The company’s quarterly results come on the heels of a 35% headcount reduction. Better Therapeutics said the headcount cut comes as part of a cost reduction initiative. It aims to improve its cash runway and “focus on the long-term success of the company.”
Better Therapeutics develops a range of digital therapeutics, including BT-001 for treating type 2 diabetes. The company submitted an FDA de novo request in September 2022 for the therapeutic.
Shares of BTTX rose 10% to 70¢ apiece in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — rose 0.45%.
In the quarter, the San Francisco-based digital therapeutics developer posted losses of $8.8 million. That amounts to 37¢ per share. It marks a year-over-year improvement on the bottom line from losses of $13.9 million in Q4 2021.
Adjusted to exclude one-time items, losses per share totaled $1.69, falling $1.18 behind Wall Street expectations.
“Better Therapeutics made significant progress in 2022 highlighted by the successful completion of our pivotal clinical trial of BT-001 in type 2 diabetes, the submission of our de novo classification request to the FDA seeking marketing authorization for BT-001 and the positive topline results from our exploratory trial for fatty liver disease,” said Frank Karbe, president and CEO of Better Therapeutics. “Despite our recent restructuring, the long-term outlook for the potential of our digital therapeutics’ platform and our guidance for potential FDA authorization remains unchanged, and we continue to prepare for commercial launch.”
Better Therapeutics aims big in 2023
With a restructuring plan in place to extend its financial runway, Better Therapeutics has lofty goals in 2023.
First, the company commenced preparations for the potential launch fo BT-001 in mid-2023, should the company receive FDA authorization. Better Therapeutics also has a randomized, controlled real-world trial for BT-001. It expects results in the fourth quarter of 2023.
The company also said it plans to apply for FDA breakthrough device designation for its investigational liver therapeutic. The prescription digital therapeutic treats nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH). Better Therapeutics expects to submit its application in the first half of 2023.