As of and the Company had an accumulated deficit of million and million, respectively, and the Company has generated positive cash flow from operations since its inception.

 

Additional funding will be required to continue the Company’s research and development and other operating activities. In the next months, we will likely seek to raise additional funds through various sources, such as equity or debt financings, or through strategic collaborations and license agreements. We can give assurances that we will be able to secure additional sources of funds to support our operations, or if such funds are available to us, that such additional financing will be sufficient to meet our needs or on terms acceptable to us. This risk would increase if our clinical data is positive or economic and market conditions deteriorate.

 

There can be assurances that we will be able to obtain additional financing on commercially reasonable terms, or at all. To the extent we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our shareholders will be diluted. Debt financing, if available, involve agreements that include conversion discounts or covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through government or other -party funding, marketing and distribution arrangements or other collaborations, or strategic alliances or licensing arrangements with parties, we have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that be favorable to us. The availability of financing be affected by our clinical data and other results of scientific and clinical research; the ability to attain regulatory approvals; market acceptance of our product candidates; the state of the capital markets generally with particular reference to pharmaceutical, biotechnology, and medical companies; the status of strategic alliance agreements; and other relevant commercial considerations.

 

If adequate funding is available when needed, we be required to scale back our operations by taking actions that include, among other things, reducing use of outside professional service providers, reducing the number of our employees or employee compensation, or implementing other cost reduction strategies; significantly modify or delay the development of our product candidate; license to parties the rights to commercialize our product candidate for CKD, AIS or other indications that we would otherwise seek to pursue, or otherwise relinquish significant rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that be favorable to us; and/or divest assets or cease operations through a merger, sale, or liquidation of our company.