CORAL GABLES, FL / ACCESSWIRE / October 14, 2015 / In the rush of sector-wide biotech news, especially since Hillary Clinton's now infamous tweet that rocked the entire sector late last month, some developments that would have otherwise been big news may have gotten a bit lost in the ruckus. This is even more the case with foreign stocks that already receive less focus than US-based biotechs. Lest we lose sight of potential opportunities, here are three Canadian biotechs with catalysts pending.

BELLUS Health Inc.

In April this year, Bellus (BLU.TO) leadership released a statement that announced the company's shift from a multi focus biotech to one that limits its focus to the rare disease space. The reason for the shift is simple enough. The reduced phase III study size requirements and other perks of Orphan status make it an attractive option for companies with less capital. It is estimated that 20% of global pharma revenues will derive from rare diseases by 2020.

As part of its refocus, Bellus has one primary candidate with two lead indications, one primary and one secondary, that could bring near term catalysts. The first is its primary pipeline candidate Kiacta for AA Amyloidosis. AA Amyloidosis occurs when proteins in the body fold abnormally and form stacks of protein deposits called amyloids. The disease is similar to Creutzfeldt-Jakob disease (AKA mad cow disease in cows) where proteins fold abnormally and stack in the brain. Amyloids are insoluble in water and end up deposited in certain organs and tissues, especially the kidneys. Kiacta disrupts a key chemical process that turns normal proteins into amyloids in the kidneys. This delays disease progression.

A final Phase 3 Confirmatory Study is being conducted as we speak, and will be completed next quarter (1Q2016) with top-line data expected by the middle of 2016. Amyloidosis currently has no approved treatment, so Bellus would have a monopoly on the approximately 15,000 patients with this incurable disease, so marketing costs after approval should be comparatively low.

The secondary indication for Kiacta is for sarcoidosis, a condition that occurs when the immune system fails to isolate foreign substances and results in a collection of immune cells and inflammation in the lungs. Bellus plans to finalize the protocol for a phase II/III and submit an IND to the FDA before the end of the year. This is a minor catalyst though, and the main thing to watch will be the completion of Kiacta's final Phase 3 for amyloidosis next quarter and subsequent announcement of top-line data.

As a quick side note on risk, generally the major risk associated with this sort of exposure is finance related, whether the cash clock has enough fuel to run through all trials. Bellus has an ongoing partnership with Auven Therapeutics, a private equity firm, that will see the company through to the completion of both trials mentioned without having to raise capital and, in turn, without diluting the current float.

Trillium Therapeutics Inc.

Trillium (NASDAQ: TRIL) is a Nasdaq-listed stock based in Toronto, which focuses on drug development for cancer indications. The company's primary candidate is called SIRP?Fc, an immune-oncology treatment that mediates cancer cell proliferation. In this instance, the treatment binds to CD47, which is a molecule that binds to cancer cells and essentially tells the immune system not to attack. SIRP?Fc binds to CD47, hiding it from the macrophages that do the attacking so they can kill the cancer.

This is a very small company, and one that would normally be a little risky to gain exposure to at this stage of its development because it is very thinly traded and preclinical, but the announcement that Steven Cohen of Point72 had taken a position that amounts to a little of 5.6% of the company back in April has made it a little more enticing. Point72 is a $15 billion hedge fund and doesn't take positions on speculative companies lightly, indicating that Cohen may know something.

That said, Trillium announced the submission of an IND at the end of September, so it is reasonable to assume we will get an update from the FDA before the end of this quarter as to the status of this IND. Preclinical trials are complete, and we could see the initiation of a phase I dose escalation in late 2015 or early 2016. The investigation will spread across a range of indications, so any update as to its progress, including the announcing of its commencement, could boost Trillium's current sub $100 million market cap near term.

The positioning of a multibillion dollar hedge fund though may point in other directions such as an acquisition.

Nuvo Research Inc.

Nuvo (NRI.TO) is an interesting one. Nuvo Research announced that it was splitting into two totally separate entities ? one to focus on its already commercialized treatments and another to focus on development of fresh products. The first company is expected to become almost instantly profitable, as it will comprise revenues from products already being sold under license by other companies. The primary source of this first entity's revenues is a knee pain treatment called Pennsaid,a twice daily ointment. Nuvo sold the US rights to the treatment to Horizon Pharma (NASDAQ:HZNP) last year, and reported in September this year that it had generated $2.1 million in product sales to Horizon during the second quarter of this year.

The second entity will focus on design and development. Upon the split, it will have a few pipeline candidates, but realistically near term drivers will come from one primary candidate ? WF10. This is the one to keep an eye on post-split, and the one that could offer an upside catalyst near term. WF10 is an immunomodulator, meaning that it stimulates macrophages into an enhanced response to pathogens. Nuvo is currently trialling the treatment for an allergic rhinitis indication, flu-like symptoms from allergens like pollens and animal hair. The company announced promising top-line data from a phase II back in January, and is currently undertaking a second phase II targeting sufferers of an allergy to ragweed. Top-line data from this trial is expected during the final quarter of this year. If data are as positive as the previous phase 2, expect a popup in market cap for the Nuvo R&D spinoff mainly, and possibly for the larger developed Nuvo company as well. The company split should take place before the data release.

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