Critical Outcome Technologies Inc. (TSX-V: COT), a biopharmaceutical company, has reported second quarter financial and operational results. With the three-month and six-month periods ending on Oct. 31, 2015, the major highlight of the quarter was the signing of a clinical trial agreement for COTI-2 in gynecologic cancers on December 8, 2015 following the company’s substantial efforts involved with working through the institutional approval process at MD Anderson Cancer Centre.
"The recent signing of the clinical trial agreement to begin human testing with COTI-2 was extremely rewarding following our concerted effort toward this objective in the second quarter," said Dr. Wayne Danter, President and CEO of Critical Outcome Technologies. "We look forward to expanding the cancer indications for COTI-2 to include Li-Fraumeni syndrome and head and neck cancers while we continue to work with MD Anderson Cancer Center to realize our goal of transforming cancer treatment options, not just for women with ovarian and other gynecological cancers, but for all patients afflicted with p53 mutations."
In Q2, the company focused on three key areas: the negotiation and planning of a clinical trial agreement, financing efforts to fund the Phase 1 clinical trial and 2016 operations, and development initiatives.
Other Q2 highlights include:
- Conducting animal tests of COTI-2 in Li-Fraumeni syndrome leading to an FDA application for an Orphan Drug Designation
- Strengthening the Board and management support at the Annual General Meeting with the addition of an independent director with substantial experience in clinical oncology, head and neck cancer surgery, and cancer trial participation.
Reported financial results include:
- The company incurring a net loss of $938,861, or $0.01 per share, for the quarter compared to a net loss of $946,204, or $0.01 per share, for the second quarter a year earlier.
- For the six months ending on October 31, 2015, the Company reported a loss of $1,923,981 or $0.02 per common share, compared to a loss of $1,917,000 or $0.03 per common share on fewer shares outstanding for the same period a year earlier.
- Research and development expenditures decreased $6,538 for the quarter and increased $57,344 year-to-date primarily reflecting costs related to COTI-2 including the completion of the IND approval from the FDA, the planning of the Phase 1 trial, and continued development costs for new cancer indications.
- During the quarter, the Company realized approximately $248,000 in gross proceeds through the exercise of warrants and share options to provide further funding for operations.
Critical Outcome Technologies’ mission is to advance the treatment of cancer through targeted therapeutics. The Company's lead compound, COTI-2, has a novel p53-dependent mechanism of action with selective and potent anti-cancer activity. The initial indication is in gynecologic cancers (ovarian, cervical, and endometrial) that will begin a Phase 1 clinical trial at MD Anderson Cancer Center in late December 2015 or early January of 2016.
Despite mixed financial results, Critical Outcome’s operational milestones, particularly the company’s clinical trial agreement for for COTI-2, continues to move the company forward with the development of effective cancer treatment options.
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