Quarterly report pursuant to Section 13 or 15(d)

2. CAPITALIZATION AND MANAGEMENT'S PLANS (Notes)

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2. CAPITALIZATION AND MANAGEMENT'S PLANS (Notes)
9 Months Ended
Jan. 31, 2015
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Capitalization And Management's Plans

Capitalization

 

The Company's financial statements are prepared using generally accepted accounting principles in the United States (“GAAP”) applicable to a going concern which contemplates the realization of assets and liquidation of liabilities in the normal course of business. As of January 31, 2015, the Company has an accumulated deficit of $77,065,081 and incurred a net loss for nine months ended January 31, 2015 of $7,106,547.

 

Funding has been provided by management and investors to maintain and expand the Company and acquire Bio Blue Bird. New investors enabled the completion of the acquisition of Bio Blue Bird which provided the Company the ability to begin preparations toward clinical trials in patients with advanced, inoperable pancreatic cancer. Additional funding enabled the Company to obtain the diabetes license and to advance the Company’s preclinical studies and preparations for clinical trials of its product candidates. The remaining challenges, beyond the regulatory and clinical aspects, include accessing further funding for the Company to cover its future cash flow needs. The Company continues to acquire additional funds through management's efforts.

 

On October 28, 2014, the Company filed a Form S-3 Registration Statement under the Securities Act of 1933, as amended. This Registration Statement registered $50 million of securities which may be issued by the Company from time to time in indeterminate amounts and times and at the discretion of the Company. The Company has utilized this Registration Statement to issue shares to fund a portion of the Company’s activities.

 

The Company requires substantial additional capital to finance its planned business operations and expects to incur operating losses in future periods due to the expenses related to the Company’s core businesses. The Company has not realized material revenue since it commenced doing business in the biotechnology sector, and it is not without doubt that it will be successful in generating revenues in the future in this sector.

 

The Company will continue to be dependent on outside capital to fund its research and operating expenditures for the foreseeable future. If the Company fails to generate positive cash flows or fails to obtain additional capital when required, the Company may need to modify, delay or abandon some or all of its business plans.

 

Management Goals and Strategy

 

The Company's first goal is to ensure that the success engendered in the previous Phase 1/2 pancreatic cancer clinical trials can be built upon and advanced. The Company’s overall goal is to have the Company become an industry-leading biotechnology company.

 

The strategy of the Company to achieve its goals includes several primary components:

 

  · The completion of the preparations for the Phase 2b clinical trial in advanced, inoperable pancreatic cancer to be carried out in Australia;

 

  · The conducting of preclinical studies and clinical trials that will examine the effectiveness of the Company’s pancreatic cancer treatment in ameliorating the pain and accumulation of malignant ascites fluid in the abdomen that are characteristic of pancreatic cancer. These studies and trials will be conducted by Translational Drug Development in the United States;

 

  ·

The conducting of preclinical studies and clinical trials that involve the encapsulation of a human cell line engineered to produce and store insulin and secrete it at levels in proportion to the levels of glucose (blood sugar) in the human body. The encapsulation will be done using the Cell-in-a-Box® technology;

 

The enhancement of the Company’s ability to expand into the biotechnology arena through further research and partnering;

 

  · The acquisition of new contracts and revenue utilizing both in-house products and the newly acquired biotechnology licensing rights;

 

  · The further development of uses of the Cell-in-a-Box® technology platform through contracts, licensing agreements and joint ventures with other companies; and

 

  · The completion of testing, expansion and marketing of existing and newly derived product candidates.