On October 2, 2018 Cotinga Pharmaceuticals Inc. (TSX Venture: COT; OTCQB: COTQF) ("Cotinga" or the "Company"), a clinical-stage pharmaceutical company advancing a pipeline of targeted therapies for the treatment of cancer, reported its financial and operating results today for the three-month period ended July 31, 2018 (Press release, Cotinga, OCT 2, 2018, View Source [SID1234533150]):
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. Recent highlights include: Advanced the clinical development of COTI-2:
In May 2018, Cotinga announced FDA clearance of a protocol amendment for its ongoing Phase 1b/2a trial of COTI-2. The multi-part protocol amendment expands the trial to evaluate COTI-2 as a combination therapy in a wide spectrum of cancers.
Presented novel scientific findings from its COTI-2 clinical program:
In June 2018, Cotinga and its collaborators from MD Anderson Cancer Center presented data on COTI-2 at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois;
Subsequent to the reporting quarter, in September 2018, Cotinga presented data on COTI-2 at the 11th International Symposium on Translational Research in Oncology in Dublin, Ireland.
Secured financing and appointed management and board members to support corporate strategy:
In May 2018, Cotinga closed a brokered private placement and a non-brokered private placement for total proceeds of approximately CAD $2,010,000;
In July 2018, Cotinga announced the appointment of Victor Hugo as Chief Financial and the appointment of J. Matthew Bond as a member of the Board of Directors and Chairman of the Audit Committee.
"We began the fiscal year with renewed progress across the entire business, including implementation of an expanded protocol for our ongoing Phase 1b/2a clinical trial of COTI-2," said Alison Silva, President & Chief Executive Officer. "We were also pleased to reduce our operating expenses during the quarter, while simultaneously securing the capital and personnel necessary to support our corporate strategy. We look forward to continuing to provide updates at critical milestones as we efficiently advance COTI-2 through clinical development."
Upcoming Milestones
COTI-2:
Dose first patient with combination therapy in Phase 1b/2a clinical trial in solid tumor;
Complete additional exploratory endpoint data analysis for dose escalation portion of Phase 1 trial in gynecological malignancies;
Complete Phase 1 dose escalation trial in HNSCC;
Initiate p53 basket trial with COTI-2;
Initiate breast cancer trial with COTI-2.
COTI-219:
Complete IND-enabling studies;
Finalize GMP manufacturing;
File an IND.
Corporate:
Strengthen the balance sheet;
Opportunistically pursue regional or co-development partnerships for COTI-2, pipeline programs and other technologies.
Financial Results
The Company’s operational activities during the quarter were primarily focused on advancing the Phase 1b/2a clinical trial of COTI-2.
For the three-months ended July 31, 2018, the Company incurred a net loss of $0.982 million, or $0.04 per share, compared to a net loss of $0.242 million, or $0.02 per share, for the three-months ended July 31, 2017. The increase in net loss during the three-month period is primarily due to changes in fair value warrant liability, partially offset by decreases in Research and Development (R&D) expense, Sales and Marketing (S&M) expense and General and Administrative (G&A) expense.
There was no revenue for the three-month period ended July 31, 2018 or in the comparative period in the year prior.
R&D expense in the three-month period ended July 31, 2018 decreased by $0.283 million over the same period in the year prior. The decrease in R&D expense in the three-month period is primarily due to a decrease in salaries and benefits due to lower headcount and preclinical testing.
S&M expense in the three-month period ended July 31, 2018 decreased by $0.048 million over the same period in the year prior. The decrease in R&D expense in the three-month period is primarily due to cost reduction implemented last financial year.
G&A expense in the three-month period ended July 31, 2018 decreased by $0.287 million over the same period in the year prior. The decrease in R&D expense in the three-month period is primarily due to a decrease in salaries due to lower head count and lower share-based compensation.
Detailed operating and financial results can be found in the Company’s Unaudited Condensed Interim Financial Statements and Management Discussion and Analysis for the three-month period ended July 31, 2018, which can be found on SEDAR at www.sedar.com or on the Company’s website at www.cotingapharma.com.