By Chris Wack


Spero Therapeutics Inc. shares were down 66% to $1.71 after the company said it would immediately defer current commercialization activities for tebipenem HBr and cut its workforce by 75%.

The stock hit its 52-week low of $1.50 earlier in the session. The stock is now down 89% year-to-date.

The company said the moves were based on feedback from a recent Late Cycle Meeting with the U.S. Food and Drug Administration regarding its New Drug Application for tebipenem HBr.

The biopharmaceutical company said that although the review is still continuing and the FDA hasn't yet made any final determination regarding approvability, the discussion suggested that the data package may be insufficient to support approval during this review cycle.

Due to this development, Spero said it is reducing its workforce by 75%, and restructuring its operations to reduce operating costs and reallocate resources toward the clinical development programs of SPR720 and SPR206, while continuing engagement with the FDA on the appropriate path forward for tebipenem HBr.

Based on the anticipated cost-savings of this restructuring and other assumptions, Spero believes it would be able to fund its planned operating expenses and capital expenditure requirements with the priorities of its strategic refocusing through late 2023.

Spero ended the fourth quarter and 2021 with an estimated $146.4 million in cash. The company's strategic refocusing now prioritizes advancing SPR720 and SPR206 to Phase 2 milestones and includes key deliverables through 2024.


Write to Chris Wack at chris.wack@wsj.com


(END) Dow Jones Newswires

05-03-22 1332ET