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Beta Bionics, Inc. SEC Filings

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Welcome to our dedicated page for Beta Bionics SEC filings (Ticker: BBNX), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.

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Rhea-AI Summary

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.

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FAQ

What is the current stock price of Beta Bionics (BBNX)?

The current stock price of Beta Bionics (BBNX) is $14.56 as of June 30, 2025.

What is the market cap of Beta Bionics (BBNX)?

The market cap of Beta Bionics (BBNX) is approximately 685.0M.

What is the main focus of Beta Bionics, Inc.?

Beta Bionics, Inc. focuses on the design, development, and commercialization of advanced insulin delivery systems that leverage adaptive closed-loop algorithms to simplify diabetes management.

How does the company’s flagship product improve diabetes care?

The flagship product autonomously determines insulin doses using sophisticated sensor data and continuous monitoring, which simplifies treatment regimens and aims to maintain stable glycemic control.

What technology underpins Beta Bionics' insulin delivery system?

Beta Bionics utilizes adaptive closed-loop algorithms that integrate real-time data to provide automated and precise insulin dosing, representing a significant technological advancement in diabetes management.

How does Beta Bionics differentiate itself in the competitive medical devices market?

The company differentiates itself by focusing exclusively on a single, advanced insulin delivery system that offers autonomous dosing, supported by rigorous clinical testing and quality assurance processes.

What is the significance of the adaptive closed-loop algorithm in their product?

The adaptive closed-loop algorithm continuously adjusts insulin delivery based on real-time data, reducing manual interventions and potentially improving overall treatment outcomes for patients with diabetes.

How does Beta Bionics ensure the safety and efficacy of its product?

Beta Bionics emphasizes a disciplined approach in design and development, incorporating extensive clinical assessments and adherence to regulatory standards to ensure safety and effectiveness.

What kind of patients benefit from Beta Bionics' technologies?

Patients who require consistent and precise insulin management, particularly those with diabetes requiring constant monitoring and dosing adjustments, benefit from the company’s innovative solutions.
Beta Bionics, Inc.

NASDAQ:BBNX

BBNX Rankings

BBNX Stock Data

685.03M
12.00M
7.4%
57.73%
2.73%
Medical Devices
Surgical & Medical Instruments & Apparatus
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United States
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