Beta Bionics, Inc.

Current report

Risks Related to the Development, Regulatory Approval and Commercialization of our iLet Bionic Pancreas and Product Candidates

Current report

We are highly dependent on the success of our iLet for the treatment of T1D, which is cleared by the FDA for commercial sale in the United States for the treatment of T1D, and we do not have any other commercial products. If we are unable to obtain and maintain regulatory clearance or approval for planned modifications to the iLet or for new indications, or for any current or future development-stage products, or if we are unsuccessful in our efforts to continue to commercialize our cleared version of the iLet, our business will be materially harmed.

Current report

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 cleared for sale and may never be able to develop other marketable products. Our iLet will require additional clinical development, testing and marketing authorization or regulatory clearance before we are permitted to commercialize it in a bihormonal system for the treatment of T1D or for any future indications we may pursue. Further, as we develop a bihormonal system of the iLet, which is designed to use both insulin and glucagon for the treatment of T1D, we will separately need to develop and obtain approval for our glucagon product candidate as a drug via an NDA submission in order to successfully commercialize our iLet in a bihormonal system. We expect that the bihormonal system will require completion of clinical trials and submission of a 510(k) for both the infusion pump and algorithm. In addition, we expect that the single hormone and bihormonal algorithms will require separate studies to be performed in T1D and T2D populations in order to seek clearance in these patient populations. In addition, we are developing Mint, an insulin pump, also commonly referred to as a “patch pump,” for which we have submitted a 510(k) application to the FDA. We currently expect to fully commercialize Mint by the end of the second quarter of 2027, subject to regulatory clearance by the FDA. However, there can be no assurance that the FDA will clear the Mint 510(k) application on the anticipated timeline, or at all, or that we will be able to scale our manufacturing processes sufficiently to meet anticipated demand at launch. The future regulatory and commercial success of our iLet, Mint and any other product candidate is subject to a number of risks, including the following:

Current report

completion of preclinical studies with favorable results;

Current report

successful enrollment in, and completion of, planned and future clinical trials with favorable results;

Current report

sufficiency of our financial and other resources to complete the necessary clinical trials and regulatory activities;

Current report

successful patient enrollment in clinical trials;

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successful data from our clinical program that supports an acceptable risk-benefit profile in the intended populations;

Current report

whether we are required by the FDA to conduct additional clinical trials or to modify the design of current or planned trials to support any future application seeking marketing authorization or clearance of the iLet in a bihormonal system for the treatment of T1D or for other indications we may pursue, or seeking initial marketing authorization or clearance for any of our other product candidates;

Current report

receipt and maintenance of marketing authorizations or clearances from applicable regulatory authorities;

Current report

obtaining and maintaining patent and trade secret protection and regulatory exclusivity for our iLet;

Current report

making arrangements with third-party manufacturers and ensuring such third-party manufacturers supply sufficient quantities of components of our products and product candidates;

Current report

scaling up our manufacturing capabilities, for both commercial and clinical supplies of our products and product candidates;

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entry into collaborations to further the development of our iLet’s capabilities;

Current report

expanding sales, marketing and distribution capabilities as we continue our commercialization efforts of the iLet, whether alone or in collaboration with others;

Current report

successfully launching commercial sales of the iLet, patch pump and any other product candidate, if authorized for marketing or cleared;

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acceptance of our products by PWD, the medical community and third-party payors;

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

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maintaining regulatory compliance;

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effectively competing with other treatment options and the availability, perceived advantages, relative cost, relative safety and relative effectiveness of alternative and competing treatments;

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the emergence of competing technologies and other adverse market developments, and our need to enhance existing products and/or develop new products to maintain market share in response to such competing technologies or market developments;

Current report

maintaining healthcare coverage and adequate reimbursement from third-party payors;

Current report

continuing to build and maintain an organization of people who can successfully develop our products; and

Current report

Many of these risks are beyond our control, including the risks related to clinical development, the regulatory submission process, potential threats to our intellectual property rights and the manufacturing, marketing and sales efforts of any future collaborator. If we are not successful in commercializing our iLet or obtaining marketing authorization or clearance for the iLet in its bihormonal system for the treatment of T1D or in other indications, such as T2D, the investigational glucagon product, Mint, or any other product candidate, or if we experience delays as a result of any of these risks or otherwise, our business could be materially harmed.

Current report

Furthermore, even though we have received clearance for our iLet for insulin-only delivery for the treatment of T1D, any other configuration for the treatment of T1D such as a bihormonal system using both insulin and glucagon or other indications we may pursue for which we receive marketing authorization or clearance may be subject to limitations on the patient populations for which we may market the product. Even if we are able to obtain the requisite financing to continue to fund our development programs, we cannot assure you that we will successfully develop, obtain marketing authorization or clearance for, and commercialize our iLet in its bihormonal system for the treatment of T1D or for any future indication we may pursue, Mint, the investigational glucagon product, or any other development-stage products. If we are unable to continue commercializing the iLet for T1D, or if we are unable to develop, or obtain marketing authorization or clearance for, or, if authorized for marketing or cleared, successfully commercialize the iLet for the treatment of any future indications, we may not be able to generate sufficient revenue to continue our business.

Current report

Our future growth depends on the continued success, enhancement, and expanded use of the iLet as well as the development and commercial release of the patch pump, Mint. If we fail to advance the iLet platform, the Mint platform or expand their indications, our business may be adversely affected.

Current report

It is important to our business and our long-term growth that we continue to develop and enhance the iLet, including in a bihormonal system, as well as expand our product portfolio, including our patch pump in development, Mint. For example, we have completed over 20 pre-pivotal trials testing the algorithms in order to enhance its learning capabilities. We intend to continue to invest in research and development activities focused on improvements and enhancements to the iLet. Additionally, we intend to pursue marketing authorization or clearance for other indications in the United States in the future.

Current report

Developing enhancements to the iLet and developing Mint has, and will continue to be expensive and time-consuming and has, and may continue to, divert management’s attention away from the commercialization of the iLet and Mint and divert financial resources from other operations. The success of any new products or new product enhancements, including marketing authorization or clearance for additional indications, will depend on several factors, including our ability to:

Current report

properly identify and anticipate physician and patient needs, and develop enhancements to meet those needs;

Current report

demonstrate, if required, the safety and effectiveness of new enhancements to our products, including additional indications, with data from preclinical studies and clinical trials;

Current report

obtain in a timely manner the necessary marketing authorization or clearance for new enhancements to the iLet, product modifications or expanded indications;

Current report

avoid infringing upon the intellectual property rights of third parties;

Current report

comply with all applicable laws and regulations, including those governing the marketing of new devices or modified products;

Current report

develop an effective and dedicated sales and marketing team to provide adequate education and training to potential users of the iLet; and

Current report

receive adequate coverage and reimbursement for procedures performed with the iLet.

Current report

While we have commercialized the iLet as an automated insulin dosing system cleared for the treatment of T1D in adults and children six years of age and older, we may not be successful in expanding the configurations or indications and developing and commercializing new products or product enhancements. This could negatively impact our ability to achieve and maintain market share and increase our revenue, which could have a material adverse effect on our business, financial condition and results of operations.

Current report

Risks Related to Government Regulation

Current report

We and our suppliers are subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and subject us to penalties if we fail to comply with applicable regulatory requirements.

Current report

Once we obtain marketing authorization or clearance for FDA-regulated products, such as our iLet and any future products, we and such products will be subject to continued and pervasive regulatory review, oversight, requirements, and periodic inspections by the FDA and other domestic and foreign regulatory bodies governing, among other things, the manufacture, marketing, advertising, reporting, sale, promotion, import, export, registration, and listing of our products. For example, medical device manufacturers must submit periodic reports to the FDA as a condition of obtaining marketing authorization or clearance. These reports include information about failures and certain adverse events associated with the device after its marketing authorization or clearance. Failure to submit such reports, or failure to submit the reports in a timely manner, could result in enforcement action by the FDA. Following its review of the periodic reports, the FDA might ask for additional information or initiate further investigation. In particular, unless exempt, we and our suppliers are required to comply with the FDA’s QMSR for medical device products and cGMPs for any approved drug products, such as glucagon if it is ultimately approved, and other regulations enforced outside the United States which cover the manufacture of our products and the methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging, storage and shipping of medical devices. Regulatory bodies, such as the FDA, enforce the QMSR and cGMPs and other regulations through periodic inspections. The failure by us or one of our suppliers to comply with applicable statutes and regulations administered by the FDA and other regulatory bodies, or the failure to timely and adequately respond to any adverse inspectional observations or product safety issues, could result in, among other things, any of the following enforcement actions and/or other negative consequences:

Current report

customer notification, or orders for repair, replacement or refunds;