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Nature of Business and Overview | 12 Months Ended
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Dec. 31, 2019
Nature of Business and Overview |
Nature of Business and Overview | (1) Nature of Business and Overview Celldex Therapeutics, Inc. (the “Company” or “Celldex”) is a biopharmaceutical company focused on the development and commercialization of several immunotherapy technologies and other cancer-targeting biologics. The Company is primarily focusing its efforts and resources on the continued research and development of CDX-1140, CDX-3379, CDX-0159 and CDX-527. The Board of Directors of the Company approved a one for fifteen reverse stock split of the Company’s outstanding common stock, which was effected on February 8, 2019. All share and per share amounts in the financial statements have been retroactively adjusted for all periods presented to give effect to the reverse stock split, including reclassifying an amount equal to the reduction in par value to additional paid-in capital. Under U.S. GAAP, the Company has the responsibility to evaluate whether conditions and/or events raise substantial doubt about its ability to meet its future financial obligations as they become due within one year after the date that the financial statements are issued. This evaluation shall initially not take into consideration the potential mitigating effects of plans that have not been fully implemented as of the date the financial statements are issued. The Company’s financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities in the ordinary course of business. At December 31, 2019, the Company had cash, cash equivalents and marketable securities of $64.4 million. The Company has had recurring losses and incurred a loss of $50.9 million for the year ended December 31, 2019. Net cash used in operations for the year ended December 31, 2019 was $46.4 million. As of March 26, 2020, the date of issuance of the consolidated financial statements, the Company expects that its cash, cash equivalents and marketable securities of $64.4 million as of December 31, 2019 will be sufficient to fund its operating expenses and capital expenditure requirements into the first quarter of 2021. The future viability of the Company beyond that point is dependent on the Company’s ability to raise additional capital to finance its operations. The Company has generated no product revenue to date and cannot predict when and if it will generate product revenue. The Company has had recurring losses and anticipate operating losses to continue for the foreseeable future due to, among other things, costs related to research, development of product candidates, conducting preclinical studies and clinical trials, facilities and general and administrative expenses. These conditions raise substantial doubt about the Company’s ability to continue as a going concern for one year after the date that the financial statements are issued. During the next twelve months and beyond, the Company will take further steps to raise additional capital to meet its liquidity needs including, but may not be limited to, one or more of the following: the licensing of drug candidates with existing or new collaborative partners, possible business combinations, issuance of debt, or the issuance of common stock or other securities via private placements or public offerings. Although the Company has been successful in raising capital in the past, there can be no assurance that additional financing will be available on acceptable terms, if at all, and the Company’s negotiating position in capital-raising efforts may worsen as existing resources are used. There is also no assurance that the Company will be able to enter into further collaborative relationships. Additional equity financings may be dilutive to the Company’s stockholders; debt financing, if available, may involve significant cash payment obligations and covenants that restrict the Company’s ability to operate as a business; and licensing or strategic collaborations may result in royalties or other terms which reduce the Company’s economic potential from products under development. The Company’s ability to continue funding its planned operations into and beyond twelve months from the issuance date is also dependent on the timing and manner of payment of contingent milestones from the Kolltan acquisition, in the event that the Company achieves the drug candidate milestones related to those payments. The Company, at its option, may decide to pay those milestone payments in cash, shares of its common stock or a combination thereof. If the Company is unable to raise the funds necessary to meet its liquidity needs, it may have to delay or discontinue the development of one or more programs, discontinue or delay ongoing or anticipated clinical trials, license out programs earlier than expected, raise funds at a significant discount or on other unfavorable terms, if at all, or sell all or a part of the Company. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. In December 2019, a novel strain of coronavirus, now referred to as COVID-19, surfaced in Wuhan, China. The virus continues to spread globally, has been declared a pandemic by the World Health Organization and has spread to over 100 countries, including the United States. The impact of this pandemic has been and will likely continue to be extensive in many aspects of society, which has resulted in and will likely continue to result in significant disruptions to the global economy, as well as business and capital markets around the world. In an effort to halt the outbreak of COVID-19, the United States has placed significant restrictions on travel and many businesses have announced extended closures which could adversely impact our operations. Potential impactions to our business include delays in planned and ongoing preclinical and clinical trials including enrollment of patients, disruptions in time and resources provided by independent clinical investigators, contract research organizations, other third-party service providers, temporary closures of our facilities, disruptions or restrictions on our employees’ ability to travel, and delays in manufacturing and/or shipments to and from third party supplies and contract manufacturer for APIs and drug product. Any prolonged negative impacts to our business could materially impact our operating results and could lead to impairments of our Intangible (IPR&D) assets which amounted to $48.7 million at December 31, 2019.

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