Press Release: Biograil and CSL Sign Collaboration Agreement for development of certain CSL compounds using Biograil’s proprietary BIONDD™ technology.

COPENHAGEN, DENMARK, July 17th, 2024 – Biograil ApS, a Copenhagen based biotech company developing a unique oral device for delivery of therapeutics that would otherwise have to be injected, has signed a Collaboration Agreement with CSL Behring Lengnau AG (CSL), a subsidiary of CSL Limited, headquartered in Melbourne, Australia. After obtaining successful early feasibility data, CSL and Biograil agreed to expand their collaboration. The agreement includes upfront payments and research funding and an option to enter into an exclusive license incorporating a signing fee, development and commercial milestones, and royalties on product sales.

Under the agreement, CSL and Biograil will work together to advance BIONDD™, the Biograil drug delivery technology with respect to certain CSL proprietary compounds, seeking to achieve effective oral drug delivery of a compound which is injected today.

Biograil CEO Karsten Lindhardt said: “We have generated promising early feasibility data which demonstrates the potential for oral delivery of select CSL candidate drug compounds with the BIONDD™ technology”. “Biograil is thrilled about this agreement with CSL, being a key leader in several pharmaceutical fields. The collaboration provides additional solid external confidence to the Biograil platform and further strengthens our commitment to bring this important technology to the market. Our goal is to provide relief and benefit to many patients by replacing frequent injections with an easy to swallow oral capsule, convenient and seamless for patients to take.”

About Biograil Aps

Biograil is a Copenhagen based biotech company developing pharmaceutical products based upon the BIONDD™ device contained in a standard size capsule able to deliver active therapeutics into the gastrointestinal wall to be effectively distributed in the human body. Such therapeutics can be currently marketed products, including multi-billion-dollar injectable pharmaceuticals or new chemical entities that cannot otherwise be delivered orally. The Biograil device uses a novel mechanism to facilitate the delivery of active substances i.e., biologics, efficiently into the gastrointestinal wall utilizing a proprietary platform technology manufactured by injection molding. The team behind Biograil is a combination of seasoned entrepreneurs with extensive experience in creating successful biotech companies as well as R&D executives behind the world’s first injection molded oral tablet approved by the FDA. The Biograil investor syndicate is formed by Megatrend Invest (Denmark), Verve Investment, High-Tech Gründerfonds, Eli Lilly and Co., Sanner Ventures, Evonik Venture Capital and Roquette Ventures.

About CSL

CSL (ASX:CSL) (USOTC:CSLLY) is a global biotechnology company with a dynamic portfolio of medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses: CSL Behring, CSL Seqirus and CSL Vifor – provides products to patients in more than 100 countries and employs 32,000 people. For more information about CSL, visit www.CSL.com.