On May 1, 2021 iCo Therapeutics ("iCo" or the "Company") (TSX-V: ICO) (OTCQB: ICOTF), reported financial results for the year ended December 31, 2020 (Press release, iCo Therapeutics, MAY 1, 2021, View Source [SID1234578999]). Amounts, unless specified otherwise, are expressed in Canadian dollars and presented under International Financial Reporting Standards ("IFRS").
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William Jarosz, CEO of iCo Therapeutics Inc., noted "We were very pleased by the progress of our Oral Amp B program during the year with our compound being safe and well tolerated in Phase 1b clinical trials and potential as a therapeutic agent for novel Coronavirus. We are also excited for the new strategic directions that are open for us in this new year with Satellos, and the associated concurrent financing, previously announced."
The Company also announced the resignation of Susan Koppy as President of the Company and from the Board of Directors, effective April 30, 2021. "While I’ve had a long affiliation with iCo, I now feel that the Company is on a solid trajectory. For personal reasons, it’s the right time for me to move on and tender my resignation. I wish the Company every success," noted Susan Koppy.
"We have benefitted from the guidance that Susan has provided for Business Development and thank her for all her hard work," said William Jarosz. The Company expects to appoint new officers and new members to the Board in conjunction with the Satellos transaction.
Operational and Financial Highlights
Corporate
On March 21, 2021, the Company entered into an agreement (the "Arrangement Agreement"), providing for the business combination of iCo and Satellos Bioscience Inc. ("Satellos") by way of a plan of arrangement (the "Arrangement") in accordance with Section 192 of the Canada Business Corporations Act (the "CBCA"). Pursuant to the Arrangement, Satellos will become a wholly-owned subsidiary of iCo, and the parties expect to complete an amalgamation of iCo and Satellos, with the resulting entity named "Satellos Bioscience Inc." (the "Resulting Issuer"), operating in the life sciences industry. Following the Arrangement, and the Concurrent Financing (described below) shareholders of iCo will hold an approximately 27.7% ownership interest, and the shareholders of Satellos will hold approximately 58.8.% of the outstanding common shares of the Resulting Issuer.
The completion of the Arrangement will result in a reverse takeover of iCo as defined in the policies of the TSX Venture Exchange (the "Exchange"). Completion of the Arrangement is subject to, among other things, the approval of the Exchange, court approval, and approval from iCo and Satellos’ shareholders. 51255844.3 As part of the Arrangement, iCo has closed a private placement (the "Concurrent Financing") of subscription receipts (the "Subscription Receipts") issuing 85,294,117 subscription receipts at a price of $0.085 per Subscription Receipt for aggregate gross proceeds of approximately C$7.25 million, representing an upsize from the C$6 million financing announced on March 22, 2021. Each Subscription Receipt entitles the holder thereof to receive, upon satisfaction of certain escrow release conditions, and without payment of additional consideration, one common share in the Resulting Issuer. The proceeds from the Concurrent Financing have been placed in escrow and, upon satisfaction of the release conditions and completion of the Arrangement, will be used for research, development, and general corporate expenses of the Resulting Issuer.
Also, subsequent to year end, warrant holders exercised 27,435,000 for proceeds of $1,763,795 to the Company.
Oral Amp B Delivery System
On February 25, 2020, iCo announced the completion of the Phase 1b study in which both (100 mg and 400 mg) doses of the oral Amphotericin B were well tolerated with no adverse events reported, including no signs of kidney or other toxicity.
On April 15, 2020, 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 December 31, 2020, iCo and Skymount Medical, Inc. ("Skymount") announced that they entered into a non-binding Memorandum of Understanding to develop iCo-019, iCo’s oral Amphotericin B formulation. Skymount is expected to initially commit up to $US 550,000 for pre-clinical work targeting the use of iCo019 as a therapeutic product for infections relating to COVID-19.
On March 15, 2021, iCo announced that its wholly owned subsidiary, Amphotericin B Technologies, Inc., entered into an agreement with IIT Research Institute to test the in vivo efficacy of iCo’s novel oral amphotericin B asset ("iCo-019") against SARS-CoV-2, the causative agent of COVID-19 in the hACE2 mouse model (the "iCo-019 Study"). iCo anticipates that the iCo-019 Study will be completed by the end of Q2 2021.
Financial results for Year End 2020
We incurred a total comprehensive loss of $1,470,112 for the year ended December 31, 2020 compared to a total comprehensive loss of $1,932,202 for the year ended December 31, 2019, representing a decrease of $462,090. The decrease is primarily the result of lower general and administrative expenses offset by lower research and development tax credits recognized during 2020.
Research and development expenses were $895,112 for the year ended December 31, 2020 compared to $917,475 for the year ended December 31, 2019, representing a decrease of $22,363 or 2%. For both years the research and development expenses primarily reflected contract research expenses for a Phase 1b clinical trial conducted on the Oral Amp B program.
For the year ended December 31, 2020 general and administrative expenses were $760,464 compared to $1,288,198 for the year ended December 31, 2019, representing a decrease of $527,734. The decrease reflects lower consulting and professional fees during the period. The Company’s participation in the 51255844.3 IMMUNE bankruptcy process last year caused an increase in consulting and professional fees in the prior year.
Liquidity and Outstanding Share Capital As at December 31, 2020, we had cash and cash equivalents of $65,413 compared to $989,937 as at December 31, 2019. Subsequent to year end, warrant holders exercised 27,435,000 for proceeds of $1,763,795 to the Company. As at April 27, 2021 we had an unlimited number of authorized common shares with 181,182,713 common shares issued and outstanding. For complete financial results, please see our filings at www.sedar.com.