Carisma Therapeutics (US:CARM)2020-05-11 14:40Business Updates & Clinical Development - Patient enrollment in the VISTA trial was completed in March 2018, with all patients finishing treatment and data submitted to the FDA in December 2019[3] - The company anticipates finalizing the BLA submission in 2H 2020, following positive interactions with the FDA [3, 18] - EMA submission for Vicinium is expected in early 2021, with potential approval anticipated in early 2022 [19] Market Opportunity & Research - Market research indicates a large commercial opportunity for Vicinium, supported by a highly differentiated mechanism of action and clinical profile [5, 31] - In Q1 2020, market research showed high-prescribing urologists prefer the Vicinium profile [10] - Urologists would use a branded agent in approximately 80% of their high-risk, BCG-unresponsive patients [11] - The company estimates that approximately 1,500 urologists treat 75% of BCG patients, allowing for efficient commercial targeting [22, 101] Financial Status - As of March 31, 2020, the company's cash and cash equivalents totaled $42.5 million, sufficient to fund key strategic priorities into 2021 [29]