INVEST IN MULTI-TARGET CELL & GENE THERAPIES

CHRONIC WOUNDS, CANCER, INFLAMMATION AND BEYOND

We are committed to developing curative therapies for chronic wounds, cancer, and inflammatory diseases through our innovative multi-target cell and gene therapy platform.

Our goal is to provide life-changing treatments for millions of patients worldwide by building a strong foundation of clinical safety and efficacy in treating Diabetic Foot Ulcers, chronic wounds, and deadly cancers. Through strategic partnerships, we aim to bring our platform to market, transforming healthcare and improving lives.

We are currently raising 35M Series B to advance our clinical program. DIAMEND Phase 2 DFU clinical trial completed.

Aurealis Logo website

EXPLORE THE OPPORTUNITY

  • Chronic Wounds: $100Bn cost to society and $15Bn global market (Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer).
  • Ovarian Cancer: 207,252 deaths/year and over $5Bn global market.
  • Bladder Cancer: 212,536 deaths/year and over $8Bn global market.
  • Inflammation: Global anti-inflammatory market to grow 4% and reach $146Bn in 2032.

Curing complex diseases requires multi-targeting – current treatments do not enable that.

Cell and gene therapies have therapeutic potential but cannot be scaled and COGS is unacceptable.

Aurealis Therapeutics 4-in-1 platform.
Aurealis’ technology enables multi-targeting with superior scalability and low COGS.

Aurealis 4-in-1 platform

AUP-16 for chronic wounds

AUP-55 for cancer

Aurealis 4-in-1 platform

Illustration of the Aurealis Therapeutics Technology Platform

AUP-16 for chronic wounds

Illustration of Aurealis Therapeutics AUP-16 indication

AUP-55 for cancer

Illustration of Aurealis Therapeutics AUP-55 indication
Modality | Product Discovery In vivo POC GLP, S&T, CMC IND/CTA Phase 1 Phase 2 Phase 3 NDA/MAA
Chronic wounds | AUP-16
Diabetic Foot Ulcer (DFU)
Venous Leg Ulcer (VLU)
Pressure Ulcer (PU)
Oncology | AUP-55
Ovarian and Peritoneal Cancer
Bladder Cancer
Recurrent Melanoma
Inflammation | AUP-18
Dermatology (undisclosed)
Inflammation | AUP-20
Metabolic (undisclosed)

CLINICAL TRIALS IN DIABETIC FOOT ULCERS

AUP-16 phase 1 AND 2 cOMPLETED

PHASE 1 CLINICAL STUDY IN DFU

83% of the patients achieved complete healing. No healed ulcer recurred after 12 months follow-up.

In June 2022, we successfully completed the Phase 1 study (NCT04281992 and EudraCT 2018-003415-22) in non-healing Diabetic Foot Ulcer patients with our lead product AUP-16. The last patient last visit (LPLV) was on 20th March 2023. Results were presented during European Wound Management Association (EWMA) 2023 conference in Milan and published on the Therapeutic Advances in Endocrinology and Metabolism peer-reviewed journal in November 2024.

Aurealis Therapeutics technology platform works in real life: non-healing diabetic wounds heal. Clinical results: 83% of patients reached complete healing, no healed ulcer recurred after 12 months follow-up.

More details about our Phase 1 Clinical Study:
NIH National Library of Medicine record

More details about our Phase 1 Clinical Study:
EU Clinical Trials Register

PHASE 2 CLINICAL STUDY IN DFU

AUP-16 "DIAMEND" international Phase 2 RCT in Diabetic Foot Ulcer: +50% additional full healing compared to placebo

AUP-16 Phase 2 study (NCT06111183 and EudraCT 2022-502048-10-00) in DFU received CTA approval in May 2023. It is a multi-center, single-blinded, randomized, standard-of-care plus placebo-controlled study in patients with non-healing diabetic foot ulcers, conducted in Germany, Italy and Poland. The first DFU patient was dosed in August 2023 and the last patient last treatment was completed in October 2024. Study results were presented during EWMA 2025 conference in Barcelona.

More details about our DIAMEND Phase 2 Clinical Study:
NIH National Library of Medicine record

More details about our DIAMEND Phase 2 Clinical Study:
EU Clinical Trials Register

IN VIVO STUDIES FOR CANCER

AUP-55 IN VIVO RESULTS SHARED AT ASCO

In-vivo data with AUP-55 in Ovarian Cancer and Peritoneal Carcinomatosis were shared during ASCO Annual Meeting. They show treatment with AUP-55 resulted in 91.3% survival and lower tumor compared to the 0% survival and massively increased tumor load in untreated patients.

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