Cassava Sciences, Inc. Q2 FY2024 earnings call

• Phase III Trials: Progressed with Phase III trials; expect last patient/last visit in ReTHINK trial in early Q4 and topline data by year-end; ReFOCUS trial to readout in mid-year. - Financing: Raised $123 million from warrant distribution, bolstering the balance sheet. - Open-Label Extensions: Lengthened open-label extension trials for Phase II and III patients, with 89% of patients choosing to continue. - Commercial Preparation: Ramping up active pharmaceutical ingredient purchases and securing manufacturing capacity in preparation for commercial launch. - SEC Settlement: Took a $40 million reserve for potential settlement with the SEC, with ongoing constructive conversations with the SEC and DOJ.

At the end of the June quarter, Cassava Sciences had $207.3 million in cash. Net income in the second quarter was $6.2 million, contrasting with a net loss of $26.4 million in the same period of 2023. Research and development expenses in the second quarter were $15.2 million, a decrease from $25 million in the corresponding period of 2023, mainly due to the completion of patient screening and enrollment for Phase III clinical programs in fall 2023. The company expects to end 2024 with a cash balance ranging from $117 million to $127 million.

• End 2024 cash balance expected to be between $117 million and $127 million. - Anticipate last patient/last visit in ReTHINK trial in early Q4 and topline data by year-end; ReFOCUS trial to readout in mid-year.

• There is a potential $40 million loss contingency related to the settlement with the Securities and Exchange Commission.

Q: Could you describe the key driver for the discontinuation dropout rate of about 20% to 22%?

A: The most typical reason is study fatigue, patient fatigue, and withdrawal of consent.

Q: Regarding ADAS-Cog12 as the endpoint, is it still appropriate and any FDA guidance?

A: ADAS-Cog12 is appropriate for the mild to moderate population as agreed with the FDA earlier.

Q: Will biomarkers be part of the topline announcement for ReTHINK?

A: Hoping to have some biomarker data available later this year.

Q: How was the figure of $40 million for potential SEC settlement arrived at?

A: Still in discussions with the SEC, and it's not appropriate to give more details.

Q: Analyzed worldwide demand for Simufilam and steps to deliver quickly after approval?

A: Interviewing firms for commercial plan, beefing up active pharmaceutical ingredient, and seeking additional manufacturing capacity