Beta Bionics, Inc.

Previous wording

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. T1D is an autoimmune disorder that often develops during childhood or adolescence, but can occur at any age, and arises from a person’s immune system attacking and destroying the insulin-producing beta cells in the pancreas. According to the Centers for Disease Control and Prevention (CDC), there are approximately 1.8 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. These systems require PWD to set and to periodically adjust several insulin pump parameters, to quantify daily carbohydrate intake, and to frequently calculate proper doses of insulin for their pump to deliver. We believe this complexity, and the constant engagement that is required in order to enjoy the full therapeutic benefits that these systems can offer, limits their uptake to a subset of PWD and to subspecialty healthcare providers (HCPs). 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. This is based on our internal estimates factoring epidemiologic data from government and leading industry organizations such as the CDC (to establish the overall size of the T1D population) and industry sales data from public filings and disclosures made by the leading device manufacturers (Medtronic, Tandem and Insulet, who collectively hold approximately 96% market share) and aggregated by third-party data service providers (to provide independent estimates of both overall device penetration of various diabetes populations). Our initial commercial results suggest that the iLet’s value proposition is resonating strongly within the MDI population as approximately 71% and 66% of the iLet’s adoption through March 31, 2025 and 2024, respectively, came from PWD who were previously utilizing MDI.

Current wording

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. T1D is an autoimmune disorder that often develops during childhood or adolescence, but can occur at any age, and arises from a person’s immune system attacking and destroying the insulin-producing beta cells in the pancreas. According to the Centers for Disease Control and Prevention (CDC), there are approximately 1.8 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. These systems require PWD to set and to periodically adjust several insulin pump parameters, to quantify daily carbohydrate intake, and to frequently calculate proper doses of insulin for their pump to deliver. We believe this complexity, and the constant engagement that is required in order to enjoy the full therapeutic benefits that these systems can offer, limits their uptake to a subset of PWD and to subspecialty healthcare providers (HCPs). 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. This is based on our internal estimates factoring epidemiologic data from government and leading industry organizations such as the CDC (to establish the overall size of the T1D population) and industry sales data from public filings and disclosures made by the leading device manufacturers (Medtronic, Tandem and Insulet, who collectively hold approximately 96% market share) and aggregated by third-party data service providers (to provide independent estimates of both overall device penetration of various diabetes populations). Our initial commercial results suggest that the iLet’s value proposition is resonating strongly within the MDI population as approximately 71% and 66% of the iLet’s adoption through six months ended June 30, 2025 and 2024, respectively, came from PWD who were previously utilizing MDI.

Previous wording

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 thethree months ended March 31, 2025 and 2024, PBP channel sales represented 22% and 6% of net sales, respectively.

Current wording

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, 2025 and 2024, PBP channel sales represented 21% and 6% of net sales, respectively.

Previous wording

In addition to our commercialized product and to maintain our competitive position in the marketplace, we intend to continue investing in disruptive technologies through our experienced research and development team. We are in the early stages of developing an insulin pump that adheres directly to the skin and administers insulin without the need for tubing, commonly known in the diabetes industry as a “patch pump.” We are also in the early stages of developing a first-of-its-kind bihormonal configuration 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, we are conducting a clinical trial to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of our glucagon product candidate (the PK-PD Trial). The PK-PD Trial is intended to enable us to bridge our previous bihormonal clinical data, which tested prior formulations of glucagon in three pre-pivotal inpatient and six pre-pivotal outpatient clinical trials, to our glucagon product candidate. In March 2025, we began enrolling patients into the PK-PD Trial in Canada. We also intend to pursue the development of the iLet for expanded patient populations and indications, such as people with type 2 diabetes (T2D), as we believe the size and composition of this population make it a compelling opportunity.

Current wording

In addition to our commercialized product and to maintain our competitive position in the marketplace, we intend to continue investing in disruptive technologies through our experienced research and development team. We are in the early stages of developing an insulin pump that adheres directly to the skin and administers insulin without the need for tubing, commonly known in the diabetes industry as a “patch pump.” We are also in the early stages of developing a first-of-its-kind bihormonal configuration 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, we are conducting a clinical trial to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of our glucagon product candidate (the PK-PD Trial). The PK-PD Trial is intended to enable us to bridge our previous bihormonal clinical data, which tested prior formulations of glucagon in three pre-pivotal inpatient and six pre-pivotal outpatient clinical trials, to our glucagon product candidate. In March 2025, we began enrolling patients into the PK-PD Trial in Canada. The clinical trial is currently ongoing. Preliminary PD data are supportive of continued development of the glucagon candidate. We expect to have full results from the PK-PD Trial in the second half of 2025, which will inform the go-forward development strategy for our glucagon product candidate. We also intend to pursue the development of the iLet for expanded patient populations and indications, such as people with type 2 diabetes (T2D), as we believe the size and composition of this population make it a compelling opportunity.

Previous wording

In May 2024, we and Xeris Pharmaceuticals, Inc. (Xeris) entered into a collaboration and license agreement (Collaboration and License Agreement). Under the Collaboration and License Agreement, we received a worldwide, exclusive, royalty-bearing, sublicensable license under certain patent rights and know-how related to Xeris’ proprietary non-aqueous formulation technology and technology developed during the collaboration (Xeris Technology) to develop and commercialize glucagon products that are reformulated using the Xeris Technology and developed by Xeris under a development plan under the Collaboration and License Agreement, for use in a pump product or system for glycemic control (Glucagon Products) in the field of chronic glycemic control in diabetes mellitus, excluding single-dose, one-time use form for treatment of severe hypoglycemia and diagnostic uses (Field). We also received a worldwide, exclusive, sublicensable manufacturing license under the Xeris Technology to manufacture Glucagon Products in the Field following a future manufacturing transfer date to be agreed with Xeris and subject to a separate commercial supply agreement.

Current wording

In May 2024, we and Xeris Pharmaceuticals, Inc. (Xeris) entered into a collaboration and license agreement (Collaboration and License Agreement). Under the Collaboration and License Agreement, we received a worldwide, exclusive, royalty-bearing, sublicensable license under certain patent rights and know-how related to Xeris’ proprietary non-aqueous formulation technology and technology developed during the collaboration (Xeris Technology) to develop and commercialize glucagon products that are reformulated using the Xeris Technology and developed by Xeris under a development plan under the Collaboration and License

Previous wording

In consideration for the licenses and other rights granted to us under the Collaboration and License Agreement, we paid Xeris a one-time payment of $0.5 million and a one-time milestone payment of $3.0 million for the achievement of certain development milestones, both of which are recognized as research and development expense when incurred. In addition, we are required to pay Xeris tiered royalties of low double-digit percentages based on net sales of Glucagon Products by us or our sublicensees, subject to certain customary reductions.

Current wording

In consideration for the licenses and other rights granted to us under the Collaboration and License Agreement, we paid Xeris a one-time payment of $0.5 million and a one-time milestone payment of $3.0 million for the achievement of certain development milestones, both of which are recognized as research and development expense when incurred. Additionally, we are required to pay Xeris tiered royalties of low double-digit percentages based on net sales of Glucagon Products by us or our sublicensees, subject to certain customary reductions.

Previous wording

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. Forthree months ended March 31, 2025 and 2024, PBP channel sales represented 22% and 6%, 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.

Current wording

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 six months ended June 30, 2025 and 2024, PBP channel sales represented 21% and 6%, 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.

Previous wording

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 (components of the iLet), 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 between the United States. and China, the Russia/Ukraine conflict, the Israel-Hamas war and global pandemics on U.S. and global economic conditions including changes in monetary and fiscal policy, United States political developments and other sources of instability.

Current wording

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 (components of the iLet), 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 between the United States and China, the Russia/Ukraine conflict, the conflict in the Middle East which has recently included actions by Iran, Hamas, Israel and the United States and global pandemics on the U.S., and global economic conditions, including changes in monetary and fiscal policy, United States political developments and other sources of instability.

Previous wording

Our other income (expense) consists of (i) interest income, (ii) other income and (iii) change in fair value of warrant liabilities.

Current wording

Our other income (expense) consists of (i) interest income, (ii) other income (expense) and (iii) change in fair value of warrant liabilities.

Previous wording

Other income consists of miscellaneous income unrelated to our core operations.

Current wording

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

Previous wording

Net sales for thethree months ended March 31, 2025 was $17.6 million, compared to $12.9 million for thethree months ended March 31, 2024. This $4.7 million increase in net sales was driven by an increase in the number of single-use products sold. With the increase in the installed customer base, iLet users' consumption of associated single-use products, which are disposed of and replaced every 2-3 days, also increased proportionally. For thethree months ended March 31, 2025, single-use products sales accounted for 43% of net sales, up from 18% of net sales as of thethree months ended March 31, 2024.

Current wording

Net sales for the six months ended June 30, 2025 was $40.9 million, compared to $28.0 million for thesix months ended June 30, 2024. This increase in net sales of $12.9 million was primarily driven by an increase in the number of single-use products sold, correlated to the growth in our installed base. For thesix months ended June 30, 2025, single-use products accounted for 42% of net sales, up from 19% of net sales as of thesix months ended June 30, 2024.

Previous wording

Research and development expenses were $7.6 million for thethree months ended March 31, 2025, compared to $5.5 million for thethree months ended March 31, 2024. This increase of $2.1 million was primarily attributable to a $1.1 million increase in engineering, materials, and clinical trial related expenses incurred for the development of our patch pump, bihormonal configuration of the iLet and incremental software and product updates. The remaining increase is attributable to a net increase of $0.9 million in payroll-related expenses and $0.1 million in allocated facilities-related expenses driven by an increase in headcount.

Current wording

Research and development expenses for thesix months ended June 30, 2025 was$16.5 million, compared to $11.8 million for thesix months ended June 30, 2024. The increase of $4.6 million was primarily attributable to a $2.1 million increase in engineering, materials, and clinical trial related expenses incurred for the development of our patch pump, bihormonal configuration of the iLet and incremental software and product updates. The remaining increase is attributable to a net increase of $2.2 million in payroll-related expenses, including stock-based compensation related to RSUs granted on March 15, 2025 to eligible employees under the 2025 Plan, driven by an increase in headcount primarily with our tech transfer team focused on supporting our innovation activities, and $0.3 million in allocated facilities-related expenses driven by an increase in headcount.

Previous wording

Sales and marketing expenses were $13.4 million for the three months ended March 31, 2025, compared to $7.7 million for the three months ended March 31, 2024. This increase of $5.7 million was primarily attributable to an increase of $3.6 million in payroll-related costs, including salaries and wages, sales incentive bonuses, and stock-based compensation, as well as an increase of $0.9 million in travel-related expenses, 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 $0.7 million in HCP-related marketing, training and professional education and $0.5 million in allocated facilities-related expenses driven by an increase in headcount.

Current wording

Sales and marketing expenses for the three months ended June 30, 2025 was $15.6 million, compared to $9.0 million for the three months ended June 30, 2024. The increase of $6.6 million was primarily attributable to an increase of $4.2 million in payroll-related costs, including salaries and wages, sales incentive bonuses, and stock-based compensation due to an increase in headcount of our sales force and customer care team in connection with the expansion of our sales territories within the United States. The remaining increase includes HCP-related marketing, training and professional education.

Previous wording

General and administrative expenses were $6.6 million for the three months ended March 31, 2025, compared to $3.5 million for the three months ended March 31, 2024. This increase of $3.1 million was primarily attributable to an increase of $1.5 million in payroll-related expenses, driven by an increase in headcount following the Company's growth post-commercialization, particularly within our quality assurance team to accommodate the growing demand for the iLet, as well as increased corporate bonus incentives provided to management level employees. The remaining increase is attributable to professional fees, including legal and accounting services of $0.8 million primarily related to our initial public offering, software license fees of $0.4 million, and other operating expenses of $0.4 million.

Current wording

General and administrative expenses for the three months ended June 30, 2025 was $7.9 million, compared to $4.5 million for the three months ended June 30, 2024. The increase of $3.3 million was primarily attributable to an increase of $2.2 million in payroll-related expenses, driven by an increase in headcount following the Company's initial public offering as well as increased stock-based compensation related to RSUs granted on March 15, 2025 to eligible employees under the 2025 Plan. The remaining increase is partially attributable to professional fees, including legal and accounting services of $0.5 million primarily related to operating as a public company.

Previous wording

Total other expense, net was $10.0 million for thethree months ended March 31, 2025, compared to $3.0 million for thethree months ended March 31, 2024. This increase of $7.0 million was attributable to a $8.3 million increase in expense from the change in fair value of our warrant liabilities due to changes in inputs associated with the fair value measurement immediately prior to our initial public offering. This was partially offset by a $1.3 million increase in interest income from our short-term and long-term investments.

Current wording

Total other expense, net for thesix months ended June 30, 2025 was $7.0 million, compared to $5.7 million for thesix months ended June 30, 2024. This increase of $1.3 million was attributable to a $4.6 million increase in expense from the change in fair value of our warrant liabilities due to changes in inputs associated with the fair value measurement immediately prior to our initial public offering compared to June 30, 2024. This was partially offset by a $3.3 million increase in interest income from our short-term and long-term investments due to the investment of our IPO proceeds during the first quarter of 2025.

Previous wording

We calculate adjusted EBITDA as net loss adjusted to exclude (i) depreciation and amortization expense, (ii) stock-based compensation expense, (iii) interest income, (iv) provision for state taxes and (v) change in fair value of warrant liabilities.

Current wording

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 expense and (vi) change in fair value of warrant liabilities.

Previous wording

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 and amortization expense are 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.

Current wording

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.

Previous wording

Our quarterly research and development expenses increased in all periods presented, except the second quarter of 2023 and third quarter of 2024, primarily due to increases in engineering, third-party consulting costs and payroll-related expenses incurred to support our continued research and development efforts to enhance our existing product and develop new products.

Current wording

Our quarterly research and development expenses increased in all periods presented, except the third quarter of 2024 and first quarter of 2025, primarily due to increases in engineering, third-party consulting costs and payroll-related expenses incurred to support our continued research and development efforts to enhance our existing product and develop new products.

Previous wording

Our general and administrative expenses increased in all periods presented, except the third quarter of 2023, primarily due to increases in payroll-related expenses driven by headcount increases in our quality assurance team, and public company costs, including accounting and audit services, insurance premiums and legal expenses, as well as expenses incurred for operational overhead expenses to meet the growing demand for the iLet.

Current wording

Our general and administrative expenses increased in all periods presented, except the fourth quarter of 2024, primarily due to increases in payroll-related expenses driven by headcount increases in our quality assurance team, and public company costs, including accounting and audit services, insurance premiums and legal expenses, as well as expenses incurred for operational overhead expenses to meet the growing demand for the iLet.

Previous wording

Our quarterly Adjusted EBITDA increased from the second quarter 2023 to the fourth quarter of 2023 primarily due to an increase in Net Sales and Gross Profit. Our quarterly Adjusted EBITDA decreased from the fourth quarter of 2023 to the third quarter of 2024 primarily due to increases in Sales & Marketing and Research & Development expenses. The decrease in Adjusted EBITDA from the third quarter of 2024 to the fourth quarter of 2024 was primarily driven by a $3.0 million milestone payment made to Xeris in the fourth quarter of 2024 for the achievement of certain developmental milestones. The decrease in Adjusted EBITDA from the fourth quarter of 2024 to the first quarter of 2025 was primarily driven by an increase in the change in fair value of warrant liabilities and an increase in stock compensation expenses as a result of additional headcount.

Current wording

Our quarterly Adjusted EBITDA increased from the third quarter 2023 to the fourth quarter of 2023 primarily due to an increase in Net Sales and Gross Profit. Our quarterly Adjusted EBITDA decreased from the fourth quarter of 2023 to the third quarter of 2024 primarily due to increases in Sales & Marketing and Research & Development expenses. The decrease in Adjusted EBITDA from the third quarter of 2024 to the fourth quarter of 2024 was primarily driven by a $3.0 million milestone payment made to Xeris in the fourth quarter of 2024 for the achievement of certain developmental milestones. The decrease in Adjusted EBITDA from the fourth quarter of 2024 to the first quarter of 2025 was primarily driven by an increase in the change in fair value of warrant liabilities and an increase in stock compensation expenses as a result of additional headcount. Adjusted EBITDA improved from the first quarter of 2025 to the second quarter of 2025 due to higher revenue, improved margins and increased operating leverage despite continued headcount increases.

Previous wording

In thethree months ended March 31, 2024, a low-single digit percentage of our new patient starts were reimbursed through the PBP channel. In the three months ended March 31, 2025, a low-twenties percentage of our new patient starts were reimbursed through the PBP channel. The increase in new patient starts through the pharmacy benefit pathway reflects enhanced formulary access and broader pharmacy coverage for iLet. These improvements are primarily attributable to the execution of contracts with key PBMs.

Current wording

In thesix months ended June 30, 2024, a mid-single digit percentage of our new patient starts were reimbursed through the PBP channel. In the six months ended June 30, 2025, a mid-twenties percentage of our new patient starts were reimbursed through the PBP channel. The increase in new patient starts through the pharmacy benefit pathway reflects enhanced formulary access and broader pharmacy coverage for iLet. These improvements are primarily attributable to the execution of contracts with key PBMs.

Previous wording

To date, we have funded our operations primarily with proceeds from the sale of our convertible preferred stock, raising an aggregate of approximately $356.6 million of gross proceeds, including net proceeds of approximately $101.7 million from the issuance and sale of our Series D convertible preferred stock in August 2023 and approximately $59.7 million from the issuance and sale of our Series E convertible preferred stock in November 2024. In January 2025, we completed our initial public offering and a concurrent private placement, pursuant to which we received aggregate net proceeds of approximately $190.4 million and approximately $15.6 million, respectively, in each case after deducting underwriting discounts, commissions, and other offering expenses. We have also received payments in connection with collaboration agreements and government grants, receiving $6.1 million to date from these types of arrangements, as well as from the sale of the iLet and single-use products utilized with the iLet from our contracts with customers. As of March 31, 2025, we had cash, cash equivalents and short-term and long-term investments of $295.5 million.

Current wording

To date, we have funded our operations primarily with proceeds from the sale of our convertible preferred stock, raising an aggregate of approximately $356.6 million of gross proceeds, including net proceeds of approximately $101.7 million from the issuance and sale of our Series D convertible preferred stock in August 2023 and approximately $59.7 million from the issuance and sale of our Series E convertible preferred stock in November 2024. In January 2025, we completed our initial public offering and a concurrent private placement, pursuant to which we received aggregate net proceeds of approximately $190.4 million and approximately $15.6 million, respectively, in each case after deducting underwriting discounts, commissions, and other offering expenses. We have also received payments in connection with collaboration agreements and government grants, receiving $6.1 million to date from these types of arrangements, as well as from the sale of the iLet and single-use products utilized with the iLet from our contracts with customers. As of June 30, 2025, we had cash, cash equivalents and short-term and long-term investments of $280.9 million.

Previous wording

During the three months ended March 31, 2025, net cash used in operating activities was $20.0 million, primarily resulting from our net loss of $28.7 million and net cash used by changes in our operating assets and liabilities of $6.5 million. This was partially offset by non-cash charges of $15.2 million, including $12.5 million attributable to the change in fair value of our warrant liabilities as a result of the remeasurement, $2.8 million in stock-based compensation expense due to increase in headcount, $0.3 million in amortization of operating lease right-of-use asset, $0.3 million in depreciation expense, $0.1 million in provision for excess and obsolete inventory and $0.1 million in provision for net realizable value of inventory, partially offset by the $0.9 million in accretion of discount on short-term investments. Changes in our operating assets and liabilities for the three months ended March 31, 2025 are primarily attributable to a $2.6 million increase in inventories from the growth in commercial sales. Additionally, there was a $1.6 million increase in prepaid expenses and other current assets attributable to directors and officers insurance premiums, prepaid material components, and software license renewals, a $0.1 million increase in accounts payable, a $5.3 million decrease in accrued expenses and other current liabilities from the payout of the 2024 accrual bonus, and a $0.3 million decrease in operating lease liabilities. These were partially offset by a $2.9 million decrease in accounts receivable due to collections and a $0.5 million increase in deferred revenue.

Current wording

During the six months ended June 30, 2025, net cash used in operating activities was $33.6 million, primarily resulting from our net loss of $45.5 million and net cash used by changes in our operating assets and liabilities of $8.0 million. This was partially offset by non-cash charges of $19.9 million, including $12.5 million attributable to the change in fair value of our warrant liabilities as a result of the remeasurement, $7.6 million in stock-based compensation expense due to increase in headcount, $0.6 million in amortization of operating lease right-of-use asset, $0.6 million in depreciation expense, $0.2 million in provision for excess and obsolete inventory and $0.2 million in provision for net realizable value of inventory, partially offset by the $1.7 million in accretion of discount on short-term investments. Changes in our operating assets and liabilities for the six months ended June 30, 2025 are primarily attributable to a $4.4 million increase in inventories from the growth in commercial sales, a $3.6 million increase in prepaid expenses and other current assets attributable to directors and officers insurance premiums, prepaid material components, and software license renewals, a $2.6 million decrease in accrued expenses and other current liabilities due primarily to the payout of the 2024 corporate bonus offset by the six months of accrual for 2025 corporate bonus based on company goals, and a $0.6 million decrease in operating lease liabilities. These decreases to cash were offset by a $.6 million decrease in accounts receivable due to additional collections offset by revenue recognized from sales, a $0.5 million increase to accounts payable, a $1.0 million increase to other long-term liabilities, and a $1.0 million increase in deferred revenue.

Previous wording

During the three months ended March 31, 2024, net cash used in operations was $12.1 million, primarily attributable to our net loss of $12.4 million and net cash used by changes in our operating assets and liabilities of $4.9 million. The net cash used by changes in our operating assets and liabilities was partially offset by non-cash charges of $5.2 million, including $4.1 million attributable to the change in the fair value of our warrant liabilities during the year, $1.4 million in stock-based compensation expense due to increase in headcount, $0.3 million in depreciation expense and $0.3 million in amortization of operating lease right-of-use asset, partially offset by the $0.9 million in accretion of discount on short-term investments. For three months ended March 31, 2024, net cash used from changes in our operating assets and liabilities was primarily attributable to a $1.9 million increase in accounts receivable due to an increase in commercial sales of the iLet and a $2.4 million increase in inventories from the growth in commercial sales. Additionally, there was a $1.1 million increase in prepaid expenses and other current assets attributable to prepaid material components, software license renewals and clinical supply purchases, a $0.2 million decrease in accrued expenses and other current liabilities and a $0.2 million decrease in operating lease liabilities. These were partially offset by a $0.4 million increase in accounts payable and a $0.5 million increase in deferred revenue.

Current wording

During the six months ended June 30, 2024, net cash used in operations was $24.4 million, primarily attributable to our net loss of $26.9 million and net cash used by changes in our operating assets and liabilities of $7.6 million. The net cash used by changes in our operating assets and liabilities was partially offset by non-cash charges of $10.1 million, including $7.8 million attributable to the change in the fair value of our warrant liabilities during the year, $2.9 million in stock-based compensation expense due to increase in headcount, $0.6 million in depreciation expense and $0.6 million in amortization of operating lease right-of-use asset, partially offset by the $1.7 million in accretion of discount on short-term investments. For six months ended June 30, 2024, net cash used from changes in our operating assets and liabilities was primarily attributable to a $4.6 million increase in accounts receivable due to an increase in commercial sales of the iLet, a $6.3 million increase in inventories from the growth in commercial sales, and $0.9 million increase in prepaid expenses and other current assets attributable to prepaid material components, software license renewals and clinical supply purchases, and a $0.5 million decrease in operating lease liabilities. These decreases to cash were offset by a $1.5 million increase in accounts payable, a $2.1 million increase in accrued expenses and other current liabilities due primarily to the payout of the 2023 corporate bonus net with the accrual for 2024 corporate bonus based on company goals, and a $1.1 million increase in deferred revenue.

Previous wording

During the three months ended March 31, 2025, net cash used in investing activities was $179.1 million, primarily attributable to $142.9 million in purchases of short-term investments and $63.9 million in purchases of long-term investments based on the proceeds received from our IPO in January 2025 as well as $0.3 million in additional investment in property and equipment for additional manufacturing equipment, offset by a $28.0 million in proceeds from maturities and redemptions of short-term investments.

Current wording

During the six months ended June 30, 2025, net cash used in investing activities was $172.9 million, primarily attributable to $190.8 million in purchases of short-term investments and $31.1 million in purchases of long-term investments based on the proceeds received from our IPO in January 2025 as well as $2.1 million in additional investment in property and equipment for additional manufacturing equipment. These decreases to cash are offset by $51.0 million in proceeds from maturities and redemptions of short-term investments.

Previous wording

During the three months ended March 31, 2024, net cash used in investing activities was $7.6 million, primarily attributable to a $8.0 million in proceeds from maturities and redemptions of short-term investments, offset by $0.4 million in purchases of short-term investments.

Current wording

During the six months ended June 30, 2024, net cash provided by investing activities was $10.9 million, primarily attributable to $32.0 million in proceeds from maturities and redemptions of short-term investments, offset by $20.2 million in purchases of short-term investments and $0.9 million in additional investment in property and equipment for additional manufacturing equipment.

Previous wording

During thethree months ended March 31, 2025, net cash provided by financing activities was $211.1 million, primarily attributable to the net proceeds of $195.4 million received from our IPO and $15.6 million from the private placement.

Current wording

During thesix months ended June 30, 2025, net cash provided by financing activities was $211.2 million, primarily attributable to the net proceeds of $195.4 million received from our IPO,$15.6 million from the private placement, and $0.1 million from stock option exercises.

Previous wording

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

Current wording

the impact of geopolitical and macroeconomic events, including tariffs or other trade measures, future bank failures, increased geopolitical tensions between the United States and China, the Russia/Ukraine conflict, the conflict in the Middle East which has recently included actions by Iran, Hamas, Israel and the United States and global pandemics, on U.S. and global economic conditions including changes in monetary and fiscal policy, United States political developments and other sources of instability that may impact our ability to access capital on acceptable terms, if at all.

Previous wording

In May 2024, in connection with research and development activities, we entered into an exclusive worldwide License and Collaboration Agreement with Xeris which contains a number of contractual obligations. In consideration for the licenses and other rights granted to us under the License and Collaboration 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 the arrangement with Xeris, during the twelve months ended December 31, 2024, we ordered $0.9 million in clinical material, covering both material and labor costs, to be used in phase 2 clinical trials and have paid a deposit equal to 30% of the estimated clinical material costs, which is recognized in prepaid expenses and other current assets in the condensed balance sheets. As of March 31, 2025, the clinical material has been delivered to us and the remaining payment of $0.6 million was made in March 2025. In addition, we are required to pay tiered royalties of low double-digit percentages based on net sales of Glucagon Products, subject to certain reductions. For additional information, see the subsection above titled “—License and Collaboration Agreements.” We may continue to incur costs as we progress into Phase 2 and Phase 3 clinical trials.

Current wording

In May 2024, in connection with research and development activities, we entered into an exclusive worldwide License and Collaboration Agreement with Xeris which contains a number of contractual obligations. In consideration for the licenses and other rights granted to us under the License and Collaboration 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, during the twelve months ended December 31, 2024, under our Clinical Supply Agreement with Xeris, we ordered clinical material totaling $0.9 for Phase 2 clinical trials and paid a deposit equal to 30% of the estimated clinical material costs, which was recognized in prepaid expenses and other current assets in the condensed balance sheets. As of March 31, 2025, the clinical material has been delivered to us and the remaining payment of $0.6 million was made.