Beta Bionics, Inc.
For the period ended Sep 30, 2026. Filed Oct 27, 2026.
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Sep 30, 2026 · Filed Oct 27, 2026
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Notes to Financial Statements (Unaudited)
NOTES TO FINANCIAL STATEMENTS
Organization and Basis of Presentation
The Company
Beta Bionics, Inc. (the “Company”) is a commercial-stage medical device company focused on the design, development and commercialization of solutions to improve the health and quality of life of insulin-requiring people with diabetes (PWD) through the use of adaptive closed-loop algorithms. The Company was incorporated as a Massachusetts benefit corporation in October 2015 and converted to a Delaware corporation in August 2024. The Company’s commercially available product, the iLet, was cleared by the U.S. Food and Drug Administration (the “FDA”) in May 2023 for the treatment of type 1 diabetes in adults and children six years of age and older, and the Company commenced U.S. commercialization in May 2023. In September 2026, the Company received FDA clearance for Mint, its patch pump. The Company has not yet commenced commercial sales of Mint.
The Company has devoted its resources to research and development, manufacturing scale-up and commercialization of its products. The Company has funded its operations primarily through equity financings and revenue from product sales.
Basis of Presentation
The Company’s unaudited condensed financial statements have been prepared pursuant to the rules and regulations of the U.S. Securities and Exchange Commission applicable to interim financial information. Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) have been condensed or omitted pursuant to such rules and regulations. Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC”).
Interim financial results are not necessarily indicative of results anticipated for the full year or any other period(s). These unaudited condensed financial statements should be read in conjunction with the audited financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025 (“2025 Annual Report”).
Emerging Growth Company Status
The Company is an emerging growth company, as defined in the JOBS Act, enacted in 2012. Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued after the enactment of the JOBS Act until those standards apply to private companies. The Company has elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that it (i) is no longer an emerging growth company or (ii) affirmatively and irrevocably opts out of the extended transition period provided in the JOBS Act. As a result, these financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates.
Significant Accounting Policies
Use of Estimates
The preparation of the financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, certain judgments regarding revenue recognition, including variable consideration, inventory valuation, warranty reserve and valuation of stock-based compensation awards. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates as there are changes in circumstances, facts, and experience. Changes in estimates are recorded in the period in which they become known. Actual results may differ from those estimates or assumptions.
Short-Term Investments
The Company classifies its short-term investments as available-for-sale securities. Available-for-sale securities are carried at fair value with net unrealized gains and losses reported as a component of accumulated other comprehensive income (loss) in stockholders’equity and as a component of other comprehensive income (loss) within the statements of operations and comprehensive loss. The Company determines realized gains or losses on the sale of available-for-sale securities using the specific identification method and includes net realized gains and losses as a component of other income or expense within the statements of operations and comprehensive loss. The Company periodically evaluates its short-term investments for credit losses, considering the significance of the decline in value and the market and economy in general. The Company hasnot recognized any impairment losses related to its short-term investments during thenine months ended September 30, 2026 and 2025. All short-term investments are classified as current based on the nature of the investments and their availability for use in current operations.
Long-Term Investments
Long-term investments include U.S. Treasury securities with maturities of 12 months or more. The Company classifies its long-term investments as available-for-sale securities. Available-for-sale securities are carried at fair value, with net unrealized gains and losses reported as a component of accumulated other comprehensive income (loss) in stockholders’ equity and as a component of other comprehensive income (loss) within the statements of operations and comprehensive loss. The Company determines realized gains or losses on the sale of available-for-sale securities using the specific identification method and includes net realized gains and losses as a component of other income (expense), net within the statements of operations and comprehensive loss. The Company periodically evaluates its available-for-sale securities in unrealized loss positions to determine whether a credit loss exists. If a U.S. Treasury security has an unrealized loss and the Company either intends to sell the security or it is more likely than not that the Company will be required to sell the security before recovery of its amortized cost basis, the Company will recognize an impairment charge in other income (expense), net for the entire amount of the unrealized loss and adjust the amortized cost basis of the security. The Company hasnot recognized any impairment losses related to its long-term investments during thenine months ended September 30, 2026 and 2025. All long-term investments are classified as noncurrent based on the nature of the investments.
Concentrations of Credit Risk and of Significant Suppliers
Financial instruments that potentially expose the Company to concentrations of credit risk primarily consist of cash and cash equivalents and short-term and long-term investments. The Company maintains its cash and cash equivalents in accounts at multiple accredited financial institutions and short-term and long-term investments in custodian accounts, in excess of federally insured limits. Additionally, the Company has established guidelines regarding investment instruments and their maturities, which are designed to maintain preservation of principal and liquidity. The Company does not believe that it is subject to unusual risk beyond the normal credit risk associated with commercial banking relationships.
The Company is exposed to concentration risk as it relates to its customers. The following table summarizes the percentages of total sales and accounts receivable, net for customers who accounted for 10% or more of the respective amounts for the periods presented:
| Net Sales · Net Sales · Accounts Receivable, net | ||||||
|---|---|---|---|---|---|---|
| Three Months Ended September 30, · Nine Months Ended September 30, · September 30, · December 31, | ||||||
| 2026 | 2025 | 2026 | 2025 | 2026 | 2025 | |
| Distributor A | 12.0% | 13.8% | 12.4% | 14.0% | 15.1% | 14.7% |
| Distributor B | 10.2% | 12.7% | 10.6% | 13.1% | * | * |
| Distributor C | * | * | * | 12.6% | * | * |
| Distributor D | 10.5% | 14.1% | 10.2% | 12.1% | * | * |
| Distributor E | * | * | * | * | * | 14.0% |
| Distributor F | * | * | * | * | 12.2% | 19.4% |
| Distributor G | 18.9% | 11.7% | 17.1% | 12.1% | 20.1% | 10.9% |
| Distributor H | 20.1% | * | 19.7% | * | 17.5% | 16.0% |
- Amount related to the respective customer represented less than 10% for the period presented.
Fair Value Measurements
Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the price received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. When determining the fair value measurements for assets and liabilities required to be recorded at their fair values, the Company considers the principal or most advantageous market in which it would transact and considers assumptions that market participants would use when pricing the assets or liabilities, such as inherent risk, transfer restrictions and risk of nonperformance. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:
| Level 1 — | Quoted prices in active markets for identical assets or liabilities. |
| Level 2 — | Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. |
| Level 3 — | Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies, and similar techniques. |
The Company’s cash equivalents, restricted cash, short-term investments and long-term investments are carried at fair value, determined according to the fair value hierarchy described above (see Note 4). The fair values of the Company’s accounts receivable, accounts payable and accrued expenses approximate their carrying values due to the short-term nature of these assets and liabilities.
Leases
Leases include all agreements in which the Company obtains control of an identified asset. A lease liability is recognized at the commencement date based on the present value of the lease payments over the lease term. When available, the Company uses the rate implicit in the lease to discount lease payments to present value; otherwise, the Company estimates the incremental borrowing rate to discount the lease payments based on information available at lease commencement (see Note 14).
The Company’s leases have initial lease terms of approximatelyone tosix years, with some including options to extend for up tofive additional years. If a lease includes options to extend the lease term, the Company only includes the periods it is reasonably certain to exercise as of the lease commencement date. The decision to exercise lease renewal options is at the Company’s sole discretion. Variable lease costs, including maintenance and utilities, real estate taxes, and insurance are expensed as incurred and excluded from the measurement of the lease liability. Lease agreements that include lease and non-lease components are accounted for as a single lease component. Leases with an initial term of 12 months or less are expensed and not recorded on the balance sheet. The Company’s leases provide for fixed rental payments with annual rent escalations. The Company does not have any leases that are classified as financing leases.
Segment Information
Operating segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed by the Chief Operating Decision Maker (“CODM”) in deciding how to allocate resources to an individual segment and in assessing performance. The Company’s Chief Executive Officer is the Company’s CODM. The CODM reviews financial information presented on a total company basis for purposes of making operating decisions, allocating resources, and evaluating financial performance. As such, the Company has determined that it operates as one operating segment. The measure of segment assets is presented as total assets in the balance sheets. The Company has concluded that gross profit and net income (loss) are the primary measures of segment profit or loss used by the CODM. The CODM assesses performance for the Company, monitors budget versus actual results, and determines how to allocate resources based on net income (loss) as reported in the statements of operations and comprehensive loss. There are no other expense categories regularly provided to the CODM that are not already included in the primary financial statements herein. During thenine months ended September 30, 2026 and 2025, the Company didnot generate any international revenues and as of September 30, 2026 and December 31, 2025, the Company didnot have a material amount of assets located outside of the United States.
Revenue Recognition
Net Sales
Revenue is generated primarily from sales of the iLet and its associated single-use products, such as cartridges for insulin storage and delivery, and infusion sets that connect the iLet to a user’s body. These products are distributed through a network of distributors and pharmacies, which then resell the products to insulin-requiring PWD. The Company recognizes revenue when it transfers control of the promised goods or services to its distributor and pharmacy customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services, net of estimated returns and estimated variable consideration adjustments, including rebates, patient assistance and chargebacks.
Revenue Recognition for Arrangements with Multiple Performance Obligations
The Company considers the individual deliverables in its contracts with customers as separate performance obligations. The iLet and single-use products that are used together with the iLet are deemed performance obligations that are satisfied at a point in time when the customer obtains control of the promised good, which typically is upon shipment. The Company has determined that the user’s ability to access the mobile application and receive unspecified software updates through the mobile application are considered distinct performance obligations that are satisfied over time, as access and support are provided throughout the typical four-year warranty period of the iLet. Accordingly, revenue related to access to the mobile application and unspecified software updates is 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, the Company recognizes revenue for these performance obligations as if they were a single performance obligation.
The transaction price is determined based on the consideration expected to be received, based on the stated value in contractual arrangements. The Company allocates the consideration to the individual performance obligations based on the estimated relative standalone selling price of the performance obligations and recognizes the consideration based on when the performance obligation is satisfied, considering whether or not this occurs at a point in time or over time. Where there is no observable standalone selling price, the Company estimates standalone selling price by applying the expected cost plus a margin approach.
Variable Consideration
The amount of variable consideration that is included in the transaction price 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. The Company estimates reductions to revenues for rebates paid to pharmacy benefit managers. Rebates are based on contractual arrangements, which may vary by customer. The estimates are based on products sold, historical experience, trends, specific known market events and, as available, channel inventory data. Provisions for rebates and patient assistance are accounted for as a reduction of sales when revenue is recognized and are included within accrued expenses and other current liabilities within the balance sheets. Provisions for chargebacks are accounted for as a reduction of sales when revenue is recognized and are included as a reduction of accounts receivable, net within the balance sheets, as the right of offset exists. If the actual amounts of consideration that the Company receives differ from estimates, the Company adjusts these estimates, which affects reported revenue, in the period that such variances become known or at the end of each reporting period.
Sales Returns
The Company offers a 90-day right of return from the date of shipment of its iLet from one of its authorized distributors, provided a physician’s confirmation of the good faith medical reason for the return is received. Estimated allowances for sales returns are based on historical returned quantities as compared to iLet shipments in those same periods of return, adjusted for known or expected changes in the marketplace when appropriate. Actual product returns have not differed materially from estimated amounts recorded in the accompanying financial statements.
Contract Costs
The Company recognizes an asset for incremental costs of obtaining a contract with a customer if it expects to recover those costs. The Company has elected the practical expedient to expense the costs as they are incurred, within sales and marketing expenses, since the amortization period is less than one year.
Product Warranty
The Company provides afour-year warranty on the iLet to end-users to replace any iLets that do not function as intended in accordance with the product specifications. Estimated warranty costs are recorded at the time of shipment. Warranty costs are estimated primarily based on the current expected product replacement cost and expected replacement rates which utilize management’s understanding of the hardware and factor in a patient attrition rate to reserve for only the active patient population using the pump. Although the Company’s history of product sales is limited, management also utilizes historical warranty cost data to reevaluate the estimated warranty obligation on a regular basis. Product returns and warranty replacements to date have been consistent with amounts accrued. Warranty expense is recorded as a component of cost of sales in the statements of operations and comprehensive loss.
Reconciliations of the changes in the Company’s product warranty liability for thethree and nine months ended September 30, 2026 and 2025 were as follows:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| (in thousands) · (in thousands) | ||||
| Product warranty liability at beginning of period | $3,288 | $2,062 | $3,154 | $657 |
| Warranty expense | 517 | 1,046 | 1,651 | 3,406 |
| Warranty fulfillment | (638) | (553) | (1,638) | (1,508) |
| Product warranty liability at end of period | $3,167 | $2,555 | $3,167 | $2,555 |
As of September 30, 2026 and December 31, 2025, total product warranty reserves were included in the following balance sheet accounts:
| September 30,2026 | December 31,2025 | |
|---|---|---|
| (in thousands) | ||
| Accrued expenses and other current liabilities | $1,756 | $1,607 |
| Other long-term liabilities | 1,411 | 1,547 |
| Total warranty liability | $3,167 | $3,154 |
Net Loss Per Share
Basic net loss per share is computed by dividing net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period. Shares issuable for nominal or no cash consideration are considered outstanding common shares for the purposes of the computation of basic net loss per share. Accordingly, the 1,043,484 shares of common stock underlying the pre-funded warrant issued on September 17, 2026 are included in the weighted-average number of shares of common stock outstanding beginning on September 17, 2026, as the remaining exercise price of $0.0001 per share is nominal. Diluted net loss per share is computed by giving effect to all potentially dilutive securities outstanding during the period, unless their effect is anti-dilutive. Potentially dilutive securities include stock options and restricted stock units. Because the shares underlying the pre-funded warrant are included in basic net loss per share, the pre-funded warrant does not result in incremental dilutive shares and is therefore not included in the table below. The amounts presented below represent potentially dilutive securities outstanding as of the end of each period, including both vested and unvested awards, that were excluded from the calculation of diluted net loss per share as their effect would have been anti-dilutive.
| Nine Months Ended September 30, | ||
|---|---|---|
| 2026 | 2025 | |
| Stock options to purchase common stock | 6,730,716 | 6,765,251 |
| RSUs | 2,287,525 | 824,771 |
| Total | 9,018,241 | 7,590,022 |
For the three and nine months ended September 30, 2026 and 2025, there was no difference in the weighted average number of shares used to calculate basic and diluted net loss per share due to the Company’s net loss position in each period.
Recently Adopted Accounting Pronouncements
In July 2025, FASB issued ASU 2025-05, Credit Losses (Topic 326) – Measurement of Credit Losses for Accounts Receivable and Contract Assets, which provides a practical expedient to assume that the current conditions as of the balance sheet date will remain unchanged for the remaining life of the asset when developing a reasonable and supportable forecast as part of estimating expected credit losses on current accounts receivable and current contract assets arising from revenue transactions. The Company adopted ASU 2025-05 on January 1, 2026. The adoption of this guidance didnot have a material impact on the Company’s financial statements.
Recently Issued Accounting Pronouncements
In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses (ASU 2024-03), and in January 2025, the FASB issued ASU 2025-01, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date ("ASU 2025-01"). ASU 2024-03 requires additional disclosure of the nature of expenses included in the income statement as well as disclosures about specific types of expenses included in the expense captions presented in the income statement. ASU 2024-03, as clarified by ASU 2025-01, is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the impact that this guidance may have on its financial statements.
In December 2025, the FASB issued ASU 2025-11, Interim Reporting (Topic 270): Narrow-Scope Improvements, which clarifies the applicability of Topic 270, the form and content of interim financial statements, and interim disclosure requirements. The guidance also establishes a principle requiring disclosure of events since the end of the most recent annual reporting period that have a material impact on an entity. The amendments are effective for the Company for interim reporting periods within annual reporting periods beginning after December 15, 2028 under the extended transition period available to emerging growth companies, provided the Company continues to qualify for and utilize such extended transition period. Early adoption is permitted. The Company is currently evaluating the guidance and does not expect adoption to have a material impact on its financial statements.
Revenue
The Company disaggregates net sales by product category and reimbursement channel, which the Company believes provides a meaningful depiction of how the nature, timing and uncertainty of net sales are affected by economic factors.
During the three and nine months ended September 30, 2026 and 2025, the Company’s revenues were predominantly generated from sales of the iLet and its associated single-use products. The iLet requires the use of separately purchased single-use products which include cartridges for storing and delivering insulin, and infusion sets that connect the iLet to the user’s body. These single-use products generate recurring revenue for the Company, as these are typically replaced by the end-user every 2-3 days or as directed by a healthcare provider.
The Company’s customers are distributors and pharmacies who sell these products to insulin-requiring PWD, through the durable medical equipment (“DME”) and the pharmacy benefit plan (“PBP”) reimbursement channels, which entail differing payment outlays. For the three and nine months ended September 30, 2026 and 2025, the majority of the Company’s sales were through the DME channel.
The following table summarizes the Company’s disaggregated revenues:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| (in thousands) · (in thousands) | ||||
| DME channel | ||||
| iLet(1) | $11,563 | $14,175 | $34,303 | $37,217 |
| Single-use products | 10,334 | 6,840 | 24,930 | 16,269 |
| Total DME channel | 21,897 | 21,015 | 59,233 | 53,486 |
| PBP channel | ||||
| iLet(1) | (37) | 148 | 649 | 859 |
| Single-use products | 13,645 | 6,090 | 35,262 | 13,785 |
| Total PBP channel | 13,608 | 6,238 | 35,911 | 14,644 |
| Total net sales | $35,505 | $27,253 | $95,144 | $68,130 |
(1)
iLet includes the over-time recognition related to software updates and mobile app access.
The Company recognizes revenue at a point in time once control has transferred to the customer, as well as over time for the performance obligation to provide ongoing services such as unspecified software updates. Revenue recognized during the nine months ended September 30, 2026 that was included in the deferred revenue balance as of December 31, 2025 was approximately $1.2 million.
At September 30, 2026 and December 31, 2025, $5.5 million and $4.9 million, respectively, were recorded as deferred revenue on the accompanying balance sheets for the portion of the transaction price allocated to performance obligations that were not yet satisfied. At September 30, 2026 and December 31, 2025, of the performance obligations not yet satisfied, $2.0 million and $1.6 millionfor each period, respectively, is expected to be recognized as revenue in the next 12 months, with the remainder expected to be recognized over the next 36 months. At September 30, 2026 and December 31, 2025, the $5.5 million and $4.9 million, respectively, relate to amounts deferred associated with the unspecified software updates promised to users and the users' access to the mobile application.
Financial Instruments and Fair Value Measurements
The following tables present the Company’s fair value hierarchy for its assets and liabilities that are measured at fair value on a recurring basis:
| Fair Value Measurements at | ||||
|---|---|---|---|---|
| Level 1 | Level 2 | Level 3 | Total | |
| Assets · (in thousands) | ||||
| Cash equivalents: | ||||
| Money market fund | $74,219 | $— | $— | $74,219 |
| Restricted cash: | ||||
| Money market fund | 100 | — | — | 100 |
| Short-term investments | ||||
| U.S. Treasury securities | 158,653 | — | — | 158,653 |
| Long-term investments | ||||
| U.S. Treasury securities | 133,436 | — | — | 133,436 |
| Total assets | $366,408 | $— | $— | $366,408 |
| Fair Value Measurements at | ||||
|---|---|---|---|---|
| Level 1 | Level 2 | Level 3 | Total | |
| Assets · (in thousands) | ||||
| Cash equivalents: | ||||
| Money market fund | $26,249 | $— | $— | $26,249 |
| Restricted cash: | ||||
| Money market fund | 100 | — | — | 100 |
| Short-term investments | ||||
| U.S. Treasury securities | 187,549 | — | — | 187,549 |
| Long-term investments | ||||
| U.S. Treasury securities | 45,431 | — | — | 45,431 |
| Total assets | $259,329 | $— | $— | $259,329 |
Money market funds and U.S. Treasury securities were valued by the Company based on quoted market prices, which represent a Level 1 measurement within the fair value hierarchy. There were no changes to the valuation methods during the nine months ended September 30, 2026 and 2025. The Company evaluates transfers between levels at the end of each reporting period. There wereno transfers between Level 1 or Level 2 during thenine months ended September 30, 2026 and 2025.
Warrant Liabilities
In connection with the Company’s initial public offering ("IPO") in January 2025, all outstanding warrant liabilities were remeasured and subsequently net exercised and reclassified to stockholders’ equity. No warrant liabilities were outstanding as of September 30, 2026 or December 31, 2025.
Pre-Funded Warrant
In September 2026, the Company completed a follow-on public offering in which it issued 8,956,523 shares of common stock and, in lieu of shares of common stock to certain investors, a pre-funded warrant to purchase 1,043,484 shares of the Company’s common stock. The pre-funded warrant is immediately exercisable at an exercise price of $0.0001 per share, subject to a beneficial ownership limitation, and does not expire until exercised in full.
The Company determined that the pre-funded warrant does not meet the definition of a derivative under ASC 815. The Company further determined that the pre-funded warrant is indexed to the Company’s own stock and meets the requirements for classification within stockholders’ equity. Accordingly, amounts attributable to the pre-funded warrant were recorded in additional paid-in capital and the warrant is not subsequently remeasured. As of September 30, 2026,1,043,484 shares of common stock remained issuable upon exercise of the pre-funded warrant. Refer to Note 2 for the treatment of the pre-funded warrant in the Company’s calculation of net loss per share.
Short-Term and Long-Term Investments
The following represents a summary of the estimated fair value of short-term and long-term investments at September 30, 2026 and December 31, 2025:
| Fair Value Measurements at | ||||
|---|---|---|---|---|
| Amortized | Unrealized | Unrealized | Estimated | |
| Cost | Gains | Losses | Fair Value | |
| (in thousands) | ||||
| Short-term investments | ||||
| U.S. Treasury securities | $159,069 | — | $(416) | $158,653 |
| Long-term investments | ||||
| U.S. Treasury securities | 133,897 | — | (461) | 133,436 |
| Total | $292,966 | $— | $(877) | $292,089 |
| Fair Value Measurements at | ||||
|---|---|---|---|---|
| Amortized | Unrealized | Unrealized | Estimated | |
| Cost | Gains | Losses | Fair Value | |
| (in thousands) | ||||
| Short-term investments | ||||
| U.S. Treasury securities | $187,167 | $382 | $— | $187,549 |
| Long-term investments | ||||
| U.S. Treasury securities | 45,411 | 20 | — | 45,431 |
| Total | $232,578 | $402 | $— | $232,980 |
As of September 30, 2026, all available-for-sale debt securities in an unrealized loss position had been in a continuous unrealized loss position for less than 12 months. There wereno available-for-sale debt securities in an unrealized loss position as of December 31, 2025. The Company did not record an allowance for credit losses on its available-for-sale debt securities because the unrealized losses were primarily attributable to changes in market interest rates and not credit deterioration. The Company does not intend to sell these securities and expects to hold them until recovery of their amortized cost bases upon maturity.
The following represents the contractual maturities of available-for-sale debt securities as of September 30, 2026:
| Fair Value Measurements at | ||||
|---|---|---|---|---|
| Years to Maturity | ||||
| Within One | One to Two | More Than Two | Estimated | |
| Year | Years | Years | Fair Value | |
| (in thousands) | ||||
| U.S. Treasury securities | $158,653 | $133,436 | $— | $292,089 |
| Total | $158,653 | $133,436 | $— | $292,089 |
Accounts Receivable, Net
Accounts receivable, net consisted of the following:
| September 30,2026 | December 31,2025 | |
|---|---|---|
| (in thousands) | ||
| Accounts receivable | $20,875 | $17,274 |
| Less: allowance for credit losses | (208) | (156) |
| Accounts receivable, net | $20,667 | $17,118 |
Accounts receivable are stated at the amount expected to be collected. The allowance for credit losses reflects expected losses on accounts receivable based primarily on historical experience and customer credit quality. The allowance for credit losses and related write-offs were not material for the periods presented.
Inventories
Inventories consisted of the following:
| September 30,2026 | December 31,2025 | |
|---|---|---|
| (in thousands) | ||
| Raw materials | $9,812 | $8,556 |
| Work in process | 2,811 | 2,750 |
| Finished goods | 10,348 | 10,416 |
| Total inventories | $22,971 | $21,722 |
Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following:
| September 30,2026 | December 31,2025 | |
|---|---|---|
| (in thousands) | ||
| Prepaid expenses | $5,924 | $7,064 |
| Interest receivable | 2,787 | 2,511 |
| Income tax receivable and other current assets | 293 | 265 |
| Prepaid expenses and other current assets | $9,004 | $9,840 |
Property and Equipment, Net
Property and equipment, net consisted of the following:
| September 30,2026 | December 31,2025 | |
|---|---|---|
| (in thousands) | ||
| Manufacturing equipment | $13,865 | $9,247 |
| Leasehold improvements | 2,859 | 830 |
| Furniture | 1,020 | 939 |
| Construction in progress | 1,958 | 3,339 |
| Total cost | 19,702 | 14,355 |
| Less: Accumulated depreciation and amortization | (7,938) | (5,755) |
| Property and equipment, net | $11,764 | $8,600 |
Depreciation expense was $2.2 million and$1.0 millionfor the nine months ended September 30, 2026 and 2025, respectively.
Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following:
| September 30,2026 | December 31,2025 | |
|---|---|---|
| (in thousands) | ||
| Employee compensation and benefits | $13,654 | $12,656 |
| Sales returns, rebates and patient assistance | 3,050 | 3,161 |
| Professional fees | 2,660 | 1,713 |
| Warranty | 1,756 | 1,607 |
| Inventory in transit | 1,310 | 1,961 |
| Royalties | 876 | 1,005 |
| Clinical trials | 81 | — |
| Other | 1,269 | 328 |
| Accrued expenses and other current liabilities | $24,656 | $22,431 |
Stock-Based Compensation
2016 Stock Incentive Plan
The Company’s 2016 Stock Incentive Plan, as amended (the “2016 Plan”), previously provided for the grant of stock options and restricted stock awards to employees, officers, directors and consultants. Following the adoption of the 2025 Equity Incentive Plan in connection with the Company’s IPO in January 2025, no further awards are granted under the 2016 Plan. Outstanding awards previously granted under the 2016 Plan continue to be governed by their original terms.
2025 Equity Incentive Plan
The Company maintains the 2025 Equity Incentive Plan (the “2025 Plan”), which became effective in January 2025. The 2025 Plan provides for the grant of incentive stock options, restricted stock units and other equity-based awards to employees, directors and consultants. The 2025 Plan replaced the 2016 Plan, and no further awards are granted under the 2016 Plan. A total of 12,016,744 shares of common stock were initially reserved for issuance under the 2025 Plan. As of September 30, 2026,14,234,787 shares of common stock were reserved for issuance under the 2025 Plan.
Stock Options
The following table presents, on a weighted-average basis, the assumptions used in the Black-Scholes option pricing model to determine the grant-date fair value of stock options granted:
| Nine Months Ended September 30, | ||
|---|---|---|
| 2026 | 2025 | |
| Weighted average grant date fair value per share | $8.22 | $14.38 |
| Risk-free interest rate | 3.69% | 4.25% |
| Expected term (in years) | 5.86 | 5.97 |
| Expected volatility | 70.58% | 100.01% |
| Expected dividend yield | 0% | 0% |
The following table summarizes stock option activity for thenine months ended September 30, 2026:
| Weighted- | ||||
|---|---|---|---|---|
| Weighted- Average · AverageRemaining · Aggregate | ||||
| Number ofOptions | ExercisePrice | ContractualTerm | IntrinsicValue | |
| (in years) · (in thousands) | ||||
| Outstanding at December 31, 2025 | 6,453,036 | $9.87 | 7.4 | $141,925 |
| Granted | 872,846 | $12.67 | ||
| Exercised | (439,418) | $6.81 | ||
| Forfeited or cancelled | (153,263) | $13.64 | ||
| Expired | (2,485) | $10.93 | ||
| Outstanding at September 30, 2026 | 6,730,716 | $10.34 | 7.1 | $58,497 |
| Vested and expected to vest at September 30, 2026 | 6,730,716 | $10.34 | 7.1 | $58,497 |
| Options exercisable at September 30, 2026 | 4,383,804 | $8.93 | 6.4 | $44,233 |
The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s common stock for those stock options that had exercise prices lower than the fair value of the Company’s common stock. The total intrinsic value of options exercised during the nine months ended September 30, 2026 and 2025 was$4.2 million and $6.3 million, respectively.
The weighted-average grant-date fair value of stock options granted during the nine months ended September 30, 2026 and 2025 was$8.22 per share and$14.38 per share, respectively. The total fair value of stock options vested during thenine months ended September 30, 2026 and 2025 was $7.2 million and $6.5 million, respectively.
The following table summarizes the non-vested stock options that were outstanding as of September 30, 2026 and December 31, 2025:
| Weighted- Average | ||
|---|---|---|
| Number ofOptions | ExercisePrice | |
| Non-vested options, September 30, 2026 | 2,346,912 | $12.98 |
| Non-vested options, December 31, 2025 | 2,840,777 | $12.21 |
Restricted Stock Units
The following table summarizes RSU activity under the Company's incentive plansfor the nine months ended September 30, 2026:
| Weighted- Average | ||
|---|---|---|
| Number of Shares | Grant Date Fair Value | |
| RSUs outstanding, December 31, 2025 | 753,885 | $15.12 |
| Granted | 2,219,735 | $13.00 |
| Vested | (513,953) | $13.71 |
| Cancelled | (172,142) | $13.72 |
| RSUs outstanding, September 30, 2026 | 2,287,525 | $13.48 |
Stock-Based Compensation Expense
Stock-based compensation expenseby type and financial statement line is included in the Company’s statements of operations and comprehensive loss as follows:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| (in thousands) · (in thousands) | ||||
| Options | $3,176 | $3,116 | $9,695 | $8,721 |
| RSUs | 3,330 | 1,362 | 8,500 | 3,360 |
| Employee stock purchase plan | 209 | — | 942 | — |
| Total stock-based compensation expense | $6,715 | $4,478 | $19,137 | $12,081 |
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| (in thousands) · (in thousands) | ||||
| Cost of sales | $187 | $140 | $557 | $399 |
| Research and development | 1,559 | 893 | 4,333 | 2,319 |
| Sales and marketing | 2,136 | 1,273 | 5,990 | 3,388 |
| General and administrative | 2,833 | 2,172 | 8,257 | 5,975 |
| Total stock-based compensation expense | $6,715 | $4,478 | $19,137 | $12,081 |
As of September 30, 2026, total unrecognized stock-based compensation expense related to the unvested options was $21.8 million, which is expected to be recognized over a weighted-average period of 2.1 years. As of September 30, 2026, total unrecognized stock-based compensation expense related to the unvested RSUs was $28.7 million, which is expected to be recognized over a weighted-average period of 2.2 years.
Employee Stock Purchase Plan
The Company’s Employee Stock Purchase Plan (“ESPP”) was approved by the Board in January 2025. The ESPP enables eligible employees to purchase shares of the Company’s common stock using their after-tax payroll deductions, subject to certain conditions. The ESPP is intended to qualify as an “employee stock purchase plan” within the meaning of Section 423 of the Code. Eligible employees may contribute, through payroll deductions, up to 15% of their earnings for the purchase of common stock under the ESPP. The purchase price of common stock under the ESPP is the lesser of: (a)85% of the fair market value of a share of the Company’s common stock on the first date of an offering or (b)85% of the fair market value of a share of the Company’s common stock on the date of purchase, limited to themaximum number of shares they may purchase on any single purchase date. Each offering under the ESPPhas asix-month duration, beginning on January 1 and July 1 of each year, with purchases occurring on June 30 and December 31, respectively. The initial offering period under the ESPP commenced on January 1, 2026, and the first purchase under the ESPP occurred on June 30, 2026. A total of 410,000 shares of common stock were initially reserved for issuance under the ESPP. As of September 30, 2026,853,608 shares of common stock were reserved for issuance under the ESPP, including shares added pursuant to the annual evergreen provision.
Employee Benefit Plan
The Company maintains a 401(k) retirement plan (the “401(k) Plan”) for the benefit of eligible employees. Each participant may elect to contribute up to 100% of his or her compensation to the 401(k) Plan each year, subject to certain Internal Revenue Service (the “IRS”) limitations. Under the terms of the Plan, the Company matches 100% of the first 6% of employee contributions. During thenine months ended September 30, 2026 and 2025, the Company contributed$2.9 million and$2.2 million, respectively, to the 401(k) Plan.
Income Taxes
During thenine months ended September 30, 2026 and 2025, the Company didnot record income tax benefits for the net operating losses (“NOLs”) incurred or for the research and development tax credits generated in each year, due to its uncertainty of realizing a benefit from those items. The Company does not have any foreign operations and therefore has no foreign income taxes.
The Company files income tax returns as prescribed by the tax laws of the jurisdictions in which it operates. In the normal course of business, the Company is subject to examination by federal and state jurisdictions, where applicable. The Company is open to future tax examination under statute by the IRSfrom 2022 to present and by most state tax authorities from 2021 to present. However, to the extent allowed by law, the taxing authorities may have the right to examine periods where NOLs and research and development credits were generated and carried forward, and make adjustments to the amount of the NOL and research credits carryforwards.
Leases
The Company leases office and manufacturing facilities under operating lease arrangements. The components of lease expense were as follows:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| (in thousands) · (in thousands) | ||||
| Operating lease cost–fixed | $516 | $409 | $1,561 | $1,242 |
| Operating lease cost–variable | 47 | 62 | 145 | 146 |
| Short-term lease expense | 13 | 20 | 40 | 28 |
| Total lease expense | $576 | $491 | $1,746 | $1,416 |
Cash paid for amounts included in the measurement of operating lease liabilitieswas $1.5 million and $1.2 million, respectively, for the nine months ended September 30, 2026 and 2025.
The weighted-average remaining lease term and discount rate were as follows:
| Weighted-average remaining lease term | 4.99 |
|---|---|
| Weighted-average discount rate | 6.89% |
Future lease payments under non-cancellable leases as of September 30, 2026 were as follows:
| (in thousands) | |
|---|---|
| Year Ending December 31, | |
| 2026 | 466 |
| 2027 | 1,418 |
| 2028 | 1,384 |
| 2029 | 1,092 |
| 2030 | 1,136 |
| Thereafter | 1,782 |
| Total future lease payments | $7,278 |
| Less: imputed interest | (1,177) |
| Total lease liabilities | $6,101 |
Commitments and Contingencies
Legal Proceedings
From time to time, the Company may become involved in various legal proceedings, including those that may arise in the ordinary course of business. In September 2026, a purported stockholder of the Company filed a securities class action against the Company and certain of its executive officers in the United States District Court for the Central District of California, captioned Holtzman vs. Beta Bionics, Inc. et al., Case No. 8:26-cv-2612-JWH (KESx). The complaint alleges that defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, and SEC Rule 10b-5 promulgated thereunder, by making material misstatements or omissions concerning the safety, efficacy, and commercial success of iLet. The complaint seeks, on behalf of the putative class, unspecified damages, pre- and post-judgment interest, attorneys’ fees, expert fees and costs, as well as class certification and such other relief as the court may deem just and proper. The Company intends to vigorously defend against the claims in this action. Any potential loss arising from this claim is not currently probable nor estimable.
Xeris Agreements
In May 2024, the Company and Xeris Pharmaceuticals, Inc. (“Xeris”) entered into a collaboration and license agreement (“Collaboration and License Agreement”) to develop and commercialize glucagon products for use in the Company’s pump-based systems. Under the Collaboration and License Agreement, the Company received a worldwide, exclusive, sublicensable license to certain Xeris technology for use in the field of chronic glycemic control, as well as a manufacturing license subject to a future technology transfer and commercial supply arrangement.
In consideration for the rights granted under the agreement, the Company paid Xeris an upfront fee of $0.5 million and a development milestone payment of $3.0 million, both of which were recognized as research and development expenses when incurred. The Company is also required to pay Xeris tiered royalties in the low double-digit percentage range on future net sales of licensed products, subject to customary reductions.
In connection with clinical development activities, the Company entered into the Clinical Supply Agreement with Xeris and incurred $0.9 million of costs for Phase 2 clinical materials during 2024, with the remaining balance paid in 2025. In May 2026, the Company entered into a letter agreement under the Clinical Supply Agreement with Xeris for additional Phase 2 clinical material, including a one-time non-refundable payment of $0.5 million and reimbursement of certain internal and travel costs. In connection with entering into Phase 3 of the collaboration, the Company expects to incur development and manufacturing costs, including ordering clinical materials and technical transfer, development, and testing of the product, totaling up to $5.1 million. As of September 30, 2026, the Company has completed payments totaling $4.0 million. Amounts are initially recorded as prepaid expenses and recognized as research and development expense as the related services are performed. The Company may incur additional research and development expenses and, upon commercialization, royalty obligations under these agreements.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.