Encouraging results of pilot study testing bionic pancreas in cystic fibrosis-related diabetes published in journal of cystic fibrosis

  • A pilot study performed by researchers at the Massachusetts General Hospital tested autonomous glycemic control using the bionic pancreas system in both insulin-only and bihormonal configurations
  • While using the bionic pancreas, the study subjects experienced improved glycemic control and decreased diabetes-management burden
  • The study suggests that autonomous glycemic control using the bionic pancreas is worthy of further investigation on a wider scale in patients with cystic fibrosis-related diabetes (CFRD)

Boston, MA – December 3, 2019 – Beta Bionics, Inc. — a medical technology company developing and aiming to commercialize the world’s first fully automated bionic pancreas today announced that its bionic pancreas glucose control algorithms that use lifelong autonomous learning were deployed in a pilot study comparing usual care with automated insulin-only and bihormonal (insulin and glucagon) delivery in three patients with cystic fibrosis related diabetes (CFRD). Results of the study were published in the Journal of Cystic Fibrosis (J.S. Sherwood, R.Z. Jafri, C.A. Balliro, et al., Automated glycemic control with the bionic pancreas in cystic fibrosis-related diabetes: A pilot study, Journal of Cystic Fibrosis, https://doi.org/10.1016/j.jcf.2019.08.002).

Researchers at the Massachusetts General Hospital performed a three-arm, random-order, cross-over, pilot study comparing the bihormonal bionic pancreas versus the insulin-only bionic pancreas versus usual care for CFRD. The bionic pancreas dosing algorithms utilized in this pilot study were identical to those used in other studies in subjects with type 1 diabetes. There were no restrictions on activity and subjects continued their normal diet, exercise, and work throughout the study. The bionic pancreas was initialized only with subject body weight, without any information regarding their usual insulin regimen.

Given the sample size of the study, only descriptive statistics were reported for the group. The group mean blood-glucose level, as measured by continuous glucose monitoring (CGM), was nominally lower in both the bihormonal (139 ± 15 mg/dl) and insulin-only (149 ± 10 mg/dl) bionic pancreas study arms relative to the usual care study arm (159 ± 35 mg/dl). During bionic pancreas arms, subjects used the meal announcement feature on average less than once per day, and survey data suggested that subjects had a decreased diabetes-management burden. Subjects reported they spent less time thinking about diabetes, felt more freedom with food choices, and had overall greater peace of mind.

We are encouraged by the results of this pilot study suggesting that our bionic pancreas technology can potentially be deployed in multiple conditions of glycemic disregluation, including CFRD

said Ed Damiano, President and Chief Executive Officer of Beta Bionics.

We look forward to continuing our commitment to innovation through clinical research as we plan to test multiple applications of our technology in further clinical studies in an effort to maximize the potential good our technology and company can bring to the diabetes community.

This pilot study was supported by the National Institutes of Health under award number R01DK119699-01.

About Beta Bionics

Beta Bionics is a for-profit Massachusetts public benefit corporation founded in 2015 to commercialize the iLet, a revolutionary bionic pancreas that is driven by mathematical dosing algorithms, which incorporate lifelong autonomous learning to automatically control glycemia. These mathematical dosing algorithms were developed in the Damiano Lab at Boston University and refined based on results from home-use clinical trials in adults and children with T1D. Beta Bionics is a Certified B Corporation™ whose founders — in addition to Ed Damiano — include other parents of children with type 1 diabetes and people with type 1 diabetes. Beta Bionics is committed to acting in the best interests of the diabetes community and to profoundly disrupting the diabetes medical device industry by bringing the iLet to market as expeditiously and responsibly as possible. Beta Bionics is pursuing regulatory approval of its insulin-only bionic pancreas, followed by its dual-hormone system, which will also administer a glucagon analog in order to raise blood-sugar levels without the need to consume carbohydrates.

Beta Bionics operates in Massachusetts and California. For further information, please visit www.betabionics.com or follow Beta Bionics Facebook, YouTube, Instagram, LinkedIn and Twitter @BetaBionics.

Beta Bionics

Ed Damiano
edamiano@betabionics.com

Ed Raskin
eraskin@betabionics.com

Investor Relations Contact

Jeremy Feffer
jeremy@lifesciadvisors.com

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Beta Bionics and ConvaTec announce partnership to bring unomedical infusion set portfolio to the iLet™ Bionic Pancreas System

  • ConvaTec is a leading global manufacturer of widely popular infusion sets offering a variety of patient choice
  • Beta Bionics is developer of the iLet Bionic Pancreas System and is committed to device interoperability and patient choice
  • ConvaTec will manufacture infusions sets for delivery of both insulin and glucagon via the iLet Bionic Pancreas System

Boston, MA and Reading, United Kingdom – July 17, 2019 – Beta Bionics, Inc. — a medical technology company leveraging lifelong autonomous learning to develop and commercialize the world’s first fully automated bionic pancreas — and ConvaTec Group Plc (LSE: CTEC) — a leading global medical products and technologies company — today announced that ConvaTec’s Unomedical subsidiary and Beta Bionics have entered into a collaboration and development agreement that will make portions of Unomedical’s world class infusion sets available for use with the iLet Bionic Pancreas System.

The arrangement between Beta Bionics and ConvaTec creates a deep and meaningful partnership between the two companies for the benefit of the diabetes community. The arrangement is non- exclusive, consistent with other Beta Bionics partnerships designed to protect patient choice. The Unomedical sets will be deployed in two pivotal trials testing the iLet in its insulin-only and bihormonal (insulin and glucagon) configurations in 2020. ConvaTec’s Unomedical subsidiary develops, produces, and supplies a range of disposable infusion sets used in insulin infusion therapy, including their highly popular flexible-cannula sets currently used with insulin pumps today.

Under the Beta Bionics public benefit structure, we are committed to acting in the best interests of the type 1 diabetes community with every decision that we make

said Ed Damiano, co-founder and CEO of Beta Bionics.

We are very impressed with Unomedical’s products and world class manufacturing capabilities, and have great confidence in their steel and flexible-cannula infusion sets, having used them in all of our iLet clinical studies. Making the world’s most popular infusion sets compatible with the iLet is very exciting for us, and underscores our deep commitment to patient choice.

We at Unomedical are proud to be selected by Beta Bionics as infusion set partner for the iLet Bionic Pancreas system. Being the world’s largest manufacturer of infusion sets within diabetes technology, and committed to highest standards in patient safety, product efficacy and patient-centered design, we will do our utmost to support this exciting programme. Published clinical data has clearly surpassed our expectations to the potential of bihormonal infusion therapy and we are excited to be part of this development,

John M. Lindskog, President of Unomedical, adds.

About the iLet Bionic Pancreas System

The iLet consists of a dual-chamber, pocket-sized, wearable medical device that autonomously controls blood-sugar levels in people with diabetes. Embedded in the system are clinically tested mathematical dosing algorithms driven by lifelong autonomous learning to automatically calculate and dose insulin and/or glucagon as needed, based on data from a continuous glucose monitor. To initialize the iLet, users enter only their body weight. Immediately thereafter, the iLet begins controlling blood-sugar levels automatically, without requiring the user to count carbohydrates, set insulin delivery rates, or deliver bolus insulin for meals or corrections

In previous home-use studies in adults and children with T1D, these algorithms demonstrated dramatic improvements in glycemic control relative to the standard of care. These improvements included significant reductions in blood-glucose levels, in hypoglycemia, and in intersubject and intrasubject glycemic variability (New England Journal of Medicine. 2014, 371:313-25; Lancet Diabetes and Endocrinology. 2016, 4:233-43; Lancet. 2016, 389:369-80).

The iLet is effectively three medical devices in one. It can be configured as an insulin-only bionic pancreas, a glucagon-only bionic pancreas, or a dual-hormone bionic pancreas (insulin and glucagon). The glucagon-only configuration may be helpful in rare, chronic, low blood-sugar conditions, such as congenital hyperinsulinism (CHI) and insulinoma syndrome. Beta Bionics is committed to obtaining regulatory approval and commercializing all three iLet configurations.

About Beta Bionics

Beta Bionics is a for-profit Massachusetts public benefit corporation founded in 2015 to commercialize the iLet, a revolutionary bionic pancreas that is driven by mathematical dosing algorithms, which incorporate lifelong autonomous learning to automatically control glycemia. These mathematical dosing algorithms were developed in the Damiano Lab at Boston University and refined based on results from home-use clinical trials in adults and children with T1D. Beta Bionics is a Certified B Corporation™ whose founders — in addition to Ed Damiano — include other parents of children with type 1 diabetes and people with type 1 diabetes. Beta Bionics is committed to acting in the best interests of the diabetes community and to profoundly disrupting the diabetes medical device industry by bringing the iLet to market as expeditiously and responsibly as possible. Beta Bionics is pursuing regulatory approval of its insulin-only bionic pancreas, followed by its dual-hormone system, which will also administer a glucagon analog in order to raise blood-sugar levels without the need to consume carbohydrates.

Beta Bionics operates in Massachusetts and California. For further information, please visit www.betabionics.com or follow Beta Bionics Facebook, YouTube, Instagram, LinkedIn and Twitter @BetaBionics.

About ConvaTec

ConvaTec is a global medical products and technologies company focused on therapies for the management of chronic conditions. The Company is listed on the London Stock Exchange (stock symbol: CTEC) and has leading market positions in advanced wound care, ostomy care, continence and critical care, and infusion devices. ConvaTec’s products provide a range of clinical and economic benefits, including infection prevention, protection of at-risk skin, improved patient outcomes and reduced total cost of care. www.convatecgroup.com.

Beta Bionics

Ed Damiano
edamiano@betabionics.com

Ed Raskin
eraskin@betabionics.com

Investor Relations Contact

Jeremy Feffer
jeremy@lifesciadvisors.com

ConvaTec

Analysts and Investors
investorrelations@convatec.com

John Crosse, VP Investor Relations +44 (0)7500 141435

Mark Reynolds, Director Investor Relations +44 (0)7551 036625

Media
mediarelations@convatec.com

Bobby Leach, VP Group Corporate Affairs +44 (0)7770 842226

Finsbury +44 (0)207 2513801

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Beta Bionics announces closing of a $63 million Series B2 financing, bringing the total Series B and B2 financings to $126 million

  • The round was co-led by new investors Perceptive Advisors and Soleus Capital
  • New investor Farallon Capital also participated in the round, as did previous Series B investors RTW Investments, ArrowMark Partners and funds managed by Eventide Asset Management
  • Funds will support final product development, regulatory submission and commercial launch of the iLet TM Bionic Pancreas System

Boston, MA – July 1, 2019 – Beta Bionics, Inc. — a medical technology company leveraging lifelong autonomous learning to develop and commercialize the world’s first fully automated bionic pancreas — today announced that the company has completed a $63 million Series B2 equity financing. This follows six months after the final close of another $63 million equity financing and brings the total combined Series B and B2 financings to just over $126 million.

The Series B2 financing round was co-led by new investors Perceptive Advisors and Soleus Capital Management. In addition, Farallon Capital joined the round as a new investor in Beta Bionics. Series B lead investor, Eventide, together with RTW and ArrowMark, all participated in the Series B2 round. Beta Bionics will use the proceeds from these financings to complete final product development, phase 3 clinical trials, regulatory submissions, and product launch of the iLet Bionic Pancreas System.

We are delighted, to have completed our second round of institutional financing for Beta Bionics,

said Ed Damiano, co-founder and CEO of Beta Bionics.

Having now closed more than $120 million over the past 10 months, we have placed Beta Bionics on a secure footing for the future, and positioned ourselves well for the commercial success we envision for the iLet. We are thrilled to have Perceptive, Soleus, and Farallon round out our strong syndicate of supportive and visionary investors.

Diabetes is a disease that affects millions of patients and their families around the world,

commented Guy Levy, Founder and Managing Member of Soleus Capital Management.

Until Beta Bionics, people with diabetes had to trade-off tight management of their blood sugar for higher rates of dangerous hypoglycemia. With the iLet, the potential for an autonomous bionic pancreas exists, which we believe can greatly improve the quality of life and clinical outcomes for patients compared to existing technologies. We are excited to partner with the team at Beta Bionics to help bring the iLet’s paradigm-shifting technology to patients.

About the iLet Bionic Pancreas System

The iLet consists of a dual-chamber, autonomous, pocket-sized, wearable medical device that device that autonomously controls blood-sugar levels in people with diabetes like a biological pancreas. Embedded in the system are clinically tested mathematical dosing algorithms driven by lifelong autonomous learning to automatically calculate and dose insulin and/or glucagon as needed, based on data from a continuous glucose monitor. To initialize the iLet, users enter only their body weight. Immediately thereafter, the iLet begins controlling blood-sugar levels automatically, without requiring the user to count carbohydrates, set insulin delivery rates, or deliver bolus insulin for meals or corrections.

In previous home-use studies in adults and children with T1D, these algorithms demonstrated dramatic improvements in glycemic control relative to the standard of care. These improvements included significant reductions in blood-glucose levels, in hypoglycemia, and in intersubject and intrasubject glycemic variability (New England Journal of Medicine. 2014, 371:313-25; Lancet Diabetes and Endocrinology. 2016, 4:233-43; Lancet. 2016, 389:369-80).

The iLet is effectively three medical devices in one. It can be configured as an insulin- only bionic pancreas, a glucagon-only bionic pancreas, or a dual-hormone bionic pancreas (insulin and glucagon). The glucagon-only configuration may be helpful in rare, chronic, low blood-sugar conditions, such as congenital hyperinsulinism (CHI) and insulinoma syndrome. Beta Bionics is committed to obtaining regulatory approval and commercializing all three iLet configurations.

About Perceptive Advisors

Founded in 1999, Perceptive Advisors focuses on supporting progress in the life sciences industry by identifying opportunities and directing financial resources toward the most promising technologies in modern healthcare. The firm manages approximately $4 billion across its strategies, including approximately $1 billion focused in its credit opportunities vertical. The firm is headquartered in New York, NY. For more information, visit https://www.perceptivelife.com.

About Soleus Capital

Soleus Capital, founded in 2018 and headquartered in Greenwich, Connecticut, is a healthcare investment firm primarily focused on the innovative areas of life sciences, including biotech and medtech. Soleus Capital invests globally across the healthcare lifecycle from developmental-stage companies through commercial companies. The firm manages a private equity fund as well as a public equity fund.

About Beta Bionics

Beta Bionics is a for-profit Massachusetts public benefit corporation founded in 2015 to commercialize the iLet, a revolutionary bionic pancreas that is driven by mathematical dosing algorithms, which incorporate lifelong machine-learning, and artificial intelligence to autonomously control glycemia. These mathematical dosing algorithms were developed in the Damiano Lab at Boston University and refined based on results from home-use clinical trials in adults and children with T1D. Beta Bionics is a Certified B Corporation™ whose founders — in addition to Ed Damiano — include other parents of children with type 1 diabetes and people with type 1 diabetes. Beta Bionics is committed to acting in the best interests of the diabetes community and to profoundly disrupting the diabetes medical device industry by bringing the iLet to market as expeditiously and responsibly as possible. Beta Bionics is pursuing regulatory approval of its insulin-only bionic pancreas, followed by its dual-hormone system, which will also administer a glucagon analog in order to raise blood-sugar levels without the need to consume carbohydrates.

Beta Bionics operates in Massachusetts and California. For further information, please visit www.betabionics.com or follow Beta Bionics Facebook, YouTube, Instagram, LinkedIn and Twitter @BetaBionics.

Company Contacts

Ed Damiano
edamiano@betabionics.com

Ed Raskin
eraskin@betabionics.com

Investor Relations Contact

Jeremy Feffer
jeremy@lifesciadvisors.com

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Beta Bionics and Zealand Pharma announce superior glycemic control in phase 2 home-use clinical trial testing the iLet™ Bionic Pancreas using dasiglucagon

  • First home-use trial of the iLet Bionic Pancreas System using pre-filled cartridges of dasiglucagon compatible with iLet has been successfully completed
  • The preliminary study results reveal superior blood glucose control during the study period that used the bihormonal configuration of the iLet with dasiglucagon compared to the period that used the insulin-only configuration
  • iLet therapy was initialized with body weight only, with no device training periods, and with no physician intervention to optimize therapy

Boston, MA and Copenhagen, Denmark – June 6, 2019 – Beta Bionics, Inc. and Zealand Pharma A/S (NASDAQ: ZEAL) announced today that a home-use study of dasiglucagon in the iLet™ Bionic Pancreas System has been successfully completed.

The iLet, developed by Beta Bionics, is the world’s first autonomous bionic pancreas device — a bihormonal system leveraging lifelong machine learning and artificial intelligence to deliver insulin and glucagon analogs for the autonomous treatment of type 1 diabetes (T1D). In addition to dosing insulin, the iLet doses dasiglucagon — a glucagon analog with a unique stability profile in a ready-to-use aqueous solution. Dasiglucagon is in development by Zealand Pharma.

This home-use clinical trial was conducted by Dr. Steven Russell and his clinical research team at the Massachusetts General Hospital (MGH) and was designed as a randomized, two-period, cross-over trial to assess whether the iLet operated as intended. The trial compared operational performance of the iLet in the insulin-only configuration for one week versus the bihormonal configuration for one week in 10 adult participants with T1D. Trial participants started therapy by entering only their body weight into the device; there was no device training period and no physician intervention to optimize therapy. The iLet is designed to autonomously and continuously adapt to each patient’s changing insulin needs. This adaptation is typically most pronounced in the first 24 hours after the initiation of therapy.

The iLet operated as expected, meeting the primary aim of the study. Preliminary data analysis demonstrated that the bihormonal iLet using dasiglucagon provided superior glycemic control over the insulin-only iLet. During the bihormonal period, participants achieved a mean glucose level, as measured by continuous glucose monitoring (CGM), of 139 mg/dL on days 2–7 of use, versus 149 mg/dL during the insulin-only period (p <0.01). During the bihormonal period, participants spent 79% of the time with their CGM glucose level in range (70–180 mg/dL) on days 2–7 of use, versus 71% during the insulin-only period (p<0.01). During the bihormonal period, 90% of participants had a mean CGM glucose level of < 154 mg/dL, a level that corresponds to an HbA1c level of 7%, the therapeutic goal for adults recommended by the American Diabetes Association. In contrast, 50% of participants had a mean CGM glucose level < 154 mg/dL during the insulin-only period.

Hypoglycemia was observed to be low throughout the study. The mean percentage of time CGM glucose was < 54 mg/dL was 0.3% during the bihormonal period versus 0.6% during the insulin-only period. The mean percentage of time CGM glucose was < 70 mg/dL was 2.4% during the bihormonal period versus 3.6% during the insulin-only period.

We are extremely pleased to have now tested the performance of our bihormonal iLet Bionic Pancreas System with dasiglucagaon — the first-ever, liquid-stable glucagon analog — in a convenient ready-to-use, pre-filled cartridge designed to fit our system,

said Ed Damiano, Co-founder and President & CEO of Beta Bionics.

Preliminary results from this trial have helped reaffirm the final implementation of our dosing algorithms in the bihormonal configuration of the iLet. I am ecstatic about this historic achievement for Beta Bionics, Zealand Pharma, and our clinical collaborators at MGH, and I am looking forward with eager anticipation to the day when people with T1D can enjoy the real-life benefits of combining ready-to-use dasiglucagon with the iLet.

Beta Bionics and Zealand Pharma have partnered to carry out several co-development activities with the primary goal of obtaining regulatory approval to use dasiglucagon in the bihormonal configuration of the iLet.

The bihormonal iLet Bionic Pancreas System demonstrated tight glycemic control in a home-use setting with dasiglucagon,

commented Emmanuel Dulac, President and Chief Executive Officer at Zealand Pharma.

We look forward to proceeding with the Phase 3 trial and continuing to demonstrate the transformational opportunity that the iLet with dasiglucagon could offer for improved and fully automated diabetes management.

Beta Bionics and Zealand Pharma are planning for a Phase 3 pivotal trial testing the bihormonal configuration of the iLet with dasiglucagon in 2020. That trial is intended to support regulatory submission to the U.S. FDA of a pre-market approval (PMA) application and a new drug application (NDA) for the bihormonal configuration of the iLet with dasiglucagon in people with T1D.

About the iLet

The iLet bionic pancreas system is a pocket-sized, wearable medical device that autonomously controls blood-sugar levels in people with diabetes. The dosing control algorithms integrated into the iLet were licensed by Beta Bionics from Boston University. In previous home-use studies in adults and children with T1D, these algorithms demonstrated dramatic improvements in glycemic control relative to the standard of care. These improvements included significant reductions in blood-glucose levels, in hypoglycemia, and in intersubject and intrasubject glycemic variability (New England Journal of Medicine. 2014, 371:313-25; Lancet Diabetes and Endocrinology. 2016, 4:233-43; Lancet. 2016, 389:369-80).

To initialize the iLet, users enter only their body weight. Immediately thereafter, the iLet begins controlling blood-sugar levels automatically, without requiring the user to count carbohydrates, set insulin delivery rates, or deliver bolus insulin for meals or corrections. The iLet is effectively three medical devices in one. It can be configured as an insulin-only bionic pancreas, a glucagon-only bionic pancreas, or a bihormonal bionic pancreas (insulin and glucagon). The glucagon-only configuration may be helpful in rare, chronic, low blood-sugar conditions, such as congenital hyperinsulinism (CHI) and insulinoma syndrome. Beta Bionics is committed to obtaining regulatory approval and commercializing all three iLet configurations.

About dasiglucagon for use in other indications

Dasiglucagon is a Zealand Pharma-invented glucagon analog with a unique stability profile in a ready-to-use aqueous solution. It is also in development for two additional indications: treatment of severe hypoglycemia, and treatment for children born with a genetic mutation that causes congenital hyperinsulinism (CHI).

About Beta Bionics

Beta Bionics is a for-profit Massachusetts public benefit corporation founded in 2015 to commercialize the iLet, a revolutionary bionic pancreas system that is driven by mathematical dosing algorithms to autonomously control glycemia. These mathematical dosing algorithms were developed in the Damiano Lab at Boston University and refined based on results from home-use clinical trials in adults and children with T1D. Beta Bionics is a Certified B Corporation™ whose founders—in addition to Ed Damiano— include other parents of children with type 1 diabetes and people with type 1 diabetes. Beta Bionics is committed to acting in the best interests of the diabetes community and to profoundly disrupting the diabetes medical device industry by bringing the iLet to market as expeditiously and responsibly as possible.

Beta Bionics is operated out of Boston, Massachusetts and Irvine, California. For further information, please visit www.betabionics.com or follow Beta Bionics Facebook, YouTube, Instagram, LinkedIn and Twitter @BetaBionics.

About Zealand Pharma A/S

Zealand Pharma A/S (Nasdaq Copenhagen and New York: ZEAL) (“Zealand”) is a biotechnology company focused on the discovery and development of innovative peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market. Zealand’s current pipeline of internal product candidates focus on specialty gastrointestinal and metabolic diseases. Zealand’s portfolio also includes two clinical license collaborations with Boehringer Ingelheim and pre-clinical license collaboration with Alexion Pharmaceuticals.

Zealand is based in Copenhagen (Glostrup), Denmark. For further information about the Company’s business and activities, please visit www.zealandpharma.com or follow Zealand on LinkedIn or Twitter @ZealandPharma.

Company Contacts

Beta Bionics

Ed Damiano
edamiano@betabionics.com

Ed Raskin
eraskin@betabionics.com

Investor Relations Contact

Jeremy Feffer
jeremy@lifesciadvisors.com

Zealand Pharma

Emmanuel Dulac
President and Chief Executive Officer
DK: +45 50 60 36 36
US: +1 857 777 6060
edu@zealandpharma.com

Lani Pollworth Morvan
Investor Relations and Communication
Tel.: +45 50 60 37 78
lpm@zealandpharma.com

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Beta Bionics and Zealand Pharma initiate home-use trial of the iLet™ bionic pancreas with dasiglucagon for autonomous bihormonal treatment of Type 1 diabetes

  • First home-use trial of the bihormonal iLet Bionic Pancreas System with dasiglucagon in a pre-filled, commercial-ready, pump cartridge has been initiated by a clinical team at Massachusetts General Hospital
  • The iLet Bionic Pancreas System is a pocket-sized, wearable medical device that autonomously controls blood-sugar levels in people with diabetes
  • Dasiglucagon is a potential first-in-class stable glucagon analog

Boston, MA and Copenhagen, Denmark, May 22, 2019 – Beta Bionics, Inc. and Zealand Pharma A/S (NASDAQ: ZEAL) announced today the first patients dosed in a clinical trial investigating the home-use of dasiglucagon in the iLet™ Bionic Pancreas System. The iLet, developed by Beta Bionics, is the world’s first autonomous bionic pancreas device — a bihormonal system leveraging lifelong machine learning and artificial intelligence to deliver insulin and glucagon analogs for the autonomous treatment of type 1 diabetes. In addition to dosing insulin, the iLet doses dasiglucagon — a glucagon analog developed by Zealand Pharma with a unique stability profile in a ready-to-use aqueous solution.

This home-use clinical trial is being conducted by Dr. Steven Russell and his clinical research team at the Massachusetts General Hospital. The current trial is designed as a randomized, two-arm, cross-over trial to assess whether the iLet operates as designed. It compares the operational performance of the iLet in its insulin-only configuration to its bihormonal configuration using dasiglucagon in adults with type 1 diabetes. Secondary objectives of the study include assessing the impact of the insulin-only and bihormonal configurations of the iLet Bionic Pancreas System on glycemic control, quality of life, and treatment satisfaction among study participants, their caregivers, partners, and/or family members.

The start of this home-use clinical trial with the iLet in its bihormonal configuration — autonomously and independently pumping both insulin and Zealand’s dasiglucagon — marks the achievement of a long- awaited and eagerly anticipated milestone,

said Ed Damiano, Co-founder and President & CEO of Beta Bionics.

Beta Bionics and Zealand Pharma have partnered to carry out several co-development activities with the primary goal of obtaining regulatory approval to use dasiglucagon in the bihormonal configuration of the iLet.

Fully automated diabetes care, realized by a dual-hormone artificial pancreas system using insulin together with dasiglucagon, could significantly improve life for millions of people living with type 1 diabetes,

said Emmanuel Dulac, President and Chief Executive Officer at Zealand Pharma.

For further information, please contact:

Beta Bionics

Ed Damiano
edamiano@betabionics.com

Ed Raskin
eraskin@betabionics.com

Investor Relations Contact

Jeremy Feffer
jeremy@lifesciadvisors.com

Zealand Pharma

Emmanuel Dulac
President and Chief Executive Officer
+45 50 60 36 36
edu@zealandpharma.com

Lani Pollworth Morvan
Investor Relations and Communication
+45 50 60 37 78
lpm@zealandpharma.com

About the iLet

The iLet bionic pancreas system is a pocket-sized, wearable medical device that autonomously controls blood-sugar levels in people with diabetes. The lifelong, machine-learning, mathematical dosing algorithms integrated into the iLet were licensed by Beta Bionics from Boston University. In previous home-use studies in adults and children with T1D, these algorithms demonstrated dramatic improvements in glycemic control relative to the standard of care. These improvements included significant reductions in blood-glucose levels, in hypoglycemia, and in intersubject and intrasubject glycemic variability (New England Journal of Medicine. 2014, 371:313-25; Lancet Diabetes and Endocrinology. 2016, 4:233-43; Lancet. 2016, 389:369-80).

To initialize the iLet, users enter only their body weight. Immediately thereafter, the iLet begins controlling blood-sugar levels automatically, without requiring the user to count carbohydrates, set insulin delivery rates, or deliver bolus insulin for meals or corrections. The iLet is effectively three medical devices in one. It can be configured as an insulin-only bionic pancreas, a glucagon-only bionic pancreas, or a bihormonal bionic pancreas (insulin and glucagon). The glucagon-only configuration may be helpful in rare, chronic, low blood-sugar conditions, such as congenital hyperinsulinism (CHI) and insulinoma syndrome. Beta Bionics is committed to obtaining regulatory approval and commercializing all three iLet configurations.

About dasiglucagon for use in other indications

Dasiglucagon is a Zealand-invented glucagon analog with a unique stability profile in a ready-to-use aqueous solution. It is also in development for two additional indications: treatment of severe hypoglycemia, and treatment for children born with a genetic mutation that causes congenital hyperinsulinism (CHI).

About Beta Bionics

Beta Bionics is a for-profit Massachusetts public benefit corporation founded in 2015 to commercialize the iLet, a revolutionary bionic pancreas system that is driven by machine-learning artificial intelligence to autonomously control glycemia. These mathematical dosing algorithms were developed in the Damiano Lab at Boston University and refined based on results from home-use clinical trials in adults and children with T1D. Beta Bionics is a Certified B Corporation™ whose founders—in addition to Ed Damiano—include other parents of children with type 1 diabetes and people with type 1 diabetes. Beta Bionics is committed to acting in the best interests of the diabetes community and to profoundly disrupting the diabetes medical device industry by bringing the iLet to market as expeditiously and responsibly as possible.

Beta Bionics is operated out of Boston, Massachusetts and Irvine, California. For further information, please visit www.betabionics.com or follow Beta Bionics Facebook, YouTube, Instagram, LinkedIn and Twitter @BetaBionics.

About Zealand Pharma A/S

Zealand Pharma A/S (Nasdaq Copenhagen and New York: ZEAL) (“Zealand”) is a biotechnology company focused on the discovery and development of innovative peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market. Zealand’s current pipeline of internal product candidates focus on specialty gastrointestinal and metabolic diseases. Zealand’s portfolio also includes two clinical license collaborations with Boehringer Ingelheim and pre-clinical license collaboration with Alexion Pharmaceuticals.

Zealand is based in Copenhagen (Glostrup), Denmark. For further information about the Company’s business and activities, please visit www.zealandpharma.com or follow Zealand on LinkedIn or Twitter @ZealandPharma.

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Beta Bionics Announces Final Closing of Its $63 Million Series B Financing

  • New investors include ArrowMark, LifeSci Venture Partners, and strategic partner, Dexcom
  • RTW made an additional Series B investment
  • Strategic partner, Zealand Pharma completed $5 million Series B investment

BOSTON, Jan. 08, 2019 (GLOBE NEWSWIRE) — Beta Bionics, Inc. – a medical technology company leveraging lifelong, machine-learning, artificial intelligence to develop and commercialize the world’s first autonomous bionic pancreas – today announced that the company has now completed its Series B equity financing, which has reached a total of $63 million.

New investors in the round include strategic partner Dexcom, and funds managed by ArrowMark Partners and LifeSci Venture Partners.

We are thrilled to help Beta Bionics fund their innovative iLet™ system through pivotal clinical trials and the FDA approval process. Based on our due diligence, we believe the iLet will transform glucose control for millions of people living with diabetes across the globe,

stated Paul Yook, General Partner of LifeSci Venture Partners.

The team at Beta Bionics has the potential to develop the world’s first bionic pancreas that could revolutionize the management of diabetes,

said Tuan Huynh of ArrowMark Partners.

Currently with about 3.2 million intensively managed patients in the US, there is tremendous opportunity to not only help reduce patient burden, but also for Beta Bionics.

RTW Investments added to their initial investment with a follow-on investment in this final close.

We are excited by the potential the iLet has to transform the lives of patients and thrilled to support the talented team at Beta Bionics,

said Naveen Yalamanchi, M.D., Partner and Portfolio Manager at RTW Investments.

The Series B round was led by Eventide Asset Management, LLC, the advisor to Eventide Mutual Funds, which invested alongside RTW in an earlier closing that was announced on August 31, 2018.

Also participating in this final close was strategic partner Zealand Pharma, developer of a stable and pump compatible glucagon analog called dasiglucagon. In 2017, Zealand made an initial $1.5 million equity investment in Beta Bionics with an option to invest a further $3.5 million pending the achievement of specific development milestones. Zealand has now exercised this option based on the significant regulatory and clinical progress Beta Bionics and Zealand have made throughout 2018.

Beta Bionics is the developer of the iLet Bionic Pancreas System, which was recently tested in home-use clinical trials in 2018 in adults and children with type 1 diabetes (T1D). The iLet consists of a dual-chamber, autonomous, infusion pump that mimics a biological pancreas. Embedded in the system are clinically tested mathematical dosing algorithms driven by lifelong machine learning to autonomously calculate and dose insulin and/or glucagon as needed, based on data from a continuous glucose monitor. Designed with unprecedented simplicity of use, the iLet requires only body weight for initialization and then proceeds to autonomously control the individual’s blood- glucose levels, and to continuously adapt to the individual’s ever-changing insulin needs.

Funds will be used to support ongoing product development at Beta Bionics, iLet phase 3 clinical trials, and regulatory submission of the iLet PMA application to the US Food and Drug Administration.

We are delighted to have completed our first institutional financing of Beta Bionics,

said Ed Damiano founder and CEO of Beta Bionics.

This is an historic milestone for Beta Bionics for sure, but it is also a noteworthy precedent for the medical technology industry and investment community, as well. As the first and only public benefit corporation and Certified B Corp in the medical technology industry, Beta Bionics is a force for public good; and this commitment has resonated with the strong syndicate of supportive and visionary investors we have assembled alongside our strategic investors, including Eli Lilly, Novo Nordisk, Zealand Pharma and Dexcom. The enthusiastic reception that we were met with from the investment community in 2018 led to a larger-than-anticipated Series B financing, which has put us in a strong position going into 2019 to advance our ambitious mission of bringing to market the world’s first, fully autonomous, bionic pancreas.

Piper Jaffray served as the Company’s advisors for the Series B transaction.

About the iLet

The iLet bionic pancreas system is a pocket-sized, wearable medical device that autonomously controls blood-sugar levels in people with diabetes. The lifelong, machine-learning, mathematical dosing algorithms integrated into the iLet were licensed by Beta Bionics from Boston University. In previous home-use studies in adults and children with T1D, these algorithms demonstrated dramatic improvements in glycemic control relative to the standard of care. These improvements included significant reductions in blood-glucose levels, in hypoglycemia, and in intersubject and intrasubject glycemic variability (New England Journal of Medicine. 2014, 371:313-25; Lancet Diabetes and Endocrinology. 2016, 4:233-43; Lancet. 2016, 389:369-80).

To initialize the iLet, users enter only their body weight. Immediately thereafter, the iLet begins controlling blood-sugar levels automatically, without requiring the user to count carbohydrates, set insulin delivery rates, or deliver bolus insulin for meals or corrections. The iLet is effectively three medical devices in one. It can be configured as an insulin-only bionic pancreas, a glucagon-only bionic pancreas, or a dual-hormone bionic pancreas (insulin and glucagon). The glucagon-only configuration may be helpful in rare, chronic, low blood-sugar conditions, such as congenital hyperinsulinism (CHI) and insulinoma syndrome. Beta Bionics is committed to obtaining regulatory approval and commercializing all three iLet configurations.

About Beta Bionics

Beta Bionics is a for-profit Massachusetts public benefit corporation founded in 2015 to commercialize the iLet, a revolutionary bionic pancreas that is driven by mathematical dosing algorithms, which incorporate machine-learning artificial intelligence to autonomously control glycemia. These mathematical dosing algorithms were developed in the Damiano Lab at Boston University and refined based on results from home-use clinical trials in adults and children with T1D. Beta Bionics is a Certified B Corporation™ whose founders—in addition to Ed Damiano— include other parents of children with type 1 diabetes and people with type 1 diabetes. Beta Bionics is committed to acting in the best interests of the diabetes community and to profoundly disrupting the diabetes medical device industry by bringing the iLet to market as expeditiously and responsibly as possible. Beta Bionics is pursuing regulatory approval of its insulin-only bionic pancreas, followed by its dual-hormone system, which will also administer a glucagon analog in order to raise blood-sugar levels without the need to consume carbohydrates.

Beta Bionics is headquartered in Boston, Massachusetts with certain operations in Irvine, California. For further information, please visit www.betabionics.com or follow Beta Bionics Facebook, YouTube, Instagram, LinkedIn and Twitter @BetaBionics.

Company Contacts

Ed Damiano
edamiano@betabionics.com

Ed Raskin
eraskin@betabionics.com

Investor Relations Contact

Jeremy Feffer
jeremy@lifesciadvisors.com

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Beta Bionics awarded up to $2 million NIH small business innovation research (SBIR) grant

  • Award from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Grant provides up to $2 million in funding over the next 24 months under the Fast-Track mechanism (pending demonstration of successful achievement of Phase I milestones)
  • Research activities directed toward the Beta Bionics insulin-only and bihormonal bionic pancreas technology.

Boston, MA – October 2, 2018: Beta Bionics, Inc. – a medical technology company leveraging lifelong machine learning and artificial intelligence to develop and commercialize the world’s first autonomous bionic pancreas – today announced that it has been awarded up to $2 million in the form of an SBIR grant (R44-DK120234) by the NIDDK, which is part of the U.S. National Institutes of Health (NIH).

Beta Bionics is the developer of the iLet™ Bionic Pancreas System, which is currently undergoing home-use clinical trials in adults and children with type 1 diabetes (T1D). The iLet consists of a dual-chamber, autonomous, infusion pump that mimics a biological pancreas. Embedded in the system are clinically-tested dosing algorithms driven by lifelong machine learning to autonomously calculate and dose insulin or glucagon as needed based on data from the patient’s continuous glucose monitor (CGM). With unprecedented simplicity of use, the iLet requires only body weight for initialization after which it autonomously controls the individual’s blood-glucose levels, continuously adapting to that individual’s ever-changing requirements.

The SBIR grant was reviewed and awarded under the NIH Fast-Track mechanism where the Phase I will include R&D activities centered around (1) establishing and implementing the final design and use requirements of the iLet Bionic Pancreas System, (2) building and testing the clinical-ready prototypes, and (3) submitting the investigational device exemption (IDE) application to the US Food and Drug Administration (FDA). Pending demonstration of successful achievement of Phase I milestones, Phase II activities will include R&D activities centered around designing, testing, implementing, and optimizing automation equipment within the Beta Bionics manufacturing facility.

This SBIR grant represents an important contributing source of support to Beta Bionics to aid in its effort to bring this transformational technology to people who face the relentless, daily, life-long challenges of managing diabetes,

said Ed Damiano, co-founder and CEO of Beta Bionics and Professor of Biomedical Engineering at Boston University.

The iLet has grown out of technology developed at my lab at Boston University and subsequently at Beta Bionics. The progress we have made through over 10 years of clinical research and technology development simply would not have been possible without the financial support and resources provided by the NIDDK and the Special Diabetes Program to my lab and my clinical collaborators, and now to Beta Bionics. This SBIR grant will allow Beta Bionics to leverage all of the NIDDK’s past clinical research support of the bionic pancreas technology and its current clinical research support of the iLet technology through another ongoing NIDDK award (UC4- DK108612) to Boston University.

This SBIR award reflects NIDDK’s commitment to support the development of novel technologies by small business concerns in order to improve self-management of diabetes, reduce the burden of care and prevent acute and chronic complications,

said Guillermo Arreaza-Rubín, M.D., director of the NIDDK Diabetes Technology Program.

In May and July, Beta Bionics announced a first-of-its-kind, US-based, multicenter, multi-arm, cross-over clinical trial to test the iLet in its insulin-only configuration in adults and children with T1D. This clinical trial is currently underway, testing insulin lispro and conventional insulin aspart with the iLet using the Dexcom G5 CGM in children with T1D. This trial is also testing insulin lispro, conventional insulin aspart, and Novo Nordisk’s recently approved ultra-rapid-acting, insulin-analog formulation called Fiasp®, with the iLet using the Dexcom G5 and Senseonics Eversense CGMs in adults with T1D. Both Dexcom and Senseonics are development partners with Beta Bionics. Beta Bionics plans to enter pivotal trials with its final iLet design in 2019 and expects to launch its first product in 2020.

About the iLet

The iLet bionic pancreas system is a pocket-sized, wearable medical device that autonomously controls blood-sugar levels in people with diabetes. The lifelong, machine-learning, mathematical dosing algorithms integrated into the iLet were licensed by Beta Bionics from Boston University. In previous home-use studies in adults and children with T1D, these algorithms demonstrated dramatic improvements in glycemic control relative to the standard of care. These improvements included significant reductions in blood-glucose levels, in hypoglycemia, and in intersubject and intrasubject glycemic variability (New England Journal of Medicine. 2014, 371:313-25; Lancet Diabetes and Endocrinology. 2016, 4:233-43; Lancet. 2016, 389:369-80).

To initialize the iLet, the user enters only their body weight. Thereafter, iLet does not require the patient to count carbohydrates, set insulin delivery rates or deliver bolus insulin for meals or corrections. The iLet is effectively three medical devices in one. It can be configured as an insulin-only bionic pancreas, a glucagon-only bionic pancreas, or a dual-hormone bionic pancreas. The glucagon-only configuration may be helpful in rare, chronic, low blood-sugar conditions, such as congenital hyperinsulinism (CHI) and insulinoma syndrome. Beta Bionics is committed to obtaining regulatory approval and commercializing all three iLet configurations.

About Beta Bionics

Beta Bionics is a for-profit Massachusetts public benefit corporation founded in 2015 to commercialize the iLet, a revolutionary bionic pancreas driven by mathematical dosing algorithms, which incorporate machine-learning artificial intelligence to autonomously control glycemia. These dosing algorithms were developed in the Damiano Lab at Boston University and refined based on results from home-use clinical trials in adults and children with T1D. Beta Bionics is a Certified B Corporation™ whose founders—in addition to Ed Damiano—include other parents of children with type 1 diabetes. Beta Bionics is committed to acting in the best interests of the diabetes community and to profoundly disrupting the diabetes medical device industry by bringing the iLet to market as expeditiously and responsibly as possible. Beta Bionics is pursuing regulatory approval of its insulin-only bionic pancreas, followed by its dual- hormone system that will also administer a glucagon analog in order to raise blood- sugar levels without the need to consume carbohydrates.

Beta Bionics is headquartered in Boston, Massachusetts with certain operations in Irvine, California. For further information, please visit www.betabionics.com or follow Beta Bionics Facebook, YouTube, Instagram, LinkedIn and Twitter @BetaBionics.

The content of this news release is solely the responsibility of the authors and does not necessarily represent the official views or imply endorsement of the National Institutes of Health.

Company Contacts

Ed Damiano
edamiano@betabionics.com

Ed Raskin
eraskin@betabionics.com

Investor Relations Contact

Jeremy Feffer
jeremy@lifesciadvisors.com

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Beta Bionics secures an initial $50 million Series B round

  • The round was led by Eventide Asset Management
  • Other institutional investors in Series B include RTW Investments
  • Corporate strategic partner and Series A investor, Novo Nordisk, has also participated in Series B
  • Corporate strategic partner, Zealand Pharm, previously committed $5m to Series B in December 2017

Boston, MA – September 17, 2018 – Beta Bionics, Inc. – a medical technology company leveraging lifelong machine learning, artificial intelligence to develop and commercialize the world’s first autonomous bionic pancreas – today announced that the company has so far raised $50m of a Series B equity financing. The round was led by Eventide Asset Management, LLC the advisor to Eventide Mutual Funds. Eventide was founded in 2008 with a vision to provide high performance, value-based investments that are socially responsible. RTW Investments, LP also participated, along with Series A investor, Novo Nordisk A/S. Strategic partner Zealand Pharma A/S, developer of a stable and pump compatible glucagon analog, called dasiglucagon, previously committed $5 million to the round. Funds will be used to support ongoing product development of the Beta Bionics commercial-generation bionic pancreas technology for use in its insulin-only, glucagon-only, and bihormonal configurations.

Beta Bionics is developer of the iLet Bionic Pancreas System, which is currently deployed in home- use clinical trials in adults and children with type 1 diabetes (T1D), as previously announced in May and July 2018. The iLet consists of a dual-chamber, autonomous, infusion system that mimics a biological pancreas. Embedded in the system are clinically tested mathematical dosing algorithms driven by lifelong machine learning to autonomously calculate and dose insulin and/or glucagon as needed, based on data from a continuous glucose monitor. Designed with simplicity of use, the iLet requires only body weight for initialization and then proceeds to autonomously control the individual’s blood-glucose levels, and to continuously adapt to the individual’s ever- changing insulin needs.

From the outset the Damiano Lab, and now Beta Bionics, have been committed to demonstrating meaningful clinical-outcomes data through rigorous clinical trials in collaboration with Dr. Steven Russell of the Massachusetts General Hospital and Harvard Medical School, Dr. Bruce Buckingham of Stanford University, and other clinical investigators. We take great satisfaction in Eventide and RTW’s appreciation for our clinical data, and support of our technological vision, commercial ambitions, public benefit corporation structure, and certified B Corp status,

said Ed Damiano, founder and CEO of Beta Bionics.

Piper Jaffray acted as financial advisor and placement agent to the Company.

About the iLet

The iLet bionic pancreas system is a pocket-sized, wearable medical device that autonomously controls blood-sugar levels in people with diabetes. The mathematical dosing algorithms integrated into the iLet were licensed by Beta Bionics from Boston University and were refined over years of clinical research to incorporate lifelong machine learning technology that adapts continuously to each person’s unique insulin requirements. In previous home-use and outpatient studies in adults and children with T1D, these algorithms demonstrated dramatic improvements in glycemic control relative to the standard of care. These improvements included significant reductions in blood-glucose levels, in hypoglycemia, and in intersubject and intrasubject glycemic variability (New England Journal of Medicine. 2014, 371:313-25; Lancet Diabetes and Endocrinology. 2016, 4:233-43; Lancet. 2016, 389:369-80).

The iLet is initialized by entering body weight only and does not require the patient to count carbohydrates, set insulin delivery rates or deliver bolus insulin for meals or corrections. The iLet is effectively three medical devices in one. It can be configured as an insulin-only bionic pancreas, a glucagon-only bionic pancreas, or a dual-hormone bionic pancreas. The glucagon-only configuration may be helpful in rare, chronic, low -lood-sugar conditions, such as congenital hyperinsulinism (CHI) and insulinoma syndrome. Beta Bionics is committed to obtaining regulatory approval and commercializing all three iLet configurations.

About Beta Bionics

Beta Bionics is a for-profit Massachusetts public benefit corporation founded in 2015 to commercialize the iLet, a revolutionary bionic pancreas that is driven by mathematical dosing algorithms to autonomously control glycemia in people with diabetes. These algorithms were developed and refined in the Damiano Lab at Boston University based on results from years of clinical research in adults and children with T1D. Beta Bionics is a Certified B Corporation™ whose founders—in addition to Ed Damiano—include other parents of children with type 1 diabetes. Beta Bionics is committed to acting in the best interests of the diabetes community and to profoundly disrupting the diabetes medical device industry by bringing the iLet to market as expeditiously and responsibly as possible. Beta Bionics is pursuing regulatory approval of its insulin-only bionic pancreas, which will be followed by its dual-hormone system that will also administer a glucagon analog in order to raise blood-sugar levels without the need to consume carbohydrates.

Beta Bionics is headquartered in Boston, Massachusetts with certain operations in Irvine, California. For further information, please visit www.betabionics.com or follow Beta Bionics Facebook, YouTube, Instagram, LinkedIn and Twitter @BetaBionics.

Company Contacts

Ed Damiano
edamiano@betabionics.com

Ed Raskin
eraskin@betabionics.com

Investor Relations Contact

Jeremy Feffer
jeremy@lifesciadvisors.com

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Beta Bionics Announces Start of Home-Use Clinical Trials with the iLet™ Bionic Pancreas System and Receives IDE Approval from the FDA to Expand its Clinical Trials to Include the Senseonics Eversense CGM Integrated into the iLet

  • The Beta Bionics iLet Bionic Pancreas System is now approved for clinical trials in adults with type 1 diabetes (T1D) using two highly accurate continuous glucose monitoring (CGM) systems: the Dexcom CGM and the Senseonics Eversense CGM
  • iLet compatibility with both CGM systems demonstrates unique commitment by Beta Bionics to patient choice, interoperability, and the highest CGM accuracy standards
  • First dosing in adults with T1D with the iLet using the Dexcom CGM and Fiasp® in PumpCart began in July 2018
  • First children with T1D will be dosed with the iLet using the Dexcom CGM beginning in July 2018
  • First adults with T1D will be dosed with the iLet using the Senseonics Eversense CGM beginning in August 2018

Boston, MA – July 12, 2018 – Beta Bionics, Inc., a medical technology company leveraging life-long, machine-learning, artificial intelligence to develop and commercialize the iLet Bionic Pancreas System — the world’s first fully autonomous bionic pancreas — announced today that the FDA has approved a supplement filed by Beta Bionics to its previously approved investigational device exemption (IDE) expanding ongoing home- use clinical trials testing its new integrated technology, which combines the iLet bionic pancreas and the Senseonics Eversense CGM.

The FDA previously granted IDE approval for clinical testing of the iLet integrated with the Dexcom CGM. The FDA’s recent approval to begin clinical testing of an Eversense- compatible iLet comes less than three weeks after Senseonics received FDA approval to begin commercial marketing of Eversense in adults with diabetes. Eversense is the only CGM system to feature an implantable glucose sensor, designed for long-term continuous use for up to three months, a removable and rechargeable transmitter, and on-body vibratory alerts for high and low glucose levels.

The Senseonics Eversense CGM represents a categorically differentiated CGM choice for people with diabetes, in addition to transcutaneous CGM, and offers new patient preferences that have not previously been possible,

said Ed Damiano, President and CEO of Beta Bionics.

We’re excited that the Eversense CGM System is now part of this important clinical study and by the work Beta Bionics has done to ensure the compatibility of Eversense with the iLet Bionic Pancreas System,

said Tim Goodnow, President and CEO of Senseonics.

It’s especially important to include another accurate CGM system in this trial to give patients an option. Giving patients a choice is critical, especially when they’re considering the CGM component of their artificial pancreas and whether an implantable, long-term sensor might be a good fit for their needs.

Beta Bionics has set itself apart as a market leader committed to unprecedented interoperability and patient choice. The Company has developed its iLet Bionic Pancreas System to be interoperable with multiple insulins (including Humalog®, Novolog®, and Fiasp®), multiple hormones (including dasiglucagon by Zealand Pharma), and now two very different CGM options. Beta Bionics has again demonstrated its commitment to interoperability and patient choice, in contrast to those companies that have locked their technologies into exclusive arrangements that limit choices for people with type 1 diabetes.

Patient choice of two highly accurate and differentiated CGM technologies is good for our kids, good for the T1D community and essential to building an innovative and sustainable business. With this milestone, Beta Bionics continues its commitment to remaining at the bleeding edge of product innovation for people with diabetes,

said Dr. Damiano.

Just weeks after Beta Bionics received the go-ahead from the FDA, home-use clinical trials began in adults with T1D at the Massachusetts General Hospital (MGH) using the Dexcom-integrated iLet in the insulin-only configuration with Humalog and Novolog and then again, several weeks later, at Stanford University Medical Center using the Dexcom- integrated iLet in the insulin-only configuration with Humalog, Novolog, and Fiasp. Under the Beta Bionics IDE and newly approved IDE supplement, an additional cohort of adults with T1D will begin using the Eversense-integrated iLet in the insulin-only configuration next month at MGH.

Beta Bionics plans to enter pivotal trials with its final iLet design in 2019 and expects to launch its first product in 2020.

About the IDE and PMA Process

Investigational use of the iLet was approved by the FDA under an investigational device exemption (IDE). An IDE allows testing of an investigational device in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application to the FDA. An IDE application and any IDE supplement is approved only after extensive review by the FDA of the device and clinical trial design.

About the iLet

The iLet bionic pancreas system is a pocket-sized, wearable medical device that autonomously controls blood-sugar levels in people with diabetes. The machine- learning, mathematical dosing algorithms integrated into the iLet were licensed by Beta Bionics from Boston University. In previous home-use studies in adults and children with T1D, these algorithms demonstrated dramatic improvements in glycemic control relative to the standard of care. These improvements included significant reductions in blood-glucose levels, reductions in hypoglycemia, and reductions in intersubject and intrasubject glycemic variability (New England Journal of Medicine. 2014, 371:313-25; Lancet Diabetes and Endocrinology. 2016, 4:233-43; Lancet. 2016, 389:369-80).

The iLet is initialized by entering body weight only and does not require the patient to count carbohydrates, set insulin delivery rates or deliver bolus insulin for meals or corrections. The iLet is effectively three medical devices in one. It can be configured as an insulin-only bionic pancreas, a glucagon-only bionic pancreas, or a dual-hormone bionic pancreas. The glucagon-only configuration may be helpful in rare, chronic, low blood-sugar conditions, such as congenital hyperinsulinism (CHI) and insulinoma syndrome. Beta Bionics is committed to obtaining regulatory approval and commercializing all three iLet configurations.

About Beta Bionics

Beta Bionics is a for-profit Massachusetts public benefit corporation founded in 2015 to commercialize the iLet, a revolutionary bionic pancreas that is driven by mathematical dosing algorithms, which incorporate machine-learning artificial intelligence to autonomously control glycemia. These mathematical dosing algorithms were developed in the Damiano Lab at Boston University and refined based on results from home-use clinical trials in adults and children with T1D. Beta Bionics is a Certified B Corporation™ whose founders—in addition to Ed Damiano—include other parents of children with type 1 diabetes. Beta Bionics is committed to acting in the best interests of the diabetes community and to profoundly disrupting the diabetes medical device industry by bringing the iLet to market as expeditiously and responsibly as possible. Beta Bionics is pursuing regulatory approval of its insulin-only bionic pancreas, which will be followed by its dual-hormone system that will also administer a glucagon analog in order to raise blood-sugar levels without the need to consume carbohydrates.

Beta Bionics is headquartered in Boston, Massachusetts with certain operations in Irvine, California. For further information, please visit www.betabionics.com or follow Beta Bionics Facebook, YouTube, Instagram, LinkedIn and Twitter @BetaBionics.

Beta Bionics Company Contacts

Ed Damiano
edamiano@betabionics.com

Ed Raskin
eraskin@betabionics.com

Beta Bionics Investor Relations Contact

Jeremy Feffer
jeremy@lifesciadvisors.com

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Beta Bionics Receives IDE Approval from the FDA to Begin a Home-Use Clinical Trial Testing the New iLet™ Bionic Pancreas System

  • First trial to test Fiasp® – Novo Nordisk’s latest formulation of fast-acting insulin aspart – using autonomous insulin delivery
  • The bionic pancreas will also be tested with the conventional formulations of insulin aspart and insulin lispro in both adults and children with type 1 diabetes who use either an insulin pump or multiple daily injection therapy for their usual care
  • Trial to use Dexcom’s Continuous Glucose Monitoring System

Boston, MA – May 21, 2018 – Beta Bionics, Inc. – a medical technology company leveraging machine learning artificial intelligence to develop and commercialize the world’s first autonomous bionic pancreas – today announced that it has received FDA approval to begin recruitment for home-use studies testing the insulin-only configuration of its iLet bionic pancreas system in a series of groundbreaking trials in adults and children with type 1 diabetes (T1D). Adults 18 years and older with T1D will be recruited through Massachusetts General Hospital and Stanford University, and children 6-17 years old with T1D will be recruited through Nemours Children’s Health System, the Barbara Davis Center for Diabetes at the University of Colorado, and Stanford University.

The US-based multicenter, multi-arm, cross-over, clinical trial is the first of its kind, testing Novo Nordisk’s recently approved, fast-acting insulin called Fiasp® with the iLet bionic pancreas system in adults with T1D, and insulin lispro and conventional insulin aspart using the iLet in adults and children with T1D. This trial is also the first to use the new Beta Bionics-manufactured iLet device, which is capable of dosing only insulin, only glucagon, or both hormones as needed.

The iLet consists of a dual-chamber, autonomous, infusion pump that mimics a biological pancreas. Embedded in the system are clinically tested mathematical dosing algorithms driven by machine learning to autonomously calculate and dose insulin and/or glucagon as needed, based on data from a continuous glucose monitor. With unprecedented simplicity of use, the iLet requires only body weight for initialization. Once initialized, the iLet engages its machine-learning, artificial intelligence to autonomously control the individual’s blood-glucose levels, and to continuously adapt to the individual’s ever-changing insulin needs. The iLet to be used in this trial integrates glucose data from the Dexcom G5 Continuous Glucose Monitoring (CGM) System.

The design of this ambitious insulin-only bionic pancreas study builds on the foundation of previous studies we have conducted with our clinical collaborators testing our bionic pancreas algorithms with previous investigational platforms,

said Ed Damiano, Founder and CEO of Beta Bionics, and Principal Investigator of the trial. Dr. Damiano is also a Professor of Biomedical Engineering at Boston University.

This trial is exciting not only because it represents the first time we will be able to test our bionic pancreas algorithms with our own proprietary iLet platform, and not only because it will include both children and adults with T1D, and not only because it will draw upon those who use MDI therapy in equal number to those who use insulin pumps for their usual care, but also because we will be breaking new ground by being the first group to test autonomous insulin delivery using Fiasp®. The iLet Bionic Pancreas System trial is a concrete example of patient-centered innovation, and it is ultimately through innovation and research that we’ll defeat diabetes,

said Stephen Gough, Global Chief Medical Officer of Novo Nordisk.

We are proud that Fiasp®, our ultra-fast acting insulin, has been chosen for this trial, among other rapid-acting insulins and look forward to see the results. The intent is to show meaningful benefits for people living with diabetes in need of this technology.

Novo Nordisk, an investor in Beta Bionics, has partnered with Beta Bionics to carry out several co-development activities. Eli Lilly and Zealand Pharma are also investors and development partners. Dexcom is a development partner with Beta Bionics as well and recently received FDA approval of its G6 Dexcom under the new interoperable CGM designation (iCGM).

We have worked with Beta Bionics and Ed Damiano’s team for many years to provide our highly accurate and reliable CGM technologies to drive the bionic pancreas,

said Steve Pacelli, Executive Vice President of Strategy and Corporate Development at Dexcom.

We support the efforts of Beta Bionics to bring their iLet bionic pancreas system to market and look forward to seeing our G6 system incorporated into their future iLet platform and validated in future clinical trials.

Beta Bionics plans to enter pivotal trials with its final iLet design in 2019 and expects to launch its first product in 2020.

About the IDE and PMA process

Investigational use of the iLet was approved by the FDA under an investigational device exemption (IDE). An IDE allows testing of an investigational device in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application to the FDA. An IDE application is approved only after extensive review by the FDA of the device and clinical trial design.

About the iLet

The iLet bionic pancreas system is a pocket-sized, wearable medical device that autonomously controls blood-sugar levels in people with diabetes. The machine- learning mathematical dosing algorithms integrated into the iLet were licensed by Beta Bionics from Boston University. In previous home-use studies in adults and children with T1D, these algorithms demonstrated dramatic improvements in glycemic control relative to the standard of care. These improvements included significant reductions in blood-glucose levels, reductions in hypoglycemia, and reductions in intersubject and intrasubject glycemic variability (New England Journal of Medicine. 2014, 371:313-25; Lancet Diabetes and Endocrinology. 2016, 4:233-43; Lancet. 2016, 389:369-80).

The iLet is initialized by entering body weight only and does not require the patient to count carbohydrates, set insulin delivery rates or deliver bolus insulin for meals or corrections. The iLet is effectively three medical devices in one. It can be configured as an insulin-only bionic pancreas, a glucagon-only bionic pancreas, or a dual-hormone bionic pancreas. The glucagon-only configuration may be helpful in rare, chronic, low blood-sugar conditions, such as congenital hyperinsulinism (CHI) and insulinoma syndrome. Beta Bionics is committed to obtaining regulatory approval and commercializing all three iLet configurations.

About Fiasp® (insulin aspart injection) 100 U/mL

Fiasp® is a fast-acting mealtime insulin indicated to improve glycemic control in adults with type 1 and type 2 diabetes. Fiasp® is the first fast-acting mealtime insulin injection that does not have a pre-meal dosing recommendation. Fiasp® should be administered at the beginning of a meal or within 20 minutes after starting a meal due to its appearance in the blood in approximately 2.5 minutes.*

*Reference: Fiasp® [package insert]. Plainsboro, NJ: Novo Nordisk Inc; September 2017.

About Beta Bionics

Beta Bionics is a for-profit Massachusetts public benefit corporation founded in 2015 to commercialize the iLet, a revolutionary bionic pancreas that is driven by mathematical dosing algorithms, which incorporate machine-learning artificial intelligence to autonomously control glycemia. These mathematical dosing algorithms were developed in the Damiano Lab at Boston University and refined based on results from home-use clinical trials in adults and children with T1D. Beta Bionics is a Certified B Corporation™ whose founders—in addition to Ed Damiano—include other parents of children with type 1 diabetes. Beta Bionics is committed to acting in the best interests of the diabetes community and to profoundly disrupting the diabetes medical device industry by bringing the iLet to market as expeditiously and responsibly as possible. Beta Bionics is pursuing regulatory approval of its insulin-only bionic pancreas, which will be followed by its dual-hormone system that will also administer a glucagon analog in order to raise blood-sugar levels without the need to consume carbohydrates.

Beta Bionics is headquartered in Boston, Massachusetts with certain operations in Irvine, California. For further information, please visit www.betabionics.com or follow Beta Bionics Facebook, YouTube, Instagram, LinkedIn and Twitter @BetaBionics.

Company Contacts

Ed Damiano
edamiano@betabionics.com

Ed Raskin
eraskin@betabionics.com

Investor Relations Contact

Jeremy Feffer
jeremy@lifesciadvisors.com

Back