Quarterly report pursuant to Section 13 or 15(d)

Organization, Plan of Business Operations

v3.10.0.1
Organization, Plan of Business Operations
9 Months Ended
Sep. 30, 2018
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block]
Note 1 — Organization, Plan of Business Operations
 
Avenue Therapeutics, Inc. (the “Company” or “Avenue”) was incorporated in Delaware on February 9, 2015, as a wholly owned subsidiary of Fortress Biotech, Inc. (“Fortress”), to develop and market pharmaceutical products for the acute care setting in the United States. The Company is focused on developing its product candidate, an intravenous (“IV”) formulation of tramadol HCI (“IV Tramadol”), for moderate to moderately severe post-operative pain.
 
On November 12, 2018, the Company and InvaGen Pharmaceuticals Inc. (“InvaGen”), entered into definitive agreements with two closing stages for a proposed acquisition of the Company.  The transaction will be subject to Avenue’s stockholders’ and regulatory approvals, and other closing conditions.
 
At the first stage closing, which is anticipated in the first quarter of 2019, InvaGen will purchase 5,833,333 newly issued shares of Avenue’s common stock at $6.00 per share for a total consideration of $35.0 million. Simultaneously with the closing of the stock issuance, InvaGen will appoint three members (including one independent) on Avenue’s seven-member Board of Directors.
 
At the second stage closing, InvaGen will acquire the remaining shares of Avenue’s common stock, pursuant to a reverse triangular merger with Avenue remaining as the surviving entity, for up to $180.0 million in the aggregate. The second stage closing is subject to the satisfaction of certain closing conditions, including conditions pertaining to U.S. Food and Drug Administration approval, labeling, scheduling and the absence of any Risk Evolution and Mitigation Strategy (“REMS”) or similar restrictions in effect with respect to IV Tramadol.
 
Credit Agreement and Guaranty
 
Concurrently with the execution and delivery of the Stock Purchase and Merger Agreement, the Company and Invagen entered into a credit agreement (the “Credit Agreement”), pursuant to which Invagen will provide initial financing to the Company in an amount of up to $3.0 million in the form of a line of credit, up to the closing of the Stock Purchase Transaction. Any amounts drawn on the line of credit will be deducted from the aggregate consideration payable to the Company pursuant to the Stock Purchase Transaction. Subject to the terms and conditions described in the Stock Purchase and Merger Agreement, Invagen may also provide interim financing to the Company in an amount of up to $7.0 million during the time period between the Stock Purchase Transaction and the Merger Transaction. Any amounts drawn on the interim financing will be deducted from the aggregate consideration payable to Company stockholders by virtue of the Merger Transaction.
 
Concurrently with the execution and delivery of the Credit Agreement, Fortress and Invagen entered into a guaranty (the “Guaranty”), pursuant to which Fortress guaranteed the full payment to Invagen, when due, of all amounts of (x) all obligations of the Company to Invagen under the Credit Agreement, whether for principal interest, fees, charges, expenses or otherwise, and (y) any and all costs and expenses incurred by Invagen in enforcing any of its rights under the Guaranty.
 
Liquidity and Capital Resources
 
The Company has incurred substantial operating losses since its inception and expects to continue to incur significant operating losses for the foreseeable future as it executes on its product development plan and may never become profitable. As of September 30, 2018, the Company had an accumulated deficit of $38.3 million.