MINNEAPOLIS, June 24, 2024 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (OTCQB: PBLA), a clinical-stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today announced that the independent Data Safety Monitoring Board (DSMB) has completed its third pre-specified safety review of the ongoing Phase 3 ASPIRE clinical trial evaluating ivospemin in combination with gemcitabine and nab-Paclitaxel for the first-line treatment of metastat ...

财务数据和关键指标变化 - 一季度一般及管理费用约为120万美元,同比下降14.3%,主要是专业费用下降 [33] - 一季度研发费用约为550万美元,同比增加57.1%,主要是ASPIRE试验入组增加 [34] - 一季度净亏损710万美元,每股亏损2.28美元,去年同期净亏损510万美元,每股亏损392.76美元 [35] - 截至3月31日,公司现金约26万美元,包括1月公开发行募集的约810万美元净额 [35] - 一季度经营活动使用现金940万美元,包括支付2023年费用和采购标准化疗药品约90万美元 [40] 各条业务线数据和关键指标变化 - ASPIRE III期试验入组进度超过50%,预计2025年第一季度完成全部约600例入组 [10][11][12] - ASPIRE试验中期分析预计将在2025年第一季度进行,比原计划提前 [11][12] - FAP项目正在与FDA、EMA和FAP社区协调全球注册计划 [17] - PACES III期预防大肠癌复发试验已完成入组,预计2026年下半年有数据 [18] - 已与US WorldMeds签约出售儿童神经母细胞瘤eflornithine项目,获得400万美元现金和额外里程碑付款 [19][20][41] - 正在开展eflornithine治疗转移性前列腺癌和1型糖尿病的II期试验 [21][22] - 计划于今年下半年开始评估ivospemin治疗铂耐药性卵巢癌的II期试验 [22][23][24][27] 各个市场数据和关键指标变化 - 尽管最近获批的ONIVYDE联合方案在转移性胰腺癌中取得了1.9个月的总生存期获益,但患者的预后仍然很差,中位总生存期不到12个月 [15] - 公司认为ivospemin联合标准化疗方案有望显著改善转移性胰腺癌患者的预后,优于最近获批方案的增量获益 [16] 公司战略和发展方向及行业竞争 - 公司正在与约翰斯·霍普金斯大学合作,计划开展ivospemin治疗铂耐药性卵巢癌的II期试验 [22] - 公司正在与默菲癌症中心合作开展I/II期试验,并计划启动自主发起的I期试验 [28] - 公司还与MD安德森癌症中心合作,评估聚胺代谢抑制剂与CAR-T细胞疗法和双特异性单克隆抗体的联合应用 [28] - 公司最近获得了eflornithine和sulindac固定剂量组合的新专利 [29] 管理层对经营环境和未来前景的评论 - ASPIRE试验入组和事件发生速度快于预期,表明患者生存期延长,这是一个积极信号 [10][11][12] - 公司相信ivospemin联合标准化疗方案有望显著改善转移性胰腺癌患者的预后 [16] - 公司正在积极推进各项临床试验,并计划在2024年和2025年取得多个重要里程碑 [30][31] 问答环节重要的提问和回答 问题1 **Jonathan Aschoff 提问** 询问ASPIRE试验中期分析的停止标准,包括疗效和无效性 [44] **Jennifer Simpson 回答** 中期分析时约有33%的总事件发生,即约170例事件。这是一个优效性分析,不太可能会停止试验。公司设计了很小的α消耗,试验有90%的统计功效,假设hazard ratio为0.75 [45][49] 问题2 **Unidentified Analyst 提问** 询问公司当前的现金状况及采取的措施 [56] **Susan Horvath 回答** 公司一季度末现金约26万美元,包括1月公开发行的约810万美元净额。但由于试验费用增加,每季度现金消耗可能接近1000万美元。公司已在4月完成S-1备案,计划通过上市筹集更多资金 [57][58][59][60]

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 No.: 001-39468 Panbela Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 88-2805017 (State or other juri ...

Q1 2024 and recent Highlights: Clinical Exhibit 99.1 Panbela Provides Business Update and Reports Q1 2024 Financial Results MINNEAPOLIS, May 15, 2024 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (OTCQB: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today provides a business update and reports financial results for the quarter ended March 31, 2024. As previously announced, management is hosting earnings call today at 4:30 p ...

MINNEAPOLIS, May 15, 2024 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (OTCQB:PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today provides a business update and reports financial results for the quarter ended March 31, 2024. As previously announced, management is hosting earnings call today at 4:30 p.m. ET. "We were thrilled to announce that our ongoing ASPIRE trial, evaluating ivospemin (SBP-101) in combination with stand ...

Company Participants Conference Call Participants Operator I will now turn the conference over to your host, James Carbonara, Investor Relations. James you may begin. Thank you, operator. With me on the call are Jennifer Simpson, Chief Executive Officer; and Sue Horvath, Chief Financial Officer. Any forward-looking statements made on this call are made only as of today's date, and the company does not undertake any obligation to update or supplement any such statements to reflect subsequent developments. Je ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 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: 001-39468 PANBELA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction of incorporation) ...

Exhibit 99.1 Panbela Provides Business Update and Reports Q4 and FY 2024 Financial Results MINNEAPOLIS, March 26, 2024 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (NASDAQ:PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today provides a business update and reports financial results for the quarter and full year ended December 31, 2023. As previously announced, management is hosting earnings call today at 4:30 p.m. ET. Collab ...

Panbela Therapeutics, Inc. (OTC:PBLA) Q3 2023 Earnings Conference Call November 9, 2023 4:30 PM ET Company Participants James Carbonara - IR Jennifer Simpson - CEO Sue Horvath - CFO Conference Call Participants Jonathan Aschoff - ROTH MKM Operator Greetings, and welcome to the Panbela Therapeutics Third Quarter 2023 Earnings Call. [Operator Instructions] Please note this conference is being recorded. I will now turn the conference over to your host, James Carbonara, Investor Relations at Panbela. James, you ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 For the transition period from ________ to ________. Commission File No.: 001-39468 Panbela Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of incorporation or organization) 712 Vista Blvd #305, Waconia, Minnesota 55387 (Mark One) ...