Carisma Therapeutics (US:CARM)2020-06-03 20:07Regulatory & Clinical Updates - A BLA amendment was filed in May 2020 to further support the favorable safety and tolerability profile of Vicinium[4, 5, 6] - The PPQ campaign is expected to begin in June 2020 to demonstrate analytical comparability[4, 7] - CHMP provided CMC advice on May 29, 2020, supporting a clear regulatory path forward in Europe, aligning with global standards issued by the ICH[4, 9] - The MAA for Vicinium is expected to be submitted to the EMA in early 2021, with potential approval anticipated in early 2022[9] - Phase III trial data shows a 40% complete response rate (CRR) at 3 months for CIS patients[47, 48] - 76% of patients are cystectomy-free for 3 years based on Phase III trial data[47, 48, 62] Financial Status - The company had cash and cash equivalents of $425 million as of March 31, 2020[13] - Net proceeds from the ATM facility were $19 million in 4Q 2019, $32 million in 1Q 2020, and an estimated $30 million in April/May 2020[13] - Approximately $26 million remains available on a $35 million ATM facility[13] Commercial Opportunity - The company estimates that approximately 1500 urologists treat 75% of BCG patients, allowing for efficient targeting[81, 97]