PALI — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-10

• We are a clinical-stage biopharmaceutical company developing next-generation prodrugs for patients with inflammatory and fibrotic diseases. Our lead clinical product candidate, PALI-2108, is being advanced into Phase 2 clinical trials as a treatment for patients living with inflammatory bowel diseas…

• During the first half of 2026, we completed our Phase 1 clinical development program for PALI-2108 and advanced the program into Phase 2 development. In June 2026, the U.S. Food and Drug Administration ("FDA") cleared our Investigational New Drug Application (“IND”) for our global Phase 2 ASCENTRA-U…

• We are developing a biomarker-based patient selection approach that we believe may aid clinicians in identifying patients who may better respond to PALI-2108, thereby improving the rate of clinical response previously demonstrated with PDE4 inhibitors. Our approach involves the use of clinical and m…

• The Phase 1 clinical study of PALI-2108 consisted of a single-center study evaluating the safety, tolerability, pharmacokinetics (“PK”) and pharmacodynamics ("PD") of PALI-2108 in healthy volunteers, patients with UC and patients with fibrostenotic Crohn's disease ("FSCD"). The clinical study includ…

• On October 9, 2024, Health Canada issued a No Objection Letter for our Phase 1 human clinical study of PALI-2108. The study of the SAD, MAD and FE cohorts and the Phase 1b UC patient cohort commenced on November 7, 2024.

Text removed vs the prior filing · source: 10-Q · 2026-05-12

• We are a clinical-stage biopharmaceutical company developing next-generation, once-daily, oral phosphodiesterase-4 (“PDE4”) inhibitor prodrugs designed for targeted delivery to the terminal ileum and colon. Our lead clinical product candidate, PALI-2108, is being developed as a treatment for patient…

• We are developing a biomarker-based patient selection approach that we believe may aid clinicians in identifying patients who may better respond to PALI-2108, thereby improving the rate of clinical response previously demonstrated with PDE4 inhibitors. Our approach involves the use of clinical and m…

• local exposure with controlled systemic distribution, and is engineered to reduce peak plasma levels, thereby improving the overall therapeutic index and reducing tolerability limitations such as diarrhea, nausea and headache that have constrained systemic PDE4 inhibitors.

• The Phase 1 clinical study of PALI-2108 is a single-center, randomized, double-blinded, placebo-controlled clinical study focused on safety, tolerability, and pharmacokinetics (“PK”) in both healthy volunteers and UC patients. The clinical study included an open-label UC patient cohort with multiple…

• On October 9, 2024, Health Canada issued a No Objection Letter for our Phase 1 human clinical study of PALI-2108 for the treatment of UC. We officially began the study on November 7, 2024. We have completed the dosing of 89 subjects across all planned cohorts of the study. Each of the five Single As…

Text added vs the prior filing · source: 10-Q · 2026-08-10

• As previously disclosed, during the quarter ended June 30, 2021, we identified a material weakness in our internal controls over financial reporting due to a lack of controls in the financial closing and reporting process, including a

• lack of segregation of duties and the documentation and design of formalized processes and procedures surrounding the creation and posting of journal entries and account reconciliations. This material weakness contributed to a material weakness in our control activities based on the criteria set for…

• As described below, management has begun designing the plan and executing the remediation actions to address the material weakness and further actions are ongoing as of June 30, 2026. The material weakness continues to be present as of June 30, 2026.

Text removed vs the prior filing · source: 10-Q · 2026-05-12

• As previously disclosed, during the quarter ended June 30, 2021, we identified a material weakness in our internal controls over financial reporting due to a lack of controls in the financial closing and reporting process, including a lack of segregation of duties and the documentation and design of…

• As described below, management has begun designing the plan and executing the remediation actions to address the material weakness and further actions are ongoing as of March 31, 2026. The material weakness continues to be present as of March 31, 2026.

Text added vs the prior filing · source: 10-Q · 2026-08-10

• Foreign regulatory authorities may not accept data generated from our recently completed Phase 1 clinical trial of PALI-2108 in Canada.

• Foreign regulatory authorities may not accept data generated from our recently completed Phase 1 clinical trial of PALI-2108 in Canada.

• We recently completed a Phase 1 clinical trial of PALI-2108 in Canada and have received approval from the FDA to conduct a Phase 2 clinical trial of PALI-2108 in the U.S. However, our Phase 2 clinical trial of PALI-2108 for the treatment of UC is designed as a global trial, and we have not received …

• In addition, regulatory approval for clinical trials and eventual drug approval in foreign jurisdictions can be influenced by several factors, including:

• the adequacy and relevance of the Phase 1 clinical trial data in supporting progression to Phase 2, as evaluated by the foreign regulatory authority;

Text removed vs the prior filing · source: 10-Q · 2026-05-12

• We recently completed a Phase 1 clinical trial of PALI-2108 in Canada, and the U.S. Food and Drug Administration (“FDA”) or applicable foreign regulatory authorities may not accept data generated from trials conducted outside of the U.S.

• We recently completed a Phase 1 clinical trial of PALI-2108 in Canada, and the FDA or applicable foreign regulatory authorities may not accept data generated from trials conducted outside of the U.S.

• We recently completed a Phase 1 clinical trial of PALI-2108 in Canada. However, we have not received approval from the FDA to commence any clinical trials in the U.S., and there is no guarantee that we will be able to obtain such approval in a timely manner, if at all. The FDA’s acceptance of foreig…

• design, patient population, endpoints, and other factors meet the standards expected for clinical trials conducted within the U.S.

• In addition, regulatory approval for clinical trials and eventual drug approval in the U.S. is a complex process, influenced by several factors, including: