Thermalin Announces:

Thermalin’s Insulin Analog T-1123 and StampPump™ Presented at The 13th International Conference on Advanced Technologies & Treatments for Diabetes

Madrid, Spain, February 20, 2020 – Thermalin Inc., a privately held biotechnology company with its main laboratories in Cleveland, Ohio, USA, today shared initial details of the novel insulin analog, T‑1123 along with StampPump, the groundbreaking delivery device that the analog enables, with the diabetes scientific community at The 13th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD).  Thermalin was awarded a grant from ATTD to participate in The International Fair of New Technologies in Diabetes, where start-ups and emerging companies exhibited cutting-edge technologies and medical devices for diabetes treatment. In addition to one-on-one discussions with conference participants at the Thermalin booth in the exhibit hall, Thermalin’s Chief Scientific Officer Dod Michael, Ph.D. presented lectures to two different audiences.

Dr. Michael discussed T-1123, Thermalin’s first-in-class, stabilized insulin analog that has an ultra-rapid time-action profile in both U-100 and U-500 formulations. He shared that both the U-100 and U-500 formulations of T-1123 show remarkably enhanced resistance to thermally-induced physical loss of potency and that T-1123 demonstrates six-fold less potency to stimulate proliferation of human breast cancer cells compared to human insulin.  This unprecedented confluence of favorable features promises to enable the factory-filling of today’s insulin pump reservoirs with a U‑100 formulation of T-1123 as well as use of the U-500 formulation of T-1123 in Thermalin’s StampPump—a truly disruptive innovation in the medical care of those with diabetes.

Dr. Michael also discussed StampPump, a postage stamp-sized glucose management system that will deliver the concentrated, ultra-rapid-acting formulation of T-1123 for people with Type 1 (T1D) or Type 2 diabetes mellitus (T2D).  StampPump is a wearable, skin-adhering, miniaturized (36 x 33 x 6.5 mm, 8 g) closed-loop insulin delivery system that is easily placed using a disposable applicator, delivers insulin for a full week, and is discarded after use.  The device will have multiple sensors onboard to improve closed-loop glucose control and also will be connected via Bluetooth to both an external continuous glucose monitor (CGM) and a mobile device and through that device to the cloud.  StampPump will carry up to 600 units of the T‑1123 insulin analog in a 1.2 ml reservoir that is filled at the time of manufacture.  Due to the stability of T‑1123, the factory-filled StampPump will be stored at room temperature on the pharmacy shelf and in the patient’s home instead of in a refrigerator.

Thermalin intends to start IND-enabling work for T-1123 in 2020 and to test a functional, right-sized prototype of StampPump in 2021.

About Thermalin

Thermalin is developing next-generation insulin solutions for people with T1D and T2D.  Thermalin’s programs include (1) clinical candidate T-1123—a stabilized insulin analog that is ultra-rapid at both U-100 and U-500, (2) StampPump—a miniaturized glucose management system that will deliver the concentrated, ultra-rapid-acting formulation of T-1123, (3) basal and mix insulins that never need refrigeration, and (4) a glucose-responsive insulin that protects against hypoglycemia by losing potency when glucose levels are below normal. For more information, please visit www.thermalin.com.  For background on insulin therapy for diabetes, please visit www.thermalin.com/background.

Contact:

Thermalin
Richard Berenson
Tel:  617-695-0523
E-mail:  info@thermalin.com

Thermalin Announces:

Collaboration with Sanofi to Develop Next Generation Insulin Therapies

First Closing on $17.5M Series A Preferred Financing to Support its Cleveland-based R&D Team

Cleveland. – September 28, 2017 – Thermalin, Inc., a privately held company with its main laboratories in Cleveland, announced today a worldwide collaboration with Sanofi to discover and develop novel, engineered insulin analogues. The collaboration builds on Thermalin’s pioneering science, which alters the insulin molecule to achieve greater therapeutic performance.

Thermalin also announced the first closing of a tranched, Series A Preferred financing that will raise at least $17.5M to support the advancement of Thermalin’s programs. The round is being led by Sanofi, with participation by JSR・mblVC LifeScience Investment Limited Partnership (a Tokyo-based fund), Green Park & Golf Ventures (a Dallas-based fund), Thermalin’s existing investors, and other undisclosed investors.

“Thermalin is dedicated to making life easier for people living with diabetes,” said Richard Berenson, Chief Executive Officer of Thermalin. “Thermalin’s candidate therapies have the potential to lower the burden of insulin therapy and thereby improve adherence and outcomes.”

John Brooks, Chairman of the Thermalin Board of Directors and former CEO of the Joslin Diabetes Center in Boston, said “The Sanofi – Thermalin collaboration brings together significant insulin expertise and commitment to innovation in order to deliver disruptive insulins to address the growing diabetes pandemic.”

The collaboration with Sanofi, which represents one of the largest research and development commitments to next-generation engineered insulin analogues, encompasses two Thermalin programs.  The collaboration is an outgrowth of Sanofi’s successful Sunrise initiative (www.sanofi-sunrise.com), a strategic-partnership model that seeks to invest in early-stage opportunities that align with Sanofi’s research, development, and commercialization expertise. The funding and commitment of resources from Sanofi will accelerate and broaden Thermalin’s discovery capabilities and will support a shared commitment to bringing much needed therapies to diabetes patients.

Michael Weiss, M.D., Ph.D., scientific founder of Thermalin, Cowan-Blum Professor of Cancer Research and Professor of Biomedical Engineering, Biochemistry & Medicine (Endocrine) and Director of the Institute for Therapeutic Protein Engineering at Case Western Reserve University (“CWRU”), said, “This alliance will allow us to move our advances in insulin analogue design from the bench to the bedside.” Dr. Weiss, who began studying insulin more than 30 years ago as a student in the Harvard-MIT Program in Health Sciences & Technology (HST), foresees a renaissance in this field. “We are just beginning to learn how targeted modifications of the insulin molecule can fine-tune both its own properties and the downstream signaling functions of the insulin receptor.” The academic team at CWRU, which also includes Prof. Faramarz Ismail-Beigi (Medicine) and Associate Prof. Nelson Phillips (Biochemistry), will work closely with Thermalin and Sanofi.

“We believe that Thermalin’s expertise and capabilities will significantly augment our own deep experience in insulin and enable Sanofi to remain a leader in bringing innovative and beneficial insulin therapies to patients,” said Philip Larsen, Global Head of Diabetes Research and Translational Medicine at Sanofi.

The collaboration could generate for Thermalin up to $788 million in equity investments, milestone payments, and research-and-development services, of which $9 million has already been received as an upfront licensing fee and an initial equity investment. In addition, Sanofi will assume the clinical development costs of these insulin programs and pay royalties on commercial sales of products.

Thermalin will use the new funds to expand its R&D team in Cleveland and will be recruiting from around the Midwest and elsewhere.

About Thermalin

Thermalin is developing next-generation insulin solutions for people with Type 1 (T1D) and Type 2 diabetes (T2D).  Thermalin’s preclinical programs include ultra-rapid-acting insulin, insulins that never need refrigeration, glucose-responsive insulin, and a once-a-week insulin patch.

Thermalin’s new molecular designs are the creation of Dr. Michael Weiss at Case Western Reserve University School of Medicine (http://case.edu/medicine) and exclusively licensed to Thermalin. Thermalin and Dr. Weiss’s work has been supported by numerous academic and SBIR grants from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the US NIH, and is particularly indebted to Dr. Guillermo Arreaza-Rubin, whose inspirational leadership at NIDDK has been instrumental in advancing academic and industry progress on new therapies for Diabetes (www.niddk.nih.gov). Thermalin and Dr. Weiss have also benefited from generous support from the JDRF (www.jdrf.org). Dr. Weiss gratefully acknowledges additional generous support by the Leona M. and Harry B. Helmsley Charitable Trust (www.helmsleytrust.org).

For more information, please visit www.thermalin.com.  For background on insulin therapy for diabetes, please visit www.thermalin.com/background.

Contact:
Thermalin
Richard Berenson
Tel:  617-695-0523
E-mail:  info@thermalin.com