Better Therapeutics (Nasdaq:BTTX) shares fell today after its first-quarter earnings report included a wide-ranging business update.
Shares of BTTX fell 3.2% at 76¢ apiece in mid-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — fell 0.2%.
Better Therapeutics recorded a net loss of $9.4 million, compared to $9.7 million for the same period in 2022. On a per common share basis, net loss totaled 39¢, while analysts expected harsher losses of 74¢ per share.
The San Francisco-based digital therapeutic developer reported that it responded to a February request for information from the FDA. It relates to the company’s de novo submission for BT-001, a digital therapeutic for treating type 2 diabetes. The company submitted an FDA de novo request in September 2022 for the solution. FDA review remains ongoing and Better Therapeutics said it expects a decision to come in the middle of the year.
The company anticipates a commercial launch within a few months of that decision, should the FDA approve the submission.
Better Therapeutics reports other highlights
Additionally, Better Therapeutics noted that it implemented a number of cost-saving measures to further extend its cash runway. That includes a 35% workforce reduction announced in March. (Read here for a list of recent layoffs around the medtech industry.)
Last month, Better Therapeutics also announced a private placement of nearly 7.9 million shares of its common stock. It picked up gross proceeds of approximately $6.5 million.
The company commenced FDA breakthrough device designation submission work for two investigational treatments as well. Better Therapeutics expects to submit treatments for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) in the third quarter of 2023.
“We successfully navigated several challenges in the first quarter of this year, laying the foundations for long-term success. The reduction in force, coupled with the completion of a private placement financing, extended our cash runway sufficiently to reach multiple significant milestones,” said Frank Karbe, president and CEO of Better Therapeutics. “We look forward to a decision from the FDA on our de novo submission within the next 90 days and remain focused on preparing for the potential commercial launch of BT-001 in type 2 diabetes.”