Every 8-K that Beta Bionics, Inc. (BBNX) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow BBNX and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full BBNX filings page.
Beta Bionics, Inc. (BBNX) entered into an underwriting agreement for an underwritten public offering of 7,652,175 shares of common stock at $17.25 per share and, in lieu of common shares to certain investors, pre-funded warrants to purchase 1,043,484 shares at $17.2499 per warrant. The company expects gross proceeds of $150.0 million before underwriting discounts, commissions and expenses. The offering is expected to close on or about September 17, 2026, subject to customary closing conditions.
The underwriters have a 30-day option to purchase up to 1,304,348 additional shares at the public offering price, less underwriting discounts and commissions. Beta Bionics states it expects to use net proceeds for general corporate purposes, including commercialization of its Mint™ product, expansion of manufacturing facilities, research and clinical development, product enhancements, potential strategic opportunities, and working capital and operating expenses.
Beta Bionics, Inc. (BBNX) reports U.S. FDA clearance of its Mint patch insulin pump and outlines an updated growth strategy and outlook. Mint uses a reusable/disposable design that does not require recharging, integrates with leading continuous glucose monitors, and allows smartphone control. The company expects full U.S. commercial launch in the first quarter of 2027 and anticipates manufacturing capacity for at least 1.5 million disposable Mint units in 2027, with initial U.S. pharmacy-benefit access for about 40% of insured lives, increasing to at least 50% within the first year of full commercialization.
Beta Bionics has submitted a 510(k) application for its 3D Intelligence next‑generation insulin‑dosing algorithm, expected, subject to FDA clearance, to power the iLet 3D and Mint 3D platforms, with U.S. commercialization targeted by the end of 2026 for iLet 3D and alongside Mint’s full launch for Mint 3D. Real‑world data from 14,952 iLet users showed an average HbA1c improvement from 8.9% to a GMI of 7.3%, with over 84% meeting American Diabetes Association hypoglycemia goals, and post‑market data indicated 8.1 users with ≥1 severe hypoglycemia event per 100 patient‑years.
The company raises its 2026 total revenue guidance to $131–136 million from $121–126 million, while maintaining guidance for new patient starts through the pharmacy channel at 37–39% and gross margin at 58.5–59.5%. Management notes an anticipated deferral of up to $10 million of revenue in Q4 2026 as some prospective iLet users await Mint’s launch. Beta Bionics also discloses that a stockholder has filed a securities class action related to prior statements about iLet; the company states it intends to defend the case and that any potential loss is not currently probable or estimable.
Beta Bionics, Inc. reported strong growth for the quarter ended June 30, 2026, with net sales of $32.0 million, up 38% from $23.2 million a year earlier. Durable Medical Equipment channel sales were $20.4 million, while Pharmacy Benefit Plan channel sales more than doubled to $11.6 million.
Gross margin improved to , but the company remained unprofitable, with a loss from operations of $25.6 million and a net loss of $23.4 million, both wider than in 2025. Adjusted EBITDA was negative $17.7 million. Cash, cash equivalents, and investments totaled $225.2 million as of June 30, 2026.
Management reaffirmed 2026 revenue guidance of $131–$136 million and the expected mix of new patient starts via the PBP channel, while modestly raising gross margin guidance to 58.5%–59.5%. The company also highlighted progress on its iLet pivotal trial in type 2 diabetes and commercialization plans for the Mint patch pump, both subject to future FDA clearance.
Beta Bionics, Inc. reported the results of its 2026 Annual Meeting of Stockholders. As of March 23, 2026, there were 44,561,695 shares outstanding, and a quorum of 36,061,048 shares was represented in person or by proxy.
Stockholders elected Class I directors Sean D. Carney and Christy Jones to serve until the 2029 Annual Meeting, with Carney receiving 30,659,060 votes for and Jones 25,865,542 votes for, alongside broker non-votes. Stockholders also ratified the appointment of Ernst & Young LLP as independent registered public accounting firm for the fiscal year ending December 31, 2026.
Beta Bionics, Inc. has updated expectations for Mint, its patch insulin pump in development. The company now expects to fully commercialize Mint by the end of the second quarter of 2027, subject to U.S. FDA regulatory clearance of its alternate controller enabled (ACE) insulin pump 510(k) application.
The new timeline reflects the FDA’s initial responses to that application and progress in scaling Mint manufacturing, and the company expects capacity to meet anticipated demand at launch. Mint is expected to offer a 200‑unit insulin reservoir, about three days of wear plus a 12‑hour grace period, smartphone control, waterproof use, and compatibility with leading continuous glucose monitors and Beta Bionics’ FDA‑approved fully adaptive dosing algorithm.
Beta Bionics, Inc. reported strong first quarter 2026 growth and raised its full year 2026 outlook. Net sales reached $27.6 million, up 57% from $17.6 million a year earlier, driven by both Durable Medical Equipment and Pharmacy Benefit Plan channels.
Gross margin improved to 59.5% from 50.9%, while net loss narrowed to $21.9 million from $28.7 million as operating expenses increased to support growth. The company ended March 31, 2026 with $239.5 million in cash, cash equivalents, and investments and now expects 2026 revenue of $131–$136 million, higher gross margins, and a greater share of new patient starts through the PBP channel.
Beta Bionics, Inc. reported sharp growth for the fourth quarter and full year 2025 while remaining loss-making. Full-year net sales reached $100.3 million, up 54% from $65.1 million, driven by both Durable Medical Equipment and Pharmacy Benefit Plan channels. Fourth-quarter net sales were $32.1 million, up 57% year over year.
Gross margin improved modestly to 55.4% for 2025. The installed customer base rose to 35,011 users, up 129%, with 19,713 new patient starts, a 52% increase. A high-20s percentage of 2025 new patient starts and a low-30s percentage in the fourth quarter were reimbursed through the PBP channel, showing rapid pharmacy channel expansion.
The company still posted a full-year net loss of $73.2 million, or $1.81 per share, with adjusted EBITDA of negative $52.8 million. Beta Bionics ended 2025 with $264.7 million in cash, cash equivalents, and investments and issued 2026 guidance for revenue of approximately $130 million to $135 million and gross margin of 55.5% to 57.5%.
Beta Bionics reported that it received a warning letter from the U.S. FDA on January 29, 2026 following an inspection of its Irvine, California facility conducted in June 2025. The FDA cited deficiencies in the company’s responses to a prior Form 483 and highlighted non-conformities in its quality system, medical device reporting, and correction and removal processes.
The letter does not currently limit Beta Bionics’ ability to manufacture, market, or distribute products, or to seek FDA 510(k) clearance for new products. The company has begun corrective actions, is preparing a written response, and plans ongoing updates to the FDA, but notes that additional regulatory action is possible until issues are resolved. Beta Bionics states it does not expect this warning letter to materially affect its previously disclosed guidance to launch commercialization of Mint by the end of 2027.
Beta Bionics, Inc. filed a current report to disclose that it has issued a press release with preliminary, unaudited fourth quarter 2025 topline financial results and key operating metrics. The company furnished this information under its results of operations and financial condition disclosure and attached the press release as Exhibit 99.1. The report clarifies that these materials are being furnished rather than filed, which affects how they are treated under securities law.
Beta Bionics, Inc. reported that it issued a press release announcing financial results for the third quarter ended September 30, 2025. The release is included as Exhibit 99.1.
The information under Item 2.02 is furnished and is not deemed “filed” under the Exchange Act or incorporated by reference unless expressly stated otherwise.
Beta Bionics, Inc. (Nasdaq: BBNX) filed an 8-K to disclose materials from its first Investor & Analyst Event held on 22 June 2025 in conjunction with the ADA Scientific Sessions. Exhibit 99.1 contains a detailed slide deck highlighting two-year, real-world performance of the iLet Bionic Pancreas.
The company analysed data from 16,439 commercial users who uploaded ≥3 weeks of CGM readings between 19 May 2023 and 18 May 2025. A core cohort of 14,952 users with baseline HbA1c records showed an average HbA1c reduction from 8.9 % to a GMI of 7.3 %. Across multiple sub-groups—MDI converts (8,802 users), competitive HCL converts (2,910 users), endocrinology vs. primary-care settings, and “fully-closed loop” users—similar improvements were observed, with ≥83 % of patients meeting ADA hypoglycaemia targets (<4 % time <70 mg/dL; <1 % time <54 mg/dL).
Algorithmic performance data from 30,077 device sessions indicate the system reaches a steady-state GMI of 7.4 % within two days of initiation, underscoring rapid optimisation.
Management emphasises the potential clinical benefit of iLet but cautions that the forward-looking statements are subject to regulatory, financing and market risks. No financial metrics, revenue guidance or earnings updates were provided, and the furnished information is not deemed “filed” under the Exchange Act.