GENERAL | NOTE 1: - GENERAL a. SteadyMed Ltd. (the “Company” or “SteadyMed”) was incorporated and is located in Israel, commenced its operations on June 15, 2005 and, together with its wholly-owned subsidiary, SteadyMed Therapeutics, Inc. (“Inc.”), and Inc.’s wholly-owned subsidiary, SteadyMed U.S. Holdings, Inc. (“Holdings”), is a specialty pharmaceutical company focused on the development and commercialization of therapeutic product candidates that address the limitations of market-leading products in certain orphan and other well-defined high-margin specialty markets. The Company’s primary focus is to obtain approval in the United States for the sale of Trevyent® for the treatment of pulmonary arterial hypertension (“PAH”). On June 30, 2017, the Company filed a New Drug Application (“NDA”) for Trevyent, with the United States Food and Drug Administration (“FDA”). On August 28, 2017, the Company received a Refusal to File letter from the FDA, stating that based on a preliminary review of the NDA, the FDA had determined that it is not sufficiently complete to permit a substantive review. The FDA requested further information on certain device specifications and performance testing and has requested additional design verification and validation testing on the final, to-be-marketed Trevyent product. A Type a meeting with the FDA to gain further clarification on the additional information required for resubmission and acceptance of the NDA took place on November 1, 2017. Management believes that the meeting was constructive and that the Company will be able to sufficiently address the FDA’s concerns. The Company revised its operating plan and is focused on re-submitting the NDA in the fourth quarter of 2018. The Company is also at an earlier stage of development with two products for the treatment of post-surgical and acute pain in the home setting. Its product candidates are enabled by its proprietary PatchPump®, which is a discreet, water resistant and disposable drug administration technology that is aseptically prefilled with liquid drug at the site of manufacture and pre-programmed to deliver an accurate, steady flow of drug to a patient, either subcutaneously or intravenously. Inc. and Holdings are located in the United States, and commenced operations on January 1, 2012 and March 25, 2015, respectively. The principal executive officers of the Company are located in the offices of Inc. and Holdings, and Inc.’s and Holdings’ principal business activities are to provide executive management, treasury and administrative support functions to the Company. b. The Company is devoting substantially all of its efforts toward research, development, regulatory approvals and marketing of Trevyent®. In the course of such activities, the Company expects operating losses for the foreseeable future. For the three months ended March 31, 2018, the Company incurred operating losses of $6,080 and negative cash flows from operating activities of $5,332. Until the Company has positive cash flows from operating activities, it will need to raise significant additional capital by way of the exercise of the remaining outstanding warrants issued in the 2016 and 2017 private placements, another private placement of debt and/or equity and/or a secondary public offering to allow the Company to continue as a going concern. These factors raise substantial doubt about the Company’s ability to continue as a going concern. There is no assurance, however, that the Company will be successful in obtaining an adequate level of financing for its long-term needs, and therefore, there is a substantial doubt in the Company’s ability to continue as a going concern. The accompanying financial statements in this quarterly report do not include any adjustments to reflect the possible future effects on recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome of this uncertainty. c. On June 28, 2015, the Company entered into an Exclusive License and Supply Agreement (the “Agreement”) with Cardiome Pharma Corp. and Correvio International Sárl (hereinafter collectively referred to as “Cardiome”) pursuant to which an exclusive royalty bearing license to certain of the Company’s patents relating to Trevyent® (“License”) was granted to Cardiome in order to develop and commercialize Trevyent, if approved for the treatment of PAH, in certain regions outside the United States, specifically, Europe, Canada and the Middle East (the “Regions”). During March 2018, Cardiome licensed the Canadian rights to Trevyent to Cipher Pharmaceuticals. The Company provided certain services for Cardiome through the fourth quarter of 2017. Cardiome is responsible for the regulatory submissions and approvals and commercialization of Trevyent in the Regions. In addition, the Company has agreed to supply Trevyent as finished goods to Cardiome upon commercialization of Trevyent® in the Regions (“Supply Services”). Cardiome made a $3,000 upfront payment to the Company (the “Upfront”) and the Agreement provides for future regulatory, third-party payor reimbursement approval and commercialization milestone payments to be achieved by Cardiome of up to $9,250 and a scaling royalty ranging from the low teens to mid-teens percent on future Trevyent sales by Cardiome in the Regions. In addition, there is a fixed price on finished goods to be supplied by the Company as part of the Supply Services. d. On April 29, 2018 United Therapeutics Corporation and the Company signed a definitive merger agreement under which United Therapeutics will acquire the Company (See also Note 10). |