In the normal course of business, the Company incurs obligations to make future payments as it executes its business plan. These contracts relate to preclinical or clinical studies, manufacturing or manufacturing process development and other product development activities. Currently, these contracts include clinical study sites in our Phase CKD study, home nursing services and various vendors supporting the performance of the study. These commitments are subject to significant change and the ultimate amounts due be materially different as these obligations are affected by, among other factors, the number and pace of patients enrolled, the number of clinical study sites enrolling subjects, the amount of time to complete study enrollments and the time required to finalize, analyze and report of study results. Clinical research agreements are generally cancelable upon days' notice, with the Company's obligation limited to costs incurred up to that date, including any non-cancelable costs. Cancelation terms for product manufacturing and process development contracts vary and are generally dependent upon timelines for sourcing research materials and reserving laboratory time. As of the Company estimates that its outstanding commitments, including such cancellable contracts, are approximately million over the next months and in the following months.

 

On we announced the enrollment of the subject in REDUX, a multi-center, open-label, Phase clinical trial investigating participants with Stage II or III CKD, who will be enrolled in equal cohorts. The study is being conducted in the United States at sites and is focused on participants with CKD: Cohort I is focused on non-diabetic, hypertensive African Americans with Stage II or III CKD. African Americans are at greater risk for CKD than Caucasians, and those African Americans who have the gene mutation are at an even higher risk. The study is designed to capture the gene mutation as an exploratory biomarker in this cohort. Cohort II is focused on participants with IgA Nephropathy (IgAN). Cohort III, which was added after the completion of our public offering, is focused on participants with Type diabetes mellitus with CKD, hypertension and albuminuria. The study will evaluate dose levels of within each cohort. Study participants receive by subcutaneous injection twice weekly for days. The primary study endpoints include safety, tolerability, blood pressure, albuminuria and kidney function, which will be evaluated by changes from baseline in estimated glomerular filtration rate (eGFR) and albuminuria, as measured by the urinary albumin to creatinine ratio.

 

Additional clinical trials will be subsequently required if the results of the Phase REDUX study are positive. In addition, we are preparing an Investigational New Drug submission to initiate an adaptive Phase randomized, double-blind, placebo-controlled study. This study is intended to assess the efficacy, safety and tolerability of in patients with mild to moderate AIS. The study is expected to enroll approximately to subjects age and over. At this time, we are unable to reasonably estimate the total costs of future trials. Such costs are contingent on and subject to change depending on the results of current and future clinical trials as well as developments in the regulatory requirements.

 

 

The Company has entered into a license agreement with Catalent Pharma Solutions, LLC (Catalent) whereby we have licensed certain gene expression technology and we contract with Catalent for the manufacture of Under the terms of this license, certain milestone and royalty payments become due under this agreement and are dependent upon, among other factors, clinical trials, regulatory approvals and ultimately the successful development of a new drug, the outcome and timing of which is uncertain. As of milestones remain which include due upon the initiation of dosing in our Phase trial and upon our regulatory approval for commercial sale. Following the launch of our product, we will also incur a royalty of less than on net sales. The royalty term is indefinite but the license agreement be canceled by us on days' prior written notice. The license be terminated by Catalent unless we fail to make required milestone and royalty payments. There were amounts due or payable under this agreement during and

 

 

The Company, as permitted under laws of British Columbia and in accordance with the Company's articles and indemnification agreements, will indemnify and advance expenses to its directors and officers to the fullest extent permitted by law and choose to indemnify other employees or agents from time to time. The Company has secured insurance on behalf of any officer, director, employee or other agent for any liability arising out of his or her actions in connection with their services to the Company. As of there was pending litigation or proceeding involving any director or officer of the Company as to which indemnification is required or permitted, and we are aware of any threatened litigation or proceeding that result in a claim for indemnification. Insofar as indemnification for liabilities arising under the United States Securities Act of as amended (Securities Act) be permitted to directors, officers and controlling persons of the Company, the Company has been advised that, in the opinion of the United States Securities and Exchange Commission, such indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable. The Company believes the fair value of these indemnification agreements is minimal. Accordingly, the Company had recorded any liabilities for these obligations as of or