Bayer’s BlueRock Therapeutics Establishes European Site For Cell Therapy Innovation

Establishment of BlueRock site in Berlin expands company’s footprint and strengthens Bayer’s cell therapy capabilities

Acceleration of the development of cell therapies in BlueRock’s pipeline, with initial focus on the ongoing BRT-DA01 clinical trial in Parkinson’s disease

Berlin, June 8, 2022 – Bayer AG announced today that BlueRock Therapeutics LP (BlueRock), a clinical stage biopharmaceutical company and wholly-owned subsidiary of Bayer AG, has established a new site for cell therapy innovation on Bayer’s campus in Berlin, Germany. This move comes as part of the company’s focused growth strategy. While operating independently, the team at BlueRock will benefit from the expertise of various teams at Bayer to enable the expansion and acceleration of the company’s clinical trials to Europe. BlueRock recently closed enrollment for a Phase I clinical trial for BRT-DA01, its novel cell therapy for treating Parkinson’s disease, and intends to initiate a global non-interventional study for Parkinson’s patients in the second half of 2022.

“Today’s announcement is a significant step forward in advancing our leadership in cell therapies globally. Establishing a presence for BlueRock in Europe offers the opportunity to strengthen our collaboration, with the ultimate goal to deliver cell therapies with transformational potential,” said Stefan Oelrich, Member of the Board of Management, Bayer AG and President of Bayer’s Pharmaceuticals Division. “We look forward to seeing BlueRock thrive and accelerate the growth of the company. Together we will translate pioneering science into tangible therapies for patients.”

A multidisciplinary BlueRock team will be set up during 2022 to provide clinical development and operational support for Europe, including chemistry, manufacturing and control (CMC). The team will expand as the company’s growing pipeline of innovative cell therapies for treating patients with neurological, immunological, cardiovascular and ophthalmic diseases progresses. The co-location of the companies’ teams in Berlin will enable BlueRock to leverage Bayer’s global reach and know-how in areas such as regulatory affairs, clinical development, and commercialization. With the establishment of its new site, BlueRock significantly broadens its geographical footprint, with presence in the US, Canada, and now Europe.

“We are excited to expand our operations to Europe,” said Seth Ettenberg, President and CEO of BlueRock Therapeutics. “The establishment of a site in Europe is an important milestone in our growth strategy that will enable us to extend the reach of our advancing pipeline of novel cell therapies to patients globally.”

Bayer and BlueRock share a commitment to developing new therapies to treat devastating diseases in areas of high unmet medical need. Since the inception of BlueRock in 2016 by Versant Ventures and Bayer AG, the company has grown from a pre-clinical start-up to a clinical-stage company with sites in the United States, Canada and now Europe. As a foundational element of Bayer’s cell and gene therapy strategy, the expansion of BlueRock’s geographical presence strengthens Bayer’s capabilities in cell therapies and as a driver of new technologies worldwide.

About the BRT-DA01 Phase I Trial

The primary objective of the PhI trial is to assess the safety and tolerability of BRT-DA01 transplantation at one-year post-transplant. The secondary objectives of the trial are to assess the evidence of transplanted cell survival and motor effects at one- and two-years post-transplant, to evaluate continued safety and tolerability at two years, and to assess feasibility of transplantation.

In the United States, the trial was initiated at Weill Cornell Medicine with Dr. Harini Sarva, M.D. as the Principal Investigator (PI) and first surgeries being performed by Dr. Viviane Tabar, Chair of the Department of Neurosurgery at Memorial Sloan Kettering Cancer Center. Additional Neurology sites were added at the University of California, Irvine, under the guidance of Dr. Claire Henchcliffe, M.D., D.Phil., F.A.A.N., F.A.N.A. (PI), and at the University Health Network (UHN), under the guidance of Dr. Lozano, O.C., M.D., Ph.D., F.R.C.S.C., F.R.S.C., F.C.A.H.S. (PI) and Dr. Alfonso Fasano, M.D., PhD., Chair in Neuromodulation and Multi-Disciplinary Care, UHN and UoT.

More information about the Phase I trial is available at clinicaltrials.gov (NCT#04802733).

As a next step, BlueRock Therapeutics plans to initiate a global non-interventional study in the second half of 2022.

More information about the non-interventional study is available at clinicaltrials.gov (NCT#05363046).

About Parkinson’s Disease
Parkinson’s disease is a progressive neurodegenerative disorder caused by nerve cell damage in the brain, leading to decreased dopamine levels. The worsening of motor and non-motor symptoms is caused by the loss of dopamine-producing neurons. At diagnosis, it is estimated that patients have already lost 60-80% of their dopaminergic neurons. Parkinson’s disease often starts with a tremor in one hand. Other symptoms are rigidity, cramping and slowness of movement (bradykinesia). According to the Parkinson’s Foundation, more than 10 million people worldwide suffer from Parkinson’s disease. BRT-DA01 is being clinically evaluated in a subset of patients with Parkinson’s disease, where regular medications are no longer fully effective.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its 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 2021, the Group employed around 100,000 people and had sales of 44.1 billion euros. R&D expenses before special items amounted to 5.3 billion euros. For more information, go to www.bayer.com.

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About BlueRock Therapeutics
BlueRock Therapeutics is a leading engineered cell therapy company with a mission to create authentic cellular medicines to reverse devastating diseases, with the vision of improving the human condition. The Company’s cell+gene platform harnesses the power of cells to create new medicines for neurology, cardiology, immunology and ophthalmology indications. BlueRock Therapeutics’ cell differentiation technology recapitulates the cell’s developmental biology to produce authentic cells, some of which are engineered for additional therapeutic function. Utilizing these cell therapies to replace damaged or degenerated tissue brings the potential to restore lost function. BlueRock Therapeutics was founded in 2016 by Versant Ventures and Bayer AG and capitalized with one of the largest-ever Series A financings in biotech history by Bayer AG (through its Leaps by Bayer unit) and Versant Ventures. The company was fully acquired by Bayer in 2019. BlueRock Therapeutics’ 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.

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 www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Contact information:

Nuria Aiguabella Font
Phone: +49 30 2215-41582
Email: nuria.aiguabellafont@bayer.com

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