Mountain Crest Acquisition Corp. II

Third-quarter 2023 operating expenses were $5.3 million, down from $7 million in Q2 2023 and $11 million in Q3 2022. R&D was $1.8 million versus $5.5 million a year ago; sales and marketing was $1.4 million versus $1.6 million; G&A was $2.1 million versus $4 million; and interest expense was $500,000 versus $400,000. Net loss was $5.9 million, or $0.15 per share, versus $11.4 million, or $0.48 per share, last year. Cash and cash equivalents were $6.6 million at September 30, 2023; after the October ATM raise of $2.9 million, pro forma cash was $9.5 million. Management said this extends runway into the first quarter of 2024. No quarterly revenue or EPS guidance was provided; Frank Karbe said revenue guidance will begin only after the company has at least two to three quarters of commercial experience.

Frank Karbe framed the quarter as a transition from R&D to commercialization, emphasizing that FDA authorization has been secured and the product is now in market. His tone was optimistic but measured: he repeatedly pointed to payer discussions, provider interest, and the possibility of early commercial traction as the next de-risking steps. He also highlighted broader strategic opportunities, including a planned breakthrough device request for MASLD/MASH, a business development partnership, and the potential for AspyreRx to pair with GLP-1 therapies.

Mark Heinen focused on improved expense control and runway management. He cited operating expense reductions to $5.3 million, lower R&D and G&A costs from the completed pivotal trial and restructuring, and said the October ATM raised $2.9 million, bringing pro forma cash to $9.5 million. He also noted that Hercules loan payments restarted on November 1 and that the company is discussing potential amendments with Hercules.

Analysts pressed on launch staffing, payer coverage timing, pricing, and the impact of FDA’s PDURS guidance. Management said the initial team will be about 10 people, focused on priority geographies, while payer engagements are nationwide and are progressing toward a first agreement expected by year-end. On pricing, the company reiterated a $750 list price for a 90-day course and a $65 self-pay option, and said the PDURS guidance could help support combo use cases, including with GLP-1s, by making the added value of digital therapy more visible in labeling.