Immune Regulation Announces Rebranding to Revolo Biotherapeutics, Reflecting a Revolutionary Approach to Resetting the Immune System to Treat Autoimmune and Allergic Diseases

— Plans to initiate four Phase 2 trials in second half of 2021

— Exploring additional autoimmune and allergic disease indications for portfolio candidates

NEW ORLEANS, LA and LONDON UK, March 5, 2021 – Immune Regulation, today announced it is rebranding as Revolo Biotherapeutics (“Revolo Bio”). The new brand, which will be implemented immediately, comes ahead of the advancement of the Company’s drug candidates into five clinical programs, including four Phase 2 trials.

The new brand better reflects the Company’s revolutionary approach to developing therapies that reset the immune system with the goal of achieving superior long-term disease remission for patients with autoimmune and allergic diseases. Revolo Bio’s drug candidates, ‘1805 and ‘1104, have already demonstrated efficacy and safety in both preclinical and human studies while preventing the unwanted effects of chronic immune suppression. Revolo Bio will advance ‘1805 through two Phase 2 trials for patients with moderate-to-severe rheumatoid arthritis and for patients with non-infectious uveitis. Additionally, Revolo Bio is advancing a Phase 2 trial of ‘1104 for patients with eosinophilic esophagitis (EoE) and a Phase 2 allergen sensitivity study. In addition, Revolo Bio recently initiated an additional Phase 1 study of ‘1104 designed to evaluate the safety of ascending doses in healthy volunteers to support future phase 2 clinical trials.

“Revolo Biotherapeutics reflects our focused mission to reset the immune system to achieve long-term disease remission of autoimmune and allergic disease,” said Jonathan Rigby, Group Chief Executive Officer of Revolo Biotherapeutics. “We are advancing four phase 2 clinical programs with multiple near-term readouts occurring, and we believe that the unique, disease-agnostic mechanisms of action of our drug candidates creates vast optionality across multiple indications. Our team of successful industry professionals and immunology and allergic disease experts is rapidly growing to include more dedicated revolutionizers ready to support our upcoming milestones.”

About Revolo Biotherapeutics

Revolo Biotherapeutics is developing therapies that reset the immune system to achieve superior long-term remission for patients with autoimmune and allergic disease, without the immune system suppression seen with current therapies. Its two drug candidates, ‘1805 and ‘1104, a protein and a peptide respectively, reset the immune system by preventing the chronic pro-inflammatory immune response that results in autoimmune or allergic disease. ‘1805 is a modified analogue of a key protein in immune function and is entering clinical development for moderate-to-severe rheumatoid arthritis and non-infectious uveitis. ‘1104 is a peptide derived from a natural immune-regulatory protein and is entering clinical development for patients with eosinophilic esophagitis (EoE) and allergic disease. The disease-agnostic mechanism of action of Revolo Biotherapeutic’s assets provides a potential platform for the development of treatments for multiple autoimmune and allergic diseases. For further information, please visit revolobio.com.

Company Contact

Marylyn Rigby, VP Investor Relations & Marketing

Media Contact

Monica Rouco Molina, Ph.D.
LifeSci Communications
+1-929-469-3850
mroucomolina@lifescicomms.com

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Michael Albisser

Non-Executive Director​

Michael is a partner of Metellus, a Zurich and London-based venture capital firm investing in technology and life sciences with ground-breaking potential. Having more than 25 years of experience in the finance area he is responsible for finance, tax, and deal structures. He serves on the board of various venture-backed companies.

Dr. Isaac Cheng, m.d.

Non-Executive Director

Dr. Isaac Cheng is currently an investment professional at Morningside, a venture capital and private equity institution based in China. Dr. Cheng focuses primarily on biopharmaceutical and healthcare investments. He has served on numerous public and private company boards.

Peter Greenleaf

Chairman

Peter Greenleaf currently serves as the chief executive officer (CEO) and member of the Board of Directors of Aurinia, (NASDAQ: AUPH / TSX: AUP), an autoimmune therapeutics company. He has held several other CEO and chairman roles. He is also currently a member of the Board of Directors of Antares Pharmaceuticals, Inc. (NASDAQ: ATRS) and Chairman of the Board of Directors of Biodelivery Sciences International, Inc. (NASDAQ: BDSI).

Marylyn Rigby

VP of Marketing and Investor Relations

Marylyn Rigby is an experienced pharmaceutical, biotech, and drug delivery professional. In addition to her expertise in marketing, public and investor relations, she has a successful track record with business development, licensing, public and private equity financing, strategy and other key corporate functions.

Nancy Vinh

VP of Clinical Operations

Nancy Vinh brings over 20 years of experience in managing early and late phase, international clinical trials for drugs, biologics, cell therapy and combination products across a wide range of therapeutic areas to the team. She has served as head of clinical operations and led registrational and label expansion trials execution.

Dr. Clare Burgess

Chief Development Officer

Dr. Clare Burgess has 24 years of experience in clinical drug development as a pharmacologist and has worked across a wide range of therapeutic areas within the pharmaceutical industry. She has held multiple leadership roles and has led multidisciplinary teams across the world.

Jeff Myers, m.d., ph.d

Chief Medical Officer

Jeff Myers, M.D., Ph.D., has 20 years of experience in medical affairs, regulatory and clinical development within the biopharmaceutical industry, with focuses on cardiovascular, pulmonary, oncology, and inflammatory diseases.

Before entering the industry, he practiced as a congenital cardiac surgeon and served as the chief of pediatric cardiac surgery at Massachusetts General Hospital and as Associate Professor of Surgery at Harvard Medical School.

Dr. Roly Foulkes

Chief Scientific Officer

A true drug discoverer, Dr. Roly Foulkes has 25 years of experience building and delivering innovative therapeutic portfolios within the immunology and inflammatory disease space. He has a strong record advising small and medium sized immunology biopharma companies in developing competitive therapeutic strategies and bringing new innovative molecules to the clinic.

Jones w (woody) Bryan, ph.d.

Chief Business Officer

Jones (Woody) Bryan, Ph.D., brings almost 30 years of experience in the healthcare industry to the team, having led successful business development operations in both private and public pharma and biotech companies.

Perry Calias, ph.d.

Chief Operating Officer

Perry Calias, Ph.D., brings over 25 years of experience in pre-clinical and clinical development, CMC and global regulatory submissions across the drug and device sectors of healthcare. He has held numerous executive positions leading clinical and non-clinical operations, with a strong focus on diseases of the central nervous system and rare diseases.

Jonathan Rigby, mba

Group Chief Executive Officer

As employee #1 of Revolo Biotherapeutics in the US, Jonathan Rigby has led the company through substantial and rapid growth. He brings three decades of experience creating value and opportunities for companies in the pharmaceutical, biotech and drug delivery technology industry.