CHATHAM, N.J., June 06, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that it will effect a 1-for-32 reverse stock split of its outstanding common stock. The reverse stock split will be effective for trading purposes as of the commencement of trading on June 10, 2024. The reverse stock split is intended to increase the per share trad ...

TNX-1500 displays potential as a monotherapy or combination therapy to prevent rejection in organ transplantation in allograft and xenograft animal models Research Directed by Faculty of the Center for Transplantation Sciences, Massachusetts General Hospital Transplantation is also believed to be a model for treating autoimmunity CHATHAM, N.J., June 06, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with markete ...

Presentation to highlight statistically significant Phase 3 results of Tonmya™ (TNX-102 SL) for the management of fibromyalgia New Drug Application (NDA) submission to the FDA on track for the second half of 2024 CHATHAM, N.J., June 05, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced a poster presentation at the Annual European Congr ...

Tonmya™治疗纤维肌痛 - Tonix计划在2024年下半年为Tonmya提交NDA，用于治疗纤维肌痛[5] - 预计在2024年下半年为Tonmya™提交NDA，用于治疗纤维肌痛；第二季度2024年与FDA安排了预NDA会议[1] - 预计FDA批准后，Tonmya可能成为美国约1000万纤维肌痛患者的首选治疗药物[3] Tonix药物研究和开发 - Tonix在2024年2月宣布了Tonmya在健康成年男性和女性日裔和华裔志愿者中的临床药代动力学（PK）桥接研究的统计显著结果[6] - Tonix预计将在2024年第二季度启动TNX-1300用于急诊室治疗可卡因中毒的2期临床研究[15] - Tonix在2024年3月宣布获得FDA颁发的TNX-2900用于普拉德-威利综合征（PWS）治疗的罕见儿科疾病认定[19] 财务状况 - 截至2024年3月31日，Tonix的现金及现金等价物为700万美元，较2023年12月31日的2490万美元有所下降[29] - 2024年第一季度净产品收入约为250万美元，主要来自于Zembrace® SymTouch®和Tosymra®的净销售[31] - 2024年第一季度，Tonix的总务和行政费用为930万美元，较2023年同期的740万美元增加[33] - 2024年第一季度，Tonix的净亏损为1490万美元，基本和稀释每股亏损分别为0.18美元和0.18美元，较2023年同期的3300万美元净亏损和3.21美元基本和稀释每股亏损有所减少[34] 公司概况 - Tonix是一家专注于开发、许可和商业化治疗和预防人类疾病以及减轻痛苦的全面生物制药公司，其发展组合主要集中在中枢神经系统（CNS）疾病上[35]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ Commission file number: 001-36019 TONIX PHARMACEUTICALS HOLDING CORP. (Exact name of registrant as specified in its charter) Nevada 26- ...

Exhibit 99.01 Tonix Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Operational Highlights Positive results from confirmatory Phase 3 RESILIENT study reported in December 2023 position Tonmya™ for fibromyalgia for NDA submission second half of 2024; pre-NDA meeting with FDA scheduled for second quarter 2024 Commercial planning underway, including go-to-market, supply chain and manufacturing strategies, for U.S. launch of Tonmya, a potential new first-line, centrally-acting, n ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-36019 TONIX PHARMACEUTICALS HOLDING CORP. (Exact name of registrant as specified in its charter) Nevada 26-1434750 (State or other jurisdiction of incorporation or organi ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from _________ to _________ Commission file number: 001-36019 TONIX PHARMACEUTICALS HOLDING CORP. (Exact name of registrant as specified in its charter) Nevada ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from _________ to _________ Commission file number: 001-36019 TONIX PHARMACEUTICALS HOLDING CORP. (Exact name of registrant as specified in its charter) Nevada 26-1 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ Commission file number: 001-36019 TONIX PHARMACEUTICALS HOLDING CORP. (Exact name of registrant as specified in its charter) Nevada 26- ...