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Subsequent Events
12 Months Ended
Dec. 31, 2020
Subsequent Events [Abstract]  
Subsequent Events

Note 11—Subsequent Events

 

Fuji Film

 

In March 2021, the Company entered into an agreement with FUJIFILM Diosynth Biotechnologies (“FDB”) to manufacture the Generx [Ad5FGF-4] angiogenic gene therapy product candidate for Phase 3 clinical evaluation for the treatment of refractory angina due to late-stage coronary artery disease. Manufacturing operations will be conducted at FDB’s facilities in College Station, Texas where FDB will perform technology transfer and process development activities for Phase 3 clinical and commercial-scale GMP manufacturing of Generx. The required funding for the Fuji agreement is approximately $3.8 million. At present, we do not have the requisite financial resources to initiate FDB’s manufacturing of Generx [Ad5FGF-4] necessary to the conduct of the planned FDA-cleared Phase 3 clinical study. We are currently evaluating alternative financing arrangements, but there are no agreements in place for such financing at this time. As a result, we are unable to provide a start date for the initiation of the planned FDA-cleared Phase 3 AFFIRM clinical study.

 

Series A Preferred Stock Purchase Agreement Between Nostrum and Sabby

 

Subsequent to the May 2020 agreement between Nostrum and Sabby, as of April 28, 2021, Sabby converted all of its remaining 570 shares of Series A Convertible Preferred Stock into 50,442,489 shares of Common and no further shares of the Series A Convertible Preferred Stock were purchased by Nostrum. As a result, Nostrum did not acquire any further shares of the Series A Convertible Preferred beyond their initial 220 share acquisition.

 

Nostrum Additional Investment Funding

 

Subsequent to the current period covering between the period May 31, 2021, through December 31, 2021, Nostrum provided an additional $371,080 in equity capital, covering the pending issuance of 32,838,938 shares of our Common Stock, to support the operations of the Company as we execute on our current business plan and seek alternative sources of financing, to fund the Company’s research, development and commercialization activities for our lead product Generx [Ad5FGF-4]. For its equity investment, the Company will issue Nostrum additional shares of the Series A preferred stock. In addition to its equity investments Nostrum has provided the Company with various services including, financial management, legal, scientific, information technology for which Nostrum has not received any compensation.