Form 8-K
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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):  May 21, 2026

_______________________________

Beta Bionics, Inc.

(Exact name of registrant as specified in its charter)

_______________________________

Delaware001-4249147-5386878
(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 classTrading Symbol(s)Name of each exchange on which registered
Common Stock, $0.0001 par value per shareBBNXNasdaq 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 May 21, 2026, Beta Bionics, Inc. (the “Company”) issued a press release announcing updated timeline expectations for the commercialization of its patch pump in development, Mint. A copy of the press release is attached hereto as Exhibit 99.1.

 

The information contained under this Item 7.01, including Exhibit 99.1 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 the Company expressly sets forth in such filing that such information is to be considered “filed” or incorporated by reference therein.

 

Item 8.01. Other Events.

 

On May 21, 2026, the Company announced that it expects to fully commercialize Mint by the end of the second quarter of 2027, subject to regulatory clearance by the U.S. Food and Drug Administration (“FDA”). The updated Mint commercialization timeline expectation is based on the FDA’s initial responses to the Company’s Mint alternate controller enabled (“ACE”) insulin pump 510(k) application, and the progress the Company has made in scaling its Mint manufacturing processes. The Company expects manufacturing capacity to meet anticipated demand at launch.

 

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: the Company’s expectations regarding the timing or certainty of the FDA’s approval of Mint as an ACE insulin pump, and the timing or certainty of commercialization of Mint and related updates; and the Company’s manufacturing capacity at launch. 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, 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 Securities and Exchange Commission, including the section titled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026. 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, the Company undertakes 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 May 21, 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.
   
  
Date: May 21, 2026By: /s/ Sean Saint        
  Sean Saint
  President and Chief Executive Officer
  

 

EXHIBIT 99.1

Beta Bionics Updates Commercialization Timeline Expectations for Mint™, its Patch Pump in Development

IRVINE, Calif., May 21, 2026 (GLOBE NEWSWIRE) -- Beta Bionics, Inc. (Nasdaq: BBNX), a pioneering leader in the development of advanced diabetes management solutions, today announced that it expects to fully commercialize Mint by the end of the second quarter of 2027, subject to regulatory clearance by the U.S. Food and Drug Administration (FDA). The updated Mint commercialization timeline expectation is based on the FDA’s initial responses to the company’s Mint alternate controller enabled (ACE) insulin pump 510(k) application, and the progress the company has made in scaling its Mint manufacturing processes. The company expects manufacturing capacity to meet anticipated demand at launch.

“We believe that Mint, which stands for Mini Insulin Therapy, will represent a meaningful advancement for people with diabetes,” said Sean Saint, President & CEO of Beta Bionics. “In pairing our fully adaptive insulin dosing algorithm with Mint, subject to regulatory clearance, we expect to deliver an innovation to the market that expands choice of form factor for our existing customers, and choice of insulin dosing algorithm for existing and prospective patch pump users.”


The image shown is for illustrative purposes only. Actual product specifications may vary.

Mint Features Expected at the Time of Commercialization*

*Commercialization of the Mint patch pump is subject to regulatory clearance, and the device is not available for sale. Actual product specifications and features may vary.

1.  Cook, K., et.al (2025). Defining the Automated Insulin Delivery Continuum: User Engagement and System Adaptation. ADCES 2025. Poster Presentation, 2025 Aug 9

More details will be shared when FDA clearance is secured.

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. The iLet Bionic Pancreas is the first FDA-cleared insulin delivery device 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 timing or certainty of the FDA’s approval of Mint as an ACE insulin pump, and the timing or certainty of commercialization of Mint and related updates; the Company’s manufacturing capacity at launch; Mint’s potential benefits for people with diabetes; the anticipated specifications and features for Mint; and the Company’s ability to leverage existing iLet market access footprint and agreements for iLet in the pharmacy channel to build pharmacy coverage for Mint. 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, 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 Securities and Exchange Commission, including the section titled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026. 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
[email protected]

Source: Beta Bionics, Inc.

Photos accompanying this announcement are available at:

https://www.globenewswire.com/NewsRoom/AttachmentNg/dd9f136d-aea8-46b4-8bfa-63568d4bc933

https://www.globenewswire.com/NewsRoom/AttachmentNg/4719df89-36b7-46eb-acbf-732b33220499