Ascelia Pharma (ACE) DNB Carnegie Småbolagsdag summary

Company overview and mission

• Focuses on developing new drugs for rare cancer conditions, addressing unmet needs in cancer treatment.

• Lead product is a liver-specific imaging agent for MRI scans, targeting patients with cancer that has spread to the liver.

• Uses manganese as a safer alternative to gadolinium, reducing risk for patients with kidney issues.

• Holds orphan drug designation from the FDA, providing regulatory and market advantages.

Product development and clinical progress

• Lead product, Orviglance, is in the final stages of FDA review, with expected approval around July 3rd next year.

• Completed nine clinical studies, including a pivotal phase III trial (Sparkle) showing strong results.

• Phase III study demonstrated improved detection of small liver lesions compared to unenhanced MRI.

• Orviglance is administered orally as a powder mixed with water, offering a unique safety profile.

Market positioning and patient impact

• Targets patients needing liver imaging, especially those with significant kidney problems (about 5% of liver cancer cases).

• Market research shows 60% of these patients currently receive suboptimal imaging without contrast agents.

• Accurate imaging is critical for timely and effective cancer treatment decisions.

• Orviglance provides high-quality images without the risks associated with gadolinium.