Table of Contents 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, 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 001-38114 AVENUE THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 47-4113275 (State or ...

Exhibit 99.1 Avenue Therapeutics Reports Third Quarter 2024 Financial Results and Recent Corporate Highlights - Topline data in Phase 1b/2a clinical trial of AJ201 for spinal and bulbar muscular atrophy anticipated around year-end 2024 Miami, FL – November 14, 2024 – Avenue Therapeutics, Inc. (Nasdaq: ATXI) ("Avenue" or the "Company"), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today reported financial results an ...

MIAMI, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) ("Avenue" or the "Company"), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today reported financial results and recent corporate highlights for the third quarter ended September 30, 2024. "We have generated considerable momentum this past quarter in advancing our pipeline of innovative treatments for neurologic diseases," said Alexandr ...

MIAMI, Oct. 09, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that Alexandra MacLean, M.D., Chief Executive Officer of Avenue Therapeutics, will participate in a fireside chat at Maxim Group’s 2024 Healthcare Virtual Summit on Tuesday, October 15, 2024 at 1:30 PM ET. The fireside chat will be available to r ...

MIAMI, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that Alexandra MacLean, M.D., Chief Executive Officer of Avenue Therapeutics, will participate in the following upcoming investor conferences: H.C. Wainwright 26th Annual Global Investment ConferenceDate: Monday, September 9, 2024Location: New Y ...

财务状况 - 公司在2024年6月30日的累计亏损约为9800万美元[141] - 公司预计未来几年内将继续发生研发和管理费用,并将持续亏损[142] - 公司在2024年6月30日的现金及现金等价物为490万美元[201] - 2024年上半年经营活动使用现金537.3万美元[202] - 2024年上半年筹资活动提供现金850.9万美元,主要来自于2024年5月认股权证诱导[207] - 2024年上半年现金及现金等价物净增加313.6万美元[202] - 2024年上半年归属于普通股股东的净亏损为1584.2万美元,较2023年同期增加37%[192] 融资活动 - 公司计划通过出售债务或股权证券等方式获得额外资金,但无法保证能够以可接受的条款筹集到所需资金[143] - 公司于2024年1月5日与投资者签订了认股权证激励协议,投资者同意以现金以较低的行权价格行使其认股权证,作为回报公司同意向投资者发行新的系列A和系列B认股权证[162] - 公司于2024年4月28日与投资者签订了认股权证激励协议,投资者同意以现金以较低的行权价格行使其认股权证,作为回报公司同意向投资者发行新的系列C和系列D认股权证[164,165] - 公司于2024年5月10日与H.C. Wainwright & Co. LLC签订了"随时发行"协议,可以不时地通过该公司发行和出售公司普通股[169] 产品开发 - 公司于2023年2月与AnnJi Pharmaceutical Co., Ltd.签订独家许可协议,获得AJ201的知识产权[146][147][148] - 公司正在进行AJ201的12周期1b/2a期临床试验,预计于2024年下半年公布试验结果[149][150] - 公司与FDA就IV曲美布汀的临床试验方案达成一致,计划尽快启动新的III期安全性试验[151][152] - 公司通过收购Baergic公司获得BAER-101化合物,该化合物在动物模型中显示抗癫痫作用[153][154] 费用情况 - 2024年第二季度研发费用为136.1万美元,较2023年同期下降了166.6万美元,主要是临床开发成本减少[181] - 2024年第二季度一般及行政费用为146.2万美元,较2023年同期增加了56.6万美元,主要是支付给InvaGen的费用增加、向Fortress发行普通股以及非现金股份支付成本增加[184] - 2024年上半年研发费用为375.2万美元,较2023年同期下降12%[189] - 2024年上半年研发费用中无2023年上半年4.23亿美元的许可费支出[190] - 2024年上半年一般及行政费用为277.8万美元,较2023年同期增加48%[190] - 2024年上半年损失结算普通股认股权证负债为75.9万美元[199] - 2024年上半年普通股认股权证公允价值变动收益为13.9万美元,2023年同期为损失102.8万美元[200]

临床试验进展 - 完成最后一名患者的随访,预计在2024年下半年公布AJ201 I期/II期a期临床试验的首次数据[3] - 正在与FDA就IV曲美布汀III期安全性研究的方案和统计分析方法达成最终协议,计划在获得额外融资或合作伙伴后启动该研究[6] - 在获得额外融资的前提下,计划启动BAER-101用于治疗局灶性癫痫和其他癫痫性疾病的II期a期临床试验[7] 公司资金情况 - 2024年5月完成4.4百万美元的认股权证行权交易,获得额外资金[8] - 2024年4月完成1:75的反向股票拆分,并获得纳斯达克持续上市的批准[8] - 截至2024年6月30日,现金及现金等价物为490.9万美元,较上一季度增加170万美元,较2023年12月31日增加310万美元[9] 财务数据 - 2024年第二季度研发费用为136.1万美元,较2023年同期下降54.9%[9] - 2024年第二季度管理费用为146.2万美元,较2023年同期增加63.3%[9] - 2024年第二季度归属于普通股股东的净亏损为269.2万美元,每股亏损6.43美元,较2023年同期的400.7万美元和38.74美元每股亏损有所下降[9] 公司资产 - 公司目前正在开发三项资产,包括SBMA治疗候选药物AJ201、选择性GABAA α2、α3受体正性致敏调节剂BAER-101以及用于急性术后疼痛管理的IV曲美布汀[10]

- Last patient visit complete in Phase 1b/2a clinical trial of AJ201 for spinal and bulbar muscular atrophy; topline data anticipated in second half of 2024 – - Raised $4.4 million in gross proceeds from a May 2024 warrant exercise transaction - MIAMI, Aug. 09, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today reported f ...

MIAMI, June 20, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ:ATXI) ("Avenue" or the "Company"), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that Alexandra MacLean, M.D., Chief Executive Officer of Avenue Therapeutics, will present at the H.C. Wainwright 5th Annual Neuro Perspectives Virtual Conference. The presentation will be available to registered attendees for on-demand viewing on ...

MIAMI, June 20, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that Alexandra MacLean, M.D., Chief Executive Officer of Avenue Therapeutics, will present at the H.C. Wainwright 5th Annual Neuro Perspectives Virtual Conference. The presentation will be available to registered attendees for on-demand viewing o ...