临床试验和研发进展 - 公司计划加快推进第三期临床试验，正在选址并启动第三期LEVEL研究，并计划于2025年启动第二项第三期临床试验[136] - 公司暂时中止启动伊马替尼第三期临床试验的计划，将重点放在利伐西美汀的第三期临床试验上[137] - 公司计划利用与Orion公司的合作关系,利用已有的临床试验数据和研究成果支持利伐西美汀在新适应症的FDA批准[143] - 公司计划利用第三方研究合作和自身在相关领域的研究成果,有效探索新的高潜力治疗应用[141][142] 知识产权保护 - 公司已获得两项美国专利,分别涵盖静脉和口服利伐西美汀在肺动脉高压合并心力衰竭保留射血分数(PH-HFpEF)患者中的使用[137][146] - 公司将继续拓展知识产权组合,目前已获得多项专利,并有更多专利申请正在审批中[144][146] 商业化和合作 - 公司计划通过授权和产品联合开发等方式,加快产品开发,降低开发和运营成本,并拓展全球商业化能力[147][148] 财务情况 - 公司2024年第二季度的总运营费用为3,672,021美元,其中研发费用为2,327,632美元,较上年同期大幅增加[150] - 公司2024年第二季度的一般及行政费用为1,344,389美元,较上年同期增加29%,主要由于人员成本和专业服务费用的增加[152][154][155] - 公司认为现有资金加上2024年私募融资所得约1亿美元,足以支持公司运营至2027年底[135] - 公司研发费用大幅增加，从2023年同期的46.4万美元增加到2024年上半年的5,003.3万美元，增幅达979%[177][178] - 临床和临床前开发费用大幅增加，从2023年同期的14.1万美元增加到2024年上半年的4,516.7万美元，增幅达3100%[177][179] - 人员费用增加，从2023年同期的26.9万美元增加到2024年上半年的459.0万美元，增幅达71%[177][180] - 2024年2月和8月分别完成了9.0百万美元和100百万美元的股权融资[188][189][187] - 公司预计未来几年内将持续亏损,需要大量资金支持产品的开发和商业化[183][184][186] - 一般及行政费用增加11%,从2023年同期的2,312.0万美元增加到2024年上半年的2,577.1万美元[165][170] - 法律和专业费用增加18%,从2023年同期的886.9万美元增加到2024年上半年的1,050.1万美元[169][172] - 设施费用下降67%,从2023年同期的22.8万美元下降到2024年上半年的7.6万美元[169][176] - 其他费用增加9%,从2023年同期的395.4万美元增加到2024年上半年的429.9万美元[169][175] - 公司于2023年2月3日进行了公开发行,共发行86,994股普通股和21,341股预付款认股权证,以及216,667股普通股的认股权证,总募集资金约1560万美元[190] - 公司于2022年5月17日进行了私募配售,共发行6,623个单位,每个单位包括一份预付款认股权证和一份认股权证,募集资金约790万美元[191] - 2024年上半年经营活动产生的净现金流出约820万美元,较2023年上半年增加,主要由于当期研究费用活动增加[193] - 2024年上半年筹资活动产生的净现金流入约780万美元,较2023年上半年减少,主要由于2024年2月股票和认股权证发行所得款项减少[196] - 公司预计目前资金储备可支持运营至2027年底[198] - 公司自成立以来未参与任何表外融资安排[200]

融资情况 - 公司在第二季度完成了约1亿美元的私募融资[7] - 公司于2024年6月30日的现金及现金等价物为938.4万美元[11] 专利和权利 - 公司获得了口服、皮下和静脉注射用利伐西米坦在治疗PH-HFpEF适应症的美国专利保护[8] - 公司获得了利伐西米坦在治疗PH-HFpEF适应症的全球开发和商业化权利[5] 研发进展 - 公司在4月份举办了"LEVEL Setting"科学圆桌会议,邀请了4位全球知名的心力衰竭专家就PH-HFpEF的未满足医疗需求和利伐西米坦的潜力进行讨论[9] - 第二季度研发费用为230万美元,同比增加210万美元,主要由于正在进行的III期LEVEL研究成本增加[12] - 公司正在积极推进III期LEVEL研究,已有39个试验点启动[5] - 公司可能会恢复开发其独特的口服曲美布汀制剂[16] 财务情况 - 第二季度净亏损为357.6万美元,每股亏损1.83美元[14] 公司战略 - 公司正专注于开发和商业化治疗心血管和肺部疾病的产品[16]

Tenax Therapeutics (NASDAQ:TENX) stock is soaring higher on Tuesday after the company announced the completion of an oversubscribed private placement for its shares.This oversubscribed private placement has Tenax Therapeutics expecting $100 million in gross proceeds. The company will use this money to continue its Phase 3 LEVEL trial, to start a second Phase 3 trial and for other general purposes.The private placement was led by new investor BVF Partners LP alongside several other investors. It includes 1,4 ...

CHAPEL HILL, N.C., Aug. 06, 2024 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (NASDAQ:TENX) (the "Company" or "Tenax Therapeutics"), a Phase 3, development-stage pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today announced that it has entered into a securities purchase agreement for an oversubscribed private placement financing that is expected to result in total gross proceeds of appro ...

CHAPEL HILL, N.C., Aug. 06, 2024 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX) (the “Company” or “Tenax Therapeutics”), a Phase 3, development-stage pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today announced that it has entered into a securities purchase agreement for an oversubscribed private placement financing that is expected to result in total gross proceeds of appr ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ 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 001-34600 TENAX THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 26-2593535 (State of incorporation) (I.R.S. ...

EX-99.1 2 tenx_ex991.htm PRESS RELEASE EXHIBIT 99.1 Tenax Therapeutics Reports First Quarter 2024 Financial Results and Provides a Corporate Update Currently Enrolling Patients in Phase 3 LEVEL Study with 24 Investigative Sites Initiated Secured Global Development and Commercial Rights to Levosimendan for Treatment of PH-HFpEF Expanded Intellectual Property Estate for Levosimendan with Issuance of New U.S. Patent Recently Hosted KOL Event, “LEVEL Setting,” Featuring Four Experts in Heart Failure Discussing ...

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 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 No. 001-34600 TENAX THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 26-2593535 (State or other jur ...

EX-99.1 2 tenx_ex991.htm PRESS RELEASE EXHIBIT 99.1 Tenax Therapeutics Provides Business and Clinical Development Updates with Full Year 2023 Financial Results · First Patient Enrolled in Phase 3 LEVEL Trial Evaluating TNX-103 (oral levosimendan) for the Treatment of Pulmonary Hypertension from Heart Failure with Preserved Ejection Fraction (PH-HFpEF) · Expansion of U.S. Intellectual Property Covering the Use of Levosimendan for the Treatment of PH-HFpEF and for Use in Combination with Other Cardiovascular ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ 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 001-34600 TENAX THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 26-2593535 (State of incorporation) (I.R ...