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Subsequent Events
6 Months Ended
Jun. 30, 2016
Subsequent Events [Abstract]  
Subsequent Events

Note 7—Subsequent Events

We have evaluated events that occurred subsequent to June 30, 2016 and through the date the condensed consolidated financial statements were issued.

Closing of Angionetics financing with Huapont

On July 5, 2016, the initial closing under the Share Purchase Agreement dated June 7, 2016 among Taxus Cardium and Angionetics an entity affiliated with Huapont took place and Angionetics sold 200,000 Shares in exchange for a cash payment of $750,000 in addition to $250,000 received on March 18, 2016.  

On September 28, 2016, following FDA clearance of the Phase 3 AFFIRM study discussed below, Angionetics sold an additional 400,000 Shares in exchange for cash payment of $2,000,000.   Angionetics will require additional capital to complete the Phase 3 AFFIRM study, which it expects to secure through the sale of additional equity or debt securities. There are no agreements or arrangement for any additional financing in place at this time.

FDA Approval of Phase 3 Clinical Trial for GenerxTM

On December 18, 2015, pursuant to Section 505(i) of the U.S. Federal Food, Drug and Cosmetic Act, Angionetics submitted a request to the FDA Center for Biologics Evaluation and Research requesting transfer of sponsorship for the GenerxTM Investigational New Drug (IND) application to Angionetics.  Transfer of sponsorship was acknowledged by the FDA on January 5, 2016.  Additionally, the FDA acknowledged Angionetics’ U.S. activation of the Ad5FGF-4 (Generx) Investigational New Drug Application (IND) pursuant to Section 505(i) of the Federal Food, Drug and Cosmetic Act. Consequently, the previously granted FDA “Fast Track” designation for the GenerxTM development program continues forward.  In addition, Angionetics submitted for FDA clearance a new U.S.-based Phase 3 clinical study protocol (the “AFFIRM” study) to evaluate the further safety and definitive efficacy of GenerxTM [Ad5FGF-4] for men and women with advanced ischemic heart disease and refractory angina.

On September 9, 2016, the U.S. FDA Center for Biologics Evaluation and Research (CBER) cleared Angionetics’ AFFIRM Phase 3 clinical study protocol, thus allowing Angionetics to proceed with late-stage clinical evaluation of GenerxTM.  The AFFIRM study patient population and trial design are based on Ad5FGF-4 responder data from the four prior FDA-cleared clinical studies.  The primary efficacy endpoint is improvement in exercise treadmill test (ETT) duration in GenerxTM -treated patients compared to a placebo control group.  Enrolled patients must have refractory angina, documented clinical evidence of myocardial ischemia, clinically significant limitation of physical activity due to angina, and angina-limited ETT duration of 3-7 minutes.

On February 3, 2017, Angionetics received notice that the FDA has granted Fast Track designation for the Phase 3 clinical investigation of Generx [Ad5FGF-4] cardiovascular angiogenic gene therapy as a one-time treatment for improving exercise tolerance in patients who have angina that is refractory to standard medical therapy and not amenable to conventional revascularization procedures (coronary artery bypass surgery and percutaneous coronary intervention and stents).  Under the FDA Modernization Act of 1997, designation as a Fast Track product means that FDA will take actions, as appropriate, to expedite the development and review of a biologics license application (BLA) for product approval. The FDA’s Fast Track process is designed to facilitate clinical and commercial development and expedite the review of new drugs and biologics that are intended to treat serious conditions that demonstrate the potential to address an unmet medical need.

Status of Term Sheet with Dr. Reddy’s and Russian GenerxTM Clinical Development Program

Following the formation of Angionetics, our management team initiated a comprehensive review of Taxus Cardium’s global GenerxTM regulatory and clinical dossier, and elected to primarily focus on the clinical advancement and registration of GenerxTM in the United States and China, which we believe to be the most dynamic medical markets in the world for new and novel breakthrough products such as the GenerxTM product candidate. As a result of this review, on July 13, 2016 we notified Dr. Reddy’s of our decision to discontinue the planned GenerxTM development in the Russian Federation and other countries set forth in the term sheet and to focus on the late stage clinical and commercial development of GenerxTM in key target markets that include the U.S. and China. Consequently, the commercialization opportunity with Dr. Reddy’s Laboratories, previously reported by Taxus Cardium, will not be advanced to a definitive agreement.

Exchange and Redemption Agreement with Sabby Healthcare Volatility Master Fund, Ltd.

On September 23, 2016, we entered into a second Exchange and Redemption Agreement with Sabby covering the 1,000 shares of Preferred Stock outstanding at the time. Under the terms of the Exchange and Redemption Agreement, Taxus Cardium agreed to reduce the conversion price at which Sabby can convert shares of Preferred Stock to common shares to an effective price of $0.18 per share. The Exchange and Redemption Agreement grants Taxus Cardium a right to redeem any or all of the outstanding Preferred Stock for its Stated Value (approximately $1,000 per share) at any time after the date of the Agreement until November 29, 2016.  We entered into the Agreement to increase our options for retiring the outstanding Preferred Stock and financing our continued business operations. As a result of the conversion price changing from $0.30 to $0.18 per share, the 1,000 shares of Preferred Stock outstanding are convertible to 5,554,667 shares of Taxus Cardium common stock, an additional 2,221,867 compared to before the conversion price change. A hypothetical conversion of all of the outstanding Preferred Stock of 829 shares as of March 6, 2017 into 4,604,674 common shares would increase the common stock outstanding from 14,173,544 shares as of March 6, 2017, to 18,778,218, an increase of 32%.

As a result of this reduction of the conversion price of the preferred stock, the Company was also required to issue an additional 4,823,733 of warrants, to such warrant holders (substantially all current and former employees), in accordance with the original terms of their agreements.  The fair value of these issuances was recorded as compensation expenses.

Retirement of Members of the Board of Directors

In November 2016, Tyler Dylan-Hyde, Ph.D. and Mr. Lon Otremba retired as directors of the Company’s Board of Directors after almost a decade of service.