BBNX — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-10-27

• In September 2026, we announced a partnership with Senseonics Holdings, Inc. to integrate its Eversense 365 continuous glucose monitoring system with the iLet and Mint. We expect to commercially launch the integrated iLet and Eversense 365 system in the fourth quarter of 2026, subject to completion …

• On September 14, 2026, we announced FDA clearance of Mint, our patch pump featuring a transformative reusable and disposable architecture that does not require recharging, integrates with industry-leading CGMs and enables smartphone control for iOS and Android users. We expect to initiate the full c…

• In addition to our commercialized product and to maintain our competitive position in the marketplace, we intend to continue investing in disruptive technologies through our experienced research and development team.

• We are in the early stages of developing a first-of-its-kind bihormonal system of the iLet, which combines automated delivery of insulin and glucagon, the BG-raising hormone that protects against low blood sugar, or hypoglycemia, with adaptive closed-loop algorithms where all doses of both hormones …

• recorded as prepaid expenses and expensed to research and development as services are performed. The Company may incur additional research and development expenses and, upon commercialization, royalty obligations under these agreements.

Text removed vs the prior filing · source: 10-Q · 2026-07-29

• In addition to our commercialized product and to maintain our competitive position in the marketplace, we intend to continue investing in disruptive technologies through our experienced research and development team. We are developing Mint, a next-generation, tubeless insulin patch pump designed to …

• We are also in the early stages of developing a first-of-its-kind bihormonal system of the iLet, which combines automated delivery of insulin and glucagon, the BG-raising hormone that protects against low blood sugar, or hypoglycemia, with adaptive closed-loop algorithms where all doses of both horm…

• the integrated bihormonal system, including the glucagon formulation, pump, and dosing algorithms. In the first quarter of 2026, we initiated an additional Phase 2a feasibility trial to further evaluate the system, including the glucagon formulation, pump, and dosing algorithms. Based on the results…

• We have a Commercialization Agreement and Development and Commercialization Agreement with DexCom, Inc. and Abbott Diabetes Care Inc., respectively, related to integrated automated insulin delivery systems. These agreements primarily involve shared development responsibilities and cross-licensing of…

• payments, or ongoing royalty obligations. As a result, these arrangements have not had a material direct impact on our results of operations or cash flows to date, though they may affect future operating expenses associated with development, regulatory activities, and commercialization. As of June 3…

Text added vs the prior filing · source: 10-Q · 2026-10-27

• From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. In September 2026, a purported stockholder of our company filed a securities class action against our company and certain of our executive officers in the United States District Court for t…

Text removed vs the prior filing · source: 10-Q · 2026-07-29

• From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. There are currently no claims or actions pending against us that we believe could have, individually or in the aggregate, a material adverse effect on our results of operations, financial c…

Text added vs the prior filing · source: 10-Q · 2026-10-27

• Risks Related to Our Limited Commercial History, Financial Position and Need for Additional Capital

• We may need to raise additional funds in the future, and these funds may not be available on acceptable terms, if at all.

• The development of medical devices is capital-intensive. Our operations have consumed substantial amounts of cash since inception. As of September 30, 2026, our cash, cash equivalents and short-term investments were $240.3 million. In January 2025, we completed our initial public offering and a conc…

• We expect our expenses to increase gradually in connection with our ongoing activities. The timing and amount of our funding requirements, will depend on many factors, including:

• the cost of maintaining FDA clearance for the iLet as an automated insulin dosing system cleared for the treatment of T1D in adults and children six years of age and older, including updates and revisions to our quality system;

Text removed vs the prior filing · source: 10-Q · 2026-07-29

• We only have one commercialized device, the iLet, which is an automated insulin dosing system cleared for the treatment of T1D in adults and children six years of age and older. Our business primarily depends on the successful commercialization of the iLet. We currently have no other products cleare…

• maintaining a continued acceptable safety profile following marketing authorization or clearance;

• processes, withdrawal of the products from the market, voluntary or mandatory recalls, a requirement to repair, replace or refund the cost of any medical device we manufacture or distribute, fines, suspension of regulatory approvals, product seizures, injunctions or the imposition of civil or crimin…