NAYA to both leverage Atley's planned network of clinical manufacturing and development partners & deploy additional GMP drug manufacturing sites using the Atley C100 for the final clinical-dose manufacturing of 211 At Targeted Alpha Therapies

MIAMI, FL AND GOTHENBURG, SWEDEN / ACCESS Newswire / September 2, 2025 / NAYA Therapeutics ("NAYA"), a clinical-stage biopharmaceutical company dedicated to pioneering the next generation of cancer therapies through the development of astatine-211 (²¹¹At) targeted alpha therapies (TATs) and NK cell engaging bifunctional antibodies today announced that it has selected Atley Solutions, global leader in commercial products and services for astatine-related pharmaceutical development and manufacturing, as a partner and supplier to accelerate the development, pre-clinical and clinical translation, and commercialization of NAYA's ²¹¹At radiopharmaceuticals. This will involve making use of Atley's radiopharmaceutical manufacturing platform (Atley C100), development services, and planned network of clinical manufacturing and development partners.

"We're thrilled to partner with Atley Solutions, a leader in the advancement of astatine-211 as a preferred radionuclide," commented NAYA CEO Dr. Daniel Teper. "This partnership will enable us to use Atley's scalable and automated Atley C100 manufacturing module, which allows for the purification, conjugation, preparation of therapeutic doses in close proximity to outpatient treatments centers - a breakthrough in unlocking a scalable ²¹¹At supply chain. In addition, we plan to leverage and expand on Atley's planned decentralized manufacturing & clinical development network, allowing us to enroll patients in clinical trials globally, starting with NY-703, our GPC3-targeting ²¹¹At targeted alpha therapy for the treatment of hepatocellular carcinoma."

"Astatine-211's short half-life, clean decay, chelatorless chemistry, and ability to be produced using naturally-abundant Bismuth-209 address key safety & supply limitations of other alpha and beta emitters and make it a highly-promising radionuclide for multiple therapeutic applications," added Milton Lönnroth, CEO of Atley Solutions. "We're delighted to partner with NAYA, one of the pioneering biotech companies advancing astatine-211 therapeutics to clinical and commercial use, and deliver the transformative potential of these therapies to patients."

About Atley Solutions
Atley Solutions is the global leader in commercial products and services for the development and manufacturing of At-211 radiopharmaceuticals. The Atley C100 is the world's only commercial module for automated manufacturing of At-211 radiopharmaceuticals. Atley also offers non-clinical radiopharmaceutical development services and At-211-related targetry. For more, please visit atley.com.

About Atley C100
The Atley C100 is the world's first and only commercial manufacturing system specifically designed for At-211 radiopharmaceuticals. This state-of-the-art platform addresses the critical challenges of At-211 radiopharmaceutical manufacturing, enabling reliable and scalable manufacturing from non-clinical R&D to full-scale commercial rollout. Its process involves two key stages: purification of At-211 from irradiated Bi-209 targets through dry distillation, followed by automated radiopharmaceutical synthesis and purification.

About NAYA Therapeutics
NAYA Therapeutics is pioneering the next generation of cancer therapies, aiming to unlock deeper, more durable responses in patients not responding to current standard-of-care. NAYA's pipeline harnesses the transformational potential of two synergistic modalities: astatine-211 (²¹¹At) targeted alpha therapies & NK cell engaging bifunctional antibodies, with an initial focus on hepatocellular carcinoma (HCC). For more information, please visit www.nayatx.com.

About NY-703
NY-703 is a GPC3-targeting astatine-211 (²¹¹At) targeted alpha therapy for the treatment of residual & metastatic hepatocellular carcinoma (HCC), aiming to achieve initial clinical data in 2026. It consists of a GPC3-antibody fragment F(ab')2 conjugated to an astatine-211 isotope through an optimized proprietary linker. Hepatocellular Carcinoma is a rapidly-growing cancer with an estimated one million new patients every year and a lack of safe and effective therapeutic options. Up to 75% of HCC patients treated with surgery and/or immunotherapy relapse within 5 years, often due to the presence of metastases and minimal residual disease (MRD).

Atley Media & Investor Contact
Milton Lönnroth
Co-Founder & CEO
Phone: +46 (0) 704 34 84 57
info@atley.com

NAYA Media & Investor Contact
Lyn Falconio
Chief Communications Officer
+1-917-575-1844
lyn@nayatx.com

SOURCE: NAYA Therapeutics