PALI — what changed in the latest 10-Q

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

• Our lead clinical product candidate, PALI-2108, is a once-daily, oral prodrug designed for targeted delivery of PDE4 inhibition to the terminal ileum and colon through local bacterial bioactivation. The prodrug is pharmacologically inactive until it reaches the lower intestine, where bacterial enzym…

• 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.

• On March 30, 2026, we announced positive results from the exploratory Phase 1b cohort in FSCD. The study demonstrated favorable safety and tolerability, robust PD target engagement in ileal tissue, and encouraging early signals of clinical activity in the five patients with FSCD that were dosed. We …

• We anticipate dosing the first patient in a Phase 2 clinical trial to assess PALI-2108’s efficacy, safety, and tolerability in patients with moderate to severe UC in the third quarter of 2026.

• In addition to conducting clinical studies in Canada, we anticipate the results from the Phase 1/1b UC program together with the data from the exploratory Phase 1b cohort in FSCD will support Investigational New Drug Application (“IND”) submissions to the FDA for a Phase 2 UC study in the second qua…

Text removed vs the prior filing · source: 10-Q · 2025-11-10

• Our lead product candidate, PALI-2108, is a prodrug inhibitor designed to help treat UC and FSCD by targeting the key PDE4 in colon tissues and preventing it from breaking down cyclic Adenosine Monophosphate (“cAMP”) molecules that regulate inflammation in the body. By inhibiting PDE4, intracellular…

• elevated, which may lead to a reduction of inflammatory molecules and an increase of anti-inflammatory molecules within tissues of the colon. Additionally, we believe that PALI-2108 may help prevent the movement of inflammatory cells from the blood into colon tissues, thereby lowering the activity o…

• The exploratory Phase 1b cohort in FSCD is expected to be followed by the initiation of Phase 2 clinical programs to assess PALI-2108’s efficacy, safety, and tolerability in patients with FSCD, as well as those with moderate to severe UC.

• In addition to conducting clinical studies in Canada, we anticipate data from the exploratory Phase 1b cohort in FSCD together with results from the Phase 1a/1b UC program will support an Investigational New Drug Application (“IND”) submission to the United States Food and Drug Administration ("FDA"…

• On October 2, 2025, we closed on an underwritten public offering to issue and sell 197,154,844 shares of common stock and common stock equivalents for gross proceeds, including the full exercise of the underwriter's over-allotment option, of approximately $138.0 million prior to deducting underwriti…

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

• We have hired or contracted with additional finance and accounting employees with appropriate experience, certification, education and training.

Text removed vs the prior filing · source: 10-Q · 2025-11-10

• remediation efforts summarized below, which have been or are in the process of being implemented, are intended to address the identified material weakness.

• We have hired or contracted with additional finance, accounting and information technology employees with appropriate experience, certification, education and training.

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

• Risks Related to Healthcare Laws and Other Legal Compliance Matters

• Recent and future changes in healthcare legislation and regulations may increase the difficulty and cost to obtain marketing approval for a drug candidate, increase the costs to commercialize an approved product, and adversely affect the price set for such product.

• Our business operations and current and future relationships with contractors, investigators, healthcare professionals, consultants, third-party payors, patient organizations, customers, and others will be subject to applicable healthcare regulatory laws, which could expose us to penalties.

• Our product candidates, including our lead clinical product candidate, PALI-2108, may cause undesirable side effects or have other unexpected properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in post-approval regulatory act…

• Risks Related to Healthcare Laws and Other Legal Compliance Matters

Text removed vs the prior filing · source: 10-Q · 2025-11-10

• Even if PALI-2108 is approved for commercialization, future regulatory reviews or inspections may result in its suspension or withdrawal, closure of a facility or substantial fines.

• The successful commercialization of PALI-2108, if approved, will depend in part on the extent to which government authorities and health insurers establish adequate reimbursement levels and pricing policies.

• We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability for a product candidate and we may need to limit our commercialization.

• Even if a product candidate obtains regulatory approval, it may fail to achieve the broad degree of physician and patient adoption and use necessary for commercial success.

• Our common stock could be delisted from the Nasdaq Stock Market if we are unable to maintain compliance with the Nasdaq Stock Market’s continued listing standards.