Thermalin Inc. Company Profile

Background

Thermalin Inc., founded in 2007, is a biotechnology company dedicated to developing next-generation insulin analogs to improve the management of diabetes. The company's mission is to create innovative insulin therapies that enhance patient adherence, reduce the burden of insulin therapy, and ultimately lower the overall cost of diabetes care. Thermalin's vision encompasses addressing unmet needs in insulin therapy through advanced molecular designs and delivery systems.

Key Strategic Focus

Thermalin's strategic focus centers on engineering novel insulin analogs with enhanced properties, including ultra-rapid action, high concentration, and improved stability. The company specializes in:

• Ultra-Rapid-Acting Insulin: Developing insulin formulations that provide faster onset and offset of action to better mimic natural insulin response.

• Ultra-Concentrated Insulin: Creating high-concentration insulin solutions to enable smaller, more convenient delivery devices.

• Heat-Stable Insulin: Formulating insulins that do not require refrigeration, facilitating easier storage and transport.

• Glucose-Responsive Insulin: Innovating insulin that adjusts its activity based on blood glucose levels, reducing the risk of hypoglycemia.

• Once-a-Week Insulin Patch: Designing a weekly insulin delivery system to improve patient compliance.

Thermalin targets both Type 1 and Type 2 diabetes markets, aiming to provide solutions that cater to diverse patient needs and improve overall treatment outcomes.

Financials and Funding

Thermalin has secured significant funding to support its research and development initiatives:

• Series A Financing: In September 2017, Thermalin announced a $17.5 million Series A Preferred financing round led by Sanofi, with participation from JSR･mblVC LifeScience Investment Limited Partnership, Green Park & Golf Ventures, and existing investors. This funding aimed to advance Thermalin's insulin analog discovery programs.

• Additional Series A Closing: In June 2018, the company secured an additional $8 million, bringing the total Series A financing to $21 million. This round was led by Delos Capital, with participation from Robin Hood Ventures. The funds were intended to support the expansion of Thermalin's R&D team in Cleveland.

• Series B Financing: In July 2014, Thermalin raised $5.9 million in the first tranche of a Series B round, bringing the total equity raised to approximately $15 million at that time. The funding supported IND-enabling studies for Thermalin's highly concentrated, rapid-acting insulin, Flurolog.

Pipeline Development

Thermalin's pipeline includes several promising candidates:

• T-1123: A stabilized insulin analog with an ultra-rapid time-action profile in both U-100 and U-500 formulations. T-1123 has demonstrated improved resistance to physical and chemical degradation compared to marketed insulin products. Preclinical studies have shown ultra-rapid absorption kinetics and glucose-lowering potency comparable to human insulin. The company has received a $2.99 million Phase II SBIR grant to advance T-1123 through preclinical toxicology testing and manufacturing scale-up.

• StampPump™: A postage-stamp-sized, fully self-contained, closed-loop insulin patch pump system designed to carry enough ultra-rapid U-500 insulin to manage blood glucose for a full week. The device aims to disrupt the insulin therapy market by offering a low-cost system that enhances adherence and outcomes. Thermalin received a $276,277 Phase I SBIR grant to develop proof-of-principle for StampPump's fluidics and control systems.

Technological Platform and Innovation

Thermalin's innovation is rooted in proprietary technologies and scientific methodologies:

• Proprietary Insulin Analogs: Engineered insulin molecules with enhanced stability, rapid action, and high concentration capabilities.

• Protein Engineering: Utilizing advanced protein design techniques to modify insulin's molecular structure for improved therapeutic performance.

• Delivery Systems: Developing novel delivery devices like StampPump™ to provide convenient and effective insulin administration.

Leadership Team

• Richard Berenson: Chief Executive Officer. A serial entrepreneur with experience in launching and financing life science organizations. Former McKinsey consultant with a JD-MBA from Harvard Business and Law Schools.

• Michael Weiss, MD, PhD: Founder & Chief Innovation Officer. Expert in insulin analog design, currently Chair of Biochemistry & Molecular Biology at Indiana University School of Medicine. Holds an MD and PhD in biophysics from Harvard.

• Mervyn (Dod) Michael, PhD: Chief Scientific Officer. Former Senior Director responsible for insulin biology research at Eli Lilly and Company. Post-doctoral fellow at the Joslin Diabetes Center/Harvard Medical School.

• John Brooks: Chairman. CEO of Healthcare Capital, LLC; former CEO of Joslin Diabetes Center; founder of Prism Ventures.

• Bruce Frank, PhD: Vice President of Insulin Development. Co-inventor of Humalog with a 34-year career at Eli Lilly in insulin discovery, development, manufacturing, and regulatory affairs. PhD in Physical Biochemistry from Northwestern University.

• Thomas Hattier, PhD: Vice President of R&D. Experienced researcher in biotech and biopharma sectors, including roles at Myriad Genetics and AmpliCon. PhD in pathology from Case Western Reserve University.

Leadership Changes

In May 2018, Mervyn (Dod) Michael, PhD, joined Thermalin as Chief Scientific Officer, bringing extensive experience from his tenure at Eli Lilly and Company.

Competitor Profile

Market Insights and Dynamics

The global insulin market is substantial and growing, driven by the increasing prevalence of diabetes. Thermalin's focus on innovative insulin analogs positions it within a competitive landscape seeking to address unmet needs in insulin therapy.

Competitor Analysis

Key competitors include:

• Seraxis: Focuses on developing cell-based therapies for diabetes.

• Immunovative Therapies: Develops immunotherapy treatments, including those targeting diabetes-related complications.

• Apeptico: Specializes in peptide-based therapies for various diseases, including metabolic disorders.

• AdvanCell: Engages in the development of advanced cell therapies for metabolic diseases.

• Amolyt Pharma: Develops therapeutic peptides for endocrine and metabolic diseases.

Strategic Collaborations and Partnerships

• Sanofi Collaboration: In September 2017, Thermalin entered into a worldwide collaboration with Sanofi to discover and develop novel, engineered insulin analogs. The partnership could generate up to $788 million for Thermalin in equity investments, milestone payments, and research-and-development services. Sanofi assumed clinical development costs and agreed to pay royalties on commercial sales.

Operational Insights

Thermalin's strategic considerations include:

• Market Position: Leveraging proprietary insulin analogs to differentiate from competitors.

• Competitive Advantages: Focus on ultra-rapid, ultra-concentrated, and heat-stable insulin formulations.

• Collaborative Strengths: Partnerships with major pharmaceutical companies like Sanofi to enhance development capabilities.

Strategic Opportunities and Future Directions

Thermalin's roadmap includes:

• Advancing Pipeline Candidates: Progressing T-1123 and StampPump™ through clinical development.

• Expanding Partnerships: Seeking additional collaborations to accelerate product development and commercialization.

• Market Expansion: Targeting global markets, including underserved regions, with innovative insulin solutions.

Contact Information

• Website: www.thermalin.com

• Headquarters: Cleveland, Ohio, USA

Note: As of May 2023, Thermalin Inc. is reported to be out of business.