Akthelia Pharmaceuticals

What Akthelia Pharmaceuticals does

Akthelia Pharmaceuticals is a preclinical-stage biopharmaceutical company headquartered in Reykjavík, Iceland, that develops host-directed small-molecule immunotherapies aimed at strengthening innate immunity of epithelial barriers. Founded by four professors from the Karolinska Institute and the University of Iceland based on more than a decade of research into human host defense peptides, the company is led by CEO Egill Masson and CSO/Co-founder Prof Gudmundur Gudmundsson. Its lead clinical candidate, AKT-011, is positioned as the first-in-class oral therapy for chemotherapy-induced gastrointestinal mucositis (CIGM), with the first defined patient population being multiple myeloma patients undergoing high-dose conditioning before stem cell transplantation; secondary programmes address topical diabetic wound healing and, via the IN-ARMOR consortium, antimicrobial resistance and inflammatory diseases including IBD, COPD and asthma.\n\nThe company's core platform is the Aroylated Phenylene Diamines (APDs) chemistry — a patent-protected class of small molecules that mimic and amplify the immunomodulatory effects of short-chain fatty acids via HDAC inhibition and direct acetylation of STAT3, upregulating host defense peptides such as LL-37, calprotectin, human beta defensin-1, lipocalin, Reg1-alpha and Reg3-gamma. APDs were identified using a proprietary high-throughput cell-based reporter assay that selects for compounds amplifying LL-37 expression, originally developed by the founding scientists who were the first to isolate and characterise LL-37. The company operates a small core team (under 10 named individuals) supplemented by retained advisors, a Scientific Advisory Board chaired by Prof Yaron Ilan, and a network of collaborators including Evotec (R&D), Recipharm (CDMO), TheraIndx Lifesciences, Mewburn Ellis (IP), the University of North Texas, and the IN-ARMOR consortium partners (Enamine Bienta, University of Groningen).\n\nAkthelia is pre-revenue and funds its operations through non-dilutive grants and private capital. It received a €6 million EU Horizon Europe grant in April 2023 as the largest industrial participant in the 16-member IN-ARMOR consortium (Grant Agreement No. 101080889), signed an exclusive worldwide licence to IN-ARMOR-generated IP in December 2024, and filed a new UK patent in February 2025 covering additional immune-modulating small molecules from that collaboration. The stated future revenue model is out-licensing, milestone payments and royalties from a pharmaceutical partner; the company is currently raising $25 million (with a $3 million first tranche) to take AKT-011 through end of Phase IIA proof-of-concept, having presented the opportunity at BIO2025 in Boston and held an "Approaching the Clinical Inflection Point" AGM presentation in Reykjavík in May 2025.

Name

Akthelia Pharmaceuticals

Legal name

Akthelia Pharmaceuticals

Website

https://aktheliapharma.com

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

1–10 employees

Short description

Preclinical-stage Icelandic biopharmaceutical company developing host-directed small-molecule immunotherapies based on aroylated phenylene diamines (APDs) that strengthen epithelial barrier immunity, with lead candidate AKT-011 targeting chemotherapy-induced gastrointestinal mucositis in multiple myeloma patients undergoing stem cell transplantation.

Ownership category

akta.pro rank

Product category

Host-directed biopharmaceuticals

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Pharmaceutical and Medicine Manufacturing (3254)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Immunology & Autoimmune Specialty Pharmaceuticals (HLAIACAB)

akta.pro secondary industries

Immunology & Inflammation Pharmaceuticals (HLAIAAAD), Infectious Disease Specialty Pharmaceuticals (Non-vaccine) (HLAIACAM)

Keywords

• Host-directed therapeutics
• Innate immunity drugs
• Small molecule immunotherapy
• Antimicrobial resistance therapy
• Epithelial barrier therapy

Headquarters

HQ city

Reykjavík

HQ country

Iceland

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Pre-revenue; capital raising for clinical development: Akthelia is a preclinical-stage biopharmaceutical company that has not yet generated product revenue. The current commercial focus is on raising capital — targeting $25 million to fund AKT-011 through end of Phase IIA proof-of-concept, with an immediate $3 million first tranche to complete preclinical studies and initiate Phase I trials. Past non-dilutive funding includes a €6 million EU Horizon Europe grant for the IN-ARMOR project. Future revenue model is expected to involve out-licensing, milestone payments and royalties from a future pharma partner.

Go-to-market motion1 record

Marketing channels5 records

Core offering

Akthelia Pharmaceuticals is a late preclinical-stage biopharmaceutical company developing a pipeline of host-directed small-molecule immunotherapies (aroylated phenylene diamines) that up-regulate the innate immunology of epithelial barriers. Its lead asset AKT-011 is an oral therapy being prepared for first clinical studies in chemotherapy-induced gastrointestinal mucositis in multiple myeloma patients undergoing stem-cell transplantation, with additional preclinical programs in febrile neutropenia prophylaxis, diabetic wound healing, and antimicrobial resistance/inflammatory disease via the EU Horizon Europe IN-ARMOR collaboration.

Product overview

Akthelia Pharmaceuticals operates a single integrated preclinical-stage biopharmaceutical platform centred on epithelial science and host-directed therapeutics. The platform foundation is its patent-protected Aroylated Phenylenediamines (APDs) chemical scaffold library, which mimics and amplifies the immunomodulatory effects of microbiome-derived short-chain fatty acids on epithelial surfaces. Built on this platform, the company has a portfolio of preclinical candidates, with its lead asset AKT-011 being prepared for first clinical studies in chemotherapy-induced gastrointestinal mucositis (CIGM) in multiple myeloma patients undergoing stem cell transplantation. The portfolio also includes a chemotherapy-induced febrile neutropenia prophylactic program and a topical wound healing program for diabetic wounds, alongside the EU Horizon Europe IN-ARMOR collaboration, which extends the platform into antimicrobial resistance (AMR) and inflammatory conditions.

Differentiator

Problem solved

Functional benefit

Products and services

• AKT-011 AKT-011 is Akthelia's lead, patent-protected, host-directed small-molecule oral therapy designed to prevent and treat gastrointestinal mucositis (CIGM) in cancer and stem-cell transplant patients. It is currently being prepared for first clinical studies, with the first defined patient group consisting of multiple myeloma patients undergoing high-dose chemotherapy before stem cell transplantation.
• Chemotherapy-Induced Febrile Neutropenia Prophylactic Program An oral prophylactic small molecule treatment designed to prevent life-threatening infections in immunocompromised patients undergoing cancer chemotherapy. The program focuses on enhancing the gastrointestinal epithelium's immune response to prevent harmful microbiome leakage, thereby reducing infection and sepsis risks.
• Wound Healing Program (Topical Diabetic Wound Formulation) Akthelia's second preclinical program is a topical formulation targeting diabetic wounds by fortifying the immune resilience of the skin's epithelial barriers. The approach aims to facilitate rapid and robust wound regeneration by enhancing the local immune system.

Quantifiable outcome

• Around one-fifth (≈20%) of cancer patients experience chemotherapy-related GI complications — the addressable population for AKT-011
• +3 more outcomes

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Nine partnerships are on record, tiered flagship — largest grant co-participant and source of founding science, flagship — founding scientific institution, core — in-armor project partner and medicinal chemistry cro, core — in-armor project partner, core collaborator and supporting collaborator.

• University of Icelandflagship — largest grant co-participant and source of founding scienceStrategic or Co-development PartnerCo-founder institution alongside Karolinska Institute. Listed partner on Akthelia's homepage collaborators section. Joint recipient of the €6 million EU Horizon Europe IN-ARMOR grant (Grant Agreement No. 101080889) — Akthelia and the University of Iceland are the largest participants in the consortium. Co-signed the December licensing agreement granting Akthelia an exclusive, worldwide licence to IP generated within the IN-ARMOR project.
• Karolinska Instituteflagship — founding scientific institutionStrategic or Co-development PartnerCo-founder institution alongside the University of Iceland. Akthelia was founded by four eminent professors from Karolinska Institute and the University of Iceland, based on more than a decade of research into human host defense peptides and barrier dysfunction. Co-founder Prof Birgitta Agerberth serves as Biology Advisor; Prof Peter Bergman is part of the Clinical & Scientific Advisors group.
• Enaminecore — in-armor project partner and medicinal chemistry croStrategic or Co-development PartnerUkrainian contract research organization specialising in medicinal and synthetic chemistry. Listed as partner 'Enamine Bienta' on Akthelia's homepage collaborators. Co-signatory of the December licensing agreement that grants Akthelia an exclusive, worldwide licence to intellectual property generated within the IN-ARMOR project, focused on discovery and optimisation of novel immune-modulating small molecules.
• University of Groningen (Netherlands)core — in-armor project partnerStrategic or Co-development PartnerCo-signatory of the December licensing agreement within the Horizon Europe IN-ARMOR project. Collaboration focuses on the discovery and optimisation of novel immune-modulating small molecules alongside Enamine and the University of Iceland.
• Evoteccore collaboratorImplementation/ SI/ Consulting PartnerListed on Akthelia's homepage partners/collaborators section as a research and development partner supporting the company's therapeutic programmes.
• TheraIndx Lifesciencessupporting collaboratorStrategic or Co-development PartnerListed on Akthelia's homepage partners/collaborators section as a collaborator.
• Recipharmsupporting collaboratorImplementation/ SI/ Consulting PartnerListed on Akthelia's homepage partners/collaborators section as a development and manufacturing partner (Recipharm is a CDMO).
• University of North Texassupporting collaboratorStrategic or Co-development PartnerListed on Akthelia's homepage partners/collaborators section as an academic research collaborator.
• Mewburn Ellissupporting collaboratorImplementation/ SI/ Consulting PartnerListed on Akthelia's homepage partners/collaborators section as an IP/legal advisory collaborator.

Scale indicators7 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• G1 Therapeutics: Developed trilaciclib (Cosela), the first FDA-approved therapy to reduce the incidence of chemotherapy-induced myelosuppression in small cell lung cancer. Most advanced commercial-stage peer addressing Akthelia's same chemotherapy-complication supportive care opportunity (acquired by Pharmacosmos in 2024).
• Iterum Therapeutics: Clinical-stage anti-infectives company developing sulopenem for resistant bacterial infections, addressing the AMR opportunity that Akthelia's IN-ARMOR platform targets. Comparable early-commercial-stage peer in the infectious disease/AMR space.
• Soligenix: Late-stage biopharmaceutical company with dusquetide (SGX942) in clinical development for oral mucositis in head and neck cancer. Directly comparable indication, mechanism class (innate defense regulator) and development stage for Akthelia's lead program.
• Innovation Pharmaceuticals: Clinical-stage company developing brilacidin, a defensin-mimetic innate defense peptide, for oral mucositis and other inflammation-driven indications. Closest mechanistic analogue to Akthelia's host defense peptide amplification approach.
• Galera Therapeutics: Clinical-stage biotech developing avasopasem manganese for severe oral mucositis in patients receiving chemoradiation, head and neck cancer and stem cell transplant. Most directly comparable peer to Akthelia's AKT-011 in oncology supportive care and mucosal injury.
• Monopar Therapeutics: Clinical-stage oncology-focused company developing supportive-care therapeutics including therapies for chemotherapy-induced mucositis. Comparable size, stage and oncology supportive-care focus to Akthelia.

Emerging players

• Aprea Therapeutics: Clinical-stage oncology biotech developing small-molecule therapies that reactivate tumor suppressor p53. Comparable in scale, private/small-cap profile, single-platform R&D focus and dependence on a Big Pharma partnership for late-stage value capture.
• Acurx Pharmaceuticals: Preclinical/early-clinical stage antibiotic development company targeting C. difficile and other resistant Gram-positive infections. Similar size and stage profile to Akthelia, with overlap in AMR/anti-infective adjacency though narrower mechanism (direct antibiotic vs. Akthelia's host-directed approach).

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xtwitter.com/akthelia
• Facebookfacebook.com/Akthelia
• LinkedInlinkedin.com/company/akthelia

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles17 records

Funding overview

Funding rounds5 records

Investors2 records

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M&A

Investments

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

Frequently asked questions about Akthelia Pharmaceuticals