December 2, 2019, Vancouver, Canada — iCo Therapeutics (“iCo” or the “Company”) (TSX-V: ICO) (OTCQB: ICOTF), today reported financial results for the Quarter ended September 30, 2019. Amounts, unless specified otherwise, are expressed in Canadian dollars and presented under International Financial Reporting Standards (“IFRS”).
Stated Andrew Rae, President and CEO of iCo Therapeutics Inc., “Several important milestones have been achieved in recent weeks with ethics approval to enter our second oral Amphotericin B (“Oral Amp B”) clinical study in Australia and the conclusion of court proceedings in the US and Israel, resulting in approval of Alexion’s asset purchase agreement related to iCo-008, an anti-eotaxin-1 antibody. Moving forward we currently expect the conclusion of the next Oral Amp B clinical study in Q1 2020, immediately followed by a 90-patient Phase 2 study in Q2 2020, comparing Oral Amp B to fluconazole in vulvovaginal candidiasis (“VVC”).”
Q3 2019 Financial and Operational Highlights
- On August 16, 2019, the Company closed a non-brokered private placement financing issuing 41,200,000 units at $0.05 per unit for aggregate gross proceeds of $2,060,000.
- The Company completed its revised ethics submission for a multi-dose, escalation clinical study with its Oral Amp B formulation in healthy volunteers and received ethics approval on November 8, 2019. Screening recently commenced and first patient dosing is expected in December 2019.
- 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 courts approval of the US driven sales order. Alexion currently expects the sale to close in Q1 2020.
Financial results for Quarter ended September 30, 2019
We incurred a total comprehensive loss of $513,499 for the quarter ended September 30, 2019 compared to a total comprehensive loss of $418,516 for the quarter ended September 30, 2018, representing an increased loss of $94,983. The increase in the loss is primarily the result of higher general and administrative expenses and lower other income offset by lower research and development expenses recognized during 2019.
Research and development expenses were $84,253 for the quarter ended September 30, 2019 compared to $144,773 for the quarter ended September 30, 2018, representing a decrease of $60,520. The decrease related to lower contract research expenses related to the Oral Amp B Phase 1 clinical study. This study was completed in 2018.
With the initiation of the multi-dose, escalation clinical study in healthy volunteers, we expect research and development expenses to increase until the study is completed in Q1 2020. The net cost of this study is expected to be approximately $650,000 taking into consideration tax refunds from the Australian tax authorities related to this study. The Company believes it has sufficient funds to complete this study and initiate the companion 90 patient VVC study.
For the quarter ended September 30, 2019, general and administrative expenses were $440,257 compared to $309,137 for the quarter ended September 30, 2018, representing an increase of $131,120. The increase reflects increased professional fees and management consulting fees during the quarter due to the Company’s participation in the IMMUNE bankruptcy process.
Liquidity and Outstanding Share Capital
As at September 30, 2019, we had cash and cash equivalents of $1,560,866 compared to $10,140 as at December 31, 2018. As at November 29, 2019, 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.
Andrew Rae, CEO