TORONTO and BOSTON, Aug. 29, 2018 (GLOBE NEWSWIRE) -- 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. 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) 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) 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.
About Cotinga Pharmaceuticals Inc.
Cotinga Pharmaceuticals is a clinical-stage pharmaceutical company that uses proprietary artificial intelligence technologies to pursue a targeted and transformational approach to treating cancer and other unmet medical needs. Cotinga’s CHEMSAS® technology is intended to accelerate the discovery and development of novel drug therapies, allowing the Company to build a pipeline of potential drug candidates faster and with a higher probability of success than traditional methods.
The Company’s lead compound, COTI‐2, has a novel p53‐dependent mechanism of action with selective and potent anti‐cancer activity. P53 mutations occur in over 50% of all cancers. COTI‐2 is initially being evaluated in combination with various standard of care chemotherapy regimens for the treatment of a wide spectrum of cancers in a Phase 1b/2a clinical trial at the MD Anderson Cancer Center at the University of Texas and the Lurie Cancer Center at Northwestern University. The Company has secured orphan drug status in the United States for COTI‐2 for the treatment of ovarian cancer. Preclinical data suggests that COTI-2 could dramatically improve the treatment of cancers with mutations in the p53 gene.
The Company’s second lead compound, COTI-219, is a novel oral small molecule compound targeting the mutant forms of KRAS without inhibiting normal KRAS function. KRAS mutations occur in up to 30% of all cancers and represent a tremendous unmet clinical need and a desirable drug target. COTI-219 is undergoing IND-enabling studies to support a regulatory submission.
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Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
For more information, visit http://www.cotingapharma.com/ or contact:
Alison Silva
President and CEO
Tel: 1-800-798-6860
Email: asilva@cotingapharma.com
Notice to Readers:
Information contained in this press release may contain certain statements which constitute “forward-looking statements” as such term is defined under applicable securities laws. Forward‐looking statements by their nature are not guarantees of future performance and are based upon management’s current expectations, estimates, projections and assumptions. For example, “we look forward to providing an update as our ongoing Phase 1b/2a trial of COTI-2 progresses”, “First patient dosed with COTI-2 in combination with standard of care chemotherapy in ongoing Phase 1b/2a trial expected in calendar year 2018” and “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” are forward-looking statements. Cotinga operates in a highly competitive environment that involves significant risks and uncertainties, which could cause actual results to differ materially from those anticipated in these forward‐looking statements. Management of Cotinga considers the assumptions on which these forward‐looking statements are based to be reasonable, but as a result of the many risk factors, cautions the reader that actual results could differ materially from those expressed or implied in these forward-looking statements. Information in this press release should be considered accurate only as of the date of the release and may be superseded by more recent information disclosed in later press releases, filings with the securities regulatory authorities or otherwise. Except as required by law, Cotinga assumes no obligation to update forward-looking statements should circumstances or management's expectations, estimates, projections and assumptions change.