This announcement does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, any securities. There will be no public offer of the securities in any jurisdiction. Neither this announcement nor anything contained herein shall form the basis of, or be relied upon in connection with, any offer or commitment whatsoever in any jurisdiction. An investment decision regarding the securities referred to herein should only be made on the basis of the securities prospectus.
This announcement is an advertisement and does not, under any circumstances, constitute a public offering or an invitation to the public in connection with any offer within the meaning of Regulation (EU) 2017/1129. The final prospectus, when published, will be available on the website of the Luxembourg Stock Exchange (https://www.luxse.com).
The securities referred to herein will not be registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), or any U.S. State security laws and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements under the U.S. Securities Act or to, or for the benefit of, U.S. persons.
The tender offer referenced herein is not being made, directly or indirectly, in or into the United States by use of the mails or by any means or instrumentality (including, without limitation, e-mail, facsimile transmission, telephone and the internet) of interstate or foreign commerce, or of any facility of a national securities exchange of the United States and the tender offer cannot be accepted by any such use, means, instrumentality or facility or from within the United States.
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The following materials are not directed at or to be accessed by persons located in the United States, Australia, Canada or Japan. These materials do not constitute or form a part of any offer or solicitation to purchase or subscribe for securities in the United States, Australia, Canada or Japan or in any other jurisdiction in which such offer or solicitation is not authorized or to any person to whom it is unlawful to make such offer or solicitation.
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In the United Kingdom the following materials are only directed at (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order") or (ii) high net worth companies, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as "relevant persons"). The securities are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such securities will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on the materials or any of their contents.
In relation to each member state of the European Economic Area which has implemented the Directive 2003/71/EC, and any amendments thereto (the "Prospectus Directive")(each a "Relevant Member State"), an offer to the public of the securities has not been made and will not be made in such Relevant Member State, except that an offer to the public in such Relevant Member State of any securities may be made at any time under the following exemptions from the Prospectus Directive, if they have been implemented in the Relevant Member State:
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- in any other circumstances falling within Article 3(2) of the Prospectus Directive;
provided that no such offer shall result in a requirement to publish a prospectus pursuant to Article 3 of the Prospectus Directive or supplement a prospectus pursuant to Article 16 of the Prospectus Directive.
For the purposes of this provision, the expression an "offer to the public" in relation to any securities in any Relevant Member State means the communication in any form and by any means of sufficient information on the terms of the offer and any securities to be offered so as to enable an investor to decide to purchase any securities, as the same may be varied in that Relevant Member State by any measure implementing the Prospectus Directive in that Relevant Member State, and the expression "Prospectus Directive" includes any relevant implementing measure in each Relevant Member State.
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Basis of accessAccess to electronic versions of these materials is being made available on this webpage by Bayer in good faith and for information purposes only. Making press announcements and other documents available in electronic format on this webpage does not constitute an offer to sell or the solicitation of an offer to buy securities issued by Bayer. Further, it does not constitute a recommendation by Bayer, or any other party to buy or sell securities issued by Bayer.
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This announcement does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, any securities. There will be no public offer of the securities in any jurisdiction. Neither this announcement nor anything contained herein shall form the basis of, or be relied upon in connection with, any offer or commitment whatsoever in any jurisdiction. An investment decision regarding the securities referred to herein should only be made on the basis of the securities prospectus.
This announcement is an advertisement and does not, under any circumstances, constitute a public offering or an invitation to the public in connection with any offer within the meaning of Regulation (EU) 2017/1129. The final prospectus, when published, will be available on the website of the Luxembourg Stock Exchange (https://www.luxse.com).
The securities referred to herein will not be registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), or any U.S. State security laws and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements under the U.S. Securities Act or to, or for the benefit of, U.S. persons.
The tender offer referenced herein is not being made, directly or indirectly, in or into the United States by use of the mails or by any means or instrumentality (including, without limitation, e-mail, facsimile transmission, telephone and the internet) of interstate or foreign commerce, or of any facility of a national securities exchange of the United States and the tender offer cannot be accepted by any such use, means, instrumentality or facility or from within the United States.
Viewing the materials you seek to access may not be lawful in certain jurisdictions. In other jurisdictions, only certain categories of person may be allowed to view such materials. Any person who wishes to view these materials must first satisfy themselves that they are not subject to any local requirements that prohibit or restrict them from doing so.
If you are not permitted to view materials on this webpage or are in any doubt as to whether you are permitted to view these materials, please exit this webpage.
Basis of accessAccess to electronic versions of these materials is being made available on this webpage by Bayer in good faith and for information purposes only. Making press announcements and other documents available in electronic format on this webpage does not constitute an offer to sell or the solicitation of an offer to buy securities issued by Bayer. Further, it does not constitute a recommendation by Bayer, or any other party to buy or sell securities issued by Bayer.
Confirmation of understanding and acceptance of disclaimerBy clicking on the "I AGREE" button, I certify that I am not located in the United States, Australia, Canada, South Africa or Japan or any other jurisdiction, where access to the materials is prohibited or restricted.
I have read and understood the disclaimer set out above. I understand that it may affect my rights. I agree to be bound by its terms. By clicking on the "I AGREE" button, I confirm that I am permitted to proceed to electronic versions of these materials.
This announcement does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, any securities. There will be no public offer of the securities in any jurisdiction. Neither this announcement nor anything contained herein shall form the basis of, or be relied upon in connection with, any offer or commitment whatsoever in any jurisdiction. An investment decision regarding the securities referred to herein should only be made on the basis of the securities prospectus.
This announcement is an advertisement and does not, under any circumstances, constitute a public offering or an invitation to the public in connection with any offer within the meaning of Regulation (EU) 2017/1129. The final prospectus, when published, will be available on the website of the Luxembourg Stock Exchange (https://www.luxse.com).
The securities referred to herein will not be registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), or any U.S. State security laws and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements under the U.S. Securities Act or to, or for the benefit of, U.S. persons.
The tender offer referenced herein is not being made, directly or indirectly, in or into the United States by use of the mails or by any means or instrumentality (including, without limitation, e-mail, facsimile transmission, telephone and the internet) of interstate or foreign commerce, or of any facility of a national securities exchange of the United States and the tender offer cannot be accepted by any such use, means, instrumentality or facility or from within the United States.
Viewing the materials you seek to access may not be lawful in certain jurisdictions. In other jurisdictions, only certain categories of person may be allowed to view such materials. Any person who wishes to view these materials must first satisfy themselves that they are not subject to any local requirements that prohibit or restrict them from doing so.
If you are not permitted to view materials on this webpage or are in any doubt as to whether you are permitted to view these materials, please exit this webpage.
Basis of accessAccess to electronic versions of these materials is being made available on this webpage by Bayer in good faith and for information purposes only. Making press announcements and other documents available in electronic format on this webpage does not constitute an offer to sell or the solicitation of an offer to buy securities issued by Bayer. Further, it does not constitute a recommendation by Bayer, or any other party to buy or sell securities issued by Bayer.
Confirmation of understanding and acceptance of disclaimerBy clicking on the "I AGREE" button, I certify that I am not located in the United States, Australia, Canada, South Africa or Japan or any other jurisdiction, where access to the materials is prohibited or restricted.
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This announcement does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, any securities. There will be no public offer of the securities in any jurisdiction. Neither this announcement nor anything contained herein shall form the basis of, or be relied upon in connection with, any offer or commitment whatsoever in any jurisdiction.
The securities referred to herein will not be registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), or any U.S. State security laws and may not be offered or sold in the United States or to, or for the benefit of, U.S. persons absent registration or an applicable exemption from the registration requirements under the U.S. Securities Act.
Viewing the materials you seek to access may not be lawful in certain jurisdictions. In other jurisdictions, only certain categories of person may be allowed to view such materials. Any person who wishes to view these materials must first satisfy themselves that they are not subject to any local requirements that prohibit or restrict them from doing so.
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Basis of accessAccess to electronic versions of these materials is being made available on this webpage by Bayer in good faith and for information purposes only. Making press announcements and other documents available in electronic format on this webpage does not constitute an offer to sell or the solicitation of an offer to buy securities issued by Bayer. Further, it does not constitute a recommendation by Bayer, or any other party to buy or sell securities issued by Bayer.
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This announcement is an advertisement and does not, under any circumstances, constitute a public offering or an invitation to the public in connection with any offer within the meaning of Regulation (EU) 2017/1129. The final prospectus, when published, will be available on the website of the Luxembourg Stock Exchange (https://www.luxse.com).
The securities referred to herein will not be registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), or any U.S. State security laws and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements under the U.S. Securities Act or to, or for the benefit of, U.S. persons.
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U.S. FDA designations are for treating retinitis pigmentosa and cone-rod dystrophy / EU EMA designations are for treating 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 iPSC-derived investigational cell therapy being clinically tested in a Phase 1/2a study for the treatment of retinitis pigmentosa, Usher syndrome, and cone-rod dystrophies
Berlin, Germany, and Cambridge, MA, USA, September 30, 2026 - Bayer AG and its wholly owned, independently operated subsidiary BlueRock Therapeutics LP, 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, BlueRock'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 BlueRock, 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. Lemiretprocel is the International Nonproprietary Name for OpCT-001 as acknowledged by the World Health Organization.2
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
2https://cdn.who.int/media/docs/default-source/international-nonproprietary-names-(inn)/pl134.pdf?sfvrsn=87a89aba_3&download=true
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 atwww.clinicaltrials.gov (NCT06789445).
About BlueRock Therapeutics LP
BlueRock Therapeutics LP 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 U.S. 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. BlueRock 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, BlueRock 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, visitwww.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 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 towww.bayer.com.
Forward-Looking Statements BlueRock 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 BlueRock'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, BlueRock does not undertake an obligation to update or revise any forward-looking statement. All of BlueRock'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 atwww.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Bayer AG is a holding company with operating subsidiaries worldwide. References to "Bayer" or "the company" herein may refer to one or more subsidiaries as context requires.
Bayer Global Media Contact:
Kathryne Delves-Broughton, phone +33 6 02180163
Email:kathryne.delvesbroughton@bayer.com
BlueRock Media Contact:
Jeff Lockwood, phone +1 (617) 5106997
Email:jlockwood@bluerocktx.com
- 2026-0157e.pdf
- 2026-0157e.rtf