Palisade Bio(US:PALI)2025-11-10 21:14Financial Performance - The company reported a net loss of $2.868 million for the three months ended September 30, 2025, a decrease of 18% compared to a net loss of $3.487 million in the same period of 2024[144]. - Net loss for the nine months ended September 30, 2025, was $7.9 million, a reduction of 29% compared to a net loss of $11.1 million in 2024[151]. - The company expects to incur substantial operating losses for the foreseeable future and will require additional funding for future clinical activities[161]. - The company has incurred significant operating losses and negative cash flows since inception, with no significant revenues generated to date[176]. Operating Expenses - Total operating expenses for the three months ended September 30, 2025, were $2.922 million, down 19% from $3.593 million in the same period of 2024[144]. - General and administrative expenses increased by 5% to $1.528 million for the three months ended September 30, 2025, compared to $1.456 million in the same period of 2024[144]. - Research and development expenses decreased by approximately $0.7 million, or 35%, for the three months ended September 30, 2025, primarily due to a $1.1 million decrease in preclinical joint development expenses related to PALI-2108[145]. - General and administrative expenses decreased by approximately $0.4 million, or 10%, for the nine months ended September 30, 2025, compared to the same period in 2024[158]. - Total operating expenses for the nine months ended September 30, 2025, were $8.1 million, a decrease of 30% from $11.5 million in 2024[151]. Cash Flow and Financing - Cash used in operating activities was approximately $7.7 million for the nine months ended September 30, 2025, down from $9.8 million in 2024[169]. - Cash provided by financing activities for the nine months ended September 30, 2025, was approximately $3.1 million, primarily from net cash proceeds of approximately $3.5 million from the exercise of common stock warrants[172]. - The October 2025 Offering generated gross proceeds of approximately $138 million, which will fund operations through major clinical development milestones[162]. - The company has a cash and cash equivalents balance of $138 million from an underwritten public offering that closed on October 2, 2025, sufficient to fund operations through major clinical development milestones[176]. - Cash provided by financing activities for the nine months ended September 30, 2024, was approximately $5.4 million, attributed to net cash proceeds from common stock warrants and private placement financing[173]. Clinical Development - The company completed dosing of 89 subjects in the Phase 1 clinical study of PALI-2108, which included five Single Ascending Dose cohorts and four Multiple Ascending Dose cohorts[129]. - Positive results were announced from the Phase 1 clinical study, with all five patients in the UC cohort demonstrating rapid and consistent clinical activity[130]. - The exploratory Phase 1b cohort in FSCD is expected to be followed by Phase 2 clinical programs to assess PALI-2108's efficacy, safety, and tolerability[132]. - The company anticipates submitting an Investigational New Drug Application to the FDA in the first half of 2026 based on data from the exploratory Phase 1b cohort and Phase 1a/1b UC program[133]. - PALI-2108's Phase 1 clinical trial commenced in November 2024, with top-line results reported in Q2 and Q3 2025[147]. Milestones and Obligations - A development milestone payment of $235,000 is owed to Giiant upon the dosing of the first patient in a Phase 1b clinical trial of PALI-2108, which was achieved on October 16, 2025[174]. - The company will settle the milestone payment to Giiant in cash within 30 days of the milestone being met[174]. - The company recognized a non-cash loss of approximately $0.3 million in the nine months ended September 30, 2025, due to the fair value remeasurement of the contingent consideration liability[157]. Research and Development - Research and development expenses decreased by approximately $3.0 million, or 42%, for the nine months ended September 30, 2025, compared to the same period in 2024[152]. - Clinical trial-related expenses increased to approximately $2.4 million for the nine months ended September 30, 2025, compared to $0.4 million in 2024[156]. - The company has initiated the development of biomarker assays for PDE4-related biomarkers to improve patient selection for PALI-2108[124]. Accounting and Reporting - The company has not reported significant changes in critical accounting policies and estimates since the last Annual Report[178]. - The company is considered a smaller reporting company and is not required to provide certain market risk disclosures[180].