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 June 30, 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 001-39756 ARS Pharmaceuticals, Inc. (Exact name of Registrant as specified in its Charter) Delaware 81-1489190 (State or other jurisd ...

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, 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 001-39756 ARS Pharmaceuticals, Inc. (Exact name of Registrant as specified in its Charter) Delaware 81-1489190 (State or other juris ...

产品开发和监管审批 - 公司专注于开发首创的新型产品候选药物neffy®,用于紧急治疗I型过敏反应,包括过敏性休克[21] - neffy是一种无针无注射的鼻喷剂,可以提供与注射剂相当的肾上腺素吸收,具有易携带、易使用、高可靠性等优势[25,27,28,29] - neffy的临床试验数据显示其药代动力学和药效学与已上市注射剂相当[26] - neffy有望成为首个获批的无针无注射的肾上腺素产品,用于紧急治疗I型过敏反应[21,33] - 公司已提交新药申请,预计2023年中获得FDA批准[21,33] - 公司提交了2.0 mg neffy成人和儿童(体重大于30 kg)的新药申请(NDA)，并于2022年第四季度获FDA受理，预计2023年中期获批[36] - 公司在欧盟提交了2.0 mg neffy(体重大于30 kg)的上市申请(MAA)，并于2022年第四季度获EMA受理[36] - 公司计划提交1.0 mg neffy儿童(体重15-30 kg)的补充新药申请(sNDA)给FDA[36] - 公司计划在EMA批准2.0 mg neffy后提交1.0 mg neffy的上市后变更申请[36] - 公司需要完成 Phase 2 和 Phase 3 临床试验以评估药物的安全性和有效性[104][105] - 公司需要进行 Phase 4 临床试验以获取更多临床使用经验[106] - 公司需要与FDA定期沟通并达成共识以推进临床试验[106] - 公司需要提交新药申请(NDA)并获得FDA的审批[108] - FDA可能要求公司进行儿科临床试验或提供豁免[108] - FDA可能给予快速通道或优先审评以加快审批进程[110] - 获批后公司需要持续满足FDA的生产和监管要求[111][112][113] 商业化和市场前景 - neffy预计具有较高的市场需求和良好的商业化前景[34] - neffy拥有强大的知识产权保护,预计至2038年到期[34] - 公司正积极推进neffy在美国和欧洲的监管审批[33] - 公司计划在美国通过直接推广、虚拟销售顾问和非人工推广等方式商业化neffy[38,39] - 公司认为neffy可以扩大市场,覆盖更多既往未使用或已停用自注射肾上腺素的患者[39] - 公司认为neffy在美国以外市场也有重大商业潜力,正在与合作伙伴推进相关监管申报[40] - 2.0 mg neffy剂量旨在与批准的0.3 mg肌肉注射产品相当,适用于体重大于30 kg的人群,占美国处方的约80%[49] - 约80%的患有严重I型过敏反应的患者表示他们更喜欢使用neffy[66] - 100%的医生表示如果患者要求使用neffy,他们会开具处方[66] - 大多数患者表示他们会在neffy上市3个月内开始使用[67] - 69%的患者表示他们会比当前的自动注射器更早使用neffy[67] - 65-72%的患者表示他们会优先使用neffy而不是非处方抗组胺药[67] - 88%的患者表示他们更愿意在公共场合使用neffy[67] - 目前美国约有330万患者使用肾上腺素自动注射器,neffy有望被这些患者快速采用[68] - 过去14年肾上腺素肌肉注射剂的销量年增长约5%,主要由于患有严重I型过敏的人群不断增加[68] - 预计neffy的营销和教育推广将带来31%的市场增长[69] - 约有250万患者未能持续使用肾上腺素注射剂,75%的这些患者表示如果有neffy上市会重新使用[70][71] 公司管理团队和融资 - 公司管理团队拥有丰富的药物开发和商业化经验,包括参与NARCAN®和VALTOCO®等鼻喷剂产品的上市[35] - 公司已获得超过3.6亿美元的融资,并与多家公司建立了合作关系[35] 合作伙伴和许可协议 - 公司计划通过与多家制药公司建立战略合作伙伴关系在美国以外的市场获得neffy的监管批准和销售[85] - 与Alfresa签订合作和许可协议，授予Alfresa在日本独家开发、使用和进口neffy相关产品的权利[94] - 与Alfresa分担neffy在日本获批所需的任何额外临床试验费用[94] - 从Alfresa获得一次性前期付款200万美元和2021年实现临床里程碑后的500万美元付款[94] - 有资格获得最高800万美元的监管里程碑付款，以及在日本获批上市后的低双位数百分比的净销售额[94] - 与Pediatrix签订合作和分销协议，授予其在中国、澳门、香港和台湾的独家权利[95,96] - 从Pediatrix获得300万美元的一次性前期付款，有资格获得400万美元的监管里程碑付款和最高8000万美元的净销售额里程碑付款[96] - 公司与Aegis Therapeutics签有许可协议，获得其INTRAVAIL给药技术的独家全球许可[92] - 根据协议Aegis有权获得最高3.95百万美元的里程碑付款和最高16百万美元的商业化里程碑付款[92] 法规和政策 - 美国Hatch-Waxman法案规定了三种新药上市申请途径:505(b)(1)NDA、505(b)(2)NDA和505(j)ANDA[116] - 505(b)(2)NDA申请可以部分依赖已有药物的安全性和有效性数据[116] - ANDA申请可以通过生物等效性试验来获得上市批准,无需重复临床试验[116] - 专利挑战的ANDA或505(b)(2)NDA申请可能会面临30个月的审批延迟[116]

THE FIRST NO-NEEDLE, NO-INJECTION SOLUTION for Type I Allergic Reactions Q1 2023 1 Forward ...

Corporate Presentation February 2022 Forward-looking statements and disclaimers Any reproduction or distribution of this presentation, in whole or in part, or the disclosure of any of its contents is prohibited. This presentation includes certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements regarding Silverback Therapeutics, ...

SILVERBA Corporate Presentation November 2021 Forward-looking statements and disclaimers Any reproduction or distribution of this presentation, in whole or in part, or the disclosure of any of its contents is prohibited. This presentation includes certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements regarding Silverback Thera ...

SBT6050-101: Phase 1/1B Interim Clinical Study Update Investor Presentation at the European Society of Medical Oncology 2021 September 16, 2021 Forward-looking statements and disclaimers Any reproduction or distribution of this presentation, in whole or in part, or the disclosure of any of its contents is prohibited. This presentation includes certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any ...

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