What Micregen does

Micregen is a privately held UK biotechnology company developing cell-free, stem cell-derived therapeutics through its proprietary Secretomix® platform. Founded in 2015 by Barry Sharples and Stephen Ray, the company is headquartered at Thames Valley Science Park in Reading with a commercial office at Alderley Park, Cheshire, and operates with a lean team of 11–50 staff. Its lead therapeutic candidate, MRG1061, is being advanced toward combined Phase I/II clinical trials in the UK for two neonatal orphan indications — necrotising enterocolitis (NEC) and bronchopulmonary dysplasia (BPD) — both of which lack effective pharmacological treatments and carry peak forecasted annual sales above $1 billion each.

The Secretomix® platform produces multi-factorial biologics — including miRNA, extracellular vesicles (exosomes), cytokines, anti-inflammatory factors, lipids, and growth factors — from a proprietary GMP-certified allogeneic stem cell bank. Products are cell-free, allogeneic, scalable, storable under standard (non-ultra-cold) conditions, and administerable off-the-shelf, addressing the principal limitations of conventional stem cell therapies (graft rejection, graft-versus-host disease, tumor formation, ultra-cold logistics). The platform has produced more than 2,000 characterized components in lead formulations, with a completed suite of in-process, potency, and release assays supporting clinical-grade manufacture. Beyond the lead neonatal program, Micregen is pursuing preclinical programs in neurodegeneration (Alzheimer's, MND/ALS) and hallmarks-of-ageing applications.

Micregen is pre-revenue and funded to date by approximately £5.4 million in cumulative capital, comprising a £5 million funding round completed in April 2021 and a £395,000 Innovate UK Smart Award granted in September 2018. The company is currently raising an investment round to fund Phase I/II clinical development. It holds an MHRA Innovation Passport, ILAP membership (December 2022), UKRI Scale-Up Programme selection (January 2023), and the UK Pharma Industry Awards Innovation of the Year (2023), and is supported by collaborations with Great Ormond Street Hospital, SickKids Toronto, Washington University, and the University of Bradford. Future revenue, once approved, is expected from sale of orphan-disease therapeutics distributed via hospital pharmacies and specialty channels; pricing for investigational products is not publicly disclosed.

Name

Micregen

Legal name

Micregen Ltd

Website

https://micregen.com

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

1–10 employees

Short description

Micregen is a privately held UK biotechnology company developing cell-free, stem cell-derived therapeutics via its proprietary Secretomix® platform, with lead candidate MRG1061 advancing toward clinical trials for neonatal orphan diseases NEC and BPD.

Ownership category

akta.pro rank

Product category

Regenerative Medicine Biologics

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)

akta.pro primary industry

Stem Cell–Based Regenerative Therapies (HLAAAGAA)

akta.pro secondary industries

Rare Pediatric & Congenital Disorder Therapies (HLAIAIAN), Rare Neurology & Neurodegenerative Disorder Therapies (HLAIAIAD), Neurology & CNS Specialty Pharmaceuticals (HLAIACAC)

Keywords

• Stem cell therapeutics
• Regenerative medicine
• Cell-free biologics
• Secretome therapeutics
• Neonatal orphan drugs

Headquarters

HQ city

Alderley Edge

HQ country

United Kingdom

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Therapeutic Product Revenue: Pre-revenue biotech company developing stem cell secretome therapeutics. Future revenue expected from sale of approved therapeutic products targeting orphan diseases (NEC, BPD) and broader degenerative/age-associated conditions. The company is currently in investment round to fund clinical trials.
2. Investment Capital: Privately held company funded by founders, angel investors, and life science professionals. Completed £5m funding round in 2021 and £395k Innovate UK Smart Award in 2018. Currently raising capital for clinical development.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels6 records

Core offering

Micregen develops proprietary cell-free, stem cell-derived secretome therapeutics using its Secretomix® platform, produced from a GMP-certified allogeneic stem cell bank. Its lead therapeutic candidate, MRG1061, is being advanced toward clinical trials for neonatal orphan diseases including necrotising enterocolitis (NEC) and bronchopulmonary dysplasia (BPD), with additional preclinical programs targeting neurodegeneration (Alzheimer's, MND/ALS) and age-associated degenerative conditions. The company is pre-revenue and currently raising capital to fund combined Phase I/II clinical trials.

Product overview

Micregen offers a unified platform technology called Secretomix®, which generates cell-free stem cell-derived therapeutic products. The platform produces multi-component biologics including miRNA, extracellular vesicles (exosomes), cytokines, anti-inflammatory factors, lipids, and proteins that act to enhance tissue repair and regeneration. The lead therapeutic candidate MRG1061, derived from this platform, is advancing toward clinical trials for neonatal conditions. The Secretomix® platform is designed to create various secretome formulations targeting conditions from rare pediatric diseases to age-associated degenerative conditions.

Differentiator

Problem solved

Functional benefit

Brands

• Secretomix®: Proprietary platform technology for producing cell-free, stem cell-derived secretome therapeutics for regenerative medicine applications.

Products and services

• Secretomix® Platform Proprietary cell-free, stem cell-derived secretome therapeutic platform. Secretomix® products are multi-component biologics (miRNA, extracellular vesicles/exosomes, cytokines, anti-inflammatory factors, lipids, and proteins including growth factors) produced from a GMP-certified allogeneic stem cell bank. The platform yields scalable, storable, off-the-shelf therapeutics that avoid graft rejection, graft-versus-host disease and tumour risk and can be administered immediately at the point of care.
• MRG1061 Micregen's lead Secretomix® therapeutic candidate, a tailored combination of regenerative and anti-inflammatory factors designed to reduce intestinal injury, promote healing and improve survival outcomes in preterm infants with necrotising enterocolitis (NEC) and bronchopulmonary dysplasia (BPD) — orphan neonatal diseases with no effective pharmacological treatments today and combined peak-sales potential above $2B.

Quantifiable outcome

• Measurable preservation of memory function in preclinical Alzheimer's models
• +4 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability4 records

Feature5 records

Partnerships

Eleven partnerships are on record, tiered core, secondary and minor.

• NEC-ACCELERATOR ConsortiumcoreStrategic or Co-development Partner · 17 July 2024Micregen featured as 'Industry Partner' in Nature's Pediatric Research paper for NEC-ACCELERATOR (NECrotizing Enterocolitis-ACceleration of CELl-based & Regenerative medicine Advancements for Translation in neOnates). The consortium aims to enhance clinical translation of stem cell-based potential treatments for NEC in neonates. This partnership validates Micregen's scientific approach and provides peer-reviewed publication support.
• The Hospital for Sick Children (SickKids), TorontocoreStrategic or Co-development PartnerSickKids is Canada's most research-intensive hospital and No.1 paediatric hospital in the world (2022 Newsweek). Micregen collaborates on various preclinical studies. Dr. Augusto Zani serves as Staff Surgeon and has made landmark discoveries in amniotic fluid stem cells. Preclinical studies conducted in USA, UK, and Canada.
• Great Ormond Street Hospital (GOSH) / UCL Institute of Child HealthcoreStrategic or Co-development PartnerGOSH ranked No. 3 paediatric hospital in the world (2022 Newsweek). Micregen has worked with GOSH specialists for over ten years on preclinical studies and clinical advice for trial preparation. MRC grant awarded to partnership for PhD programme on Secretomix® as therapeutic option in NEC, led by Dr. Loukogeorgakis and Dr. Sivaraj.
• University of BradfordsecondaryStrategic or Co-development PartnerCollaborating on validation of Secretomix® as a therapeutic for neurodegeneration. Studies designed to determine efficacy of Secretomix® in various disease models for Alzheimer's and Motor Neurone Disease.
• Washington University School of MedicinesecondaryStrategic or Co-development PartnerCollaborating with world-renowned neonatal surgeon and professor on research into Bronchopulmonary Dysplasia and other neonatal lung indications. Washington University is recognized as one of the top 10 medical schools in the United States.
• Boyds ConsultantscoreImplementation/ SI/ Consulting PartnerRegulatory advisors specializing in pharma, biotech, and spinouts supporting new medicine development. Boyds has advised Micregen since 2018 with extensive experience in novel advanced biologic therapies and trusted relationships with regulatory bodies, enabling support in scenarios with limited or no precedents.
• Addleshaw Goddard LLPcoreImplementation/ SI/ Consulting PartnerCorporate lawyers first established in 1775, globally recognized with clients including many UK FTSE100 listed companies. Their cross-disciplinary healthcare team has in-depth knowledge across virtually every area of healthcare.
• Cowgill HollowaysecondaryImplementation/ SI/ Consulting PartnerOne of the North West's leading independent firms of Chartered Accountants and Business Advisors providing financial and business advisory services.
• Handelsbanken plcminorOthersFounded in 1871, Handelsbanken is one of the world's strongest banks with home markets in Denmark, Finland, Netherlands, Norway, Sweden, and the UK, providing banking services to Micregen.
• Karolinska InstituteminorGTM or Marketing PartnerMicregen sponsored the 37th International Symposium on Pediatric Surgical Research 2024 held at Karolinska Institute in Stockholm, Sweden. Conference united clinicians and researchers engaged in pioneering research on pediatric diseases.
• Longevity Investors ConferenceminorGTM or Marketing PartnerMicregen Co-founder Barry Sharples was one of 10 exclusive global speakers at the invite-only 2024 Longevity Investors Conference in Gstaad, Switzerland. Event brought together leading figures in longevity including Eric Verdin (Buck Institute), Dr. Nir Barzilai, Aubrey de Grey, and Bryan Johnson.

Scale indicators10 records

Recent moves8 records

Expansion highlights5 records

Broad incumbents

• Athersys: Athersys develops MultiStem, an allogeneic stem cell therapy for inflammatory, neurological, and acute conditions. A broader incumbent in regenerative cell therapy with multi-indication ambitions similar to Micregen's pipeline breadth.
• Pluristem Therapeutics: Pluristem develops placenta-derived allogeneic cell therapies for inflammatory, ischemic, and hematological conditions. Comparable as a broader stem cell therapy incumbent targeting similar regenerative and anti-inflammatory mechanisms.
• Mesoblast: Mesoblast is a late-stage commercial regenerative medicine company with allogeneic cell therapies (e.g., remestemcel-L) for inflammatory and rare diseases. A broader incumbent in the cell-therapy regenerative medicine space overlapping Micregen's anti-inflammatory mechanism.

Direct peers

• Evox Therapeutics: Evox is a UK-based biotech engineering exosomes for delivery of nucleic acids and proteins to treat rare diseases. Directly comparable to Micregen in leveraging extracellular vesicles/secretomes as a therapeutic modality and in targeting rare and serious diseases.
• Cynata Therapeutics: Cynata develops iPSC-derived mesenchymal stem cell therapies with an off-the-shelf, scalable manufacturing model. Comparable in offering allogeneic, scalable stem cell-derived therapeutics, including in inflammatory and rare disease indications.
• ILIAS Biologics: ILIAS Biologics develops engineered exosomes (EXO-LOAD technology) for therapeutic delivery of proteins, including anti-inflammatory applications. A direct peer in the engineered exosome/secretome therapeutics space.
• Prolacta Bioscience: Prolacta develops human milk-based nutritional and biologic products specifically for premature infants, including for NEC. Closest direct competitor in the NICU/preterm orphan indication that Micregen's MRG1061 targets.
• Capricor Therapeutics: Capricor develops exosome-based and cell-derived therapeutics (e.g., CAP-1002, exosomes from cardiosphere-derived cells) for rare diseases and regenerative indications. Closest direct competitor to Micregen's cell-free stem cell-derived secretome platform targeting orphan and degenerative conditions.

Emerging players

• Turn Biotechnologies: Turn Bio is an early-stage company developing mRNA-based epigenetic reprogramming therapies to reverse cellular aging. An emerging player in the regenerative/longevity space that overlaps with Micregen's anti-aging and degenerative disease pipeline.
• ReAlta Life Sciences: ReAlta is a clinical-stage biotech developing anti-inflammatory peptides (RLS-0071) for NEC and other rare inflammatory diseases. Emerging player in the same NEC indication Micregen is targeting, validating the unmet need.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/micregen-ltd

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Micregen