Cassava Sciences, Inc.

Pain Therapeutics reported Q3 2018 cash on hand of $20.4 million, after raising approximately $12.3 million in equity financing during the quarter. R&D expense was $0.4 million, down from $1.6 million in the same period last year, a 73% decrease; G&A was $0.8 million vs. $1.0 million, down 13%; net loss was $1.3 million vs. $2.6 million, and net loss per share was $0.11 vs. $0.40. The company also said it received $1.1 million in NIH grant reimbursement during the quarter, and reiterated full-year 2018 cash utilization of $5 million to $6 million. For the pipeline, management said the Alzheimer’s Phase IIa study should begin by the end of calendar 2018, with Phase IIb expected to start in mid-2019; NIH grants for the program total up to $6.7 million, and warrant exercises could add up to $11.5 million.

Remi Barbier spent most of his remarks on two strategic priorities: pushing the Alzheimer’s program forward and continuing to pursue REMOXY after the FDA said in August that its benefits do not outweigh its risks. He was upbeat about the science behind PTI-125, calling it a first-in-class approach centered on filamin A, and said the Phase I data supported further development. At the same time, his tone on REMOXY was skeptical and frustrated, saying he viewed the FDA’s decision as a “bizarre conclusion” and warning that the formal dispute resolution is a necessary procedural step but may not change the outcome.

Eric Schoen, in his first full-time call as CFO, emphasized financial strength and lower spending. He highlighted approximately $12.3 million raised in Q3 equity financing, $20.4 million in cash at quarter-end, and up to $11.5 million of additional cash if warrants are exercised; he also pointed to up to $6.7 million of non-dilutive NIH grant support. On expenses, he said R&D was $0.4 million vs. $1.6 million a year ago, G&A was $0.8 million vs. $1.0 million, and the quarter’s net loss was $1.3 million vs. $2.6 million, while full-year 2018 cash usage is expected to be $5 million to $6 million.

The main analyst question focused on the Alzheimer’s target and the cognition endpoint. Remi explained that the target is filamin A, described the biology as a scaffolding protein tied to altered protein folding in Alzheimer’s, and said PTI-125 had shown animal-model effects including reduced amyloid deposits, reduced neuroinflammation, improved insulin receptor signaling, and improved learning and memory. On the clinical design, he said the Phase IIb study will use a cognition assay he identified as Cox 8 and stressed that, because the studies are small, the goal is not statistical significance but directional biomarker changes and target engagement.