SAN DIEGO, Aug. 21, 2007 (PRIME NEWSWIRE) -- MicroIslet, Inc. (OTCBB:MIIS) announced that it filed its Quarterly Report on Form 10-QSB for the quarter ended June 30, 2007, with the Securities and Exchange Commission, yesterday. The Form 10-QSB includes updates concerning the Company's execution of its new strategy.
As previously announced, MicroIslet has refocused its efforts to accelerate the clinical testing of the Company's xenograft MicroIslet-P(tm) product. The Company intends to finalize its international clinical trial plans after consultation with the FDA and appropriate foreign regulatory agencies, with plans to follow up international testing with domestic clinical trials. All international work will be conducted under Good Clinical Practices and will utilize only Designated Pathogen Free porcine tissue. MicroIslet has an exclusive supply arrangement with a Designated Pathogen Free porcine barrier facility, which the Company believes is the only one in North America.
MicroIslet reported in its recent Form 10-QSB the following corporate developments toward execution of its new strategy:
* The Company is in negotiations with a U.S. contract manufacturing
organization for islet isolation and encapsulation in their Cgmp
(Current Good Manufacturing Practices) registered facility.
* The Company is preparing for a pre-IND meeting with the FDA in
the fourth quarter of 2007 to update the FDA on the Company's
revised strategy and to coordinate the Company's international
plans to maximize the applicability of data to the planned IND
filing for U.S. trials.
* The Company has signed its first non-binding Memorandum of
Understanding with a program in Ahmedabad, India for clinical
testing of its MicroIslet-P(tm) encapsulated islet preparation for
patients with type 1 diabetes.
* On September 1, 2007, the Company is eligible to begin drawing
grant revenue from the third year funding under its Phase II
Small Business Innovation Research (SBIR) grant by the National
Institutes of Health (NIH). This grant funds further development
efforts for the Company's islet cell transplantation technology
for treatment of insulin-dependent diabetes. In addition, the
Company has submitted applications for a total of approximately
$1.7 million in NIH grants for terms starting in 2007 and 2008.
"The new board of directors and management came in with a mandate to accelerate human clinical testing of the Company's key MicroIslet-P(tm) product. We began working immediately to execute on that mandate, and we are very pleased with the progress we have made in a short period of time," said Michael J. Andrews, CEO.
"We look forward to working with the FDA, foreign regulatory agencies, and various professional groups and societies, to plan for the success of xenotransplantation in type 1 diabetics," said Jonathan Lakey, Ph.D., a Company Director and consultant who will serve as the Company's President and Chief Scientific Officer. "I am confident that we have the right team and strategy to fulfill our vision to produce the first commercially viable self-regulating treatment for type 1 diabetes," he added.
The Company reported a net loss of $2,245,000, or $0.04 per share, for the three months ended June 30, 2007, compared with a net loss of $2,610,000 or $0.06 per share, for the same period in 2006. The net loss was $5,139,000 or $0.10 per share for the six months ended June 30, 2007, compared with a net loss of $5,875,000 or $0.13 per share, for the same period in 2006.
Grant revenue was $349,000 for the six months ended June 30, 2007, as compared to $295,000 for the six months ended June 30, 2006, and was derived from the three year $1.7 million Phase II SBIR grant by the NIH.
General and administrative expenses decreased $373,000 to $717,000 for the three months ended June 30, 2007 compared to $1,090,000 for the same period in 2006, and decreased $934,000 to $1,722,000 for the six months ended June 30, 2007 compared to $2,656,000 for the same period in 2006. The decreases were due to lower salaries and fees paid to senior management, offset by temporary consulting fees to fill open positions, decreased travel expenses incurred by former executives, decreased legal expenses, decreased stock issuances to certain stockholders resulting from contractual liquidated damages owed them, and decreased stock-based compensation.
Research and development expenses decreased $286,000 to $1,411,000 for the three months ended June 30, 2007 from $1,697,000 in the same period in 2006, and decreased $4,000 to $3,571,000 for the six months ended June 30, 2007 from $3,575,000 for the same period in 2006. The decrease was due to decreased salaries and benefits and stock based-compensation, but offset by increased costs from the Company's collaboration with UC Davis and other research facilities and related supplies.
About MicroIslet:
MicroIslet is a biotechnology company engaged in the research, development, and commercialization of proprietary and patented technologies in the field of transplantation therapy for people with conditions requiring cell-based replacement treatments, with a focus on type 1, or insulin-dependent, diabetes. MicroIslet's patented islet transplantation technology, exclusively licensed from Duke University, along with its own proprietary developments, constitute methods for isolating, culturing, cryopreservation, and immuno-protection (microencapsulation) of islet cells. MicroIslet intends to continue its research and development efforts, and ultimately, to introduce products to the market.
Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor'' provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including MicroIslet's immediate need to raise substantial additional funds in order to fund its new strategy and continue as a going concern, competition for grants and the uncertainty of receipt of any applied for grants, the early stages of identification of new revenue sources and the possible need for third party approvals before significant revenues could be generated, the risks and uncertainties inherent in medical treatment discovery, development and commercialization, the risks and uncertainties associated with MicroIslet's early stage xenotransplantation technologies, the risks and uncertainties of governmental approvals and regulation, including foreign government approvals for clinical trials outside the United States, the non-binding nature of the Memorandum of Understanding with a clinical testing facility in India and the need to identify governmental requirements before the specific terms of such arrangement can be finalized, dependence on a sole source supplier of animal parts for pre-clinical and clinical studies, Dr. Lakey's need for a temporary visa to commence employment in the United States, the risks and uncertainties associated with third-party outsourced manufacturing and strategic partnerships, including the need to negotiate definitive terms with such entities, the risks that MicroIslet's competitors will develop or market technologies or products that are more effective or commercially attractive than MicroIslet's products, and other risks detailed from time to time in MicroIslet's most recent filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. MicroIslet disclaims any intent or obligation to update these forward-looking statements.
Additional information about MicroIslet can be found at http://www.microislet.com.