ERAD Therapeutics Inc.
- Location : Ontario, Canada and Delaware, USA
- Sector : Biotechnology
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Meet
ERAD Therapeutics Inc. (ETI) is an early-stage biotechnology company advancing proprietary therapeutic technologies for high-need, rare genetic diseases with limited or no current treatment options.
The company has been under new management and board leadership since 2023. ETI’s lead innovation, mCT, is a novel platform capable of addressing a wide range of rare genetic disorders associated with misfolded proteins and endoplasmic reticulum-associated degradation (ERAD).
The technology can be used alone or in combination with existing therapies to preserve protein function and improve disease outcomes. ETI also has access to proprietary gene therapy vectors targeting rare diseases and is exploring partnerships for broader applications in larger market indications.
Problem They’re Solving
ERAD’s proprietary mCT technology temporarily halts the intracellular degradation of misfolded, partially functional proteins, thereby restoring normal—or near-normal—cellular activity.
This therapeutic effect has been demonstrated in both cellular and animal models of Cystic Fibrosis, Gaucher Disease Type 1, Tay-Sachs Disease, and SP1 Lysase Deficiency. The company believes that mCT is a “gene-agnostic” platform with broad potential to treat a wide range of rare genetic disorders in which misfolded proteins retain partial function. It may also serve as a critical therapeutic bridge for ultra-rare diseases lacking viable treatment options, offering hope until more permanent solutions such as gene therapy become available.
Where They Are Headed
ERAD is advancing its proprietary mCT platform through preclinical development, including toxicology studies slated for 2025, with plans to enter human clinical trials in 2026. Initial clinical efforts will focus on one to three ultra-rare genetic diseases where misfolded proteins retain partial function.
In parallel, the company has in-licensed a complementary gene therapy platform—complete with a robust toxicology dataset—and intends to commence animal model studies in 2025. The goal is to reach clinical development readiness for this gene therapy program by 2026.
Opportunity Highlights
- Transformative Technology: ERAD’s proprietary mCT and mCT-Gene Therapy platforms are gene-agnostic, targeting hundreds of rare diseases with one therapeutic—unlocking a potential market exceeding $2B+.
- Strong IP Position: Backed by issued U.S. and international patents for mCT and gene therapy assets, with plans to expand patent coverage and protect long-term value.
- Orphan Drug Designation: mCT holds Orphan Drug status for Gaucher Disease, offering market exclusivity; the company plans to expand this protection to additional indications.
- Experienced Leadership: The new CEO and Board bring deep expertise in drug development, commercialization, and IP strategy—supported by a skilled advisory team across biotech, finance, and medical sectors.
- Innovative Mindset: A forward-thinking team with a track record in biologics and orphan drugs, focused on scalable product development and strategic positioning in niche therapeutic markets.
Management Team
Craig Sibley – President & CEO
Craig brings over 25 years of experience in early-stage drug development, with a focus on cancer and rare genetic diseases. With a background in biochemistry and life sciences, he has held research and commercial roles at Schering-Plough (Merck), Amgen, and Ares-Serono (Merck), contributing to the success of biologics like Intron-A®, Neupogen®, and Rebif®.
David Downey – Director & Treasurer
David has more than 30 years of pharmaceutical sales and marketing experience across the U.S., Canada, and international markets. His expertise spans discovery through commercial launch, with a track record of developing and executing strategic plans across diverse therapeutic areas.
Jeff Margolis – Consultant CFO
Jeff is a veteran executive with 33 years in finance and operations for private and public life science companies. His experience includes investment banking, strategic transactions, M&A, licensing, and financial planning—backed by deep knowledge of corporate governance, IP, and regulatory frameworks.
Dr. Lisa Michaels – Clinical Consultant
Dr. Michaels is a physician executive with extensive leadership experience in advancing innovative treatments from discovery to market. She has guided programs from pre-IND through successful commercialization, with expertise in gene therapies, recombinant proteins, CRISPR editing, and pediatric rare diseases.
Key Metrics
- U.S.-based Operations: ERAD Therapeutics Inc. was established in the U.S. to drive the development of its proprietary mCT technology.
- Experienced Leadership & Capital Reinvestment: A new management team and experienced consultants have re-energized the company with fresh capital and strategic direction.
- R&D Program Launched: ERAD has initiated a revitalized research and development program centered around mCT and complementary technologies.
- Gene Therapy Expansion Underway: The company is building a gene therapy franchise targeting rare genetic diseases and second-generation indications.
- Strengthening IP Position: Ongoing initiatives to expand and enhance the company’s intellectual property through patent strategies and technology acquisitions.
Milestones
- 2014-2020: Proof of Concept (PoC) for mCT in Cystic Fibrosis and Gaucher Disease (cellular and animal models)
- Animal PoC expected Q3 2025: PoC in cellular models for Tay-Sachs and SP-1 Lyase Deficiency; animal PoC for Tay-Sachs pending
- Q2 2025: Additional patent filings and expansion of IP protection for mCT
- Q2 2025: In-licensing of 2–3 proprietary gene therapy vectors for rare diseases
- Q1–Q3 2025: Toxicology studies for gene therapy programs
- Q2–Q3 2025: Animal model studies across multiple disease targets
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