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NeoStem (NBS) Enters $20M Secured Facility; Updates on Remaining Milestones for FY14

September 29, 2014 7:41 AM EDT
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Price: $2.25 --0%

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Operating loss: -6.86M

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NeoStem (Nasdaq: NBS) has entered into a Loan and Security Agreement (the "Loan Agreement") with Oxford Finance LLC ("Oxford") pursuant to which Oxford has agreed to make a term loan to the Company in the principal amount of up to $20 million, and has made the initial disbursement of $15 million. The loan matures in September 2018 and the additional $5 million disbursement is available in the event of the Company's consummation of a partnering transaction around the Company's NBS10 development program for post acute myocardial infarction ("AMI") patients. Oxford will have a security interest in substantially all the Company's real and personal property, excluding intellectual property. No warrants or common stock were issued in connection with this financing.

"This new debt facility will serve as an excellent source of non-dilutive capital to support the launch of our Intus Phase 3 clinical trial in metastatic melanoma, a significant milestone we anticipate meeting by the end of this year," said Dr. Robin L. Smith, Chairman and CEO of NeoStem. "We are pleased both by the terms of the loan and the flexibility it offers us to meet our near-term goals."

WBB Securities, LLC acted as a financial advisor to NeoStem on the transaction.

NeoStem is on track to present data from its PreSERVE AMI study at the American Heart Association's Scientific Sessions on November 17, 2014. PreSERVE AMI is a randomized, double-blinded, placebo-controlled Phase 2 clinical trial testing NBS10, an autologous (donor and recipient are the same) adult stem cell product for the treatment of patients with left ventricular dysfunction following acute ST segment elevation myocardial infarction ("STEMI").

The Company plans to begin the Intus Study, its Phase 3 clinical trial to evaluate the lead product candidate in its targeted immunotherapy program for cancer, NBS20, as an autologous treatment for patients with Stage IV or recurrent Stage III metastatic melanoma, by the end of 2014. NBS20, also referred to as DC/TC (dendritic cell/tumor cell), targets malignant melanoma initiating cells, has been granted fast track and orphan designation by the Food and Drug Administration ("FDA"), and has a Phase 3 protocol that is the subject of a Special Protocol Assessment ("SPA"). The SPA indicates that the FDA is in agreement with the design, clinical endpoints, and planned clinical analyses of the Phase 3 trial that would serve as the basis for a Biologics License Application ("BLA") that would be filed with the FDA requesting marketing approval of this therapeutic candidate.



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