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• Bayer bolsters development portfolio by acquisition of two investigational imaging agents (AT-01 and AT-05) from Attralus, Inc. to advance diagnosis for cardiac amyloidosis
• PET tracer AT-01 in Phase III and SPECT tracer AT-05 in Phase I of clinical development specifically designed for the diagnosis of cardiac as well as other types of systemic amyloidosis
• Potential to address the growing need for earlier and accurate diagnosis of these often underdiagnosed conditions
• AT-01 (124-Iodine-evuzamitide) is first pan-amyloid imaging agent with U.S. FDA Breakthrough Therapy Designation for cardiac amyloidosis; AT-01 also holds Orphan Drug Designation in U.S. and EU
• Building on its comprehensive radiology portfolio including advanced fluid delivery devices in molecular imaging, Bayer reinforces its ambition to expand in this rapidly growing field by entering the area of diagnostic tracers, while bolstering its position in cardiovascular precision medicine
• Attralus will now focus on advancing its innovative pan-amyloid removal therapeutics, with AT-02 in Phase II and next generation candidates in preclinical development

Bayer, a leading company in key areas of radiology and cardiology, and Attralus, Inc. (Attralus), a clinical stage biopharmaceutical company focused on developing medicines and diagnostics for systemic amyloidosis, today announced that the companies have entered into definitive agreements for Bayer to acquire AT-01 (124-Iodine-evuzamitide) and AT-05 (PAR-Peptide + technetium-99m), two investigational molecular imaging agents for the diagnosis of cardiac amyloidosis, from Attralus. This strategic acquisition reinforces Bayer’s ambition to expand in the rapidly growing field of molecular imaging and supports the company’s broader precision cardiology strategy.

“With this strategic acquisition and the integration of novel molecular tracers into our development portfolio, we are advancing Bayer’s innovation strategy,” said Stefan Oelrich, Member of the Board of Management of Bayer AG and President of Bayer’s Pharmaceuticals Division. “AT-01 and AT-05 are precisely engineered to detect cardiac amyloidosis with high accuracy, enabling timely intervention and improved patient outcomes – a clear extension of our commitment to tackling cardiovascular disease and addressing significant unmet needs.”

The acquired molecular imaging portfolio consists of AT-01 (124-Iodine-evuzamitide, a tracer for Positron Emission Tomography; PET) in Phase III of clinical development and AT-05 (PAR-Peptide + technetium-99m, a tracer for Single Photon Emission Computed Tomography; SPECT) in Phase I of clinical development, focused on the diagnosis of cardiac amyloidosis. The development of these tracers has the potential to address the urgent need for earlier and accurate diagnosis of systemic and specifically cardiac amyloidosis, a rarely diagnosed and often fatal heart disease that affects an estimated 400,000 people globally. With current methods, these conditions are often underdiagnosed and difficult to detect.

“With new therapies emerging for often insufficiently treated conditions such as cardiac amyloidosis, it becomes increasingly relevant to precisely detect and monitor diseases on the molecular level,” said Nelson Ambrogio, President Radiology at Bayer. “This acquisition marks our entry into diagnostic tracers. Leveraging our expertise in medical imaging – including our pipeline and portfolio in advanced fluid delivery devices for nuclear medicine – it supports our ambition to expand in the growing field of molecular imaging. Building on Attralus’ research and development expertise, we will further advance scientific progress with the aim to broaden diagnostic options and make a meaningful difference for people living with cardiac amyloidosis.”

The global market for radio-diagnostic tracers was valued at approximately 3 billion USD in 2024 and is projected to grow significantly in the coming years. With its comprehensive portfolio in Radiology, its expertise in medical imaging and clinical development and global commercial infrastructure, Bayer is uniquely positioned to accelerate innovation and deliver integrated offerings that address evolving clinical needs and have the potential to improve patient outcomes worldwide.

“We are excited to finalize this agreement with Bayer, whose expertise and global footprint in radiology will help to accelerate the development and launch of AT-01 and AT-05, our two novel diagnostic imaging agents for systemic amyloidosis,” said Glen Firestone, President of Attralus. “Despite recent progress in systemic amyloidosis, most patients continue to remain undiagnosed or are diagnosed too late in their disease progression. Consistent with Attralus’ mission, we believe that these pan-amyloid imaging agents will enable earlier diagnosis and treatment, leading to improved patient outcomes. Bayer’s commitment to scientific rigor and patient impact makes them well-suited to bring these agents to clinicians and patients worldwide. Attralus will now focus on advancing its innovative pan-amyloid removal therapeutics, with AT-02 in Phase II and next generation candidates in preclinical development.”

The financial details of the acquisition were not disclosed.

About AT-01 and AT-05

AT-01 (124-Iodine-evuzamitide) is a non-invasive pan-amyloid PET (Positron Emission Tomography) imaging agent specifically designed for accurate diagnosis of amyloid disease, including in the heart. AT-01 utilizes a proprietary pan-amyloid binding peptide labeled with iodine-124 as an amyloid-specific radiotracer to detect all types of systemic amyloidosis using PET imaging. In clinical trials, AT-01 has been observed to detect multiple types of amyloid deposits with high sensitivity and specificity, including ATTR (transthyretin amyloid cardiomyopathy) and AL (light chain amyloidosis), in major organs such as the heart, kidney, liver, and spleen. AT-01 is one of the first investigational diagnostic imaging agents to receive Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration, and the only diagnostic imaging agent that has received BTD for cardiac amyloidosis. The compound has received orphan drug designation as a diagnostic for the management of ATTR and AL amyloidosis in the U.S. and the EU. The Phase III study REVEAL with AT-01 in patients with suspected cardiac amyloidosis is ongoing and has completed dosing as of the time of this release.

AT-05 (PAR-Peptide + technetium-99m) is a Single Photon Emission Computed Tomography (SPECT) tracer currently in Phase I development. It represents an additional diagnostic option using SPECT technology, which could broaden patient access.

About Cardiac Amyloidosis

Cardiac amyloidosis is a spectrum of diseases caused by the abnormal build-up of a protein, called amyloid, in the heart tissue. These deposits accumulate between the heart cells, making the heart muscle thick and stiff, preventing it from pumping blood effectively and leading to heart failure and heart rhythm problems. Advanced stages of cardiac amyloidosis can result in cardiomyopathy. Cardiac amyloidosis may be an underlying condition in a relevant portion of patients with heart failure.

Clinical recognition of cardiac amyloidosis at an early stage of the disease is important for adequate and effective patient management with existing therapeutic options. The disease is often diagnosed late, when the accumulation of amyloid has already occurred, and patients have irreversible loss of heart function and diminished quality of life.

As a leader in cardiology, Bayer is advancing a portfolio of innovative treatments in cardiovascular diseases of high unmet medical need. The company is accelerating its shift towards precision cardiology to advance patient outcomes. Bayer’s portfolio already includes several innovative products – from diagnosis to care – including Beyonttra™ (acoramidis) for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM), and compounds in various stages of preclinical and clinical development.

About Molecular Imaging

Molecular imaging allows clinicians to visualize and quantify biological processes at the molecular and cellular level in real time, enabling earlier disease detection and personalized treatment planning. Bayer is committed to advancing this field through innovative technologies and strategic collaborations.

About Radiology at Bayer

Building on a century of expertise, Bayer is committed to innovative products and high-quality services in diagnostic imaging to enhance patient care. As a leader in key areas of radiology, the company’s portfolio features contrast agents and devices for precise administration across modalities including computed tomography (CT), X-ray and magnetic resonance imaging (MRI), and positron emission tomography (PET). Bayer’s comprehensive offerings also include informatics solutions. In 2024, Bayer’s radiology products generated €2.1 billion in sales. Bayer continues to advance research and innovation in medical imaging, including in molecular imaging.

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 www.bayer.com.

About Attralus

Attralus is a clinical stage biopharmaceutical company focused on creating transformative medicines and diagnostics to improve the lives of patients with systemic amyloidosis. The company’s proprietary pan-amyloid removal (PAR) therapeutics are designed to directly bind to and remove toxic amyloid in organs and tissues. By targeting the disease-causing pathology in systemic amyloidosis diseases, PAR therapeutics have the potential to treat and reverse disease in patients with all types and stages of systemic amyloidosis. Attralus was founded by scientific experts in the field of amyloidosis and the company is headquartered in Naples, FL.

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ko (2026-0015e)

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.

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