Winston-Salem, NC -- (SBWIRE) -- 12/18/2013 -- Omeros Corporation (NASDAQ: OMER) $8.92, OMER. Today announced that OMS721, the company's lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the key regulator of the lectin pathway of the immune system, has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for prevention of complement-mediated thrombotic microangiopathies (TMAs).
Omeros is completing a Phase 1 study to assess the safety and pharmacokinetics of OMS721. As previously announced, at the highest subcutaneous dose administered to date in this study, OMS721 achieved serum concentrations that resulted in a high degree of inhibition of lectin pathway activation. The serum concentrations seen in the Phase 1 subjects are similar to those associated with efficacy in animal models of diseases, including TMA, linked to the lectin pathway. Omeros expects to report additional Phase 1 clinical data in early 2014.
The Phase 2 clinical program evaluating OMS721 for the prevention of complement-mediated TMAs is expected to begin in the first quarter of 2014.
What They Do: Omeros is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics targeting inflammation, coagulopathies and disorders of the central nervous system.
Syntroleum Corporation (NASDAQ: SYNM) $2.46, and Renewable Energy Group announced today that they have entered into an asset purchase agreement pursuant to which REG would acquire substantially all of the assets of Syntroleum Corporation, and assume substantially all of the material liabilities of Syntroleum. The terms of the transaction call for Syntroleum to receive 3,796,000 shares of REG common stock (subject to reduction in the event that the aggregate market value of the REG common stock to be issued would exceed $49 million or if the cash transferred to REG is less than $3.2 million).
Syntroleum's Board of Directors also has approved a plan of dissolution for Syntroleum pursuant to which Syntroleum will be liquidated and dissolved, in accordance with Delaware law, following consummation of the asset sale and subject to stockholder approval of the plan of dissolution at the special meeting. Before distributing any amounts to its stockholders, Syntroleum must satisfy all of its obligations not being assumed by REG, as well as pay certain costs, including employee expenses and expenses associated with the asset sale and the dissolution. The asset purchase agreement with REG provides for Syntroleum to retain a cash reserve equal to the lesser of $5.3 million or the amount of cash on hand at Syntroleum as of the closing, which Syntroleum will use to satisfy these obligations and expenses. Syntroleum currently intends to distribute all of the shares of REG common stock received in the asset sale to Syntroleum's stockholders, assuming that the cash reserve is sufficient to discharge Syntroleum's obligations and expenses, which would result in Syntroleum stockholders receiving 0.3809 shares of REG common stock for each outstanding share of Syntroleum common stock (subject to reduction in the event that the aggregate market value of the REG common stock to be issued would exceed $49 million or if the cash transferred to REG is less than $3.2 million).
However, it is possible that, in the course of the dissolution process, unanticipated expenses and liabilities will arise. If such liabilities exceed the cash reserve, Syntroleum will be required to sell a portion or all of the REG common stock received in the asset sale to satisfy its obligations before its dissolution, thereby reducing, and perhaps eliminating, the assets available for distribution to Syntroleum stockholders.
What They Do: Syntroleum Corporation owns the Syntroleum Process for Fischer-Tropsch conversion of synthesis gas into liquid hydrocarbons.
BioCryst Pharmaceuticals (NASDAQ: BCRX) $6.48. Today announced that it has selected two optimized plasma kallikrein inhibitors to advance into preclinical development as potential once-daily, oral treatments for the prevention of hereditary angioedema (HAE) attacks.
The second generation discovery program's goals of improving selectivity and bioavailability compared to BCX4161 were both met, with no effect on prothrombin time at high concentrations (>50 micromolar), and oral fraction absorbed exceeding 25%. Similar to BCX4161, these BioCryst discovered compounds demonstrate sub-nanomolar potency on the isolated enzyme and single digit nanomolar potency in suppressing kallikrein activity in an ex vivo activated human plasma kallikrein inhibition (aPKI) assay. Plasma concentrations of each of the optimized compounds exceeded the aPKI assay EC concentration at 24 hours after a single oral dose of 10 mg/kg in rats, indicating suitability for once-daily dosing.
What They Do: BioCryst Pharmaceuticals designs, optimizes and develops novel small molecule drugs that block key enzymes involved in infectious and inflammatory diseases, with the goal of addressing unmet medical needs of patients and physicians.
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