IRVINE, CA., January 6, 2025: Beta Bionics, Inc., a pioneering leader in the development of advanced diabetes management solutions, today announced that it has filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission (SEC) relating to a proposed initial public offering of shares of its common stock. The number of shares to be offered and the price range for the proposed offering have not yet been determined. Beta Bionics has applied to list its common stock on the Nasdaq Global Market under the ticker symbol “BBNX.”

BofA Securities, Piper Sandler, and Leerink Partners are acting as lead bookrunners for the proposed offering. Stifel is acting as a bookrunner and Lake Street Capital Markets is acting as co-manager for the proposed offering.

The proposed offering will be made only by means of a prospectus. When available, copies of the preliminary prospectus relating to the proposed initial public offering may be obtained from: BofA Securities, NC1-022-02-25, 201 North Tryon Street, Charlotte, North Carolina 28255-0001, Attention: Prospectus Department, or by email at dg.prospectus_requests@bofa.com; Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by e-mail at prospectus@psc.com, or by telephone at (800) 747-3924; or Leerink Partners LLC, Syndicate Department, 53 State Street, 40th Floor, Boston, Massachusetts 02109, by telephone at (800) 808-7525 ext. 6105, or by emailing syndicate@leerink.com.

A registration statement on Form S-1 relating to these securities has been filed with the SEC but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Beta Bionics
Beta Bionics, Inc. is a commercial stage medical device company engaged in the design, development, and commercialization of innovative solutions to improve the health and quality of life of insulin-requiring people with diabetes (PWDs) by utilizing advanced adaptive closed-loop algorithms to simplify and improve the treatment of their disease. The iLet Bionic Pancreas is the first FDA-cleared insulin delivery device that autonomously determines every insulin dose and offers the potential to substantially improve overall outcomes across broad populations of PWDs.

Investor Relations Contact:

Blake Beber
Head of Investor Relations
ir@betabionics.com

Media and Public Relations Contact:

Karen Hynes
Vice President of Marketing
media@betabionics.com

Now iLet users have a choice of iCGMs to customize their diabetes management.

IRVINE, CA., October 30, 2024: Beta Bionics, Inc., a pioneering leader in the development of advanced diabetes management solutions, announced today they have launched the integration of the iLet Bionic Pancreas with Abbott’s FreeStyle Libre^® 3 Plus sensor.

Beta Bionics’ flagship product, the iLet Bionic Pancreas, is an autonomous insulin delivery system that streamlines diabetes management and reduces the burden on patients, caregivers and physicians. The iLet is the first insulin delivery system in the United States to connect to Abbott’s FreeStyle Libre 3 Plus sensor, whose readings every minute will help the iLet calculate insulin doses. When iLet users “GO BIONIC” with their diabetes management, there is no carb counting* or calculating insulin corrections throughout the day – the iLet determines 100% of the insulin doses and continuously learns and adapts to the user. The only input required to get started on the iLet is the user’s weight.

“Beta Bionics continues to move at lightning speed to bring these enhancements to our userbase,” said Sean Saint, CEO of Beta Bionics. “With our recent launch of the Bionic Circle remote monitoring app, our latest updates to the iLet app, and today’s launch of the iLet integration with Abbott’s FreeStyle Libre 3 Plus sensor, we are focused on providing major product enhancements to make diabetes management even easier for our users and their families.”

The recent launch of the Beta Bionics’ Bionic Circle App allows users to invite up to 10 friends and family to remotely monitor their CGM values and insulin doses. Bionic Circle members can receive alerts and view an iLet user’s glucose levels, meal announcements, insulin doses and trends throughout the day and night. Whether the iLet user is at school, a friend’s house, work, traveling or home, friends and family can use the Bionic Circle App to see that the iLet is making 100% of the user’s dosing decisions.

This integration offers people a new way to manage their type 1 diabetes. With both Beta Bionics’ and FreeStyle Libre’s ability to sell products through the pharmacy channel, users of the integrated platform can benefit from the ease of obtaining supplies with an innovative pay-as-you-go model. The iLet and FreeStyle Libre 3 Plus sensor are also available through durable medical equipment providers.

By simply updating the iLet app and software, iLet users will have a choice of iCGMs (FreeStyle Libre 3 Plus sensor or Dexcom CGMs) when they set up a new sensor. 

*User must be carb aware

About Beta Bionics
Beta Bionics is a commercial stage medical device company engaged in the design, development, and commercialization of innovative solutions to improve the health and quality of life of insulin-requiring people with diabetes (PWDs) by utilizing advanced adaptive closed-loop algorithms to simplify and improve the treatment of their disease. The iLet Bionic Pancreas is the first FDA-cleared autonomous insulin delivery device in the market and offers the potential to substantially improve overall outcomes across broad populations of PWDs. To learn more, visit www.betabionics.com.

Important Safety Information

Product for prescription only. For important safety information, please visit https://www.freestyle.abbott/us-en/safety-information.html.

For iLet Bionic Pancreas safety information, visit www.betabionics.com/safety .

CONCORD, Mass., August 15, 2024: Beta Bionics, a commercial stage medical technology company, proudly announces the 10,000th patient start on the iLet Bionic Pancreas. This significant milestone marks a major step forward in the company’s mission to alleviate the daily burden of diabetes management for patients and healthcare providers alike.

The iLet Bionic Pancreas is the first FDA-cleared autonomous closed-loop insulin delivery device designed to be both easier to prescribe for healthcare professionals and simpler to use for patients. With no carb counting*, no corrections and no settings to adjust, the iLet does the work for the user instead of depending on the user to proactively manage their diabetes, which is required with other hybrid closed-loop insulin pumps. The iLet automates glucose management, thereby reducing the mental and physical stress on patients.

“Reaching 10,000 iLet Bionic Pancreas patients is a testament to our commitment to making diabetes easier, for everyone, every day,” said Sean Saint, CEO of Beta Bionics. “By taking the work off their plate, we are empowering patients to live more freely and with greater peace of mind. The iLet offers an easier and more reliable way to manage diabetes relative to other insulin delivery devices, and we are thrilled to see its impact grow.”

Healthcare providers have also embraced the iLet due to the results they are seeing with their patients. “The iLet Bionic Pancreas has been a great addition to my practice. Now that I have experience in prescribing the iLet, I know that it helps all of my patients – whether they have a high HbA1c or those who are in the 6-7 range,” explained Bruce Bode, MD, FACE of Atlanta Diabetes Associates. “For those patients in the HbA1c higher range, it gets them closer to goal,⁺ and for those in the lower range, it keeps them at goal with a lot less work, stress and anxiety.”

The iLet’s advanced algorithms streamline the process of getting patients started by only requiring the user’s weight. Without numerous settings to adjust, the iLet allows healthcare providers to focus on patient care without being bogged down by complicated device management.

The Beta Bionics team remains dedicated to simplifying and alleviating the burden of managing diabetes with life-changing solutions and is continuously striving to enhance the quality of life for patients with diabetes. As the company celebrates this remarkable milestone, it looks forward to further advancements and continued growth.

*User must be carb aware.
⁺Individual results may vary.

About Beta Bionics

Beta Bionics is a commercial stage medical technology company engaged in the design, development, and commercialization of innovative solutions to improve the health and quality of life of insulin-requiring people with diabetes (PWDs) by utilizing advanced adaptive algorithms to simplify and improve the treatment of their disease. The iLet Bionic Pancreas is the first FDA-cleared autonomous closed-loop insulin delivery device in the market and offers the potential to substantially improve overall outcomes across broad populations of PWDs. To learn more, visit www.betabionics.com.

Beta Bionics is a for-profit, public benefit corporation and Certified B Corporation. Since its founding in 2015, its mission has been to help improve health outcomes and the quality of life of children and adults living with diabetes and other conditions of glycemic dysregulation.

Investor Relations Contact:
ir@betabionics.com

Media and Public Relations Contact:
media@betabionics.com

Beginning Dec. 18, iLet users will have the option of using a Dexcom G7 CGM System.

CONCORD, Mass., December 7, 2023: Beta Bionics, Inc., a pioneering leader in the development of advanced diabetes management solutions, announced today the nationwide launch of the iLet Bionic Pancreas automated insulin delivery system with the Dexcom G7 Continuous Glucose Monitoring (CGM) System planned for December 18, 2023. With a firmware update, users will be able to update their iLet to integrate with Dexcom G7 without any additional cost for new hardware.

Beta Bionics’ flagship product, the iLet Bionic Pancreas, is an autonomous insulin delivery system that streamlines diabetes management and reduces the burden on patients and physicians. The only input required to get started is the user’s weight — the iLet does the rest. Healthcare providers no longer need to determine complex settings including correction factors, insulin-to-carb ratios or pre-set basal rates. When iLet users “GO BIONIC” with their diabetes management, there’s no carb counting* or calculating insulin corrections throughout the day – the iLet determines 100% of the insulin doses.

With the Dexcom G7 integration, users can experience the freedom and benefits of the iLet Bionic Pancreas with the fastest^‡ and most accurate CGM^1,2 available. Dexcom G7 features an all-in-one sensor and transmitter, no fingersticks from day 1^† and only a 30-minute warmup^‡ time when starting a new sensor. Dexcom CGM also enables you to share your numbers with up to 10 people^§ with the Dexcom Follow app, allowing users to stay connected with their loved ones and care teams. This iLet Bionic Pancreas firmware update will allow users to select Dexcom G7 or Dexcom G6 CGMs, or switch back and forth, depending on their supplies.

“Our goal is to give our patients choice with their CGM technology and to be able to update quickly and easily without new hardware or additional costs,” explained Sean Saint, CEO at Beta Bionics. “We truly appreciate our partnership with Dexcom and their speed and adaptability. Once we established our timeline, we were able to rapidly integrate, test and launch with Dexcom G7 in only four months. It’s a clear testament to our teams working in unison with a common goal of providing the latest technology to help users manage their diabetes with less work and less burden.”

“Dexcom G7 was designed with connectivity in mind and this latest integration with Beta Bionics is a testament to that,” said Jake Leach, executive vice president and chief operating officer at Dexcom. “We look forward to offering iLet Bionic Pancreas users even more choice in their diabetes management and the opportunity to experience the industry-leading accuracy and simplicity of Dexcom G7.”

To upgrade, existing iLet Bionic Pancreas users can download or update the iLet app from the Apple App store or Google Play store (available on December 18, 2023). Once they have updated their iLet app, they can easily update the firmware on their iLet Bionic Pancreas. During setup, users will be able to select whether they wear a Dexcom G6 or Dexcom G7 CGM when connecting a sensor and will also experience other features to help streamline the setup process.

 *User must be carb aware

‡Dexcom G7 can complete warmup within 30 minutes, whereas other CGM brands require up to an hour or longer.
1 U.S. Food and Drug Administration, 510(k) Substantial Equivalence Determination Decision Summary, K213919. Published December 7, 2022. https://www.accessdata.fda.gov/cdrh_docs/reviews/K213919.pdf.
2 U.S. Food and Drug Administration, 510(k) Substantial Equivalence Determination Decision Summary, K222447. Published March 3, 2023. https://www.accessdata.fda.gov/cdrh_docs/reviews/K222447.pdf.
^†Fingersticks required for diabetes treatment decisions if symptoms or expectations do not match readings.
^§Separate Follow app and internet connection required.

About Beta Bionics

Beta Bionics is a medical technology company focused on the design, development, and commercialization of its iLet Bionic Pancreas in both the single hormone and bi-hormonal configurations. The iLet Bionic Pancreas platform is designed to use adaptive, self-learning, control algorithms, together with continuous glucose monitoring and pump technology, to autonomously compute and administer doses of insulin and/or glucagon and mimic the body’s natural ability to maintain tight glycemic control, relieving some of the burden of living with diabetes. To learn more, visit www.betabionics.com.

Beta Bionics is a for-profit, public benefit corporation and Certified B Corporation. Since its founding in 2015, its mission has been to help improve health outcomes and the quality of life of children and adults living with diabetes and other conditions of glycemic dysregulation.

Investor Relations Contact:

ir@betabionics.com

Media and Public Relations Contact:

media@betabionics.com

CONCORD, Mass., August 30, 2023: Beta Bionics, Inc., a pioneering leader in the development of advanced diabetes management solutions, is thrilled to announce the successful closure of its Series D funding round securing $100 million in new equity capital.

The Series D funding was co-led by new investors Sands Capital and Omega Funds with an additional new investor, Marshall Wace, also participating. Previous investors Soleus Capital, Eventide Asset Management LLC, Farallon Capital, Perceptive Advisors, certain funds managed by RTW Investments, LP, ArrowMark Partners, and Pura Vida Investments also participated.

Sean Saint, CEO of Beta Bionics, “This significant investment represents a powerful vote of confidence in Beta Bionics’ mission to redefine diabetes management with user-centric technologies. We are deeply grateful to our investors for recognizing the immense potential of our products. We are eager to push the boundaries of what’s possible by expanding access to the iLet Bionic Pancreas nationwide and further develop and test the bi-hormonal bionic pancreas.”

“We’re excited to support the Beta Bionics team as they work to launch and develop breakthrough technologies that help reduce the burden of diabetes,” said Parker Cassidy, Partner, Sands Capital Ventures.

“Our ability to secure this capital is a testament to iLet’s competitive differentiation and our financial discipline,” said Stephen Feider, CFO of Beta Bionics. “Thank you to the investors for believing in our team and the mission.”

Beta Bionics’ flagship product, the iLet Bionic Pancreas, is an autonomous insulin delivery system that streamlines diabetes management and reduces the burden on patients and physicians. The only input required to get started is the user’s weight — the iLet does the rest. Healthcare providers no longer need to determine complex settings including correction factors, insulin-to-carb ratios or pre-set basal rates. When iLet users “GO BIONIC” with their diabetes management, there’s no carb counting* or calculating insulin corrections throughout the day – the iLet determines 100% of the insulin doses.

*User must be carb aware

About Beta Bionics

Beta Bionics is a medical technology company focused on the design, development, and commercialization of its iLet Bionic Pancreas in both the single hormone and bi-hormonal configurations. The iLet Bionic Pancreas platform is designed to use adaptive, self-learning, control algorithms, together with continuous glucose monitoring and pump technology, to autonomously compute and administer doses of insulin and/or glucagon and mimic the body’s natural ability to maintain tight glycemic control, relieving some of the burden of living with diabetes. To learn more, visit www.betabionics.com.

Beta Bionics is a for-profit, public benefit corporation and Certified B Corporation. Since its founding in 2015, its mission has been to help improve health outcomes and the quality of life of children and adults living with diabetes and other conditions of glycemic dysregulation.