Beta Bionics raises 2026 revenue view to $131–136M
Beta Bionics secures FDA clearance for its Mint patch pump, raises 2026 revenue guidance, and details real-world iLet outcomes while outlining new regulatory and litigation risks.
Rhea-AI Filing Summary
Beta Bionics, Inc. (BBNX) reports U.S. FDA clearance of its Mint patch insulin pump and outlines an updated growth strategy and outlook. Mint uses a reusable/disposable design that does not require recharging, integrates with leading continuous glucose monitors, and allows smartphone control. The company expects full U.S. commercial launch in the first quarter of 2027 and anticipates manufacturing capacity for at least 1.5 million disposable Mint units in 2027, with initial U.S. pharmacy-benefit access for about 40% of insured lives, increasing to at least 50% within the first year of full commercialization.
Beta Bionics has submitted a 510(k) application for its 3D Intelligence next‑generation insulin‑dosing algorithm, expected, subject to FDA clearance, to power the iLet 3D and Mint 3D platforms, with U.S. commercialization targeted by the end of 2026 for iLet 3D and alongside Mint’s full launch for Mint 3D. Real‑world data from 14,952 iLet users showed an average HbA1c improvement from 8.9% to a GMI of 7.3%, with over 84% meeting American Diabetes Association hypoglycemia goals, and post‑market data indicated 8.1 users with ≥1 severe hypoglycemia event per 100 patient‑years.
The company raises its 2026 total revenue guidance to $131–136 million from $121–126 million, while maintaining guidance for new patient starts through the pharmacy channel at 37–39% and gross margin at 58.5–59.5%. Management notes an anticipated deferral of up to $10 million of revenue in Q4 2026 as some prospective iLet users await Mint’s launch. Beta Bionics also discloses that a stockholder has filed a securities class action related to prior statements about iLet; the company states it intends to defend the case and that any potential loss is not currently probable or estimable.
Positive
- FDA clearance of Mint patch pump, with U.S. full commercial launch targeted for Q1 2027 and integration with leading CGMs and smartphone control.
- Submission of a 510(k) for the 3D Intelligence algorithm, with plans for iLet 3D and Mint 3D commercialization in late 2026 and early 2027, subject to FDA clearance.
- Real‑world iLet data show an average HbA1c improvement from 8.9% to 7.3% and over 84% of users meeting ADA hypoglycemia goals.
- Raised 2026 total revenue guidance to $131–136 million from $121–126 million, indicating higher expected sales.
- Total U.S. insulin delivery addressable market cited at $12 billion, underscoring the potential scale of the company’s opportunity.
Negative
- A stockholder has filed a securities class action regarding prior statements about iLet; the company notes litigation costs and potential adverse effects if claims are not successfully defended.
- The business is highly dependent on iLet and Mint, with no other commercialized products, and faces substantial regulatory and clinical risks for planned indications and new products.
- Management anticipates a revenue deferral of up to $10 million in Q4 2026 as some prospective iLet users wait for Mint’s launch.
- Risk disclosures highlight potential higher directors’ and officers’ insurance costs and possible reductions in coverage, which could increase exposure to litigation-related expenses.
Filing Explained
The September 14 Form 8-K says Mint has FDA clearance but is not yet fully commercialized, so the company still reports only one commercialized device—iLet—while 3D Intelligence remains under FDA review.
8-K Event Classification
Key Figures
Key Terms
510(k) application regulatory
Glucose Management Indicator (GMI) medical
hypoglycemia medical
bihormonal system medical
severe hypoglycemia event medical
Adjusted EBITDA financial
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What FDA milestone did Beta Bionics (BBNX) announce for the Mint patch pump?
What is Beta Bionics’ updated 2026 revenue guidance for BBNX?
What manufacturing and coverage plans does BBNX have for Mint in 2027?
What did Beta Bionics report about real-world iLet glycemic outcomes?
What securities litigation did Beta Bionics disclose for BBNX?
What is the status of Beta Bionics’ 3D Intelligence insulin-dosing algorithm?
How does Beta Bionics describe severe hypoglycemia rates with iLet?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
| Item 7.01. | Regulation FD Disclosure. |
On September 14, 2026, Beta Bionics, Inc. (the Company, we, our, or us) issued a press release announcing, among other things, clearance by the U.S. Food and Drug Administration (FDA) of Mint, our patch pump, and our submission of a 510(k) application to the FDA for 3D Intelligence, our anticipated next-generation insulin dosing algorithm. A copy of the press release is attached hereto as Exhibit 99.1.
On September 14, 2026, we also made available an updated corporate presentation. A copy of the presentation is attached hereto as Exhibit 99.2.
The information contained under this Item 7.01, including Exhibits 99.1 and 99.2 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Exchange Act, regardless of any general incorporation language in any such filing, unless we expressly set forth in such filing that such information is to be considered “filed” or incorporated by reference therein.
| Item 8.01. | Other Events. |
Mint Approval and Commercial Launch
On September 14, 2026, we announced FDA clearance of Mint, our patch pump featuring a transformative reusable and disposable architecture that does not require recharging, integrates with industry-leading continuous glucose monitors (CGM) and enables smartphone control for iOS and Android users.
We expect to initiate the full commercial launch of Mint in the United States in the first quarter of 2027, and anticipate manufacturing capacity to produce at least 1.5 million total disposable units in the full year 2027.
Mint is expected to launch exclusively through the pharmacy channel, with approximately 40% of insured U.S. lives expected to be able to purchase it using their pharmacy benefit. We anticipate coverage for Mint to increase to at least 50% of insured U.S. lives within the first year of full commercialization as we leverage our market access footprint.
Mint features
| • | Transformative, two-piece reusable and disposable architecture |
| • | Smaller compared to the industry-leading patch pump |
| • | Seamless disposable patch change process with no phone re-pairing required |
| • | Firmware-over-the-air updates |
| • | Limits environmental waste |
| • | Three days of wear time, with an additional 12-hour grace period |
| • | 200-unit insulin reservoir |
| • | Never requires recharging |
| • | Waterproof with an IPX8 rating for up to 5 feet deep for 60 minutes |
| • | Comprehensive software and digital integration |
| • | Compatible with industry-leading CGMs: Dexcom G7, Dexcom G7 15 Day, and Abbott’s FreeStyle Libre 3 Plus |
| • | iOS and Android smartphone controlled |
3D Intelligence
Additionally, on September 14, 2026, we announced our submission of a 510(k) application to the FDA for 3D Intelligence, our anticipated next-generation insulin dosing algorithm. 3D Intelligence is designed with three
algorithm experiences intended to enable a more customizable treatment approach tailored to each user’s unique insulin requirements:
| • | Original – the algorithm currently available with iLet, with proven real-world experience across more than 40,000 users**. |
| • | Optimized – an enhanced experience that builds on the currently available algorithm and incorporates learnings from our real-world experience with iLet. |
| • | Conservative – an alternative experience designed to provide a more measured response when correcting high glucose levels. |
Subject to regulatory clearance by the FDA, the 3D Intelligence insulin-dosing algorithm is expected to power both iLet 3D and Mint 3D, our investigational next-generation automated insulin delivery (AID) platforms. Commercialization of iLet 3D in the United States is expected by the end of 2026, and commercialization of Mint 3D in the United States is expected to be simultaneous with the full Mint launch in the first quarter of 2027, in each case, subject to regulatory clearance by the FDA.
| ** | Minor differences in adaptation compared to previous algorithm are not anticipated to have a significant impact on outcomes. |
Fully-Closed Loop Algorithm
We are developing a fully-closed loop algorithm and intend to initiate a pivotal trial studying the algorithm in adults with type 1 (T1D) and type 2 (T2D) diabetes in the coming quarters.
iLet Real-World Data Highlights
The iLet is the first insulin delivery device cleared by the FDA to utilize adaptive closed-loop algorithms to autonomously determine every insulin dose without requiring a user to count carbohydrate intake. Based on real-world data from the first two years (5/19/2023–5/18/2025) of iLet usage (the Usage Period) among iLet users with baseline HbA1c data and who uploaded data to us (n=14,952), greater than 84% of iLet users met the American Diabetes Association (ADA) hypoglycemia goals of less than 4% time below 70mg/dL and less than 1% time below 54mg/dL. In addition, overall HbA1c of 8.9% to glucose management indicator (GMI) of 7.3%, or an average reduction of 1.5%, was observed, with a meaningful change regardless of baseline HbA1c. These real-world results are consistent with the investigator-initiated iLet Bionic Pancreas Pivotal Trial, in which an average reduction in HbA1c of 0.6%, from a baseline of 7.9% to 7.3% over 13 weeks was observed.
Improvements in baseline HbA1c have been observed just two days after initiating use of iLet, with an average baseline HbA1c of 8.9% to follow-up GMI on iLet of 7.4% observed among iLet users within the Usage Period who uploaded CGM data to us (n=30,077 sessions), 90% of whom had baseline HbA1c data available.
Similar improvements in GMI have been observed regardless of provider type with an average baseline HbA1c of 8.9% to follow-up GMI on iLet of 7.3% observed from both endocrinology (n=13,566) and primary care (n=1,036) providers of iLet for users within the Usage Period with provider type data available.
We have also observed similar improvements regardless of engagement levels with an average baseline HbA1c of 8.9% to follow-up GMI on iLet of 7.3% for low engagement users (≤ 4 average daily swipes to unlock iLet, n=302) as compared to an average baseline HbA1c of 8.0% to follow-up GMI on iLet of 7.2% for high engagement users (≥ 10 average daily swipes to unlock iLet, n=301) observed in iLet users within the Usage Period.
When analyzing data from iLet users from the 21-day period ending May 18, 2025 with baseline HbA1c data available, we estimate that approximately 16% (n=2,416) use iLet in a fully-closed loop manner (announced <1 meal per day on average during the observation period), with an average of approximately 1 meal announced every three days. During the observation period, these fully-closed loop users achieved approximately 62% time in range on average and approximately 83% meet ADA hypoglycemia goals of less than 4% time below 70mg/dL and less than 1% time below 54mg/dL. Among these users, an average baseline HbA1c of 9.4% to follow-up GMI on iLet of 7.5% was observed. In addition, among a subgroup of these users (n=530) who did not announce a single meal during the observation period, an average baseline HbA1c of 9.4% to follow-up GMI on iLet of 7.4% was observed, with approximately 86% of this subgroup meeting ADA hypoglycemia goals.
Furthermore, based on post-market data (n=2,741, ≥ 4 yrs, Patient Years ~434), 8.1 users had ≥1 severe hypoglycemia event per 100 patient years. This compares to 9.6 users for Control-IQ (n=3,061, ≥ 6 yrs, Patient Years ~3,061)1, an AID, and reported severe hypoglycemia events per 100 patient years in non-AID systems of 121 (n=3,813, ≥ 18 yrs, Patient Years ~3,813)2 and 70 (n=3,827, ≥ 15 yrs, Patient Years ~220)3.
| 1. | Graham et al. (2024) Real-World Use of Control-IQ Technology Is Associated with a Lower Rate of Severe Hypoglycemia and Diabetic Ketoacidosis Than Historical Data: Results of the Control-IQ Observational (CLIO) Prospective Study. Diabetes Technol Therapy; 26: 24-32. |
| 2. | Kristensen et al. (2012) Insulin analogues and severe hypoglycaemia in type 1 diabetes. Diabetes Res Clin Pract; 96:17-23. |
| 3. | Ostenson et al. (2014) Self-reported non-severe hypoglycaemic events in Europe. Diabetic Medicine; 31:92-101. |
Legal Proceedings and Risk Factor Update
On September 4, 2026, a purported stockholder of the Company filed a securities class action against us and certain of our executive officers in the United States District Court for the Central District of California, captioned Holtzman vs. Beta Bionics, Inc. et al., Case No. 2:26-cv-09999. The complaint alleges that defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, and SEC Rule 10b-5 promulgated thereunder, by making material misstatements or omissions concerning the safety, efficacy, and commercial success of iLet. The complaint seeks, on behalf of the putative class, unspecified damages, pre- and post-judgment interest, attorneys’ fees, expert fees and costs, as well as class certification and such other relief as the court may deem just and proper. We intend to vigorously defend against the claims in this action. Any potential loss arising from this claim is not currently probable or estimable.
The following risk factor supplements, and should be read together with, the risks described in our Annual Report on Form 10-K for the year ended December 31, 2025, and subsequent Quarterly Reports on Form 10-Q.
We could be subject to securities class action litigation.
In the past, securities class action litigation has often been brought against a company following a decline in the market price of its securities. This risk is especially relevant for us because medical device companies have experienced significant stock price volatility in recent years. For example, in September 2026, a purported stockholder of the Company filed a securities class action against us and certain of our executive officers in the United States District Court for the Central District of California, captioned Holtzman vs. Beta Bionics, Inc. et al., Case No. 2:26-cv-09999, alleging violations of certain federal securities laws related to certain statements made with respect to the safety, efficacy and commercial success of iLet. We intend to vigorously defend ourselves in this matter. If we are not successful in defense of these claims or any other claims we may face in the future, we may have to make significant payments to, or other settlements with, our stockholders and their attorneys. Even if such claims are not successful, this litigation has resulted in additional costs to us and this litigation and any other claims we may face in the future could result in further substantial costs and diversion of our management’s attention and resources in the future, which could have a material adverse effect on our business, operating results or financial condition. Additionally, the increase in the cost of directors’ and officers’ liability insurance may cause us to opt for lower overall policy limits or to forgo insurance that we may otherwise rely on to cover significant defense costs, settlements and damages awarded to plaintiffs.
We are highly dependent on the success of our iLet and Mint for the treatment of T1D, which are cleared by the FDA for commercial sale in the United States for the treatment of T1D. If we are unable to obtain and maintain regulatory clearance or approval for planned modifications to the iLet or Mint or for new indications, or for any current or future development-stage products, such as 3D Intelligence, iLet 3D and Mint 3D, or if we are unsuccessful in our efforts to continue to commercialize our cleared products, our business will be materially harmed.
We currently have one commercialized device, the iLet, which is an automated insulin dosing system cleared for the treatment of T1D in adults and children six years of age and older. Our business primarily depends on the successful commercialization of the iLet. In September 2026, we announced FDA clearance of Mint, our patch pump featuring a transformative reusable and disposable architecture, for the treatment of T1D in adults and children six years of age and older, and our expected initiation of full commercialization of Mint in the United States in the first quarter of 2027. We currently have no other products cleared for sale and may never be able to develop other marketable products. Additionally, in September 2026, we announced our submission of a 510(k) application to the FDA for 3D Intelligence, our anticipated next-generation insulin dosing algorithm and, subject to and following regulatory clearance by the FDA, our expectation for 3D Intelligence to power both iLet 3D and Mint 3D, our investigational next-generation automated insulin delivery platforms. Our iLet will require additional clinical development, testing and marketing authorization or regulatory clearance before we are permitted to commercialize it in a bihormonal system for the treatment of T1D or for any future indications we may pursue. Further, as we develop a bihormonal system of the iLet, which is designed to use both insulin and glucagon for the treatment of T1D, we will separately need to develop and obtain approval for our glucagon product candidate as a drug via an NDA submission in order to successfully commercialize our iLet in a bihormonal system. We expect that the bihormonal system will require completion of clinical trials and submission of a 510(k) for both the infusion pump and algorithm. In addition, we expect that the single hormone and bihormonal algorithms will require separate studies to be performed in T1D and T2D populations in order to seek clearance in these patient populations. Our iLet and Mint will also require additional marketing authorization or regulatory clearance before we are permitted to commercialize them with 3D Intelligence as iLet 3D and Mint 3D, respectively. However, there can be no assurance that the FDA will clear the 3D Intelligence or any other application on the anticipated timeline, or at all, that we will ultimately be able to market and commercialize 3D Intelligence, iLet 3D or Mint 3D, or that we will be able to scale our manufacturing processes sufficiently to meet anticipated demand at launch. The future regulatory and commercial success of 3D Intelligence, iLet and Mint, including versions powered by 3D Intelligence, and any other product candidate is subject to a number of risks, including the following:
| • | completion of preclinical studies with favorable results; |
| • | successful enrollment in, and completion of, planned and future clinical trials with favorable results; |
| • | sufficiency of our financial and other resources to complete the necessary clinical trials and regulatory activities; |
| • | successful patient enrollment in clinical trials; |
| • | successful data from our clinical program that supports an acceptable risk-benefit profile in the intended populations; |
| • | whether we are required by the FDA to conduct additional clinical trials or to modify the design of current or planned trials to support any future application seeking marketing authorization or clearance of the iLet in a bihormonal system for the treatment of T1D or for other indications we may pursue, or seeking initial marketing authorization or clearance for any of our other product candidates; |
| • | receipt and maintenance of marketing authorizations or clearances from applicable regulatory authorities; |
| • | obtaining and maintaining patent and trade secret protection and regulatory exclusivity, including for our iLet; |
| • | making arrangements with third-party manufacturers and ensuring such third-party manufacturers supply sufficient quantities of components of our products and product candidates; |
| • | scaling up our manufacturing capabilities, for both commercial and clinical supplies of our products and product candidates; |
| • | entry into collaborations to further the development of capabilities; |
| • | expanding sales, marketing and distribution capabilities as we continue our commercialization efforts, whether alone or in collaboration with others; |
| • | successfully launching and driving commercial sales of our existing products and any other product candidate, if authorized for marketing or cleared; |
| • | acceptance of our products by people with diabetes, the medical community and third-party payors; |
| • | maintaining a continued acceptable safety profile following marketing authorization or clearance, including in respect of our post-market surveillance order issued by the FDA for our iLet; |
| • | managing and responding to voluntary or mandatory recalls, including our four open recalls; |
| • | maintaining regulatory compliance; |
| • | effectively competing with other treatment options and the availability, perceived advantages, relative cost, relative safety and relative effectiveness of alternative and competing treatments; |
| • | the emergence of competing technologies and other adverse market developments, and our need to enhance existing products and/or develop new products to maintain market share in response to such competing technologies or market developments; |
| • | maintaining healthcare coverage and adequate reimbursement from third-party payors; |
| • | continuing to build and maintain an organization of people who can successfully develop our products; and |
| • | enforcing and defending intellectual property rights and claims. |
Many of these risks are beyond our control, including the risks related to clinical development, the regulatory submission, oversight and review processes, potential threats to our intellectual property rights and the manufacturing, marketing and sales efforts of any future collaborator. If we are not successful in commercializing our iLet or Mint, or in obtaining marketing authorization or clearance for the iLet in its bihormonal system for the treatment of T1D or for the iLet or Mint in other indications, such as T2D, the investigational glucagon product, or any other product candidate, or if we experience delays as a result of any of these risks or otherwise, our business could be materially harmed.
Furthermore, even though we have received clearance for our iLet for insulin-only delivery for the treatment of T1D, any other configuration for the treatment of T1D such as a bihormonal system using both insulin and glucagon or other indications we may pursue for which we receive marketing authorization or clearance may be subject to limitations on the patient populations for which we may market the product. Even if we are able to obtain the requisite financing to continue to fund our development programs, we cannot assure you that we will successfully develop, obtain marketing authorization or clearance for, and commercialize our iLet in its bihormonal system for the treatment of T1D or for any future indication we may pursue, the investigational glucagon product, or any other development-stage products. If we are unable to continue commercializing the iLet or Mint for T1D, or if we are unable to develop, or obtain marketing authorization or clearance for, or, if authorized for marketing or cleared, successfully commercialize the iLet or Mint for the treatment of any future indications, we may not be able to generate sufficient revenue to continue our business.
Forward-Looking Statements Disclaimer
This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this Current Report on Form 8-K that are not statements of historical fact are forward-looking statements. Such forward-looking statements include, without limitation, statements regarding: our expectations regarding the potential clearance by the FDA, including of 3D Intelligence, and the timing thereof; the implication and potential benefits of the FDA’s clearance of Mint; the timing or certainty of full commercial launch of Mint, iLet 3D and Mint 3D in the United States and related updates; our anticipated manufacturing timeline and capacity of production of Mint at commercial launch and during 2027; the implications
and potential benefits of 3D Intelligence, iLet 3D and Mint 3D for people with diabetes; the anticipated specifications and features of 3D Intelligence and Mint 3D; the anticipated coverage for Mint at commercial launch and within the first year of commercialization; the potential benefits, effectiveness, and safety of the iLet, Mint, 3D Intelligence algorithm and other product candidates; and our expectations with regard to the design, results and timing of our research and development efforts, clinical trials and real world use or experience, including the timing and availability of data from such trials and real world use. Words such as “believe,” “anticipate,” “could,” “plan,” “estimate,” “expect,” “intend,” “will,” “may,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are based on our management’s beliefs as well as assumptions made by and information currently available to us. Such statements reflect our current views with respect to future events and are subject to known and unknown risks and uncertainties, including business, regulatory, economic and competitive risks and uncertainties about us, risks inherent in developing product candidates, our ability to obtain adequate financing to fund our product development and other expenses, our ability to attain regulatory clearance from the FDA on our anticipated timeline, our ability to manufacture and scale production of our products and manage our supply chain, our ability to obtain adequate reimbursement and payer coverage for our products, trends in the industry, our relationships with our existing and future collaboration partners, the legal and regulatory framework for the industry, future expenditures, the potential impacts of global macroeconomic conditions and the outcome of any pending litigation. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. The actual results may vary from the anticipated results and the variations may be material. Other factors that may cause our actual results to differ from current expectations are discussed in our filings with the U.S. Securities and Exchange Commission (the SEC), including our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on February 24, 2026, as updated by our Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, filed with the SEC on July 29, 2026, and other filings that we may make from time to time with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date this Current Report on Form 8-K is given. Except as required by law, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit |
Description | |
| 99.1 | Press Release, dated September 14, 2026. | |
| 99.2 | Beta Bionics, Inc. Corporate Presentation (September 2026) | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Beta Bionics, Inc. | ||
| By: | /s/ Sean Saint | |
| Sean Saint | ||
| President and Chief Executive Officer | ||
Dated: September 15, 2026
Investor Presentation September 2026 Exhibit 99.2
Disclaimer This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this presentation that are not statements of historical fact are forward-looking statements. Such forward-looking statements include, without limitation, statements regarding: expectations of Beta Bionics, Inc. (the “Company,” “we,” “our” or “us”) regarding the potential benefits, effectiveness, and safety of the iLet, Mint, 3D Intelligence algorithm and other product candidates; our expectations with regard to the design, results and timing of our research and development efforts, clinical trials and real world use or experience, including the timing and availability of data from such trials and real world use; our regulatory development plans for the iLet, Mint, iLet 3D, Mint 3D and bi-hormonal system and other product candidates, including the timing for potential regulatory approvals; the markets and market opportunities for the iLet, Mint and other product candidates, if approved; the timing, likelihood or success of our business strategy, including commercialization and our multi-channel reimbursement strategy, as well as plans and objectives of management for future operations including market and indication expansion; and our anticipated growth and other measures of future operating results and financial performance including 2026 full year guidance regarding revenue, new patient starts through pharmacy, and gross margin. In some cases, you can identify forward-looking statements by terms such as “expect,” “should,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “believe,” “estimates,” “potential” or “continue” or the negative of these terms or other similar expressions. These forward-looking statements are based on the beliefs of the management of the Company as well as assumptions made by and information currently available to the Company. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, timing of results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Other factors that may cause the Company’s actual results to differ from current expectations are discussed in the Company’s filings with the Securities and Exchange Commission (the “SEC”), including in its Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on February 24, 2026, as updated by its Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, filed with the SEC on July 29, 2026, and other filings that the Company may make from time to time with the SEC the section titled “Risk Factors” in the Company’s Form 10-Q for the quarter ended June 30, 2026, filed with the SEC on June 30, 2026. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date this presentation is given. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. We operate in a very competitive and rapidly changing environment, and new risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially and adversely from those anticipated or implied in the forward-looking statements. We may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. The forward-looking statements in this presentation represent our views as of the date of this presentation. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. Except as required by law, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements in this presentation and the accompanying oral commentary. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this presentation.
Disclaimer (Cont’d) This presentation contains trademarks, service marks, trade names and copyrights of the Company and other companies which are the property of their respective owners. This presentation discusses certain product candidates that have not yet received marketing authorization or clearance by the U.S. Food and Drug Administration. No representation is made as to the safety, effectiveness or likelihood of marketing authorization or clearance of these product candidates. In addition to the financial information presented in accordance with U.S. generally accepted accounting principles (GAAP), this presentation and accompanying oral presentation includes certain non-GAAP financial measures. These measures are presented for supplemental informational purposes only, have limitations as analytical tools and should not be considered in isolation or as a substitute for financial information presented in accordance with GAAP. Our calculations of each of these measures may differ from the calculations of measures with the same or similar titles by other companies and therefore comparability may be limited. Because of these limitations, when evaluating our performance, you should consider each of these non-GAAP financial measures alongside other financial performance measures, including the most directly comparable financial measure calculated in accordance with GAAP and our other GAAP results. A reconciliation of non-GAAP measures to the most directly comparable GAAP measures are included in the Appendix to this presentation and can be found in our filings with the SEC. We have not provided the forward-looking GAAP equivalents for certain forward-looking non-GAAP measures presented in this presentation or the accompanying oral presentation, or a GAAP reconciliation, as a result of the uncertainty regarding, and the potential variability of, reconciling items such as stock-based compensation expense. Accordingly, a reconciliation of these non-GAAP guidance metrics to their corresponding forward-looking GAAP equivalents is not available without unreasonable effort. However, it is important to note that material changes to reconciling items could have a significant effect on future GAAP results.
Our mission is to simplify and alleviate the burden of managing diabetes with life-changing solutions.
Market-Leading Innovators Beta Bionics has the only fully adaptive insulin-dosing algorithm, and most advanced system available in the U.S.1 Note:Data as of Q2 2026. Multiple Daily Injections (MDI). Year End (YE). Cook, K., et al. (2025). Defining the Automated Insulin Delivery Continuum: User Engagement and System Adaptation. ADCES 2025. Poster Presentation, 2025 Aug 9 69% New Patient Starts from MDI in Q2’26 $32.0M Q2’26 Net Sales 59.0% Q2’26 Gross Margin Key Operating Highlights High 30s% New Patient Starts reimbursed through pharmacy in Q2’26 Q1’27 Targeted Mint™ patch pump full commercial launch in the U.S.
Total $12B Total Addressable Market for Insulin Delivery in the U.S. ~1.2M On multiple daily injections (MDI) >1.7M On multiple daily injections (MDI) >0.7M On pump therapy <0.2M On pump therapy 1.9M People in the U.S. 1.9M People in the U.S. Pump penetration ~39% Pump penetration <10% Type 1 Diabetes Type 2 Diabetes (Insulin-Intensive) Source: Internal estimates informed by data from the CDC, Seagrove Partners, and publicly-reported 2025 product sales data. Note: Type 1 Diabetes (T1D). T1D $6B Current Pump Market $3.2B Large & Underpenetrated Insulin Pump Market
~80% not at treatment goal, defined by the ADA as HbA1c <7% ~80% of people with T1D are not at ADA goal1,2 ~20% of people with T1D are at ADA goal, but many are overburdened with their diabetes management ~380K People with T1D Not meeting goal & overburdened ~1.5M People with T1D Meeting goal & overburdened Meeting goal & content Source: Internal estimates informed by data from the CDC, Seagrove Partners, and publicly-reported 2025 product sales data. Note:Type 1 Diabetes (T1D). American Diabetes Association (ADA). Foster et al. Diabetes Technol Ther. 2019;21:66-72. Pettus et al., Diabetes Care. 2019;42:2220–2227. Poor Clinical Outcomes for People with T1D in the U.S.
Penetration remains low and treatment outcomes are poor Source: Internal estimates informed by data from the CDC, Seagrove Partners, and publicly-reported 2025 product sales data. Note:Type 1 Diabetes (T1D). Type 2 Diabetes (T2D), American Diabetes Association (ADA). Foster et al. Diabetes Technol Ther. 2019;21:66-72. Pettus et al., Diabetes Care. 2019;42:2220–2227. Burdensome for users to manage everyday Difficult for physicians to setup and manage, particularly primary care providers Costly for users to purchase pump and monthly supplies Obstacles to Pump Use Insulin pump therapy penetration ~39% Not at ADA treatment goal1,2 ~80% T1D Unmet Needs Complexity of Pumps Physician Adjusts every 3 months Insulin-to-Carb Ratio Correction Factor Basal Rate User Adjusts everyday as needed Carb Counting for Meal Doses Manual Correction Doses Temporary Basal Rate Significant Unmet Market Needs Remain Pump complexity is a major obstacle to adoption
First FDA-approved CGM without calibration CGM and Pump Penetration in T1D 2013-2025 in the U.S. Source: Internal estimates informed by data from the CDC, Seagrove Partners, and publicly-reported 2025 product sales data. Note: Continuous Glucose Monitor (CGM), U.S. Food & Drug Administration (FDA), Type 1 Diabetes (T1D). First FDA-approved hybrid closed-loop pump systems The Market Responds to Major Ease-of-Use Innovations No fingerstick calibration was the key innovation for CGMs; Beta Bionics’ fully adaptive insulin-dosing algorithm may be that innovation for pumps Beta Bionics’ algorithm launch (iLet) ~ ~
We believe we can do more for people with diabetes.
Most Advanced Pump Platform in the U.S.1 Adaptive-Closed Loop Algorithm Robust Digital Ecosystem Pharmacy Channel Access One Engine. A New Standard. iLet (Tubed Pump) Mint (Patch Pump) Note:Mint is not yet available for sale. Cook, K., et al. (2025). Defining the Automated Insulin Delivery Continuum: User Engagement and System Adaptation. ADCES 2025. Poster Presentation, 2025 Aug 9
Meal Announcement No Carb Counting User must be carb aware Beta Bionics Adaptive Closed-Loop Algorithms Algorithm learns and adapts to the user’s insulin requirements Initialized with only the user’s body weight User only announces meals; no carb counting* No adjustment of settings by the provider required after initialization First and Only Fully Adaptive Closed-Loop Algorithm Generates similar or better clinical outcomes, with substantially less work for the user and provider1,2 Note:Continuous glucose monitor (CGM). *User must be carb aware Russell, S.J., et al. (2022) A Multicenter Randomized Trial of a Bionic Pancreas in Type 1 Diabetes. The New England Journal of Medicine. 387:1161–1172. Damiano et al. (2024) Glycemic and CGM Outcomes are nearly independent of the frequency of user engagement with the iLet in the Bionic Pancreas Pivotal Trial and real-world setting. https://www.betabionics.com/wp-content/uploads/iLet-Glycemic-and-CGM-outcomes-vs-user-engagement.pdf Requires quarterly adjustment of settings by the provider Adjusts Daily As Needed Adjusts Every 3 Months Hybrid Closed-Loop System Adjusts Basal Rates (based on settings) Limited Correction Doses Carb Counting to Calculate Meal Dose Manual Correction ü ü ü ü CGM Target ü Correction Factor ü Insulin-to-Carb Ratio ü Basal Rate ü Pump Competitors Hybrid Closed-Loop System Algorithm responds to ongoing inputs from the user and provider Initialized with numerous inputs determined by the provider User continuously makes daily decisions about their diabetes iLet / Mint Insulin Doses for Meals ü Correction Insulin ü Basal Insulin ü Inputs Weight ü CGM Target ü ü
*Minor differences in adaptation compared to previous algorithm are not anticipated to have a significant impact on outcomes. Note:Commercialization of iLet 3D and Mint 3D is subject to regulatory clearance of 3D Intelligence by the FDA, and the devices are not available for sale. Actual product features may vary. 3D Intelligence™, Beta Bionics’ Next-Gen Algorithm Three selectable algorithm experiences offer greater personalization while maintaining the core simplicity and automation of the current Beta Bionics algorithm iLet 3D™ Mint 3D™ Original The currently available, fully adaptive algorithm* Proven real-world experience across more than 40,000 users Optimized New algorithm experience with enhanced learning Builds on and incorporates real-world learnings from the currently available, fully adaptive algorithm to optimize performance Conservative New, alternative algorithm experience Designed to provide a more measured response when correcting high glucose levels Expected commercial launch by the end of 2026 Expected commercial launch in Q1 2027
iLet Bionic Pancreas Sleek tubed pump design with control screen on pump and option to use pre-filled Fiasp PumpCart Abbott’s FreeStyle Libre 3 Plus Sensor Dexcom G7 & G7 15 Day Dexcom G6 Smartphone Insulin Cartridge Infusion Set
Note: The images shown are for illustrative purposes only. Actual product specifications may vary. Mint is not yet available for sale. Continuous glucose monitor (CGM). Mint Patch Pump FDA Cleared in September 2026; Full Commercial Launch in the U.S. expected in Q1 2027 New, innovative reusable-disposable architecture Reusable Controller Designed for 2 years of use iOS and Android smartphone controlled Never requires charging Firmware-over-the-air updates Waterproof for up to 5ft deep for 60 minutes (IPX8) Disposable Cartridge 200U insulin reservoir 3-day wear time; additional 12-hour grace period Disposable batteries No phone required for patch change Waterproof for up to 5ft deep for 60 minutes (IPX8) Powered by fully adaptive algorithm Seamless patch change process Compatible with industry-leading CGMs & smartphones
Potential Business Advantages Expands Addressable Market Reimbursed Exclusively in the Pharmacy Channel Cost Effective to Manufacture at Scale Limits Environmental Waste R x Targeting Mint Full U.S. Commercialization in Q1 2027 Note: Mint is not yet available for sale.
Note:The information presented on this slide is for illustrative purposes only and expresses estimated dollar amounts. Durable Medical Equipment (DME). DME (Medical) Pharmacy Traditional reimbursement channel for durable insulin pumps Pay-as-you-go model with advantages for users, providers, payors, and Beta Bionics Illustrative Economics for User and Payor User (out of pocket) Upfront cost ~$500 to ~$2,000 ~$0 to ~$100 Monthly cost ~$35 ~$25 or less Commitment Typically 4 years None Payor Pump ~$3,500 up front ~$450 / month Supplies ~$70 / month Providing Flexible Reimbursement We believe iLet is the first durable pump to access the pharmacy channel; Mint will be exclusively available in the pharmacy channel
Pharmacy Channel Strategy Streamlined insurance approval Users Providers Payers Beta Bionics Less administrative burden Lower out-of-pocket costs Higher Customer Lifetime Value No 4-year pump commitment Faster Access to New Users Pay-as-you-go economics PBM Agreement 1 Health Plan Adoption 2 Time & Logistics 3 Pharmacy New Patient Starts ü Shifting risk to manufacturer Note:Pharmacy Benefit Manager (PBM) Three-step process delivers benefits to users, healthcare providers, payers, and Beta Bionics
Robust Digital Ecosystem For our users, their caregivers, and their healthcare providers iLet and Mint Apps (iOS & Android) Easy-to-use interface Automatic data uploads to the cloud Bionic Circle App (iOS & Android) Remote monitoring experience for family members, friends, and caregivers Bionic Portal, Report & Insights Web-based portal for healthcare providers with patient reports and actionable insights CGM Compatibility iLet and Mint are both compatible with Dexcom G7, Dexcom G7 15 Day, and Abbott’s FreeStyle Libre 3 Plus
Positioning for success
Fully Adaptive Algorithm Tubeless Hybrid Closed-loop System Tubed Hybrid Closed-loop System Smart Insulin Pens Insulet2 MiniMed and Tandem3,4 Multiple Algorithm(s) Algorithm(s) initialized with only body weight ü × × × Algorithm(s) determines 100% of insulin doses ü × × × No carb counting5 ü × × × Form Factor Tubed / durable pump ü × ü × Prefilled cartridges (for tubed pump) ü × × × Patch pump (FDA-cleared) ü ü × × CGM Integration Dexcom G7 & G7 15 Day ü ü ü × Abbott Freestyle Libre 3 Plus ü ü ü × Reimbursement DME (medical) channel ü × ü × Pay-as-you-go pharmacy channel ü ü ü ü Note: Continuous Glucose Monitor (CGM), Durable medical equipment (DME). Mint is not yet available for sale. Beta Bionics. iLet Bionic Pancreas User Guide. 2022. Insulet. Omnipod 5 User Guide. 2022. MiniMed 780g System User Guide. 2020. Tandem Diabetes Care. t:slimx2 Insulin Pump with Control IQ Technology User Guide. 2023. User must be carb aware. User Decision-Making Framework (Tandem only) Differentiation Where it Matters Most
- 0.6 - 0.0 - 0.7 - 0.1 - 0.6 - 0.0 - 0.9 - 0.1 - 1.0 - 0.0 - 0.5 - 0.0 - 0.3 - 0.1 HbA1c % Improvement with iLet1 HbA1c % Improvement with SoC1 All Users Adults Children At least 7% Baseline HbA1c Multiple Daily Injections (MDI) Pumps Hybrid Closed-Loop2 iLet delivered greater reduction in HbA1c vs. competitive hybrid-closed loop systems3 Source:Russell, S.J., et al. (2022) A Multicenter Randomized Trial of a Bionic Pancreas in Type 1 Diabetes. The New England Journal of Medicine. 387:1161–1172., Data on File. Note: Standard of Care (SoC). Data reflects percentage point improvements in HbA1c measurements at 13 weeks as compared to baseline. Hybrid-closed loop systems included t:slim X2 with Control-IQ, and MiniMed 670G or 770G Analyses of subgroups represent post hoc analyses of the pivotal trial data. The pivotal trial was not designed to evaluate the effect of the iLet Bionic Pancreas in the listed subgroups. Superior Pivotal Trial Outcomes vs. Standard of Care
Baseline HbA1c Group Average Baseline HbA1c Average Change Average GMI on the iLet 15.0% 13.7% 12.5% 11.5% 10.5% 9.5% 8.9% 8.5% 7.6% 6.6% 5.7% 14-19% 13-14% 12-13% 11-12% 10-11% 9-10% 8-9% Overall 7-8% 6-7% 4-6% (N=215) (N=457) (N=533) (N=895) (N=1,388) (N=2,238) (N=14,952) (N=3,095) (N=3,615) (N=2,067) (N=449) Overall HbA1c of 8.9% to GMI of 7.3% Meaningful change regardless of baseline HbA1c -7.3% -5.8% -4.8% -3.9% -3.0% -2.1% -1.5% -1.2% -0.4% +0.4% +1.2% >84% of users meeting ADA hypoglycemia goals of <4% time below 70 mg/dL and <1% time below 54 mg/dL1 Baseline HbA1c to Follow-Up GMI 7.8% 7.9% 7.7% 7.7% 7.6% 7.4% 7.3% 7.3% 7.2% 7.0% 6.9% Source:The postmarket surveillance data presented is observational data. These data do not come from a prospective study designed to evaluate the effect of the iLet Bionic Pancreas in subgroups by baseline HbA1c. Real-world data comes from the first two years (5/19/2023–5/18/2025) of iLet usage among iLet users with baseline HbA1c data and who uploaded data to Beta Bionics, Inc., including users who do not meet all criteria in the Indications for use. Individual user results may vary from the average values shown here. Note: Glucose Management Indicator (GMI). American Diabetes Association (ADA). American Diabetes Association Professional Practice Committee. 6. Glycemic Goals and Hypoglycemia: Standards of Care in Diabetes-2024. Diabetes Care. 2024;47:S111-S125 Real World Results Are Consistent with the Pivotal Trial
SH1 Event(s) per 100 Patient Years Note: Severe Hypoglycemia (SH) defined as hypoglycemia with cognitive impairment requiring the assistance of a third party for treatment. Automated Insulin Delivery (AID). Data presented are not based on head-to-head studies. As a result, cross-study comparisons cannot be made, and caution is advised when attempting to extrapolate these data to new patients. Kristensen et al. (2012) Insulin analogues and severe hypoglycaemia in type 1 diabetes. Diabetes Res Clin Pract; 96:17-23. Ostenson et al. (2014) Self-reported non-severe hypoglycaemic events in Europe. Diabetic Medicine; 31:92-101. Graham et al. (2024) Real-World Use of Control-IQ Technology Is Associated with a Lower Rate of Severe Hypoglycemia and Diabetic Ketoacidosis Than Historical Data: Results of the Control-IQ Observational (CLIO) Prospective Study. Diabetes Technol Therapy; 26: 24-32. Data on file. The iLet Bionic Pancreas is indicated for people with type 1 diabetes ages 6 years and older. Real World Severe Hypoglycemia in Non-AID vs. AID Systems iLet Post-Market Data4 N=2,741, ≥ 4 yrs Patient Years ~434 Kristensen et al. 20121 N=3,813, ≥ 18 yrs Patient Years ~3,813 Ostenson et al. 20142 N=3,827, ≥ 15 yrs Patient Years ~220 Control-IQ Post-Market Data3 N=3,061, ≥ 6 yrs Patient Years ~3,061 SmartAdjust (Omnipod 5) MiniMed 780G Undisclosed Undisclosed Non-AID AID Systems # of Users with ≥ 1 SH1 Event(s) per 100 Patient Years
Time to Steady-State GMI (N=30,077 sessions1) Average baseline HbA1c of 8.9% to follow-up GMI on iLet of 7.4% just 2 days after initiation Baseline HbA1c (%) Source:The real-world data presented are observational data. These data do not come from a prospective study designed to assess safety and efficacy of the iLet by duration of iLet use. Data comes from the first 2 years (5/18/2023-5/19/2025) of real-world iLet usage among those people who uploaded CGM data to Beta Bionics, Inc., including users who do not meet all criteria in the Indications for use. Ninety percent of users had a baseline HbA1c available. Individual user results may vary from the average values shown above. Note: Glucose Management Indicator (GMI). Continuous Glucose Monitor (CGM). Most iLets had only one session. A session reflects each initial use of an iLet or after a factory reset. Beta Bionics’ Adaptive Algorithm “Warms-Up” in ~2 Days
-1.6 Baseline HbA1c to Follow-Up GMI Practice Type: Endocrinology Practice Type: Primary Care -1.6 Similar improvement in GMI with >84% of users meeting ADA hypoglycemia goals, regardless of provider practice type N=13,566 N=1,036 Source:The real-world data presented is observational data. These data do not come from a prospective study designed to evaluate the effect of the iLet Bionic Pancreas in subgroups by provider practice type. Real-world data comes from the first two years (5/19/2023–5/18/2025) of iLet usage among iLet users with baseline HbA1c data and provider practice type data from Symphony Health Solutions and the Centers for Medicare & Medicaid Services’ National Plan and Provider Enumeration System, and who uploaded data to Beta Bionics, Inc., including users who do not meet all criteria in the Indications for use. Individual user results may vary from the average values shown here. Note: Glucose Management Indicator (GMI). Primary Care Provider (PCP). American Diabetes Association (ADA). Similar Improvement in GMI Regardless of Provider Type
iLet Real-world Data: Change from Baseline HbA1c to Mean GMI by Level of Engagement in Adults (≥ 18 years old) Source:The real-world data presented is observational data. These data do not come from a prospective study designed to evaluate the effect of the iLet Bionic Pancreas in subgroups by baseline HbA1c or user engagement. Real-world data comes from the first year (5/19/2023–5/18/2024) of iLet usage among those people with baseline HbA1c data and who uploaded data to Beta Bionics, Inc., including users who do not meet all criteria in the Indications for Use. Individual user results may vary from the average values shown here. Note: Glucose Management Indicator (GMI). Low Engagement (≤ 4 average daily swipes to unlock iLet, N=302) High Engagement (≥10 average daily swipes to unlock iLet, N=301) Clinical Results Are Independent of User Engagement Historically, low engagement with pumps meant poor outcomes – not with iLet
-1.9 Baseline HbA1c to Follow-Up GMI ~16% of iLet users (with available data) use the pump in a “fully-closed loop” manner1 On average, “fully-closed loop” iLet users announced ~1 meal every 3 days “Fully-closed loop” users achieved ~62% time in range, on average ~83% of “fully-closed loop” iLet users meeting ADA hypoglycemia goals 530 iLet users have not announced a single meal over the past 21 days Improvement from baseline A1c of 9.4% to a follow-up GMI of 7.4% ~86% meeting ADA hypoglycemia goals N=2,416 Source:The real-world data presented is observational data. These data do not come from a prospective study designed to evaluate the effect of the iLet Bionic Pancreas in subgroups by frequency of meal announcements. Real-world data comes from the 21-day period ending 5/18/2025 of iLet usage among those people with baseline HbA1c data and who uploaded data to Beta Bionics, Inc., including users who do not meet all criteria in the Indications for use. Individual user results may vary from the average values shown here. Note: Glucose Management Indicator (GMI). American Diabetes Association (ADA). Fully-closed loop iLet users defined as users who announced <1 meal per day on average over the 21-day period ending May 18, 2025 Use of iLet in a “Fully-Closed Loop” Manner
Where we are going next
~69% New patient starts coming from multiple daily injections in Q2’26 High 30s % New patient starts reimbursed through pharmacy in Q2’26 Gross Margin ($ in millions) Build On iLet’s Highly Successful Commercial Launch Launched in May 2023, iLet is expanding the pump market and taking market share Revenue
Next-Gen Algorithm: 3D Intelligence Type 2 Diabetes (T2D) Indication Expansion Fully-Closed Loop (FCL) Algorithm Bihormonal System Note: U.S. Food & Drug Administration (FDA). Investigational Device Exemption (IDE), New Drug Application (NDA). Subject to regulatory clearance The Company estimates that greater than 30% of its new patient starts in Q2'26 were from off-label use by T2D patients. Beta Bionics Innovation Pipeline Innovations designed to expand our addressable market and enhance the user experience Designed with three algorithm experiences (Original, Optimized, Conservative) to enable a more customizable treatment approach 510(k) application submitted to FDA Expect to commercialize in the U.S. by the end of 2026 as iLet 3D1 and in Q1 2027 as Mint 3D1 Pivotal trial enrollment initiated in July 2026 Expect to expand the algorithm’s indications for use to adults with T2D in the U.S. around mid-20271 Expanded algorithm indication1 is expected to enable sales of both iLet and Mint to adults with T2D in the U.S.2 Intend to initiate a fully-closed loop pivotal trial in adults with type 1 and type 2 diabetes in the coming quarters Completed first-in-human Phase 2a feasibility trial in Q4’25 Additional Phase 2a feasibility trial initiated in Q1’26 Path through Phase 2b and Phase 3 trials to support NDA (glucagon) and 510(k) (algorithm and pump) filings
Of the 1.9M people with T1D in the U.S. are treated by PCPs ~50% Of people with T2D in the U.S. are treated by PCPs ~90% Pump penetration in primary care in the U.S. <10% 1.9M People with T2D in the U.S. who require intensive insulin (IIT) Pump penetration in T2D IIT population in the U.S. <10% <0.2M People with T2D IIT in the U.S. use an insulin pump Primary Care Type 2 Diabetes (IIT)1 Pharmacy reimbursement reduces administrative burden for PCPs and streamlines approval process for people with T2D Label expansion in T2D expected in mid-2027, subject to regulatory clearance Change institution-level protocols that drive PCP prescribing patterns at the clinic level Simplicity combined with efficacy Similar glycemic outcomes relative to usual care for PCPs Recently approved patch form factor Our Path to Win Our Approach Source: Internal estimates informed by data from the CDC, Seagrove Partners, The Diabetes Forum: 2021 Diabetes Blue Book, and publicly-reported 2024 product sales data. Note:Type 1 Diabetes (T1D). Type 2 Diabetes (T2D), Insulin-Intensive Therapy (IIT), Primary Care Provider (PCP). Oser SM et al. Diabetes 2024; 73(Supplement_1):957-P. Expansion in Primary Care & Type 2 Diabetes Largely untapped segments of the diabetes market that iLet may be uniquely positioned to address
First-of-its-kind bihormonal configuration of the iLet Intended to utilize adaptive closed-loop algorithms that autonomously determine and deliver 100% of all insulin and glucagon doses Exclusive collaboration and license agreement with Xeris Pharmaceuticals for a pump-compatible, shelf-stable, glucagon formulation Clear path to market Phase 2a (current stage): Feasibility trials to stress test the system’s capabilities and iterate accordingly. Completed first-in-human Phase 2a feasibility trial in Q4’25; additional Phase 2a feasibility trial initiated in Q1’26 Phase 2b: Robust pivotal-enabling feasibility trial Phase 3: Concurrent pivotal trials to support regulatory filings for the glucagon asset (NDA), algorithm (510(k)), and pump (510(k)) Potentially transformative treatment outcomes and burden reduction In 6 pre-pivotal outpatient clinical trials, participants achieved reduced hypoglycemia and increased time in range relative to both standard-of-care treatment and our insulin-only bionic pancreas configuration1,2,3,4,5 Potential to substantially reduce fear of hypoglycemia and regimen burden which could lead to reduction in the challenges associated with diabetes management6,7 Russell et al. (2014) New England Journal of Medicine, 371:313-325 Russell et al. (2016) The Lancet Diabetes and Endocrinology, 4:233-243 El-Khatib et al. (2017) The Lancet, 389:369-380 Balliro et al. (2017) 77th Scientific Sessions of the American Diabetes Association, 1062-P Sherwood et al. (2018) 78th Scientific Sessions of the American Diabetes Association, 299-OR Weissberg-Benchell et al. (2017) Diabetes Technology & Therapeutics, 12: 723-729 Weissberg-Benchell et al. (2016) Journal of Diabetes Science & Technology 4: 840-4 Bihormonal Pump in Development Potential to revolutionize diabetes care
Anticipated revenue deferral of up to $10 million in Q4 2026 as new prospective iLet users await the launch of Mint Stable utilization and retention across DME and pharmacy channels Contribution from at least 20 new sales territories onboarded in the first half of 2026 Execution of additional formulary agreements and deeper adoption of iLet at the individual health plan level to drive increases in pharmacy new patient starts Continued cost discipline and improved leverage of manufacturing overhead at greater scale Assumptions & Drivers $121-126M Total Revenue 37-39% New Patient Starts through Pharmacy 58.5-59.5% Gross Margin $131-136M 37-39% 58.5-59.5% Previous New Note:Previous guidance as of July 2026. New guidance as of September 2026. Full Year 2026 Guidance
Innovating for today and the future Strategic Outlook iLet launch (Black & White) CGM integrations (Dexcom G6 & G7, Abbott Freestyle Libre 3 Plus) Formulary agreements (e.g., Express Scripts & CVS Caremark) Collaboration and licensing agreement with Xeris Pharmaceuticals Color iLet launch Expansion to 43 sales territories Lay the Foundation 2023 to 2024 Achievements Capitalize on recent launches (Color iLet, Libre 3 Plus, Bionic Circle, Bionic Portal) Continued expansion of sales territories Additional formulary agreements Growth of pharmacy coverage at the individual health plan level Mint patch pump clearance iLet 3D commercial launch1 Advance bi-hormonal pump projects Execute Relentlessly 2025 to 2026 Objectives Mint 3D full commercial launch1 Bi-hormonal system commercialization1 Expansion of sales territories Growth of pharmacy channel mix Market and indication expansion Primary care Type 2 insulin-intensive diabetes1 International markets1 Other insulin-requiring diseases1 Revolutionize Care Future Objectives Subject to regulatory clearance
Appendix
Adjusted EBITDA addbacks include stock-based compensation expense, depreciation and amortization expense, interest income, provision for state taxes, litigation settlement expense, quality system remediation, and change in fair value of warrant liabilities. Amounts presented under “Quality system remediation” for the three months ended December 31, 2025, March 31, 2026, and June 30, 2026 reflect the same category of expenses previously labeled “Other non-recurring” in our Form 10-K for the year ended December 31, 2025. These expenses relate to our one-time remediation efforts in response to the Form 483 and the Warning Letter, including contractor support and the various updates to our quality system to meet FDA expectations. Quarterly Financials & Reconciliation to GAAP Financials