美国

证券交易委员会

华盛顿特区 20549

表格 10-Q

（勾选一项）

\n \n \n \n \n \n \n

\n	\n
☒	根据《1934年证券交易法》第13条或第15(d)条提交的季度报告

截至以下日期的季度期间 2026年9月30日

或

\n \n \n \n \n \n \n

\n	\n
☐	根据《1934年证券交易法》第13条或第15(d)条提交的过渡报告，过渡期间自至

委员会档案编号 001-42491

BETA BIONICS, INC.

（注册人章程中所列的注册人准确名称）

\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n

\n	\n
特拉华州	47-5386878
（州或其他司法管辖区）（注册成立或组织地）	（美国国税局雇主）识别号）
11 Hughes 尔湾，加利福尼亚州	92618
（主要行政办公室地址）	（邮政编码）

注册人电话号码（包括区号）：（949）427-7785

根据该法第12(b)条注册的证券：

\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n

各类别名称

交易

代码

各注册交易所名称

普通股，每股面值 $0.0001

BBNX

纳斯达克全球市场

请勾选说明注册人是否：(1) 已在此前12个月内（或在注册人须提交此类报告的较短期间内）提交《1934年证券交易法》第13条或第15(d)条要求提交的所有报告；以及 (2) 在过去90天内一直须遵守此类提交要求。是 ☒ 否 ☐

请勾选说明注册人是否已在此前12个月内（或在注册人须提交此类文件的较短期间内）以电子方式提交根据S-T条例第405条（本章§232.405）要求提交的每个交互式数据文件。是 ☒ 否 ☐

请勾选说明注册人属于大型加速申报人、加速申报人、非加速申报人、较小申报公司还是新兴成长公司。参见《交易法》规则12b-2中“大型加速申报人”“加速申报人”“较小申报公司”和“新兴成长公司”的定义。

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\n	\n	\n	\n	\n	\n	\n
大型加速申报人		☐		加速申报人		☐

非加速申报人		☒		较小申报公司		☒

新兴成长公司		☒

如果属于新兴成长公司，请勾选说明注册人是否选择不采用《交易法》第13(a)条规定的、适用于任何新订或修订财务会计准则的延长过渡期。 ☐

请勾选说明注册人是否为壳公司（定义见《交易法》规则 12b-2）。是 ☐ 否 ☒

截至 2026年10月26日，注册人已发行在外的普通股股数为54,367,067。

\n	\n	\n
		页码
第一部分	财务信息	4
第1项	财务报表	4
	截至2026年9月30日（未经审计）和2025年12月31日的简明资产负债表	4
	截至2026年和2025年9月30日止三个月和九个月的简明经营报表及综合亏损报表（未经审计）	5
	截至2026年和2025年9月30日止三个月和九个月的可转换优先股和股东权益简明报表	6
	截至2026年和2025年9月30日止九个月的简明现金流量表（未经审计）	8
	财务报表附注（未经审计）	9
第2项	管理层对财务状况和经营业绩的讨论与分析	23
第3项	有关市场风险的定量和定性披露	41
第4项	控制和程序	41

第二部分	其他信息	43
第1项	法律诉讼	43
第1A项	风险因素	43
第2项	未注册股权证券的销售及所得款项用途	50
第3项	优先证券违约	50
第4项	矿山安全披露	50
第5项	其他信息	50
第6项	附件	51
	签名	52

关于前瞻性陈述的特别说明

本10-Q表季度报告（本季度报告）包含有关我们及所在行业的前瞻性陈述，涉及重大风险和不确定性。本季度报告所载的所有非历史事实陈述，包括有关我们未来经营业绩、财务状况、业务战略和计划以及管理层未来运营目标的陈述，均为前瞻性陈述。在某些情况下，您可以通过“预期”“相信”“考虑”“继续”“可能”“估计”“预计”“打算”“可以”“计划”“潜在”“预测”“预计”“寻求”“应当”“目标”“将”或“会”等词语，或这些词语的否定形式或其他类似术语或表达来识别前瞻性陈述。

我们主要依据当前对未来事件和趋势的预期与预测作出这些前瞻性陈述，并认为这些事件和趋势可能影响我们的财务状况、经营业绩、业务战略和资金需求。这些前瞻性陈述受多项风险、不确定性、因素和假设的影响，相关内容见本季度报告第二部分第1A项“风险因素”及其他部分，包括但不限于：

•

我们预期的未来增长；

•

我们产品市场的规模和增长潜力，以及我们服务这些市场的能力；

•

我们准确预测产品需求的能力；

•

市场接受我们产品的速度和程度；

•

我们销售和营销组织预期的未来发展；

•

我们对多渠道覆盖和报销策略的预期，以及实施该策略的能力；

•

第三方在我们产品商业化过程中的表现及我们对其的依赖，包括单一来源供应商；

•

对我们产品商业需求的预测，以及我们的制造预期和能力；

•

美国的监管动态；

•

我们维持产品监管批准或为美国新产品取得监管批准的能力；

•

我们对现有产品及任何未来产品的研发、监管审批和商业化，以及相关时间安排；

•

竞争产品的开发、监管审批和商业化；

•

我们留住和聘用高级管理人员及关键人才的能力；

•

我们根据《促进初创企业融资法案》（JOBS Act）符合新兴成长型公司资格的期限预期；

•

我们对地缘政治和宏观经济因素影响的预期；

•

我们的财务表现和资本需求；

•

我们对为产品取得并维持知识产权保护能力的预期，以及我们在不侵犯他人知识产权的情况下运营业务的能力；

•

我们对现有现金、现金等价物以及短期和长期投资的预期用途，包括首次公开募股及其他融资交易所得净款项的预期用途；以及

•

其他风险和不确定性，包括本季度报告第二部分第1A项“风险因素”所述内容。

这些风险并非详尽无遗。本季度报告的其他部分可能还包含会损害我们业务和财务表现的其他因素。我们所处的环境竞争激烈且瞬息万变，新的风险因素可能不时出现；管理层无法预测所有风险因素，也无法评估所有因素对我们业务的影响，或评估任何因素或因素组合可能在多大程度上导致实际结果与任何前瞻性陈述中所载或所暗示的结果存在重大差异。

你不应将前瞻性陈述视为对未来事件的预测。本季度报告中的前瞻性陈述主要基于我们对未来事件和趋势的当前预期与预测，我们认为这些事件和趋势可能影响我们的业务、财务状况和经营业绩。这些前瞻性陈述仅截至本季度报告发布之日。除法律要求外，我们不承担更新本季度报告中作出的任何前瞻性陈述的义务，以反映本季度报告日期之后发生的事件或情况、新信息或未预见事件的发生。我们可能无法实际实现前瞻性陈述中披露的计划、意图或预期，因此你不应过度依赖我们的前瞻性陈述。我们的前瞻性陈述未反映任何未来收购、合并、处置、合资或投资的潜在影响。我们拟使本季度报告中的前瞻性陈述受经修订的《1933年证券法》（《证券法》）第27A条和经修订的《1934年证券交易法》（《交易法》）第21E条所载前瞻性陈述安全港条款的保护。

此外，“我们认为”及类似表述反映了我们对相关主题的信念和意见。这些陈述基于截至本季度报告日期我们可获得的信息。尽管我们认为这些信息为此类陈述提供了合理依据，但这些信息可能有限或不完整。我们的陈述不应被理解为表明我们已对所有相关信息进行全面调查或审查。这些陈述本质上存在不确定性，投资者应谨慎，切勿过度依赖这些陈述。

你应阅读本季度报告以及本季度报告中提及并作为附件提交的文件，并理解我们的实际未来业绩、活动水平、表现和成就可能与我们的预期不同。我们的所有前瞻性陈述均受上述警示性声明的限定。

第一部分：财务信息

第1项：财务报表。

BETA BIONICS, INC.

简明资产负债表

（单位：千，股份数除外）

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\n	\n	\n	\n	\n	\n	\n	\n	\n
		2026年9月30日			2025年12月31日
		（未经审计）
资产
流动资产：
现金及现金等价物		$	81,551			$	31,576
受限现金，流动			100				100
短期投资			158,653				187,549
应收账款，净额			20,667				17,118
存货			22,971				21,722
预付费用及其他流动资产			9,004				9,840
流动资产总额			292,946				267,905
财产和设备，净额			11,764				8,600
经营租赁使用权资产			5,401				6,627
长期投资			133,436				45,431
其他长期资产			212				180
资产总额		$	443,759			$	328,743

负债和股东权益
流动负债：
应付账款		$	4,682			$	4,998
应计费用及其他流动负债			24,656				22,431
经营租赁负债			1,452				1,938
递延收入			2,046				1,557
流动负债总额			32,836				30,924
经营租赁负债，扣除流动部分			4,649				5,365
递延收入，扣除流动部分			3,480				3,297
其他长期负债			1,411				1,547
负债总额			42,376				41,133
承诺和或有事项（附注 15）
股东权益：
普通股，面值 $0.0001 ，授权发行 700,000,000 股；截至 2026 年 9 月 30 日和 2025 年 12 月 31 日，已发行并流通 54,362,972 股和 44,360,873 股			5				4
额外实收资本			841,843				657,140
累计其他综合收益（亏损）			(877	)			403
累计亏损			(439,588	)			(369,937	)
股东权益总额			401,383				287,610
负债和股东权益总额		$	443,759			$	328,743

随附附注是这些未经审计的简明财务报表的组成部分。

BETA BIONICS, INC.

简明经营及综合亏损报表

（未经审计）

（单位：千，股份数和每股数据除外）

\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n
		截至 9 月 30 日的三个月			截至 9 月 30 日的九个月
		2026			2025			2026			2025
净销售额		$	35,505			$	27,253			$	95,144			$	68,130
销售成本			15,174				12,134				39,474				31,537
毛利			20,331				15,119				55,670				36,593
营业费用：
研发			11,975				8,195				32,571				24,658
销售和营销			25,124				16,045				70,499				45,070
一般及行政			9,841				7,922				29,058				22,422
营业费用总额			46,940				32,162				132,128				92,150
经营亏损			(26,609	)			(17,043	)			(76,458	)			(55,557	)
其他收入（费用）：
利息收入			2,258				2,833				6,811				8,274
其他收入（费用），净额			(2	)			1				(4	)			(1	)
认股权证负债公允价值变动			—				—				—				(12,450	)
其他收入（费用）总额，净额			2,256				2,834				6,807				(4,177	)
净亏损		$	(24,353	)		$	(14,209	)		$	(69,651	)		$	(59,734	)
其他综合收益（亏损）：
短期和长期投资未实现收益（亏损）			(487	)			205				(1,280	)			289
综合亏损		$	(24,840	)		$	(14,004	)		$	(70,931	)		$	(59,445	)
归属于普通股股东的每股净亏损，基本和稀释后		$	(0.52	)		$	(0.33	)		$	(1.54	)		$	(1.52	)
加权平均流通普通股数，基本和稀释后			46,541,997				43,634,006				45,224,038				39,293,798

随附附注是这些未经审计的简明财务报表的组成部分。

BETA BIONICS, INC.

简明可转换优先股及股东权益变动表

（未经审计）

（单位：千，股份数除外）

截至 2026 年 9 月 30 日的九个月

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																		累计
		可转换										额外			其他						总计
		优先股				普通股			实收			综合			累计			股东
		股份			金额				股份			金额			资本			收益（亏损）			亏损			权益
2025 年 12 月 31 日余额			—			$	—					44,360,873			$	4			$	657,140			$	403			$	(369,937	)		$	287,610
限制性股票单位归属			—				—					513,953				—				—				—				—				—
行使股票期权			—				—					439,418				1				2,995				—				—				2,996
根据员工股票购买计划发行普通股			—				—					92,205				—				1,228				—				—				1,228
股份支付费用			—				—					—				—				19,137				—				—				19,137
短期投资未实现收益（亏损）			—				—					—				—				—				(1,280	)			—				(1,280	)
后续公开发行中发行普通股及预先出资认股权证，扣除承销折扣、佣金及发行费用 $11.2 百万			—				—					8,956,523				—				161,343				—				—				161,343
净亏损			—				—					—				—				—				—				(69,651	)			(69,651	)
2026 年 9 月 30 日余额			—			$	—					54,362,972			$	5			$	841,843			$	(877	)		$	(439,588	)		$	401,383

截至 2026 年 9 月 30 日的三个月

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																		累计
		可转换										额外			其他						总计
		优先股				普通股			实缴			综合			累计			股东
		股数			金额				股数			金额			资本			收益（亏损）			亏损			权益
截至2026年6月30日的余额			—			$	—					44,981,606			$	5			$	671,986			$	(390	)		$	(415,235	)		$	256,366
受限股票单位归属			—				—					210,325				—				—				—				—				—
行使股票期权			—				—					214,518				—				1,799				—				—				1,799
根据员工股票购买计划发行普通股			—				—					—				—				—				—				—				—
股票薪酬费用			—				—					—				—				6,715				—				—				6,715
短期投资未实现收益（亏损）			—				—					—				—				—				(487	)			—				(487	)
后续公开发行中发行普通股和预付认股权证，扣除承销折扣和佣金以及发行成本$11.2 百万			—				—					8,956,523				—				161,343				—				—				161,343
净亏损			—				—					—				—				—				—				(24,353	)			(24,353	)
截至2026年9月30日的余额			—			$	—					54,362,972			$	5			$	841,843			$	(877	)		$	(439,588	)		$	401,383

截至2025年9月30日的九个月

\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n
																		累计
		可转换										额外			其他						总计
		优先股				普通股			实缴			综合			累计			股东
		股数			金额				股数			金额			资本			收益			亏损			权益
截至2024年12月31日的余额			17,228,954			$	321,373					6,667,793			$	1			$	51,311			$	65			$	(296,737	)		$	(245,360	)
首次公开募股时将可转换优先股转换为普通股			(17,228,954	)			(321,373	)				19,827,003				2				321,371				—				—				321,373
首次公开募股中发行普通股，扣除承销折扣和佣金以及发行成本$21.7 百万			—				—					12,475,000				1				190,378				—				—				190,379
根据私募发行发行普通股，扣除发行成本$1.4 百万										1,000,000				—				15,591				—				—				15,591
首次公开募股时将可转换优先股和普通股认股权证重新分类为普通股			—				—					3,369,473				—				57,348				—				—				57,348
受限股票单位归属			—				—					190,222				—				—				—				—				—
行使股票期权			—				—					462,107				—				2,793				—				—				2,793
股票薪酬费用			—				—					—				—				12,081				—				—				12,081
短期投资未实现收益（亏损）			—				—					—				—				—				289				—				289
净亏损			—				—					—				—				—				—				(59,734	)			(59,734	)
截至2025年9月30日的余额			—			$	—					43,991,598			$	4			$	650,873			$	354			$	(356,471	)		$	294,760

截至2025年9月30日的三个月

\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n
																		累计
		可转换										额外			其他						总计
		优先股				普通股			实缴			综合			累计			股东
		股数			金额				股数			金额			资本			收益			亏损			权益
截至2025年6月30日的余额			—			$	—					43,465,136			$	4			$	643,742			$	149			$	(342,262	)		$	301,633
首次公开募股时将可转换优先股转换为普通股			—				—					—				—				—				—				—				—
首次公开募股中发行普通股，扣除承销折扣和佣金以及发行成本$21.7 百万			—				—					—				—				—				—				—				—
根据私募发行发行普通股，扣除发行成本$1.4 百万										—				—				—				—				—				—
首次公开募股时将可转换优先股和普通股认股权证重新分类为普通股			—				—					—				—				—				—				—				—
受限股票单位归属			—				—					85,732				—				—				—				—				—
行使股票期权			—				—					440,730				—				2,653				—				—				2,653
股票薪酬费用			—				—					—				—				4,478				—				—				4,478
短期投资未实现收益（亏损）			—				—					—				—				—				205				—				205
净亏损			—				—					—				—				—				—				(14,209	)			(14,209	)
截至2025年9月30日的余额			—			$	—					43,991,598			$	4			$	650,873			$	354			$	(356,471	)		$	294,760

随附附注是这些未经审计的简明财务报表不可分割的一部分。

BETA BIONICS, INC.

简明现金流量表

（未经审计）

（单位：千）

\n	\n	\n	\n	\n	\n	\n	\n	\n
		截至9月30日的九个月
		2026			2025
经营活动产生的现金流量：
净亏损		$	(69,651	)		$	(59,734	)
将净亏损调节为经营活动所用现金净额的调整项：
折旧费用			2,186				1,035
预期信用损失准备			52				24
股份薪酬费用			19,137				12,081
过剩及陈旧存货准备（转回）净额			(567	)			624
认股权证负债公允价值变动			—				12,450
短期及长期投资溢价（折价）摊销			228				(2,029	)
经营租赁使用权资产摊销			1,226				905
处置不动产及设备损失			86				—
经营资产和负债变动：
应收账款			(3,601	)			433
存货			(682	)			(7,677	)
预付费用及其他流动资产			836				(5,395	)
其他长期资产			(32	)			(33	)
应付账款			(823	)			1,571
应计费用及其他流动负债			1,530				1,565
其他长期负债			(136	)			1,205
经营租赁负债			(1,202	)			(852	)
递延收入			672				1,529
经营活动所用现金净额			(50,741	)			(42,298	)
投资活动产生的现金流量：
购买短期投资			(43,944	)			(236,772	)
购买长期投资			(158,673	)			(45,297	)
短期投资到期及赎回所得款项			142,000				122,000
购买不动产及设备			(4,691	)			(3,394	)
投资活动所用现金净额			(65,308	)			(163,463	)
融资活动产生的现金流量：
发行普通股所得款项，扣除承销折扣、佣金及发行成本			—				195,430
私募发行普通股所得款项，扣除发行成本			—				15,591
发行普通股及预融资认股权证所得款项，扣除承销折扣、佣金及发行成本			161,801				—
行使股票期权及员工股票购买计划发行所得款项			4,223				2,793
融资活动提供的现金净额			166,024				213,814
现金、现金等价物及受限现金净增加额			49,975				8,053
期初现金、现金等价物及受限现金			31,676				30,532
期末现金、现金等价物及受限现金		$	81,651			$	38,585

非现金投资和融资信息补充披露：
将长期投资重新分类为短期投资		$	70,174			$	125,842
首次公开募股时转换可转换优先股		$	—			$	321,373
首次公开募股时通过净额行权转换认股权证		$	—			$	57,348
首次公开募股时将递延发行成本重新分类至权益		$	—			$	5,051
通过承担经营租赁义务取得的经营租赁使用权资产		$	—			$	1,284
应计发行成本		$	456			$	—
现金、现金等价物及受限现金的调节：
现金及现金等价物		$	81,551			$	38,485
受限现金			100				100
现金流量表所列现金、现金等价物及受限现金总额		$	81,651			$	38,585

随附附注是这些未经审计的简明财务报表不可分割的一部分。

BETA BIONICS, INC.

财务报表附注

（未经审计）

组织架构和列报基础

公司

Beta Bionics, Inc.（以下简称“公司”）是一家处于商业化阶段的医疗器械公司，专注于通过使用自适应闭环算法，设计、开发和商业化解决方案，以改善需要胰岛素治疗的糖尿病患者（PWD）的健康和生活质量。公司于2015年10月在马萨诸塞州注册为公益公司，并于2024年8月转为特拉华州公司。公司的商业化产品 iLet 于2023年5月获得美国食品药品监督管理局（以下简称“FDA”）批准，用于治疗6岁及以上成人和儿童的1型糖尿病，公司于2023年5月开始在美国商业化销售。2026年9月，公司获得FDA对其贴片泵 Mint 的批准。公司尚未开始 Mint 的商业销售。

公司将资源投入产品的研发、制造规模扩大和商业化。公司主要通过股权融资和产品销售收入为运营提供资金。

列报基础

公司的未经审计简明财务报表系根据美国证券交易委员会适用于中期财务信息的规则和条例编制。根据该等规则和条例，按照美国公认会计原则（以下简称“GAAP”）编制的年度财务报表通常包含的某些信息和脚注披露已予以简化或省略。本附注中对适用准则的任何引用均指会计准则汇编（以下简称“ASC”）中的权威GAAP规定。

中期财务业绩未必能反映全年或任何其他期间的预期业绩。阅读本未经审计简明财务报表时，应同时参阅公司截至2025年12月31日财政年度的10-K表格年度报告（以下简称“2025年年度报告”）中所载的经审计财务报表及其附注。

新兴成长型公司地位

根据2012年颁布的《JOBS法案》，公司属于新兴成长型公司。根据《JOBS法案》，新兴成长型公司可以延迟采用该法案颁布后发布的新会计准则或修订后的会计准则，直至这些准则适用于私营公司。公司选择采用这一延长过渡期，以遵守对上市公司和私营公司设定不同生效日期的新会计准则或修订后的会计准则，直至以下较早日期：(i) 公司不再是新兴成长型公司；或 (ii) 公司明确且不可撤销地选择退出《JOBS法案》规定的延长过渡期。因此，本财务报表可能无法与按上市公司生效日期遵守新会计公告或修订后会计公告的公司进行比较。

重要会计政策

估计的使用

按照 GAAP 编制财务报表要求管理层作出估计和假设，这些估计和假设会影响财务报表中列报的资产和负债金额、财务报表日或有资产和负债的披露，以及报告期内列报的收入和费用金额。财务报表中反映的重大估计和假设包括但不限于：关于收入确认（包括可变对价）、存货估值、保修准备金以及股权激励薪酬奖励估值的某些判断。公司根据历史经验、已知趋势以及其他特定市场或相关假设作出估计，并认为这些假设在当时情况下是合理的。管理层会随着情况、事实和经验的变化持续评估其估计。估计发生变化时，在变化得以确认的期间予以记录。实际结果可能与这些估计或假设不同。

短期投资

公司将其短期投资归类为可供出售证券。可供出售证券按公允价值列账，未实现净收益和损失作为累计其他综合收益（损失）的组成部分列报于

股东权益中，并作为其他综合收益（损失）的组成部分列报于经营及综合亏损报表中。公司采用个别认定法确定出售可供出售证券的已实现收益或损失，并将已实现净收益和损失作为其他收入或费用的组成部分列报于经营及综合亏损报表中。公司定期评估其短期投资的信用损失，并考虑价值下降的重要程度以及整体市场和经济状况。在截至2026年和2025年9月30日的九个月期间，公司未确认与其短期投资相关的任何减值损失。根据投资性质及其在当前经营中可用的情况，所有短期投资均归类为流动资产。

长期投资

长期投资包括期限为12个月或以上的美国国债。本公司将长期投资归类为可供出售证券。可供出售证券按公允价值列账，未实现净收益和损失作为股东权益中累计其他综合收益（损失）的组成部分，以及经营和综合亏损表中其他综合收益（损失）的组成部分列报。本公司采用个别识别法确定出售可供出售证券的已实现收益或损失，并将已实现净收益和损失作为经营和综合亏损表中其他收入（费用）净额的组成部分列报。本公司定期评估处于未实现亏损状态的可供出售证券，以确定是否存在信用损失。如果美国国债出现未实现亏损，且本公司打算出售该证券，或很可能需要在摊余成本基础收回之前出售该证券，本公司将在其他收入（费用）净额中确认相当于全部未实现亏损的减值费用，并调整该证券的摊余成本基础。本公司在未确认与长期投资相关的减值损失，期间为截至2026年和2025年9月30日的九个月。根据投资性质，所有长期投资均归类为非流动资产。

信用风险及重要供应商集中度

可能使本公司面临信用风险集中的金融工具主要包括现金及现金等价物以及短期和长期投资。本公司将现金及现金等价物存放于多家经认可的金融机构账户，并将短期和长期投资存放于托管账户，金额均超过联邦保险限额。此外，本公司制定了有关投资工具及其期限的指引，旨在确保本金保值和流动性。本公司认为，除与商业银行关系相关的正常信用风险外，其并未面临异常风险。

本公司面临与客户相关的集中风险。下表汇总了在所列期间占相应金额10%或以上的客户占净销售额和应收账款净额的比例：

\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n
		净销售额		净销售额		应收账款净额
		截至9月30日的三个月		截至9月30日的九个月		9月30日		12月31日
		2026		2025		2026		2025		2026		2025
经销商A		12.0%		13.8%		12.4%		14.0%		15.1%		14.7%
经销商B		10.2%		12.7%		10.6%		13.1%		*		*
经销商C		*		*		*		12.6%		*		*
经销商D		10.5%		14.1%		10.2%		12.1%		*		*
经销商E		*		*		*		*		*		14.0%
经销商F		*		*		*		*		12.2%		19.4%
经销商G		18.9%		11.7%		17.1%		12.1%		20.1%		10.9%
经销商H		20.1%		*		19.7%		*		17.5%		16.0%

* 该客户相关金额占所列期间的比例低于10%。

公允价值计量

根据 GAAP，某些资产和负债按公允价值列账。公允价值定义为在计量日，市场参与者之间有序交易中出售资产所收取的价格或转移负债所支付的价格。在确定需按公允价值入账的资产和负债的公允价值计量时，公司会考虑其将进行交易的主要市场或最有利市场，并考虑市场参与者为资产或负债定价时会采用的假设，例如固有风险、转让限制和不履约风险。用于计量公允价值的估值技术必须最大限度地使用可观察输入值，并尽量减少使用不可观察输入值。按公允价值列账的金融资产和负债

根据以下公允价值层级的三个级别之一进行分类和披露，其中前两个级别被视为可观察，最后一个级别被视为不可观察：

\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n

\n	\n	\n
	第 1 级 —	活跃市场中相同资产或负债的报价。

	第 2 级 —	可观察输入值（第 1 级报价除外），例如活跃市场中类似资产或负债的报价、非活跃市场中相同或类似资产或负债的报价，或其他可观察或可由可观察市场数据佐证的输入值。

	第 3 级 —	市场活动很少或没有市场活动支持、且对确定资产或负债公允价值具有重要影响的不可观察输入值，包括定价模型、贴现现金流方法及类似技术。

公司的现金等价物、受限现金、短期投资和长期投资均按公允价值列账，其公允价值根据上述公允价值层级确定（见附注 4）。由于应收账款、应付账款和应计费用期限较短，其公允价值接近账面价值。

租赁

租赁包括公司取得已识别资产控制权的所有协议。租赁负债在起租日确认，金额按租赁期内租赁付款额的现值计量。在条件允许时，公司使用租赁内含利率将租赁付款额折现至现值；否则，公司根据租赁起租时可获得的信息估算增量借款利率，对租赁付款额进行折现（见附注 14）。

公司的租赁初始租期约为 1 至 6 年，部分租赁包含最多可延长 5 年的续租选择权。如果租赁包含延长租期的选择权，公司仅将其在租赁开始日合理确定会行使的期间纳入租期。是否行使租赁续租选择权由公司自行决定。可变租赁成本（包括维护和公用事业费用、房地产税及保险费）在发生时计入费用，不纳入租赁负债的计量。包含租赁和非租赁组成部分的租赁协议作为单一租赁组成部分进行会计处理。初始租期为 12 个月或更短的租赁计入费用，不记录在资产负债表中。公司的租赁规定固定租金，并按年递增。公司没有被分类为融资租赁的租赁。

分部信息

经营分部是指实体中可获取单独财务信息，且首席经营决策者（“CODM”）会定期审阅该信息以决定如何向各个分部分配资源及评估其业绩的组成部分。公司的首席执行官是公司的 CODM。CODM 会审阅以公司整体为基础呈列的财务信息，以作出经营决策、分配资源并评估财务业绩。因此，公司认定其仅经营一个经营分部。分部资产以资产负债表中的总资产列示。公司认定，毛利和净利润（亏损）是 CODM 使用的主要分部损益衡量指标。CODM 根据经营及综合亏损报表中列报的净利润（亏损）评估公司业绩、监控预算与实际结果，并决定如何分配资源。定期提供给 CODM 的其他费用类别均已包含在本文所列的主要财务报表中。在截至 2026 年和 2025 年 9 月 30 日的九个月期间，公司未产生任何国际收入；截至 2026 年 9 月 30 日和 2025 年 12 月 31 日，公司在美国境外没有重大金额的资产。

收入确认

净销售额

收入主要来自 iLet 及其相关一次性使用产品的销售，例如用于储存和输送胰岛素的药筒，以及连接 iLet 与用户身体的输注器。这些产品通过分销商和药房网络进行分销，随后由它们转售给需要胰岛素的 PWD。本公司在向分销商和药房客户转移承诺的商品或服务控制权时确认收入，确认金额反映本公司预期有权以这些商品或服务换取的对价，并扣除预计退货及预计可变对价调整，包括返利、患者援助和追偿款。

含多项履约义务安排的收入确认

本公司将与客户合同中的各项交付物视为单独的履约义务。iLet 及与 iLet 配套使用的一次性产品属于在客户取得承诺商品控制权时履行的履约义务，该时点通常为发货时。本公司认定，用户访问移动应用以及通过移动应用接收未明确指定的软件更新，属于随时间履行的可明确区分的履约义务，因为在 iLet 通常为期四年的保修期内会持续提供访问权限和支持。因此，与访问移动应用及未明确指定的软件更新相关的收入递延，并在四年期间内按比例确认。鉴于移动应用访问权限和未明确指定的软件更新向客户转移的模式相同，且在同一四年期间内提供，本公司将这些履约义务作为一项履约义务确认收入。

交易价格根据预期收到的对价确定，以合同安排中列明的金额为依据。本公司根据各项履约义务估计的相对单独售价分摊对价，并根据履约义务是在某一时点还是一段时间内履行来确认对价。若不存在可观察的单独售价，本公司采用预期成本加利润法估算单独售价。

可变对价

只有在未来期间很可能不会发生累计已确认收入金额重大转回的情况下，才将可变对价金额计入交易价格并计入收入。公司估计支付给药品福利管理机构的返利所导致的收入减项。返利基于合同安排，且可能因客户而异。估计依据包括已售产品、历史经验、趋势、已知的特定市场事件，以及在可获得的情况下的渠道库存数据。返利和患者援助准备金在确认收入时作为销售额的减项入账，并列入资产负债表中的应计费用及其他流动负债。退货折让准备金在确认收入时作为销售额的减项入账；由于存在抵销权，因此在资产负债表中作为应收账款净额的减项列示。如果公司收到的实际对价金额与估计不同，公司将在相关差异变得明确的期间或每个报告期末调整这些估计，从而影响报告收入。

销售退货

自其授权分销商发货之日起，公司为 iLet 提供 90天退货权，前提是收到医生确认退货具有正当医疗原因的证明。销售退货预计备抵基于相应退货期间的历史退货数量与 iLet 发货量，并在适当时根据已知或预期的市场变化进行调整。实际产品退货与随附财务报表中记录的估计金额相比并无重大差异。

合同成本

如果公司预计能够收回为获取客户合同而发生的增量成本，则将其确认为资产。公司选择采用实务简便方法，在发生时将成本计入销售和营销费用，因为摊销期不足一年。

产品保修

公司向最终用户提供 iLet 四年保修，以更换任何未能按照产品规格正常运行的 iLet。预计保修成本在发货时入账。保修成本的估计主要基于当前预期的产品更换成本和预期更换率；预期更换率采用管理层对硬件的了解，并考虑患者流失率，仅为仍在使用该泵的活跃患者群体计提准备金。尽管公司的产品销售历史有限，管理层还会利用历史保修成本数据定期重新评估预计保修义务。迄今为止的产品退货和保修更换情况与已计提金额一致。保修费用作为销售成本的一部分计入经营及综合亏损报表。

公司截至2026年和2025年9月30日止三个月和九个月的产品保修负债变动调节如下：

\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n
		截至9月30日止三个月			截至9月30日的九个月
		2026			2025			2026			2025
		（单位：千）			（单位：千）
期初产品保修负债		$	3,288			$	2,062			$	3,154			$	657
保修费用			517				1,046				1,651				3,406
保修履约			(638	)			(553	)			(1,638	)			(1,508	)
期末产品保修负债		$	3,167			$	2,555			$	3,167			$	2,555

截至2026年9月30日和2025年12月31日，产品保修准备金总额计入以下资产负债表科目：

\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n

\n	\n	\n	\n	\n	\n	\n	\n	\n
		2026年9月30日			2025年12月31日
		（单位：千）
应计费用及其他流动负债		$	1,756			$	1,607
其他长期负债			1,411				1,547
保修负债总额		$	3,167			$	3,154

每股净亏损

基本每股净亏损的计算方法是，将归属于普通股股东的净亏损除以该期间普通股流通股数的加权平均值。以名义金额或无需支付现金即可发行的股份，在计算基本每股净亏损时视为已发行普通股。因此，2026年9月17日发行的预付认股权证所对应的1,043,484股普通股，自2026年9月17日起计入普通股流通股数的加权平均值，因为每股剩余行权价$0.0001属于名义金额。稀释每股净亏损的计算会考虑该期间所有可能具有稀释性的流通证券，但若其影响具有反稀释性则不予考虑。可能具有稀释性的证券包括股票期权和限制性股票单位。由于预付认股权证对应的股份已计入基本每股净亏损，预付认股权证不会产生增量稀释股份，因此未列入下表。下列金额为各期间期末尚未行使的可能具有稀释性的证券，包括已归属和未归属奖励；由于其影响具有反稀释性，因此未计入稀释每股净亏损的计算。

\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n

\n	\n	\n	\n	\n	\n	\n	\n	\n
		截至9月30日的九个月
		2026			2025
购买普通股的股票期权			6,730,716				6,765,251
RSU			2,287,525				824,771
总计			9,018,241				7,590,022

截至2026年和2025年9月30日的三个月和九个月期间，由于公司在各期间均处于净亏损状态，用于计算基本和稀释每股净亏损的加权平均股数没有差异。

近期已采纳的会计公告

2025年7月，FASB发布了ASU 2025-05，信用损失（主题326）——应收账款和合同资产信用损失的计量，该准则提供了一项实务简便方法：在估计收入交易产生的流动应收账款和流动合同资产的预期信用损失时，制定合理且有依据的预测，可假定资产负债表日的当前状况在资产剩余存续期内保持不变。公司已于2026年1月1日采纳ASU 2025-05。采纳该指引未对公司的财务报表产生重大影响。

近期发布的会计公告

2024年11月，FASB发布了ASU 2024-03，损益表——综合收益报告——费用分解披露（子主题220-40）：损益表费用分解（ASU 2024-03）；2025年1月，

FASB发布了ASU 2025-01，损益表——综合收益报告——费用分解披露（子主题220-40）：明确生效日期（“ASU 2025-01”）。ASU 2024-03要求额外披露损益表中所列费用的性质，并披露损益表费用项目中包含的特定类型费用。经ASU 2025-01澄清后，ASU 2024-03适用于2026年12月15日之后开始的财政年度，以及2027年12月15日之后开始的财政年度内的中期期间；允许提前采用。公司目前正在评估该指引可能对其财务报表产生的影响。

2025年12月，FASB发布了ASU 2025-11，中期报告（主题270）：范围有限的改进，该准则明确了主题270的适用范围、中期财务报表的形式和内容以及中期披露要求。该指引还确立了一项原则，要求披露自最近一个年度报告期末以来对实体产生重大影响的事件。根据新兴成长型公司可享有的延长过渡期，若公司继续符合资格并采用该延长过渡期，这些修订适用于公司在2028年12月15日之后开始的年度报告期间内的中期报告期间。允许提前采用。公司目前正在评估该指引，并预计采用该指引不会对其财务报表产生重大影响。

收入

公司按产品类别和报销渠道细分净销售额，公司认为这能够有意义地反映经济因素如何影响净销售额的性质、时间和不确定性。

截至2026年和2025年9月30日止三个月和九个月期间，公司的收入主要来自iLet及其相关一次性产品的销售。iLet需要使用单独购买的一次性产品，包括用于储存和输送胰岛素的储液盒，以及将iLet连接到用户身体的输注器。这些一次性产品为公司带来经常性收入，因为最终用户通常每2-3天更换一次，或按照医疗服务提供者的指示更换。

公司的客户是分销商和药房，他们通过耐用医疗设备（“DME”）和药房福利计划（“PBP”）报销渠道向需要胰岛素的PWD销售这些产品，这些渠道的支付支出有所不同。截至2026年和2025年9月30日止三个月和九个月期间，公司大部分销售通过DME渠道完成。

下表汇总了公司的细分收入：

\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n
		截至9月30日止三个月			截至9月30日止九个月
		2026			2025			2026			2025
		（千元）			（单位：千）
DME 渠道
iLet(1)		$	11,563			$	14,175			$	34,303			$	37,217
一次性使用产品			10,334				6,840				24,930				16,269
DME 渠道总计			21,897				21,015				59,233				53,486

PBP 渠道
iLet(1)			(37	)			148				649				859
一次性使用产品			13,645				6,090				35,262				13,785
PBP 渠道总计			13,608				6,238				35,911				14,644
净销售额总计		$	35,505			$	27,253			$	95,144			$	68,130

(1)

iLet 包括与软件更新和移动应用访问相关的随时间确认的收入。

公司在控制权转移给客户时确认收入，同时也会在提供未具体说明的软件更新等持续服务的履约义务期间确认收入。截至2026年9月30日的九个月内确认的收入中，约有$1.2百万计入截至2025年12月31日的递延收入余额。

截至2026年9月30日和2025年12月31日，分别有$5.5百万和$4.9百万作为尚未履行的履约义务所分配交易价格部分的递延收入，计入随附的资产负债表。截至2026年9月30日和2025年12月31日，对于尚未履行的履约义务，分别有$2.0百万和$1.6

百万（各期间）预计将在未来12个月内确认为收入，其余部分预计将在未来36个月内确认为收入。截至2026年9月30日和2025年12月31日，分别有$5.5百万和$4.9百万与递延金额有关，这些金额涉及向用户承诺的未具体说明的软件更新以及用户访问移动应用。

金融工具和公允价值计量

下表列示了公司按经常性基础以公允价值计量的资产和负债的公允价值层级：

\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n
		公允价值计量日
		2026年9月30日
		第1级			第2级			第3级			总计
资产		（单位：千）
现金等价物：
货币市场基金		$	74,219			$	—			$	—			$	74,219
受限现金：
货币市场基金			100				—				—				100
短期投资
美国国债			158,653				—				—				158,653
长期投资
美国国债			133,436				—				—				133,436
资产总计		$	366,408			$	—			$	—			$	366,408

\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n
		公允价值计量日
		2025年12月31日
		第1级			第2级			第3级			总计
资产		（单位：千）
现金等价物：
货币市场基金		$	26,249			$	—			$	—			$	26,249
受限现金：
货币市场基金			100				—				—				100
短期投资
美国国债			187,549				—				—				187,549
长期投资
美国国债			45,431				—				—				45,431
资产总计		$	259,329			$	—			$	—			$	259,329

货币市场基金和美国国债由公司根据报价市场价格估值，该价格代表公允价值层级中的第 1 级计量。于截至2026年9月30日和2025年9月30日止九个月期间，估值方法未发生变化。公司在每个报告期末评估层级之间的转移。截至2026年9月30日和2025年9月30日止九个月期间，第 1 级或第 2 级之间没有转移。

认股权证负债

在公司于2025年1月进行首次公开募股（“IPO”）时，所有未偿认股权证负债均重新计量，随后通过净额行使结算并重分类至股东权益。截至2026年9月30日或2025年12月31日，没有未偿认股权证负债。

预付资金认股权证

2026年9月，公司完成了一次后续公开发行，发行了8,956,523股普通股，并向某些投资者发行了可购买1,043,484股公司普通股的预付资金认股权证，以代替普通股。该预付资金认股权证可立即行使，行权价为每股$0.0001，但受益所有权比例受限，且在全部行使前不会到期。

公司认定该预付资金认股权证不符合 ASC 815 中衍生工具的定义。公司进一步认定，该预付资金认股权证与公司的自身股票挂钩，并符合

classification within stockholders’ equity. Accordingly, amounts attributable to the pre-funded warrant were recorded in additional paid-in capital and the warrant is not subsequently remeasured. As of September 30, 2026, 1,043,484 shares of common stock remained issuable upon exercise of the pre-funded warrant. Refer to Note 2 for the treatment of the pre-funded warrant in the Company’s calculation of net loss per share.

Short-Term and Long-Term Investments

The following represents a summary of the estimated fair value of short-term and long-term investments at September 30, 2026 and December 31, 2025:

\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n
		Fair Value Measurements at
		September 30, 2026
		Amortized			Unrealized			Unrealized			Estimated
		Cost			Gains			Losses			Fair Value
		(in thousands)
Short-term investments
U.S. Treasury securities		$	159,069				—			$	(416	)		$	158,653
Long-term investments
U.S. Treasury securities			133,897				—				(461	)			133,436
Total		$	292,966			$	—			$	(877	)		$	292,089

Fair Value Measurements at

December 31, 2025

Amortized

Unrealized

Estimated

Cost

Gains

Losses

Fair Value

(in thousands)

Short-term investments

U.S. Treasury securities

187,167

382

—

187,549

Long-term investments

U.S. Treasury securities

45,411

—

45,431

Total

232,578

402

—

232,980

As of September 30, 2026, all available-for-sale debt securities in an unrealized loss position had been in a continuous unrealized loss position for less than 12 months. There were no available-for-sale debt securities in an unrealized loss position as of December 31, 2025. The Company did not record an allowance for credit losses on its available-for-sale debt securities because the unrealized losses were primarily attributable to changes in market interest rates and not credit deterioration. The Company does not intend to sell these securities and expects to hold them until recovery of their amortized cost bases upon maturity.

The following represents the contractual maturities of available-for-sale debt securities as of September 30, 2026:

Fair Value Measurements at

September 30, 2026

Years to Maturity

Within One

One to Two

More Than Two

Estimated

Year

Years

Fair Value

(in thousands)

U.S. Treasury securities

158,653

133,436

—

292,089

Total

158,653

133,436

—

292,089

Accounts Receivable, Net

Accounts receivable, net consisted of the following:

\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n

\n	\n	\n	\n	\n	\n	\n	\n	\n
		September 30, 2026			December 31, 2025
		(in thousands)
Accounts receivable		$	20,875			$	17,274
Less: allowance for credit losses			(208	)			(156	)
Accounts receivable, net		$	20,667			$	17,118

Accounts receivable are stated at the amount expected to be collected. The allowance for credit losses reflects expected losses on accounts receivable based primarily on historical experience and customer credit quality. The allowance for credit losses and related write-offs were not material for the periods presented.

Inventories

Inventories consisted of the following:

\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n

\n	\n	\n	\n	\n	\n	\n	\n	\n
		September 30, 2026			December 31, 2025
		(in thousands)
Raw materials		$	9,812			$	8,556
Work in process			2,811				2,750
Finished goods			10,348				10,416
Total inventories		$	22,971			$	21,722

Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consisted of the following:

\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n

\n	\n	\n	\n	\n	\n	\n	\n	\n
		September 30, 2026			December 31, 2025
		(in thousands)
Prepaid expenses		$	5,924			$	7,064
Interest receivable			2,787				2,511
Income tax receivable and other current assets			293				265
Prepaid expenses and other current assets		$	9,004			$	9,840

Property and Equipment, Net

Property and equipment, net consisted of the following:

\n	\n	\n	\n	\n	\n	\n	\n	\n
		September 30, 2026			December 31, 2025
		(in thousands)
Manufacturing equipment		$	13,865			$	9,247
Leasehold improvements			2,859				830
Furniture			1,020				939
Construction in progress			1,958				3,339
Total cost			19,702				14,355
Less: Accumulated depreciation and amortization			(7,938	)			(5,755	)
Property and equipment, net		$	11,764			$	8,600

Depreciation expense was $2.2 million and $1.0 million for the nine months ended September 30, 2026 and 2025, respectively.

10.

Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of the following:

\n	\n	\n	\n	\n	\n	\n	\n	\n
		September 30, 2026			December 31, 2025
		(in thousands)
Employee compensation and benefits		$	13,654			$	12,656
Sales returns, rebates and patient assistance			3,050				3,161
Professional fees			2,660				1,713
Warranty			1,756				1,607
Inventory in transit			1,310				1,961
Royalties			876				1,005
Clinical trials			81				—
Other			1,269				328
Accrued expenses and other current liabilities		$	24,656			$	22,431

11.

Stock-Based Compensation

2016 Stock Incentive Plan

The Company’s 2016 Stock Incentive Plan, as amended (the “2016 Plan”), previously provided for the grant of stock options and restricted stock awards to employees, officers, directors and consultants. Following the adoption of the 2025 Equity Incentive Plan in connection with the Company’s IPO in January 2025, no further awards are granted under the 2016 Plan. Outstanding awards previously granted under the 2016 Plan continue to be governed by their original terms.

2025 Equity Incentive Plan

The Company maintains the 2025 Equity Incentive Plan (the “2025 Plan”), which became effective in January 2025. The 2025 Plan provides for the grant of incentive stock options, restricted stock units and other equity-based awards to employees, directors and consultants. The 2025 Plan replaced the 2016 Plan, and no further awards are granted under the 2016 Plan. A total of 12,016,744 shares of common stock were initially reserved for issuance under the 2025 Plan. As of September 30, 2026, 14,234,787 shares of common stock were reserved for issuance under the 2025 Plan.

Stock Options

The following table presents, on a weighted-average basis, the assumptions used in the Black-Scholes option pricing model to determine the grant-date fair value of stock options granted:

\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n

\n	\n	\n	\n	\n	\n	\n	\n	\n
		Nine Months Ended September 30,
		2026			2025
Weighted average grant date fair value per share		$	8.22			$	14.38
Risk-free interest rate			3.69	%			4.25	%
Expected term (in years)			5.86				5.97
Expected volatility			70.58	%			100.01	%
Expected dividend yield			0	%			0	%

The following table summarizes stock option activity for the nine months ended September 30, 2026:

\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n
								Weighted-
					Weighted- Average			Average Remaining			Aggregate
		Number of Options			Exercise Price			Contractual Term			Intrinsic Value
								(in years)			(in thousands)
Outstanding at December 31, 2025			6,453,036			$	9.87				7.4			$	141,925
Granted			872,846			$	12.67
Exercised			(439,418	)		$	6.81
Forfeited or cancelled			(153,263	)		$	13.64
Expired			(2,485	)		$	10.93
Outstanding at September 30, 2026			6,730,716			$	10.34				7.1			$	58,497
Vested and expected to vest at September 30, 2026			6,730,716			$	10.34				7.1			$	58,497
Options exercisable at September 30, 2026			4,383,804			$	8.93				6.4			$	44,233

The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s common stock for those stock options that had exercise prices lower than the fair value of the Company’s common stock. The total intrinsic value of options exercised during the nine months ended September 30, 2026 and 2025 was $4.2 million and $6.3 million, respectively.

The weighted-average grant-date fair value of stock options granted during the nine months ended September 30, 2026 and 2025 was $8.22 per share and $14.38 per share, respectively. The total fair value of stock options vested during the nine months ended September 30, 2026 and 2025 was $7.2 million and $6.5 million, respectively.

The following table summarizes the non-vested stock options that were outstanding as of September 30, 2026 and December 31, 2025:

\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n

\n	\n	\n	\n	\n	\n	\n	\n	\n
					Weighted- Average
		Number of Options			Exercise Price

Non-vested options, September 30, 2026			2,346,912			$	12.98
Non-vested options, December 31, 2025			2,840,777			$	12.21

Restricted Stock Units

The following table summarizes RSU activity under the Company's incentive plans for the nine months ended September 30, 2026:

\n	\n	\n	\n	\n	\n	\n	\n	\n
					Weighted- Average
		Number of Shares			Grant Date Fair Value

RSUs outstanding, December 31, 2025			753,885			$	15.12
Granted			2,219,735			$	13.00
Vested			(513,953	)		$	13.71
Cancelled			(172,142	)		$	13.72
RSUs outstanding, September 30, 2026			2,287,525			$	13.48

Stock-Based Compensation Expense

Stock-based compensation expense by type and financial statement line is included in the Company’s statements of operations and comprehensive loss as follows:

\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n
		Three Months Ended September 30,			Nine Months Ended September 30,
		2026			2025			2026			2025
		(in thousands)			(in thousands)
Options		$	3,176			$	3,116			$	9,695			$	8,721
RSUs			3,330				1,362				8,500				3,360
Employee stock purchase plan			209				—				942				—
Total stock-based compensation expense		$	6,715			$	4,478			$	19,137			$	12,081

\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n
		Three Months Ended September 30,			Nine Months Ended September 30,
		2026			2025			2026			2025
		(in thousands)			(in thousands)
Cost of sales		$	187			$	140			$	557			$	399
Research and development			1,559				893				4,333				2,319
Sales and marketing			2,136				1,273				5,990				3,388
General and administrative			2,833				2,172				8,257				5,975
Total stock-based compensation expense		$	6,715			$	4,478			$	19,137			$	12,081

As of September 30, 2026, total unrecognized stock-based compensation expense related to the unvested options was $21.8 million, which is expected to be recognized over a weighted-average period of 2.1 years. As of September 30, 2026, total unrecognized stock-based compensation expense related to the unvested RSUs was $28.7 million, which is expected to be recognized over a weighted-average period of 2.2 years.

Employee Stock Purchase Plan

The Company’s Employee Stock Purchase Plan (“ESPP”) was approved by the Board in January 2025. The ESPP enables eligible employees to purchase shares of the Company’s common stock using their after-tax payroll deductions, subject to certain conditions. The ESPP is intended to qualify as an “employee stock purchase plan” within the meaning of Section 423 of the Code. Eligible employees may contribute, through payroll deductions, up to 15% of their earnings for the purchase of common stock under the ESPP. The purchase price of common stock under the ESPP is the lesser of: (a) 85% of the fair market value of a share of the Company’s common stock on the first date of an offering or (b) 85% of the fair market value of a share of the Company’s common stock on the date of purchase, limited to the maximum number of shares they may purchase on any single purchase date. Each offering under the ESPP has a six-month duration, beginning on January 1 and July 1 of each year, with purchases occurring on June 30 and December 31, respectively. The initial offering period under the ESPP commenced on January 1, 2026, and the first purchase under the ESPP occurred on June 30, 2026. A total of 410,000 shares of common stock were initially reserved for issuance under the ESPP. As of September 30, 2026, 853,608 shares of common stock were reserved for issuance under the ESPP, including shares added pursuant to the annual evergreen provision.

12.

Employee Benefit Plan

The Company maintains a 401(k) retirement plan (the “401(k) Plan”) for the benefit of eligible employees. Each participant may elect to contribute up to 100% of his or her compensation to the 401(k) Plan each year, subject to certain Internal Revenue Service (the “IRS”) limitations. Under the terms of the Plan, the Company matches 100% of the first 6% of employee contributions. During the nine months ended September 30, 2026 and 2025, the Company contributed $2.9 million and $2.2 million, respectively, to the 401(k) Plan.

13.

Income Taxes

During the nine months ended September 30, 2026 and 2025, the Company did not record income tax benefits for the net operating losses (“NOLs”) incurred or for the research and development tax credits generated in each year, due to its uncertainty of realizing a benefit from those items. The Company does not have any foreign operations and therefore has no foreign income taxes.

The Company files income tax returns as prescribed by the tax laws of the jurisdictions in which it operates. In the normal course of business, the Company is subject to examination by federal and state jurisdictions, where applicable. The Company is open to future tax examination under statute by the IRS from 2022 to present and by most state tax authorities from 2021 to present. However, to the extent allowed by law, the taxing authorities may have the right to examine periods where NOLs and research and development credits were generated and carried forward, and make adjustments to the amount of the NOL and research credits carryforwards.

14.

Leases

The Company leases office and manufacturing facilities under operating lease arrangements. The components of lease expense were as follows:

\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n
		Three Months Ended September 30,			Nine Months Ended September 30,
		2026			2025			2026			2025
		(in thousands)			(in thousands)
Operating lease cost–fixed		$	516			$	409			$	1,561			$	1,242
Operating lease cost–variable			47				62				145				146
Short-term lease expense			13				20				40				28
Total lease expense		$	576			$	491			$	1,746			$	1,416

Cash paid for amounts included in the measurement of operating lease liabilities was $1.5 million and $1.2 million, respectively, for the nine months ended September 30, 2026 and 2025.

The weighted-average remaining lease term and discount rate were as follows:

\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n

\n	\n	\n	\n	\n
		September 30, 2026
Weighted-average remaining lease term			4.99
Weighted-average discount rate			6.89	%

Future lease payments under non-cancellable leases as of September 30, 2026 were as follows:

\n	\n	\n	\n	\n
(in thousands)
Year Ending December 31,
2026			466
2027			1,418
2028			1,384
2029			1,092
2030			1,136
Thereafter			1,782
Total future lease payments		$	7,278
Less: imputed interest			(1,177	)
Total lease liabilities		$	6,101

15.

Commitments and Contingencies

Legal Proceedings

From time to time, the Company may become involved in various legal proceedings, including those that may arise in the ordinary course of business. In September 2026, a purported stockholder of the Company filed a securities class action against the Company and certain of its executive officers in the United States District Court for the Central District of California, captioned Holtzman vs. Beta Bionics, Inc. et al., Case No. 8:26-cv-2612-JWH (KESx). The complaint alleges that defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, and SEC Rule 10b-5 promulgated thereunder, by making material misstatements or omissions concerning the safety, efficacy, and commercial success of iLet. The complaint seeks, on behalf of the putative class, unspecified damages, pre- and post-judgment interest, attorneys’ fees, expert fees and costs, as well as class certification and such other relief as the court may deem just and proper. The Company intends to vigorously defend against the claims in this action. Any potential loss arising from this claim is not currently probable nor estimable.

Xeris Agreements

In May 2024, the Company and Xeris Pharmaceuticals, Inc. (“Xeris”) entered into a collaboration and license agreement (“Collaboration and License Agreement”) to develop and commercialize glucagon products for use in the Company’s pump-based systems. Under the Collaboration and License Agreement, the Company received a worldwide, exclusive, sublicensable license to certain Xeris technology for use in the field of chronic glycemic control, as well as a manufacturing license subject to a future technology transfer and commercial supply arrangement.

In consideration for the rights granted under the agreement, the Company paid Xeris an upfront fee of $0.5 million and a development milestone payment of $3.0 million, both of which were recognized as research and development expenses when incurred. The Company is also required to pay Xeris tiered royalties in the low double-digit percentage range on future net sales of licensed products, subject to customary reductions.

In connection with clinical development activities, the Company entered into the Clinical Supply Agreement with Xeris and incurred $0.9 million of costs for Phase 2 clinical materials during 2024, with the remaining balance paid in 2025. In May 2026, the Company entered into a letter agreement under the Clinical Supply Agreement with Xeris for additional Phase 2 clinical material, including a one-time non-refundable payment of $0.5 million and reimbursement of certain internal and travel costs. In connection with entering into Phase 3 of the collaboration, the Company expects to incur development and manufacturing costs, including ordering clinical materials and technical transfer, development, and testing of the product, totaling up to $5.1 million. As of September 30, 2026, the Company has completed payments totaling $4.0 million. Amounts are initially recorded as prepaid expenses and recognized as research and development expense as the related services are performed. The Company may incur additional research and development expenses and, upon commercialization, royalty obligations under these agreements.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed financial statements and the related notes included elsewhere in this Quarterly Report, our financial statements and the related notes thereto for the fiscal year ended December 31, 2025 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, which are contained in our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our planned investments in our research and development, sales and marketing and general and administrative functions, and our current plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the section titled “Risk Factors,” our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. You should carefully read the section titled “Risk Factors” and “Special Note Regarding Forward-Looking Statements” in both our Annual Report on Form 10-K for the year ended December 31, 2025 and in this Quarterly Report to gain an understanding of the important factors that could cause actual results to differ materially from our forward-looking statements. Unless the context requires otherwise, references in this Quarterly Report to the “Company,” “we,” “us” and “our” refer to Beta Bionics, Inc.

Overview

We are a commercial-stage medical device company engaged in the design, development, and commercialization of innovative solutions to improve the health and quality of life of insulin-requiring people with diabetes (PWD) by utilizing advanced adaptive closed-loop algorithms to simplify and improve the treatment of their disease. Diabetes is a chronic condition that requires ongoing insulin management, and despite advances in care, many PWD continue to struggle to achieve optimal outcomes. Despite decades of innovation, a significant unmet need remains. Our product, the iLet, is the first insulin delivery device cleared by the U.S. Food and Drug Administration (FDA) to utilize adaptive closed-loop algorithms to autonomously determine every insulin dose without requiring a user to count carbohydrate intake. We believe this represents a significant advancement over currently available insulin delivery options by offering a differentiated combination of improved glycemic control and a simplified experience for users and caregivers. Our mission is to simplify and alleviate the burden of managing diabetes with life-changing solutions. Our vision is to make diabetes easier, for everyone, every day. Our goal is to establish the iLet as the standard of care for insulin delivery.

The iLet was specifically designed to provide improvements in glycemic control relative to currently available treatment options, such as insulin pumps, including partially automated insulin delivery (AID) systems (also known as hybrid closed-loop systems), and multiple daily injections (MDI), also reducing the complexity and burden of achieving these improved results for PWD. It is enabled by adaptive closed-loop algorithms that continuously learn each person’s unique and ever-changing insulin requirements and then autonomously delivers the correct insulin doses every five minutes throughout the day and night. Only the user’s body weight is required for device initialization and the autonomous determination of all insulin doses, unlike insulin pumps and hybrid closed-loop systems, which require a complex host of parameters to configure.

Our initial commercialization efforts for the iLet are in type 1 diabetes (T1D), an indication for which we received FDA clearance in patients six and older in May 2023, in the United States. According to the Centers for Disease Control and Prevention (CDC), there are approximately 1.9 million people with T1D currently in the United States, all of whom require daily insulin replacement to manage their disease. We believe that one of the principal causes of suboptimal outcomes as it relates to disease management is the complexity of the user experience with most currently available insulin pumps and hybrid closed-loop systems, which has kept the majority of PWD from adopting them despite the improved disease management they can offer. We believe that approximately one-third of people with T1D in the United States utilize insulin pumps or hybrid closed-loop systems to receive their daily insulin, while the majority receive their daily insulin via MDI, which is less complex, but often less effective, and has been shown to be associated with higher HbA1c levels. Our initial commercial results suggest that the iLet’s value proposition is resonating strongly within the MDI population as approximately 69% and 70% of the iLet’s adoption during the nine months ended September 30, 2026 and 2025, respectively, came from PWD who were previously utilizing MDI.

We have also partnered with Dexcom and Abbott—global leaders in popular and easy to use iCGM technology—to integrate the iLet with the Dexcom G6 and G7 iCGMs and with Abbott’s FreeStyle Libre 3 Plus Continuous Glucose Monitor (CGM) sensor. Use of the iLet requires the independent purchase of a compatible third-party iCGM to provide real-time data to the iLet user.

In September 2026, we announced a partnership with Senseonics Holdings, Inc. to integrate its Eversense 365 continuous glucose monitoring system with the iLet and Mint. We expect to commercially launch the integrated iLet and Eversense 365 system in the fourth quarter of 2026, subject to completion of integration, testing and validation activities and applicable regulatory requirements. We have also committed to integrate Mint with Eversense 365 in the future.

The iLet requires the use of single-use products, which we sell separately to our customers. These single-use products include cartridges for storing and delivering insulin, as well as infusion sets. These single-use products are generally recommended to be disposed of entirely every 2-3 days, or as directed by a healthcare provider. We also offer a mobile application that receives information from the iLet and displays that information discreetly to the user. This intuitive mobile application delivers real-time glucose readings, trends and graphs, with data securely stored in the cloud.

To maximize the commercial value of the iLet opportunity, we have assembled a team across our organization with broad experience in the successful commercialization of innovative technologies in the field of diabetes disease management. We are promoting sales of the iLet through an internal sales organization focused on high-volume endocrinology practices in the United States and may expand to primary care physicians (PCP) over time. We believe that the iLet’s core value proposition of marrying effective glycemic control with the simplicity of use that is brought about by adaptive closed-loop algorithm insulin-dose determination may resonate particularly well among PCP who do not have the subspecialty-level of expertise, the resources, or the clinical bandwidth that is needed to initiate insulin-pump or hybrid closed-loop therapy or for the continual demand (such as adjustments at quarterly visits) those systems place on clinical practices in follow-on care.

Our primary customers are distributors and pharmacies who sell the iLet and single-use products that are used together with the iLet. PWD acquire our products through the DME channel and the PBP channel. Currently, the majority of our new patient starts are reimbursed through the DME channel.

The durable medical equipment (DME) and pharmacy benefit plans (PBP) reimbursement channels for the iLet and its single-use products entail different payment outlays and therefore differentially impact PWD and our financial results. DME reimbursement requires the user and insurance carrier to make a large, upfront payment and reimbursement, respectively, for the iLet, which is typically in the thousands of dollars.

By contrast, PBP reimbursement requires the user and insurance carrier to make a small upfront payment and reimbursement, respectively, for the iLet, allowing for a potentially higher rate of adoption by PWD. The insurance carrier then makes larger reimbursement payments for the purchase of single-use products, with the user’s payments for the single-use products being generally consistent with what the user would likely pay for single-use products in DME reimbursement. As a result, we recognize a small amount of revenue at or around the date the iLet is sold in the PBP channel and we absorb initial negative gross margin. iLet sales in the PBP channel are generally expected to then start generating cumulative positive gross margin for us following the third month the user utilizes the iLet and continues to purchase single-use products. For the nine months ended September 30, 2026 and 2025, PBP channel sales represented 38% and 21% of net sales, respectively.

When considering the overall economics over the lifetime of each iLet, sales through the DME channel generally result in higher upfront cash flows from the large upfront payment and reimbursement for the iLet, but lead to lower cash flows over time as the user purchases the necessary single-use products. By contrast, sales through the PBP channel generally result in lower upfront cash flows from the small payment and reimbursement for the iLet, but lead to higher cash flows over time as the user purchases the necessary single-use products. This reflects differences in both the upfront device economics and the pricing of recurring single-use products across channels. When comparing sales through the DME and PBP channels, we expect sales through the PBP channel will have a more favorable economic impact on our financial results over the expected life of the iLet, which we generally expect to be four years. As such, our current strategic priority is to direct demand to the PBP reimbursement channel.

On September 14, 2026, we announced FDA clearance of Mint, our patch pump featuring a transformative reusable and disposable architecture that does not require recharging, integrates with industry-leading CGMs and enables smartphone control for iOS and Android users. We expect to initiate the full commercial launch of Mint in the United States in the first quarter of 2027 and anticipate manufacturing capacity to produce at least 1.5 million total disposable units in the full year 2027. Mint is expected to launch exclusively through the pharmacy channel, with approximately 40% of insured U.S. lives expected to be able to purchase it using their pharmacy benefit. We anticipate coverage for Mint to increase to at least 50% of insured U.S. lives within the first year of full commercialization as we leverage our market access footprint.

In addition to our commercialized product and to maintain our competitive position in the marketplace, we intend to continue investing in disruptive technologies through our experienced research and development team.

We are in the early stages of developing a first-of-its-kind bihormonal system of the iLet, which combines automated delivery of insulin and glucagon, the BG-raising hormone that protects against low blood sugar, or hypoglycemia, with adaptive closed-loop algorithms where all doses of both hormones are autonomously determined. As part of our development plans, in September 2025, we completed a clinical trial in Canada assessing the pharmacokinetics (PK) and pharmacodynamics (PD) of our glucagon product candidate (also referred to as the glucagon asset, and referred to herein as the PK-PD Trial). The completion of the PK-PD Trial enables us to bridge our previous bihormonal clinical data to our glucagon product candidate. We believe that the results from the PK-PD Trial are supportive of the continued development of our glucagon product candidate for use in our bihormonal system of the iLet. In the fourth quarter of 2025, we completed our first-in-human Phase 2a feasibility trial in New Zealand evaluating the integrated bihormonal system, including the glucagon formulation, pump, and dosing algorithms. In the first quarter of 2026, we initiated an additional Phase 2a feasibility trial to further evaluate the system, including the glucagon formulation, pump, and dosing algorithms. Based on the results from this feasibility work, we identified opportunities to improve the system, including the glucagon asset’s excipient profile and dosing algorithms. During the third quarter of 2026, we continued our efforts to reformulate the glucagon asset and refine the dosing algorithms. We are also pursuing the development of the iLet for expanded patient populations and indications, including people with type 2 diabetes (T2D). In October 2026, we completed enrollment of adults with T2D in a pivotal trial in the United States, with the goal of expanding the iLet’s indications for use to include adults with T2D around mid-year 2027, subject to regulatory clearance by the FDA. Also, in the fourth quarter of 2026, we intend to initiate a pivotal trial studying a next-generation fully-closed loop (FCL) algorithm in adults with type 1 and type 2 diabetes.

License and Collaboration Agreements

Below is a summary of the key terms of certain of our license and collaboration agreements. For a more detailed description of these agreements, see “Business—License and Collaboration Agreements” in our Annual Report on Form 10-K for the year ended December 31, 2025.

Device License Agreement with Boston University

We have a Device License Agreement with Boston University (BU) that requires ongoing royalty payments and other financial obligations related to products incorporating BU-licensed technology. Under the agreement, we are required to pay (i) quarterly royalties in the mid-single-digit percentage range based on net sales of licensed products by us and our affiliates, (ii) quarterly royalties in the low double-digit percentage range based on net sales by sublicensees, which are creditable against a minimum annual royalty amount, and (iii) quarterly lump-sum payments in the low double-digit percentage range based on certain non-royalty sublicensing revenue. We are also responsible for reimbursing BU for patent-related costs and may be required to pay an assignment fee in the event of a sale of substantially all assets related to the licensed technology. During the nine months ended September 30, 2026, we continued to incur royalty and license-related costs under this agreement which were recorded as cost of sales or operating expenses, as applicable, and expect these costs to increase as sales volumes grow.

Control Algorithm License Agreement with Boston University

We have a Control Algorithm license agreement with BU covering automated control system technology incorporated into the iLet. Under the financial terms of the agreement, we are required to pay BU (i) quarterly royalties of a mid-single-digit percentage based on net sales by us and our affiliates, (ii) quarterly royalties of a low double-digit percentage based on net sales by sublicensees, in each case of (i) and (ii) creditable against a minimum annual royalty amount, and (iii) quarterly lump-sum payments of a low double-digit percentage of certain non-royalty sublicensing revenue received from sublicensees. We are also responsible for reimbursing patent-related costs and are required to make a one-time change-of-control payment of $65,000 if such an event occurs. During the nine months ended September 30, 2026, we continued to incur royalty and license-related costs under this agreement and expect these costs to increase as sales volumes grow.

Collaboration and License Agreement with Xeris Pharmaceuticals, Inc.

We have a Collaboration and License Agreement with Xeris Pharmaceuticals, Inc. to develop and commercialize a glucagon formulation for use in our bihormonal system. Under this agreement, we paid an upfront fee of $0.5 million and a milestone payment of $3.0 million, both of which were recognized as research and development expense when incurred. We are also obligated to pay tiered royalties in the low double-digit percentage range on future net sales of glucagon products, subject to customary reductions.

In connection with clinical development activities, we entered into the Clinical Supply Agreement with Xeris and incurred $0.9 million of costs for Phase 2 clinical materials during 2024, with the remaining balance paid in early 2025. In May 2026, we entered into a letter agreement under the Clinical Supply Agreement with Xeris for additional Phase 2 clinical material to support ongoing development activities for our bihormonal system. We expect to incur up to $5.1 million in additional development and manufacturing costs related to Phase 3 activities, of which $4.0 million had been paid as of September 30, 2026. Amounts are

recorded as prepaid expenses and expensed to research and development as services are performed. The Company may incur additional research and development expenses and, upon commercialization, royalty obligations under these agreements.

Development and Commercial Agreements

Below is a summary of the key terms of certain of our development and commercial agreements. For a more detailed description of these agreements, see “Business—Development and Commercial Agreements” in our Annual Report on Form 10-K for the year ended December 31, 2025.

We have a Commercialization Agreement and Development and Commercialization Agreement with DexCom, Inc. and Abbott Diabetes Care Inc., respectively, related to integrated automated insulin delivery systems. These agreements primarily involve shared development responsibilities and cross-licensing of technology and trademarks and do not require upfront payments, milestone payments, or ongoing royalty obligations. As a result, these arrangements have not had a material direct impact on our results of operations or cash flows to date, though they may affect future operating expenses associated with development, regulatory activities, and commercialization. As of September 30, 2026, there have been no material changes to the terms of these agreements or their impact on our results of operations or cash flows.

Key Factors Affecting Our Performance

Our ability to successfully address the factors below is subject to various risks and uncertainties, including those described in the section titled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025, and the risk factors described in Part II, Item 1A. “Risk Factors” in this Quarterly Report on Form 10-Q.

New Patient Adoption and iLet Sales

Our financial performance has largely been driven by, and in the future will continue to be impacted by, the rate of sales of our products to new patients. Management focuses on new patient starts as a key indicator of current business success. We expect our new patient starts to continue to grow as we increase penetration in our existing markets and expand into, or offer new features and solutions that appeal to, new markets.

We plan to grow our sales in the coming years through multiple strategies, including expanding our sales efforts to focus on the more diffuse population of people with T1D who are treated by PCP over time, expanding our marketing initiatives including via the Bionic Universe, leveraging our partnerships with global leaders in CGM technology like Dexcom and Abbott, growing our internal customer support team, continuing to enhance our product offerings and pursuing a multi-channel coverage and reimbursement strategy.

Third-Party Payor Reimbursement and Impact of Our Multi-Channel Reimbursement Strategy

As a medical device company, our revenue and results of operations may be impacted if we are unable to secure sufficient coverage or reimbursement from third-party payors for our current or future products, or if reimbursement structures change under our multi-channel strategy.

We are pursuing a multi-channel coverage and reimbursement strategy to maximize access to the iLet within the T1D population, provide flexibility for PWD in choosing their device and provide PWD with advantageous coverage and reimbursement terms. We are working with payors to establish coverage and reimbursement under both the DME and PBP channels as we believe this strategy increases access and optimizes the potential for better medical outcomes for PWD through the adoption of the iLet. The DME and PBP channels for the iLet and its single-use products entail different payment outlays and therefore differentially impact PWD and our financial results. When considering the overall economics over the lifetime of each iLet, sales through the DME channel generally result in higher upfront cash flows from the large, upfront payment and reimbursement for the iLet, but lead to lower cash flows over time as the user purchases the necessary single-use products. By contrast, sales through the PBP channel generally result in lower upfront cash flows from the small payment and reimbursement for the iLet, but lead to higher cash flows over time as the user purchases the necessary single-use products. This is because single-use products under the PBP channel are sold at a much higher per unit cost than under the DME. As a result of a small amount of revenue recognized at or around the date the iLet is sold in the PBP channel, we absorb initial negative gross margin. iLet sales in the PBP channel are generally expected to start generating cumulative positive gross margin for us following the third month the user utilizes the iLet and continues to purchase single-use products. For the nine months ended September 30, 2026 and 2025, PBP channel sales represented 38% and 21%, respectively, of net sales. When comparing sales through the DME and PBP channels, we expect sales through the PBP channel will have a more favorable economic impact on our financial results over the lifetime of the iLet. To the extent that our mix of channel reimbursement fluctuates, our financial results may vary from period to period.

Continued Investment In Growth and Innovation

Our revenue growth has been driven by rapid innovation and quick adoption of our products by our customer base. We intend to continue to make focused investments to increase revenue and grow our business, and therefore expect expenses in this area to increase.

We have invested, and will continue to invest, significantly in our manufacturing capabilities and commercial and customer support infrastructure. We expect that our 50,000 square foot facility in Irvine, California, which commenced operations in 2020, will have sufficient production capacity to support our anticipated clinical and commercial demand for the foreseeable future. We also plan to invest in sales and marketing activities, expect to incur additional general and administrative expenses and to have higher stock-based compensation expenses as we support our growth.

The medical device industry is intensely competitive, subject to rapid change and highly sensitive to the introduction of new products, treatment techniques or technologies. We expect our business to be impacted by the introduction of new diabetes devices and treatments by us or our competitors. In order to maintain our competitive position in the marketplace, we intend, through our experienced research and development team, to continue investing in disruptive technologies, such as a bihormonal system of the iLet, as well as pursuing the development of the iLet and Mint, our patch pump, for expanded patient populations and indications such as people with T2D.

As cost of revenue, operating expenses and capital expenditures fluctuate over time, we may experience short-term, negative impacts to our results of operations and cash flows, but we are undertaking such investments in the belief that they will contribute to long-term growth. Moreover, introduction of new products may negatively impact aspects of our financial performance such as our overall gross margins.

Regulatory Approvals and Actions

The medical devices we manufacture are subject to laws and regulation by numerous regulatory bodies, including the FDA. The laws and regulations govern, among other things, the research and development, design, testing, manufacture, packaging, storage, recordkeeping, approval, labeling, promotion, post-approval monitoring and reporting, distribution and import and export of medical devices. Any adverse event involving any products that we distribute could result in future corrective actions, such as recalls or customer notifications, or regulatory agency actions, which could include warning letters, inspection, mandatory recalls or other enforcement actions. For example, in January 2026, we received a Warning Letter (“Warning Letter”) from the FDA following inspection of our facility in Irvine, California that occurred from June 9, 2025 through June 26, 2025. In the Warning Letter, the FDA cited deficiencies in the response letters we sent to the FDA following the FDA’s issuance of a Form 483, List of Inspectional Observations (“Form 483”) in June 2025. The Warning Letter highlights non-conformities observed by the FDA in relation to our Quality Management System, Medical Device Reporting, and Correction and Removals, which were previously communicated by the FDA in the Form 483. We have responded to the FDA regarding the Warning Letter and continue to work to address the FDA’s observations. In the future, we also intend to pursue additional products, such as a bihormonal system of the iLet, as well as pursue the development of the iLet and Mint, our patch pump, for expanded patient populations and indications such as people with T2D, which will increase our expenses and subject us to increased regulatory-related risks.

For additional information regarding regulatory approval and actions, including the Warning Letter and the Form 483, see the section titled “Business—Government Regulation and Product Approval” in Part I, Item 1. “Business” in our Annual Report on Form 10-K for the year ended December 31, 2025, the related risk factors described in Part I, Item 1A. “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025, and the risk factors described in Part II, Item 1A. “Risk Factors” in this Quarterly Report on Form 10-Q.

Seasonality

We anticipate that the revenue generated from our product sales will vary from quarter to quarter as we continue to commercialize the iLet. Specifically, we expect to typically experience lower sales in the first quarter of each year compared to the preceding fourth quarter. This seasonal sales pattern in the United States is associated with the annual insurance deductible resets and coinsurance requirements of the medical insurance plans providing coverage to PWD using the iLet.

Macroeconomic Factors, Global Supply Chain Challenges and Inventory

Our costs are subject to fluctuation, and we continue to evaluate contributing factors, specifically those leading to inflationary cost increases in logistics, price of raw materials, cost of labor, transportation and operating supplies. While we are experiencing higher raw material, labor, transportation, and operating supply costs, we intend to continue to work to improve productivity to help offset these costs as we navigate these global macroeconomic challenges, including tariffs or other trade measures, future bank

failures, increased geopolitical tensions and conflicts, global pandemics, global economic conditions, including changes in monetary and fiscal policy, U.S. political developments and other sources of instability.

We currently rely on a number of suppliers who manufacture the components of the iLet and obtain them on a purchase order basis. We have a supply agreement with Unomedical for the production of infusion sets for our iLet, a contract manufacturing agreement with PMC SMART Solutions LLC (PMC) for the manufacture of our cartridge connectors and a supplier quality agreement with Maxon Precision Motors, Inc. (Maxon) for the supply of pump motors for our iLet. Unomedical, PMC and Maxon are our only suppliers of infusion sets, cartridge connections and pump motors, respectively. For additional information regarding the risks of our reliance on these suppliers, please see the risk factors described in Part I, Item 1A. “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025, and the risk factors described in Part II, Item 1A. “Risk Factors” in this Quarterly Report on Form 10-Q.

To date, we have not experienced a material interruption in supply to our customers. However, there may be times at which we determine that our inventory does not meet our product requirements or we maintain an insufficient level of inventory. We may also over- or underestimate the quantities of required components, in which case we may expend extra resources or be constrained in the amount of end product that we can procure. These factors subject us to the risk of obsolescence and expiration, which may lead to impairment charges.

Components of Results of Operations

Net Sales

We generate product revenue from the sale of the iLet and single-use products that are used together with the iLet, including cartridges for storing and delivering insulin, and infusion sets that connect the insulin pump to a user’s body. We recognize revenue when control of the promised goods or services is transferred to our distributor and pharmacy partners, in an amount that reflects the consideration we expect to receive, net of estimated returns and variable consideration adjustments, including rebates, chargebacks and patient assistance, which differ by product and sales mix. Revenue is recognized either over time or at a point in time, depending on when control of the associated performance obligation is transferred to the customer.

Cost of Sales

Cost of sales includes raw materials, labor costs, manufacturing overhead expenses, royalties, freight, import tariffs, scrap and reserves for expected warranty costs and excess and obsolete inventory. Manufacturing overhead expenses include expenses relating to manufacturing engineering, material procurement, inventory and quality control, facilities, depreciation, information technology and operations supervision and management.

Gross Profit and Gross Margin

Gross profit and gross margin, or gross profit as a percentage of revenue, has been and will continue to be affected by various factors, including the timing of new patient adoption, iLet and associated single-use products sales, reimbursement, length of product usage, our introduction of new products, including the costs associated with producing and bringing those new products to market, cost reduction and operational efficiency. As a result of the small revenue recognized at or around the date the iLet is sold in the PBP channel, we absorb initial negative gross margin. iLet sales in the PBP channel are generally expected to start generating cumulative positive gross margin for us beyond the third month the user uses the iLet and continues to purchase single-use products. Given the differences in the timing and amount of outlays which correlate directly to revenue between the DME and PBP channels, changes in our future sales mix may also impact our gross profit and gross margin.

Operating Expenses

Our operating expenses consist of (i) research and development expenses, (ii) sales and marketing expenses and (iii) general and administrative expenses.

Research and Development

Our research and development expenses include engineering and clinical trial activities for the iLet and Mint, our patch pump, regulatory efforts, personnel costs such as salaries, bonuses, stock-based compensation and benefits, payments under third-party license agreements, supplies, development prototypes, design and testing services, depreciation and allocated facilities and information technology expenses, all of which are expensed as incurred. We track research and development expenses by individual product candidate. We expect research and development expenses to increase significantly for the foreseeable future as we advance clinical development, pursue new products and indications including the bihormonal system and potential T2D use, enhance the iLet

and Mint, expand technical and operational staffing, make required payments under license arrangements, and establish commercial scale manufacturing capabilities.

Sales and Marketing

We are in the early commercialization stages of the iLet and are focused on driving awareness and adoption among new customers. Sales and marketing expenses primarily include personnel costs for our sales and clinical teams, the development of customer support infrastructure, marketing and branding activities, healthcare conference and market research costs, payer education and market access initiatives, data purchases, website and consulting fees, and facilities, travel, and other related operating expenses. We anticipate a significant increase in sales and marketing expenses for the foreseeable future to support the continued commercialization of the iLet and our future products.

General and Administrative

General and administrative expenses include personnel-related costs, including salaries, bonuses, stock-based compensation expense and benefits for our personnel in executive, legal, finance, accounting, human resources, information technology, quality assurance and other administrative functions, as well as expenses for patent filings, legal services, accounting and tax services, insurance, travel, facilities and depreciation. We expect these expenses to increase significantly as we continue operating as a public company, driven by higher professional services costs, director and officer insurance, investor and public relations activities and compliance with SEC and stock exchange listing requirements. We anticipate a significant increase in general and administrative expenses for the foreseeable future in order to continue to scale the business and support future demand.

Other Income (Expense)

Our other income (expense) consists of (i) interest income, and (ii) other income (expense).

Interest Income

Interest income consists of cash interest earned on our cash, cash equivalents and short-term and long-term investment balances.

Other Income (Expense)

Other income (expense) consists of miscellaneous income or expenses unrelated to our core operations.

Results of Operations

Comparison of the three and nine months ended September 30, 2026 and 2025

The following table summarizes our results of operations for the periods indicated:

\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n
		Three Months Ended September 30,			Change
		2026			2025			$			%
		(in thousands, except percentages)
Net sales		$	35,505			$	27,253			$	8,252				30	%
Cost of sales(1)			15,174				12,134				3,040				25	%
Gross profit			20,331				15,119				5,212				34	%
Operating expenses:
Research and development(1)			11,975				8,195				3,780				46	%
Sales and marketing(1)			25,124				16,045				9,079				57	%
General and administrative(1)			9,841				7,922				1,919				24	%
Total operating expenses			46,940				32,162				14,778				46	%
Loss from operations			(26,609	)			(17,043	)			(9,566	)			56	%
Other income (expense):
Interest income			2,258				2,833				(575	)			-20	%
Other income (expense), net			(2	)			1				(3	)				*
Total other income (expense), net			2,256				2,834				(578	)			-20	%
Net loss		$	(24,353	)		$	(14,209	)		$	(10,144	)			71	%

\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n
		Nine Months Ended September 30,			Change
		2026			2025			$			%
		(in thousands, except percentages)
Net sales		$	95,144			$	68,130			$	27,014				40	%
Cost of sales(1)			39,474				31,537				7,937				25	%
Gross profit			55,670				36,593				19,077				52	%
Operating expenses:
Research and development(1)			32,571				24,658				7,913				32	%
Sales and marketing(1)			70,499				45,070				25,429				56	%
General and administrative(1)			29,058				22,422				6,636				30	%
Total operating expenses			132,128				92,150				39,978				43	%
Loss from operations			(76,458	)			(55,557	)			(20,901	)			38	%
Other income (expense):
Interest income			6,811				8,274				(1,463	)			-18	%
Other income (expense), net			(4	)			(1	)			(3	)				*
Change in fair value of warrant liabilities			—				(12,450	)			12,450				-100	%
Total other income (expense), net			6,807				(4,177	)			10,984				-263	%
Net loss		$	(69,651	)		$	(59,734	)		$	(9,917	)			17	%

* Not meaningful

(1)

Includes stock-based compensation expense. See Note 11, Stock-Based Compensation, for stock-based compensation expense by financial statement line item.

Net Sales

Net sales for the three months ended September 30, 2026 were $35.5 million, compared to $27.3 million for the three months ended September 30, 2025. The increase in net sales of $8.2 million was primarily driven by an increase in the number of single-use products sold, correlated to the growth in our installed base, and growth in new patient starts. For the three months ended September 30, 2026, single-use products accounted for 68% of net sales, up from 47% for the three months ended September 30, 2025.

For the three months ended September 30, 2026, 62% of net sales were generated through the DME channel and 38% through the PBP channel, compared to 77% and 23%, respectively, for the three months ended September 30, 2025. The shift toward the PBP channel was driven by expanded pharmacy benefit coverage enabled through contracts with PBMs and their affiliated health plans, resulting in a higher proportion of new patient starts being reimbursed through this channel.

Net sales for the nine months ended September 30, 2026 were $95.1 million, compared to $68.1 million for the nine months ended September 30, 2025. This increase in net sales of $27.0 million was primarily driven by an increase in the number of single-use products sold, correlated to the growth in our installed base, and growth in new patient starts. For the nine months ended September 30, 2026, single-use products accounted for 63% of net sales, up from 44% for the nine months ended September 30, 2025.

For the nine months ended September 30, 2026, 62% of net sales were generated through the DME channel and 38% through the PBP channel, compared to 79% and 21%, respectively, for the nine months ended September 30, 2025. The shift toward the PBP channel was driven by expanded pharmacy benefit coverage, resulting in a larger percentage of new patient starts reimbursed through this channel.

Cost of Sales

Cost of sales for the three months ended September 30, 2026 was $15.2 million, compared to $12.1 million for the three months ended September 30, 2025. This increase of $3.1 million was primarily attributable to increased volumes of single-use products and iLets sold through the PBM channel.

Cost of sales for the nine months ended September 30, 2026 was $39.5 million, compared to $31.5 million for the nine months ended September 30, 2025. This increase of $8.0 million was primarily attributable to increased volumes of single-use products and iLets sold through the PBM channel.

Gross Profit and Gross Margin

Gross profit for the three months ended September 30, 2026 was $20.3 million, compared to $15.1 million for the three months ended September 30, 2025. Gross margin was 57% for the three months ended September 30, 2026, compared to 55% in the three months ended September 30, 2025. Gross profit increased by $5.2 million, primarily driven by higher sales volume. Gross margin improved year over year due to increased production scale, lower warranty expense and improved cost absorption.

Gross profit for the nine months ended September 30, 2026 was $55.7 million, compared to $36.6 million for the nine months ended September 30, 2025. Gross margin was 59% for the nine months ended September 30, 2026, compared to 54% in the nine months ended September 30, 2025. Gross profit increased by $19.1 million, primarily driven by higher sales volume. Gross margin improved year over year due to increased production scale, lower warranty expense and improved cost absorption.

Research and Development Expenses

Research and development expenses for the three months ended September 30, 2026 were $12.0 million, compared to $8.2 million for the three months ended September 30, 2025. The increase of $3.8 million was primarily attributable to a net increase of $3.1 million in materials, engineering and clinical trial-related expenses incurred in the development of Mint, our patch pump, the bihormonal system of the iLet and incremental software and product updates. The remaining increase is attributable to payroll-related expenses, including stock-based compensation, driven by an increase in headcount focused on supporting our innovation activities.

Research and development expenses for the nine months ended September 30, 2026 were $32.6 million, compared to $24.7 million for the nine months ended September 30, 2025. The increase of $7.9 million was primarily attributable to a net increase of $4.2 million in materials, engineering and clinical trial-related expenses incurred in the development of Mint, our patch pump, the bihormonal system of the iLet and incremental software and product updates. The remaining increase is attributable to payroll-related expenses, including stock-based compensation, driven by an increase in headcount focused on supporting our innovation activities.

The table below summarizes the nature of research and development expense by major expense category:

\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n
		Three Months Ended September 30,			Change
		2026			2025			$			%
		(in thousands, except percentages)
External research and development(1)		$	2,341			$	1,129			$	1,212				107	%
Internal research and development(2)			8,075				6,173				1,902				31	%
Stock-based compensation			1,559				893				666				75	%
Total research and development expense		$	11,975			$	8,195			$	3,780				46	%

\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n
		Nine Months Ended September 30,			Change
		2026			2025			$			%
		(in thousands, except percentages)
External research and development(1)		$	4,742			$	4,250			$	492				12	%
Internal research and development(2)			23,496				18,089				5,407				30	%
Stock-based compensation			4,333				2,319				2,014				87	%
Total research and development expense		$	32,571			$	24,658			$	7,913				32	%

(1)

External research and development costs primarily include expenses incurred with third parties such as clinical research organizations conducting the clinical trials and engineering and product development consulting services associated with our development of the iLet and Mint, our patch pump.

(2)

Internal research and development costs primarily include personnel-related expenses for research and development functions, excluding stock-based compensation and internal costs to manufacture product candidates before FDA marketing authorization, such as raw materials and internal facilities-related expenses.

Sales and Marketing Expenses

Sales and marketing expenses for the three months ended September 30, 2026 were $25.1 million, compared to $16.0 million for the three months ended September 30, 2025. The increase of $9.1 million was primarily attributable to an increase of $6.2 million in payroll-related costs, including salaries and wages, sales incentive bonuses, and stock-based compensation due to an increase in headcount of our sales force and customer care team in connection with the expansion of our sales territories within the United States. The remaining increase includes healthcare provider (HCP)-related marketing and travel-related costs to support our business growth.

Sales and marketing expenses for the nine months ended September 30, 2026 were $70.5 million, compared to $45.1 million for the nine months ended September 30, 2025. The increase of $25.4 million was primarily attributable to an increase of $17.5 million in payroll-related costs, including salaries and wages, sales incentive bonuses, and stock-based compensation due to an increase in headcount of our sales force and customer care team in connection with the expansion of our sales territories within the United States. The remaining increase includes HCP-related marketing and training and travel-related costs to support our business growth.

General and Administrative Expenses

General and administrative expenses for the three months ended September 30, 2026 were $9.8 million, compared to $7.9 million for the three months ended September 30, 2025. The increase of $1.9 million was primarily attributable to a $2.1 million increase in software-related expenses, professional service fees and payroll-related expenses, including stock-based compensation, due to an increase in headcount. These increases were partially offset by a decrease in legal fees.

General and administrative expenses for the nine months ended September 30, 2026 were $29.1 million, compared to $22.4 million for the nine months ended September 30, 2025. The increase of $6.7 million was primarily attributable to an increase of $3.7 million in payroll-related expenses, including stock-based compensation, due to an increase in headcount, as well as increases of $3.5 million in software-related expenses, quality remediation expenses, and professional service fees. These increases were partially offset by a decrease in accounting and legal fees.

Other Income (Expense)

Total other income (expense), net for the three months ended September 30, 2026 was $2.3 million of income, compared to $2.8 million of income for the three months ended September 30, 2025. This change of $0.6 million was primarily attributable to lower interest income on investments, reflecting a reduction in invested balances as IPO proceeds were used to fund operating activities.

Total other income (expense), net for the nine months ended September 30, 2026 was $6.8 million of income, compared to $4.2 million of expense for the nine months ended September 30, 2025. This change of $11.0 million was primarily attributable to the absence of a loss from the change in fair value of warrant liabilities in the current period, as the warrants were remeasured and net exercised in connection with our IPO in January 2025, partially offset by lower interest income on investments, reflecting a reduction in invested balances as IPO proceeds were used to fund operating activities.

Selected Quarterly Financial Information

The following tables set forth our selected unaudited quarterly statements of operations data for each of the eight quarters in the period ended September 30, 2026. The information for each of these quarters has been prepared in accordance with GAAP, on a basis consistent with our unaudited condensed financial statements included elsewhere in this Quarterly Report and our audited financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2025 and include, in our opinion, all normal recurring adjustments necessary for the fair presentation of the results of operations for the periods presented, with the exception of adjusted earnings before interest, taxes, depreciation and amortization (EBITDA), which is a non-GAAP financial measure discussed below. Our historical quarterly results are not necessarily indicative of the results that may be expected in the future and these quarterly results are not necessarily indicative of our operating results for a full year. The following quarterly financial information should be read in conjunction with our financial statements and related notes thereto included elsewhere in this Quarterly Report.

The following tables set forth our selected unaudited quarterly statements of operations data for the periods presented:

\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n
		Three Months Ended
		December 31, 2025			March 31, 2026			June 30, 2026			September 30, 2026
		(unaudited)
		(in thousands, except percentages)
Net sales		$	32,121			$	27,626			$	32,013			$	35,505
Cost of sales(1)			13,177				11,189				13,111				15,174
Gross profit			18,944				16,437				18,902				20,331
Gross margin			59.0	%			59.5	%			59.0	%			57.3	%
Operating expenses:
Research and development(1)			10,131				10,356				10,240				11,975
Sales and marketing(1)			16,334				20,735				24,640				25,124
General and administrative(1)			8,603				9,617				9,600				9,841
Total operating expenses			35,068				40,708				44,480				46,940
Loss from operations			(16,124	)			(24,271	)			(25,578	)			(26,609	)
Other income (expense):
Interest income			2,658				2,376				2,177				2,258
Other income (expense), net			—				—				(2	)			(2	)
Total other income (expense), net			2,658				2,376				2,175				2,256
Net loss		$	(13,466	)		$	(21,895	)		$	(23,403	)		$	(24,353	)

Adjusted EBITDA		$	(10,512	)		$	(17,718	)		$	(17,656	)		$	(18,906	)

\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n
		Three Months Ended
		December 31, 2024			March 31, 2025			June 30, 2025			September 30, 2025
		(unaudited)
		(in thousands, except percentages)
Net sales		$	20,440			$	17,639			$	23,238			$	27,253
Cost of sales(1)			8,751				8,668				10,735				12,134
Gross profit			11,689				8,971				12,503				15,119
Gross margin			57.2	%			50.9	%			53.8	%			55.5	%
Operating expenses:
Research and development(1)			9,214				7,590				8,873				8,195
Sales and marketing(1)			10,804				13,402				15,623				16,045
General and administrative(1)			4,708				6,621				7,879				7,922
Total operating expenses			24,726				27,613				32,375				32,162
Loss from operations			(13,037	)			(18,642	)			(19,872	)			(17,043	)
Other income (expense):
Interest income			951				2,436				3,005				2,833
Other income (expense), net			—				—				(2	)			1
Change in fair value of warrant liabilities			(6,022	)			(12,450	)			—				—
Total other income (expense), net			(5,071	)			(10,014	)			3,003				2,834
Net loss		$	(18,108	)		$	(28,656	)		$	(16,869	)		$	(14,209	)

Adjusted EBITDA		$	(11,254	)		$	(15,535	)		$	(14,526	)		$	(12,179	)

(1)

Includes stock-based compensation expense as follows:

\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n
		Three Months Ended
		December 31, 2025			March 31, 2026			June 30, 2026			September 30, 2026
		(unaudited)
		(in thousands)
Cost of sales		$	143			$	164			$	206			$	187
Research and development			886				1,138				1,636				1,559
Sales and marketing			1,237				1,615				2,239				2,136
General and administrative			2,037				2,489				2,935				2,833
Total stock-based compensation expense		$	4,303			$	5,406			$	7,016			$	6,715

\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n
		Three Months Ended
		December 31, 2024			March 31, 2025			June 30, 2025			September 30, 2025
		(unaudited)
		(in thousands)
Cost of sales		$	74			$	106			$	153			$	140
Research and development			300				502				924				893
Sales and marketing			511				801				1,314				1,273
General and administrative			666				1,395				2,408				2,172
Total stock-based compensation expense		$	1,551			$	2,804			$	4,799			$	4,478

The following tables set forth our selected unaudited quarterly key business metrics for the periods presented:

\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n
		Three Months Ended
		December 31, 2025			March 31, 2026			June 30, 2026			September 30, 2026
		(unaudited)
% of Total Net Sales:
Durable Medical Equipment (DME) Channel			70	%			61	%			64	%			62	%
Pharmacy Benefit Plan (PBP) Channel			30	%			39	%			36	%			38	%
Total			100	%			100	%			100	%			100	%

% of New Patient Starts (NPS) Reimbursed Through Pharmacy		Low 30s %			High 30s %			High 30s %			High 30s %

\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n
		Three Months Ended
		December 31, 2024			March 31, 2025			June 30, 2025			September 30, 2025
		(unaudited)
% of Total Net Sales:
Durable Medical Equipment (DME) Channel			88	%			78	%			80	%			77	%
Pharmacy Benefit Plan (PBP) Channel			12	%			22	%			20	%			23	%
Total			100	%			100	%			100	%			100	%

% of New Patient Starts (NPS) Reimbursed Through Pharmacy		Low-teens %			Low 20s %			High 20s %			Low 30s %

Adjusted EBITDA

In addition to our financial results determined in accordance with GAAP, we believe the following adjusted EBITDA non-GAAP measure is useful in evaluating our operating performance. We use adjusted EBITDA to evaluate our ongoing operations and for internal planning and forecasting purposes. We believe that this non-GAAP financial measure, when taken together with the corresponding GAAP financial measures, provide meaningful supplemental information regarding our performance by excluding certain items that may not be indicative of our business, results of operations, or outlook. However, non-GAAP financial information is presented for supplemental informational purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with GAAP. In addition, other companies, including companies in our industry, may calculate similarly-titled non-GAAP measures differently or may use other measures to evaluate their performance, all of which could reduce the usefulness of our non-GAAP financial measures as tools for comparison. A reconciliation is provided below for adjusted EBITDA to the most directly comparable financial measure stated in accordance with GAAP. Investors are encouraged to review the related GAAP financial measures and the reconciliation of this non-GAAP financial measure to its most directly comparable GAAP financial measure, and not to rely on any single financial measure to evaluate our business.

The following table presents a reconciliation of adjusted EBITDA from the most comparable GAAP measure, net loss, for the eight quarters in the period ended September 30, 2026:

\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n
		Three Months Ended
		December 31, 2025			March 31, 2026			June 30, 2026			September 30, 2026
		(unaudited)
		(in thousands)
Net loss		$	(13,466	)		$	(21,895	)		$	(23,403	)		$	(24,353	)
Add:
Depreciation expense			537				585				709				892
Stock-based compensation expense			4,303				5,406				7,016				6,715
Interest income			(2,658	)			(2,376	)			(2,177	)			(2,258	)
Income tax expense (benefit)			—				—				2				2
Litigation settlement and other related expense			210				—				135				66
Quality system remediation(1)			562				562				62				30
Adjusted EBITDA		$	(10,512	)		$	(17,718	)		$	(17,656	)		$	(18,906	)

(1)

Amounts presented under “Quality system remediation” for the three months ended December 31, 2025, March 31, 2026, June 30, 2026, and September 30, 2026 reflect the same category of expenses previously labeled “Other non-recurring” in our Form 10-K for the year ended December 31, 2025. These expenses relate to our one-time remediation efforts in response to the Form 483 and the Warning Letter, including contractor support and the various updates to our quality system to meet FDA expectations.

\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n	\n
		Three Months Ended
		December 31, 2024			March 31, 2025			June 30, 2025			September 30, 2025
		(unaudited)
		(in thousands)
Net loss		$	(18,108	)		$	(28,656	)		$	(16,869	)		$	(14,209	)
Add:
Depreciation expense			232				303				347				386
Stock-based compensation expense			1,551				2,804				4,799				4,478
Interest income			(951	)			(2,436	)			(3,005	)			(2,833	)
Income tax expense			—				—				2				(1	)
Litigation settlement and other related expense			—				—				200				—
Change in fair value of warrant liabilities			6,022				12,450				—				—
Adjusted EBITDA		$	(11,254	)		$	(15,535	)		$	(14,526	)		$	(12,179	)

Adjusted EBITDA is a key performance measure that we use to assess our operating performance. Because adjusted EBITDA facilitates internal comparisons of our historical operating performance on a more consistent basis, we use this measure for business planning purposes.

We calculate adjusted EBITDA as net loss adjusted to exclude (i) depreciation expense, (ii) stock-based compensation expense, (iii) interest income, (iv) income tax expense (benefit), (v) litigation settlement and other related expenses, (vi) quality system remediation and (vii) change in fair value of warrant liabilities.

Some of the limitations of adjusted EBITDA include: (i) adjusted EBITDA does not properly reflect capital commitments to be paid in the future and (ii) although depreciation expense includes non-cash charges, the underlying assets may need to be replaced and adjusted EBITDA does not reflect these capital expenditures. Our adjusted EBITDA may not be comparable to similarly titled measures of other companies because they may not calculate adjusted EBITDA in the same manner as we calculate the measure, limiting its usefulness as a comparative measure. In evaluating adjusted EBITDA, you should be aware that in the future we will incur expenses similar to the adjustments in this presentation. Our presentation of adjusted EBITDA should not be construed as an inference that our future results will be unaffected by these expenses or any unusual or non-recurring items. When evaluating our performance, you should consider adjusted EBITDA alongside other financial performance measures, including our net loss and other GAAP results.

Selected Quarterly Trends

Net sales

Net sales generally increased across the periods presented, primarily due to higher sales volumes, driven by continued growth in new patient starts and the installed base, which resulted in higher sales of both iLets and supplies. The quarterly trend reflects continued commercial adoption of the iLet and growth in our installed base, with seasonal decreases in net sales in the first quarters of 2026 and 2025 compared to the immediately preceding fourth quarters.

Cost of sales

Cost of sales generally increased across the periods presented, primarily driven by higher sales volume, including increased pharmacy channel iLet sales, partially offset by improved manufacturing efficiencies. Cost of sales increased in the third quarter of 2026 compared to the second quarter of 2026, primarily due to higher sales volume and a less favorable product mix within the DME channel, reflecting a higher contribution from DME supplies and a lower contribution from DME iLets. Consistent with seasonal sales trends, cost of sales decreased in the first quarters of 2026 and 2025 compared to the immediately preceding fourth quarters.

Gross Margin

Gross margin generally improved across the periods presented through the second quarter of 2026, driven by lower material costs, increased production volumes, and improved manufacturing cost absorption. Gross margin decreased to 57.3% in the third quarter of 2026 from approximately 59% in the second quarter of 2026, primarily due to unfavorable product mix within the DME channel.

The proportion of new patient starts reimbursed through the PBP remained in the high-30% range in the third quarter of 2026, consistent with the first and second quarter of 2026.

Operating expenses

Research and development expenses generally increased over the periods presented, reflecting the timing of various clinical trial-related expenses, as well as increased engineering, materials, third-party consulting and payroll-related costs to support ongoing product development and enhancement efforts, including Mint, our patch pump, the bihormonal system, and incremental software and product updates.

Sales and marketing expenses increased across the periods presented, primarily driven by higher payroll-related costs associated with expansion of the sales force and customer care team, as well as increased marketing efforts.

General and administrative expenses generally increased over the periods presented, primarily due to higher payroll-related costs to support growth.

Adjusted EBITDA

Adjusted EBITDA fluctuated across the periods presented, reflecting the impact of revenue seasonality, continued investment in operating expenses and changes in gross margin. Adjusted EBITDA improved through the second half of 2025 as revenue growth, improved gross margins and operating leverage more than offset increases in operating expenses. Adjusted EBITDA declined in the first quarter of 2026 compared to the fourth quarter of 2025, remained relatively consistent in the second quarter of 2026, and declined further in the third quarter of 2026, primarily reflecting continued investment in operating expenses to support commercial growth. Variability across the periods presented was also impacted by discrete items, including a milestone payment to Xeris in the fourth quarter of 2024 and quality system remediation expenses beginning in the fourth quarter of 2025 and continuing through 2026.

Liquidity and Capital Resources

Since our inception, we have incurred significant operating losses. To date, research and development, market development and commercial launch activities have accounted for a significant portion of our overall operating expenses. We expect to incur significant expenses and operating losses for the foreseeable future as we advance the commercialization of Mint, our patch pump, and further develop the bihormonal system of the iLet.

To date, we have funded our operations primarily through equity financings, including our IPO completed in January 2025 and our follow-on public offering in September 2026, as well as revenue generated from the sale of the iLet and related single-use

products. We have also received payments under collaboration agreements and government grants. As of September 30, 2026, we had cash, cash equivalents and short-term and long-term investments of $373.6 million.

Cash Flows

The following table summarizes our cash flows for the periods presented:

\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n

\n	\n	\n	\n	\n	\n	\n	\n	\n
		Nine Months Ended September 30,
		2026			2025
		(in thousands)
Net cash used in operating activities		$	(50,741	)		$	(42,298	)
Net cash used in investing activities			(65,308	)			(163,463	)
Net cash provided by financing activities			166,024				213,814
Net increase in cash, cash equivalents and restricted cash		$	49,975			$	8,053

Operating Activities

Net cash used in operating activities was $50.7 million for the nine months ended September 30, 2026, compared to $42.3 million for the nine months ended September 30, 2025. The increase in net cash used of $8.4 million was primarily driven by a higher net loss in the current period and the absence of a $12.5 million non-cash adjustment for the change in fair value of warrant liabilities recorded in the prior-year period, as the warrants were net exercised in connection with our IPO in January 2025. These impacts were partially offset by higher stock-based compensation expense, favorable changes in the amortization of premiums and discounts on investments and higher depreciation expense. Working capital activity also partially offset the increase in cash used, primarily due to favorable changes in inventories and prepaid expenses and other current assets reflecting the timing of payments on software licenses and prepaid inventory, partially offset by unfavorable changes in accounts receivable and accounts payable, with the increase in accounts receivable primarily reflecting higher sales activity late in the quarter for amounts not yet due, and the change in accounts payable reflecting the timing of vendor payments on inventory and capital purchases.

Investing Activities

Net cash used in investing activities was $65.3 million for the nine months ended September 30, 2026, compared to net cash used of $163.5 million for the nine months ended September 30, 2025. The decrease of $98.1 million in net cash used in investing activities was primarily driven by a $192.8 million decrease in purchases of short-term investments and a $20.0 million increase in proceeds from maturities and redemptions of short-term investments. These decreases in cash used were partially offset by a $113.4 million increase in purchases of long-term investments, primarily from investing a portion of the proceeds from our September 2026 follow-on public offering, and a $1.3 million increase in purchases of property and equipment to support further development of Mint.

Financing Activities

In September 2026, we completed a follow-on public offering of common stock and a pre-funded warrant to purchase common stock. Net cash provided by financing activities was $166.0 million for the nine months ended September 30, 2026, compared to $213.8 million for the nine months ended September 30, 2025. The decrease of $47.8 million was primarily due to the higher proceeds from IPO-related financing activities in the prior-year period, which included $195.4 million of cash proceeds from our IPO, which, after $5.0 million of offering costs paid in prior periods, resulted in $190.4 million of net proceeds, and $15.6 million from the concurrent private placement, compared with $161.8 million of cash proceeds from the follow-on public offering, after underwriting discounts, commissions and offering expenses, in the current period. This decrease was partially offset by a $1.4 million increase in proceeds from stock option exercises and employee stock purchase plan issuances.

Future Funding Requirements

We expect our expenses to increase gradually in connection with our ongoing activities. The timing and amount of our funding requirements will depend on many factors, including:

•

the cost of maintaining FDA clearance for the iLet as an automated insulin dosing system cleared for the treatment of T1D in adults and children six years of age and older, including updates and revisions to our quality system;

•

the cost of maintaining FDA clearance for Mint, our patch pump, including costs associated with ongoing regulatory requirements and future product modifications;

•

the cost of obtaining and maintaining FDA marketing authorization or clearance for other future indications or other product candidates, including for the iLet for T1D using both insulin and glucagon (a bihormonal system), and the iLet for T2D;

•

future revenue generated by sales of the iLet and Mint, and any future product candidates, if approved or cleared;

•

costs associated with scaling up and expanding our manufacturing capacity, including in preparation for the commercial launch of Mint;

•

costs associated with building and expanding our sales and marketing efforts in the United States, including the commercialization of Mint and, in the future, internationally;

•

costs associated with conducting research and development efforts for future improvements to the iLet or Mint, our patch pump;

•

costs associated with conducting research and development efforts for future product offerings, such as bihormonal system of the iLet;

•

the cost of complying with regulatory requirements;

•

costs associated with capital expenditures;

•

the costs associated with hiring additional personnel as our business grows;

•

the costs of operating as a public company;

•

costs associated with any future litigation;

•

the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; and

•

the impact of geopolitical and macroeconomic events, including tariffs or other trade measures, future bank failures, increased geopolitical tensions and conflict, global pandemics, global economic conditions including changes in monetary and fiscal policy, U.S. political developments and other sources of instability that may impact our ability to access capital on acceptable terms, if at all.

Based on our current operating plans, we believe that our existing cash, cash equivalents and short-term and long-term investments, as well as cash generated from sales of our products, will be sufficient to fund our projected operating expenses and capital expenditure requirements for the foreseeable future. This assessment is based on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect.

We expect to finance our operations through product revenue. We may also seek additional capital in the future through equity or debt financing, collaborations or strategic alliances. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures or declaring dividends. If we raise additional funds through collaborations or strategic alliances with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams or investigational devices, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts, or grant rights to develop and market products that we would otherwise prefer to develop and market ourselves.

Contractual Obligations and Other Commitments

Leases

We have entered into various non-cancelable operating leases for certain office, laboratory and manufacturing space. The leases have varying initial lease terms of approximately one to six years. For additional information, see Notes 2 and 14 of our unaudited condensed financial statements included elsewhere in this Quarterly Report.

Research and Development Costs

In May 2024, in connection with research and development activities, we entered into an exclusive worldwide Collaboration and License Agreement with Xeris which contains a number of contractual obligations. In consideration for the licenses and other rights granted to us under the Collaboration and License Agreement, we paid Xeris a one-time, non-refundable payment of $0.5 million and a one-time, non-refundable milestone payment of $3.0 million for the achievement of certain developmental milestones. In connection with entering into Phase 2 of the collaboration, we ordered and paid for clinical material totaling $0.9 million. In May 2026, we entered into a letter agreement under the Clinical Supply Agreement with Xeris for additional Phase 2 clinical material, including a one-time non-refundable payment of $0.5 million and reimbursement of certain internal and travel costs. In connection with entering into Phase 3 of the collaboration, we expect to incur development and manufacturing costs, including ordering clinical materials and technical transfer, development, and testing of the product, totaling $5.1 million. As of September 30, 2026, we have completed payments totaling $4.0 million. The payments were initially recognized in prepaid expense and other current assets in the balance sheets and a portion of the payment was expensed to research and development related to the services completed. In addition, we are required to pay tiered royalties of low double-digit percentages based on net sales of glucagon products, subject to certain reductions. We may continue to incur costs as we progress into Phase 2 and Phase 3 clinical trials. For additional information, see “Business—License and Collaboration Agreements” in our Annual Report on Form 10-K for the year ended December 31, 2025. We expect to continue to incur costs as development activities progress.

Royalty Obligations

In connection with the development, production and sale of the iLet, we have entered into certain agreements that obligate us to pay royalties based on specific production or net sales metrics. Among other obligations, certain license agreements with BU require us to pay quarterly royalties of a mid-single-digit percentage based on net sales (and royalties of a low double-digit percentage of net sales by sublicensees), of any products licensed under the agreements, which royalties are creditable against the minimum royalty amount. For additional information on these license agreements with BU, see “Business—License and Collaboration Agreements” in our Annual Report on Form 10-K for the year ended December 31, 2025. As of September 30, 2026, we have not identified any material changes to these agreements or the related royalty obligations described above.

Off-Balance Sheet Arrangements

We did not have during the periods presented, and we do not currently have, any relationships with unconsolidated organizations or financial partnerships, such as structured finance or special purpose entities, that would have been established to facilitate off-balance sheet arrangements or other contractually narrow or limited purposes.

Critical Accounting Policies and Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our unaudited condensed financial statements, which are prepared in accordance with GAAP. The preparation of our unaudited condensed financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue, costs and expenses, and the disclosure of contingent assets and liabilities in our unaudited condensed financial statements. We base our estimates on historical experience, known trends and events, and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.

While our significant accounting policies are described in more detail in Part I. Item 1. Note 2 to our unaudited condensed financial statements included elsewhere in this Quarterly Report, we believe that the following accounting policies are the most critical to the judgments and estimates used in the preparation of our unaudited condensed financial statements.

Revenue Recognition

Our revenue from contracts with customers is generated from the iLet and single-use products that are used together with the iLet, including cartridges for storing and delivering insulin, and infusion sets that connect the insulin pump to a user’s body. Our primary customers are distributors and pharmacy partners who sell our products to insulin-requiring PWD. We recognize revenue when we transfer control of the promised goods or services to customers in an amount that reflects the consideration we expect to be entitled to in exchange for those goods or services, net of estimated returns and estimated variable consideration. Variable consideration related to pharmacy rebates and chargebacks is accounted for as a reduction in revenue and is estimated based on contractual arrangements, actual sales of products qualifying for rebates or chargebacks, and historical payments made related to pharmacy rebates and chargebacks. Estimates associated with pharmacy rebates and chargebacks on products sold are the most

significant component of our variable consideration estimates and most at risk for material adjustment because of the time delay between the recording of the provision and its ultimate settlement, an interval that generally ranges from 30 to 90 days. Due to this time lag, in any given period, our adjustments to reflect actual amounts can incorporate changes of estimates related to prior periods. The amount of variable consideration that is included in the transaction price is estimated and is included in revenue only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. If the actual amounts of consideration that we receive differ from estimates, we adjust these estimates, which affects reported revenue, in the period that such variances become known or at the end of each reporting period.

We have identified the ability for a customer to access the mobile application and our promise to provide firmware upgrades to the iLet through the mobile application as distinct performance obligations, as access and support is provided throughout the standard four-year warranty period of the device. Accordingly, revenue related to the mobile application and firmware upgrades are deferred and recognized ratably over a four-year period. Given that access to the mobile application and unspecified software updates follow the same pattern of transfer to the customer and are provided over the same four-year period, we recognize revenue for these performance obligations as if they were a single performance obligation. As there is no observable standalone selling price for access to the mobile application or promise to provide firmware upgrades, we estimate standalone selling price by applying the expected cost plus a margin approach.

Stock-Based Compensation

We measure stock options and employee stock purchase plan purchase rights based on their fair value on the date of grant using the Black-Scholes option pricing model. We measure restricted stock units based on the fair value of our common stock on the date of grant. Stock-based compensation expense for those awards is recognized over the requisite service period, which is generally the vesting period of the respective award for employees and directors and the period during which services are performed for non-employees. Stock-based compensation expense for non-employee awards is recognized in the same manner as if we had paid cash in exchange for the goods or services, which is generally the vesting period of the award. We have issued awards with only service-based vesting conditions and record the expense for these awards using the straight-line method. We have not issued any stock-based awards with performance-based or market-based vesting conditions.

We determined the assumptions for the Black-Scholes option pricing model as discussed below. Each of these inputs is subjective and generally requires significant judgment to determine.

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Fair Value of Our Common Stock—The fair value of stock-based awards is determined based on the market price of our common stock on the date of grant.

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Expected Volatility—Expected volatility is derived from the average historical stock volatilities of several public companies within our industry that we consider to be comparable to our business over a period equivalent to the expected term of the stock-based awards. We will continue to apply this process until a sufficient amount of historical information regarding the volatility of our own stock price becomes available.

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Expected Term—The expected term represents the period that the stock-based awards are expected to be outstanding. The expected term for our stock options was calculated based on the weighted-average vesting term of the awards and the contract period, or the simplified method.

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Risk-Free Interest Rate—The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant for zero-coupon U.S. treasury notes with maturities approximately equal to expected term of the stock options.

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Expected Dividend Yield—The expected dividend is zero as we have not paid and do not anticipate paying any dividends in the foreseeable future.

Forfeitures are accounted for as they occur.

See Part I. Item 1. Note 11 of our unaudited condensed financial statements included elsewhere in this Quarterly Report for more information concerning certain of the specific assumptions we used in applying the Black-Scholes option pricing model to determine the estimated fair value of our stock options. Certain of these assumptions involve inherent uncertainties and generally require significant analysis and judgment to develop. Changes in these assumptions can materially impact the fair value and ultimately how much stock-based compensation expense is recognized.

Recent Accounting Pronouncements

A description of recently issued accounting standards that may potentially impact our financial position, results of operations, and cash flows is included in Part I. Item 1. Note 2 to our unaudited condensed financial statements included elsewhere in this Quarterly Report.

Emerging Growth Company and Smaller Reporting Company Status

We are an “emerging growth company” as defined in the Jumpstart Our Business Startups (JOBS) Act. For as long as we remain an “emerging growth company”, we may take advantage of reduced reporting requirements that are otherwise applicable to public companies. These provisions include, but are not limited to: (i) not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act; (ii) reduced disclosure obligations regarding executive compensation in our periodic reports, proxy statements and registration statements; and (iii) exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and any golden parachute payments not previously approved.

In addition, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This provision allows an emerging growth company to delay the adoption of some accounting standards until those standards would otherwise apply to private companies. We have elected to take advantage of the benefits of this extended transition period, and therefore, we are not subject to the same requirements to adopt new or revised accounting standards as other public companies that are not emerging growth companies; however, we may adopt certain new or revised accounting standards early. We may use these provisions until the last day of our fiscal year following the fifth anniversary of the completion of our initial public offering. However, if certain events occur prior to the end of such five-year period, including if we become a “large accelerated filer,” our annual gross revenues exceed $1.235 billion or we issue more than $1.0 billion of non-convertible debt in any three-year period, we will cease to be an emerging growth company prior to the end of such five-year period.

We are no longer a “smaller reporting company” as defined by Rule 12b-2 of the Exchange Act because our annual revenue exceeded $100.0 million during the most recently completed fiscal year. However, we may continue to take advantage of certain of the scaled disclosures available to smaller reporting companies through the end of the year ended December 31, 2026 and until our Form 10-Q for the quarter ended March 31, 2027. If we are a smaller reporting company or are otherwise eligible to take advantage of the scaled disclosure available to smaller reporting companies at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of unaudited condensed financial statements in our Quarterly Report on Form 10-Q and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

We are eligible to take advantage of the scaled disclosures available to “smaller reporting company” as defined by Item 10(f)(1) of Regulation S-K. Accordingly, we are not required to provide the information required by this item.

Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

As of September 30, 2026, management, with the participation of our principal executive officer and our principal financial officer, have evaluated our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act as of the end of the period covered by this Quarterly Report. Based on such evaluation, our principal executive officer and our principal financial officer have concluded that as of September 30, 2026, our disclosure controls and procedures were effective at the reasonable assurance level. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act are recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports we file or submit under the Exchange Act is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

Changes in Internal Control Over Financial Reporting

There have been no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended September 30, 2026, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II. OTHER INFORMATION

Item 1. Legal Proceedings.

From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. In September 2026, a purported stockholder of our company filed a securities class action against our company and certain of our executive officers in the United States District Court for the Central District of California, captioned Holtzman vs. Beta Bionics, Inc. et al., Case No. 8:26-cv-2612-JWH (KESx). The complaint alleges that defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, and SEC Rule 10b-5 promulgated thereunder, by making material misstatements or omissions concerning the safety, efficacy, and commercial success of iLet. The complaint seeks, on behalf of the putative class, unspecified damages, pre- and post-judgment interest, attorneys’ fees, expert fees and costs, as well as class certification and such other relief as the court may deem just and proper. We intend to vigorously defend against the claims in this action. Any potential loss arising from this claim is not currently probable or estimable.

Item 1A. Risk Factors.

Refer to the “Item 1A. Risk Factors” section in our Annual Report on Form 10-K for the year ended December 31, 2025 for a discussion of risks to which our business, financial condition, results of operations and cash flows are subject. Other than as described below, there have been no material changes to the risk factors disclosed in the aforementioned Annual Report.

Risks Related to Our Limited Commercial History, Financial Position and Need for Additional Capital

We may need to raise additional funds in the future, and these funds may not be available on acceptable terms, if at all.

The development of medical devices is capital-intensive. Our operations have consumed substantial amounts of cash since inception. As of September 30, 2026, our cash, cash equivalents and short-term investments were $240.3 million. In January 2025, we completed our initial public offering and a concurrent private placement, pursuant to which we received aggregate net proceeds of approximately $190.4 million and approximately $15.6 million, respectively, in each case after deducting underwriting discounts, commissions, and other offering expenses. In September 2026, we completed a follow-on public offering of common stock and a pre-funded warrant to purchase common stock, resulting in net proceeds of approximately $161.3 million after underwriting discounts, commissions and offering expenses. Based on our current and planned use of the net proceeds of these offerings and our current cash, cash equivalents and short-term investments, we estimate that our funds will be sufficient to enable us to fund our operating expenses and capital expenditure requirements for the foreseeable future. This estimate is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Changing circumstances could cause us to consume capital significantly faster than we currently anticipate, and we may need to spend more than currently expected because of circumstances beyond our control.

We expect our expenses to increase gradually in connection with our ongoing activities. The timing and amount of our funding requirements, will depend on many factors, including:

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the cost of maintaining FDA clearance for Mint, our patch pump, including costs associated with ongoing regulatory requirements and future product modifications;

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the cost of commercializing our Mint patch pump;

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future revenue generated by sales of the iLet and Mint and any future product candidates, if approved or cleared;

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costs associated with scaling up and expanding our manufacturing capacity, including in preparation for the commercial launch of Mint;

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costs associated with building and expanding our sales and marketing efforts in the United States, including the commercialization of Mint, and, in the future, internationally;

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costs associated with conducting research and development efforts for future improvements to the iLet or Mint, our patch pump;

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costs associated with conducting research and development efforts for future product offerings, such as bihormonal system of the iLet;

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the cost of complying with regulatory requirements;

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costs associated with capital expenditures;

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the costs associated with hiring additional personnel as our business grows;

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the costs of operating as a public company;

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costs associated with any future litigation;

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the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; and

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We may require additional capital beyond the proceeds of these offerings, which we may raise through public or private equity or debt financings or other capital sources, which may include strategic collaborations and other strategic arrangements with third parties. Furthermore, we expect to incur additional costs associated with operating as a public company. Adequate additional financing may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed would have a negative effect on our financial condition and our ability to pursue our business strategy. In addition, attempting to secure additional financing may divert the time and attention of our management from day-to-day activities and harm our development, manufacturing and commercialization efforts.

Our ability to raise additional funds may also be adversely impacted by potential worsening global economic conditions and the disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from geopolitical tensions, such as the ongoing war in Ukraine, the Israel and Palestine conflict, government actions implemented as a result of either of the foregoing, as well as tensions with and economic uncertainty in China, tariffs and other trade measures, inflation, interest rates, liquidity concerns at, and failures of, banks and other financial institutions, changes in monetary and fiscal policy and U.S. political developments and other sources of instability. If the equity and credit markets further deteriorate, or do not improve, it may make any necessary debt or equity financing more difficult, more costly and more dilutive. Market volatility may further adversely impact our ability to access capital as and when needed.

If we are unable to raise capital when needed or on acceptable terms, we would be forced to delay, reduce or eliminate certain of our research and development programs or manufacturing or commercialization efforts. If this were to occur, our ability to grow and support our business and to respond to market challenges could be significantly limited, which could have a material adverse effect on our business, financial condition and results of operations.

Risks Related to Our Business, Strategy and Industry

We may not be able to successfully commercialize Mint, our patch pump, on the timeline we anticipate or at all, and Mint may not achieve market acceptance among patients, healthcare providers, or payors, which would adversely affect our business, financial condition, and results of operations.

In September 2026, we announced that the FDA had cleared Mint, our patch pump. Our future growth depends in significant part on our ability to successfully commercialize Mint, and we have no experience launching a patch pump. Mint is a new product with a different form factor from the iLet, which is currently our only commercialized product and source of revenue. Our strategy for Mint therefore requires us to execute on the risks described below, many of which are outside our control.

We currently expect to commercially launch Mint in the United States by the end of the first quarter of 2027. This timeline has changed before, and we may not meet it. Our ability to launch depends on, among other things:

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completing scale-up and validation of manufacturing processes, including those of our contract manufacturers and component suppliers;

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building sufficient inventory;

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obtaining and maintaining quality system compliance;

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training and expanding our sales, clinical support, and customer service organizations;

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developing training, onboarding, and technical support for a new product category; and

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completing any remaining regulatory, software, or cybersecurity activities required for launch.

Any delay in these activities, or any product quality, reliability, or supply issue, could postpone the launch, increase our costs, harm our reputation, or lead to recalls, corrective actions, or field safety notices.

Risks Related to the Development, Regulatory Approval and Commercialization of our iLet Bionic Pancreas and Product Candidates

We are highly dependent on the success of our iLet and Mint for the treatment of T1D, which are cleared by the FDA for commercial sale in the United States for the treatment of T1D. If we are unable to obtain and maintain regulatory clearance or approval for planned modifications to the iLet or Mint or for new indications, or for any current or future development-stage products, such as 3D Intelligence, iLet 3D and Mint 3D, or if we are unsuccessful in our efforts to continue to commercialize our cleared products, our business will be materially harmed.

We currently have one commercialized device, the iLet, which is an automated insulin dosing system cleared for the treatment of T1D in adults and children six years of age and older. Our business primarily depends on the successful commercialization of the iLet. In September 2026, we announced FDA clearance of Mint, our patch pump featuring a transformative reusable and disposable architecture, for the treatment of T1D in adults and children six years of age and older, and our expected initiation of full commercialization of Mint in the United States in the first quarter of 2027. We currently have no other products cleared for sale and may never be able to develop other marketable products. Additionally, in September 2026, we announced our submission of a 510(k) application to the FDA for 3D Intelligence, our anticipated next-generation insulin dosing algorithm and, subject to and following regulatory clearance by the FDA, our expectation for 3D Intelligence to power both iLet 3D and Mint 3D, our investigational next-generation automated insulin delivery platforms. In October 2026, pursuant to discussion with FDA, we voluntarily withdrew the 510(k) notification for 3D Intelligence, and intend to revise and resubmit it mid-fourth quarter of 2026. Our iLet will require additional clinical development, testing and marketing authorization or regulatory clearance before we are permitted to commercialize it in a bihormonal system for the treatment of T1D or for any future indications we may pursue. Further, as we develop a bihormonal system of the iLet, which is designed to use both insulin and glucagon for the treatment of T1D, we will separately need to develop and obtain approval for our glucagon product candidate as a drug via an NDA submission in order to successfully commercialize our iLet in a bihormonal system. We expect that the bihormonal system will require completion of clinical trials and submission of a 510(k) for both the infusion pump and algorithm. In addition, we expect that the single hormone and bihormonal algorithms will require separate studies to be performed in T1D and T2D populations in order to seek clearance in these patient populations. Our iLet and Mint will also require additional marketing authorization or regulatory clearance before we are permitted to commercialize them with 3D Intelligence as iLet 3D and Mint 3D, respectively. However, there can be no assurance that we will be able to revise and timely resubmit 3D Intelligence or that the FDA will clear the 3D intelligence or any other application on the anticipated timeline, or at all, that we will ultimately be able to market and commercialize 3D Intelligence, iLet 3D or Mint 3D, or that we will be able to scale our manufacturing processes sufficiently to meet anticipated demand at launch. The future regulatory and commercial success of 3D Intelligence, iLet and Mint, including versions powered by 3D Intelligence, and any other product candidate is subject to a number of risks, including the following:

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completion of preclinical studies with favorable results;

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successful enrollment in, and completion of, planned and future clinical trials with favorable results;

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sufficiency of our financial and other resources to complete the necessary clinical trials and regulatory activities;

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successful patient enrollment in clinical trials;

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successful data from our clinical program that supports an acceptable risk-benefit profile in the intended populations;

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whether we are required by the FDA to conduct additional clinical trials or to modify the design of current or planned trials to support any future application seeking marketing authorization or clearance of the iLet in a bihormonal system for the treatment of T1D or for other indications we may pursue, or seeking initial marketing authorization or clearance for any of our other product candidates;

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receipt and maintenance of marketing authorizations or clearances from applicable regulatory authorities;

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obtaining and maintaining patent and trade secret protection and regulatory exclusivity, including for our iLet;

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making arrangements with third-party manufacturers and ensuring such third-party manufacturers supply sufficient quantities of components of our products and product candidates;

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scaling up our manufacturing capabilities, for both commercial and clinical supplies of our products and product candidates;

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entry into collaborations to further the development of capabilities;

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expanding sales, marketing and distribution capabilities as we continue our commercialization efforts of the iLet, whether alone or in collaboration with others;

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successfully launching and driving commercial sales of our existing products and any other product candidate, if authorized for marketing or cleared;

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acceptance of our products by PWD, the medical community and third-party payors;

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maintaining a continued acceptable safety profile following marketing authorization or clearance, including in respect of our post-market surveillance order issued by the FDA for our iLet;

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managing and responding to voluntary or mandatory recalls, including our four open recalls;

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maintaining regulatory compliance;

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effectively competing with other treatment options and the availability, perceived advantages, relative cost, relative safety and relative effectiveness of alternative and competing treatments;

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the emergence of competing technologies and other adverse market developments, and our need to enhance existing products and/or develop new products to maintain market share in response to such competing technologies or market developments;

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maintaining healthcare coverage and adequate reimbursement from third-party payors;

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continuing to build and maintain an organization of people who can successfully develop our products; and

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enforcing and defending intellectual property rights and claims.

Many of these risks are beyond our control, including the risks related to clinical development, the regulatory submission, oversight and review processes, potential threats to our intellectual property rights and the manufacturing, marketing and sales efforts of any future collaborator. If we are not successful in commercializing our iLet or Mint, or in obtaining marketing authorization or clearance for the iLet in its bihormonal system for the treatment of T1D or for the iLet or Mint in other indications, such as T2D, the investigational glucagon product, or any other product candidate, or if we experience delays as a result of any of these risks or otherwise, our business could be materially harmed.

Furthermore, even though we have received clearance for our iLet for insulin-only delivery for the treatment of T1D, any other configuration for the treatment of T1D such as a bihormonal system using both insulin and glucagon or other indications we may pursue for which we receive marketing authorization or clearance may be subject to limitations on the patient populations for which we may market the product. Even if we are able to obtain the requisite financing to continue to fund our development programs, we cannot assure you that we will successfully develop, obtain marketing authorization or clearance for, and commercialize our iLet in its bihormonal system for the treatment of T1D or for any future indication we may pursue, the investigational glucagon product, or any other development-stage products. If we are unable to continue commercializing the iLet or Mint for T1D, or if we are unable to develop, or obtain marketing authorization or clearance for, or, if authorized for marketing or cleared, successfully commercialize the iLet or Mint for the treatment of any future indications, we may not be able to generate sufficient revenue to continue our business.

Our future growth depends on the continued success, enhancement, and expanded use of the iLet as well as the development and commercial release of the patch pump, Mint. If we fail to advance the iLet platform, the Mint platform or expand their indications, our business may be adversely affected.

It is important to our business and our long-term growth that we continue to develop and enhance the iLet, including in a bihormonal system, as well as expand our product portfolio, including our patch pump, Mint. For example, we have completed over 20 pre-pivotal trials testing the algorithms in order to enhance its learning capabilities. We intend to continue to invest in research and development activities focused on improvements and enhancements to the iLet. Additionally, we intend to pursue marketing authorization or clearance for other indications in the United States in the future.

Developing enhancements to the iLet and developing Mint has, and will continue to be expensive and time-consuming and has, and may continue to, divert management’s attention away from the commercialization of the iLet and Mint and divert financial resources from other operations. The success of any new products or new product enhancements, including marketing authorization or clearance for additional indications, will depend on several factors, including our ability to:

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properly identify and anticipate physician and patient needs, and develop enhancements to meet those needs;

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demonstrate, if required, the safety and effectiveness of new enhancements to our products, including additional indications, with data from preclinical studies and clinical trials;

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obtain in a timely manner the necessary marketing authorization or clearance for new enhancements to the iLet, product modifications or expanded indications;

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avoid infringing upon the intellectual property rights of third parties;

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comply with all applicable laws and regulations, including those governing the marketing of new devices or modified products;

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develop an effective and dedicated sales and marketing team to provide adequate education and training to potential users of the iLet; and

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receive adequate coverage and reimbursement for procedures performed with the iLet.

While we have commercialized the iLet as an automated insulin dosing system cleared for the treatment of T1D in adults and children six years of age and older, we may not be successful in expanding the configurations or indications and developing and commercializing new products or product enhancements. This could negatively impact our ability to achieve and maintain market share and increase our revenue, which could have a material adverse effect on our business, financial condition and results of operations.

Risks Related to Manufacturing and Our Reliance on Third Parties

We are substantially dependent on various third parties for the continued development of our iLet and product candidates. Certain of our current and future collaborators may control aspects of our clinical trials, which could result in delays or other obstacles in the development of the investigational devices or other development-stage candidates, such as glucagon, we develop. If our collaborations are terminated or are not successful, our ability to further enhance our iLet and product candidates may be adversely affected.

Our iLet is currently only compatible with DexCom’s G6 and G7 iCGM devices and Abbott’s FreeStyle Libre 3 Plus CGM sensor. In September 2026, we announced a partnership to integrate the iLet with Senseonics Holdings, Inc.’s Eversense 365 CGM. Although we are actively working to expand the compatibility of our iLet with other iCGM models, there is no assurance we will be successful in our efforts. Our development agreement with DexCom provides us with non-exclusive licenses to integrate the currently available generation of DexCom’s iCGM technology with our iLet. Under our current commercialization agreement with DexCom, we and DexCom have agreed to commercialize an AID system comprised of our iLet and DexCom’s G6 or G7 iCGM. We also have a development and commercialization agreement with Abbott, under which we and Abbott have agreed to commercialize an AID system comprised of our iLet and Abbott’s iCGM. These agreements may be terminated by the other party upon certain conditions. If our existing agreements are terminated and/or DexCom or Abbott enter into an exclusive partnership with one of our competitors, our ability to commercialize the iLet would be disrupted, which would have a material adverse impact on our business, financial condition and results of operations, negatively impact our ability to compete and cause the price of our common stock to decline.

Additionally, we entered into an exclusive collaboration and license agreement with Xeris to facilitate the development of a dual-hormone pump for PWD, whereby Xeris will develop a glucagon drug product candidate utilizing Xeris’ XeriSol technology for use in our iLet in its bihormonal system (if such configuration is authorized for marketing). We will be responsible for obtaining regulatory approval of such glucagon product candidate. We also entered into collaboration agreements with certain third-party producers of insulin, pursuant to which we have agreed to work with such parties to support the development of the iLet by researching and incorporating certain proprietary insulins in our iLet. Although we have been successful in obtaining clearance of our iLet with the use of these insulins, we are dependent upon the continued cooperation and collaboration of these parties. If any of these agreements are terminated, we would be required to purchase the applicable party’s approved insulin and fill empty insulin cartridges fitted for the iLet to evaluate such party’s insulin in trials, which would increase our costs and could delay the timing of trials. Although there are other producers of insulin, there is no assurance we could enter into agreements with them on commercially reasonable terms, if at all, and receive marketing authorizations or clearances for the use of their insulin in the iLet. Our current collaboration agreements pose, and potential future collaborations involving our iLet may pose, the following risks to us:

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we may be required to assume substantial actual or contingent liabilities;

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we may not be able to control the amount and timing of resources that our strategic collaborators devote to the development and commercialization of our products;

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collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our iLet;

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collaborators may not properly enforce, maintain or defend our intellectual property rights or may use our proprietary information in a way that gives rise to actual or threatened litigation;

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disputes may arise between a collaborator and us that cause the delay or termination of the research, development or commercialization of the investigational device, or that result in costly litigation or arbitration that diverts management attention and resources;

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collaborators may experience financial difficulties;

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our collaborators may experience legal difficulties with respect to FDA regulations or regulations of other government agencies that jeopardize their ability to continue supporting the development and commercialization of our products;

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collaborators could terminate our existing or future agreements or allow them to expire, which would delay the development and may increase the cost of developing our products;

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if a present or future collaborator of ours were to be involved in a business combination, the continued pursuit and emphasis on our product development or commercialization program under such collaboration could be delayed, diminished or terminated; and

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collaboration agreements may restrict our right to independently pursue new investigational devices.

If we enter into collaboration agreements and strategic partnerships or license our intellectual property, products or businesses, we may not be able to realize the benefit of such transactions if we are unable to successfully integrate them with our existing operations, which could delay our timelines or otherwise adversely affect our business. We also cannot be certain that, following a strategic transaction or license, we will achieve the revenue or specific net income that justifies such transaction. Any delays in entering into new collaborations or strategic partnership agreements related to any investigational device or other development-stage product we develop could delay the development and commercialization of our investigational devices or other development-stage products, which would harm our business prospects, financial condition and results of operations.

Risks Related to Government Regulation

We and our suppliers are subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and subject us to penalties if we fail to comply with applicable regulatory requirements.

Once we obtain marketing authorization or clearance for FDA-regulated products, such as our iLet and any future products, we and such products will be subject to continued and pervasive regulatory review, oversight, requirements, and periodic inspections by the FDA and other domestic and foreign regulatory bodies governing, among other things, the manufacture, marketing, advertising, reporting, sale, promotion, import, export, registration, and listing of our products. For example, medical device manufacturers must submit periodic reports to the FDA as a condition of obtaining marketing authorization or clearance. These reports include information about failures and certain adverse events associated with the device after its marketing authorization or clearance. Failure to submit such reports, or failure to submit the reports in a timely manner, could result in enforcement action by the FDA. Following its review of the periodic reports, the FDA might ask for additional information or initiate further investigation. In particular, unless exempt, we and our suppliers are required to comply with the FDA’s QMSR for medical device products and cGMPs for any approved drug products, such as glucagon if it is ultimately approved, and other regulations enforced outside the United States which cover the manufacture of our products and the methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging, storage and shipping of medical devices. Regulatory bodies, such as the FDA, enforce the QMSR and cGMPs and other regulations through periodic inspections. The failure by us or one of our suppliers to comply with applicable statutes and regulations administered by the FDA and other regulatory bodies, or the failure to timely and adequately respond to any adverse inspectional observations or product safety issues, could result in, among other things, any of the following enforcement actions and/or other negative consequences:

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untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties;

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unanticipated expenditures to address or defend such actions;

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customer notification, or orders for repair, replacement or refunds;

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voluntary or mandatory recall or seizure of our current or future products;

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administrative detention by the FDA of medical devices believed to be adulterated or misbranded;

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operating restrictions, suspension or shutdown of production;

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refusing our requests for marketing authorization or clearance of new products, or new intended uses or modifications to the iLet;

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suspending or withdrawing marketing authorizations or clearances that have already been granted; and

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criminal prosecution.

If any of these actions were to occur, our reputation would be harmed and our product sales and profitability would be adversely impacted. Furthermore, our key component suppliers may not currently be or may not continue to be in compliance with all applicable regulatory requirements which could result in our failure to manufacture our products on a timely basis and in the required quantities, if at all. Later discovery of previously unknown problems with our products, including manufacturing problems, or failure to comply with regulatory requirements such as the QMSR, may result in changes to labeling, restrictions on such products or manufacturing processes, withdrawal of the products from the market, voluntary or mandatory recalls, a requirement to repair, replace or refund the cost of any medical device we manufacture or distribute, fines, suspension of regulatory approvals, product seizures, injunctions or the imposition of civil or criminal penalties which would adversely affect our business, operating results and prospects.

In addition, the FDA may change its marketing authorization or clearance policies, adopt additional regulations or revise existing regulations, or take other actions, which may prevent or delay marketing authorization or clearance of any product candidate under development or impact our ability to modify any products authorized for market on a timely basis. Such policy or regulatory changes could impose additional requirements upon us that could delay our ability to obtain marketing authorizations or clearances, increase the costs of compliance or restrict our ability to maintain any marketing authorizations or clearances we have obtained. For example, in February 2024, the FDA issued a final rule to amend and replace the former Quality System Regulation, which set forth the FDA’s current good manufacturing practice requirements for medical devices, to align more closely with the International Organization for Standardization standards. Specifically, this final rule, which went into effect on February 2, 2026, established the QMSR, which among other things, incorporates by reference the quality management system requirements of ISO 13485:2016. Although the FDA has stated that the standards contained in ISO 13485:2016 are substantially similar to those set forth in the former Quality System Regulation, it is unclear the extent to which this final rule, once effective, could impose additional or different regulatory requirements on us that could increase the costs of compliance or otherwise negatively affect our business. If we are unable to comply with the QMSR or with any other changes in the laws or regulations enforced by the FDA or comparable regulatory authorities, we may be subject to enforcement action, which could have an adverse effect on our business, financial condition and results of operations. Additionally, the U.S. Supreme Court’s June 2024 decision in Loper Bright Enterprises v. Raimondo overturned the longstanding Chevron doctrine, under which courts were required to give deference to regulatory agencies’ reasonable interpretations of ambiguous federal statutes. The Loper decision could result in additional legal challenges to regulations and decisions issued by federal agencies, including the FDA, on which we rely. Any such legal challenges, if successful, could have a material impact on our business. Additionally, the Loper decision may result in increased regulatory uncertainty, inconsistent judicial interpretations, and other impacts to the agency rulemaking process, any of which could adversely impact our business and operations. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may be subject to enforcement action and we may not achieve or sustain profitability, which would harm our business, financial condition, results of operations and prospects.

In addition, even after we have obtained marketing authorization or clearance for a product, the FDA has the power to require us to conduct post marketing studies, such as under a 522 Order, which is an order by the FDA to conduct a post-market study of an authorized or cleared medical device. We are subject to a post-market surveillance order issued by the FDA for our iLet. If the FDA determines that our iLet does not perform as anticipated, or if the FDA identifies new concerns related to the safety and effectiveness of the device, we may need to make changes to or recall or withdraw the iLet from the field, which could harm our business. These studies can be very expensive and time-consuming to conduct. Any failure to comply with ongoing regulatory requirements may significantly and adversely affect our ability to commercialize and generate revenue from our products. If regulatory sanctions are applied or if marketing authorization or clearance is withdrawn, it would have a material adverse effect on our business, financial condition and results of operations.

In June 2025, the FDA conducted an inspection of our Irvine, California facility. Following the inspection, the FDA issued a Form 483. We initiated remediation activities and followed our communicated plan to address the FDA’s observations. We submitted our response and provided multiple updates to the FDA regarding the status of our remediation efforts. On January 29, 2026, we received a Warning Letter from the FDA following such inspection. In the Warning Letter, the FDA cited deficiencies in the response letters we sent to the FDA following the FDA’s issuance of the Form 483. The Warning Letter highlights non-conformities observed by the FDA in relation to our Quality Management System, Medical Device Reporting, and Correction and Removals, which were previously communicated by the FDA in the Form 483. The Warning Letter does not restrict our ability to produce, market, manufacture or distribute our products, nor does it restrict our ability to seek FDA 510(k) clearance of new products. We take the observations described in the Warning Letter seriously and have been regularly updating the FDA on the progress we have made in improving our quality management system in the areas outlined by the FDA in the Warning Letter. We intend to continue providing

these regular updates to the FDA until the Warning Letter is resolved. We cannot provide assurances that the FDA will be satisfied with our response or an expected timeline for resolutions of the matters included in the Warning Letter. Until the deficiencies cited in the Warning Letter are resolved to the FDA’s satisfaction, additional legal or regulatory action may be taken without further notice. We do not expect the Warning Letter to materially impact our previously disclosed guidance that we expect to fully commercialize Mint by the end of the first quarter of 2027.

The FDA can also publish Safety Communications or Letters to Health Care Providers when the agency becomes aware of new issues involving a specific product or, more broadly, a product family. These communications are posted on the FDA’s website and describe the FDA’s analysis of a current issue and provide specific regulatory approaches and clinical recommendations for patient management. If such communications occur it may harm our reputation and prevent us from generating revenue.

General Risk Factors

We could be subject to securities class action litigation.

In the past, securities class action litigation has often been brought against a company following a decline in the market price of its securities. This risk is especially relevant for us because medical device companies have experienced significant stock price volatility in recent years. For example, in September 2026, a purported stockholder of our company filed a securities class action against our company and certain of our executive officers in the United States District Court for the Central District of California, captioned Holtzman v. Beta Bionics, Inc. et al., Case No. 8:26-cv-2612-JWH (KESx), alleging violations of certain federal securities laws related to certain statements made with respect to the safety, efficacy and commercial success of iLet. We intend to vigorously defend ourselves in this matter. If we are not successful in defense of these claims or any other claims we may face in the future, we may have to make significant payments to, or other settlements with, our stockholders and their attorneys. Even if such claims are not successful, this litigation has resulted in additional costs to us and this litigation and any other claims we may face in the future could result in further substantial costs and diversion of our management’s attention and resources in the future, which could have a material adverse effect on our business, operating results or financial condition. Additionally, the increase in the cost of directors’ and officers’ liability insurance may cause us to opt for lower overall policy limits or to forgo insurance that we may otherwise rely on to cover significant defense costs, settlements and damages awarded to plaintiffs.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

Not applicable.

Item 3. Defaults Upon Senior Securities.

Not applicable.

Item 4. Mine Safety Disclosures.

Not applicable.

Item 5. Other Information.

Rule 10b5-1 Trading Plan

During the three months ended September 30, 2026, the following officers (as defined in Rule 16a-1(f) under the Exchange Act) adopted or terminated the contracts, instructions or written plans for the purchase or sale of securities of our company set forth in the table below.

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\n	\n	\n	\n	\n	\n
Name and Position	Action	Date	Rule 10b5-1*	Total Shares to be Sold	Expiration Date
Stephen Feider, Chief Financial Officer	Adoption	July 31, 2026	X	80,000	October 29, 2027
Sean Saint, President and Chief Executive Officer	Adoption	August 20, 2026	X	320,000	December 31, 2027
Maria Palasis, Director	Adoption	August 25, 2026	X	13,994	June 30, 2027
* Contract, instruction or written plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act.

Item 6. Exhibits.

\n	\n	\n	\n	\n	\n	\n
Exhibit Number	Description of Exhibit	Form	File No.	Exhibit	Filing Date	Filed Herewith
3.1	Amended and Restated Certificate of Incorporation of the Registrant.	8-K	001-42491	3.1	01/31/25
3.2	Amended and Restated Bylaws of the Registrant.	S-1	333-284147	3.4	01/06/25
4.1	Form of Common Stock Certificate.	S-1/A	333-284147	4.1	01/22/25
4.2	Amended and Restated Investor Rights Agreement, dated November 8, 2024, by and among the Registrant and certain of its stockholders.	S-1	333-284147	4.2	01/06/25
4.3	Form of Pre-Funded Warrant	8-K	001-42491	4.1	09/17/26
31.1	Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.					X
31.2	Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.					X
32.1+	Certification of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.					X
101.INS	Inline XBRL Instance Document–the instance document does not appear in the Interactive Data File as its XBRL tags are embedded within the Inline XBRL document					X
101.SCH	Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents					X
104	Cover page formatted as Inline XBRL and contained in Exhibit 101					X

+ The certification furnished in Exhibit 32.1 hereto is deemed to accompany this Quarterly Report on Form 10-Q and will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended. Such certification will not be deemed to be incorporated by reference into any filings under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except to the extent that the Registrant specifically incorporates it by reference.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized.

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\n	\n	\n	\n
		BETA BIONICS, INC.

Date: October 27, 2026		By:	/s/ Sean Saint
			Sean Saint
			President and Chief Executive Officer (Principal Executive Officer)

		By:	/s/ Stephen Feider
			Stephen Feider
			Chief Financial Officer (Principal Financial and Accounting Officer)

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10-Q - Beta Bionics, Inc. (0001674632) (Filer)