This is in response to your correspondence requesting an exception under Listing Rule 5635(f) to Nasdaq’s otherwise applicable shareholder approval requirements with respect to a proposed issuance of securities (the “Proposed Transaction”).

You represented that the Company, a biopharmaceutical company, has experienced delays in government funding for its lead product candidate, and has been unsuccessful in securing alternative funding to continue operations. Additionally, in its most recent Annual Report on Form 10-K, the Company’s independent auditor includes the qualification that there is substantial doubt concerning the Company’s ability to continue as a going concern. You stated that, without the Proposed Transaction, the Company is in imminent danger of being unable to meet its monthly payroll, lease payments and other obligations and has only enough cash to fund operations for a month, at which time it will be forced to initiate steps to cease operations, in addition to laying-off or furloughing many of its scientific employees.

In the Proposed Transaction, you stated that the Company will issue shares of common stock to one investor equal to greater than 20% of the existing total shares outstanding at a price per share expected to be greater than current market and book value. However, due to fluctuation in the Company’s stock price, the ultimate price per share of the common stock may potentially be at a discount to market value. Additionally, following the closing of the Proposed Transaction, the sole investor will obtain greater than 50% voting power and beneficial ownership in the company.

You stated that the Company has pursued multiple alternative sources of financing for more than one year, completing smaller financings that raised limited funds but failing to complete several larger transactions, including the sale of common stock in a public offering that reached late stage negotiations, but was ultimately unsuccessful. Despite these efforts, you represented that there are currently no realistic alternatives to the Proposed Transaction and that the proposed investor is unwilling to structure the Proposed Transaction in a manner consistent with the shareholder approval rules. As a result, there is not enough time to obtain shareholder approval prior to the issuance of the shares of common stock in the Proposed Transaction before the Company runs out of cash. You further indicated that if the Proposed Transaction is not completed in the very near term, the Company will be forced to cease operations, including all product development efforts, and terminate or furlough scientific employees, and that the result of these actions may negatively affect the Company’s ability to obtain government funding. Additionally, you stated that given the potential negative effects on the Company’s operations, the Company sought advice from bankruptcy counsel. Finally, you stated that the Company expects that the Proposed Transaction would enable the Company to meet the requirements for continued listing on Nasdaq for at least the next year.

Without the requested exception, shareholder approval would be required:

• pursuant to Listing Rule 5635(b) because the Proposed Transaction would result in a change of control of the Company due to the fact that the sole investor will own greater than 50% of the common stock and voting power outstanding upon completion of the Proposed Transaction; and
• pursuant to Listing Rule 5635(d) because the issuance would exceed 20% of the pre-transaction outstanding shares at a price that may be less than the greater of book or market value.

Based on our review of the circumstances described in your correspondence and your representations regarding: (i) the Company’s financial condition, (ii) the dire consequences to the Company should it not obtain the financing provided by the Proposed Transaction, and (iii) the Company’s expectation that it will remain in compliance with all applicable continued listing requirements, we have determined to grant the requested exception to the shareholder approval rules. In order to rely upon this exception, the Company must mail to all shareholders, not later than ten days before the issuance of any securities, a letter describing the Proposed Transaction (including the number of shares of common stock that could be issued and the consideration received) and alerting shareholders to the omission to seek the otherwise required approval. The letter must indicate that the Company is relying on a financial viability exception to the shareholder approval rules and that the audit committee, or a comparable independent body of the board of directors, has expressly approved reliance on this exception. The Company must also make a public announcement by filing a Form 8-K, where required by rules of the SEC, or by issuing a press release, disclosing the same information as required in the letter as promptly as possible but not later than ten days before the issuance of the securities.