Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Significant Losses In Aquestive Therapeutics To Contact Him Directly To Discuss Their Options If you suffered significant losses in Beta Bionics stock or options and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). [You may also click here for additional information] NEW YORK, March 24, 2026 (GLOBE NEWSWIRE) -- Faruqi ...

Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Beta Bionics, Inc. following a significant decline in its stock price due to disappointing performance metrics [2][4]. Group 1: Company Performance - On January 9, 2026, Beta Bionics' shares dropped approximately $11.85, or 37.04%, closing at $20.14 after the company reported preliminary fourth-quarter 2025 performance metrics that did not meet market expectations [4]. - The decline was attributed to lower-than-expected new patient starts for its iLet automated insulin delivery system, raising concerns about near-term adoption trends and revenue growth [4]. Group 2: Legal Investigation - Faruqi & Faruqi, LLP, a prominent national securities law firm, is encouraging investors who suffered significant losses in Beta Bionics stock or options to reach out for potential claims [1][2]. - The firm has a history of recovering hundreds of millions of dollars for investors since its establishment in 1995 [3].

SHAREHOLDER INVESTIGATION REMINDER: Faruqi & Faruqi, LLP Continues Investigation of Potential Securities Claims Against Bionics (NASDAQ: BBNX) Accessibility StatementSkip NavigationFaruqi & Faruqi, LLP Securities Litigation Partner James (Josh) WilsonEncourages Investors Who Suffered Significant Losses In Beta Bionics To Contact Him Directly To Discuss Their OptionsIf you suffered significant losses in Beta Bionicsstock or options and would like to discuss your legal rights, call Faruqi & Faruqi partner Jos ...

Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Significant Losses In Beta Bionics To Contact Him Directly To Discuss Their Options If you suffered significant losses in Beta Bionics stock or options and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). [You may also click here for additional information] NEW YORK, March 13, 2026 (GLOBE NEWSWIRE) -- Faruqi & Faruqi, ...

Core Viewpoint - Faruqi & Faruqi, LLP has initiated an investigation into Beta Bionics, Inc. following a significant decline in its stock price due to disappointing preliminary fourth-quarter performance metrics [1] Group 1: Company Performance - Beta Bionics reported lower-than-expected new patient starts for its iLet automated insulin delivery system, raising concerns about near-term adoption trends and revenue growth [1] - On January 9, 2026, Beta Bionics' stock fell approximately $11.85, or 37.04%, closing at $20.14 [1] Group 2: Legal Actions - Faruqi & Faruqi, LLP is encouraging investors who suffered significant losses in Beta Bionics stock or options to discuss their legal rights [1] - The law firm has a history of recovering hundreds of millions of dollars for investors since its establishment in 1995 [1]

Summary of Beta Bionics FY Conference Call Company Overview - **Company**: Beta Bionics (NasdaqGM: BBNX) - **Product**: iLet insulin delivery system, a differentiated insulin pump with automation features [19][20] Key Industry Insights - **Market Positioning**: Beta Bionics believes it is well-positioned to capture new patients in the insulin pump market due to its unique automation capabilities, which reduce the need for patient and healthcare provider engagement [20][21] - **Competitive Landscape**: The company identifies shortcomings in competitors' devices, particularly in algorithmic automation and patient engagement [23][24] - **Patient Demographics**: The company is attracting two main patient groups: early adopters of technology and those who struggle with traditional insulin pumps [32][33] Product Differentiation - **Automation**: The iLet pump uses a learning algorithm that adapts to the patient's needs, allowing for a more personalized insulin delivery experience [20][21] - **Ease of Use**: The product is designed to require minimal engagement from both patients and healthcare providers, making it easier to prescribe and manage [21][60] - **Market Opportunity**: The insulin pump market is still under-penetrated, with significant growth potential as more patients transition from injections to pumps [28][33] Sales and Market Strategy - **Sales Territories**: Beta Bionics currently operates in approximately 63 territories and plans to add at least 20 new territories in 2026, aiming for a total of 120-180 territories to effectively compete [66][72] - **Sales Force Expansion**: The company emphasizes a calculated approach to expanding its sales force, focusing on hiring high-performing salespeople [78][79] - **Primary Care Engagement**: There is a growing recognition of the importance of primary care physicians in managing diabetes, with many Type 1 patients being treated in primary care settings [54][61] Pipeline and Future Products - **Mint Patch Pump**: Expected to be commercialized by the end of 2027, the Mint patch pump will feature a reusable component and aims to provide a user-friendly experience [92][93] - **Bi-Hormonal System**: This innovative product aims to improve patient outcomes by incorporating glucagon to prevent hypoglycemia, with ongoing clinical trials planned [100][103] Competitive Dynamics - **Industry Trends**: The company acknowledges the need for behavior change within the healthcare community regarding insulin pump usage, which may take time [48][49] - **Validation of Strategy**: Competitors adopting similar reimbursement models (e.g., pay-as-you-go) are seen as validation of Beta Bionics' pioneering approach [104][106] Conclusion - Beta Bionics is positioned to leverage its innovative technology and unique business model to capture market share in the insulin delivery space, with a focus on automation and ease of use for both patients and healthcare providers. The upcoming Mint product and bi-hormonal system represent significant growth opportunities for the company.

Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Significant Losses In Beta Bionics To Contact Him Directly To Discuss Their Options If you suffered significant losses in Beta Bionics stock or options and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). [You may also click here for additional information] NEW YORK, March 03, 2026 (GLOBE NEWSWIRE) -- Faruqi & Faruqi, ...

Core Viewpoint - Block & Leviton is investigating Beta Bionics, Inc. for potential securities law violations following a significant drop in its stock price and regulatory issues with the FDA [1][2][4]. Group 1: Company Performance - Beta Bionics' shares fell over 35% in January 2026 after the company reported preliminary Q4 2025 topline results, which included new patient starts of at least 5,581, falling short of Wall Street expectations [2]. - The company received an FDA warning letter after a June 2025 inspection of its Irvine, California facility, citing quality system and reporting issues related to its iLet platform [2]. Group 2: Legal Investigation - Block & Leviton is investigating whether Beta Bionics committed securities law violations and may file an action to recover losses for investors [4]. - Investors who have lost money on their Beta Bionics investment are encouraged to contact Block & Leviton for potential recovery options [5]. Group 3: Whistleblower Information - Individuals with non-public information about Beta Bionics are encouraged to assist in the investigation or file a report with the SEC under the whistleblower program, which offers rewards of up to 30% of any successful recovery [6]. Group 4: Firm's Reputation - Block & Leviton is recognized as a leading securities class action firm, having recovered billions for defrauded investors and representing many top institutional investors [7].

Group 1 - The law firm Faruqi & Faruqi, LLP is investigating potential claims against Beta Bionics, Inc. due to significant stock losses [2][4] - Beta Bionics' shares dropped approximately 37% on January 9, 2026, following the announcement of fewer patient starts than analysts had estimated for the fourth quarter [4] - The investigation focuses on whether Beta Bionics issued misleading statements or failed to disclose important information to investors [4] Group 2 - Faruqi & Faruqi, LLP has a history of recovering hundreds of millions of dollars for investors since its establishment in 1995 [3] - The firm has offices in New York, Pennsylvania, California, and Georgia, indicating a broad national presence [3]

Financial Performance and Risks - The company generated all of its revenue from the sales of the iLet and related single-use products, with limited brand recognition in the medical industry for T1D treatment [202]. - The top four DME distributors accounted for approximately 52% of total sales for the year ended December 31, 2025, indicating significant customer concentration risk [203]. - As of December 31, 2025, the company had cash, cash equivalents, and short-term investments totaling $219.2 million, with net proceeds from the IPO and private placement amounting to approximately $206 million [207]. - The company estimates that its current funds will be sufficient to cover operating expenses and capital expenditures through the first half of 2028, based on current assumptions [207]. - The company may need to raise additional funds in the future, which may not be available on acceptable terms, impacting its business strategy [209]. - The total addressable market for the iLet may be smaller than anticipated, potentially limiting the company's ability to sell current and future products [221]. - The company faces risks related to regulatory actions, competitive pricing, and market conditions that could adversely impact sales and operations [204]. - Demand for the iLet exceeded initial forecasts, leading to backorders, but these did not materially impact financial results [227]. - The company has increased inventory levels of the iLet to mitigate unpredictability in demand, but failure to meet demand could harm customer relationships and revenue [227]. - The company faces intense competition from larger firms with greater financial resources, established relationships, and larger distribution networks, which may hinder its market penetration [223]. Product Development and Regulatory Challenges - The company is focusing on the commercialization of the iLet as an automated insulin dosing system for Type 1 Diabetes (T1D) and plans to expand its use for insulin-dependent Type 2 Diabetes (T2D) [250]. - The FDA has mandated a one-year post-market surveillance study for the iLet, requiring enrollment of 1,875 users and completion by June 2027 [276][277]. - The regulatory approval process for new product candidates is lengthy and uncertain, with the 510(k) clearance process typically taking 3 to 12 months [280]. - The company is developing a bihormonal system for the iLet, which will require separate regulatory approvals for both insulin and glucagon components [271]. - Modifications to the iLet may require new marketing authorizations or clearances, which could delay commercialization efforts [281]. - The company is subject to potential enforcement actions if the iLet does not meet safety and effectiveness standards as determined by the FDA [276]. - The company may face delays or inability to obtain marketing authorization for its iLet or other investigational devices if third-party collaborators fail to meet their contractual duties or regulatory obligations [366]. Clinical Trials and Research - Clinical trials are expensive and time-consuming, with uncertain outcomes, and delays in these trials could materially affect development costs and marketing authorization timelines [285]. - Patient enrollment in clinical trials is influenced by various factors, including trial protocol and competing studies, which could delay trial completion [290]. - The company may need to conduct additional clinical trials if initial results are not positive, leading to increased costs and potential delays [295]. - The company reports rates of severe hypoglycemia and DKA similar to those of other AID systems currently on the market, indicating comparable safety profiles [300]. - The company has completed over 20 pre-pivotal trials testing the iLet algorithms to enhance its learning capabilities [312]. Supply Chain and Manufacturing Risks - The company relies on international suppliers for significant quantities of iLet components, particularly from China, and changes in trade policies could materially increase manufacturing costs [262]. - The current single manufacturing facility in Irvine, California, poses risks related to potential disruptions from disasters, which could delay product availability and harm the company's reputation [342]. - The company relies on a limited number of suppliers for critical components of the iLet, including infusion sets, cartridge connectors, pump motors, and boards, which poses risks of production delays and revenue loss if any supplier fails to meet demand [344]. - Currently, the company does not have long-term supply agreements with most suppliers, purchasing components on a purchase order basis, which increases vulnerability to supply disruptions [346]. - The complexity of the iLet's design and manufacturing process may lead to defects that could increase costs and reduce revenue, impacting overall business performance [352]. Cybersecurity and Data Privacy - Cybersecurity threats pose risks to the company's operations, including potential disruptions and loss of sensitive data, which could harm revenue and reputation [237]. - The FDA has warned that insulin pumps, including the iLet products, may have cybersecurity vulnerabilities that could be exploited by hackers, posing risks to patients with diabetes [245]. - The company has experienced unsuccessful phishing attempts in the past and anticipates continued threats that could disrupt operations and compromise sensitive information [246]. - The company faces potential legal and financial repercussions from violations of data privacy laws, including the California Consumer Privacy Act (CCPA), which allows for significant statutory damages [395]. - The company must navigate evolving data privacy laws, which may increase compliance costs and legal risks associated with handling sensitive information [388]. Compliance and Legal Risks - The company is subject to various healthcare laws and regulations, including the federal Anti-Kickback Statute and the False Claims Act, which could expose it to significant penalties and reputational harm [380]. - The company must adhere to Medicaid rebate requirements and other pricing regulations under the U.S. Omnibus Budget Reconciliation Act of 1990 and the Affordable Care Act [383]. - The company is required to report breaches of unsecured protected health information (PHI) within 60 days, with potential civil and criminal penalties for violations of HIPAA [392]. - The company is prohibited from marketing the iLet for off-label uses, and any promotional activities deemed as such by the FDA could lead to regulatory actions [379]. - The company is subject to ongoing regulatory obligations and may incur significant additional expenses if it fails to comply with applicable regulatory requirements, which could adversely affect its business and financial condition [368].