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 000-31615 DURECT CORPORATION (Exact name of registrant as specified in its charter) Delaware 94-3297098 (State or other jurisdiction of (I.R.S. ...

财务数据和关键指标变化 - 2024年第一季度总收入为1.8百万美元,较2023年同期的2.1百万美元下降 [7] - 2024年第一季度研发费用为4.1百万美元,较2023年同期的8.6百万美元下降,主要由于临床试验相关费用减少以及员工成本下降 [7] - 2024年第一季度销售及一般管理费用为3.1百万美元,较2023年同期的4.1百万美元下降,主要由于市场研究费用、专利费用以及员工成本下降 [8] - 截至2024年3月31日,公司现金及投资为21.6百万美元,较2023年12月31日的29.8百万美元下降,第一季度现金消耗为8.9百万美元,不包括ATM融资净收益约650,000美元 [8] 各条业务线数据和关键指标变化 - 公司目前主要专注于开发用于治疗酒精相关性肝炎(AH)的药物larsucosterol [10][11][12] 各个市场数据和关键指标变化 - 在AHFIRM III期临床试验中,美国患者群体的90天死亡率分别较安慰剂组降低57%和58% [14] 公司战略和发展方向及行业竞争 - 公司正在设计一项单一的III期临床试验,如果成功可能足以支持在AH适应症下提交新药申请 [10] - 公司认为AHFIRM试验数据为设计注册性III期试验提供了坚实基础 [10] - 如果larsucosterol获批,将可能成为首个获FDA批准的AH治疗药物,并建立新的标准治疗 [15] - AH每年在美国造成超过16万例住院,90天死亡率约30%,给医疗系统带来约100亿美元的费用负担,larsucosterol有望成为一个潜在的重磅产品 [16] 管理层对经营环境和未来前景的评论 - 公司对AHFIRM试验结果感到鼓舞,认为larsucosterol具有安全有效、可能拯救生命的潜力 [15] - 公司正在与FDA进行沟通,希望尽快启动III期临床试验,将该药物尽快推向市场 [29][33] 问答环节重要的提问和回答 问题1 **Francois Brisebois 提问** 询问EASL大会上的数据更新情况以及与FDA的进展 [19] **James E. Brown 回答** EASL大会上将首次公布AHFIRM试验数据,不会有额外的FDA进展信息,但公司计划在今年秋季的AASLD会议上提供更多数据分析 [20][21] 问题2 **Carl Byrnes 提问** 询问III期临床试验的启动时间 [28] **James E. Brown 回答** 公司正在制定III期试验方案,希望尽快启动,具体时间点将在今年晚些时候公布 [29] 问题3 **Thomas Yip 提问** 询问III期临床试验的设计细节以及公司的融资计划 [32][34] **James E. Brown 和 Timothy M. Papp 回答** 公司正在最终确定III期试验方案,将在稍后公布相关细节。融资方面,公司正在评估各种选择,包括业务合作和资本市场,具体方案尚未确定 [33][36]

Durect (DRRX) came out with a quarterly loss of $0.25 per share versus the Zacks Consensus Estimate of a loss of $0.21. This compares to loss of $0.52 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -19.05%. A quarter ago, it was expected that this specialty pharmaceutical company would post a loss of $0.36 per share when it actually produced a loss of $0.27, delivering a surprise of 25%. Over the last four quarters, the comp ...

Exhibit 99.1 DURECT Corporation Reports First Quarter 2024 Financial Results and Business Update - FDA Feedback Supports Single Pivotal Trial for Approval of Larsucosterol in Alcohol-Associated Hepatitis - Webcast of Earnings Call Today, May 13th at 4:30 p.m. ET CUPERTINO, Calif., May 13, 2024 /PRNewswire / -- DURECT Corporation (Nasdaq: DRRX) today announced financial results for the three months ended March 31, 2024 and provided a business update. “We are pleased that the feedback from the U.S. Food and D ...

CUPERTINO, Calif., May 7, 2024 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX), a late-stage biopharmaceutical company pioneering the development of epigenetic therapies to transform the treatment of serious and life-threatening conditions, including acute organ injury and cancer, today announced that the company will report its first quarter financial results on Monday, May 13, 2024. Management will also host a conference call and webcast with investors to discuss financial results and provide a corporat ...

CUPERTINO, Calif., April 30, 2024 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX), a late-stage biopharmaceutical company pioneering the development of epigenetic therapies to transform the treatment of serious and life-threatening conditions such as acute organ injury and cancer, today announced acceptance of a late-breaking oral presentation at the European Association for the Study of the Liver (EASL) Congress 2024 to take place June 5-8, 2024 in Milan, Italy. The presentation will discuss data from th ...

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 number: 000-31615 DURECT CORPORATION (Exact name of registrant as specified in its charter) Delaware 94-3297098 (State or other jurisdiction of ...

DURECT Corporation (NASDAQ:DRRX) Q4 2023 Earnings Call Transcript March 27, 2024 4:30 PM ET Company Participants Tim Papp - CFO Jim Brown - CEO Norman Sussman - CMO Keith Lui - SVP, Business Development, Commercial, Medical Affairs Conference Call Participants Francois Brisebois - Oppenheimer & Co. Carl Byrnes - Northland Capital Markets Thomas Yip - H.C. Wainwright Operator Greetings and welcome to the DURECT Corporation Full Quarter and Full Year Earnings Conference Call. At this time, all participants ar ...

Exhibit 99.1 DURECT Corporation Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update - Ongoing Communication with FDA to Align on Next Steps for Larsucosterol in Alcohol-Associated Hepatitis - Webcast of Earnings Call Today, March 27th at 4:30 p.m. ET CUPERTINO, Calif., March 27, 2024 /PRNewswire / -- DURECT Corporation (Nasdaq: DRRX) today announced financial results for the fourth quarter and year ended December 31, 2023 and provided a business update. “We remain enthus ...

CUPERTINO, Calif., March 20, 2024 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX), a late-stage biopharmaceutical company pioneering the development of epigenetic therapies to transform the treatment of serious and life-threatening conditions, including acute organ injury and cancer, today announced that the company will report its fourth quarter and full year 2023 financial results on Wednesday, March 27, 2024. Management will also host a conference call and webcast with investors to discuss financial re ...