Sulindac

本周药品注册受理数据，分门别类呈现，一目了然。(11.18-11.24） 新药上市申请药品名称企业注册分类受理号氢溴酸伏硫西汀口崩片深圳市泛谷药业股份有限公司2.2CXHS2400117氢溴酸伏硫西汀口崩片深圳市泛谷药业股份有限公司2.2CXHS2400116水合氯醛口服液海南康成药业有限公司2.2CXHS2400115盐酸安罗替尼胶囊正大天晴药业集团股份有限公司2.4CXHS2400120盐酸安罗替尼胶囊正大天晴药业集团股份有限公司2.4CXHS2400119盐酸安罗替尼胶囊正大天晴药业集团股份有限公司2.4CXHS2400118伊诺格鲁肽注射液杭州先为达生物科技股份有限公司1CXSS2400129重组抗IL-17A人源化单抗注射液三生国健药业(上海)股份有限公司1CXSS2400124派安普利单抗注射液正大天晴康方(上海)生物医药科技有限公司2.2CXSS2400125 新药临床申请药品名称企业注册分类受理号QB0208-1胶囊北京清博汇能医药科技有限公司1CXHL2401276QB0208-1胶囊北京清博汇能医药科技有限公司1CXHL2401275TQB3912片正大天晴药业集团股份有限公司1CXHL2401274TQB3720片正大天晴药业集团南京顺欣制药有限公司1CXHL2401273TY-2699a胶囊浙江同源康医药股份有限公司1CXHL2401272TY-2699a胶囊浙江同源康医药股份有限公司1CXHL2401271HT-101注射液苏州星曜坤泽生物制药有限公司1CXHL2401270SPH9788片上海医药集团股份有限公司1CXHL2401269SPH9788片上海医药集团股份有限公司1CXHL2401268SPH9788片上海医药集团股份有限公司1CXHL2401267BPI-452080片贝达药业股份有限公司1CXHL2401265BPI-452080片贝达药业股份有限公司1CXHL2401264BPI-452080片贝达药业股份有限公司1CXHL2401263注射用咔喏霉素牡丹江友搏药业有限责任公司1CXHL2401258SYHA1813口服溶液上海润石医药科技有限公司1CXHL2401257SYHA1813口服溶液上海润石医药科技有限公司1CXHL2401256SYHA1813口服溶液上海润石医药科技有限公司1CXHL2401255SYHA1813口服溶液上海润石医药科技有限公司1CXHL2401249SYHA1813口服溶液上海润石医药科技有限公司1CXHL2401250SYHA1813口服溶液上海润石医药科技有限公司1CXHL2401251注射用ZHB601江苏众红生物工程创药研究院有限公司1CXHL2401252注射用硼[10B]法仑海南普利制药股份有限公司2.2CXHL2401266盐酸普萘洛尔滴剂海南诺恩生物科技有限公司2.2CXHL2401262盐酸普萘洛尔滴剂海南诺恩生物科技有限公司2.2CXHL2401261ZL2301广东众丽医药科技有限公司2.2CXHL2401260ZL2301广东众丽医药科技有限公司2.2CXHL2401259格索雷塞片上海正大天晴医药科技开发有限公司2.4CXHL2401254注射用西罗莫司(白蛋白结合型)石药集团中奇制药技术(石家庄)有限公司2.4CXHL2401253重组二价肠道病毒疫苗(汉逊酵母)维尔泰克(北京)生物技术有限公司1.4CXSL2400791BA1106注射液山东博安生物技术股份有限公司1CXSL2400796AWT020注射用无菌粉末上海君实生物医药科技股份有限公司1CXSL2400793注射用BL-M07D1成都百利多特生物药业有限责任公司1CXSL2400792HT-102注射液苏州星曜坤泽生物制药有限公司1CXSL2400790AA001单抗北京智源鸿晟生物医药有限公司1CXSL2400788HX044注射液翰思艾泰生物医药科技(武汉)股份有限公司1CXSL2400783JSKN033注射液江苏康宁杰瑞生物制药有限公司1CXSL2400787GLS-W1100胶囊杭州远大生物制药有限公司1CXSL2400784注射用BGB-A3055广州百济神州生物制药有限公司1CXSL2400785LY01015注射液山东博安生物技术股份有限公司2.2CXSL2400794LY01015注射液山东博安生物技术股份有限公司2.2CXSL2400795A140注射液四川科伦博泰生物医药股份有限公司2.2CXSL2400786恩朗苏拜单抗注射液石药集团巨石生物制药有限公司2.2CXSL2400782注射用KJ101上海宝济药业股份有限公司2.4CXSL2400781 仿制药申请药品名称企业注册分类受理号倍他米松磷酸钠注射液安徽美来药业股份有限公司3CYHS2404040碳酸司维拉姆干混悬剂山东新华制药股份有限公司3CYHS2404034碳酸司维拉姆干混悬剂山东新华制药股份有限公司3CYHS2404033醋酸特利加压素注射液成都圣诺生物制药有限公司3CYHS2404027氨甲环酸氯化钠注射液湖北津药药业股份有限公司3CYHS2404023盐酸丁螺环酮片山东京卫制药有限公司3CYHS2404018盐酸丁螺环酮片山东京卫制药有限公司3CYHS2404017秋水仙碱片江苏德源药业股份有限公司3CYHS2404014盐酸纳布啡注射液国药集团工业有限公司廊坊分公司3CYHS2404011盐酸纳美芬注射液安徽瑞旗药业有限公司3CYHS2404010氨茶碱注射液云南药科院生物医药股份有限公司3CYHS2404009重酒石酸卡巴拉汀口服液广州大光制药有限公司3CYHS2404008复方硫酸钠片山东华铂凯盛生物科技有限公司3CYHS2404007盐酸尼卡地平氯化钠注射液浙江国镜药业有限公司3CYHS2404016吡格列酮二甲双胍片海南皇隆制药股份有限公司3CYHS2404015盐酸多巴胺注射液开封康诺药业有限公司3CYHS2404003舒林酸片福安药业集团庆余堂制药有限公司3CYHS2404001舒林酸片福安药业集团庆余堂制药有限公司3CYHS2404000复方电解质醋酸钠注射液南京正科医药股份有限公司3CYHS2403996头孢克肟颗粒海南葫芦娃药业集团股份有限公司3CYHS2403992腺苷钴胺胶囊安徽省先锋制药有限公司3CYHS2403991注射用硫酸多黏菌素B海南双成药业股份有限公司3CYHS2403981盐酸非索非那定口服混悬液广州一品红制药有限公司3CYHS2403986盐酸左西替利嗪口服溶液合肥国高药业有限公司3CYHS2403983氨溴特罗口服溶液北京康而福药业有限责任公司3CYHS2403980无水乙醇注射液成都倍特药业股份有限公司3CYHS2403977盐酸二甲双胍口服液安徽新世纪药业有限公司3CYHS2403972盐酸二甲双胍口服液安徽新世纪药业有限公司3CYHS2403971硝酸甘油注射液云南药科院生物医药股份有限公司3CYHS2403970硝酸甘油注射液云南药科院生物医药股份有限公司3CYHS2403969复方聚乙二醇(3350)电解质口服溶液江苏开元药业有限公司3CYHS2403958多索茶碱颗粒浙江赛默制药有限公司3CYHS2403960西格列汀二甲双胍缓释片杭州和泽坤元药业有限公司3CYHS2403955碳酸氢钠注射液湖北多瑞药业有限公司3CYHS2403952依帕司他片广东九明制药有限公司3CYHS2403950硝苯地平缓释片(II)四川依科制药有限公司3CYHS2403949阿达帕林凝胶苏州天马医药集团天吉生物制药有限公司4CYHS2404021甲硝唑凝胶浙江恒研医药科技有限公司4CYHS2404039多替拉韦钠片江苏艾迪药业股份有限公司4CYHS2404038头孢地尼颗粒康普药业股份有限公司4CYHS2404037瑞巴派特片安徽省先锋制药有限公司4CYHS2404036氨甲环酸注射液岳阳新华达制药有限公司4CYHS2404035布洛芬缓释胶囊湖南九典制药股份有限公司4CYHS2404032阿法骨化醇软胶囊湖南银泽华浩生物科技有限公司4CYHS2404031阿法骨化醇软胶囊湖南银泽华浩生物科技有限公司4CYHS2404030米库氯铵注射液福安药业集团庆余堂制药有限公司4CYHS2404029米库氯铵注射液福安药业集团庆余堂制药有限公司4CYHS2404028丙戊酸钠缓释片(I)辰欣药业股份有限公司4CYHS2404026注射用阿立哌唑齐鲁制药有限公司4CYHS2404025注射用阿立哌唑齐鲁制药有限公司4CYHS2404024布洛芬混悬液武汉九珑医药有限责任公司4CYHS2404022氧(液态)遂宁源晗能源技术有限公司4CYHS2404020利丙双卡因乳膏唐山红星药业有限责任公司4CYHS2404019精氨酸布洛芬颗粒四川新斯顿制药股份有限公司4CYHS2404006玻璃酸钠滴眼液江苏福邦药业有限公司4CYHS2404013阿达帕林凝胶湖北科田药业有限公司4CYHS2404012沙格列汀二甲双胍缓释片(III)山西同达药业有限公司4CYHS2404005沙格列汀二甲双胍缓释片(II)山西同达药业有限公司4CYHS2404004盐酸尼卡地平注射液湖北津药药业股份有限公司4CYHS2404002拉莫三嗪片辰欣药业股份有限公司4CYHS2403999拉莫三嗪片辰欣药业股份有限公司4CYHS2403998骨化三醇软胶囊山东简道制药有限公司4CYHS2403995盐酸奥布卡因滴眼液山东辰欣佛都药业股份有限公司4CYHS2403994培哚普利氨氯地平片(III)东阳祥昇医药科技有限公司4CYHS2403993枸橼酸托法替布缓释片浙江尖峰药业有限公司4CYHS2403990盐酸米托蒽醌注射液海南倍康医药科技有限公司4CYHS2403988硫酸氨基葡萄糖胶囊江西杏林白马药业股份有限公司4CYHS2403987注射用盐酸地尔硫䓬广州瑞尔医药科技有限公司4CYHS2403985氯吡格雷阿司匹林片北京福元医药股份有限公司4CYHS2403984地夸磷索钠滴眼液深圳市宇健生物医药有限公司4CYHS2403997西甲硅油乳剂山东致泰医药技术有限公司4CYHS2403989注射用氯诺昔康开封明仁药业有限公司4CYHS2403982蛋白琥珀酸铁口服溶液石家庄市华新药业有限责任公司4CYHS2403973马来酸氟伏沙明片安徽正善生物药业有限公司4CYHS2403968注射用阿奇霉素南京海纳医药科技股份有限公司4CYHS2403967富马酸伏诺拉生片浙江诺得药业有限公司4CYHS2403979富马酸伏诺拉生片浙江诺得药业有限公司4CYHS2403978甲苯磺酸艾多沙班片宁波科尔康美诺华药业有限公司4CYHS2403976丙戊酸钠缓释片(I)南通联亚药业股份有限公司4CYHS2403975阿达帕林凝胶华东医药(西安)博华制药有限公司4CYHS2403974铝碳酸镁咀嚼片湖南千金湘江药业股份有限公司4CYHS2403957钆特酸葡胺注射液河北仁合益康药业有限公司4CYHS2403959吗啉硝唑氯化钠注射液东阳祥昇医药科技有限公司4CYHS2403961培哚普利氨氯地平片(III)海南皇隆制药股份有限公司4CYHS2403963瑞舒伐他汀依折麦布片(Ⅰ)天大药业(珠海)有限公司4CYHS2403966富马酸伏诺拉生片吉林显锋科技制药有限公司4CYHS2403965富马酸伏诺拉生片吉林显锋科技制药有限公司4CYHS2403964西甲硅油乳剂扬州市三药制药有限公司4CYHS2403962莫匹罗星软膏宝龙药业有限公司4CYHS2403956盐酸氨溴索口服溶液石药集团中诺药业(石家庄)有限公司4CYHS2403954盐酸氨溴索口服溶液石药集团中诺药业(石家庄)有限公司4CYHS2403953克立硼罗软膏福建省宝诺医药研发有限公司4CYHS2403951四价流感病毒裂解疫苗深圳康泰生物制品股份有限公司3.3CXSS2400126利妥昔单抗注射液华兰基因工程有限公司3.3CXSS2400128利妥昔单抗注射液华兰基因工程有限公司3.3CXSS2400127吸入用盐酸氨溴索溶液北京韩美药品有限公司3CYHL2400234双氯芬酸钠贴剂四川科伦药业股份有限公司3CYHL2400233双氯芬酸钠贴剂四川科伦药业股份有限公司3CYHL2400232盐酸利多卡因局部溶液呋欧医药科技(湖州)有限公司3CYHL2400231盐酸利多卡因局部溶液呋欧医药科技(湖州)有限公司3CYHL2400230甘露醇山梨醇注射液浙江恒研医药科技有限公司3CYHL2400229洛索洛芬钠凝胶贴膏江苏万高药业股份有限公司4CYHL2400235冻干人用狂犬病疫苗(人二倍体细胞)艾美荣誉(宁波)生物制药有限公司3.3CXSL2400789 进口申请药品名称企业注册分类受理号替尔泊肽注射液Eli Lilly Nederland B.V.5.1JXHS2400102替尔泊肽注射液Eli Lilly Nederland B.V.5.1JXHS2400101替尔泊肽注射液Eli Lilly Nederland B.V.5.1JXHS2400100替尔泊肽注射液Eli Lilly Nederland B.V.5.1JXHS2400099特泽利尤单抗注射液AstraZeneca AB3.1JXSS2400103特泽利尤单抗注射液AstraZeneca AB3.1JXSS2400102盐酸沙丙蝶呤片Annora Pharma Private Limited5.2JYHS2400057Adagrasib 片Mirati Therapeutics, Inc.2.4JXHL2400270输注用无菌冻干粉Telisotuzumab VedotinAbbVie Inc.1JXSL2400226MK-7240注射液Merck Sharp & Dohme LLC1JXSL2400225VGX-3100Inovio Pharmaceuticals, Inc.1JXSL2400224VAY736注射液Novartis Pharma AG1JXSL2400223罗莫索珠单抗注射液Amgen Inc.2.2JXSL2400227 中药相关申请药品名称企业注册分类受理号ZY-A001亚宝药业集团股份有限公司2.2CXZL2400079 注：绿色字体部分为潜在首仿品种； 不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

MINNEAPOLIS, Nov. 14, 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 September 30, 2024. As previously announced, management is hosting an earnings call today at 4:30 p.m. ET. Q3 2024 and Recent Highlights: Up to $12.0 million financing commitment secured from strategic investor, Nant Capital.First patient enrolled in a Phase I dose escalation study to evaluate CPP-1X-S (eflornithine sachets) in STK11 mutant non-small cell lung cancer (NSCLC). Jennifer K. Simpson, PhD, MSN, CRNP, President & CEO of Panbela, commented: "The third quarter marked another period of significant advancement for Panbela, and momentum has continued into Q4, highlighted by a transformative $12.0 million strategic financing from Nant Capital. This new investment is a nod towards potential new scientific collaborations including combining our polyamine pathway targeting approach with cutting-edge immunotherapy platforms. Our Phase III ASPIRE trial continues to progress, and the previously noted lower event rate continues to suggest potential improved survival outcomes for patients, with interim analysis still on track for Q1 2025. We're particularly encouraged by the expansion of our clinical programs, including the initiation of patient enrollment in our Phase I dose escalation study of CPP-1X-S in STK11 mutant non-small cell lung cancer. This new indication represents an important step in broadening the application of our polyamine metabolic inhibitor technology. The momentum we've built across our clinical programs, coupled with the strategic investment from Nant Capital, allows us to continue advancing our mission of delivering meaningful therapeutic options to patients. As we approach several key milestones, including our ASPIRE trial interim analysis, we remain focused on efficient execution and creating value for our stockholders." Patrick Soon-Shiong, M.D., Founder of Nant Capital and Executive Chairman, Founder and Global Chief Scientific and Medical Officer at ImmunityBio commented: "As a surgeon on a life-long scientific quest to address pancreatic cancer, I recognize the compelling potential of orchestrating the activation of the patient’s immune system and the metabolic pathways as an evolutionary approach to address this difficult to treat cancer. By combining Panbela's polyamine metabolic inhibitor platform with our immunotherapy approaches, we may change the course of how we address many solid tumors. Their lead assets, ivospemin, eflornithine, and Flynpovi, target the polyamine pathway in ways that could complement our natural killer cell and killer T cell activation technology. Given the encouraging delay in survival data for the interim analysis in the Panbela pancreatic cancer trial, I believe the combination of immunotherapy and metabolic pathway platforms could create powerful synergies in enhancing patient outcomes. This strategic investment reflects our confidence in the potential of this multi-targeted approach to reset dysregulated biology and potentially enhance anti-tumor activity. The versatility of Panbela's technology platform, from cancer applications to metabolic conditions, presents exciting opportunities for future clinical development programs that could deliver meaningful benefits to patients." Third Quarter ended September 30, 2024 Financial Results General and administrative expenses were approximately $1.1 million in the quarter, nearly flat compared the same period last year. Research and development expenses were approximately $6.0 million, compared to $6.7 million in the same period last year. Net loss in the quarter was approximately $7.2 million, or $1.48 per diluted share, compared to a net loss of $7.8 million, or $53.74 per diluted share, in the same period last year. Total cash was $142,000 as of September 30, 2024. This does not include any investment from Nant Capital as the agreement and initial loan were executed after September 30, 2024. Total current assets were $5.2 million and current liabilities were $20.1 million as of the same date. Notes payable, plus accrued interest, totaled approximately $6.9 million. The current portion of the notes payable plus accrued interest totaled approximately $3.7 million. Included in the current balance are promissory notes sold as bridge fundraising in the quarter ended September 30, 2024, which totaled $2.2 million. Conference Call InformationToll Free: 544-545-0320International: 973-528-0002Participant Access Code: 370494Webcast Link: https://www.webcaster4.com/Webcast/Page/2556/51548 Conference Call Replay InformationToll Free: 877-481-4010International: 919-882-2331Replay Passcode: 51548Webcast Replay: https://www.webcaster4.com/Webcast/Page/2556/51548 The replay will be available within approximately two hours after the completion of the call for approximately one year. About our PipelineThe pipeline consists of assets currently in clinical trials with an initial focus on familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention, ovarian cancer, and diabetes. The combined development programs have a steady cadence of catalysts with programs ranging from pre-clinical to registration studies. SBP-101 IvospeminIvospemin is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. It has shown signals of tumor growth inhibition in clinical studies of metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 14.6 months and an objective response rate (ORR) of 48%, both exceeding what is typical for the standard of care of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, ivospemin has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the previous Panbela-sponsored clinical trials provide support for continued evaluation of ivospemin in the ASPIRE trial. For more information, please visit https://clinicaltrials.gov/study/NCT03412799. Flynpovi™Flynpovi is a combination of CPP-1X (eflornithine) and sulindac with a dual mechanism inhibiting polyamine synthesis and increasing polyamine export and catabolism. In a Phase 3 clinical trial in patients with sporadic large bowel polyps, the combination prevented > 90% subsequent pre-cancerous sporadic adenomas versus placebo. Focusing on FAP patients with lower gastrointestinal tract anatomy in the recent Phase III trial comparing Flynpovi to single agent eflornithine and single agent sulindac, FAP patients with lower GI anatomy (patients with an intact colon, retained rectum or surgical pouch), Flynpovi showed statistically significant benefit compared to both single agents (p≤0.02) in delaying surgical events in the lower GI for up to four years. The safety profile for Flynpovi did not significantly differ from the single agents and supports the continued evaluation of Flynpovi for FAP. CPP-1X EflornithineCPP-1X (eflornithine) is being developed as a single agent tablet or high dose power sachet for several indications including prevention of gastric cancer and recent onset Type 1 diabetes. Preclinical studies as well as Phase 1 or Phase 2 investigator-initiated trials suggest that CPP-1X treatment may be well-tolerated and has potential activity. About PanbelaPanbela Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing disruptive therapeutics for patients with urgent unmet medical needs. Panbela’s lead assets are Ivospemin (SBP-101) and Flynpovi. Further information can be found at www.panbela.com. Panbela’s common stock is eligible for quotation on the OTCQB under the symbol “PBLA”. Cautionary Statement Regarding Forward-Looking StatementsThis press release contains “forward-looking statements, “which can be identified by words such as: “anticipate,” “design,” “hope,” “may,” “plan,” and “will.” Examples of forward-looking statements include statements we make regarding timing of trials and results of collaborations with third parties and future studies. All statements other than statements of historical fact are statements that should be deemed forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations, and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially and adversely from the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: (i) our ability to obtain additional capital, on acceptable terms or at all, required to implement our business plan; (ii) our lack of diversification and the corresponding risk of an investment in our Company and the corresponding risk of potential deterioration of our financial condition and results due to failure to diversify; (iii) our ability to obtain and maintain our listing on a national securities exchange; (iv) results, progress and success of our randomized Phase Ia/Ib and Phase II/III clinical trials; (v) our ability to demonstrate the safety and effectiveness of our product candidates: ivospemin ( SBP-101 ), Flynpovi, and eflornithine (CPP-1X); (vi) potential delays or risks to the success of our randomized Phase II/III clinical trial resulting from a termination in our relationship with our CRO; (vii) our ability to obtain regulatory approvals for our product candidates, SBP-101, Flynpovi and CPP-1X in the United States, the European Union or other international markets; (viii) the market acceptance and level of future sales of our product candidates, SBP-101, Flynpovi and CPP-1X ; (ix) the cost and delays in product development that may result from changes in regulatory oversight applicable to our product candidates, SBP-101, Flynpovi and CPP-1X ; (x) the rate of progress in establishing reimbursement arrangements with third-party payors; (xi) the effect of competing technological and market developments; (xii) the costs involved in filing and prosecuting patent applications and enforcing or defending patent claims; and (xiii) such other factors as discussed in Part I, Item 1A under the caption “Risk Factors” in our most recent Annual Report on Form 10-K , any additional risks presented in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Any forward-looking statement made by us in this press release is based on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement or reasons why actual results would differ from those anticipated in any such forward-looking statement, whether written or oral, whether as a result of new information, future developments or otherwise. Contact Information:Investors:James CarbonaraHayden IR(646) 755-7412james@haydenir.comMedia:Tammy GroenePanbela Therapeutics, Inc.(952) 479-1196IR@panbela.com Panbela Therapeutics, Inc.Consolidated Statements of Operations and Comprehensive Loss (unaudited)(In thousands, except share and per share amounts) Three months ended September 30, Nine months ended September 30, 2024 2023 Percent Change 2024 2023 Percent ChangeOperating expenses: General and administrative $1,113 $1,107 0.5% $3,422 $4,102 -16.6%Research and development 6,052 6,739 -10.2% 18,570 14,501 28.1%Operating loss (7,165) (7,846) -8.7% (21,992) (18,603) 18.2% Other income (expense): Interest income - 49 -100.0% - 114 -100.0%Gain on sale of intellectual property - 400 - 775 400 - Interest expense (442) (71) 522.5% (564) (245) 130.2%Other income (expense) 435 (382) -213.9% 203 (622) -132.6%Total other income (expense) (7) (4) 75.0% 414 (353) -217.3% Loss before income tax benefit (7,172) (7,850) -8.6% (21,578) (18,956) 13.8% Income tax benefit - 19 -100.0% 139 167 -16.8% Net loss (7,172) (7,831) -8.4% (21,439) (18,789) 14.1%Foreign currency translation adjustment (422) 381 -210.8% (204) 612 -133.3%Comprehensive Loss $(7,594) $(7,450) 1.9% $(21,643) $(18,177) 19.1% Basic and diluted net loss per share$(1.48) $(53.74) -97.2% $(5.00) $(287.01) -98.3%Weighted average shares outstanding - basic and diluted 4,854,861 145,711 3231.8% 4,289,989 65,463 6453.3% Panbela Therapeutics, Inc.Consolidated Balance Sheets (unaudited)(In thousands, except share amounts) September 30, 2024 December 31, 2023ASSETS (Unaudited) Current assets: Cash and cash equivalents $142 $2,578 Prepaid expenses 109 299 CRO deposits 4,585 - Income tax receivable 332 183 Total current assets 5,168 3,060 Other non-current assets - 8,742 Total assets $5,168 $11,802 LIABILITIES AND STOCKHOLDERS' DEFICIT Current liabilities: Accounts payable $10,950 $9,939 Accrued expenses 5,469 1,141 Accrued interest payable 523 238 Notes payable 2,200 - Debt, current portion 1,000 1,000 Total current liabilities 20,142 12,318 Debt, net of current portion 3,194 4,194 Total non-current liabilities 3,194 4,194 Total liabilities 23,336 16,512 Stockholders' deficit: Preferred stock, $0.001 par value; 10,000,000 authorized; no shares issued or outstanding as of September 30, 2024 and December 31, 2023 - - Common stock, $0.001 par value; 100,000,000 authorized; 4,854,931 and 480,095 issued as of September 30, 2024 and December 31, 2023 respectively; 4,854,861 and 480,025 shares outstanding as of September 30, 2024 and December 31, 2023, respectively 5 - Treasury Stock at cost; 70 shares at both of September 30, 2024 and December 31, 2023 (1) (1)Additional paid-in capital 128,223 120,043 Accumulated deficit (146,936) (125,497)Accumulated comprehensive income 541 745 Total stockholders' deficit (18,168) (4,710)Total liabilities and stockholders' deficit $5,168 $11,802 Panbela Therapeutics, Inc.Consolidated Statements of Cash Flows (unaudited)(In thousands) Nine Months Ended September 30, 2024 2023 Cash flows from operating activities: Net loss$(21,439) $(18,789)Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation 103 699 Non-cash interest expense 523 172 Gain on sale of intellectual property (775) (400)Changes in operating assets and liabilities: Income tax receivable (140) (112)Prepaid expenses and other current assets (170) (381)Other non-current assets 4,516 (5,541)Accounts payable 798 4,370 Accrued liabilities 4,091 (2,187)Net cash used in operating activities (12,493) (22,169) Cash flows from investing activities: Proceeds from sale of intellectual property 775 400 Net cash provided by investing activities 775 400 Cash flows from financing activities: Proceeds from public offering of common stock and warrants, net of fees and offering costs of $0.9 million and $2.1 million respectively 8,082 23,052 Cash paid for fractional shares - (9)Proceeds from sale of promissory notes 2,200 - Principal payments on notes (1,000) (1,650)Net cash provided by financing activities 9,282 21,393 Effect of exchange rate changes on cash - (2) Net change in cash (2,436) (378)Cash and cash equivalents at beginning of period 2,578 1,285 Cash and cash equivalents at end of period$142 $907 Supplemental disclosure of cash flow information: Cash paid during period for interest$279 $398