Organization and Business Activities | 1. Organization and Business Activities Nabriva Therapeutics plc, or Nabriva Ireland, together with its wholly owned and consolidated subsidiaries, Nabriva Therapeutics GmbH, or Nabriva Austria, Nabriva Therapeutics US, Inc., Zavante Therapeutics, Inc., or Zavante, and Nabriva Therapeutics Ireland DAC, collectively, Nabriva, or the Company, is a biopharmaceutical company that historically engaged in the commercialization and research and development of novel anti-infective agents to treat serious infections. The Company has the commercial rights to an approved product, XENLETA, as well as a development product candidate, CONTEPO. The Company’s headquarters are located at Alexandra House, Office 225/227, The Sweepstakes, Dublin 4, Ireland. As part of a plan approved by its board of directors on January 4, 2023 to preserve its cash to adequately fund an orderly wind down of its operations, or the Cash Preservation Plan, the Company previously reduced its operations to those necessary to: (i) make SIVEXTRO and XENLETA commercially available to wholesale customers; (ii) identify and explore strategic options, including the sale, license or other disposition of one or more of its assets, technologies or products; and (iii) wind down its business. The Company has no intention of resuming any active sales promotion or research and development activities. As part of the Cash Preservation Plan, the Company terminated all of its employees . The total cost of severance associated with the wind down of our operations is approximately $5.4 million, of which $1.3 million was recorded in research and development expenses and $4.1 million was recorded in selling, general and administrative expenses in the statement of operations for the six months ended June 30, 2023. As of June 30, 2023, the remaining unpaid balance of severance costs is $2.7 million, which is recorded in accrued expenses and other current liabilities in the consolidated balance sheet and which is expected to be paid prior to the end of 2023. In January 2023, the Company settled all outstanding balances due to Hercules Capital, Inc., or Hercules, and removed all secured liens on all of its assets. The Company also terminated its agreement with Amplity Health, the contract sales organization responsible for promoting SIVEXTRO and XENLETA and, on January 31, 2023, entered into a letter agreement, or the Letter Agreement, relating to the Company’s Sales Promotion and Distribution Agreement, or the Distribution Agreement, with MSD International GmbH, or MSD, and Merck Sharp & Dohme Corp., or the Supplier, to begin transition responsibility for the promotion and distribution of SIVEXTRO back to Merck & Co. Inc., or Merck. The Company stopped selling SIVEXTRO when its Distribution Agreement with Merck expired on June 30, 2023. On July 30, 2023, the Company entered into an Asset Purchase Agreement with Sumitomo Pharma Co., Ltd., or Sumitomo, pursuant to which Sumitomo agreed to (i) purchase, among other things, the Company’s assets and rights related to the development, manufacture, marketing and commercialization of XENLETA in the People’s Republic of China, Hong Kong, Macau and Taiwan, or collectively the Territory, and (ii) assume certain liabilities related to the acquired assets. The transactions contemplated by the Asset Purchase Agreement closed on July 30, 2023. At the closing, Sumitomo made an upfront cash payment of million was paid to the Company in cash. The cash received by the Company is not reflected on the balance sheet at June 30, 2023. As part of the transactions contemplated by the Asset Purchase Agreement, the Company terminated its license agreement and certain related agreements with certain affiliates of Sumitomo, including Sumitomo Pharmaceuticals (Suzhou), pursuant to which the Company previously had granted an exclusive license to develop and commercialize, and a non-exclusive license to manufacture, certain products containing lefamulin in the Territory. During a period of time that may extend to March 31, 2024, the Company has agreed to provide certain post-closing services to Sumitomo, including to continue and maintain the application for marketing approval for XENLETA filed by Nabriva Ireland with the National Medical Products Administration, or NMPA, of the People’s Republic of China, the import drug license for lefamulin filed with the NMPA and the existing market approval for lefamulin in the United States. In exchange for these obligations, Sumitomo has agreed to fully reimburse the Company for expenses incurred with respect to the post-closing activities. Following the closing of the transactions with Sumitomo, the Company is currently focused on the sale of its remaining assets, including CONTEPO. Liquidity Since adopting the Cash Preservation Plan in January 2023, the Company has significantly reduced its expenses. As of June 30, 2023, the Company had cash, cash equivalents and restricted cash of $2.3 million. The Company follows the provisions of Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, Topic 205-40 , Presentation of Financial Statements- Going Concern, which requires management to assess the Company’s ability to continue as a going concern for one year after the date the consolidated financial statements are issued. As a result, the Company’s liquidity condition and its existing financial obligations raise substantial doubt about the Company’s ability to continue as a going concern one year from the date that these financial statements are filed. The consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the continuity of operations, the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. Management has concluded that substantial doubt exists about the Company’s ability to continue as a going concern for one year from the date these consolidated financial statements are issued. The financial statements do not include any adjustments relating to the recovery of the recorded assets or the classification of the liabilities that might be necessary should the Company be unable to continue as a going concern. The Company previously had sources of liquidity under an “at-the-market” equity financing facility with Jefferies LLC and an equity line of credit facility with Lincoln Park Capital Fund, LLC. The Company has not raised any proceeds under such facilities during 2023 and has no plans to raise any proceeds prior to the wind down of its business. Based on its current operating plans, the Company expects that its existing cash, cash equivalents and restricted cash as of the filing date of this Quarterly Report on Form 10-Q will be sufficient to enable the Company to fund its operating expenses and debt service obligations through the end of October 2023. The Company has based this estimate on assumptions that may prove to be wrong, and the Company could use its capital resources sooner than expected. This estimate assumes, among other things, that the Company does not obtain any additional funding from the sale of its assets. |