Bayer Pharmaceuticals poised for landmark year with significant pipeline progress and blockbuster launches

As part of the ongoing transformation of its pharmaceutical business, Bayer has made significant investments in R&D to accelerate medical innovations and build a highly differentiated pipeline for long-term growth across key therapeutic areas, including oncology, cardiovascular diseases, neurology and rare diseases, and immunology. Bayer is also making significant progress with its cell and gene therapy platform, achieving important clinical trial milestones, especially in the field of Parkinson's disease.

"2025 is a landmark launch year for Bayer Pharmaceuticals, and we are pulling out all stops to drive the power of our pipeline," said Stefan Oelrich, Member of the Board of Management, Bayer AG, and President of Bayer's Pharmaceuticals Division. "Our growth strategy is on track and delivering significant value. This year, we are bringing a number of groundbreaking products with blockbuster potential to market."

Through rigorous assessment and prioritization, Bayer is advancing key programs with significant potential. Focusing on areas of greatest unmet medical need and highest value potential, the company has increased the quality of its pipeline. This year, the company plans to offer a number of new treatment options:

• Expanding its cardiology portfolio with a new treatment for transthyretin amyloid cardiomyopathy in Europe.
• New treatment option for patients with heart failure and a left ventricular ejection fraction of 40% or greater, a widespread form of heart failure, by the end of the 2025.
• Innovative hormone-free treatment to relieve moderate to severe vasomotor symptoms in menopausal women.
• New treatment option for men with metastatic hormone-sensitive prostate cancer, further building Bayer's leadership position in this field.

"We are shaping a new era of medicine, confident that we can not only transform patient care through breakthrough innovation and a robust product portfolio, but also by accelerating patient access to new medicines. With every new development, we are getting one step closer to realizing our vision to treat the untreatable, cure disease and offer hope," said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. "During Pharma Media Day, we highlighted key advancements, including new treatments for transthyretin amyloid cardiomyopathy and heart failure, as well as an upcoming hormone-free option for menopausal symptoms. We also anticipate regulatory approval for a promising oncology treatment option in 2025, reinforcing our commitment to innovation in healthcare."

"Our strategic transformation has yielded significant progress in R&D to deliver a competitively structured and differentiated pipeline. In 2024 our late-stage Phase III trials have delivered positive outcomes, so it's clear we are seeing the impact of our enhanced capabilities and clarity on our strategic priorities," said Dr. Christian Rommel, Ph.D., Member of the Executive Committee of Bayer's Pharmaceuticals Division and Head of Research and Development. "Our renewed early pipeline positions us for long-term growth and allows us to progress targeted treatments that promise to significantly improve patient outcomes. Now, we are poised to deliver innovative therapies that will make a meaningful difference in patients' lives while driving sustainable business growth."

Delivering significant growth and strengthening leadership in oncology

Driving progress throughout its oncology pipeline, which spans all phases of clinical development, Bayer is building on its goal to become a leader in the treatment of prostate cancer - the second most commonly diagnosed cancer in men.

Bayer is focused on three scientific areas that have the potential to address unmet needs for patients with cancer, which include targeted radiopharmaceuticals (specifically targeted alpha therapies), next-generation immuno-oncology and precision molecular oncology. In these areas, the company is advancing truly first-in-class, highly innovative projects within its portfolio.

Targeted radionuclide therapy (TRT) is a strategic area of focus for Bayer in oncology precision drug development, building on more than 10 years of real-world experience with a targeted alpha therapy for patients with metastatic castration-resistant prostate cancer (mCRPC). Bayer?s evolving TRT portfolio includes novel targeting approaches that combine alpha radionuclides with different targeting moieties including antibodies, small molecules or peptide-based molecules. Two TRT candidates are currently in Phase I clinical trials, including two actinium-225 based PSMA-targeting candidates designed for patients with mCRPC.

Strategic investments in R&D and platform companies in recent years are further strengthening Bayer's pipeline. With Vividion's acquisition of Tavros Therapeutics, Bayer continues to leverage its chemoproteomics technology platform to unlock traditionally undruggable targets with precision small-molecule therapeutics. Bayer has initiated Phase I trials for the treatment of solid tumors and solid and hematologic malignancies, alongside an IND-enabling program for RAS-driven cancers.

Developing the next generation of cardiovascular therapies

Building on its strong late-stage projects, Bayer has set a clear directive towards precision cardiology, exploring innovative approaches across a diverse range of modalities. By doing so, the company aims to push the boundaries of innovation for patients with cardiovascular diseases with high unmet needs and even potentially reverse life-altering conditions.

Complementing in-house expertise with external collaborations remains a vital part of Bayer's strategy to expand its R&D expertise and develop cardiovascular therapies, with the goal of addressing high unmet medical needs.

Through AskBio, a wholly owned subsidiary of Bayer, Bayer is developing a gene therapy as a potential new approach for treating congestive heart failure. Following its acquisition, Bayer gained access to AskBio's industry-leading gene therapy platform with demonstrated applicability and world-class manufacturing facilities and is already making progress with its Phase II assets.

Pioneering progress in women's health

Seeking to address unmet needs in menopausal women and identify solutions to improve the quality of life, Bayer is investing in innovations to broaden the therapeutic landscape and raise the standard of care for menopausal women.

In 2025, Bayer plans to launch a new hormone-free treatment option for menopause, which has recently shown consistent promise in reducing the frequency and severity of moderate to severe vasomotor symptoms (hot flashes) associated with menopause or caused by breast cancer treatments. Further improvements in sleep disturbances and addressing the challenges of menopause-related quality of life have also been observed in the clinical Phase III studies.

Overall, the treatment may address important unmet medical needs for women experiencing menopause or treatment-induced menopausal symptoms. With regulatory submissions under review globally, Bayer anticipates a potential launch in the U.S. and Europe this year.

Leadership in cell therapy and gene therapy in Parkinson's disease

Bayer and BlueRock Therapeutics, a wholly owned subsidiary of Bayer are developing an investigational cell therapy based on the surgical implantation of dopamine-generating nerve cell precursors into the brain. The candidate is advancing directly to Phase III clinical development following positive Phase I data. The FDA has granted a Regenerative Medicine Advanced Therapy (RMAT) designation for its innovative potential in treating Parkinson's disease.

Through AskBio Bayer is developing an investigational adeno-associated viral (AAV)-based gene therapy for Parkinson's disease that delivers the human glial cell line-derived neurotrophic factor (GDNF) transgene to the brain to potentially restore the function of dopamine-producing neurons. The candidate is advancing in Phase II, with the randomization of participants in the clinical trial. Based on preliminary clinical evidence, FDA granted RMAT to this therapy for its potential to slow disease progression and improve motor outcomes in patients with moderate Parkinson's disease the therapy also received FDA Fast Track designation. In addition the UK Medicines and Healthcare products Regulatory Agency (MHRA) granted it Innovation Passport designation, These US and UK designations further highlight its potential to address the significant global unmet medical need in Parkinson's.