Vancouver, British Columbia–(Newsfile Corp. – August 31, 2020) – iCo Therapeutics (TSXV: ICO) (OTCQB: ICOTF) (“iCo” or the “Company”), today reported financial results for the quarter ended June 30, 2020. Amounts, unless specified otherwise, are expressed in Canadian dollars and presented under International Financial Reporting Standards (“IFRS”).
Stated William Jarosz, CEO of iCo Therapeutics Inc., “Our Q2 results show a marked quarter over quarter decline in our operating expenses compared to Q1, having substantially completed our Australian Phase 1b trial in Q1. During the quarter, we continued to work closely with our partner Alexion in advancing our iCo-008 program despite the global Covid 19 pandemic.”
Q2 2020 Operational and Financial Highlights
On April 15, 2020, the iCo announced pharmacokinetic results from the Phase 1b study. The oral Amphotericin B at the 100 mg dose achieved a median plasma Cmax of 25 ng AmB/mL and AUC (0-inf) 990 hr* ng/mL after day 1 of dosing and a median plasma Cmax of 44 ng AmB/mL and AUC (0-inf) 1998 hr*ng/mL after 10 day of dosing. This approximate doubling of the AUC (0-inf) measure between day 1 and day 10 was observed not only at the 100 mg dose but at the 400 mg dose as well.
On July 30, 2020, iCo announced the publication of results of their Oral Amphotericin B (iCo 019) Phase 1a Study in one of the leading infectious diseases journals, Antimicrobial Agents and Chemotherapy entitled “Phase I Clinical Study to evaluate the safety, tolerability, and pharmacokinetics of a novel oral amphotericin B formulation (ICO-019) in healthy human subjects”.In January 2020, the assignment of the IMMUNE sublicense to Alexion was completed. Under the terms of the assignment, Alexion was required to pay US$6 million into the Court in the settlement of IMMUNE’s creditor claims in exchange for IMMUNE’s rights under the IMMUNE License Agreement.
Financial results for Quarter ended June 30, 2020
We incurred a total comprehensive loss of $ 336,468 for the quarter ended June 30, 2020 compared to a total comprehensive loss of $386,359 for the quarter ended June 30, 2019, representing a decreased loss of $49,891. The decrease in the loss is primarily the result of lower research and development expenses and lower general and administrative expenses recognized in the quarter ended June 30,2020.
Research and development expenses were $76,886 for the quarter ended June 30, 2020 compared to $156,333 for the quarter ended June 30, 2019, representing a decrease of $79,447. The decrease is related to lower intellectual property costs in the quarter ended June 30, 2020.
The Phase 1b trial was substantially completed in the prior quarter with minimal Phase1b expenses recognized in the current quarter. The Phase 1b trial was conducted in Australia, which provides refundable tax credits for qualifying research and development activities conducted there. The refundable tax credit is calculated at 43.5% of the qualifying expenditures and the Company recognized $161,867 in other income as its estimate of the tax refund related to qualifying expenditures for the six month period ended June 30, 2020.
For the quarter ended June 30, 2020 general and administrative expenses were $169,765 compared to $241,512 for the quarter ended June 30, 2019, representing a decrease of $71,747. The decrease reflects lower consulting and professional fees during the period. The Company’s participation in the IMMUNE bankruptcy process last year caused an increase in consulting and professional fees in the prior year.
Liquidity and Outstanding Share Capital
As at June 30, 2020, we had cash and cash equivalents of $365,824 compared to $989,937 as at December 31, 2019.
As at August 31, 2020, we had an unlimited number of authorized common shares with 153,747,713 common shares issued and outstanding.
For complete financial results, please see our filings at www.sedar.com.
About iCo Therapeutics Inc.
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 focus areas and if so the Company will seek to capture further value via partnerships. iCo shares 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 studies for Oral Amp Delivery System, the timing of receipt of the statistical analysis for clinical 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 April 29, 2019, a copy of which is available under iCo’s profile on SEDAR at www.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.
iCo Therapeutics Inc.
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