ADDED
Shares of common stock held by each executive officer and director and by each other person who may be deemed to be an affiliate of the registrant, have been excluded from thi s computation.
As of March 18, 2026, the registrant had 165,884,817 shares of c ommon stock, $0.01 par value per share, outstanding.
The proxy statement will be filed with the Securities and Exchange Commission within 120 days of the registrant s fiscal year ended December 31, 2025.
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.
Risks Related to Our Dependence on Third Parties We currently rely on and we intend to continue to rely on third-party Contract Research Organizations ("CROs") and other third parties to conduct and oversee our clinical trials.
Risks Related to Our Financial Operations We have a history of net operating losses, and we expect to continue to incur net operating losses and may never achieve profitability.
Any reference to common shares or common stock, refers to our $0.01 par value common stock.
Company Overview 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 Strategy We are committed to advancing a next generation of once daily, oral PDE4 inhibitor prodrugs to improve pharmacology, tolerability and convenience for patients with inflammatory and fibrotic diseases.
REMOVED
Shares o f common stock held by each executive officer and director and by each other person who may be deemed to be an affiliate of the registrant, have been excluded from this computation.
As of March 19, 2025, the registrant had 4,396,646 shares o f common stock, $0.01 par value per share, outstanding.
Forward-looking statements may include, but are not limited to, statements about: the results of our preclinical and clinical trials; estimates about the size and growth potential of the markets for our product candidates, and our ability to serve those markets, including any potential revenue to be realized; future regulatory, judicial, and legislative changes or developments in the United States ("U.S.") and foreign countries and the impact of these changes; our ability to successfully develop our licensed technologies; our ability to build a commercial infrastructure in the U.S.
Clinical drug development is expensive, time-consuming and uncertain.
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.
2 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 success depends on the attracting and retaining senior management and scientists with relevant expertise.
Risks Related to Our Dependence on Third Parties We anticipate relying on third-party Contract Research Organizations ("CROs") and other third parties to conduct and oversee our clinical trials.