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 the clinical research organization conducting our Phase II clinical trial for acute ischemic stroke, clinical study sites in our Phase II CKD study and various vendors supporting the performance of these studies. 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 initiation of REMEDY, a Phase II clinical trial evaluating in patients with acute ischemic stroke. The study drug ( or placebo) was administered as an intravenous infusion within hours of stroke symptom onset, followed by subcutaneous (under the skin) injections later that day and once every days for days. The study was designed to evaluate safety and tolerability of along with multiple tests designed to investigate therapeutic potential including plasma-based biomarkers and standard functional stroke measures assessed at days post-stroke (Modified Rankin Scale, National Institutes of Health Stroke Scale, Barthel Index, and C-reactive protein, a measure of inflammation). Enrollment completed in and a total of subjects were enrolled.

 

On we announced the enrollment of the subject in REDUX, a multi-center, open-label, Phase II clinical trial investigating participants with Stage II or III CKD, who will be enrolled in equal cohorts. The study will evaluate dose levels of within each cohort. Study participants will 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 the estimated glomerular flow rate (eGFR) and albuminuria, as measured by the urinary albumin to creatinine ratio (UACR).

 

Additional clinical trials will be subsequently required if the results of Phase II are positive. However, 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 III 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

 

 

On we entered into a litigation funding agreement with LEGALIST FUND II, L.P. (Funder) for the purpose of funding our currently pending lawsuit against PRA Netherlands. Our management believes, but cannot guarantee, that this litigation funding agreement will allow us to pursue this litigation more effectively. Although the Funder made its evaluation as to the likelihood of success, litigation is very uncertain, and assurance can be provided that, just because we have obtained litigation funding, we will be successful or that any recovery we obtain will be significant.

 

Under the terms of the litigation funding agreement, the Funder agreed to pay up to an aggregate of million to fund reasonable legal fees, court costs, and other expenses incurred by us in connection with the litigation, including for fees and costs previously paid by us. These payments, however, are conditioned upon the transfer of venue of the litigation from Delaware to Minnesota (the Transfer) and if the venue is transferred we will be entitled to receive any payments under the litigation funding agreement. If the venue is transferred, we agreed to repay the Funder from any proceeds arising from the litigation (Claim Proceeds) the amount of costs actually paid or otherwise funded by the Funder in connection with the litigation, plus the reimbursement of for its diligence and underwriting costs. Additionally, we agreed to pay the Funder from the Claim Proceeds the greater of: (i) million if repayment occurs within months of the Transfer, million if repayment occurs more than months after the Transfer but before trial has begun, or million thereafter; or (ii) of the Claim Proceeds. In the event the Funder has been repaid years after the Transfer, the Funder is entitled to receive interest on the unpaid amounts equal to per annum commencing on the year anniversary of the Transfer. Our obligation under the litigation funding agreement to make the foregoing payments to the Funder is non-recourse and limited only to the Claim Proceeds. As a result of the agreement, if we obtain Claim Proceeds, it is possible, depending on the amount of the Claim Proceeds, that we will receive net recovery after all payments have been made to the Funder.

 

 

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