A Stalking Horse Bid from a ~$24 Billion BioPharma Behemoth Could Breathe Life into this unknown 8 cent stock

Ico Therapeutics, Inc. (OTC QB: ICOTF)(TSX: ICO.V) is a Canada-based biotechnology company principally focused on the identification, development and commercialization of drug candidates to treat infectious and ocular diseases.

Their Vision is to make “existing drugs more effective and easier to deliver.”

ICOTF is focused on two main drug candidates, iCo-008, named Bertilimumab, or “Bert” for short, and ICO-019 named Amphotericin B, or “Oral Amp B” for short.

ICOTF has licensed the exclusive world-wide rights to Bertilmumab/iCo-008.  The asset was originally developed by Cambridge Antibody, and acquired by AstraZeneca upon its purchase of Cambridge.  In 2007, ICO licensed it.  Then in 2010, ICO licensed the systemic rights to Immune Pharmaceuticals, while ICO maintained all ocular rights.  As part of the deal, ICO was entitled to $32 million in milestone payments and 8.5% royalty on iCo-008 sales.

Now the story takes a fascinating turn.  Immune Pharmaceuticals filed for bankruptcy and the assets were put up for court auction.  Court filings show that Alexion Pharmaceuticals, a $24 Billion behemoth, placed a stalking horse bid for $6M and won the systemic rights.

Why would Alexion bid for Bert?  The asset has shown “clinical efficacy in a highly deleterious condition” meaning – it works.  It has passed Phase II of the FDA approval process and awarded an orphan drug designation by both the FDA and the EMA -European Medicines Agency.

The FDA has granted Fast Track Designation to Bert for the treatment of a dermatological condition called Bullous Pemphigoid (BP).  BP is an autoimmune disorder which causes painful and itchy fluid-filled blisters, primarily in elderly patients.  The global outlook for BP is projected to grow considerably over the next few years.

Bert is also a candidate for treating Ulcerative Colitis and has completed recruitment for a new clinical study.

Alexion is widely regarded as the largest pure-play orphan drug disease company with greater than $4Billion in annual sales.  In fact, every one of Alexion’s marketed products have Orphan Drug designations.  Orphan drugs have potential to be big sellers.  Alexion’s top selling drug Soliris, which has orphan designation for three indications, produced over $3.5 Billion of revenue in 2018.

The stalking horse bid sets a minimum value for the asset.  ICO will not receive any proceeds from this sale, but they benefit from the greater likelihood of receiving its development milestone payments ($32.0 Million), and royalty revenues (8.5%), if/when the product is commercialized.

Regulatory filings for both ICO and Immune indicate that the first of the $32 million in milestone payments to ICO occur once the first patient is dosed in a Phase 3 study with iCo-008.  If Alexion ends up being the new partner, they have the ability and means to push for a phase 3.  The payments would be triggered and ICO would stand to receive upfront cash and milestone payments.

ICOTF could end up with Alexion as a huge partner for this asset.  ICO still owns the Ocular rights, and Alexion may want to enter into a new licensing agreement.  Or they may want to buy them outright!  It’s not out of the question to think Alexion would want 100% ownership of the intellectual property to control any future product commercialization.  According to court filings Immune and Alexion were in discussions prior to Immune filing for Chapter 11, so the interest has always been there.

ICOTF has solicited bids from CRO’s for assistance with this Ocular asset, and is engaging with the FDA to run an additional Phase 2 study in Ophthalmology.

There are so many ways this could play out, and ICO seemingly stands to benefit from all.

ICOTF has taken a decades old IntraVenous (I.V.) generic drug and converted it to a proprietary oral drug.

Amphoericin B Delivery System is a generic drug which is currently administered intravenously to treat fungal infections and Visceral Leishmaniasis, an often fatal disease caused by a parasite.  Amphotericin B (Amp B) has been a gold standard for highly efficacious treatment of systemic fungal and parasitic infections with more than a 50-year history of intravenous (IV) formulations.  In fact, it produced $366M in sales in 2017 for Gilead.

An oral version of the drug has yet to be developed.

ICOTF has developed an oral Amp B formulation which may have significant advantages over an IV formulation with fewer adverse events and an easier way of administration. Oral formulations could resolve safety and delivery issues which would enable broader patient access.

Oral delivery of the drug would be of paramount interest to pharmaceutical and insurance companies.  The cost to administer IV drug treatments is substantial and poses risk of infections or complications.

An estimated 1.5 million people globally die from fungal infections.  The global antifungal market could be worth as much as $12.7 Billion by 2025.

ICOTF has completed Phase I safety work with their oral Amp B formulation and is preparing to enter a Phase 1b/2a proof-of-concept study.  Data from this Phase 2a study should be available in early /mid 2020.  They submitted a plan and further additional materials to an Australian IRB (Institutional Review Board) outlining a proposed multi-center study of up to 90 individuals comparing Oral Amp B to current standard of care.

The company recently raised just over $2 Million in a private placement, and raised $1.25M Canadian earlier in the year.  They act with “fiscal prudence,” prioritizing scientific and technological advances through leveraging activities, receiving tax credits from the Australian government.

The Bottom Line

Ico Therapeutics, Inc. (OTC QB: ICOTF) was recently given a $0.60 price target by KRC Insights.  If this hit, it would represent a 650% return from the current $0.08 price (10/21/2019).

Ico Therapeutics, Inc. (OTC QB: ICOTF) is an under-the-radar company offering a potential upside opportunity for timely investors.  Currently trading at a miniscule market cap of under $10.0 Million, this could prove to be highly undervalued compared to all of the short term catalysts listed, which lend credibility to this highly compelling story.

For a better understanding of ICOTF and its business, plus risks of owning its shares, click here to view ICOTF’s SEC filings.

Please read them thoroughly before making any investment decisions.

Thank you for Reading.


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