Cotinga Pharmaceuticals Announces Publication of Positive Data from Preclinical Study of COTI-2 in PLOS ONE

LONDON, ONTARIO and BOSTON, MASSACHUSETTS–(Marketwired – Jan. 25, 2018) – Cotinga Pharmaceuticals Inc. (formerly Critical Outcome Technologies 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, today announced the publication of positive data from a preclinical study demonstrating that combining COTI-2 with commonly used chemotherapeutic agents improves efficacy and exhibits a favorable drug resistance and toxicity profile in human cancer cell lines. These results were published in PLOS ONE under the title, Novel anti-cancer drug COTI-2 synergizes with therapeutic agents and does not induce resistance or exhibit cross-resistance in human cancer cell lines. The article may be found at the following link: http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0191766

“These data support our rationale to evaluate COTI-2 as a combination therapy, and we are encouraged that these results specifically suggest that COTI-2 may be safe and efficacious in a variety of oncology indications when administered alongside the standard of care” said Richard Ho, Chief Scientific Officer. “In addition to data indicating synergistic activity against multiple cancer cell lines, the favorable drug resistance and toxicity profiles elucidated in this study are key findings that support the continued development of COTI-2 as part of a combination cancer therapy regimen. We look forward to building on these positive preclinical results as we advance combination treatment with COTI-2 into the clinic later this year.”

The preclinical study, performed by Cotinga researchers and academic collaborators, evaluated COTI-2 in combination with commonly used chemotherapeutic agents through in vivo and in vitro experiments using human cancer cell lines. The study found that combining COTI-2 with commonly used chemotherapeutic agents, particularly taxanes and platins, demonstrated enhanced cytotoxic activity and tumor growth inhibition in a variety of human cancer cell lines. Combination treatment with COTI-2 did not induce drug resistance, and drug-resistant cancer cell lines showed little or no cross-resistance to COTI-2. The various combination treatment regimens evaluated did not result in any overt signs of toxicity.

Subject to sufficient financing, Cotinga plans to initiate basket, combination, and expansion studies in multiple oncology indications in 2018.

The Company is also continuing to analyze results from the gynecological arm of its Phase 1 trial of COTI-2 and expects to provide an update when further data are available in the first quarter of 2018. In addition, Cotinga is currently enrolling patients in the head and neck squamous cell carcinoma (HNSCC) dose-escalation arm of its Phase 1 trial of COTI-2, and expects to report initial safety data in the second quarter of 2018.

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 accelerates 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 for the treatment of gynecologic cancers and HNSCC in a Phase 1 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 in 2018.

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For more information, visit http://www.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. For example, the statements “We look forward to building on these positive preclinical results as we advance combination treatment with COTI-2 into the clinic later this year,” “Cotinga plans to initiate basket, combination and expansion studies in multiple oncology indications in 2018,” and “The Company is also continuing to analyze results from the gynecological arm of its Phase 1 trial of COTI-2 and expects to provide an update when further are available in the first quarter of 2018. In addition, Cotinga is currently enrolling patients in the HNSCC dose-escalation arm of its Phase 1 trial of COTI-2, and expects to report initial safety data in the second quarter of 2018” are forward-looking statements. Forward‐looking statements by their nature are not guarantees of future performance and are based upon management’s current expectations, estimates, projections and assumptions. 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.