Palisade Bio, Inc. (PALI) stock soared 67.07% in the current-market trading session at the price of $1.34 after it received a letter from FDA to proceed with its clinical trial evaluating LB1148.
PALI is a clinical-stage biopharma firm. It produces novel therapies to treat patients with gastrointestinal complications resulting from post-operative enzyme damage.
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PALI Received Study May Proceed Letter
On 22nd March 2022, PALI announced receiving a letter from FDA to proceed with its phase-III clinical trial. The trial evaluates LB1148 to boost the recovery of bowel function in patients undergoing abdominal surgery.
The study is a randomized, multi-centered, double-blinded, placebo-controlled, parallel-group clinical trial. It evaluates the efficacy and safety of LB1148 and has enrolled around 600 participants. PALI plans to commence the phase-III clinical trial by the second half of 2022.
Management Comments
CMO of PALI, Michael Dawson, commented that receiving FDA approval for the phase-III clinical trial is a tremendous landmark for LB1148. The drug could streamline healing from 7 million surgeries annually in the U.S., with a high risk of postoperative ileus. More rapid recovery to bowel function means quicker healing with lesser expenses to the healthcare system.
Michael added that LB1148 has demonstrated a considerable acceleration of recovery of GI function. They are hopeful that the phase-III clinical trial will reconfirm these findings. The clinical trial, if thriving, will lead towards product development and commercialization for the patients.
PALI Year 2021 Financial Results
On 18th March 2022, PALI published its earnings report for the year that ended on 31st December 2021. The company has also presented its business updates. The cash and cash equivalents totaled US$10.5M as of 31st December 2021.
Cash utilized in operations totaled US$14.8M for the year 2021. PALI has R&D costs of US$2.4M for the year 2021. It represents a US$0.7M drop from US$3.1M the prior year. G&A expenses were US$9.3M during 2021, representing a US$3.1M gain from US$6.2M in 2020.
