Cambium Bio (formally Regeneus)

What Cambium Bio (formally Regeneus) does

Cambium Bio (formerly Regeneus) is a Sydney-based, ASX-listed clinical-stage regenerative medicine company (ASX: CMB) developing a portfolio of cell-based and biologic therapies focused on ophthalmology and tissue regeneration. The company was formed in April 2024 through the merger of Regeneus with Cambium Medical Technologies LLC, which effected a backdoor ASX listing. Its operations are organised around two proprietary technology pillars: the Aurarix® fibrinogen-depleted human platelet lysate (FD-HPL) platform — exclusively licensed from Emory University in 2013 and protected by core patent US 9,688,959 B2 — and a Mesenchymal Signalling Cell (MSC) / Secretome platform underpinning Progenza™ and Sygenus.

The pipeline comprises three differentiated candidates. The lead asset, Elate Ocular®, is a topical biologic eye drop for dry eye disease advancing into CAMOMILE-2 and CAMOMILE-3 Phase 3 studies, and has secured FDA Fast Track Designation (Dec 2024), FDA-approved Phase 3 protocol (Feb 2025), and FDA-confirmed single pivotal trial pathway (Apr 2026). Progenza™ is an intra-articular MSC/Secretome therapy for knee osteoarthritis that demonstrated up to 12 months of pain reduction and cartilage volume stabilisation in a Phase 1 study, targeting an estimated $9.5B US/EU/Japan opportunity. Sygenus is a preclinical Secretome-based candidate for wound healing and inflammatory skin conditions.

Cambium Bio is pre-revenue and does not currently sell commercial products; its operating inflows consist of R&D Tax Incentive refunds (43.5% cash rebate through FY2027) and minor royalties from a sub-license of Aurarix® to AventaCell (Taiwan) for stem cell growth supplements. The company has raised approximately A$11.6M across four placements since April 2024, including a A$2.4M investment from strategic shareholder Zheng Yang Biomedical Technology (ZYBT) at a 20% premium in January 2026. Future monetisation is expected through licensing partnerships for Elate Ocular® in Europe and the Middle East, with the US pathway being partnership- and enterprise-led following FDA approval.

Name

Cambium Bio (formally Regeneus)

Legal name

Cambium Bio Limited

Website

https://www.cambium.bio

Company type

Public

Founded year

2007

Operating status

Operating

Headcount range

11–50 employees

Short description

Cambium Bio (formerly Regeneus) is a Sydney-based, ASX-listed clinical-stage regenerative medicine company developing biologic therapies for dry eye disease, knee osteoarthritis, and wound healing, built on the proprietary Aurarix® platelet lysate and MSC/Secretome platforms licensed from Emory University.

Ownership category

akta.pro rank

Product category

Regenerative Medicine

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) (541715), Ophthalmic Goods Manufacturing (339115)

SIC

Pharmaceutical Preparations (2834), Surgical & Medical Instruments & Apparatus (3841)

akta.pro industry

PRIMARYHLAIACAK

Ophthalmology Specialty Pharmaceuticals

Healthcare & Life Sciences/Pharmaceuticals/Specialty Pharmaceuticals

SECONDARYHLAIAAAL

Ophthalmology Pharmaceuticals

Healthcare & Life Sciences/Pharmaceuticals/Branded (Innovator) Pharmaceuticals

SECONDARYHLAAAGAD

Organoids & Organ-on-Chip (regenerative models)

Healthcare & Life Sciences/Biotechnology & Biologics/Regenerative Medicine & Tissue Engineering

Keywords

• Regenerative medicine therapeutics
• Cell-based biologic therapies
• Platelet lysate platform
• Ophthalmology drug development
• Stem cell therapeutics

Headquarters

HQ city

Pymble

HQ country

Australia

HQ region

Oceania

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Pre-revenue / Clinical-stage: Company is clinical-stage with no commercial product sales; no recurring or transactional revenue streams from product commercialization at present. Funding to date consists of R&D tax incentive refunds and strategic equity placements from major shareholders such as Zheng Yang Biomedical Technology (ZYBT).
2. Future Out-licensing of Elate Ocular® (Europe and Middle East): Management is engaged in licensing discussions for Europe and the Middle East to support future international commercialization of Elate Ocular®; would generate upfront, milestone, and royalty-based income upon execution.
3. Aurarix® Sub-licensing to AventaCell (Stem Cell Growth Supplements): Aurarix® FD-HPL technology has been sub-licensed to AventaCell, an affiliate of strategic partner Zheng Yang Biomedical Technology (ZYBT) in Taiwan, for the manufacture and commercialization of stem cell growth supplements — a non-therapeutic cell culture application.

Pricing tiers

Go-to-market motion3 records

Distribution channels2 records

Marketing channels5 records

Core offering

Cambium Bio is a clinical-stage regenerative medicine company developing biologic therapeutics based on two proprietary technology platforms: the Aurarix® fibrinogen-depleted human platelet lysate (FD-HPL) platform and a Mesenchymal Signalling Cell (MSC) / Secretome platform. Its lead candidate Elate Ocular® is an investigational topical eye drop in Phase 3 trials for dry eye disease, with additional pipeline assets Progenza™ (MSC therapy for knee osteoarthritis, Phase 1) and Sygenus (Secretome-based wound healing, preclinical). The company plans to commercialize via out-licensing partnerships in Europe and the Middle East.

Product overview

Cambium Bio operates a platform-plus-modules architecture built on two proprietary regenerative-medicine technology pillars — the Aurarix® fibrinogen-depleted human platelet lysate (FD-HPL) platform and a Mesenchymal Signalling Cell (MSC) / Secretome platform — feeding a diversified pipeline of clinical and preclinical product candidates. The Aurarix® platform powers the lead asset Elate Ocular® (a late clinical-stage topical eye drop for dry eye disease, advancing toward Phase 3 trials CAMOMILE-2 and CAMOMILE-3), while the MSC/Secretome platform underpins Progenza™ (knee osteoarthritis, Phase 1) and Sygenus (wound healing, preclinical). Therapeutic focus spans ophthalmology, orthopaedics, and wound healing, supported by an FDA Fast Track Designation for Elate Ocular® and ongoing manufacturing and licensing expansion toward Europe and the Middle East.

Differentiator

Problem solved

Functional benefit

Brands

• Elate Ocular®: Late clinical-stage biologic eye drop derived from enriched fibrinogen-depleted human platelet lysate (Aurarix® FD-HPL); lead product candidate being developed for dry eye disease (Phase 3 / registration-enabling).
• Aurarix®
• Progenza™
• Sygenus

Products and services

• Elate Ocular® Elate Ocular® is a late clinical-stage, investigational topical eye drop for dry eye disease, derived from Cambium Bio's proprietary Aurarix® fibrinogen-depleted human platelet lysate (FD-HPL). It is positioned as an improved allogeneic alternative to Autologous Serum Tears with standardised composition, enriched regenerative factors (EGF, PDGF, FGF), and pH/osmolarity that mimic natural tears. It targets ophthalmologists and dry eye disease patients post-approval.
• Progenza™ Progenza™ is Cambium Bio's mesenchymal signalling cell (MSC) and Secretome-based therapy in development for knee osteoarthritis. A completed Phase 1 study demonstrated significant treatment-related pain reductions for up to 12 months and cartilage volume stabilisation in the target dose group, targeting an osteoarthritis market estimated at $9.5B in the US, EU and Japan.
• Sygenus Sygenus is Cambium Bio's preclinical Secretome-based therapeutic candidate aimed at wound healing and inflammatory skin conditions (burns, acne, wounds, chronic/acute injuries). It is designed to control inflammation, stimulate cell migration and proliferation, and improve scarring via MSC-derived bioactive molecules.
• Aurarix® (FD-HPL Platform) Aurarix® is Cambium Bio's proprietary, enriched, fibrinogen-depleted, allogeneic human platelet lysate (FD-HPL) platform technology, ethically sourced from healthy donors and exclusively licensed from Emory University, GA, USA in 2013. The technology underpins Elate Ocular® and is sub-licensed to AventaCell (ZYBT affiliate) for stem cell growth supplements in Taiwan, generating royalty income.

Quantifiable outcome

• Significant treatment-related pain reductions for up to 12 months and cartilage volume stabilization in target dose group in Phase 1 study of Progenza™ in knee OA patients (KL Grade 1-3)
• +2 more outcomes

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Seven partnerships are on record, tiered flagship, core and minor.

• Cambium Medical Technologies LLCflagshipStrategic or Co-development Partner · 1 April 2024Counterparty in the backdoor ASX listing merger with Regeneus (announced Feb 6, 2024 and completed April 2024). The combined entity was renamed Cambium Bio Limited and trades on the ASX under ticker CMB.
• Emory University (GA, USA)flagshipOEM/ Whitelabel/ Licensing Partner · 1 January 2013Cambium Bio exclusively licensed the Aurarix® fibrinogen-depleted human platelet lysate (FD-HPL) platform technology from Emory University in 2013. The licensed technology is protected by core patent US 9,688,959 B2 in key geographies worldwide and underpins Cambium Bio's lead pipeline assets including Elate Ocular®, Progenza™, and Sygenus.
• AventaCell (affiliate of ZYBT, Taiwan)coreOEM/ Whitelabel/ Licensing PartnerSub-licensee of Cambium Bio's Aurarix® FD-HPL platform technology for the manufacture and commercialisation of stem cell growth supplements in Taiwan. AventaCell is an affiliate of strategic partner Zheng Yang Biomedical Technology (ZYBT).
• Orient Euro Pharmaceutical Co., Ltd.coreStrategic or Co-development PartnerCambium Bio board includes ChiTai Chang, PhD as Non-Executive Director (Orient Euro Pharma), indicating an institutional strategic relationship with the Taiwanese pharmaceutical company.
• Hocheng CorporationminorStrategic or Co-development PartnerCambium Bio board includes Li-Chien Chiu as Non-Executive Director (Hocheng Corporation), indicating an institutional relationship with the Taiwanese company.
• MUFG Corporate MarketsminorOthersShare registry services provider for Cambium Bio Limited; investors are directed to contact MUFG Corporate Markets via the MUFG Investor Centre for any share register-related queries.
• Australian Red Cross LifeBloodminorOthersEthical source of healthy donor platelets used by Cambium Bio to manufacture its Aurarix® FD-HPL platform; Dr Denese C. Marks, PhD serves on the Cambium Bio board as Non-Executive Director (Australian Red Cross LifeBlood), reflecting an institutional partnership.

Scale indicators10 records

Recent moves6 records

Expansion highlights6 records

Market position

Strengths4 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/Regeneus
• LinkedInlinkedin.com/company/regeneus-ltd

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Funding overview

Funding rounds3 records

Investors2 records

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M&A1 record

Investments

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

Frequently asked questions about Cambium Bio (formally Regeneus)