Mallia Therapeutics Announces Publication and Congress Presentation on Accelerated Wound Healing with sCD83

• Peer-reviewed publication in Wound Repair and Regeneration demonstrates regenerative activity of sCD83 in a human disease model of impaired wound healing
• Data highlight immunomodulatory mechanism of action and therapeutic potential in chronic wounds
• Findings will be presented in an invited talk at at the joint conference of the European Wound Management Association (EWMA) and the German Wound Congress (DEWU)

Erlangen, Germany, May 06, 2026 - Mallia Therapeutics GmbH, a biopharmaceutical company specializing in the development of innovative therapies for hair loss, today announced the publication of new data demonstrating the pro-regenerative and immunomodulatory potential of soluble CD83 (sCD83) in chronic wound healing. The study was conducted independently by researchers at the Departments of Immune Modulation, Dermatology, and Medicine at Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), including Dr. Dmytro Royzman and Prof. Dr. Alexander Steinkasserer, who are also Co-founders of Mallia. The publication appears in the peer-reviewed journal Wound Repair and Regeneration, the official journal of The Wound Healing Society, The European Tissue Repair Society, The Japanese Society for Wound Healing, and The Australian Wound Management Association. In addition, these findings will be presented in an invited talk at the Joint EWMA-DEWU 2026 Conference, the world’s largest wound care conference, which takes place from May 6-8 in Bremen.

Chronic wounds represent a growing global healthcare challenge, affecting millions of patients worldwide and placing a significant burden on healthcare systems. Despite this unmet medical need, no fundamentally new therapeutic approaches have reached clinical development in this field for more than two decades.

“Chronic wounds are driven by a persistent inflammatory environment and impaired immune regulation, which significantly limits the body’s ability to heal,” said Prof. Dr. Alexander Steinkasserer, Co-founder and Managing Director of Mallia Therapeutics. “Our data demonstrate that sCD83 can actively modulate this immune imbalance, promote resolution of inflammation and enable tissue repair. We believe this approach has the potential to address a significant unmet medical need in chronic wound care.”

The newly published study¹ demonstrates that sCD83 significantly accelerates wound closure in a human in vitro wound model. This model incorporates different cell types, keratinocytes, fibroblasts, and macrophages, to form a three-dimensional skin construct, which mimics wound healing processes in human skin. The wound model can be exposed to chronic wound fluid collected from patients to replicate the inflammatory and impaired healing environment characteristic of chronic wounds.²

Treatment with sCD83 resulted in enhanced wound closure due to a marked shift of macrophages towards a pro-regenerative phenotype, accompanied by increased production of key growth factors such as VEGF and TGF-β. In addition, epidermal stem cell activity was activated while the production of pro-inflammatory mediators was reduced. Notably, these effects were observed even under inflammatory conditions after exposure to chronic wound fluid, highlighting the potential of sCD83 to restore regenerative processes in even in hard-to-heal disease settings.

Dr. Dmytro Royzman, Co-founder & Scientific Lead of Mallia Therapeutics, commented: “What is particularly encouraging is that we were able to demonstrate the effects of sCD83 in a sophisticated human 3D wound model that closely mimics the inflammatory conditions of chronic wounds in patients. I am excited to present and discuss this wound model and the potential of sCD83 in wound healing with the medical experts at the German Wound Congress.”

Dr. Royzman has been invited to present these results at the Joint EWMA-DEWU 2026 Conference, which combines the annual meetings of the (EWMA) European Wound Management Association and the German Wound Congress (DEWU). In his presentation, which will take place on May 6^th at 2:30 pm CEST as part of the session “3D wound models”, he will discuss the characterization of the pro-regenerative potential of sCD83 in artificial skin constructs.

About sCD83

Soluble CD83 (sCD83) is an immunomodulatory protein that is currently being developed for therapeutic applications, including hair loss, (MAL‑856) and cosmetic applications for the stimulation of hair growth (MAL‑838). The soluble CD83 protein was first identified in 2001 by Mallia Co-founder Prof. Steinkasserer. It has anti-inflammatory properties via the induction of resolution of inflammation, which promotes wound healing and induces new hair growth.³ In addition, sCD83 has been shown to activate regulatory T cells (Tregs)⁴, which interact directly with hair follicles and can activate them.⁵ Furthermore, sCD83 inhibits cell death of hair follicles and directly activates follicular stem cells, as well as keratin production, thereby stimulating new hair growth. This multimodal mode of action distinguishes sCD83 from other topically applied hair growth agents.

Topically applied, sCD83 can directly reach the hair follicles but does not penetrate through the skin and thus does not enter the bloodstream. The effect is localized, which is a major advantage over systemic treatment options, which can cause severe side effects.

About Mallia

Mallia Innovations GmbH, based in Erlangen, Germany, is the holding company strategically driving the proprietary development and commercialization of biopharmaceutical therapies and cosmetic applications of the immunomodulatory sCD83 protein, targeting hair growth, hair loss and other dermatological indications, including wound healing.

Mallia Therapeutics GmbH focuses on the clinical development of novel therapies for patients suffering from androgenetic alopecia or alopecia areata, among other conditions. MAL-856 is based on the scientifically proven immunomodulatory mode of action of sCD83, which has been investigated for close to 25 years by Mallia Co‑founder Prof. Dr Alexander Steinkasserer.⁶

Mallia Aesthetics GmbH focuses on cosmetic applications for the stimulation of hair growth, which are also based on the scientifically validated sCD83 protein. The Company develops Innovative cosmetic products using MAL-838 that are marketed to specialists and consumers.

To purchase products from the 8T3 Essentials line, please visit our online shop: www.8T3.com

For more information, visit www.mallia.com and follow us on LinkedIn, Instagram, and Facebook.

¹ Hollard, C., Peckert‐Maier, K., Ronicke, M., Sinner, P., Stritt, F., Spöttl, T., ... & Royzman, D. (2026). Soluble CD83 Accelerates Wound Healing and Attenuates Inflammatory Responses Induced by Chronic Wound Fluid in a Human 3D in Vitro Wound Healing Model. Wound Repair and Regeneration, 34(2), e70158. DOI: 10.1111/wrr.70158

² Manuela, B., Milad, K., Anna-Lena, S., Julian-Dario, R., & Klara, S. E. (2017). Acute and chronic wound fluid inversely influence wound healing in an in-vitro 3D wound model. Journal of Tissue Repair and Regeneration, 1(1), 1-11. DOI: 10.14302/issn.2640-6403.jtrr-17-1818

³ Royzman, D., Peckert-Maier, K., Stich, L., König, C., Wild, A. B., Tauchi, M., ... & Steinkasserer, A. (2022). Soluble CD83 improves and accelerates wound healing by the induction of pro-resolving macrophages. Frontiers in Immunology, 13, 1012647. DOI: 10.3389/fimmu.2022.1012647

⁴ Bock, F., Rössner, S., Onderka, J., Lechmann, M., Pallotta, M. T., Fallarino, F., ... & Zinser, E. (2013). Topical application of soluble CD83 induces IDO-mediated immune modulation, increases Foxp3+ T cells, and prolongs allogeneic corneal graft survival. The Journal of Immunology, 191(4), 1965-1975. DOI: 10.4049/jimmunol.1201531

⁵ Ali, N., Zirak, B., Rodriguez, R. S., Pauli, M. L., Truong, H. A., Lai, K., ... & Rosenblum, M. D. (2017). Regulatory T cells in skin facilitate epithelial stem cell differentiation. Cell, 169(6), 1119-1129. DOI: 10.1016/j.cell.2017.05.002

⁶ Lechmann, M., Krooshoop, D. J., Dudziak, D., Kremmer, E., Kuhnt, C., Figdor, C. G., ... & Steinkasserer, A. (2001). The extracellular domain of CD83 inhibits dendritic cell–mediated T cell stimulation and binds to a ligand on dendritic cells. The Journal of experimental medicine, 194(12), 1813-1821. DOI: 10.1084/jem.194.12.1813