Form 8-K

8-K — Beta Bionics, Inc.

Accession: 0001193125-26-392088

Filed: 2026-09-15

Period: 2026-09-14

CIK: 0001674632

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — d153052d8k.htm (Primary)

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8-K

8-K (Primary)

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8-K

false 0001674632 0001674632 2026-09-14 2026-09-14

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): September 14, 2026

Beta Bionics, Inc.

(Exact name of registrant as specified in its charter)

Delaware

001-42491

47-5386878

(State or Other Jurisdiction

of Incorporation)

(Commission

File Number)

(I.R.S. Employer

Identification No.)

11 Hughes

Irvine, California 92618

(Address of Principal Executive Offices) (Zip Code)

(949) 427-7785

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading

Symbol(s)

Name of each exchange

on which registered

Common Stock, $0.0001 par value per share

BBNX

Nasdaq Global Market

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

No.

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

EX-99.1

EX-99.1

Filename: d153052dex991.htm · Sequence: 2

EX-99.1

Exhibit 99.1

Beta Bionics Announces FDA Clearance of Mint™, the Company’s Transformative Patch Pump, and

Unveils 3D Intelligence™ as its Next-Generation Insulin Dosing Algorithm

•

Mint features a new and innovative patch pump architecture

•

Full Mint U.S. commercialization expected to begin in Q1 2027

•

Manufacturing capacity expected to produce at least 1.5 million disposable Mint units during 2027

•

3D Intelligence, the Company’s next-generation insulin dosing algorithm, has been submitted to the FDA

through a 510(k) application

•

Expectations to commercialize 3D Intelligence in the U.S. by the end of 2026 as iLet 3D™, and at the time of full Mint launch as Mint

3D™, subject to regulatory clearance by the FDA

•

Updated full year 2026 guidance

IRVINE, Calif., September 14, 2026 – Beta Bionics, Inc. (Nasdaq: BBNX), a pioneering leader in the development of advanced diabetes management

solutions, today announced U.S. Food and Drug Administration (FDA) clearance of Mint, the Company’s 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. Mint is expected to meaningfully expand the Company’s addressable insulin delivery market, particularly among people with diabetes seeking a patch pump

form factor.

Additionally, the Company is unveiling 3D Intelligence, its anticipated next-generation insulin dosing algorithm, which has been submitted

to the FDA through a 510(k) application. 3D Intelligence is designed with three algorithm experiences intended to enable a more customizable treatment approach tailored to each user’s unique insulin requirements.

Subject to regulatory clearance by the FDA, Mint 3D and iLet 3D will represent Beta Bionics’

next-generation automated insulin delivery (AID) platforms, designed to maximize user choice through optionality in hardware and algorithm experience.

“We believe that our next-generation AID platform, consisting of Mint 3D and iLet 3D, will represent a transformational advancement for people living

with diabetes, subject to regulatory clearance by the FDA,” said Sean Saint, President & CEO of Beta Bionics. “Beta Bionics puts people with diabetes at the center of everything we do, and each element of Mint 3D and iLet 3D

reflects that philosophy. Delivering choice is critical to the community we serve, and that is what Mint 3D and iLet 3D are intended to offer: the choice of wearing a patch pump or tubed pump along with an algorithm experience that is uniquely

suited to each individual, all with a particular focus on improving affordability through our efforts to expand access for both iLet and Mint in the pharmacy channel.”

Expectations for Full Launch of Mint in the United States

The Company expects to initiate the full commercial launch of Mint in the United States in the first

quarter of 2027, ahead of its previous target, and anticipates manufacturing capacity to produce at least 1.5 million total disposable units in the full year 2027. The Company believes it may be able to exceed the 1.5 million unit target

by accelerating staffing, improving efficiency through additional automation, and enhancing manufacturing yield.

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. The Company anticipates coverage for Mint to increase to at least 50% of insured U.S. lives within the first

year of full commercialization as it leverages its market access footprint.

Mint 3D Features Expected at the Time of Full Launch in the United States*

•

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

•

Powered by Beta Bionics’ 3D Intelligence algorithm*

•

Compatible with industry-leading continuous glucose monitors: Dexcom G7, Dexcom G7 15 Day, and Abbott’s

FreeStyle Libre 3 Plus

•

iOS and Android smartphone controlled

*

Commercialization of Mint 3D is subject to regulatory

clearance. The device is currently investigational and not available for sale. Actual product specifications and features may vary.

3D Intelligence Features & Expectations for Launch in the United States*

3D Intelligence represents the next generation of Beta Bionics’ fully adaptive automated insulin

delivery technology. Building on the Company’s experience with iLet and its real-world use across more than 40,000 users, 3D Intelligence is designed to give people with diabetes greater

choice in how their insulin delivery algorithm responds to their individual needs.

3D Intelligence is designed to offer clinicians three selectable algorithm experiences that they can choose based on each patient’s unique insulin needs.

•

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 the Company’s real-world experience with iLet.

•

Conservative – an alternative experience designed to provide a more measured response when

correcting high glucose levels.

Clinicians will be able to select the experience that best meets each user’s individual needs.

Together, these three experiences are intended to provide greater personalization while preserving the core simplicity and automation of the currently available iLet experience.

Subject to regulatory clearance by the FDA, the 3D Intelligence insulin dosing algorithm is expected to

power both iLet 3D and Mint 3D. 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 simultaneous

with the full Mint Iaunch in the first quarter of 2027, in each case, subject to regulatory clearance by the FDA.

*

Commercialization of iLet 3D and Mint 3D is subject to

regulatory clearance by the FDA. The devices are currently investigational and not available for sale. Actual product features may vary.

**

Minor differences in adaptation compared to previous algorithm are not anticipated to have a significant impact

on outcomes.

2026 Full Year Guidance & Key Considerations for 2027

For the full year 2026, the Company estimates total revenue of approximately $121 million to $126 million (previously $131 million to $136

million), reflecting a potential revenue deferral impact of up to $10 million in the fourth quarter of 2026 as new prospective iLet users could choose to await the launch of Mint.

•

During the full year 2027, the Company expects Mint to recapture any revenue lost in the fourth quarter of 2026.

For the full year 2026, the Company reiterates its expectations for 37% to 39% of new patient starts to be reimbursed through the

pharmacy channel.

•

For the full year 2027, the Company expects pharmacy coverage for iLet to increase year over year, while the

percentage of iLet new patient starts reimbursed through the pharmacy channel is expected to decline year over year as more pharmacy-covered individuals adopt Mint.

•

With the contribution from Mint, pharmacy channel revenue as a percentage of total revenue is expected to

increase in 2027 relative to the prior year.

For the full year 2026, the Company reiterates its expectations for gross margin of 58.5%

to 59.5%.

•

The Company expects Mint to be modestly dilutive to full

year 2027 gross margin, and highly accretive to the Company’s long-term gross margin profile at scale.

About Beta Bionics

Beta Bionics, Inc. is a commercial-stage medical device company engaged in the design, development, and commercialization of innovative solutions to

improve the health and quality of life of insulin-requiring people with diabetes (PWD) by utilizing advanced adaptive closed-loop algorithms to simplify and improve the treatment of their disease. Beta Bionics’ proprietary insulin dosing

algorithm is the first FDA-cleared algorithm that autonomously determines every insulin dose and offers the potential to substantially improve overall outcomes across broad populations of PWD. To learn more,

visit www.betabionics.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this press

release 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”) regarding the

potential clearance by the FDA, including of 3D Intelligence, and the timing thereof; the implications 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; the Company’s 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; and the Company’s 2026 full year guidance

and expectations for 2027 regarding estimates of revenue, including revenue deferral and revenue recapture, new patient starts reimbursed through the pharmacy channel, pharmacy channel coverage and gross margin. Words such as “believe,”

“anticipate,” “plan,” “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 the beliefs of the management of the Company as well as assumptions made by and information currently available to the Company. Such statements reflect the current views of the Company 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 the Company, risks inherent in developing product candidates, the

Company’s ability to obtain adequate financing to fund its product development and other expenses, the Company’s ability to manufacture and scale production of its products and manage its supply chain, the Company’s ability to

obtain adequate reimbursement and payer coverage for its products, trends in the industry, the Company’s relationships with its existing and future collaboration partners, the legal and regulatory framework for the industry, future

expenditures and the potential impacts of global macroeconomic conditions. 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 the Company’s actual results to differ from current expectations are discussed in the Company’s 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 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 Beta Bionics 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 press release 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.

Investor Relations:

Blake Beber

Head of Investor Relations

ir@betabionics.com

Media and Public Relations:

Felicia Sanborn

Vice President of Marketing

media@betabionics.com

Source: Beta Bionics,

Inc.

EX-99.2

EX-99.2

Filename: d153052dex992.htm · Sequence: 3

EX-99.2

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

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