Clearside Biomedical, Inc., a late-stage clinical biopharmaceutical company, develops pharmacological therapies to treat blinding diseases of the eye. It is developing suprachoroidal injection of CLS-TA, a proprietary preservative-free formulation of the corticosteroid triamcinolone acetonide, which is in Phase III clinical trial for the treatment of macular edema associated with non-infectious uveitis; suprachoroidal injection of CLS-TA and a concomitant intravitreal injection of Eylea, an inhibitor of vascular endothelial growth factor that is in Phase III clinical trial to treat macular edema associated with retinal vein occlusion; and suprachoroidal injection of CLS-TA alone or together with intravitreal injection of Eylea that is in phase II clinical trial for diabetic macular edema. The company also engages in the development of therapies in various areas, such as gene therapy for inherited retinal disorders, neovascular age-related macular degeneration, and other ocular diseases. The company was founded in 2011 and is headquartered in Alpharetta, Georgia.
Clearside Biomedical went public at $8.00 in June 2016 and entered a strong uptrend three months later, lifting vertically into an all-time high at $25.08 in October. It carved a double top pattern at that level and broke down in December, descending at the same trajectory as the prior uptick before bottoming out at just above $5.00 in March 2017.
The stock ground sideways through the rest of the year and into 2018, testing last year's low in February. Support held into early March when it took off like a rocket in reaction to positive Phase III results for suprachoroidal CLS-TA, which treats macular edema. The uptick stalled and reversed at double top resistance in the low teens, while the pullback into this week has relinquished about four points. The March 5 breakaway gap between $7.90 and $10.00 should offer strong support, ahead of an uptrend that could reach the 2016 high.
On the heels of the Company's promising macular-edema treatment trial results, attention turns to whether the FDA will approve the marketing of CLS-TA and for what purposes. Clearside expects that it will submit a new drug application for CLS-TA to the regulatory agency in the fourth quarter of 2018, and it's also testing the drug as a treatment for macular edema associated with retinal occlusion and plans to report preliminary results from these trials in the same time window.
In March, the Company announced the pricing of its secondary public offering of 6,538,462 shares of its common stock at a price to the public of $13.00 per share.
This company is in better shape than most biotechnology or biomedical companies because they've been successful in their phase III trials. That's a huge hurdle and produces a successful product. But that doesn't mean the FDA will allow it to be sold as a product nor does it identify what specific disease and treatment will be allowed. But the odds are higher than most simply because of the phase III success.
I believe this product will be approved by the FDA but not until later this year and until that happens, there's always risk in accumulating these shares. My strategy will be to begin buying these shares very soon and at prices as close to $10 as I can. I believe that is where the support is. I will continue to buy up to about $13 because that's where the secondary was offered. At that point I'll have to make a decision on whether to continue buying.