Irinotecan Hydrochloride Lioposome

First patient dosed in Phase 2 clinical trial with NGC-Cap for metastatic breast cancer Positive data from preclinical studies support NGC-Iri’s ability to deliver more SN-38 to tumors compared with either irinotecan or Onivyde® HANOVER, Md., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (Processa or the Company), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, provides updates on its product pipeline, upcoming milestones and business activities, and reports financial results for the three and nine months ended September 30, 2024. “We continued to make progress with our programs as we further demonstrate the potential benefits of our oncology therapeutics,” said George Ng, Chief Executive Officer of Processa Pharmaceuticals. “Our NGC-Cap Phase 2 clinical trial in metastatic breast cancer is underway with the first patient dosed. As this is an open-label trial, we anticipate sharing initial data in the second half of 2025. Additionally, we reported positive findings from preclinical studies that support NGC-Iri’s potential for improved efficacy and a superior side effect profile compared with the commonly used FDA-approved chemotherapy drugs irinotecan and Onivyde®. We are pleased with our progress and remain committed to improving the lives of people with cancer.” Key Program UpdatesProcessa is focused on developing next-generation chemotherapies (NGC) by improving widely used U.S. Food and Drug Administration (FDA)-approved drugs to extend cancer patients’ survival and/or improve their quality of life. This is achieved by altering how drugs are metabolized and/or distributed in the body, including how they reach cancer cells. In addition, Processa utilizes its Regulatory Science Approach, including the principles associated with FDA’s Project Optimus Oncology initiative, in the development of its NGC drug products to achieve a more favorable benefit-risk profile. PCS6422: Next-Generation Capecitabine (NGC-Cap) NGC-Cap is a combination of PCS6422 and capecitabine, which is the oral prodrug of the cancer drug 5-fluorouracil (5-FU). PCS6422 alters the metabolism of 5-FU, resulting in more 5-FU distributed to cancer cells.Earlier this month, the first patient was dosed in a Phase 2 clinical trial (NCT06568692) evaluating NGC-Cap for the treatment of advanced or metastatic breast cancer. The Phase 2 study is a global, multicenter, open-label, adaptive-design trial comparing two different doses of NGC-Cap to FDA-approved monotherapy capecitabine in approximately 60 to 90 patients. The trial is designed to evaluate the safety-efficacy profile of NGC-Cap versus monotherapy capecitabine, to determine the potential optimal dosage regimens of NGC-Cap as required by the FDA Project Optimus Initiative and to evaluate the possibility of personalizing NGC-Cap therapy. The Company expects to announce interim data from this trial in the second half of 2025. PCS3117: Next-Generation Gemcitabine (NGC-Gem) NGC-Gem is an oral analog of gemcitabine (Gemzar®) that is converted to its active metabolite by a different enzyme system, with potential for a positive response in gemcitabine patients including those inherently resistant to or who acquire resistance to gemcitabine.Processa is evaluating the potential of NGC-Gem in patients with pancreatic and other cancers, as well as ways to identify patients who are more likely to respond to NGC-Gem than gemcitabine alone. The Company is requesting a meeting with the FDA to discuss potential trial designs, including implementation of the Project Optimus initiative. PCS11T: Next-Generation Irinotecan (NGC-Iri) NGC-Iri is an analog of SN-38, the active metabolite of irinotecan, that is expected to have an improved safety-efficacy profile in every type of cancer where irinotecan is currently used.As announced in August, two studies in a human melanoma xenograft mouse model measured SN-38 in tumors, plasma and other tissues following administration of NGC-Iri, irinotecan and Onivyde®, the liposomal formulation of irinotecan. One study compared NGC-Iri with irinotecan, and the other compared irinotecan with Onivyde®. The results found that mice administered NGC-Iri had greater accumulation of SN-38 in the tumor compared with other tissues and that less SN-38 accumulated in non-cancer tissues, which could lead to improved efficacy with a more favorable adverse event profile compared with irinotecan and Onivyde®.The Company is currently evaluating the manufacturing process and potential sites for NGC-Iri. In addition, Processa is defining the potential paths to approval, which includes defining the target patient population and the type of cancer, and expects to conduct IND-enabling toxicology studies in 2025. Third Quarter Financial Results Research and development expenses for the third quarter of 2024 were $2.3 million, compared with $1.2 million for the third quarter of 2023. General and administrative expenses for the third quarter of 2024 were $1.1 million, compared with $1.0 million for the third quarter of 2023. The net loss for the third quarter of 2024 was $3.4 million, or $1.03 per share, compared with the net loss for the third quarter of 2023 of $2.1 million, or $1.54 per share. All per-share figures reflect a 1-for-20 reverse stock split that was effective as of January 22, 2024. Cash and cash equivalents were $2.9 million as of September 30, 2024. About Processa Pharmaceuticals, Inc. Processa is a clinical-stage pharmaceutical company focused on developing the Next Generation Chemotherapy (NGC) drugs with improved safety and efficacy. Processa’s NGC drugs are modifications of existing FDA-approved oncology therapies resulting in an alteration of the metabolism and/or distribution of these drugs while maintaining the existing mechanisms of killing the cancer cells. By combining its novel oncology pipeline with proven cancer-killing active molecules and its Regulatory Science Approach, Processa’s strategy is to develop more effective therapy options with improved tolerability for cancer patients through an efficient regulatory path. For more information, visit our website at www.processapharma.com. Forward-Looking Statements This release contains forward-looking statements. The statements in this press release that are not purely historical are forward-looking statements which involve risks and uncertainties. Actual future performance outcomes and results may differ materially from those expressed in forward-looking statements. Please refer to the documents filed by Processa Pharmaceuticals with the SEC, specifically the most recent reports on Forms 10-K and 10-Q, which identify important risk factors which could cause actual results to differ from those contained in the forward-looking statements. Company Contact:Patrick Lin(925) 683-3218plin@processapharma.com Investor Relations Contact:Yvonne BriggsAlliance Advisors Investor Relations(310) 691-7100ybriggs@allianceadvisorsir.com [Financial Tables to follow]PROCESSA PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands, except share information) (unaudited) September 30, 2024 December 31, 2023 ASSETS Current Assets Cash and cash equivalents $2,891 $4,706 Prepaid expenses and other 1,947 926 Total Current Assets 4,838 5,632 Property and Equipment, net 5 3 Other Assets Lease right-of-use assets, net of accumulated amortization 93 146 Security deposit 6 6 Total Other Assets 99 152 Total Assets $4,942 $5,787 LIABILITIES AND STOCKHOLDERS’ EQUITY Current Liabilities Current maturities of lease liabilities $94 $84 Accounts payable 712 312 Due to licensor - 189 Due to related parties - - Accrued expenses 413 146 Total Current Liabilities 1,219 731 Non-current Liabilities Non-current lease liabilities 2 67 Total Liabilities 1,221 798 Commitments and Contingencies - - Stockholders’ Equity Common stock, par value $0.0001, 100,000,000 shares authorized: 3,271,944 issued and 3,266,944 outstanding at September 30, 2024; and 1,291,000 issued and 1,286,000 outstanding at December 31, 2023 - - Additional paid-in capital 88,511 80,658 Treasury stock at cost — 5,000 shares at September 30, 2024 and December 31, 2023 (300) (300)Accumulated deficit (84,490) (75,369)Total Stockholders’ Equity 3,721 4,989 Total Liabilities and Stockholders’ Equity $4,942 $5,787 PROCESSA PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(in thousands, except per share data)(unaudited) Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Operating Expenses Research and development $2,288 $1,152 $5,557 $4,479 General and administrative 1,137 1,016 3,760 4,509 Operating Loss (3,425) (2,168) (9,317) (8,988) Other Income (Expense) Interest income, net 40 86 195 271 Net Loss $(3,385) $(2,082) $(9,122) $(8,717) Net Loss per Common Share - Basic and Diluted $(1.03) $(1.54) $(3.13) $(6.81) Weighted Average Common Shares Used to Compute Net Loss Applicable to Common Shares - Basic and Diluted 3,275,998 1,350,188 2,909,941 1,279,298 # # #

精彩内容 近日，石药集团的注射用哌拉西林钠过评，拿下集采入场券。今年以来，石药集团研发管线快速推进，11个新品获批上市、12个存量品种过评。公司累计有125个品种过评（32个首家），16个品种拟纳入第十批集采。公司创新研发进展不断，年内已有15款1类新药获批临床，并达成2项BD合作。 22亿注射剂过评！11个品种获批上市 近日，NMPA官网显示，石药集团的注射用哌拉西林钠通过仿制药一致性评价。注射用哌拉西林钠属于β内酰胺青霉素类抗生素，具有广谱抗菌作用。米内网数据显示，2023年中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端注射用哌拉西林钠销售额接近22亿元，同比增长43.78%。 今年以来，石药集团研发管线持续推进，新药、新注册分类品种获批上市，及存量品种通过一致性评价消息不断。 新药注册许可方面，石药集团获批上市的1类新药恩朗苏拜单抗注射液是一款PD-1单抗，用于治疗宫颈癌；2类改良型新药注射用重组人TNK组织型纤溶酶原激活剂新增治疗急性缺血性卒中适应症，为同类产品在国内首家获批；3.3类生物类似药注射用奥马珠单抗用于治疗慢性自发性荨麻疹，为国内首仿。 2024年至今石药集团获批产品来源：米内网中国申报进度（MED）数据库 新注册分类品种审评方面，石药集团有8个品种获批上市并视同过评，包括注射用两性霉素B脂质体、阿瑞匹坦注射液、注射用右雷佐生、罗沙司他胶囊、哌柏西利片、奥拉帕利片、帕拉米韦注射液、达格列净片，进一步丰富公司产品布局。 8个高端仿制药中，多个为国内首批上市，如哌柏西利片、罗沙司他胶囊为国内首仿+首家过评，注射用两性霉素B脂质体为国产第2家+首家过评，阿瑞匹坦注射液、奥拉帕利片为国产第3家。 存量品种一致性评价方面，石药集团的注射用头孢美唑钠、艾司唑仑片、盐酸阿比多尔片、二羟丙茶碱注射液、醋酸钠林格注射液、注射用氨苄西林钠、罗红霉素分散片、奥美拉唑肠溶胶囊等12个品种首次迎来过评。 125个品种过评，16个品种备战第十批集采 截至目前，石药集团已有125个品种通过/视同通过一致性评价。其中，32个品种为国内首家过评，注射用两性霉素B脂质体、玛巴洛沙韦片、格列美脲分散片、盐酸雷尼替丁胶囊、注射用两性霉素B胆固醇硫酸酯复合物、马来酸左氨氯地平片、琥珀酸地文拉法辛缓释片、盐酸伊立替康脂质体注射液等12个品种为独家过评。 石药集团通过/视同通过一致性评价品种 从治疗领域上看，125个品种主要集中在全身用抗感染药物（42个）、抗肿瘤和免疫调节剂（18个）、神经系统药物（16个）、消化系统及代谢药（16个）。米内网数据显示，这四大治疗领域2023年在中国公立医疗机构终端销售额均超过1000亿元。 已落地执行的八批化药集采中，石药集团分别有1个、3个、8个、6个、3个、9个、2个、1个品种中标，合计33个品种。第十批集采拟纳入62个品种，石药集团有16个过评品种在列。 石药集团第十批拟集采品种竞争格局 16个通用名药品2023年在中国公立医疗机构终端合计销售额接近180亿元，其中多柔比星脂质体注射剂、阿司匹林口服常释剂型、西格列汀口服常释剂型、哌拉西林注射剂、帕拉米韦注射剂等9个药品销售额均超过10亿元。 从竞争格局上看，11个品种过评企业达10家及以上，其中西格列汀口服常释剂型过评企业有34家，帕拉米韦注射剂、己酮可可碱注射剂分别有25家、22家企业过评，竞争十分激烈。 从市场份额上看，石药集团有9个品种市占率空白或低于3%，可借助集采中标迅速抢占市场，2个品种多柔比星脂质体注射剂、己酮可可碱注射剂则面临降价压力。 15款1类新药获批临床，拿下2项BD合作 作为国内成功完成创新转型的传统药企，石药集团坚守创新和国际化本心，近年来持续加大研发投入。2023年公司研发费用48.30亿元，同比增长21.17%，2024年上半年公司研发费用25.42亿元，同比增长10.3%。目前公司在研创新药项目约130项，其中约60个重点在研药物进入临床或注册阶段。 今年以来，石药集团有15款1类新药获批临床，其中SYS6020注射液、呼吸道合胞病毒mRNA疫苗、DP303c注射液、JMT202注射液、SYS6023、SYH2039片为首次获批临床。此外，双特异性融合蛋白药物JMT106、高选择性MAT2A抑制剂SYH2039、抗体药物偶联物SYS6023获美国临床试验批准。 内部创新研发稳步推进，石药集团也积极向外寻求新发展，聘任全球研发总裁、达成两项重磅BD合作。 今年9月，石药集团宣布，聘任刘勇军博士担任执行总裁和全球研发总裁，负责公司研发、管线战略和国际业务开拓等工作。9月30日，石药集团宣布与江苏康宁杰瑞就JSKN003之中国内地开发及商业化签订独家授权许可协议，根据协议，康宁杰瑞有权收取最高合计30.8亿元预付款及里程碑付款。 10月7日，石药集团宣布，与阿斯利康就YS2302018订立独家授权协议。YS2302018是一款口服脂蛋白(a)抑制剂，用于开发新型降脂疗法等。根据协议，石药集团将获得1亿美元的首付款，未来还将有资格获得高达19.2亿美元的开发和商业化里程碑付款，以及分级特许权使用费。同时，该合作也向市场证明了公司的研发创新能力。 资料来源：米内网数据库、公司公告注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。 本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦