CURING LOCALIZED IMMUNE CONDITIONS

Starting with Type 1 Diabetes

At Rezq Bio, we are transforming the treatment of autoimmune and inflammatory diseases, beginning with Type 1 Diabetes (T1D)

With clinically validated in-human safety, our therapies centered on dendritic cells are designed to treat T1D patients at every stage of the disease - with negligible side effects

The focus of our platform is regional inflammation. This localized approach avoids the harsh effects of systemic immune suppression while creating a versatile foundation for treating a spectrum of inflammatory conditions - without significant therapy modifications

T1D IS A global PROBLEM WITH NO SOLUTION

64k

New U.S. Diagnoses Annually

2M

Patients Currently in the U.S.

18M

Patients Worldwide by 2040

$85B

Economic Impact Globally

NO LONGEr A JUVENILE CONDITION

In a 2023 study from Johns Hopkins Bloomberg School of Public Health:

● Up to 62% of T1D cases develop in patients older than 20 years (median 24 years)

● 37% of patients were diagnosed after 30 years

LACK OF EFFECTIVE TREATMENTS

There are no FDA-approved therapies for TID proven to…

● Prevent disease onset

● Arrest its progression or

● Restore insulin production safely

T1D Treatment Approaches

  • Rezq's Approach

    Treats localized problems locally…

    · Regional targeting avoids systemic effects

    · Leverages the immune system to address the inflammatory environment completely

    · Technology supports multi-disease treatment platform without therapeutic modification

    · Strong preclinical evidence to support immunosuppressant applications and microsphere delivery adding scope and scale

  • Insulin Therapy

    The standard of care is not a solution

    · Less than 1/3 of patients with T1D in the U.S. are consistently achieving target blood-glucose levels

    · Daily, lifelong insulin supplementation does not prevent comorbidities such as heart disease, stroke, nephropathy, blindness, foot amputations…

  • Systemic Therapies

    Significant side effects can offset effectiveness

    · Suppressed immunity to infection

    · Malignancy

    · Organ damage

  • targeted therapies

    Offer precision with drawbacks

    · Narrow molecular or pathway focus does not address the problem completely

    · Disease specific often with limited applicability

    · Varying degrees of systemic immunosuppression

  • Transplants / Implants

    Cell transplant from cadavers and stem cell implant technologies show promise

    · Require systemic and lifelong immunosuppressive therapy

    · Autoimmune attack still continues

platform

Our approach focuses on dendritic cells as they are the regulator cells of the immune system. They can create an inflammatory or tolerant environment

We use our technological platform to convert dendritic cells from a mature (mDC) or inflammatory state, into an immature (iDC) or tolerant state

mDC

iDC

Our lead P1B/2A ready autologous dendritic cell therapy does this ex-vivo while our microsphere loaded version has performed this preclinically in situ with equally strong performance

Through regional targeting, we can turn off unwanted immune responses locally while not suppressing the entire immune system

Pipeline

Rezq’s pipeline is led by our cell therapy designed to treat early onset T1D. With promising in-human safety it provides a launching point for our multi-disease, dual-application and dual delivery method platform

Treatment Pipeline
Therapy Name
Indication
Discovery
Optimization
IND-Enabling
Phase 1A
Phase 1B/2A
RZQ-MC1
Early Onset Type 1 Diabetes
RZQ-MC1 is an autologous dendritic cell therapy, with negligle safety concerns found in a convincing Phase 1A trial. Rezq is planning to launch a Phase 1B/2A to treat early-onset T1D in the next year
RZQ-MC2
Colitis
RZQ-MC2 uses Rezq's autologous dendritic cell therapy to treat patients with Colitis and IBD related diseases. The preclinical work helped validate Rezq's regional treatment approach
RZQ-CC1
Various Indications
RZQ-CC1 leverages Rezq's immunosuppresion technologies to support other transplant and implant treatments to reduce or eliminate needs for systemic immunosuppression. Planned partnered preclinical studies will validate previous research findings
RZQ-MM*
Type 1 Diabetes
Rezq is advancing mulitple different microsphere payloads through preclinical testing to provide a small molecule based version of its localized approach enabling broader usage scenarios

people

We have built careers in healthcare and are passionate about curing T1D and autoimmune disease

    • Over 13 years investing, operating and business development in corporate healthcare venture plus 6 years of Defense software project management and development experience

    • Portfolio company executive roles include operations, finance and product in antibody discovery, vaccine development, natural language processing driven coding, GPO/supply chain, hospital workflow tools and others

    • Spearheaded multiple newco and joint venture efforts including business planning, financial modeling, deal structuring, setup and operations in entities ranging from $5M - $200M in funding

    • MBA - Carnegie Mellon University, MS Computer Science

    • EVP, CSO and Head of R&D - Ikaria Pharmaceuticals ($2.3B exit)

    • SVP, CMO, Head of Corporate Regulatory Development and Senior Scientific Advisor - Sanofi

    • EVP Clinical Sciences and Product Development, Chairman External Board of Scientific Advisors - Merck

    • Chairman, Endocrinologic and Metabolic Drug Advisory Committee - FDA

    • Director, Diabetes Research Laboratory and Head General Clinical Research Center - University of Pittsburgh

    • Director, Michigan Diabetes Research and Training Center

    • Chief, Division of Endocrinology and Metabolism - University of Michigan SOM

    • MD - Johns Hopkins University

    • CMO - Viacyte (T1D islet cell implant device company - $330M exit to Vertex)

    • CMO - Cebix, Ritter and Metabasis

    • Diabetes Site Head - Pfizer

    • Director, Diabetes and Lipid Centers - University of Texas Medical Branch

    • MD, PhD - Baylor College of Medicine

    • Lead Researcher, Institute of Cellular Therapeutics - Allegheny General Hospital

    • Adjunct Associate Professor - University of Pittsburgh SOM and Dept. of Biological Sciences at Carnegie Mellon University

    • Expert in tolerogenic dendritic cell therapy for Type 1 Diabetes

    • Research areas include biologic, gene and cell therapy for Type 1 and 2 Diabetes as well as research into regulatory immune cells in autoimmunity and transplantation biology

    • PhD - McGill University

    • Development, characterization, scale-up, and tech transfer to GMP manufacture of advanced biologics including islets

    • Product development through Phase I-III clinical trials

    • VP Manufacturing Lead, Process Development & cGMP Cell & Product Manufacturing - DRIF, Organa Bio

    • PhD - Walden University

    • 30+ years pharmaceutical, diagnostic and clinical laboratory experience in metabolic, oncological and infectious disease

    • VP, Scientific Strategy Technology and Research - Helomics

    • VP, Research and Assay Development - Ancera, Inc.

    • VP, Immunology and Assay Development - Institute for Bioanalytics

    • Senior Research Scientist at Bayer Diagnostics

    • Supervisor of the BL-2 and BL-3 labs in the U.S. Army

    • PhD Microbiology/Immunology - Boston University SOM

    • CFO and COO roles in early-stage companies spanning biotech, energy and SaaS sectors

    • Investment banking - Renaissance Partners

    • Corporate Attorney - Keevican & Hirsch LLC

    • JD, MBA - Penn State and Carnegie Mellon

    • Experienced project manager for clinical trials and IND preparations and submissions work

    • Project management, medical affairs and planning - Labcorp/Covance, InClinica

Board and Advisory

We are fortunate to have an accomplished Board and Advisory that believe in our team, science and mission to treat autoimmune disease

    • CEO Institutes of Pharmaceutical Discovery (IPD)

    • CEO Institute of Diabetes Discovery

    • COB AdipoPharma

    • Founder Velocity Fund

    • Principal Consultant Mars

    • Chair Research Wyeth-Ayerst

    • Industry leading oncologist and successful investor and entrepreneur

    • Chairman - UPMC Hillman Cancer Center

    • Chief, Division of Hematology/Oncology - UPMC Shadyside

    • Clinical Professor of Medicine - University of Pittsburgh School of Medicine

    • Board of Directors - American Cancer Society

    • President - The Leukemia & Lymphoma Society

    • Head of the Institute of Cellular Therapeutics at Allegheny General Hospital

    • Hillman Professor of Pediatric Immunology, and Professor of Pediatrics - University of Pittsburgh

    • Adjunct Professor at the University of Pittsburgh and Carnegie Mellon University

    • Clinical physician for over 20 trials including Rezq’s Phase 1A

    • Pediatrician, Genetics Professor and Dir. MSPH at University of Pittsburgh

    • Lab Director - Ariel Therapeutics, New Hope Molecular, SignatureDx

    • Led development of first-in-class diabetes medicines, including SYMLIN, and BYETTA, BYDUREON and Myalept injections

    • Senior VP & Chief Medical Officer - Amylin

    • Medical Director - Diabetes Center at University of California Medical Center

    • Program Director - Clinical Research at Center University of California Medical Center

    • CA Chapter President - American Diabetes Association (ADA) Research Foundation

    • Director - Diabetes Clinic Parkland Hospital

    • Clifton and Betsy Robinson Chair in Biomedical Research - UT Southwestern

    • Principal Investigator in four NIH-funded multicenter diabetes trials

    • 20yr President and CEO of Diabetes Research Institute Foundation (DRIF)