Vancouver, British Columbia--(Newsfile Corp. - May 19, 2020) - iCo Therapeutics (TSXV: ICO) (OTCQB: ICOTF) ("iCo" or the "Company"), today reported financial results for the year ended December 31, 2019. Amounts, unless specified otherwise, are expressed in Canadian dollars and presented under International Financial Reporting Standards ("IFRS").
Stated William Jarosz, President and CEO of iCo Therapeutics Inc., "2019 represented a year of significant advances as we entered into a Phase 1b clinical trial for Oral Amphotericin B and we welcomed a new partner, Alexion Pharmaceuticals Inc., who are developing our iCo-008 (also known as bertilimumab). While COVID 19 has disrupted our business as with many other companies, we remain encouraged by our progress in 2019. "
2019 Operational and Financial Highlights
Oral Amp B Delivery System
On December 9, 2019, we initiated a second study using oral Amphotericin B (Phase 1b) exploring safety and pharmacokinetics of multiple ascending drug doses (MAD) in healthy subjects. On February 25, 2020 we announced that that this study was successfully completed with no serious adverse events. On April 15, 2020, we announced the pharmacokinetic data from this study which showed a doubling in the AUC (0-inf), a measure of drug accumulation, after 10 days dosing compared to day 1 dosing.
On October 21, 2019, the US Court approved a sales order which assigned IMMUNE's rights and obligations under the IMMUNE License Agreement to Alexion Pharmaceuticals Inc. This approval was followed by the Israeli court's approval of the US driven sales order. Under the terms of the sales order, 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.
During the year, we completed two private placements for net proceeds of approximate $3 million.
Financial results for Year End 2019
We incurred a total comprehensive loss of $ 1,932,202 for the year ended December 31, 2019 compared to a total comprehensive loss of $1,712,724 for the year ended December 31, 2018, representing an increased loss of $219,478 . The increase in the loss is primarily the result of higher general and administrative expenses and lower research and development tax credits offset by lower research and development expenses recognized during 2019.
Research and development expenses were $917,475 for the year ended December 31, 2019 compared to $1,420,457 for the year ended December 31, 2018, representing a decrease of $502,982. The decrease related to lower contract research expenses because there were no clinical trials conducted on the Oral Amp B program until December 2019. In the prior year, research and development expenses related to the manufacture of clinical drug supplies and the initiation and successful conclusion of its Phase 1a clinical study in Australia.
For the year ended December 31, 2019 general and administrative expenses were $1,288,198 compared to $781,282 for the year ended December 31, 2018, representing an increase of $506,916. The increase reflects higher professional fees and management consulting fees during the period due to the Company's participation in the IMMUNE bankruptcy process.
Liquidity and Outstanding Share Capital
As at December 31, 2019, we had cash and cash equivalents of $989,937 compared to $10,140 as at December 31, 2018.
As at May 15th, 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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