Xspray Pharma

Business and Financial Review • Apr 22, 2024

Xspray Pharma Announces Fourth Product Candidate, targeting USD 2.3 billion Market

STOCKHOLM, Sweden – Xspray Pharma AB announces the strategic decision to advance its fourth product candidate XS015 into clinical trials. The decision follows the successful scale-up of its innovative amorphous solid dispersion (ASD) formulation of the active substance cabozantinib, used in renal cell carcinoma and other cancers. This initiative targets the U.S. market for cabozantinib, projected to reach approximately USD 2.3 billion by 2026.

Using its proprietary HyNap™ technology, Xspray has enhanced the solubility and bioavailability of drugs, improving efficacy and patient outcomes for treatments like cabozantinib. The technology enables the delivery of products with better therapeutic outcomes, increased patient compliance, and fewer side effects. Today's announcement of the decision to advance the product candidate XS015 into clinical trials has been made possible by the successful scale-up of the company's ASD-formulation of cabozantinib.

Xspray is currently in the final phase of preparation for the anticipated launch of its first product, Dasynoc™, on September 1, 2024 pending final FDA approval. This launch marks a pivotal moment as the first output from Xspray's development pipeline and reflects significant de-risking achievements for upcoming products such as cabozantinib, notably due to synergies found in the development processes of similar PKI class of compounds.

After today's announcement, Xspray's product candidate portfolio has four announced product candidates based on the company's HyNap platform: XS004 dasatinib and XS003 nilotinib for treatment of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL), and XS008 axitinib and XS015 cabozantinibn used for treatment of kidney cancer. These are improved, amorphous versions of established and marketed protein kinase inhibitors. [CH1]

As Xspray has decided to take a new product candidate to clinical trials and the portfolio moves towards commercial launch, these developments underscore the company's commitment to innovating cancer treatment, potentially transforming standards of care in oncology.

For further information, please contact:

Kerstin Hasselgren Senior Advisor & Investor Relations Xspray Pharma AB Mob: +46 (0) 70 311 16 83 E-mail: kerstin.hasselgren@xspray.com

About Xspray Pharma

About Xspray Pharma AB

Xspray Pharma AB (publ) is a pharmaceutical company focused on the development of improved PKIs for cancer treatment, leveraging its proprietary HyNap™ technology platform. The company aims to enhance clinical outcomes for cancer patients by improving the efficacy, safety, and patient experience of existing cancer therapies. Xspray Pharma's shares are traded at Nasdaq Stockholm (Nasdaq Stockholm: XSPRAY). For more information about Xspray Pharma AB and its innovative approach to cancer treatment, please visit www.xspraypharma. com.

This information is information that Xspray Pharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2024-04-22 16:12 CEST.

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Xspray Pharma Announces Fourth Product Candidate, targeting USD 2.3 billion Market