财务数据和关键指标变化 - 公司在第一季度没有录得任何收入 [22][23] - 公司现金经营费用(研发和销售费用)为390万美元,较去年同期的480万美元有所下降,主要是由于去年4月剥离DSUVIA业务后相关成本的减少 [24] - 2024年全年现金经营费用预计将在2100万美元至2300万美元的范围内,处于较低到中间水平 [25] - 截至第一季度末,公司现金及投资总额为1860万美元,主要来自于8百万美元的DSUVIA专利权部分出售以及600万美元的首次股权融资 [25] 各条业务线数据和关键指标变化 - 公司目前主要专注于Niyad的开发,没有其他业务线数据 各个市场数据和关键指标变化 - 公司市场研究显示,自COVID-19疫情以来,需要CRRT治疗的患者人数增加了约三分之一,并保持在这一较高水平 [13] - 公司预计Niyad在CRRT和间歇性血液透析市场的峰值销售潜力超过2亿美元,其中CRRT市场占一半即1亿美元 [17] 公司战略和发展方向及行业竞争 - 公司正在推进Niyad的临床试验和商业化准备工作,包括完成GMP生产、收集稳定性数据、专利申请等 [15][18] - 公司认为Niyad相比柠檬酸抗凝剂具有更好的安全性和成本优势,有望在CRRT和血液透析市场获得广泛应用 [16][41] - 公司正在积极推进NEPHRO临床试验,预计试验完成后将尽快提交上市申请 [14] 管理层对经营环境和未来前景的评论 - 管理层认为NEPHRO临床试验的患者入组不会受到限制,预计试验将能够快速完成 [12][33] - 管理层对Niyad在CRRT和血液透析市场的销售潜力保持乐观,预计峰值销售可达1亿美元 [17] - 管理层表示公司已获得主要投资者的持续支持,确保公司有足够资金推进Niyad的开发和上市 [25][26] 其他重要信息 - 公司新任命Shakil Aslam博士为首席开发官,他拥有20多年的肾脏病临床研究经验,将支持Niyad的开发和商业化准备 [9] - 公司已成功解决之前的集体诉讼,法院裁定驳回原告的所有指控 [21] - 公司已完成部分DSUVIA专利权的出售,获得8百万美元现金,同时也获得了新一轮1800万美元的股权融资 [18][20][25] 问答环节重要的提问和回答 问题1 **Ed Arce 提问** - 询问Niyad临床试验时间表是否会有重大延迟 [28] - 询问CRRT市场规模的具体数据 [29] - 询问Niyad的定价策略 [30] **管理层回答** - 公司预计Niyad临床试验的时间表不会有重大延迟,将在下次财报时提供更新 [31][32][33] - 公司之前估计CRRT患者人数约为16.5万,疫情后有一定增长,但未具体量化 [37][38] - 公司计划将Niyad的价格定在与柠檬酸抗凝剂总成本持平或略高10%的水平 [41] 问题2 **James Molloy 提问** - 询问Niyad临床试验延迟的主要原因 [43] - 询问2024年公司的经营费用预期 [44] - 询问Niyad的预计用量和市场渗透率 [48][51] **管理层回答** - 临床试验延迟主要是由于大型学术机构的行政流程和内部准备工作较慢 [46] - 2024年全年经营费用预计在2100万-2200万美元之间 [47] - 公司假设每名患者每天使用10支Niyad,治疗6天,并预计Niyad可替代CRRT市场30%的柠檬酸使用量和50%的肝素使用量 [49][51][52][53]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 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: 001-35068 TALPHERA, INC. (Exact name of registrant as specified in its charter) Delaware 41-2193603 (State or other jurisdiction of incorporat ...

Talphera Announces First Quarter 2024 Financial Results and Provides Corporate Update First patients at multiple sites are expected to be enrolled in the NEPHRO CRRT registrational study in Q2 2024 Dr. Shakil Aslam, an expert in renal diseases, including acute kidney injury, joins Talphera as Chief Development Of icer Cash and investments at March 31, 2024 of $18.6 million Conference call and webcast to be held Tuesday, May 14, 2024 at 4:30 pm ET SAN MATEO, Calif., May 14, 2024 – Talphera, Inc. (Nasdaq: TLP ...

Talphera, Inc. (NASDAQ:TLPH) Q4 2023 Earnings Conference Call March 6, 2024 4:30 PM ET Company Participants Raffi Asadorian - Chief Financial Officer Vincent Angotti - Chief Executive Officer Pamela Palmer - Chief Medical Officer and Co-Founder Conference Call Participants Thomas Yip - H.C. Wainwright Operator Welcome to the Talphera Fourth Quarter 2023 Financial Results Conference Call. This call is being webcasted live via the events page of the Investors section of Talphera's website at www.talphera.com. ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K ☑ 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: 001-35068 TALPHERA, INC. (Exact name of registrant as specified in its charter) Delaware 41-2193603 (State or other jurisdiction of incorporation or ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 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 REPORTS PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the transition period from to Commission File Number: 001-35068 ACELRX PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 41-2193603 (State or other jurisdi ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 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 June 30, 2023 or ☐ TRANSITION REPORTS PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the transition period from to Commission File Number: 001-35068 ACELRX PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 41-2193603 (State or other jurisdiction ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 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, 2023 or ☐ TRANSITION REPORTS PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the transition period from to Commission File Number: 001-35068 ACELRX PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 41-2193603 (State or other jurisdictio ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K ☑ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 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: 001-35068 ACELRX PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 41-2193603 (State or other jurisdiction of inc ...

| --- | --- | |---------------------------------------|--------------------| | | | | | | | | | | | | | Oppenheimer 29 th Annual Healthcare | | | Conference | | | March 20, 2019 | | | | | | Investor materials | MED-US-DSU-1900037 | Cautionary statements 2 This presentation contains forward-looking statements, including, but not limited to, statements related to the safety, efficacy and therapeutic value of DSUVIA™ (sufentanil sublingual tablet, 30 mcg) and ZALVISO® (the sufentanil sublingual tablet system); ...