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, clinical and development activities, including the clinical research organization conducting our Phase II clinical trial for acute ischemic stroke. 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, amount of time to complete study enrollments and the time required to finalize the analysis and reporting of study results. Clinical research agreements are generally cancelable upon days’ notice, with the Company’s obligation then limited to costs incurred up to that date. Cancelation terms for product 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 research and development contracts are approximately million over the next months and approximately in the following months.

 

On the Company announced the initiation of REMEDY, a -patient Phase II clinical trial evaluating in patients with acute ischemic stroke. The study drug ( or placebo) will be 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 is designed to measure safety and tolerability 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).

 

On the Company announced the enrollment in its Phase Ib dose ranging study in patients with moderate or severe CKD caused by Type I or Type II diabetes. The results from this Phase Ib study will assist us in the design of upcoming Phase II studies in patients suffering from rare diseases and CKD. The drug levels from this Phase Ib study will be used to determine the optimal dose levels for testing in the Phase II studies.

 

Additional clinical trials will be subsequently required if the results of the 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. Clinical trial costs are expensed as incurred.

 

 

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 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 the Canada and in accordance with the Company’s by-laws 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 (the “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 (the “SEC”), 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

 

 

The Company leases certain office space under a non-cancelable operating lease. On the Company amended the lease agreement to extend its lease term by months, for an expiration date of and increase its leased space. Rent is expensed on a straight-line basis.

 

Future minimum lease payments under this operating lease are as follows (in thousands):

 

2019		$	64
2020			66
2021			68
2022			46
Total		$	244