestones.
Current Simpson: To recap.
Current Simpson: We have submitted our first BLA and our partnership with Nippon sheet Yahoo for our NPS programs is off to a strong start.
Current Simpson: We look forward to a potential FDA approval of <unk> hundred 21 this year.
Current Simpson: The pivotal study of <unk> 202 is moving rapidly and we believe remains well positioned to potentially serve as the next and preferred gene therapy in Duchenne.
Current Simpson: We are planning for success and will initiate commercial supply manufacturing in the coming months in anticipation of a 2027 commercial launch.
Curran Simpson: We also plan to share updated functional data in the first half of this year. And with enrollment more than halfway through, we expect to complete enrollment of the pivotal study this year and share top-line data in the first half of 2026. Our partnership with AbbVie is advancing towards multiple large global commercial opportunities. We expect to complete enrollment of two global pivotal trials for subretinal wet AMD. and are working with AbbVie on a pivotal study in diabetic retinopathy in 2025.
Current Simpson: We also plan to share updated functional data in the first half of this year.
Current Simpson: And with enrollment more than halfway through we expect to complete enrollment of the pivotal study this year and share top line data in the first half of 2026.
Current Simpson: Our partnership with Abbvie is advancing towards multiple large global commercial opportunities.
Current Simpson: We expect to complete enrollment of two global pivotal trials for sub retinal wet AMD.
Current Simpson: And are working with Abbvie on a pivotal study in diabetic retinopathy in 2025.
Curran Simpson: As we lead the way in AAV gene therapy, our team is looking forward to presenting at ASGCT this week. Our presentations in New Orleans highlight our in-house end-to-end capabilities and deep translational expertise. Presentations will include preclinical research supporting the novel construct of RGX-202, including the C-terminal domain. Tapsid Discovery Research, and the RGX202 Manufacturing Process Development, enabling industry-leading purity levels in Duchenne gene therapy. We are in a very unique position in our industry. Each of our assets represent one time treatments with the potential to transform the trajectory and management of disease for patients in need of new and better options.
Current Simpson: As we lead the way in AAV gene therapy. Our team is looking forward to presenting at <unk>. This week.
Our presentations and New Orleans highlight our in house end to end capabilities and deep translational expertise.
Current Simpson: Presentations will include preclinical research supporting the novel construct of <unk> 202, including the C terminal domain.
Current Simpson: Capsid discovery research and the <unk> manufacturing process development, enabling industry, leading purity levels and Duchenne gene therapy.
Current Simpson: We are in a very unique position in our industry each of our assets represent one time treatments with the potential to transform the trajectory in management of disease for patients in need of new and better options.
Curran Simpson: and are demonstrating beneficial differentiation against standard of care and available treatment. And we have a balance sheet that enables us to better navigate the current macro environment and execute against our near-term and exciting milestones.
Current Simpson: And are demonstrating beneficial differentiation against standard of care and available treatments.
Current Simpson: And we have a balance sheet that enables us to better navigate the current macro environment and execute against our near term and exciting milestones.
Curran Simpson: With that, thanks everyone for your time today.
Current Simpson: With that thanks, everyone for your time today, I will turn the call over for questions operator.
Operator: I'll turn the call over for questions.
Operator: Operator. Thank you. As a reminder, to ask a question, please press star 1. If your question has been answered and you would like to remove yourself from the queue, please press star 11 again.
Current Simpson: Thank you as a reminder to ask a question. Please press star one one is.
Current Simpson: Your question has been answered.
Current Simpson: Move yourself from the queue. Please press star one again.
Mani Foroohar: Our first question comes from Mani Foroohar with Lyrinc Partners. Your line is open. Hey guys, thanks for taking the call. I've got two quick ones. I think first is around timing for the Hunter BLA. You mentioned this month I had a couple of people who've reached out around timing and I admit to doing this math myself. With 60 days marched out from March 13th should be right around now. Is that math too close or are we thinking about it wrong? I think there's a little bit of sensitivity around any hypothetical FDA delay or is this just we're not taking into account federal holidays.
Manny: Our first question comes from Manny <unk> with Leerink partners. Your line is open.
Manny: Hey, guys. Thanks for taking the call I've got two quick ones.
Manny: First is around timing.
Manny: So the Hunter BLA you mentioned this month I had a couple of people who've reached out around timing and I have that youre doing this math myself.
Manny: With 60 days marched up from March 13th.
Manny: It should be right around now.
Manny: Is that is that math to close or are we thinking about ROI.
Manny: Got it up a little bit of sensitivity around any hypothetical FDA delay or is it just.
Mani Foroohar: And then I have a follow-up.
Manny: We're not taking into account federal holidays, and then I have a follow up.
Curran Simpson: Hi Mani, thanks for the call and the question.
Speaker Change: Hi, Mani thanks for the call and the question.
Curran Simpson: Yeah, we were certainly pointing towards imminent in terms of timing around the BLA acceptance. I think we feel really good about where the review stands. We've been getting regular interactions on a few areas, the information requests that normally come in as part of the review. And also we do orientation meetings early on regarding the submission and the BLA contents. All of that is pretty much business normal. We haven't gotten any questions that would lead us to believe otherwise. And so I think you'll expect to hear from us soon about hopefully an acceptance.
Speaker Change: Yes, we are certainly pointing towards imminent in terms of the timing around the BLA.
Speaker Change: Acceptance.
Speaker Change: I think we feel really good about.
Speaker Change: Where the review stands we've been getting regular interactions.
Speaker Change: A few areas the information requests that normally come in as part of the review.
Speaker Change: And also we do orientation meetings early on regarding the submission.
Speaker Change: And the BLA content all of that is.
Speaker Change: Pretty much business normal we haven't gotten any questions that would.
Speaker Change: Would lead us to believe otherwise and so I think you'll expect to hear from us soon about.
Speaker Change: Hopefully and acceptance.
Mani Foroohar: Great.
Mani Foroohar: And moving on to something a little more substantive. Obviously, you and others have watched closely as your competitor Sarepta has had some stumbles both commercially and from a regulatory perspective. And there have been changes at the helm of CBER, which have driven a lot of debate around the space.
Speaker Change: Great.
Moving on it for a little more substantive.
Speaker Change: Yes.
Speaker Change: Obviously, you and others have watched closely.
Speaker Change: Your competitor <unk>.
Speaker Change: <unk> had some stumbles the commercially and from a regulatory perspective.
Speaker Change: And there have been changes at the helm of seeber, which have driven a lot of debate around the space I'm not the first or the second our 1000th SaaS that question.
Curran Simpson: I'm not the first or the second or 1000th staff that How do you think about the bar for approvability in DMD on an accelerated basis, expectations around biomarkers, biomarker data versus functional data? Like, where is that conversation and how has it evolved with the additional input of what we've seen from SREPTA, as well as any potential changes at the helm of CBER? Yeah, thanks. I think, you know, from the very beginning on the program, we've pointed towards accelerated approval pathway. Those were discussions we had with FDA in our end of phase two meeting, which were very positive and productive.
Speaker Change: How do you think about the bar for our proven ability in DMD on an accelerated basis expectations around biomarker slash biomarker data versus the functional data.
Speaker Change: Where that conversation and how has it evolved.
Speaker Change: The additional input of what we've seen from so wrapped up.
Speaker Change: As well as any potential changes at the helm of seeber.
Speaker Change: Yes, Thanks I think.
Speaker Change: From the very beginning on the program, we've pointed towards accelerated approval pathway.
Speaker Change: Those were discussions we had with the FDA in our indices to meeting which were very positive and productive.
Curran Simpson: Our intention from the beginning has been to provide functional corollary, if you will, to micro dystrophin as part of the filing and review process. And so we feel really good about our data, the strength of the data in terms of safety profile and initial functional data that we provided. We really look forward to additional functional updates first half of this year to continue that story. And I think we've seen nothing but continued and maybe increased opportunity for us, given the benefit to risk ratio we think we're developing and the existence of what we think will be a very sizable prevalent market upon potential approval in 2027.
Speaker Change: Our intention from the beginning has been to provide.
Speaker Change: Functional corollary, if you will to micro dystrophin as part of the filing and review process and so we feel really good about our data the strength of the data in terms of the safety profile and initial functional.
Speaker Change: Data that we provided we really look forward to additional functional updates first half of this year.
Speaker Change: To continue that story.
Speaker Change: And I think we see nothing but continued in navy increased opportunity for us.
Speaker Change: The benefit to risk ratio, we think we are developing.
Speaker Change: And the existence of what we think will be a very sizeable prevalent market upon potential approval in 2027.
Mani Foroohar: So I think our conviction and our opportunity only continues to increase as the program evolves. And I think in terms of how FDA would view that, I think certainly Dr. McCary provided good context on rare disease development and, you know, the support for programs like ours, where I think we can provide benefit to patients. Great. Thanks for that clarity, guys. Thank you.
Speaker Change: So I think our conviction and our opportunity only continues to increase as the program evolves.
Speaker Change: And I think in terms of how FDA would view that.
Speaker Change: I think certainly Dr Macquarrie.
Speaker Change: Provided good context on rare disease development.
Speaker Change: And.
Speaker Change: The support for.
Programs like ours, where I think we can provide benefit to patients.
Speaker Change: Great. Thanks for that clarity guys.
Speaker Change: Thanks.
Gena Wang: Our next question comes from Gena Wang with Barclays. Your line is open. Thank you for taking my questions. I will follow Mani's questions. I will also ask a few more.
Speaker Change: Thank you. Our next question comes from Gena Wang with Barclays. Your line is open.
Thank you for taking my questions. So I will follow many questions and will also ask a few more.
Gena Wang: So giving reason, I love this safety event. So I will ask a very specific questions like, do you expect any changes from the FDA regarding requirement of the safety profiles? And also for your pivotal study, any changes in terms of enrollment speed and the patient type? And my second question, lastly, you know, after a recent appointment of a new CBAR director, and do you expect any changes on your accelerated approval path that was previously aligned with the FDA?
Speaker Change: So, giving leasing 11, just safety event.
Speaker Change: I'll ask a very specific question do you expect any changes from the FDA regarding the climate of safety profiles.
Speaker Change: And also for your pivotal study any changes in terms of enrollment speed and the patient type and then my second question.
Speaker Change: Lastly, after the recent appointment of a new Seaboard director and do you expect any changes on your accelerated approval path that was previously aligned with sbe.
Speaker Change: Okay.
Curran Simpson: I think I'll take the last one. I think it's it's very early to project any potential changes in accelerated approval, but we certainly don't see any signs of that to date. Our program in terms of enrollment is absolutely on track with how we projected it. We feel highly confident that we will enroll the study this year, the pivotal study of N equals 30. We'll continue to do enrollment throughout the remainder of the year as well to support our confirmatory study as well. And I think from the beginning of the program, I've been pointing towards during the time of submission and review, having substantial functional data to accompany that.
Speaker Change: I think I'll take the last one I think it's very early to project any.
Speaker Change: Potential changes and accelerated approval, but we certainly don't see any signs of that to date.
Speaker Change: Our program in terms of enrollment is absolutely on track with how we projected it we feel highly confident that we will enroll the study.
Speaker Change: This year the <unk>.
Speaker Change: That will study and equals 30, we'll continue to do enrollment throughout the remainder of the year as well as support our confirmatory study as well.
Speaker Change: And I think from the beginning of the program I've been pointing towards.
Speaker Change: During the time of submission and review.
Speaker Change: Having substantial functional data to accompany that so I think there's I.
Curran Simpson: So I think I don't see anything emerging in some of the dialogue that we've heard from FDA that's contrary to that approach. So I think our plan is unaltered at this point regarding that. I do think that the strong functional data we reported in November coupled with the safety profile to date that we've been able to portray in our earnings and press releases really points towards potential improvement in benefit-to-risk for Duchenne patients, and we think that will be something that will be interesting to the review team as we, you know, complete our filing next year.
I don't see anything emerging in some of the dialogue that we've heard from FDA.
Speaker Change: Contrary to that approach. So I think our plan is is an altered at this point regarding that I do think that.
Speaker Change: The strong functional data.
Speaker Change: Reported in November coupled with the safety profile.
Speaker Change: To date that we've been able to.
Speaker Change: Portray in our earnings and press releases.
Speaker Change: It really points towards.
Speaker Change: Potential improvement and benefit to risk.
Speaker Change: For <unk> patients and we think that will be something that will be interesting to the review team.
Speaker Change: As we complete our filing next year.
Curran Simpson: I do think that this points towards our immune suppression regimen, which, you know, is, I think, innovative in the sense of proactively addressing known SAE types for Duchenne patients treated with high-dose AAV.
Speaker Change: I do think that this points towards our immune suppression regimen.
Speaker Change: I think innovated in the sense of proactively addressing known SA.
Speaker Change: Types for Duchenne patients treated with high dose AAV.
Stephen Pakola: I think looking at that approach today is directly in line with potentially better outcomes for patients is what we've seen so far in terms of not just the experience during treatment, but then the post-treatment monitoring, and maybe I'll let Steve elaborate a bit on that from the clinical perspective.
Speaker Change: I think looking at that approach today.
Steve Nicola: Is directly in line with potentially better outcomes for patients is what we've seen so far in terms of not just the experienced during treatment than the post treatment monitoring and maybe I'll, let Steve elaborate a bit on that.
Speaker Change: From the clinical perspective.
Stephen Pakola: Hi, Gena. Thanks. Thanks for the question.
Steve Nicola: All right.
Speaker Change: Hi, Gena. Thanks, Thanks for the question.
Stephen Pakola: It is certainly an area of high interest in the Duchenne community, given the recent death, unfortunately, with the Elevitist program. I'd say the overarching aspect is that I think you've heard and seen, and we certainly have seen this both at MDA and in our subsequent one-on-one discussions, is this just brightens the spotlight on safety. But I think even before this event, safety is king. And I think that's why a lot of the points that Curran mentioned are only giving greater comfort to our investigators and the patient families that they speak to about the differentiated aspects of our program.
Speaker Change: Certainly.
Speaker Change: An area of high interest in the Duchenne community.
Speaker Change: Given the recent death.
Speaker Change: Unfortunately, with the <unk> program.
Speaker Change: The overarching.
Speaker Change: Aspect.
Speaker Change: Is that I think you've heard and seen and we certainly have seen this both MDA and in our subsequent one on one discussions is this just.
Speaker Change: He is a spotlight on safety, so I think even before this event.
Speaker Change: Safety is key.
Speaker Change: And I think Thats why a lot of the points that <unk> mentioned.
Speaker Change: Our only giving greater comfort.
Speaker Change: To our investigators and the patients families that they speak to about the differentiated aspects of our program.
Stephen Pakola: So I think this is why we designed the construct that we did. This is why over the years we've advanced and we're very proud of our high purity level with the highest full to empty capsid ratio in the field and also the robust immune modulation regimen that Curran mentioned. So I think those factors are giving us and the community comfort. And that's why we're absolutely on track with our recruitment.
Speaker Change: I think this is why we designed the construct that we did this is why.
Speaker Change: Over the years, we've advanced that we're very proud of our high purity level with the highest.
Full to empty capsid ratio in the field and also the.
Speaker Change: Robust immune modulation regimen that Curt mentioned, so I think those factors are giving us and the community comfort and that's why we're absolutely on track with our recruitment.
Stephen Pakola: Thank you.
Speaker Change: Thank you.
Stephen Pakola: I think I'd also point to the imminent review and outcome of the hopeful acceptance of the 121 program. I think that'll be sort of an early data point on accelerated approval. As you know, the Hunter program is following an accelerated approval pathway. In that case, we had a pre-BLA meeting that was also supportive for that program. So assuming that we conclude with an acceptance of that BLA in the near term, I think that'll be a first data point to support that that pathway is still viable and an active process in FDA.
Speaker Change: I think I'd also point to the.
Speaker Change: Eminent review.
Speaker Change: And the outcome of that.
Speaker Change: Hopeful acceptance of the $1 21.
Speaker Change: Program, I think that'll be sort of an early data point on accelerated approval as you know the Hunter program is following an accelerated approval pathway.
Speaker Change: In that case, we had.
Speaker Change: BLA meeting that was also supportive for that program. So assuming that we conclude with an acceptance of that BLA in the near term.
Speaker Change: That'll be a first data point to support that that pathway is still viable in.
Speaker Change: And active process and FDA.
Judah Frommer: Our next question comes from Judah Frommer with more comments. Your line is open. Yeah, hi, guys. Congrats on the progress. Thanks for taking the questions.
Speaker Change: Thank you. Our next question comes from Judah Frommer with Morgan Stanley. Your line is open.
Judah Frommer: Yes, hi, guys. Congrats on the progress. Thanks for taking my questions first I was just hoping we could get a little incremental color on the planning process, along with Abbvie for the diabetic retinopathy phase III trial, any updated thinking on timing or potential impacts to <unk>.
Judah Frommer: First, I was hoping we could get a little incremental color on the planning process along with Abby for the diabetic retinopathy phase three trial, any updated thinking on timing or potential impacts, the probability of recognizing that milestone, and then separately, just more broadly on interactions with FDA, given how many programs you have that you are interacting with them on. Any changes recently you'd point to or is it sort of business as usual and contact with the same individuals as you'd anticipate? Thank you. Thanks. Yeah, I think I can probably comment on the second question first, which is, we are actually having a pretty significant number of interactions with FDA, both on Submissions that have already been filed and information requests that are being provided.
Speaker Change: <unk> ability of recognizing that.
Judah Frommer: That milestone.
Judah Frommer: And then separately just more broadly on interactions with FDA given how many programs.
Judah Frommer: You have that you are interacting with them on any changes recently you'd point to or is it sort of business as usual and contact with the same individuals as you would anticipate thank you.
Judah Frommer: Thanks.
Speaker Change: Yes, I think I can probably comment on the second question first which is we.
Judah Frommer: We are actually having.
Judah Frommer: Pretty significant number of interactions with FDA both on.
Judah Frommer: Submissions that have already been filed and information requests that are being provided.
Curran Simpson: The only way I can really characterize it right now is that it is very much business normal. So without getting into detail on the type or the details of information requests, none of them are really questioning the broader strategy of the program or the clinical data that was provided. It's more customary questions about the CMC process, et cetera. So, you know, I think I just would characterize it as business normal. seem to be quite intact in terms of good continuity with the teams that we met with last year.
Judah Frommer: The only way I can really characterize it right now is that it is very much business normal so without getting into detail on the type or the details of information requests.
Judah Frommer: None of them are really questioning the broader strategy of the program or the clinical data that was provided it's more.
Judah Frommer: Customary questions about the CMC process et cetera. So.
Judah Frommer: I think I just would characterize it as <unk>.
Judah Frommer: Business normal.
Judah Frommer: The review teams.
Judah Frommer: Seem to be quite intact in terms of good continuity with the teams that we met with last year.
Curran Simpson: And like I said, with the Hunter program, we're going to have a very near-term outcome in terms of BLA acceptance, we hope, which will confirm that we're on track for a late fall potential approval. On DR, we are continuing to collect the final feedback, as we pointed to early in the year. AVI and we have obtained feedback from U.S., EU, Japan, regulatory agencies. As you know, in DR, there's choices to be made in terms of endpoints that have already been established, two steps worsening. Two steps improvement. So all of those are being considered as part of developing a final pivotal protocol.
Judah Frommer: And like I said with the Hunter program, we're going to have a very near term.
Judah Frommer: Outcome in terms of BLA acceptance, we hope which will confirm.
Judah Frommer: We're on track for a late fall potential.
Judah Frommer: Potential approval.
Speaker Change: And Dr. We are continuing to.
Speaker Change: Collect the final feedback as you as we pointed too early in the year.
Speaker Change: <unk>.
Speaker Change: Abbvie and we have obtained feedback from U S.
Speaker Change: EU, Japan regulatory agencies.
Speaker Change: As you know and Dr. There's choices to be made in terms of.
Speaker Change: End points that have already been established two steps worsening.
Speaker Change: Two steps improvement so all of those are being considered as part of developing a final pivotal protocol.
Curran Simpson: And once that's complete, we'll begin site activation, etc. We're still pointing towards first patient dose this year. And we'll be more specific on timing as we get near that event. Thank you.
Speaker Change: And once that's complete we will begin site activation et cetera, we're still pointing towards.
Speaker Change: First patient dose this year.
Speaker Change: And we'll be more specific on timing as we get near that event.
Ellie Merle: Our next question comes from Ellie Merle with UBS. Your line is open.
Speaker Change: Thank you. Our next question comes from Ellie Merle with UBS. Your line is open.
Ellie Merle: Hi guys, this is Tejasan for ELE. I guess just some of the incremental updates we can expect this year in DMD. So you mentioned some additional functional data in 1.8 . Am I correct in assuming that's not at ASGCT and then is there an arena you'd expect to present that at or should we expect to press release of that data? And then you also mentioned starting Commercial Supply Manufacturing later this year. You know, it's supply, but is it the same process that you're using in your current trials? And will you be able to provide any color on the CMC process with the FDA or any other meetings you might have on the statistical plan throughout the year?
Speaker Change: Hi, guys. This is tejas on for Ellie.
Speaker Change: Yes.
Speaker Change: Some of the incremental updates we can expect this year in DMD.
Speaker Change: Mentioned, some additional functional data in one H.
I correct in assuming that not.
Speaker Change: <unk>.
Speaker Change: Is there an arena you would expect to present that or should we expect a press release that data.
Speaker Change: And then you also mentioned starting.
Speaker Change: Commercial supply manufacturing later this year.
It's supply but is it the same process that youre using in your current trials and will you be able to provide any color on the CMC process at the FDA or any other means you might have on the statistical plan.
Curran Simpson: Thank you.
Speaker Change: Out the year.
Speaker Change: Thank you.
Curran Simpson: Sure. Let me start with the CMC process. So yes, we did point to initiation of commercial production this year. So that's a combined effort. Number one, the batches that are produced as part of our first commercial production are also batches that will be submitted as part of the plan mid-2026 BLA. And the process that will be validated as part of that exercise is the exact same process that's in the clinic today. So no changes anticipated to what patients are being dosed currently in our pivotal program as we move to our commercial process. And as we pointed out, we have a quite mature...
Speaker Change: Sure.
Speaker Change: Let me start with.
Speaker Change: The <unk>.
Speaker Change: CMC process. So yes, we did point to initiation of commercial production this year.
So that's a combined.
Speaker Change: Number one the batches that are produced as part of our first commercial production.
Speaker Change: Are also batches that will be submitted as part of the plan mid 2026 BLA.
Speaker Change: And the process Thats being will be.
Speaker Change: Alidade as part of that exercise is the exact same process. That's in the clinic today, So no changes.
Speaker Change: Anticipated to what patients are being dosed currently in our pivotal program.
Speaker Change: As we move to our commercial process and as we pointed out.
Speaker Change: We have a quite mature.
Curran Simpson: CMC approach off our platform, NavExpress process. which we think FDA will really regard highly. In fact, it's the same process that they've reviewed in other programs and actually toured on-site as part of FDA training in the last couple of years. So we feel really strongly that we have a very low-risk approach to CMC with a process that produces very high-purity capsid which FDA has been clear as an expectation and not any significant changes required to get to commercial in which we can produce 2,500 doses per year.
Speaker Change: CMC approach off our platform Nab expressed process.
Speaker Change: Which we think FDA will really regard highly in fact, it's the same process.
Speaker Change: That they've reviewed and other programs and actually toured on site as part of FDA training in the last couple of years. So we feel really strongly that.
Speaker Change: We have a very low risk approach to CMC with a process that produces very high purity capsid, which FDA has been cleared as an expectation.
And no not any significant changes required to get to commercial in which we can produce 2500 doses per year.
Curran Simpson: Back to the first question. In terms of data, so we expect so there's only I think six weeks left in first half 25. I think you could expect likely a press release around the additional data and the focus of the data will really be on expanding the dose level two patients that were treated in the phase one, two study out to 12 months. So a larger number of patients out that far and showing all the same functional outcomes that we did in November. So, just trying to enlarge the data set there and as well, update on any biomarker data that may have come in recently, but it really will be focusing on the pivotal level dose and how those patients are doing.
Speaker Change: Back to the first question.
Speaker Change: In terms of data so we expect so theres only.
Speaker Change: I think six weeks left in first half 'twenty five I think you could expect likely a press release around the additional data and the focus of the data will really be on expanding the dose level two patients that were treated in the phase one two study.
Speaker Change: Out to 12 months, so a larger number of patients out that far.
Speaker Change: And showing all the same functional outcomes that we did in November.
Speaker Change: So just trying to enlarge the data set there.
Speaker Change: And as well update on any biomarker data that may have come in recently, but it really will be focusing.
Speaker Change: On.
Speaker Change: The pivotal level dose and how those patients are doing and I think just in general the feedback we're getting from sites and from investigators is really positive right now.
Curran Simpson: And I think just in general, the feedback we're getting from sites and from investigators is really positive right now.
Curran Simpson: Thanks. And just quickly, those pivotal dose patients in the Phase 1-2 will be included in the pivotal data set for filing in NID 26, correct? Yeah, all patients that qualify for the inclusion criteria of the Pivotal program would be included in the Pivotal data set. Thanks.
Speaker Change: Thanks, and just quickly those pivotal dose patients in the phase <unk> will be included in.
Speaker Change: Pivotal data that for filing in mid 2000 X correct.
Speaker Change: Yes, all patients that qualify for the inclusion criteria of the pivotal program would be included in the pivotal dataset.
Speaker Change: Thank you.
Annabel Samimy: Our next question comes from Annabel Samimy with Stiefel. Your line is open. Hi, thanks for taking my question. Just to go back to regulatory bodies and changes there, just given the FDA's focus on safety with gene therapy, I guess we've been talking a lot about the rare conditions and how Macaria is very focused on the rare diseases and life-threatening conditions. Does that make it potentially harder for gene therapy in non-life-threatening conditions like retinal disease, for example? And are there any issues related to that for the DR indication, any delays there?
Speaker Change: Thank you.
Next question comes from Annabel <unk> with Stifel. Your line is open.
Speaker Change: Hi, Thanks for taking my question.
Speaker Change: Just to go back to <unk>.
Jorge: This is jorge.
Jorge: Bodies and changes there.
Jorge: Just given the Fda's focus on safety with gene therapy.
Jorge: I guess, we've been talking a lot about the rare conditions.
Speaker Change: I'm curious are you focused on the rare diseases and life threatening conditions does that make it potentially.
Speaker Change: Harder for gene therapy in non life threatening conditions like retinal disease for example.
Speaker Change: And are there any issues related to that for the Dr indication any delays there.
Curran Simpson: And then one last question regarding regulatory bodies. RFK Jr. just asked the HHS Committee on Genetic Screening, so can you tell us how this might affect not MPS but rather DMD in trying to get into the younger population and whether there are any complications there? Thanks.
Speaker Change: Then one last question regarding regulatory bodies.
Speaker Change: Alright, Okay Junior just ask.
Speaker Change: HHS committee on genetic screening so can you tell us how this might affect.
Speaker Change: Not MTS, but rather in DMD and trying to get into the younger population and whether there are any complications there. Thanks.
Curran Simpson: Sure, I can take the second one.
Speaker Change: Sure I can take the second one, but I think maybe first.
Curran Simpson: But I think maybe first, I'll let Steve comment on whether or not we're seeing any change in FDA stance regarding retinal programs. But I think that what I would convey before Steve speaks is, I think we know that safety in non-rare is an absolute focus. And I think that's probably the incredible promise of the subretinal program. The safety profile in the data that we've seen today looks excellent. Maybe I'll let Steve elaborate on that a little bit.
Steve Nicola: I'll, let Steve comment on <unk>.
Steve Nicola: Whether or not we're seeing any change in FDA stance regarding retinal programs, but I think what.
Speaker Change: What I would convey before Steve Speakes's.
Speaker Change: I think we know that safety in non rare.
Speaker Change: Is an absolute focus and I think thats probably.
Speaker Change: The incredible promise with the sub retinal program the safety profile in the data that we've seen today.
Speaker Change: Looks excellent maybe I'll, let Steve elaborate on that a little bit.
Stephen Pakola: Sure.
Stephen Pakola: Hi, Annabel. So on retina, I think another broad aspect is That's not an accelerated approval pathway. So there's not a request for greater flexibility. So fortunately, there we know the regulatory route, and we're already executing on that, for example, in subretinal. And we have a plan to do the same in supracaroidal. On the safety side, just as Curran mentioned, we feel very good about the safety package that we'll have for subretinal and supracaroidal. And that's because we've intentionally selected routes of administration for 314 that are compartmentalized and that decrease the risk of the types of safety findings, specifically inflammation, that have really hounded other routes of administration like intravitreal.
Steve Nicola: Sure Hi, Annabel.
Speaker Change: So on retina I think another broad aspect is that's not an accelerated approval pathway. So there's not a request for greater flexibility.
Steve Nicola: Fortunately there.
Speaker Change: The regulatory route and we're already executing on that for example in sub retinal and we have a plan to do the same in Super Choroidal on the safety side, just as current mentioned.
Speaker Change: We feel very good about the safety package that we'll have for sub retinal and Super Choroidal and Thats because we have been intentionally selected routes of administration for <unk>.
Speaker Change: <unk> four that are compartmentalize them that decrease the risk of the types of safety finding specifically inflammation that have really founded other routes of administration like Intrepid trail. So.
Stephen Pakola: So we feel very well set up, not only in our rare programs, but also in the common retina indications that we're looking at when it comes to safety.
Speaker Change: We feel very well set up.
Speaker Change: Not only in our rare programs, but also in the common retina indications that we're looking at when it comes to safety.
Curran Simpson: And Annabel, to come back to the question on genetic screening, newborn screening, we're working closely with the MPS Society and with Duchenne advocacy groups on newborn screening, and their approach largely is at a state level to advance and increase the number of states that provide that. So I think it would be ideal if all entities were working together in concert on that, but that doesn't mean that if one group is not supporting it, the others won't be able to fill that gap and move forward. So we see that as a priority in rare disease, and it's something we'll work with the advocacy groups to support.
Annabel: And Annabel.
Speaker Change: Come back to the question on.
Annabel: Genetic screening newborn screening.
Annabel: We're working closely with the MPS society, and with Duchenne advocacy groups on newborn screening and approached largely is at a state level.
Annabel: To advance.
Annabel: <unk> increased the number of states that provide that.
Annabel: I think it would be ideal if all entities. We are working together in concert on that but that doesn't mean that if one group is not supporting at the others won't be able to fill that gap and move forward. So we see that as.
Annabel: Priority in rare disease, and it's something we will work with advocacy groups to support.
Annabel Samimy: Okay, if I can just ask one quick follow up to be clear on the last question about ASGCT, you will not be presenting functional data there, correct? I understood it to be a PR within the next six weeks. Yeah, yeah, we're, yeah, it will not be at ASGCT. So no need to book your flight. We'll, we'll definitely likely provide that as a press release in the near term. Great, thank you.
Annabel: Okay, and if I can just ask one quick follow up to be clear on the last question about <unk>.
Speaker Change: You will not be presenting functional data there correct.
Understood it to be a PR within the next six weeks.
Speaker Change: Yes, yes.
Speaker Change: Yes, it will not be at <unk>, So no need to book your flight.
Speaker Change: Well definitely.
Speaker Change: We provide that is.
Speaker Change: Press release in the near term.
Speaker Change: Okay, great. Thank you.
Alec Stranahan: Our next question comes from Alec Stranahan with Bank of America. Your line is open. Hey guys, thanks for taking our questions.
Speaker Change: Thank you.
Speaker Change: Our next question comes from Alex Stranahan with Bank of America. Your line is open.
Speaker Change: Hey, guys. Thanks for taking our questions. This is Matthew on for Eric maybe.
Matthew: This is Matthew on for Alec. Maybe just double clicking on a previous point. Has there been any change in baseline characteristics, patient age, etc, that you've seen for the DMD trial? And then maybe second What's the percentage purity for your preps that you're comfortable with or looking for, you know, sort of as you're moving forward with manufacturing?
Speaker Change: Maybe just double clicking on a previous point.
Speaker Change: Has there been any change in.
Speaker Change: Baseline characteristics patient age et cetera that you've seen for the DMD trial, and then maybe second.
Speaker Change: What's the percentage of purity for your perhaps that you are comfortable with are looking for sort of pressure moving forward with manufacturing.
Curran Simpson: Yeah, we actually, that is something that will be shown at ASGCT. We have a presentation on the CMC process that I think will give quite a nice level of detail for people to see. We're very proud of it. But the purity level for the product is 80% or greater. And I think just as important, consistency between batches, which we've heard others struggle with, is also highly consistent. So that's what we would point to.
Speaker Change: Yes, we actually that is something that will be shown at <unk>. We have a presentation on the CMC process that I think will give quite a nice level of detail for people to see.
Speaker Change: We're very proud of it but the purity level.
Speaker Change: For the product is 80% or greater and I think just as important.
Speaker Change: Consistency between batches, which we've heard others struggle with.
Speaker Change: Is also highly consistent between batches so.
Speaker Change: That's what we would point to terms of I think your question was around enrollment of the pivotal study.
Curran Simpson: In terms of, I think your question was around enrollment of the pivotal study. We're quite pleased so far with not just the pace of enrollment, but the breadth of patient ages that are enrolling in the study to date. So as we look at it today, and as we look out towards the remainder of the year, we feel like we will have a very balanced number of patients across the ages to support a broad label when we file. Thank you.
Speaker Change: We're quite pleased so far with not just the pace of enrollment.
Speaker Change: But the breath of patients ages.
Speaker Change: We're enrolling in the study to date so as.
Speaker Change: As we look at it today and as we look out towards the remainder of the year, we feel like we'll have a very balanced.
Speaker Change: Number of patients across the ages to support a broad label when we file.
Luca Issi: Our next question comes from Luca Issi with RBC Capital Markets. Your line is open. Oh, great. Hi, team.
Speaker Change: Thank you. Our next question comes from Luca <unk> with RBC capital markets. Your line is open.
Shelby: This is Shelby on for Luca, and thanks for taking the question. Maybe on wet AMD subretinal, you have shown recently that the fellow eye can be treated safely, confirming that the eye is somewhat immune privileged. Are you planning on filing that data? And is your initial label going to reflect bilateral dosing? Any color there, much appreciated.
Speaker Change: Okay, Hi team. This is <unk> on for Luka and thanks for taking the question maybe on wet AMD sub retinal you have some recently that the fellow eye can be treated safely.
Speaker Change: Permian is somewhat immune privilege are you planning on filing that data and is your initial label going to reflect bilateral dosing any color there much appreciate it. Thanks.
Stephen Pakola: Hi, Shelby. Nice to see you.
Speaker Change: Hi, Shelby nice to see.
Stephen Pakola: Steve has is part of the joint development committee that plans sort of the strategy around the file is maybe he can comment on that question. Sure. Hi, Shelby. Great question. This is actually something that we prospectively address Even as early as our end of phase two meeting, because It's very relevant in wet AMD, where most patients do have bilateral disease. So it would be very advantageous if both eyes ultimately could be treated. And we, again, always saw that are safer routes of administration, where you would expect less immune response would be more amenable to being able to treat both eyes.
Steve Nicola: Steve has as part of the joint Development Committee that plans.
Speaker Change: Sort of the strategy around the filings maybe he can comment on that question.
Speaker Change: Sure Hi, Hi shall be great question.
Speaker Change: This is actually something that we prospectively addressed.
Speaker Change: Even as early as our end of phase II meeting because it is very relevant in wet AMD, where most patients do have bilateral disease. So.
Speaker Change: Would be very advantageous if both eyes ultimately could be treated and we again always saw that are safer routes of administration, where you would expect less immune response would be more amenable to being able to treat both eyes and that's why we.
Stephen Pakola: And that's why we prospectively address this explicitly with the FDA. And that's what led to our fellow eye study. And as you mentioned, we're, we're seeing. That we're in a good position as far as fellow eye. So yes, I confirm that that's certainly our intent that this is certainly part of any package that would go in that would inform clinicians on being able to treat both eyes. Thank you.
Speaker Change: <unk> addressed this explicitly with the FDA and that's what led to our fellow steady.
Speaker Change: And as you mentioned we're seeing.
Speaker Change: That we're in a good position as far as fellow eyes. So, yes, I confirm that Thats certainly our intent that this is certainly part of.
Speaker Change: Any package that would go in that would inform clinicians on being able to treat both eyes.
Paul Choi: Our next question comes from Paul Choi with Goldman Sachs. Your line is open. Hi, thank you. Good afternoon. And thanks for taking our questions.
Speaker Change: Thank you. Our next question comes from Paul Choi with Goldman Sachs. Your line is open.
Paul Choi: Hi, Thank you good afternoon, and thanks for taking our questions.
Curran Simpson: I would ask first on RGX 121 at Hunters with the imminent your expectations of an imminent acceptance of your BLA. I just want to see if you're also potentially assuming an adcom given that this could potentially be the first approved gene therapy for for the condition. And then second, regarding the RDX202 Duchenne Phase 1, Phase 1.2 functional data update that you referenced earlier, can you maybe just comment on, again, how many patients we expect follow up for and how current the data cut might potentially be for that functional update that's coming up soon? Thank you.
Paul Choi: I want to ask first on RG, one tier one hunters with the.
Paul Choi: Imminent.
Paul Choi: Expectations of an eminent acceptance of your BLA I just wanted to see if youre also potentially assuming an AD com given that this could potentially be the first approved gene therapy for the condition.
Paul Choi: And then second.
Paul Choi: Regarding the <unk> 202, Duchenne phase one.
Paul Choi: I just wanted to functional data update that you've referenced earlier can you maybe just comment on how many patients should we expect a follow up for Ed.
Paul Choi: Our current data cut might potentially be for that functional update that's coming up soon thank you.
Curran Simpson: Sure. Yeah, I can comment on the first question around adcom. We are planning as if we need an adcom from an internal perspective. We have a team working on being ready for that, should it be requested. We don't have a final answer from FDA as to whether one is required yet. Initial discussions were hinting towards no, but we're waiting to get confirmation one way or another through the review process. But we will be prepared if one is needed ahead of time.
Speaker Change: Sure, Yes, I can comment on the first question around AD Com, we are planning as if we need an AD com from an internal perspective, we have.
Speaker Change: Team working on being ready for that should it be requested we don't have a final answer from FDA as to whether one is required yet.
Initial discussions were hinting towards no.
Speaker Change: But we're waiting to get confirmation, one way or another through the review process, but we will be prepared if one is needed.
Curran Simpson: For 202, in terms of Coming back to Oh, I'm sorry. Yeah, about the next upcoming functional release. So we are planning on enlarging the data set to four, possibly five patients dosed at DL2 as part of the functional update. Not all of them may be out to 12 months, but minimally they would be out to nine months. And so that's still something that we're pulling together, QCing the data and looking forward to getting out before the first half of the year. Okay, great. Thank you for that. Thank you.
Speaker Change: Ahead of time.
Speaker Change: For 202.
Speaker Change: In terms of.
Speaker Change: Just.
Speaker Change: Coming back to.
Speaker Change: Oh, I'm, sorry, yes about the.
Speaker Change: Next upcoming functional release.
Speaker Change: So we.
Speaker Change: Our.
Speaker Change: Planning on.
Speaker Change: Enlarging the dataset to four possibly five.
Speaker Change: Ah patients dosed at Dl too as part of the functional update.
Speaker Change: Not all of them may be out to 12 months, but minimally they would be out to nine months and so.
Speaker Change: It's still something that were.
Speaker Change: Pulling together of QC ing, the data and looking forward to getting out before the first half.
Speaker Change: The year.
Speaker Change: Okay, great. Thank you for that.
Luke: Our next question comes from Brian Skorney with Baird. Your line is open.
Speaker Change: Thank you. Our next question comes from Brian <unk> with Baird. Your line is open.
Luke: Hi, this is Luke on for Brian. Thanks for the question. Sorry if this was already asked, but on the 202 commercial build out, has the team set a goal for the quantity of product that you expect to be available by the time of a potential launch? It's a great question. We're actually going through that process of review now as we evaluate our commercial strategy in total. I would just remind you that in the course of one year, we can produce 2,500 doses. We'll come to a point as we get closer to review of the BLA to talk a little bit more about how many doses we would have at launch.
Speaker Change: This is Luke on for Brian. Thanks for the question sorry. If this was already asked but on the two are two commercial build out has the team set a goal for the quantity of product that you expect to be available by the time of a potential launch.
Speaker Change: It's a great question, we're actually going through that process of a review now as we evaluate our commercial strategy in total.
Speaker Change: I would just remind you that in the course of one year, we can produce 2500 doses.
Speaker Change: And so we will come to a point.
Speaker Change: As we get closer to.
Speaker Change: The review of the BLA to talk a little bit more about how many doses. We would have at launch we would certainly want to be in a position to quickly address the prevalent market.
Curran Simpson: We would certainly want to be in a position to quickly address the prevalent market with a significant number of doses. We would estimate the prevalent market could be in the ambulatory side of the market something in the order of 5,000 to 7,000 patients, and we would want to be prepared to quickly be able to address that market. We'll get more specific on the number of doses available at launch, but we're in a unique position to be able to build a significant amount of inventory ahead of 2027.
Speaker Change: With a significant number of doses we would estimate.
Speaker Change: The prevalent market could be in the ambulatory.
Speaker Change: Side of Av.
Speaker Change: The market.
Speaker Change: Something in the order of $5 to 7000 patients and we would want to be prepared.
Speaker Change: To quickly be able to address that market. So we will get more specific on number of doses available at launch but.
Speaker Change: We're in a unique position to be able to build a significant amount of inventory ahead of 2027.
Stephen Pakola: Great, thanks. And just one more quick one. On your 314 wet AMD studies, has the availability of Pavlu impacted enrollment pace at all? Or are these generally unique groups of patients and indications? Thanks for that one.
Speaker Change: Great. Thanks, and just one more quick one on your 314 wet AMD studies has the availability of pathway will impacted enrollment pace at all or are these generally unique groups of patients in the indication.
Stephen Pakola: I think I'll ask Steve. He's a little closer to that particular question. Yeah, across different agents that are out there either on the market or investigational. We over time haven't seen any of that impact our recruitment. So we're at a good clip. So that's why we keep reiterating our guidance. So we're excited to finish enrollment this year excited to have top line results next Awesome, thank you.
Speaker Change: Thanks for that one I think I'll ask Steve He's a little closer to that particular question.
Speaker Change: Yes.
Speaker Change: Across different.
Speaker Change: Agents that are out there either on the market or investigational, we over time have seen any of that impact our recruitment. So we're at a good clip. So thats why we keep reiterating our guidance. So we're excited to finish enrollment this year.
Speaker Change: Cited to have topline results next year.
Speaker Change: Awesome. Thank you.
Sean McCutcheon: Thank you. Our next question comes from Sean McCutcheon with Raymond James. Your line is open.
Speaker Change: Thank you. Our next question comes from Sean Mccutcheon with Raymond James Your line is open.
Stephen Pakola: Hey guys, thanks for taking the question. Just to build on wet AMD, can you provide some detail on how you're thinking about the super paroidal opportunity? Obviously, we're looking forward to the start of the NPDR phase three, but I think, you know, we're all curious on the dose necessary to move forward in wet AMD, and how you're thinking about that value proposition on the heels of subretinal. Thanks.
Sean McCutcheon: Hey, guys. Thanks for taking the question just to build on wet AMD can you provide some detail on how youre thinking about the Super Choroidal opportunity. Obviously, we're looking forward to the start of the NPR phase III, but I think we're all curious on the dose necessary to move forward in wet AMD and how youre thinking about that value proposition on the heels of a sub right.
Speaker Change: Thanks.
Speaker Change: Yeah.
Hi, I think I'll let Steve answer that question. Here, so this is obviously a massive market. So if you look at the the retina space driven by the anti VEGF anti VEGF Target mechanism and treatments thereof, we're at 18 billion and continuing to grow. So I think there's a lot of opportunity across the VEGF driven retinopathies. We in AbbVie are advancing, as we were just saying, on the subretinal global program for wet AMD. So we're obviously excited about subretinal delivery for that indication. We do see increased optionality and opportunities with the one-time in-office supracaroidal. And that's why we both are advancing in that space.
Speaker Change: Hi, I think I'll, let Steve answer that question.
Steve Nicola: Sure. So this is obviously a massive market.
Speaker Change: You look at.
Speaker Change: The retina space driven by the anti that Jeff.
Speaker Change: Target mechanism and treatments thereof, we're at $18 billion.
Speaker Change: <unk> to grow so.
Speaker Change: I think there's a lot of opportunity across the VEGF driven retinal disease, we and Abbvie are.
Speaker Change: Advancing as we were just saying on the sub retinal global program for wet AMD. So we're obviously excited about sub retinal delivery for that indication.
Speaker Change: We do see increased optionality and opportunities with the one time, an office Super Choroidal and Thats why we both are advancing in that space I think Dr. In particular is compelling when you consider the reality that patients with <unk>.
I think DR in particular is compelling when you consider the reality that patients with non-proliferative diabetic retinopathy who have not developed the site-threatening complications like DME and like proliferative disease, that these patients really are going to need an in-office one-time treatment option that even if you have greater durability agents, if you're going to need repeat injections indefinitely for the rest of your life, that's not going to be a very compelling opportunity. So that's why we in AbbVie are so excited about the opportunity of a one-time in-office treatment to really address that unmet need of DR. Thank you.
Speaker Change: Non proliferative diabetic retinopathy, who have not developed the sight threatening complications.
Speaker Change: Like DMV.
Speaker Change: And like proliferative disease that these patients really are going to need it.
Speaker Change: <unk> onetime treatment option that even if you have greater durability.
Speaker Change: <unk>, if youre going to need repeat injections indefinitely.
Speaker Change: For the rest of your life, that's not going to be a very compelling opportunity. So that's why we and Abbvie are are so excited about the opportunity of a one time in office treatment to really address that unmet need is of Dr.
Speaker Change: Thank you.
Thank you.
As a reminder, to ask a question, please press star 1.
Speaker Change: Sure.
Speaker Change: Thank you as a reminder to ask a question. Please press star one.
Our next question comes from Yi Chen with H.C.
Speaker Change: Our next question comes from <unk>, Chen with H C Wainwright and company. Your line is open.
Wainwright & Company. Your line is open. Hi there, good afternoon. This is Eduardo on for Yi.
Eduardo: Hi, there. Good afternoon. This is eduardo on for you just a quick question. If you had any thoughts on the recent announcement about.
Just a quick question if you had any thoughts on the recent announcement about This morning, I think the last night about potential pricing on branded drugs, that you feel like that's going to have a significant impact on your ability to price your gene therapies across these indications. Yeah, I think it's it's early to tell. I think the if you look at some of the commentary by John Crowley from bio, or the Alliance for Regenerative Medicine, I think that initially, the impact to cell and gene therapy in general, might be less than could be for broader branded therapies It's too early to tell, so I think we, you know, from our perspective, there's no immediate impact to anything that we're doing, but certainly something we have to pay attention to in sort of the macro environment as we get closer to an approval.
Eduardo: This morning, I think the last night about potential pricing on branded drugs.
Speaker Change: That do you feel like Thats going to have a significant impact on your ability to price your gene therapies across these indications.
Speaker Change: Yes, I think it's early to tell.
Speaker Change: Think the.
Speaker Change: You look at some of the commentary by John Crowley from bio.
Speaker Change: Or the alliance for regenerative Medicine, I think that initially the impact to cell and gene therapy in general.
Speaker Change: It might be less than could be for.
Speaker Change: Broader branded therapies.
Speaker Change: It's too early to tell so I think we from.
Speaker Change: From our perspective, there is no immediate impact to anything that we're doing.
Speaker Change: But certainly something we have to pay attention to and sort of the macro environment as we get closer to an approval.
Got it. Thanks. That's really helpful. Thank you. I'm showing no further questions at this time.
Speaker Change: Got it thanks, that's really helpful.
Speaker Change: Thank you I'm showing no further questions at this time. This does conclude the question and answer session and you may now disconnect everyone enjoy the rest of your day.
This does conclude the question and answer session and you may now disconnect.
Everyone, enjoy the rest of your day.
Speaker Change: Okay.
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Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: [music].
Speaker Change: Thank you.
Speaker Change: [music].
Speaker Change: Okay.