iCo Therapeutics Announces 2018 Year End Financial
Vancouver, British Columbia–(Newsfile Corp. – April 30, 2019) – iCo Therapeutics (TSXV: ICO) (OTCQB: ICOTF) (“iCo” or the “Company”), today reported financial results for the year ended December 31, 2018. 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., “2018 represented a year of significant advances as we entered into a clinical trial for Oral Amphotericin B and saw positive Phase 2 data related to iCo-008 (also known as bertilimumab). As a result of these developments iCo is entering an exciting phase of mid stage clinical study for our antifungal candidate in 2019, including additional work in Australia given its generous tax incentives.”
2018 Financial and Operational Highlights
Oral Amp B Delivery System
On June 27, 2018, iCo announced a positive primary end point in its Phase I clinical study. The study met its primary endpoint of safety and tolerability of iCo-019 (oral Amphotericin B) following oral administration of single ascending doses in healthy subjects. There were no serious adverse events and no drug-related adverse events in the four study cohorts. All drug doses were well tolerated, including the highest dose of 800 mg with no indication of kidney or gastrointestinal toxicity.
On July 16, 2018, iCo announced a positive secondary endpoint in its Phase I clinical study and advancement into later stage clinical trials. It was noted that the distinguishing features of the Company’s Oral Amphotericin B candidate were enhanced plasma area under the concentration time curve, which is a measure of systemic drug exposure, and longer blood circulation time without the associated gastrointestinal effects or liver and kidney toxicity.
During the year, the Company’s subsidiary received its Australian tax credit of $462,000 AUD related to its research and development work in Australia. Additional tax credit reimbursement is expected for the period beginning July 1, 2018.
On May 15, 2018, positive results were reported from a completed bullous pemphigoid (BP) trial. Subjects in the study experienced a decline in the BPDAI Activity Score of 81% (p=0.015) at day 84 from a mean baseline score of 67, with 86% of subjects showing at least a 50% improvement in the BPDAI Activity Score and 57% showing at least a 90% improvement.
On July 30, 2018, the Committee for Orphan Medicinal Products of the European Medicines Agency issued a positive opinion on the application for orphan drug designation for bertilimumab for the treatment of BP. On August 20, 2018, it was announced that the FDA granted orphan drug designation to bertilimumab for the treatment of BP.
On September 11, 2018, it was announced that the FDA had granted Fast Track designation to bertilimumab for the treatment of BP.
On August 14, 2018 iCo filed a short form base shelf prospectus (the “Base Shelf”) with securities regulators in the provinces of British Columbia, Alberta and Ontario. The Base Shelf allows iCo to offer, from time to time in one or more public offerings, up to $25,000,000 of common shares, preferred shares, debt securities, subscription receipts, units or warrants, or any combination thereof, during the 25-month period ending September 14, 2020. iCo filed the Base Shelf to provide the Company with financing flexibility going forward.
Subsequent to year end
Subsequent to the year end, the Company closed several non-brokered private placements, issuing 25,000,000 units at $0.05 per unit for aggregate gross proceeds of $1,250,000. Net proceeds were $1,150,000 after related expenses.
On February 15, 2019, the Company delivered written notice terminating, with immediate effect, the iCo-008 sublicense agreement with IMMUNE (Immune Pharmaceuticals) based on a number of IMMUNE breaches, including but not limited to, the attempted subordination of iCo intellectual property to investors. Subsequent to the termination, IMMUNE filed a voluntary petition for bankruptcy in the District of New Jersey on February 17, 2019. The Company is seeking all materials related to IMMUNE’s historical activities, including but not limited to its patient database and regulatory filings. iCo is also pursuing new development partners to further advance iCo-008.
Financial results for Year End 2018
We incurred a total comprehensive loss of $1,712,724 for the year ended December 31, 2018 compared to a total comprehensive loss of $1,237,308 for the year ended December 31, 2017, representing an increased loss of $475,416. The increase in the loss is primarily the result of higher research and development expenses and general and administrative expenses recognized during 2018 partially offset by higher other income.
Research and development expenses were $1,420,457 for the year ended December 31, 2018 compared to $808,534 for the year ended December 31, 2017, representing an increase of $611,923. The increase related to higher contract research expenses related to the completion of the Oral Amp B Phase 1 clinical studies.
For the year ended December 31, 2018 general and administrative expenses were $781,282 compared to $664,814 for the year ended December 31, 2017, representing an increase of $116,468. The increase reflects increased professional fees associated with filing an annual information return and the Base Shelf prospectus.
Liquidity and Outstanding Share Capital
As at December 31, 2018, we had cash and cash equivalents of $10,140 compared to $1,127,934 as at December 31, 2017.
As at April 29, 2019, we had an unlimited number of authorized common shares with 109,457,713 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: icotherapeutics.cdmail.biz.
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 forwardlooking 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
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