Beta Bionics Inc

S-11 d880651ds1.htm S-1

As filed with the Securities and Exchange Commission on January 6, 2025.

Registration No. 333-

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

**FORMS-1 **

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

(Exact name of Registrant as specified in its charter)

11 Hughes

Irvine, California 92618

**(949)427-7785 **

(Address, including zip code, and telephone number, including area code, of Registrant’s principal executive offices)

Sean Saint

President and Chief Executive Officer

Beta Bionics, Inc.

11 Hughes

Irvine, California 92618

**(949)427-7785 **

(Name, address, including zip code, and telephone number, including area code, of agent for service)

Copies to:

Approximate date of commencement of proposed sale to the public: As soon as practicable after this Registration Statement is declared effective.

If any of the securities being registered on this form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, as amended, check the following box. ☐

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, anon-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

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 7(a)(2)(B) of the Securities Act. ☐

The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the Registration Statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

The information in this preliminary prospectus is not complete and may be changed. Neither we nor the selling stockholders may sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any state or other jurisdiction where the offer or sale is not permitted.

Subject to Completion

Preliminary Prospectus dated , 2025

PRELIMINARY PROSPECTUS

** Shares**

This is the initial public offering of shares of common stock of Beta Bionic, Inc. We are selling shares of our common stock, and the selling stockholders identified in this prospectus have granted the underwriters the option for a period of 30 days to purchase up to an additional shares from them, in each case at the initial public offering price less the underwriting discounts and commissions. We will not receive any proceeds from the sale of shares by the selling stockholders.

Prior to this offering, there has been no public market for our common stock. We currently expect the public offering price for our common stock to be between $ and $ per share. We have applied to list our common stock on the Nasdaq Global Market (Nasdaq) under the symbol “BBNX.” We believe that upon the completion of this offering, we will meet the standards for listing on Nasdaq, and the closing of this offering is contingent upon such listing.

We are an “emerging growth company” and a “smaller reporting company” under the federal securities laws and are subject to reduced public company disclosure standards. See the section titled “Prospectus Summary—Implications of Being an Emerging Growth Company and a Smaller Reporting Company.”

Investing in the common stock involves risks that are described in the section titled ‘‘Risk Factors’’ beginning on page 22 of this prospectus.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

The underwriters expect to deliver the shares of common stock to purchasers on or about , 2025.

Stifel

Lake Street

The date of this prospectus is , 2025.

New Treatment Paradigm For People with Diabetes iLet Bionic Pancreas (iLet): first FDA-cleared pump that utilizes adaptive closed-loop algorithms that are initialized only with a user’s body weight and require no additional insulin dosing parameters Note: The individual shown is for illustration purposes only and may not be an exact representation of the user of iLet. Beta Bionics iLet: Determines and Delivers 100% of All Insulin Doses1 Abbott’s FreeStyle Libre 3 Plus Sensor Dexcom G7 CGM Dexcom G6 CGM Insulin cartridge Infusion set Smartphone Adaptive algorithms learn each person’s unique and ever-changing insulin requirement to simplify and improve diabetes management Note: Abbott and Dexcom CCMs are not manufactured or sold by Beta Bionics. 1. At mealtime, the user makes a simple declaration that an upcoming meal will be within historical norms, “the usual for me,” or higher or lower than typical. Beta Bionics

Unique Algorithms Require Minimal Human Intervention Pump Competitors Hybrid Closed-Loop System Limited Correction Doses Carb Counting to Calculate Meal Dose Manual Correction Hybrid Closed-Loop System As Needed Adjusts every 3 Months Adjusts Basal Rates (based on settings) CGM Target Correction Factor Insulin-to-Carb Ratio Basal Rate Healthcare Professional determines and inputs basal rates, insulin-to-carb ratios, insulin action time and correction factors. User continuously makes decisions about their diabetes throughout the day. Hybrid Closed-Loop adjusts the basal rate based on the settings and provides limited correction doses. iLet Adaptive Closed-Loop Algorithms Meal Announcement No Carb Counting User must be carb aware Insulin Doses for Meals Correction Insulin iLet Inputs Weight CGM Target Basal Insulin Healthcare Professional enters only the patient’s weight. User only makes a meal announcement. iLet adjusts the basal rate throughout the day, doses corrections and determines meal doses based on the individual. Beta Bionics