Berlin, Germany, and Cambridge, MA, USA September 30, 2026 – Bayer AG and its wholly owned, independently operated subsidiary 91����, a clinical stage cell therapy company, today announced that its investigational cell therapy, lemiretprocel (OpCT-001), has received orphan drug designations from the U.S. FDA and the EU EMA. U.S. FDA designations are for treating retinitis pigmentosa and cone-rod dystrophy. EU EMA designations are for treating both syndromic and non-syndromic inherited retinal disorders (IRDs) of the rod-dominant phenotype and non-syndromic IRDs of the cone-dominant phenotype.

Lemiretprocel (OpCT-001) is an investigational induced pluripotent stem cell (iPSC)-derived cell therapy being tested in a Phase 1/2a clinical study (CLARICO) for the treatment of primary photoreceptor diseases, which are a subgroup of inherited retinal disorders that include retinitis pigmentosa, Usher syndrome, and cone-rod dystrophy.¹�� Lemiretprocel (OpCT-001) aims to restore vision in people living with primary photoreceptor diseases by replacing lost cells in the retina with new functional cells.

“Receiving these designations from the U.S. FDA and the EU EMA is a notable step forward for lemiretprocel,” said Amit Rakhit, MD, MBA, 91����’s Chief Medical Officer. “We believe that lemiretprocel has great promise as a potential therapeutic option for restoring vision in people living with primary photoreceptor diseases and look forward to continuing to work with health authorities on its clinical development.”

“Together with 91����, we are progressing the first-ever clinical trial for an iPSC-derived cell therapy in primary photoreceptor diseases,” said Christian Rommel, Executive Vice President and Global Head of Research and Development of the Pharmaceuticals Division at Bayer. “Receiving orphan drug designations from both the FDA and EMA recognizes lemiretprocel’s potential to address a wide range of inherited retinal disorders for patients that currently have very limited treatment options.”

Lemiretprocel (OpCT-001) is an investigational cell therapy that has not been approved by any regulatory authority, and its efficacy and safety have not been established or fully evaluated. Lemiretrpocel is the International Nonproprietary Name for OpCT-001 as acknowledged by the World Health Organization.²

¹; ;

²

About the CLARICO study
CLARICO is a Phase 1/2a first-in-human, multisite, 2-part interventional study to evaluate the safety, tolerability, and the effect on clinical outcomes of OpCT-001 in up to approximately 54 adults with primary photoreceptor disease. Phase 1 will focus on safety and features a dose-escalation design. Phase 2 is designed to gather additional safety data and assess the effect of OpCT-001 on measures of visual function, functional vision, and anatomic measures of engraftment in different clinical subgroups. Phase 1 will include 4 planned dose levels to be administered across 4 cohorts (Cohorts 1 through 4). Dose escalation in Phase 1 will be conducted using a standard 3+3 scheme in which a total of 12 to 24 legally blind participants (~3 to 6 per cohort) will receive escalating doses of OpCT-001 after acceptable safety signals with the prior lower dose. Phase 2 is planned to enroll a maximum of 30 participants across 2 cohorts (Cohorts 5 and 6) to evaluate 2 dose levels of OpCT-001 that will be selected based on Phase 1 safety and tolerability data. Phase 2 participants will be randomized 1:1 to either Cohort 5 or Cohort 6. Phase 2 participants and the investigator/study site personnel outside of the surgical team will be masked to OpCT-001 dose assignments. Further details of the trial can be found at (NCT06789445).

About 91����
91���� is a clinical stage cell therapy company focused on creating cellular medicines to treat devastating diseases. We are harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases. Two of our novel investigational cell therapies, bemdaneprocel (BRT-DA01) for the treatment of Parkinson’s disease and OpCT-001 for the treatment of primary photoreceptor diseases are clinical stage programs. Bemdaneprocel has RMAT (Regenerative Medicine Advanced Therapy) and Fast Track designation from the US FDA (Food and Drug Administration) and is being tested in a Phase 3 clinical trial, exPDite-2. OpCT-001 has Fast Track designation from the FDA and is being tested in a Phase 1/2a clinical trial, CLARICO. 91���� was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer, the impact investing arm of Bayer AG that invests in paradigm-shifting breakthrough innovation. In late 2019, 91���� became a wholly owned, independently operated subsidiary of Bayer AG. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves. For more information, visit .

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to support efforts to master major challenges presented by a growing and aging global population and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to .

Bayer Global Media Contact:
Kathryne Delves-Broughton, phone +33 6 02180163
Email: kathryne.delvesbroughton@bayer.com

91���� Media Contact:
Jeff Lockwood, phone +1 (617) 5106997
Email: jlockwood@bluerocktx.com

Find more information at .

Forward-Looking Statements 91���� Therapeutics
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “plan,” and “intend,” among others. These forward-looking statements are based on 91����’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the initiation, timing, progress, activities, goals and reporting of results of any preclinical programs and clinical trials and research and development programs, the potential benefits, timing and future operation of the agreements with FUJIFILM Cellular Dynamics and Opsis Therapeutics, the ability to advance therapies into, and successfully initiate, enrol and complete clinical trials, the potential clinical utility of product candidates, the regulatory pathway of, and the timing or likelihood of any regulatory filings and approvals for, any product candidates, and the ability to, and extent of, potentially commercializing any product candidate, are forward looking. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Except as expressly required by law, 91���� does not undertake an obligation to update or revise any forward-looking statement. All of 91����’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date hereof.

Forward-Looking Statements Bayer AG
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

The post 91���� Therapeutics’ investigational cell therapy lemiretprocel (OpCT-001) for primary photoreceptor diseases granted orphan drug designations by FDA and EMA appeared first on 91����.

Berlin, Germany, and Cambridge, MA, USA��January 22, 2026��– Bayer AG and its wholly owned, independently operated subsidiary 91����, a clinical stage cell therapy company, today announced that its investigational cell therapy, OpCT-001, has received Orphan Drug Designation from the U.S. FDA for treating retinitis pigmentosa (RP).����

OpCT-001 is an investigational induced pluripotent stem cell (iPSC)-derived cell therapy being tested in a Phase 1/2a clinical study (CLARICO) for the treatment of primary photoreceptor diseases, which are a subgroup of inherited retinal disorders that include retinitis pigmentosa and cone-rod dystrophy. Retinitis pigmentosa is one of the most common types of inherited retinal diseases��characterized by the loss of rod and cone cells, known together as photoreceptor cells.��OpCT-001 aims to restore vision in people living with RP by replacing lost cells in the retina with new functional cells.��

“Receiving Orphan Drug Designation for retinitis pigmentosa is an important milestone for the OpCT-001 program,” said Amit��Rakhit, MD, MBA,��91����’s��Chief Medical Officer. “We believe that OpCT-001 has great promise as a potential therapeutic option for restoring vision in people living with retinitis pigmentosa and other primary photoreceptor diseases and look forward to continuing to work with the FDA on its clinical development.”��

Orphan Drug Designation is given to drugs and biologics for the prevention, diagnosis, or treatment of diseases or conditions affecting fewer than 200,000 persons in the U.S.¹����

“The FDA’s Orphan Drug Designation for OpCT-001 to treat retinitis pigmentosa��underscores the importance of developing urgently needed innovative therapies for patients living with��inherited retinal disorders,” said Christian Rommel, Executive Vice President and Global Head of Research and Development of the Pharmaceuticals Division at Bayer. “Together with 91����, we are excited to be advancing the first-ever clinical trial for an iPSC-derived cell therapy in��primary photoreceptor diseases.”��

OpCT-001 is an investigational cell therapy that has not been approved by any regulatory authority, and its efficacy and safety have not been established or fully evaluated.��

¹;��;

About CLARICO��
CLARICO is a Phase 1/2a first-in-human, multisite, 2-part interventional study to evaluate the safety, tolerability, and the effect on clinical outcomes of OpCT-001 in up to approximately 54 adults with primary photoreceptor disease. Phase 1 will focus on safety and features a dose-escalation design. Phase 2 is designed to gather��additional��safety data and assess the effect of OpCT-001 on measures of visual function, functional vision, and anatomic measures of engraftment in different clinical subgroups. Phase 1 will include 4 planned dose levels to be administered across 4 cohorts (Cohorts 1 through 4). Dose escalation in Phase 1 will be conducted using a standard 3+3 scheme in which a total of 12 to 24 legally blind participants (~3 to 6 per cohort) will receive escalating doses of OpCT-001 after acceptable safety signals with the prior lower��dose. Phase 2 is planned to enroll a maximum of 30 participants across 2 cohorts (Cohorts 5 and 6) to evaluate 2 dose levels of OpCT-001 that will be selected based on Phase 1 safety and tolerability data. Phase 2 participants will be randomized 1:1 to either Cohort 5 or Cohort 6. Phase 2 participants and the investigator/study site personnel outside of the surgical team will be masked to OpCT-001 dose assignments. Further details of the trial can be found at����(NCT06789445).��

About 91����
91���� is a clinical stage cell therapy company focused on creating cellular medicines to treat devastating diseases. We are harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases. Two of our novel investigational cell therapies,��bemdaneprocel��(BRT-DA01) for the treatment of Parkinson’s disease and OpCT-001 for the treatment of primary photoreceptor diseases are clinical stage programs.��Bemdaneprocel��has RMAT (Regenerative Medicine Advanced Therapy) and Fast Track designation from the US FDA (Food and Drug Administration) and is being tested in a Phase 3 clinical trial, exPDite-2. OpCT-001 has��Fast��Track designation from the FDA and is being tested in a Phase 1 clinical trial, CLARICO. 91���� was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer, the impact investing arm of Bayer AG that invests in paradigm-shifting breakthrough innovation. In late 2019, 91���� became a wholly owned, independently operated subsidiary of Bayer AG. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves. For more information, visit��www.bluerocktx.com.��

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact��with��its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust,��reliability��and quality throughout the world. In fiscal 2024, the Group employed around��93,000 people��and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to��.��

Bayer Global Media Contact:
Dr. Imke Meyer, phone��+49 (214) 60001275
Email:��imke.meyer@bayer.com��

Kathryne Delves-Broughton, phone +33 6 02180163
Email:��kathryne.delvesbroughton@bayer.com��

91���� Media Contact:
Jeff Lockwood, phone +1 (617) 5106997
Email:��jlockwood@bluerocktx.com
Find more information at��.��

��

Forward-Looking Statements��91���� Therapeutics
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be��identified��by the use of��forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “plan,” and “intend,” among others. These forward-looking statements are based on��91����’s��current expectations and actual results could differ materially. There are��a number of��factors that could cause actual events to differ materially from those��indicated��by such forward-looking statements. These factors include, but are not limited to, the initiation, timing, progress, activities, goals and reporting of results of any preclinical programs and clinical trials and research and development programs, the potential benefits, timing and future operation of the agreements with FUJIFILM Cellular Dynamics and��Opsis��Therapeutics, the ability to advance therapies into, and successfully initiate,��enroll��and complete clinical trials, the potential clinical utility of product candidates, the regulatory pathway of, and the timing or likelihood of any regulatory filings and approvals for, any product candidates, and the ability to, and extent of, potentially commercializing any product candidate, are forward looking. As with any pharmaceutical under development, there are significant risks in the development, regulatory��approval��and commercialization of new products. Except as expressly required by law, 91���� does not undertake an obligation to update or revise any forward-looking statement.��All of��91����’s��forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth��herein��speaks only as of the date hereof.

Forward-Looking Statements��
This release may��contain��forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks,��uncertainties��and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at��. The company assumes no liability whatsoever to update these forward-looking statements or to conform��them to future events or developments.����

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• Parkinson’s disease affects approximately��10 million people��worldwide��and��250,000��in Japan��

Berlin, Germany and Cambridge, MA, USA,��December 17,��2025��–��Bayer AG and its wholly owned, independently operated subsidiary 91����, a clinical stage cell therapy company, today announced that the investigative cell therapy��bemdaneprocel, has received��Pioneering Regenerative Medical Product designation (SAKIGAKE)��from Japan’s Ministry of Health,��Labor��and Welfare (MHLW.) A drug candidate that receives Sakigake designation may be eligible for more frequent interaction with the MHLW to discuss the drug candidate’s development plan as well as eligibility for accelerated approval and priority��review, if��relevant criteria are met. ��

“We are honored that��bemdaneprocel��has received Sakigake designation in Japan, recognizing the urgent need for new and innovative treatment options for people living with this debilitating condition,” said Gabi Belfort, MD��PhD��and��Bemdaneprocel��Product Lead at 91���� Therapeutics. “This designation will allow us to work closely with Japan’s regulators to advance our therapy as efficiently as possible and bring new hope to people��living with Parkinson’s disease��and their families.”��

Parkinson’s disease is the world’s second leading neurodegenerative disease, affecting approximately��10 million people��worldwide and��250,000��in Japan.��

“Receiving the Sakigake designation for��bemdaneprocel��highlights its potential to change how we approach Parkinson’s disease treatment,” said Christian Rommel, PhD and Global Head of Research and Development for Bayer’s Pharmaceuticals Division. “Our collaboration with the Japanese regulatory authority reflects��our��dedication to partnering with healthcare systems��and regulators��worldwide. Together, we aim to improve patient access to innovative therapies and make strides in enhancing patient outcomes.” ����

About��bemdaneprocel��(BRT-DA01)
Bemdaneprocel��(BRT-DA01) is an investigational cell therapy designed to replace the dopamine producing neurons that are lost in Parkinson’s disease. These dopaminergic neuron precursors are derived from human embryonic pluripotent stem cells that continue developing into mature dopamine neurons after implantation. In a surgical procedure, these neuron precursors are implanted into the brain of a person with Parkinson’s disease. When transplanted, they have the potential to re-form neural networks that have been severely affected by Parkinson’s disease and to potentially restore motor and non-motor function to patients. In��2021��bemdaneprocel��received Fast Track Designation and in 2024 a Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. A pivotal Phase III��clinical��trial��(exPDite-2)��to assess the efficacy,��safety��and overall impact of��bemdaneprocel��compared to sham surgery control is currently enrolling participants.��Bemdaneprocel��has not been approved for treatment of any disease or medical condition by any health authority.��

About exPDite-2��
exPDite-2 is the first Phase III pivotal clinical trial for an investigational allogeneic pluripotent stem cell derived therapy to treat Parkinson’s disease. In a Phase I��study��with 12 participants,��bemdaneprocel��was well tolerated, with no serious adverse events related to drug��product��at 36 months post-surgery. In addition, encouraging trends were��observed��in secondary endpoints related to motor impairments at��36��months��post-surgery. Building on these results, exPDite-2 is a multicenter, double-blind trial that will assess the efficacy,��safety��and overall impact of��bemdaneprocel��compared to sham surgery control. The trial is designed to enroll approximately 102 participants with Parkinson’s disease��in US, Canada, and Australia. The primary endpoint of the��Phase III��study is��change��from baseline to week 78 in PD��motor��diary measure of ON-time without troublesome dyskinesia, adjusted for a 16-hour waking day. In addition, the trial will incorporate secondary endpoints designed to assess objective measures of movement, non-motor��symptoms, safety and tolerability, and instruments that capture activities of daily living and quality of life.��

About Parkinson’s disease
Parkinson’s disease (PD) is a progressive neurodegenerative disease. It has a significant impact on a person’s daily life. In PD, the death of dopamine producing nerve cells in the brain leads to the continuous loss of motor function. Symptoms include tremors, muscle rigidity, and slowness of movement. Additionally, people with PD experience non-motor symptoms, including fatigue and lack of energy, cognitive issues, and depression. Symptoms typically intensify over time and make everyday tasks demanding. The prevalence of PD has doubled over the past 25 years. Today, more than��10 million people��worldwide are estimated to be living with PD. This makes it the world’s second most prevalent neurodegenerative disease. It is also the most frequent movement disorder. At present there is no cure, and current treatment options are inadequate and lack holistic management of��symptoms��so there is an urgent need for new therapies.��

About 91����
91���� is a clinical stage cell therapy company focused on creating cellular medicines to treat devastating diseases. We are harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases. Two of our novel investigational cell therapies,��bemdaneprocel��(BRT-DA01) for the treatment of Parkinson’s disease and OpCT-001 for the treatment of primary photoreceptor diseases are clinical stage programs.��Bemdaneprocel��has RMAT (Regenerative Medicine Advanced Therapy) and Fast Track designation from the US FDA (Food and Drug Administration) and is being tested in a Phase III clinical trial, exPDite-2. OpCT-001 has Fast Track designation from the FDA and is being tested in a Phase��I��clinical trial, CLARICO��91���� was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer, the impact investing arm of Bayer AG that invests in paradigm-shifting breakthrough innovation. In late 2019, 91���� became a wholly owned, independently operated subsidiary of Bayer AG. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves. For more information, visit��www.bluerocktx.com.��

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact��with��its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability,��and quality throughout the world. In fiscal 2024, the Group employed around��93,000 people��and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to��.��

Bayer contact��for media inquiries:��

Dr. Imke Meyer, phone��+49��214 60001275
Email:��imke.meyer@bayer.com
Find more information at��
Follow us on Facebook:������

91���� Contact for media��inquiries:��
Jeff Lockwood, phone +1 617 5106997
Email:��jlockwood@bluerocktx.com
Find information at��www.bluerocktx.com
Follow us on��LinkedIn:����

Forward-Looking Statements��
This release may��contain��forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks,��uncertainties��and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at��. The company assumes no liability whatsoever to update these forward-looking statements or to conform��them to future events or developments.��

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Berlin, Germany and Cambridge, MA, USA, October 7, 2025 – Bayer AG and its wholly owned, independently operated subsidiary 91����, a clinical stage cell therapy company, today announced positive 36-month data from exPDite, a Phase I clinical trial of bemdaneprocel, an investigational cell therapy for the treatment of Parkinson’s disease (PD). The data were presented on October 6th at the International Congress of Parkinson’s Disease and Movements Disorders.��

“Bemdaneprocel represents a new approach to restoring the dopamine inputs that are lost in Parkinson’s, and leverages substantial advances in stem cell technology,” said Claire Henchcliffe, MD, chair of the UC Irvine School of Medicine’s Department of Neurology at the University of California, Irvine and one of the study’s Principal Investigators. “The new 3-year data is a critical next step to evaluate longer term safety. While there is a need for caution in interpreting the positive trends in clinical outcomes, initial signals are there, particularly in the higher dose cohort and the upcoming exPDite-2 clinical trial should shed further light on potential benefits.”��

Bemdaneprocel’s safety profile at 36 months is consistent with earlier findings, demonstrating that it continues to be well tolerated by patients, with no adverse events reported related to the therapy or surgical procedure. F-Dopa imaging suggests that transplanted cells continue to survive and engraft in the brain after discontinuing immunosuppression therapy at 12 months as outlined in the study’s protocol. In addition, secondary clinical endpoints related to motor symptoms continue to show positive trends from baseline through the duration of follow-up, with more encouraging trends in the high dose cohort than those in the low dose cohort. These were assessed by the MDS-Unified Parkinson’s Disease Rating Scale Part II and III (MDS-UPDRS Part II & III) and the Parkinson’s disease Diary, tools used to assess Parkinson’s disease severity in motor symptoms.��

“The 36-month data from this Phase I study underscores our hope that bemdaneprocel could be a potentially meaningful and durable therapeutic option for treating people living with Parkinson’s disease,” said Gabi Belfort, MD, PhD, Senior Vice President and Bemdaneprocel Product Lead at 91���� Therapeutics. “We are excited to share these data with the Parkinson’s disease community and are committed to advancing bemdaneprocel through the next stage of clinical testing.”��

In the high dose cohort (n=7), the 36-month measurement of the effects of bemdaneprocel on motor symptoms using the MDS-UPDRS Part III measured in the “OFF”-medication state, showed a mean reduction of 17.9 points compared with baseline. The low dose cohort (N=4) showed a mean decrease of 13.5 points. Both are considered to be clinically meaningful.1��

Using the PD Diary, which categorizes patients as being in the “ON” state when their symptoms are well controlled and in the “OFF” state when they experience a worsening of their symptoms, participants in the high dose cohort showed a mean increase of 1 hour in time spent in the “Good ON” state (without troublesome dyskinesias) compared with baseline after 36 months. Two participants in the high dose cohort did not submit a 36-month PD Diary. Time spent in the “OFF” state showed a mean decrease of – 0.93 hours from baseline after 36 months. The participants in the low dose cohort showed a mean increase of 0.23 hours in the “Good ON” state time compared with baseline and a corresponding mean decrease of –1.15 hours in “OFF” state time.��

In the high dose cohort, the 36-month measurement of the effects of bemdaneprocel on activities of daily living using the MDS-UPDRS Part II measured a mean reduction of -4.3 points compared with baseline. The low dose cohort showed a mean increase of 0.2 points. Participants in both cohorts continue in the long term Continued Evaluation Study.��

“The results for bemdaneprocel after 36 months mark another motivating milestone,” said Christian Rommel, Global Head of Research and Development of the Pharmaceuticals Division at Bayer. “They reinforce our commitment to developing urgently needed new treatment options for Parkinson’s patients.”��

About bemdaneprocel (BRT-DA01)
Bemdaneprocel (BRT-DA01) is an investigational cell therapy designed to replace the dopamine producing neurons that are lost in Parkinson’s disease. These dopaminergic neuron precursors are derived from human embryonic pluripotent stem cells that continue developing into mature dopamine neurons after implantation. In a surgical procedure, these neuron precursors are implanted into the brain of a person with Parkinson’s disease. When transplanted, they have the potential to re-form neural networks that have been severely affected by Parkinson’s disease and to potentially restore motor and non-motor function to patients. In 2021 bemdaneprocel received Fast Track Designation and in 2024 a Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. A pivotal Phase III trial to assess the efficacy, safety and overall impact of bemdaneprocel compared to sham surgery control is currently enrolling participants. Bemdaneprocel has not been approved for treatment of any disease or medical condition by any health authority.��

About Parkinson’s disease
Parkinson’s disease (PD) is a progressive neurodegenerative disease. It has a significant impact on a person’s daily life. In PD, the death of dopamine producing nerve cells in the brain leads to the continuous loss of motor function. Symptoms include tremors, muscle rigidity, and slowness of movement. Additionally, people with PD experience non-motor symptoms, including fatigue and lack of energy, cognitive issues, and depression. Symptoms typically intensify over time and make everyday tasks demanding. The prevalence of PD has doubled over the past 25 years. Today, more than 10 million people worldwide are estimated to be living with PD. This makes it the world’s second most prevalent neurodegenerative disease. It is also the most frequent movement disorder. At present there is no cure, and current treatment options are inadequate and lack holistic management of symptoms so there is an urgent need for new therapies.��

About 91����
91���� is a clinical stage cell therapy company focused on creating cellular medicines to treat devastating diseases. We are harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases. Two of our novel investigational cell therapies, bemdaneprocel (BRT-DA01) for the treatment of Parkinson’s disease and OpCT-001 for the treatment of primary photoreceptor diseases are clinical stage programs. Bemdaneprocel has RMAT (Regenerative Medicine Advanced Therapy) and Fast Track designation from the US FDA (Food and Drug Administration) and is being tested in a Phase III clinical trial, exPDite-2. OpCT-001 has Fast Track designation from the FDA and is being tested in a Phase I clinical trial, Clarico. 91���� was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer, the impact investing arm of Bayer AG that invests in paradigm-shifting breakthrough innovation. In late 2019, 91���� became a wholly owned, independently operated subsidiary of Bayer AG. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves. For more information, visit www.bluerocktx.com.��

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to .��

Bayer contact for media inquiries:
Silke Lengemann, phone +49 173 8990997
Email: silke.lengemann@bayer.com��

91���� Contact for media inquiries:��
Jeff Lockwood, phone +1 617 5106997
Email: jlockwood@bluerocktx.com��

Find more information at
Follow us on Facebook: ��

Find information at www.bluerocktx.com
Follow us on LinkedIn: ��

Forward-Looking Statements��
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.��

1 Hauser RA, Gordon MF, Mizuno Y, Poewe W, Barone P, Schapira AH, Rascol O, Debieuvre C, Fräßdorf M. Minimal clinically important difference in Parkinson’s disease as assessed in pivotal trials of pramipexole extended release. Parkinsons Dis. 2014;2014:467131. doi: 10.1155/2014/467131. Epub 2014 Apr 1. PMID: 24800101; PMCID: PMC3995302.��

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• Trial is a randomized, sham surgery-controlled double-blind study assessing efficacy and safety of bemdaneprocel in people living with Parkinson’s disease��

Cambridge, MA, USA September 22, 2025 – 91����, a clinical-stage cell therapy company and wholly owned, independently operated subsidiary of Bayer AG, today announced that the first patient has received randomized treatment in the pivotal Phase III clinical trial, exPDite-2, of bemdaneprocel, an investigational cell therapy for Parkinson’s disease. 

“People living with Parkinson’s disease urgently need new therapies that truly alter the course of the disease,” said Amit Rakhit, MD, MBA, 91����’s Chief Development and Medical Officer. “The initiation of the exPDite-2 trial represents a major step forward toward advancing bemdaneprocel and we are excited to build on the momentum of our earlier data to further develop it as a potentially transformative cell therapy aimed at restoring motor and non-motor function.” 

exPDite-2 is the first Phase III pivotal clinical trial for an investigational allogeneic pluripotent stem cell derived therapy to treat Parkinson’s disease. In a Phase I study with 12 participants, bemdaneprocel was well tolerated, with no serious adverse events related to drug product at 24 months post-surgery. In addition, encouraging trends were observed in secondary endpoints related to motor impairments at 24 months post-surgery. Building on these results, exPDite-2 is a multicenter, double-blind trial that will assess the efficacy, safety and overall impact of bemdaneprocel compared to sham surgery control. The trial is designed to enroll approximately 102 participants with Parkinson’s disease. The primary endpoint of the study is change from baseline to week 78 in PD diary measure of ON-time without troublesome dyskinesia, adjusted for a 16-hour waking day. In addition, the trial will incorporate secondary endpoints designed to assess objective measures of movement, non-motor symptoms, safety and tolerability, and instruments that capture activities of daily living and quality of life. 

“The initiation of the expDite-2 Phase III trial marks a significant milestone in our commitment to transform the treatment landscape for Parkinson’s disease through innovative therapies,” said Christian Rommel Ph.D., Head of Research and Development at Bayer’s Pharmaceuticals Division. “Bemdaneprocel aims to sustainably restore lost physiologic function in the dopaminergic system impacted by the disease, ultimately to enhance the quality of life for patients.” 

Depending upon the outcome, the results from this trial are intended to be part of a data package to support regulatory submissions for marketing authorization. 

About bemdaneprocel (BRT-DA01)��
Bemdaneprocel (BRT-DA01) is an investigational cell therapy designed to replace the dopamine producing neurons that are lost in Parkinson’s disease. These dopaminergic neuron precursors are derived from human embryonic pluripotent stem cells that continue developing into mature dopamine neurons after implantation. In a surgical procedure, these neuron precursors are implanted into the brain of a person with Parkinson’s disease. When transplanted, they have the potential to re-form neural networks that have been severely affected by Parkinson’s disease and to potentially restore motor and non-motor function to patients. In 2021 bemdaneprocel received Fast Track Designation and in 2024 a Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. Data from the Phase I trial’s 12 participants presented at the 2024 International Congress of Parkinson’s Disease and Movement Disorders (MDS) demonstrated good tolerability, with no serious adverse events related to drug product at 24 months post-surgery. Further, encouraging trends were observed in secondary endpoints related to motor impairments at 24 months post-surgery. These participants continue in the long term Continued Evaluation Study. Bemdaneprocel has not been approved for treatment of any disease or medical condition by any health authority.��

About Parkinson’s disease��
Parkinson’s disease (PD) is a progressive neurodegenerative disease. It has a significant impact on a person’s daily life. In PD, the death of dopamine producing nerve cells in the brain leads to the continuous loss of motor function. Symptoms include tremors, muscle rigidity, and slowness of movement. Additionally, people with PD experience non-motor symptoms, including fatigue and lack of energy, cognitive issues, and depression. Symptoms typically intensify over time and make everyday tasks demanding. The prevalence of PD has doubled over the past 25 years. Today, more than 10 million people worldwide are estimated to be living with PD. This makes it the��

world’s second most prevalent neurodegenerative disease. It is also the most frequent movement disorder. At present there is no cure, and current treatment options are inadequate and lack the holistic management of symptoms so there is an urgent need for new therapies. 

About 91������
91���� is a clinical stage cell therapy company focused on creating cellular medicines to treat devastating diseases. We are harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases. Two of our novel investigational cell therapies, bemdaneprocel (BRT-DA01) for the treatment of Parkinson’s disease and OpCT-001 for the treatment of primary photoreceptor diseases are clinical stage programs. Bemdaneprocel has RMAT (Regenerative Medicine Advanced Therapy) and Fast Track designation from the US FDA (Food and Drug Administration) and is being tested in a Phase III clinical trial, exPDite-2. OpCT-001 has Fast Track designation from the FDA and is being tested in a Phase 1 clinical trial, Clarico. 91���� was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer, the impact investing arm of Bayer AG that invests in paradigm-shifting breakthrough innovation. In late 2019, 91���� became a wholly owned, independently operated subsidiary of Bayer AG. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves. For more information, visit www.bluerocktx.com.��

About Bayer��
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to .��

Contact for media inquiries 91���� Therapeutics: 

Jeff Lockwood, phone +1 (617) 5106997��
Email: jlockwood@bluerocktx.com��
Find more information at www.bluerocktx.com.��
��

Forward-Looking Statements����
Certain statements in this press release are forward-looking which may be identified by the use of forward-looking words such as “anticipate,” “expect”, “believe,” “forecast,” “estimate” and “intend,” among others. These forward-looking statements are based on 91����’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the outcomes from our clinical trials and ongoing FDA and other regulatory requirements, and interpretation of data by the FDA. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products, and uncertainty in the outcome of clinical trials cannot be avoided. Except as expressly required by law, 91���� does not undertake an obligation to update or revise any forward-looking statement. All of 91����’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date hereof. ��

The post First Parkinson’s disease patient treated in 91����’s pivotal Phase III trial of investigational cell therapy bemdaneprocel�� appeared first on 91����.

Berlin, Germany, and Cambridge, MA, USA July 8, 2025 – Bayer AG and 91����, a clinical-stage cell therapy company and wholly owned subsidiary of Bayer AG, today announced that the first patient received the investigational therapy in CLARICO, a Phase 1/2a clinical trial of OpCT-001, an investigational induced pluripotent stem cell (iPSC)-derived cell therapy for the treatment of primary photoreceptor diseases. OpCT-001 is the first iPSC-derived investigational cell therapy to be clinically tested for treating primary photoreceptor (PR) diseases, which are a subgroup of inherited retinal disorders that includes retinitis pigmentosa and cone-rod dystrophy.

“The initiation of the CLARICO trial represents a key milestone for the OpCT-001 program,” said Amit Rakhit, MD, MBA, 91����’s Chief Development and Medical Officer. “We believe OpCT-001 holds significant promise as a novel therapeutic approach for restoring vision in people living with primary photoreceptor diseases, and we look forward to assessing its safety and tolerability profile as we advance this important program in our pipeline.”

CLARICO is a Phase 1/2a first-in-human, multisite, 2-part interventional study to evaluate the safety, tolerability, and the effect on clinical outcomes of OpCT-001 in up to approximately 54 adults with primary photoreceptor disease. Phase 1 will focus on safety and includes a dose-escalation design. Phase 2 is designed to gather additional safety data and assess the effect of OpCT-001 on measures of visual function, functional vision, and anatomic measures of engraftment in different clinical subgroups.

“We aim to transform treatment options for patients facing irreversible vision loss. OpCT-001, our investigational iPSC-derived cell therapy, has the potential to restore vision for individuals with primary photoreceptor disease,” said Christian Rommel, Executive Vice President and Global Head of Research and Development of the Pharmaceuticals Division at Bayer. “We are excited to announce the first patient in the CLARICO trial, the first-ever clinical trial for an iPSC-derived treatment in this field.”

Primary photoreceptor diseases affect the structure and function of the photoreceptor cells in the retina, leading to irreversible vision loss in both children and adults. OpCT-001 aims to restore vision in patients with primary photoreceptor diseases by replacing degenerated cells in the retina with functional cells. Limited treatment options currently exist for treating primary photoreceptor diseases which affect an estimated 110,000¹ people in the U.S.

OpCT-001 is an investigational cell therapy that has not been approved by any regulatory authority, and its efficacy and safety have not been established or fully evaluated.

¹https://www.ncbi.nlm.nih.gov/books/NBK519518/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1808442/; https://www.nidcd.nih.gov/health/usher-syndrome#b

About CLARICO
CLARICO is a Phase 1/2a first-in-human, multisite, 2-part interventional study to evaluate the safety, tolerability, and the effect on clinical outcomes of OpCT-001 in up to approximately 54 adults with primary photoreceptor disease. Phase 1 will focus on safety and features a dose-escalation design. Phase 2 is designed to gather additional safety data and assess the effect of OpCT-001 on measures of visual function, functional vision, and anatomic measures of engraftment in different clinical subgroups. Phase 1 will include 4 planned dose levels to be administered across 4 cohorts (Cohorts 1 through 4). Dose escalation in Phase 1 will be conducted using a standard 3+3 scheme in which a total of 12 to 24 legally blind participants (~3 to 6 per cohort) will receive OpCT-001. Phase 2 is planned to enroll a maximum of 15 participants in 2 cohorts (Cohorts 5 and 6) to evaluate 2 dose levels of OpCT-001 that will be selected based on Phase 1 safety and tolerability data. Phase 2 participants will be randomized 1:1 to either Cohort 5 or Cohort 6. Phase 2 participants and the investigator/study site personnel outside of the surgical team will be masked to OpCT-001 dose assignments. Further details of the trial can be found at www.clinicaltrials.gov (NCT06789445).

About 91����
91���� is a clinical stage cell therapy company focused on creating cellular medicines to treat devastating diseases. We are harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases. Two of our novel investigational cell therapies, bemdaneprocel (BRT-DA01) for the treatment of Parkinson’s disease and OpCT-001 for the treatment of primary photoreceptor diseases are clinical stage programs. Bemdaneprocel has RMAT (Regenerative Medicine Advanced Therapy) and Fast Track designation from the US FDA (Food and Drug Administration) and is being tested in a Phase 3 clinical trial, exPDite-2. OpCT-001 has Fast Track designation from the FDA and is being tested in a Phase 1 clinical trial, Clarico. 91���� was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer, the impact investing arm of Bayer AG that invests in paradigm-shifting breakthrough innovation. In late 2019, 91���� became a wholly owned, independently operated subsidiary of Bayer AG. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves. For more information, visit www.bluerocktx.com.��������

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to .

Bayer Global Media Contact:
Dr. Imke Meyer, phone +49 (214) 60001275
Email: imke.meyer@bayer.com

91���� Media Contact:
Jeff Lockwood, phone +1 (617) 5106997
Email: jlockwood@bluerocktx.com

Find more information at .

Forward-Looking Statements 91���� Therapeutics
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “plan,” and “intend,” among others. These forward-looking statements are based on 91����’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the initiation, timing, progress, activities, goals and reporting of results of any preclinical programs and clinical trials and research and development programs, the potential benefits, timing and future operation of the agreements with FUJIFILM Cellular Dynamics and Opsis Therapeutics, the ability to advance therapies into, and successfully initiate, enroll and complete clinical trials, the potential clinical utility of product candidates, the regulatory pathway of, and the timing or likelihood of any regulatory filings and approvals for, any product candidates, and the ability to, and extent of, potentially commercializing any product candidate, are forward looking. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Except as expressly required by law, 91���� does not undertake an obligation to update or revise any forward-looking statement. All of 91����’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date hereof.

Forward-Looking Statements Bayer
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

The post 91���� Therapeutics announces first patient receives investigational therapy in Phase 1/2a clinical trial of OpCT-001 for the treatment of primary photoreceptor diseases appeared first on 91����.

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Eye on the Cure Podcast | Episode 86: Lenore von Krusenstiern, MD, PhD

Dr. Lenore von Krusenstiern talks about Bluerock’s clinical trial for a photoreceptor replacement therapy for people with inherited retinal conditions such as retinitis pigmentosa and cone-rod dystrophy.

Podcast produced by Foundation Fighting Blindness, sponsored by 91���� Therapeutics.

The post Eye on the Cure Podcast appeared first on 91����.

• Bemdaneprocel is the first investigational allogeneic pluripotent stem cell-derived cell therapy for Parkinson’s disease and the most clinically advanced cell therapy being investigated for treating the disease. �į&�Բ�����;

• 91���� expects to initiate a Phase 3 clinical trial for bemdaneprocel in H1 2025. �į&�Բ�����;

Cambridge MA, USA, APRIL 16, 2025 – 91����, a clinical-stage cell therapy company and wholly owned subsidiary of Bayer AG, today announced the publication of the 18-month data from its Phase 1 exPDite clinical trial for bemdaneprocel in the journal Nature. �į&�Բ�����;

“The concept of “rebuilding” brain networks that have been lost to disease is compelling,” said Claire Henchcliffe, MD, chair of the UC Irvine School of Medicine’s Department of Neurology at the University of California, Irvine and one of the study’s Principal Investigators, “The results of this early phase clinical trial demonstrate the promise of regenerative medicine and should provide hope for Parkinson’s disease patients and their families.” &�Բ�����;

The publication, which is available , confirms that 18 months following surgery, treatment with bemdaneprocel did not cause any serious adverse events related to cell therapy. In addition, positron emission tomography (PET) imaging techniques demonstrated sustained neuron cell engraftment in the trial’s high and low dose cohorts following discontinuation of immunosuppression after one year post-treatment. The publication also reports encouraging trends in secondary and exploratory subjective and objective endpoints related to motor function. These data were first presented in March 2024 at the Alzheimer’s and Parkinson’s Diseases Conference in Lisbon, Portugal.  ��

“Cell therapy is a potential new treatment option for individuals with Parkinson’s disease and our team is immensely proud of having bemdaneprocel’s 18-month Phase 1 data published in such a prestigious journal as Nature,” said Amit Rakhit, MD, MBA Head of Development and Chief Medical Officer at 91���� Therapeutics. “Our efforts are now focused on maintaining our forward momentum to initiate and enroll the Phase 3 trial as we advance bemdaneprocel’s development to this exciting next stage.” &�Բ�����;

The Phase 3 trial, called exPDite-2, is expected to be initiated in the first half of 2025. �į&�Բ�����;

About bemdaneprocel (BRT-DA01)   &�Բ�����;
Bemdaneprocel (BRT-DA01) is an investigational cell therapy designed to replace the dopamine-producing neurons that are lost in Parkinson’s disease. These dopaminergic neuron precursors are derived from human embryonic stem cells, developing into mature dopamine neurons after implantation. In a surgical procedure, these neuron precursors are implanted into the brain of a person with Parkinson’s disease. When transplanted, they have the potential to re-form neural networks that have been severely affected by Parkinson’s disease and to potentially restore motor and non-motor function to patients. In 2021 bemdaneprocel received Fast Track designation followed in 2024 by a Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA.  Data from the Phase 1 trial’s 12 participants presented at the 2024 International Congress of Parkinson’s Disease and Movement Disorders (MDS) demonstrated good tolerability, with no serious adverse events related to drug product at 24 months post-surgery. Further, encouraging trends were observed in secondary endpoints related to motor impairments at 24 months post-surgery. These participants remain in a long-term Continued Evaluation Study. Bemdaneprocel has not been approved for treatment of any disease or medical condition by any health authority.   �į&�Բ�����;

About Parkinson’s disease  &�Բ�����;
Parkinson’s disease (PD) is a progressive neurodegenerative disease. It has a significant impact on a person’s daily life. In PD, the death of dopamine producing nerve cells in the brain leads to the continuous loss of motor function. Symptoms include tremors, muscle rigidity, and slowness of movement. Additionally, people with PD experience non-motor symptoms, including fatigue and lack of energy, cognitive issues, and depression. Symptoms typically intensify over time and make everyday tasks demanding. The prevalence of PD has doubled over the past 25 years. Today, more than 10 million people worldwide are estimated to be living with PD. This makes it the world’s second most prevalent neurodegenerative disease. It is also the most frequent movement disorder. At present there is no cure, and current treatment options lack the holistic management of symptoms so new therapies are needed. �į&�Բ�����;

About 91����    &�Բ�����;
91���� is a clinical stage cell therapy company focused on creating cellular medicines to treat devastating diseases. We are harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological, ophthalmic, cardiovascular and immunological diseases. Two of our novel investigational cell therapies, bemdaneprocel (BRT-DA01) for the treatment of Parkinson’s disease and OpCT-001 for the treatment of primary photoreceptor disease are clinical stage programs. Bemdaneprocel has RMAT (Regenerative Medicine Advanced Therapy) and Fast Track designation from the US FDA (Food and Drug Administration) and is expected to begin a Phase 3 clinical trial in H1 2025. OpCT-001 is expected to begin Phase 1 clinical testing in H1 2025. 91���� was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer, the impact-investing arm of Bayer AG that invests in paradigm-shifting breakthrough innovation. In late 2019, 91���� became a wholly owned, independently operated subsidiary of Bayer AG as a cornerstone of its newly formed Cell & Gene Therapy platform. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves. For more information, visit www.bluerocktx.com.     �į&�Բ�����;

About Bayer &�Բ�����;
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to . &�Բ�����;

Contact for media inquiries:  &�Բ�����;
Jeff Lockwood, phone +1 (617) 510 6997  �į&�Բ�����;
Email: jlockwood@bluerocktx.com  �į&�Բ�����;
Find information at www.bluerocktx.com �į&�Բ�����;

Follow us on LinkedIn:  �į&�Բ�����;

Forward-Looking Statements   
Certain statements in this press release are forward-looking which may be identified by the use of forward-looking words such as “anticipate,” “expect”, “believe,” “forecast,” “estimate” and “intend,” among others. These forward-looking statements are based on 91����’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the outcomes from our clinical trials and ongoing FDA and other regulatory requirements, and interpretation of data by the FDA. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products, and uncertainty in the outcome of clinical trials cannot be avoided. Except as expressly required by law, 91���� does not undertake an obligation to update or revise any forward-looking statement. All of 91����’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date hereof. &�Բ�����;

The post 91���� Therapeutics announces publication in Nature of 18-month data from Phase 1 clinical trial for bemdaneprocel, an investigational cell therapy for Parkinson’s disease appeared first on 91����.

• Fast Track designation is intended to facilitate the development and review of drug candidates that treat serious conditions and address an unmet medical need 

• Primary photoreceptor diseases are a subgroup of inherited retinal disorders that affect the structure and function of the photoreceptor cells in the retina, leading to irreversible vision loss in children and adults 

Berlin, Germany, and Cambridge, MA, USA February 27, 2025 – Bayer AG and 91����, a clinical-stage cell therapy company and wholly owned subsidiary of Bayer AG, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for OpCT-001, an investigational induced pluripotent stem cell (iPSC)-derived cell therapy for the treatment of primary photoreceptor diseases. OpCT-001 is the first iPSC-derived investigational cell therapy to be clinically tested for treating primary photoreceptor diseases, which are a subgroup of inherited retinal disorders that includes retinitis pigmentosa and cone-rod dystrophy.  

The FDA’s Fast Track designation is intended to facilitate the development and review of drug candidates that treat serious conditions and address an unmet medical need. A drug candidate that receives Fast Track designation may be eligible for more frequent interaction with the FDA to discuss the drug candidate’s development plan as well as eligibility for accelerated approval and priority review, if relevant criteria are met. 

“We are thrilled to receive Fast Track designation from the FDA for OpCT-001,” said Amit Rakhit, MD, MBA, 91����’s Chief Development and Medical Officer. “People living with primary photo receptor diseases need new treatments that have the potential to restore vision, and we look forward to working closely with the FDA to advance this program through clinical trials.”  

Primary photoreceptor diseases affect the structure and function of the photoreceptor cells in the retina, leading to irreversible vision loss in both children and adults. OpCT-001 aims to restore vision in patients with primary photoreceptor diseases by replacing degenerated cells in the retina with functional cells. Limited treatment options currently exist for treating primary photoreceptor diseases which affect an estimated 110,000¹ people in the U.S. 

“Receiving FDA Fast Track designation for OpCT-001 demonstrates the urgent need for innovative treatments in the field of primary photoreceptor diseases,” said Christian Rommel, Executive Vice President, Global Head of Research and Development, and Member of the Pharmaceuticals Leadership Team at Bayer. “We are proud to deliver on our commitment to advancing groundbreaking cell therapies by seeking to develop the first iPSC-derived investigational cell therapy for patients facing devastating consequences from primary photoreceptor diseases.” 

OpCT-001 was exclusively licensed from FUJIFILM Cellular Dynamics and Opsis Therapeutics in January 2024 as part of the strategic R&D and clinical manufacturing collaboration between 91���� Therapeutics, FUJIFILM Cellular Dynamics, and Opsis Therapeutics forged in 2021. As part of the collaboration, FUJIFILM Cellular Dynamics supported 91���� Therapeutics via research, development and the execution of critical IND-enabling activities including the clinical manufacturing of OpCT-001. 

OpCT-001 is an investigational cell therapy that has not been approved by any regulatory authority, and its efficacy and safety have not been established or fully evaluated. 

¹https://www.ncbi.nlm.nih.gov/books/NBK519518/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1808442/; https://www.nidcd.nih.gov/health/usher-syndrome#b 

About 91������
91���� is a clinical stage cell therapy company focused on creating cellular medicines to treat devastating diseases. We are harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological, ophthalmic, cardiovascular and immunological diseases. Two of our novel investigational cell therapies, bemdaneprocel (BRT-DA01) for the treatment Parkinson’s disease and OpCT-001 for the treatment of primary photoreceptor disease are clinical stage programs. Bemdaneprocel has RMAT (Regenerative Medicine Advanced Therapy) and Fast Track designation from the U.S. FDA (Food and Drug Administration); has completed Phase 1 clinical trial and is progressing to the next stage of clinical development. OpCT-001 has been cleared by the FDA to begin Phase 1 clinical testing. 91���� was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer, the impact investing arm of Bayer AG that invests in paradigm-shifting breakthrough innovation. In late 2019, 91���� became a wholly owned, independently operated subsidiary of Bayer AG as a cornerstone of its newly formed Cell & Gene Therapy platform. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves. For more information, visit www.bluerocktx.com.��

About Bayer 
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to . 

Bayer Global Media Contact: 
Dr. Imke Meyer, phone +49 (214) 60001275 
Email: imke.meyer@bayer.com 

91���� Media Contact:  
Jeff Lockwood, phone +1 (617) 5106997 
Email: jlockwood@bluerocktx.com 

Find more information at . 

Forward-Looking Statements 91���� Therapeutics 
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “plan,” and “intend,” among others. These forward-looking statements are based on 91����’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the initiation, timing, progress, activities, goals and reporting of results of any preclinical programs and clinical trials and research and development programs, the potential benefits, timing and future operation of the agreements with FUJIFILM Cellular Dynamics and Opsis Therapeutics, the ability to advance therapies into, and successfully initiate, enroll and complete clinical trials, the potential clinical utility of product candidates, the regulatory pathway of, and the timing or likelihood of any regulatory filings and approvals for, any product candidates, and the ability to, and extent of, potentially commercializing any product candidate, are forward looking. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Except as expressly required by law, 91���� does not undertake an obligation to update or revise any forward-looking statement. All of 91����’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date hereof. 

Forward-Looking Statements Bayer 
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.  

The post 91���� Therapeutics receives FDA Fast Track Designation for OpCT-001 for the treatment of primary photoreceptor diseases�� appeared first on 91����.