November 15, 2018, Vancouver, Canada — iCo Therapeutics (“iCo” or the “Company”) (TSX-V: ICO) (OTCQB: ICOTF), today announced several positive corporate developments and updated guidance on milestones for two drug candidates.
-iCo Therapeutics announces that it now has sufficient drug supply for a proposed mid-staged clinical trial, which may be as large as 90 patients in size, investigating the efficacy and safety study of its oral Amphotericin B (oral Amp B) candidate.
-iCo has completed solicitation of quotes for its proposed oral Amp B efficacy study, which is also anticipated to be conducted in Australia and expects to award a contract in late Q4 2018, subject to final negotiation of contract terms and financing.
-Assuming cash back reimbursement for its proposed oral Amp B study, in line with experience from its Phase 1 study, and sufficient current drug supply, iCo now estimates a pro forma twelve month budget of approximately $1.5M. In its Phase 1 study iCo received full 43.5% reimbursement of all R&D activities conducted in Australia.
-Our licensee recently announced a $5M USD financing for continued development of iCo-008. Additionally new clinical data has been reported in support of the drug candidate in bullous pemphigoid and pre-clinical data announced which is supportive of the potential use of iCo-008 in asthma.
-Finally iCo previously a clinical advisory board for oral Amphotericin B. Professor Dr. David Denning of the University of Manchester is also, for clarification, Chief Executive Officer of Global Action Fund for Fungal Infections (GAFFI), leads LIFE (Leading International Fungal Education) and is the founder of two biotechnology companies. Professor Dr. John Perfect
-Based on discussions with anti-fungal experts, iCo currently intends on conducting a comparison of oral
Amp B to an approved azole drug in this proposed oral Amp B efficacy study in the area of women’s
health where recurrent candidiasis is common.
Infectious Diseases. He is President of the Mycoses Study Group (MSG) based in USA and President-elect
is James B Duke Professor of Medicine and is
associated with Duke University, as Professor of Molecular Genetics and Microbiology and Chief of
of the international Society of Human and Animal Mycology (ISHAM). iCo expects to expand its advisory
board by Q1 2019.
About iCo Therapeutics
iCo Therapeutics identifies existing development stage assets for use in underserved ocular and infectious diseases. Such assets may exhibit utility in non-ophthalmic conditions outside the Company’s core focusareas and if so the Company will seek to capture further value via partnerships, such as its partnership with Immune Pharmaceuticals (NASDAQ: IMNP), which is in several Phase 2 studies involving iCo-008. iCoshares trade on the TSX Venture Exchange under the symbol “ICO” and on the OTCQB under the symbol “ICOTF”.
For more information, visit the Company website at: www.icotherapeutics.com.
No regulatory authority has approved or disapproved the content of this press release. Neither the TSX Venture Exchange nor its Regulatory Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.
Forward Looking Statements
Certain statements included in this press release may be considered forward-looking statements” within the meaning of applicable securities laws. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “goal,” “seek,” “believe,” “project,” “estimate,” “expect,” “strategy,” “future,” “likely,” “may,” “should,” “will,” and similar references to future periods. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on iCo’s current beliefs as well as assumptions made by and information currently available to iCo and relate to, among other things, anticipated financial performance, business prospects, strategies, regulatory developments, market acceptance and future commitments, including statements relating to reporting further data regarding the Phase 1 study for iCo-019, the timing of receipt of the statistical analysis for the Phase 1 data, the timing, receipt and amount of Australian refundable tax credits, any decrease in research and development expenditures and the completion of additional funding and commencement of additional clinical studies. Readers are cautioned not to place undue reliance on these forward-looking statements, which are based only on information currently available to iCo and speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by iCo in its public securities filings and on its website, actual events may differ materially from current expectations. In evaluating forward-looking statements, readers should consider the risk factors set out herein and in the Company’s Annual Information Form dated July 23, 2018, a copy of which is available under ICo’s profile on SEDAR atwww.sedar.com and as otherwise disclosed in the Company’s filings under its profile on SEDAR from time to time. All forward- looking statements are made as of the date of this press release, and iCo disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Andrew Rae, CEO 778-772-7775 firstname.lastname@example.org