On August 29, 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 fourth quarter and full year ended April 30, 2018 (Press release, Cotinga, AUG 29, 2018, View Source [SID1234533152]).
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Recent highlights include:
Advanced the clinical development of COTI-2:
In March 2018, Cotinga submitted an updated clinical package to regulatory authorities to expand its ongoing clinical trial of COTI-2. The protocol amendment expanded the clinical trial to evaluate COTI-2 as a combination therapy in a wide spectrum of cancers.
In April 2018, Cotinga and its collaborators from MD Anderson Cancer Center and Northwestern Medicine presented data on COTI-2 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2018 in Chicago, Illinois.
Subsequent to the reporting quarter, in May 2018, Cotinga announced the clearance of a protocol amendment for its ongoing clinical trial of COTI-2. The multi-part protocol amendment expanded the Phase 1b/2a trial to evaluate COTI-2 as a combination therapy in a wide spectrum of cancers.
Subsequent to the reporting quarter, 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.
Secured funding to support clinical development:
Subsequent to the reporting quarter, in May 2018, Cotinga closed a brokered and non-brokered private placement for total proceeds of approximately $2.010 million to support the continued clinical development of COTI-2. Roth Capital Partners, LLC acted as sole placement agent for the brokered offering in the United States.
"We executed on multiple meaningful clinical, scientific and corporate efforts in the past quarter and fiscal year as we sought to advance the development of our lead asset, COTI-2," said Alison Silva, President & Chief Executive Officer. "Supported by the various data we presented to the scientific community and bolstered by our successful financing efforts, we continued to refine our clinical development strategy and worked with regulators to implement a protocol amendment to advance COTI-2 in the clinic as a combination therapy. We are pleased by our progress over the past year transitioning to a fully-fledged clinical-stage biotechnology company, and we look forward to providing an update as our ongoing Phase 1b/2a trial of COTI-2 progresses."
Upcoming Milestones
COTI-2:
First patient dosed with COTI-2 in combination with standard of care chemotherapy in ongoing Phase 1b/2a trial expected in calendar year 2018.
Readout of additional exploratory endpoint data from the monotherapy dose escalation portion of Phase 1 trial in gynecological malignancies.
Complete monotherapy dose escalation portion of Phase 1 trial in head and neck squamous cell carcinoma (HNSCC).
Initiation of p53 basket trial and breast cancer trial.
COTI-219:
Completion of preclinical studies and finalization of GMP manufacturing to enable an IND filing.
Corporate:
Strengthen the balance sheet to execute on corporate strategies and 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 1a/2b clinical trial of COTI-2.
For the three-months ended April 30, 2018, the Company incurred a net loss of $1.579 million, or $0.10 per share, compared to a net loss of $1.907 million, or $0.13 per share, for the three-months ended April 30, 2017. The decrease in net loss during the three-month period is primarily due to a decrease in R&D and G&A costs, as well as a change in the fair value of warrant liability, partially offset by an increase in S&M cost.
For the twelve-months ended April 30, 2018, the Company incurred a net loss of $4.880 million, or $0.31 per share, compared to a net loss of $6.209 million, or $0.42 per share, for the twelve-months ended April 30, 2017. The decrease in net loss during the twelve-month period is primarily due to a decrease S&M and G&A costs, as well as a change in the fair value of warrant liability, partially offset by an increase in R&D cost.
There was no revenue for the three- and twelve-month periods ended April 30, 2018 or in the comparative periods in the year prior.
R&D expense in the three- and twelve-month periods ended April 30, 2018 decreased by $0.140 million and increased $0.042 million respectively over the same periods in the year prior. The decrease quarter over quarter is primarily due to a decrease in clinical trial expenses and synthesis and miscellaneous R&D expenses as the Company focused on COTI-2. The increase year over year is primarily due to an increase in synthesis and miscellaneous expense related to the timing of expenditures for the advancement of COTI-219 in GMP manufacturing
S&M expense in the three- and twelve-month periods ended April 30, 2018 increased by $0.014 million and decreased $0.102 million respectively over the same periods in the year prior. The increase quarter over quarter is primarily due to legal services provided, previously allocated as general and administrative expenses. The decrease year over year is primarily due to a reduction in representation at conferences and services provided by consultants as services moved internally to reduce overhead.
G&A expense in the three- and twelve-month periods ended April 30, 2018 decreased by $0.132 million and $0.704 million respectively over the same periods in the year prior. The decrease quarter over quarter is primarily due to a decrease in salaries due to departure of the former Chief Executive Officer. The decrease year over year is primarily due to a decrease in salaries due to the departure of the former Chief Executive Officer and a decrease in share-based compensation as issuance of share option awards to employees and consultants.
Fair value of warrant liability for the three- and twelve-month periods ended April 30, 2018 decreased by $0.030 million and $1.439 million respectively over the same periods in the year prior.
The Company executed on financing efforts subsequent to the reporting quarter, closing a brokered and non‐brokered private placement with accredited investors in for total proceeds of approximately $2.010 million to support the continued clinical development of COTI-2. Roth Capital Partners, LLC acted as sole placement agent for the brokered offering in the United States.
Prior to the close of the private placements, as of April 30, 2018, the Company had cash, cash equivalents and investments of $0.040 million and will have to raise equity capital in the near term in amounts sufficient to fund both research work and working capital requirements. With the approximately $2.010 million raised subsequent to fiscal year end, Cotinga expects that continued achievement of milestones, such as the progression of COTI-2 in clinical milestones and the advancement of its preclinical pipeline, will be supportive of an increase in shareholder value and may provide the Company with an opportunity to realize funding in calendar 2018 and 2019.
Detailed operating and financial results can be found in the Company’s audited annual Financial Statements and Management Discussion and Analysis for the three- and twelve-month periods ended April 30, 2018, which can be found on SEDAR at www.sedar.com or on the Company’s website at www.cotingapharma.com.