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Organization and Description of the Business
6 Months Ended
Jun. 30, 2016
Organization and Description of the Business  
Organization and Description of the Business

1. Organization and Description of the Business

 

We are a clinical-stage biopharmaceutical company focused on discovering and developing novel small molecule therapeutics in oncology, infectious diseases and autoimmune diseases. We currently have two clinical-stage product candidates in development: birinapant and suberohydroxamic acid 4-methoxycarbonyl phenyl ester (SHAPE).  Our operations to date have been directed primarily toward developing business strategies, raising capital, research and development activities, conducting pre-clinical testing and human clinical trials of our product candidates and recruiting personnel.

 

Liquidity

 

At June 30, 2016, we had a working capital deficit of $2.4 million and cash and cash equivalents of $8.7 million. We have not generated any product revenues and have not yet achieved profitable operations. There is no assurance that profitable operations will ever be achieved, and if achieved, could be sustained on a continuing basis. In addition, development activities, clinical and pre-clinical testing, and commercialization of our products will require significant additional financing.

 

On July 19, 2016, we received a delisting determination letter (the “Determination Letter”) from the Listing Qualifications Department of The NASDAQ Stock Market LLC (“Nasdaq”) notifying us that we have not regained compliance with the minimum Market Value of Listed Securities (“MVLS”) requirements set forth in Nasdaq Listing Rule 5450(b)(2)(A). Nasdaq initially notified us by letter (the “Initial Notification Letter”) on January 20, 2016 that we were not in compliance with MVLS requirements for continued listing on The Nasdaq Global Market.  The Initial Notification Letter stated that we had 180 calendar days, or until July 18, 2016, to regain compliance with Nasdaq Listing Rule 5450(b)(2)(A). To regain compliance, the MVLS of our common stock was required to reach at least $50 million for a minimum of 10 consecutive business days.

Nasdaq’s determination (the “Delisting Determination”) will not immediately result in the delisting of our common stock.  Pursuant to the Determination Letter, unless a request for a hearing to appeal the Delisting Determination was received by the Nasdaq Hearings Department by no later than 4:00 p.m. Eastern time on July 26, 2016, our common stock would have been delisted from The Nasdaq Global Market, trading of our common stock would have been suspended at the opening of business on July 28, 2016, and a Form 25-NSE would have been filed with the Securities and Exchange Commission, which would remove our securities from listing and registration on The Nasdaq Global Market.

On July 26, 2016 we requested a hearing to appeal the Delisting Determination.  Under Nasdaq rules, while the appeal process is pending, the suspension of trading of our common stock and the filing of the Form 25-NSE will be stayed, and our common stock will continue to trade on The Nasdaq Global Market until the Nasdaq hearing panel (the “Panel”) makes a determination after the hearing.  Our appeal hearing is currently scheduled for August 25, 2016.  There can be no assurance that we will be successful in our appeal, that the Panel will grant us an additional compliance period prior to suspension and delisting of our common stock from The Nasdaq Global Market or that, if the Panel grants us an additional compliance period, we would be able to regain compliance with Nasdaq Listing Rule 5450(b)(2)(A) within the required time period. 

Moreover, as previously disclosed in our Current Report on Form 8-K filed on February 26, 2016, we received separate letters (the “Additional Notification Letters”) on February 23, 2016 from Nasdaq notifying us that we are not in compliance with both the minimum bid price requirement for Primary Equity Securities (the “Minimum Bid Price”) set forth in Nasdaq Listing Rule 5450(a)(1) and with the minimum Market Value of Publicly Held Shares (“MVPHS”) requirement set forth in Nasdaq Listing Rule 5450(b)(2)(C).  Nasdaq Listing Rule 5450(a)(1) requires listed securities to maintain a Minimum Bid Price of $1.00 per share and Nasdaq Listing Rule 5450(b)(2)(C) requires listed securities to maintain a minimum MVPHS of $15 million.  The Additional Notification Letters stated that we have until August 22, 2016, to regain compliance with Nasdaq Listing Rule 5450(a)(1) and Nasdaq Listing Rule 5450(b)(2)(c), or be subject to delisting.    To regain compliance, the minimum bid price of our common stock would need to reach at least $1.00 for 10 consecutive business days by August 22, 2016, and the minimum publicly held market value of the common stock would need to reach at least $15 million for 10 consecutive business days by August 22, 2016. All of these events are outside of our control at this time.

The delisting of our common stock from The Nasdaq Global Market would be considered a fundamental change under the indenture for our 8% convertible senior notes due June 15, 2019 (the “8% Notes”), and we could be required by the noteholders to purchase for cash all of the outstanding 8% Notes at a purchase price equal to 100% of the principal amount of the 8% Notes ($43.75 million of which are outstanding as of June 30, 2016) plus accrued and unpaid interest. We do not currently have sufficient funds on hand to satisfy the put obligations for the 8% Notes if all holders exercise their put right, and there can be no assurance that we will be able to obtain sufficient funds to meet our obligations with respect to the 8% Notes in the event that delisting occurs and the holders exercise their put right.

Delisting from The Nasdaq Global Market could also significantly affect the ability of investors to trade our common stock and negatively affect the value and liquidity of the common stock.  Moreover, delisting could adversely affect our ability to raise additional financing through the public or private sale of securities, which may result in adverse effects on our operations and ability to continue as a going concern in the future. 

We may also face other adverse consequences if our common stock is delisted including, among others, limited availability of market quotations for our common stock and limited ability to issue additional securities pursuant to our short-form registration statement on Form S-3, which may require us to rely on private sales of securities, thereby increasing dilution of existing holders of our common stock and/or resulting in greater expenses and delay if we determine it becomes necessary to conduct a public offering of securities by means of a long-form registration statement on Form S-1.  In addition, if our common stock is delisted, the common stock may be deemed to be a “penny stock,” which (subject to limited exceptions) will require brokers dealing in the common stock to adhere to more stringent rules, including the requirement that broker-dealers must make a special written determination that the penny stock is a suitable investment for the purchaser, other than established customers of the broker-dealer and accredited investors, which may restrict the ability of brokers or dealers to sell our common stock and may adversely affect the ability of our stockholders to sell their shares.  

Should we regain compliance with the Nasdaq listing requirements, or otherwise satisfy our obligations with our noteholders, we believe our existing cash and investments will be sufficient to fund our current operating and investing activities through December 31, 2016.  In order for our existing cash and investments to fund operating and investing activities through December 31, 2016, we have limited our planned business activities to the completion of the Phase 2 clinical trial of SHAPE and the winding down of the Phase 2 clinical trial in birinapant in MDS, and we effectuated a reduction in force in January 2016, which reduced our headcount to 9 employees in April 2016.  Our headcount has since been reduced to 8 employees.

We have retained Houlihan Lokey Capital, Inc. as our financial advisor, to provide financial advisory, restructuring and investment-banking services in connection with analyzing and considering a wide range of transactional and strategic alternatives.  We are currently negotiating the potential sale of one or both of our primary molecules, birinapant and Shape, to a third-party purchaser.  We are also currently in active discussions with the noteholders of our 8% Notes regarding the possible early conversion of our 8% Notes into equity.  We can give no assurance that either of these transactions will occur.