TORONTO and BOSTON, Oct. 02, 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 three-month period ended July 31, 2018. 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 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.

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.

Follow @CotingaPharma on Twitter at http://twitter.com/CotingaPharma.

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, statements in the “Upcoming Milestones” section 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.