Better Therapeutics (Nasdaq:BTTX) posted second-quarter quarter results today that beat the consensus forecast on Wall Street as it prepared to submit its first product for FDA review.
Better Therapeutics has not yet generated revenue from the commercialization or sale of any product. The company went public through a special purpose acquisition company merger in October.
The San Francisco-based prescription digital therapeutics developer reported a loss of $9.9 million, or -$0.42 per share, for the three months ended June 30. That’s a 15% larger loss than the same quarter last year, but 3¢ better than analysts’ expectations of a $0.45 loss.
Better Therapeutics said last month it would seek FDA De Novo classification in Q3 for its first product, the BT-001 therapy for adults with uncontrolled type 2 diabetes.
New President and CEO Frank Karbe said today that the company is on track to submit BT-001 this quarter.
“Better Therapeutics is poised to enter the next phase of its growth as a commercial company, with the recent completion of the BT-001 pivotal trial and, if authorized by the FDA, the potential launch of our first-in-class prescription digital therapeutic for the treatment of type 2 diabetes next year,” Karbe said in a news release. “The pivotal trial of BT-001 met its primary and secondary endpoints and demonstrated a reassuring safety profile in a diverse and difficult to treat patient population, resulting in significant A1c reductions when compared with the current standard of care.”
R&D expenses for the quarter decreased to $4.2 million from $5 million in Q2 2021. Clinical study costs decreased due to the BT-001 pivotal trial wind-down, but personnel and consulting costs increased to prepare the FDA submission and expand clinical research and software development capabilities, the company said.
Investors reacted by sending BTTX shares up less than 2% to $1.81 at mid-day.