iCo Therapeutics Announces  Third Quarter 2019 Financial Results

On December 2, 2019 iCo Therapeutics ("iCo" or the "Company") (TSX-V: ICO) (OTCQB: ICOTF), 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") (Press release, iCo Therapeutics, DEC 2, 2019, View Source [SID1234552430]).

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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.