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Basis of Presentation and Going Concern
3 Months Ended
Jun. 30, 2015
Notes to Financial Statements  
Basis of Presentation and Going Concern

The accompanying unaudited Condensed Consolidated Financial Statements have been prepared in accordance with accounting principles generally accepted in the United States (U.S. GAAP) for interim financial information and with the instructions to Form 10-Q and Rule 8-03 of Regulation S-X. Accordingly, they do not contain all of the information and footnotes required for complete consolidated financial statements. In the opinion of management, the accompanying unaudited Condensed Consolidated Financial Statements reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly our interim financial information. The accompanying Condensed Consolidated Balance Sheet at March 31, 2015 has been derived from our audited consolidated financial statements at that date but does not include all disclosures required by U.S. GAAP.  The operating results for the three months ended June 30, 2015 are not necessarily indicative of the operating results to be expected for our fiscal year ending March 31, 2016 or for any other interim period or any other future period.

 

The accompanying unaudited Condensed Consolidated Financial Statements and notes to Condensed Consolidated Financial Statements should be read in conjunction with our audited Consolidated Financial Statements for the fiscal year ended March 31, 2015 contained in our Annual Report on Form 10-K, as filed with the Securities and Exchange Commission (SEC) on June 29, 2015.

 

The accompanying Condensed Consolidated Financial Statements have been prepared assuming we will continue as a going concern. As an entity having not yet achieved sustainable revenues, we have experienced recurring losses and negative cash flows from operations resulting in a deficit of $114.0 million accumulated from inception through June 30, 2015. We expect losses and negative cash flows from operations to continue for the foreseeable future as we engage in further potential development of AV-101, other potential programs involving drug development, drug rescue drug discovery and regenerative medicine.

 

Since our inception in May 1998 through June 30, 2015, we have financed our operations through (1) the issuance and sale of our common stock, preferred stock, warrants for common stock, and promissory notes for aggregate cash proceeds of approximately $30.0 million; (2) issuance of common stock and preferred stock with an approximate value at issuance of $25.2 million as consideration for, among other things, technology license payments, sponsored research, contract research, development, manufacturing and regulatory services, and legal, corporate development and financial advisory services; and, (3) receipt of aggregate non-dilutive cash proceeds of approximately $16.4 million from government research and development grant awards and strategic collaborations.

 

As described more completely in Note 7, Convertible Promissory Notes and other Notes Payable, and Note 8, Capital Stock, in May 2015, we created a new class of Series B 10% Convertible Preferred Stock (Series B Preferred). Between March 31, 2015 and June 30, 2015, we extinguished the outstanding balances of approximately $15.4 million of promissory notes, other debt obligations and certain adjustments thereto that were either already due and payable or would have otherwise matured prior to March 31, 2016, through conversion into our Series B Preferred and, with respect to a portion of the indebtedness converted, warrants to purchase common stock. More specifically, we have converted the outstanding balances of (i) all Senior Secured Convertible Promissory Notes originally issued to Platinum Long Term Growth VII, LLC (Platinum), (ii) all 2014 Unit Notes outstanding at March 31, 2015 and those issued subsequently, and (iii) other outstanding promissory notes including those issued to Cato Research Ltd., Cato Holding Company, Morrison & Foerster (Note B), University Health Network and others, through the issuance of an aggregate of 2,363,789 shares of our Series B Preferred. Additionally, through June 30, 2015, we sold in self-placed private placement transactions with Platinum and other accredited investors, Series B Preferred Units consisting of an aggregate of 86,790 unregistered shares of Series B Preferred and five year warrants exercisable at $7.00 per share to purchase 86,790 shares of our common stock and we received cash proceeds of $607,500 therefrom. See Note 10, Subsequent Events, regarding disclosure of the conversion of the outstanding balance of additional promissory notes into Series B Preferred and self-placed private placement sales of additional Series B Preferred Units after June 30, 2015.

 

At June 30, 2015, we did not have sufficient cash and cash equivalents to enable us to fund our planned operations over the next twelve months, including expected cash expenditures of approximately $6.0 million. We believe that our participation in potential strategic collaborations, including potential transactions involving AV-101 such as our February 2015 CRADA with the NIH for an NIH-funded and sponsored Phase 2 study of AV-101 in MDD, may provide resources to support a portion of our future cash needs and working capital requirements, however, no assurances can be provided.  When and as necessary, we have and will continue to seek to raise sufficient financing through issuance and sale of our securities, which may include both debt and equity securities, research and development collaborations, technology and drug candidate license fees, and government grant awards and collaboration revenues.  Our future working capital requirements will depend on many factors, including, without limitation, the scope and nature of strategic opportunities related to our success and the success of certain other companies in clinical trials, including our future development ofAV-101 as a treatment for MDD and other conditions; our stem cell technology platform, including drug rescue and cell therapy research and development efforts and the success of such programs, our ability to obtain government grant awards and our ability to enter into strategic collaborations with institutions on terms acceptable to us. To further advance the clinical development of AV-101 and potential drug rescue and regenerative medicine applications of our stem cell technology, as well as support our operating activities, we plan to continue to carefully manage our routine operating costs, including salaries and benefits, regulatory consulting, contract research and development, legal, accounting, public company compliance and other professional services and working capital costs. 

 

Notwithstanding the foregoing, substantial additional financing may not be available to us on a timely basis, on acceptable terms, or at all. If we are unable to obtain substantial additional financing on a timely basis in the near term, our business, financial condition, and results of operations may be harmed, the price of our stock may decline, we may be required to reduce, defer, or discontinue certain of our research and development activities and we may not be able to continue as a going concern. The accompanying Condensed Consolidated Financial Statements do not include any adjustments that might result from the outcome of this uncertainty.