OrbiMed Makes Big Bet on Xtant Medical
Venture capital firm OrbiMed Advisors disclosed a 9.9%, or 1,952,670 shares, stake in Xtant Medical Holdings Inc (NYSEMKT:XTNT), sending the medical firm’s shares rising nearly 30% in Wednesday’s trading session.
OrbiMed invests across the global healthcare industry, from seed-stage venture capital to large publicly-traded companies. OrbiMed manages a series of public equity funds, including long/short event-driven funds and closed-end investment trusts. The firm invests across all types of publicly-traded companies, from biopharmaceuticals to medical devices and healthcare services worldwide.
Maxim analyst Anthony Vendetti believes XTNT is implementing initiatives to improve operating efficiency, and is working towards an agreement to restructure its debt. The analyst rates the stock a Buy, with a price target of $1.50.
Vendetti wrote, “We would continue to be buyers of XTNT as it implements strategic initiatives to improve operating efficiency and continues negotiations to restructure its outstanding debt. We expect changes to the sales force to slightly disrupt 2017 revenue, but it should lead to overall improvements in EPS and free cash flow. In 1Q17, XTNT improved its gross margin by 310bps y/y, and had its fourth consecutive quarter of positive EBITDA. Management believes that it can reach breakeven – defined as positive EBITDA less cash-based interest expense – on quarterly revenue of $24.2M-$24.5M. If management is able to restructure its significant debt burden, we believe XTNT would be well-positioned to make significant improvements in its generation of free cash flow.”
Catalyst Biosciences Receives Positive Opinion for Orphan Drug Designation from EMA
Catalyst Biosciences Inc (NASDAQ:CBIO) shares are rising nearly 19% to $4.96, after the drug maker announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion recommending orphan medicinal product (orphan drug) designation for CB 2679d/ISU304 for the treatment of hemophilia B.
“Obtaining orphan drug designation is an important part of our regulatory approval strategy for CB 2679d, and the receipt of the positive COMP opinion puts us one step closer to this goal,” said Nassim Usman, Ph.D., President and Chief Executive Officer of Catalyst.
On March 28, 2017, Korean regulatory authorities approved an IND application for CB 2679d enabling ISU Abxis, Catalyst Bio’s clinical development partner, to initiate a Phase I trial in Korea in patients with severe hemophilia B in June 2017. Catalyst Bio guided to completing this trial before year-end 2017. A Phase II portion likely to enroll 40 more patients and expand outside of Korea could be completed by mid-year 2018.
Currently approved therapies for treating hemophilia B rely on frequent intravenous infusions where adherence and convenient access to peripheral veins is difficult, often requiring the use of a central venous access devices that have associated risks of infection and thrombosis. CB 2679d, a highly potent next-generation coagulation Factor IX variant, has demonstrated, in preclinical studies, the potential to normalize human Factor IX levels with a daily subcutaneous injection.