2016 will be the most important year in this firm’s history, one that we believe will transform the company with positive trials from one if not two novel compounds in billion-dollar markets, asserts biotech expert John McCamant, editor of The Medical Technology Stock Letter.
Over the past six months, Anthera (ANTH) has been one of the quietest biotech stocks we cover.
As a result, the stock has been the victim of ‘no news is bad news’ during a massive risk-off period where small-caps have been tossed aside indiscriminately.
Despite the lack of news (conservative management does not put out useless press releases), 2016 will end the drought of clinical trial releases.
The company will deliver four clinical studies (two Phase III, two Phase II) for their two core compounds beginning in the second quarter of this year.
Positive data from the Sollpura SIMPLICITY study (Fourth Quarter) could lead to an NDA filing in 2017 and subsequent FDA approval in early 2018.
Regarding Sollpura, Anthera formulated a kid-friendly version, since most children cannot swallow or tolerate the typical large pill that adults take with every meal using existing PERTs (pancreatic enzyme replacement therapy). The PERT market generates $1 billion in global sales annually.
Strong data from b-mod in CHABLIS 1 (Quarter 3)—designed from over a database of 5,000 lupus patients—could also lead to a potential FDA filing/approval around the same time frame.
Preliminary data from the interim look at the b-mod Iga nephropathy study (Second Quarter) could further support the CHABLIS trial odds of success.
Meanwhile, the stock has a market cap of approximately $115 million and over $50 million in the bank, enough to complete/release all seven clinical trial data points over the next 12 months, beginning in the Second Quarter.
Based upon the history of both compounds and the lack of clinical data over the past several years, expectations are low for either drug’s success.
As we begin to see positive clinical results in 2016, we believe that is about to change. ANTH remains one of our favorite small-cap ideas.
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