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Business Overview and Basis of Presentation
3 Months Ended
Sep. 30, 2016
Business Overview [Abstract]  
Business Overview

1.Business Overview and Basis of Presentation

Immunomedics is a clinical-stage biopharmaceutical company that develops monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases. The Company has continued to transition its focus away from the development and commercialization of diagnostic imaging products in order to accelerate the development of its therapeutic product candidates, although the Company still manufactures and commercializes its LeukoScan® product in territories where regulatory approvals have previously been granted in Europe, Canada and in other markets outside the U.S. LeukoScan® is indicated for diagnostic imaging for determining the location and extent of infection and inflammation in bone of patients with suspected osteomyelitis, including patients with diabetic foot ulcers. 

The Company has two foreign subsidiaries, Immunomedics B.V. in the Netherlands and Immunomedics GmbH in Rodermark, Germany, that assist the Company in managing sales efforts and coordinating clinical trials in Europe.  In addition, included in the accompanying condensed financial statements is the majority-owned U.S. subsidiary, IBC Pharmaceuticals, Inc. (“IBC”), which works on the development of novel cancer radiotherapeutics using patented pre-targeting technologies with proprietary, bispecific antibodies.

The accompanying unaudited condensed consolidated financial statements of Immunomedics, which incorporate our subsidiaries, have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”), for interim financial information and the instructions to the Quarterly Report on Form 10‑Q and Regulation S‑X. Accordingly, the statements do not include all of the information and footnotes required by GAAP for complete annual financial statements. With respect to the financial information for the interim periods included in this Quarterly Report on Form 10-Q, which is unaudited, management believes that all adjustments (consisting of normal recurring accruals), considered necessary for a fair presentation of the results for such interim periods have been included. Operating results for the three-month period ended September 30, 2016 are not necessarily indicative of the results that may be expected for the full fiscal year ending June 30, 2017, or any other period.

Immunomedics is subject to significant risks and uncertainties, including, without limitation, the risk that the Company may be unable to successfully obtain financing for product development; the Company’s inability to further identify, develop and achieve commercial success for new products and technologies; the possibility of delays in the research and development necessary to select drug development candidates and delays in clinical trials; the risk that clinical trials may not result in marketable products; the risk that the Company or its’ collaborators may be unable to secure regulatory approval of and market its drug candidates; the Company’s dependence upon pharmaceutical and biotechnology collaborations; the levels and timing of payments under the Company’s collaborative agreements, if any; uncertainties about the Company’s ability to obtain new corporate collaborations and acquire new technologies on satisfactory terms, if at all; the development or regulatory approval of competing products; the Company’s ability to protect its proprietary technologies; patent-infringement claims; and risks of new, changing and competitive technologies and regulations in the United States and internationally.

Since its inception in 1982, Immunomedics’ principal sources of funds have been the private and public sale of equity and debt securities, and revenues from licensing agreements, including up-front and milestone payments, funding of development programs, and other forms of funding from collaborations. As of September 30, 2016 the Company had $33.0 million in cash, cash equivalents and marketable securities. On October 12, 2016, the Company received net proceeds of approximately $28.5 million from the sale of common stock and warrants to purchase common stock. During fiscal 2017, the Company plans to continue its Phase 2 clinical trials of sacituzumab govitecan (IMMU-132) in patients with metastatic triple negative breast cancer (TNBC), metastatic non-small-cell lung cancer (NSCLC), small-cell lung cancer (SCLC), and metastatic urothelial cancers. The Company also plans to continue, without interruption, the preparation and initiation of the Phase 3 confirmatory clinical trial in TNBC, and the large-scale manufacture of IMMU-132. These activities are necessary to support the planned submission of a BLA to FDA for accelerated approval of IMMU-132 in metastatic triple-negative breast cancer. The Company anticipates that it can also continue its other operations and research and development programs at a reduced spending level. Based on the Company’s cash flow projections, it believes its cash balance as of September 30, 2016, in addition to the approximately $28.5 million in net proceeds the Company received from the sale of stock and warrants in October 2016, is sufficient to continue its planned operations and research and development programs, as described above, for at least the next twelve months.

The Company will require additional funding to complete its clinical trials currently underway or planned, continue research and new development programs, and continue operations. The Company continues to pursue potential strategic licensing or collaboration agreements as a possible source of financing to fund its business plan. These business arrangements may be with new or existing partners and may include the Company’s clinical development programs as well as any of its intellectual property estate. Other potential sources of funding include equity and potential debt financing.

Until the Company can generate significant cash through strategic licensing or collaboration agreements, it expects to continue to fund its operations with its current financial resources. These financial resources may not be adequate to sustain the Company’s operations. Consequently, if the Company cannot obtain sufficient funding through strategic licensing or collaborations, it could be required to finance future cash needs through the sale of additional equity and/or debt securities in capital markets. However, there can be no assurance that the Company will be able to raise the additional capital needed to complete its pipeline of research and development programs on commercially acceptable terms, if at all. The capital markets have experienced volatility in recent years, which has resulted in uncertainty with respect to availability of capital and hence the timing to meet an entity’s liquidity needs. The Company’s existing debt may also negatively impact the Company’s ability to raise additional capital. If the Company is unable to raise capital on acceptable terms, its ability to continue its business would be materially and adversely affected. Having insufficient funds may require the Company to further delay, scale-back, or eliminate some or all of its programs, or renegotiate less favorable terms than it would otherwise choose. Failure to obtain adequate financing also may adversely affect its ability to operate as a going concern.