BBNX

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. 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 71% of the iLet’s adoption during the six months ended June 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. 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. 22 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. 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 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 six months ended June 30, 2026 and 2025, PBP channel sales represented 37% 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. 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 developing Mint, a next-generation, tubeless insulin patch pump designed to provide the same adaptive closed-loop automation of the iLet in a discreet, wearable format. The device features a two-part design, including a reusable controller that houses the electronics and adaptive algorithm paired with a disposable cartridge. The system will be waterproof, smartphone-controlled through iOS and Android applications, and designed for efficient large-scale manufacturing with reduced environmental waste. We expect Mint to expand the addressable insulin delivery market, particularly among people seeking a tubeless form factor reimbursed through the pharmacy channel. Subject to receiving FDA 510(k) clearance as an alternate controller enabled (ACE) pump, we expect to fully commercialize Mint by the end of the second quarter of 2027. We are also 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 23 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. We are also pursuing the development of the iLet for expanded patient populations and indications, including people with type 2 diabetes (T2D). In July 2026, we began enrolling 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. 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 six months ended June 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 six months ended June 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 June 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 24 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 June 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 six months ended June 30, 2026 and 2025, PBP channel sales represented 37% 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. 25 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 patch pump and a bihormonal system of the iLet, as well as pursuing the development of the iLet 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 Mint, our patch pump, and a bihormonal system of the iLet, as well as pursue the development of the iLet 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. 26 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, 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, Mint, our patch pump, and potential T2D use, 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. 27 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 six months ended June 30, 2026 and 2025 The following table summarizes our results of operations for the periods indicated: Three Months Ended June 30, Change 2026 2025 $ % (in thousands, except percentages) Net sales $ 32,013 $ 23,238 $ 8,775 38 % Cost of sales(1) 13,111 10,735 2,376 22 % Gross profit 18,902 12,503 6,399 51 % Operating expenses: Research and development(1) 10,240 8,873 1,367 15 % Sales and marketing(1) 24,640 15,623 9,017 58 % General and administrative(1) 9,600 7,879 1,721 22 % Total operating expenses 44,480 32,375 12,105 37 % Loss from operations (25,578 ) (19,872 ) (5,706 ) 29 % Other income (expense): Interest income 2,177 3,005 (828 ) -28 % Other expense (2 ) (2 ) — * Total other income (expense), net 2,175 3,003 (828 ) -28 % Net loss $ (23,403 ) $ (16,869 ) $ (6,534 ) 39 % 28 Six Months Ended June 30, Change 2026 2025 $ % (in thousands, except percentages) Net sales $ 59,639 $ 40,877 $ 18,762 46 % Cost of sales(1) 24,300 19,403 4,897 25 % Gross profit 35,339 21,474 13,865 65 % Operating expenses: Research and development(1) 20,596 16,463 4,133 25 % Sales and marketing(1) 45,375 29,025 16,350 56 % General and administrative(1) 19,217 14,500 4,717 33 % Total operating expenses 85,188 59,988 25,200 42 % Loss from operations (49,849 ) (38,514 ) (11,335 ) 29 % Other income (expense): Interest income 4,553 5,441 (888 ) -16 % Other expense (2 ) (2 ) — * Change in fair value of warrant liabilities — (12,450 ) 12,450 -100 % Total other income (expense), net 4,551 (7,011 ) 11,562 -165 % Net loss $ (45,298 ) $ (45,525 ) $ 227 0 % * 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 June 30, 2026 was $32.0 million, compared to $23.2 million for the three months ended June 30, 2025. The increase in net sales of $8.8 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 June 30, 2026, single-use products accounted for 60% of net sales, up from 41% for the three months ended June 30, 2025. For the three months ended June 30, 2026, 64% of net sales were generated through the DME channel and 36% through the PBP channel, compared to 80% and 20%, respectively, for the three months ended June 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 six months ended June 30, 2026 was $59.6 million, compared to $40.9 million for the six months ended June 30, 2025. This increase in net sales of $18.7 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 six months ended June 30, 2026, single-use products accounted for 61% of net sales, up from 42% for the six months ended June 30, 2025. For the six months ended June 30, 2026, 63% of net sales were generated through the DME channel and 37% through the PBP channel, compared to 79% and 21%, respectively, for the six months ended June 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. 29 Cost of Sales Cost of sales for the three months ended June 30, 2026 was $13.1 million, compared to $10.7 million for the three months ended June 30, 2025. This increase of $2.4 million was primarily attributable to increased volumes of single-use products and pharmacy iLets. Cost of sales for the six months ended June 30, 2026 was $24.3 million, compared to $19.4 million for the six months ended June 30, 2025. This increase of $4.9 million was primarily attributable to increased volumes of single-use products and pharmacy iLets. Gross Profit and Gross Margin Gross profit for the three months ended June 30, 2026 was $18.9 million, compared to $12.5 million for the three months ended June 30, 2025. Gross margin was 59% for the three months ended June 30, 2026, compared to 54% in the three months ended June 30, 2025. Gross profit increased by $6.4 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 six months ended June 30, 2026 was $35.3 million, compared to $21.5 million for the six months ended June 30, 2025. Gross margin was 59% for the six months ended June 30, 2026, compared to 53% in the six months ended June 30, 2025. Gross profit increased by $13.8 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 June 30, 2026 was $10.2 million, compared to $8.9 million for the three months ended June 30, 2025. The increase of $1.3 million was primarily attributable to a net increase of $1.5 million in payroll-related expenses, including stock-based compensation, driven by an increase in headcount focused on supporting our innovation activities. This increase was partially offset by lower materials 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, primarily due to the timing of development activities and the completion of certain milestones. Research and development expenses for the six months ended June 30, 2026 was $20.6 million, compared to $16.5 million for the six months ended June 30, 2025. The increase of $4.1 million was primarily attributable to a net increase of $3.0 million in payroll-related expenses, including stock-based compensation, driven by an increase in headcount focused on supporting our innovation activities. The remaining increase is primarily attributable to higher materials and engineering expenses incurred in the development of Mint, our patch pump, the bihormonal system of the iLet and incremental software and product updates, partially offset by lower clinical trial-related expenses due to the timing of trial activities and completion of certain prior studies. The table below summarizes the nature of research and development expense by major expense category: Three Months Ended June 30, Change 2026 2025 $ % (in thousands, except percentages) External research and development(1) $ 1,141 $ 1,349 $ (208 ) (15 )% Internal research and development(2) 7,463 6,600 863 13 % Stock-based compensation 1,636 924 712 77 % Total research and development expense $ 10,240 $ 8,873 $ 1,367 15 % Six Months Ended June 30, Change 2026 2025 $ % (in thousands, except percentages) External research and development(1) $ 2,401 $ 3,121 $ (720 ) (23 )% Internal research and development(2) 15,421 11,916 3,505 29 % Stock-based compensation 2,774 1,426 1,348 95 % Total research and development expense $ 20,596 $ 16,463 $ 4,133 25 % (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. 30 (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 June 30, 2026 was $24.6 million, compared to $15.6 million for the three months ended June 30, 2025. The increase of $9.0 million was primarily attributable to an increase of $6.0 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 training and travel-related costs to support our business growth. Sales and marketing expenses for the six months ended June 30, 2026 was $45.4 million, compared to $29.0 million for the six months ended June 30, 2025. The increase of $16.4 million was primarily attributable to an increase of $11.3 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 June 30, 2026 was $9.6 million, compared to $7.9 million for the three months ended June 30, 2025. The increase of $1.7 million was primarily attributable to an increase of $1.4 million in payroll-related expenses, including stock-based compensation, due to an increase in headcount, as well as increases in software-related expenses and legal fees. These increases were partially offset by a decrease in accounting and other professional service fees. General and administrative expenses for the six months ended June 30, 2026 was $19.2 million, compared to $14.5 million for the six months ended June 30, 2025. The increase of $4.7 million was primarily attributable to an increase of $2.7 million in payroll-related expenses, including stock-based compensation, due to an increase in headcount, as well as increases in software-related expenses, quality remediation expenses, and legal fees. These increases were partially offset by a decrease in accounting and other professional service fees. Other Income (Expense) Total other income (expense), net for the three months ended June 30, 2026 was $2.2 million of income, compared to $3.0 million of income for the three months ended June 30, 2025. This change of $0.8 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 six months ended June 30, 2026 was $4.6 million of income, compared to $7.0 million of expense for the six months ended June 30, 2025. This change of $11.6 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 the Company’s 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 June 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. 31 The following tables set forth our selected unaudited quarterly statements of operations data for the periods presented: Three Months Ended September 30, 2025 December 31, 2025 March 31, 2026 June 30, 2026 (unaudited) (in thousands, except percentages) Net sales $ 27,253 $ 32,121 $ 27,626 $ 32,013 Cost of sales(1) 12,134 13,177 11,189 13,111 Gross profit 15,119 18,944 16,437 18,902 Gross margin 55.5 % 59.0 % 59.5 % 59.0 % Operating expenses: Research and development(1) 8,195 10,131 10,356 10,240 Sales and marketing(1) 16,045 16,334 20,735 24,640 General and administrative(1) 7,922 8,603 9,617 9,600 Total operating expenses 32,162 35,068 40,708 44,480 Loss from operations (17,043 ) (16,124 ) (24,271 ) (25,578 ) Other income (expense): Interest income 2,833 2,658 2,376 2,177 Other income (expense), net 1 — — (2 ) Total other income (expense), net 2,834 2,658 2,376 2,175 Net loss $ (14,209 ) $ (13,466 ) $ (21,895 ) $ (23,403 ) Adjusted EBITDA $ (12,179 ) $ (10,512 ) $ (17,718 ) $ (17,656 ) Three Months Ended September 30, 2024 December 31, 2024 March 31, 2025 June 30, 2025 (unaudited) (in thousands, except percentages) Net sales $ 16,705 $ 20,440 $ 17,639 $ 23,238 Cost of sales(1) 7,791 8,751 8,668 10,735 Gross profit 8,914 11,689 8,971 12,503 Gross margin 53.4 % 57.2 % 50.9 % 53.8 % Operating expenses: Research and development(1) 5,141 9,214 7,590 8,873 Sales and marketing(1) 9,645 10,804 13,402 15,623 General and administrative(1) 5,105 4,708 6,621 7,879 Total operating expenses 19,891 24,726 27,613 32,375 Loss from operations (10,977 ) (13,037 ) (18,642 ) (19,872 ) Other income (expense): Interest income 826 951 2,436 3,005 Other income (expense), net (4 ) — — (2 ) Change in fair value of warrant liabilities 419 (6,022 ) (12,450 ) — Total other income (expense), net 1,241 (5,071 ) (10,014 ) 3,003 Net loss $ (9,736 ) $ (18,108 ) $ (28,656 ) $ (16,869 ) Adjusted EBITDA $ (8,672 ) $ (11,254 ) $ (15,535 ) $ (14,526 ) (1)Includes stock-based compensation expense as follows: Three Months Ended September 30, 2025 December 31, 2025 March 31, 2026 June 30, 2026 (unaudited) (in thousands) Cost of sales $ 140 $ 143 $ 164 $ 206 Research and development 893 886 1,138 1,636 Sales and marketing 1,273 1,237 1,615 2,239 General and administrative 2,172 2,037 2,489 2,935 Total stock-based compensation expense $ 4,478 $ 4,303 $ 5,406 $ 7,016 32 Three Months Ended September 30, 2024 December 31, 2024 March 31, 2025 June 30, 2025 (unaudited) (in thousands) Cost of sales $ 69 $ 74 $ 106 $ 153 Research and development 294 300 502 924 Sales and marketing 472 511 801 1,314 General and administrative 1,141 666 1,395 2,408 Total stock-based compensation expense $ 1,976 $ 1,551 $ 2,804 $ 4,799 The following tables set forth our selected unaudited quarterly key business metrics for the periods presented: Three Months Ended September 30, 2025 December 31, 2025 March 31, 2026 June 30, 2026 (unaudited) % of Total Net Sales: Durable Medical Equipment (DME) Channel 77 % 70 % 61 % 64 % Pharmacy Benefit Plan (PBP) Channel 23 % 30 % 39 % 36 % Total 100 % 100 % 100 % 100 % % of New Patient Starts (NPS) Reimbursed Through Pharmacy Low 30s % Low 30s % High 30s % High 30s % Three Months Ended September 30, 2024 December 31, 2024 March 31, 2025 June 30, 2025 (unaudited) % of Total Net Sales: Durable Medical Equipment (DME) Channel 87 % 88 % 78 % 80 % Pharmacy Benefit Plan (PBP) Channel 13 % 12 % 22 % 20 % Total 100 % 100 % 100 % 100 % % of New Patient Starts (NPS) Reimbursed Through Pharmacy High-single digit % Low-teens % Low 20s % High 20s % 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. 33 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 June 30, 2026: Three Months Ended September 30, 2025 December 31, 2025 March 31, 2026 June 30, 2026 (unaudited) (in thousands) Net loss $ (14,209 ) $ (13,466 ) $ (21,895 ) $ (23,403 ) Add: Depreciation expense 386 537 585 709 Stock-based compensation expense 4,478 4,303 5,406 7,016 Interest income (2,833 ) (2,658 ) (2,376 ) (2,177 ) Income tax expense (benefit) (1 ) — — 2 Litigation settlement and other related expense — 210 — 135 Quality system remediation(1) — 562 562 62 Adjusted EBITDA $ (12,179 ) $ (10,512 ) $ (17,718 ) $ (17,656 ) (1)Amounts presented under “Quality system remediation” for the three months ended December 31, 2025, March 31, 2026, and June 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. Three Months Ended September 30, 2024 December 31, 2024 March 31, 2025 June 30, 2025 (unaudited) (in thousands) Net loss $ (9,736 ) $ (18,108 ) $ (28,656 ) $ (16,869 ) Add: Depreciation expense 333 232 303 347 Stock-based compensation expense 1,976 1,551 2,804 4,799 Interest income (826 ) (951 ) (2,436 ) (3,005 ) Income tax expense — — — 2 Litigation settlement and other related expense — — — 200 Change in fair value of warrant liabilities (419 ) 6,022 12,450 — Adjusted EBITDA $ (8,672 ) $ (11,254 ) $ (15,535 ) $ (14,526 ) 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. 34 Selected Quarterly Trends Net sales Net sales generally increased across the periods presented, primarily driven by continued growth in new patient starts and higher sales of both iLets and supplies. The quarterly trend reflects continued commercial adoption of the iLet and growth in the Company’s 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, and higher product warranty costs, partially offset by improved manufacturing efficiencies. 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, driven by material cost savings, increased production volumes, and improved manufacturing cost absorption. Gross margin remained relatively consistent at approximately 59% from the fourth quarter of 2025 through the second quarter of 2026. The proportion of new patient starts reimbursed through the PBP remained in the high-30% range in the second quarter of 2026, consistent with the first quarter of 2026. The higher PBP mix compared to prior-year periods reflects 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. 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, bihormonal system of the iLet 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 and education efforts. General and administrative expenses generally increased over the periods presented, primarily due to higher payroll-related costs, public company expenses, including audit, legal and insurance services, and increased operational overhead to support business 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, improving gross margins and operating leverage more than offset increases in operating expenses, but declined in the first half of 2026 compared to the fourth quarter of 2025 primarily due to seasonal factors and higher operating expenses to support continued commercial growth. Variability across prior periods was also impacted by discrete items, including a milestone payment to Xeris in the fourth quarter of 2024 and quality system remediation expenses in the fourth quarter of 2025 and first half of 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 our iLet, including future development of Mint, our patch pump, and the bihormonal system of the iLet. To date, we have funded our operations primarily through equity financings, including our IPO completed in January 2025, as well as revenue generated from the sale of the iLet and related single-use products. We have also received payments under 35 collaboration agreements and government grants. As of June 30, 2026, we had cash, cash equivalents and short-term and long-term investments of $225.2 million. Cash Flows The following table summarizes our cash flows for the periods presented: Six Months Ended June 30, 2026 2025 (in thousands) Net cash used in operating activities $ (38,454 ) $ (33,569 ) Net cash provided by (used in) investing activities 48,772 (172,949 ) Net cash provided by financing activities 2,424 211,161 Net increase (decrease) in cash, cash equivalents and restricted cash $ 12,742 $ 4,643 Operating Activities Net cash used in operating activities was $38.5 million for the six months ended June 30, 2026, compared to $33.6 million for the six months ended June 30, 2025. The increase in net cash used of $4.9 million was primarily driven by the impact of a $12.5 million non-cash adjustment from the change in fair value of warrant liabilities in the prior year period, which did not recur in the current period due to the net exercise of warrant liabilities upon our IPO in January 2025, partially offset by higher stock-based compensation expense, a favorable change in amortization of premiums and discounts on investments, higher depreciation expense, and a lower net loss in the current period. Working capital activity was relatively consistent year-over-year, as favorable changes in prepaid expenses and other current assets due to timing of payments on software licenses and prepaid inventory, were mostly offset by higher cash outflows from accrued expenses and other current liabilities due to timing of services incurred and accounts payable due to timing of vendor payments, mainly on inventory and progress billings on capital purchases. Investing Activities Net cash provided by investing activities was $48.8 million for the six months ended June 30, 2026, compared to net cash used of $172.9 million for the six months ended June 30, 2025. The increase of $221.7 million of cash provided by investing activities was primarily driven by reduced investment activity in the current period following the deployment of IPO proceeds in the prior year period. Specifically, purchases of short-term investments decreased by $190.8 million and proceeds from maturities and redemptions of short-term investments increased by $45.0 million. These increases in cash provided were partially offset by a $13.7 million increase in purchases of long-term investments as part of our cash management strategy and a $0.3 million increase in purchases of property and equipment to support further development of Mint, our patch pump. Financing Activities Net cash provided by financing activities was $2.4 million for the six months ended June 30, 2026, compared to $211.2 million for the six months ended June 30, 2025. The decrease of $208.8 million was primarily due to IPO-related financing activities in the prior year period, which included $195.4 million in net proceeds from the Company’s IPO and $15.6 million from the concurrent private placement. This decrease was partially offset by a $2.3 million increase in proceeds from stock option exercises and employee stock purchase plan issuances in the current period. 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 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), the iLet for T2D and Mint, our patch pump; •future revenue generated by sales of the iLet and any future product candidates, if approved; •costs associated with scaling up and expanding our manufacturing capacity; 36 •costs associated with building and expanding our sales and marketing efforts in the United States and, in the future, internationally; •costs associated with conducting research and development efforts for future improvements to the iLet; •costs associated with conducting research and development efforts for future product offerings, such as Mint, our patch pump, and 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 through the first half of 2028. We have based this estimate 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, as well as potentially 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 June 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, 37 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 June 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 38 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. •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. •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. •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. •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. •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 39 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.

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, the Company is not required to provide the information required by this item.

From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. There are currently no claims or actions pending against us that we believe could have, individually or in the aggregate, a material adverse effect on our results of operations, financial condition or cash flows. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other 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 the Development, Regulatory Approval and Commercialization of our iLet Bionic Pancreas and Product Candidates We are highly dependent on the success of our iLet for the treatment of T1D, which is cleared by the FDA for commercial sale in the United States for the treatment of T1D, and we do not have any other commercial products. If we are unable to obtain and maintain regulatory clearance or approval for planned modifications to the iLet or for new indications, or for any current or future development-stage products, or if we are unsuccessful in our efforts to continue to commercialize our cleared version of the iLet, our business will be materially harmed. We only 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. We currently have no other products cleared for sale and may never be able to develop other marketable products. 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. In addition, we are developing Mint, an insulin pump, also commonly referred to as a “patch pump,” for which we have submitted a 510(k) application to the FDA. We currently expect to fully commercialize Mint by the end of the second quarter of 2027, subject to regulatory clearance by the FDA. However, there can be no assurance that the FDA will clear the Mint 510(k) application on the anticipated timeline, or at all, 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 our iLet, Mint and any other product candidate is subject to a number of risks, including the following: •completion of preclinical studies with favorable results; •successful enrollment in, and completion of, planned and future clinical trials with favorable results; •sufficiency of our financial and other resources to complete the necessary clinical trials and regulatory activities; •successful patient enrollment in clinical trials; •successful data from our clinical program that supports an acceptable risk-benefit profile in the intended populations; •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; •receipt and maintenance of marketing authorizations or clearances from applicable regulatory authorities; •obtaining and maintaining patent and trade secret protection and regulatory exclusivity for our iLet; •making arrangements with third-party manufacturers and ensuring such third-party manufacturers supply sufficient quantities of components of our products and product candidates; •scaling up our manufacturing capabilities, for both commercial and clinical supplies of our products and product candidates; 41 •entry into collaborations to further the development of our iLet’s capabilities; •expanding sales, marketing and distribution capabilities as we continue our commercialization efforts of the iLet, whether alone or in collaboration with others; •successfully launching commercial sales of the iLet, patch pump and any other product candidate, if authorized for marketing or cleared; •acceptance of our products by PWD, the medical community and third-party payors; •maintaining a continued acceptable safety profile following marketing authorization or clearance; •maintaining regulatory compliance; •effectively competing with other treatment options and the availability, perceived advantages, relative cost, relative safety and relative effectiveness of alternative and competing treatments; •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; •maintaining healthcare coverage and adequate reimbursement from third-party payors; •continuing to build and maintain an organization of people who can successfully develop our products; and •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 process, 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 obtaining marketing authorization or clearance for the iLet in its bihormonal system for the treatment of T1D or in other indications, such as T2D, the investigational glucagon product, Mint, 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, Mint, the investigational glucagon product, or any other development-stage products. If we are unable to continue commercializing the iLet 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 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 in development, 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: •properly identify and anticipate physician and patient needs, and develop enhancements to meet those needs; •demonstrate, if required, the safety and effectiveness of new enhancements to our products, including additional indications, with data from preclinical studies and clinical trials; 42 •obtain in a timely manner the necessary marketing authorization or clearance for new enhancements to the iLet, product modifications or expanded indications; •avoid infringing upon the intellectual property rights of third parties; •comply with all applicable laws and regulations, including those governing the marketing of new devices or modified products; •develop an effective and dedicated sales and marketing team to provide adequate education and training to potential users of the iLet; and •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 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: •untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties; •unanticipated expenditures to address or defend such actions; •customer notification, or orders for repair, replacement or refunds; •voluntary or mandatory recall or seizure of our current or future products; •administrative detention by the FDA of medical devices believed to be adulterated or misbranded; •operating restrictions, suspension or shutdown of production; •refusing our requests for marketing authorization or clearance of new products, or new intended uses or modifications to the iLet; •suspending or withdrawing marketing authorizations or clearances that have already been granted; and •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 43 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 second quarter of 2027, subject to regulatory clearance by the FDA. 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. 44