Guard Therapeutics

What Guard Therapeutics does

Guard Therapeutics International AB (publ) is a Swedish clinical-stage biotechnology company headquartered in Stockholm and listed on Nasdaq First North Growth Market (ticker: GUARD). Originally established as A1M Pharma and renamed in October 2019, the company develops drug candidates built on the endogenous human protein alpha-1-microglobulin (A1M). Its lead asset, RMC-035, is a recombinant modified variant of A1M intended as an intravenous, kidney-protective therapy for patients at high risk of acute kidney injury during open-heart surgery. A broader GTX-peptide platform spans additional A1M-derived therapeutic peptides. The company received FDA Fast Track Designation and IND clearance for RMC-035 and ran the multi-center Phase 2b POINTER study across 19 European and Canadian sites.

Operationally, Guard Therapeutics is pre-revenue and finances its burn through periodic equity issuances — most notably a SEK 60m directed share issue in June 2024, a SEK 7.2m repair issue in August 2024, and a SEK 120m rights issue in Q1 2025. Following the December 2025 failure of the POINTER study (which missed primary and key secondary efficacy endpoints), Guard discontinued RMC-035 development, initiated a strategic review, and on 10 June 2026 announced a conditional reverse takeover of Disruptive Pharma Holding AB. Post-transaction, Guard Therapeutics will be renamed Disruptive Pharma AB, with Disruptive Pharma shareholders owning approximately 55% of the combined company and Guard shareholders approximately 45%. The GTX peptide platform is concurrently being divested through a separate transaction process.

The target customer base — cardiac surgery patients at risk of AKI — is a clinical end-user population rather than a paying customer base; Guard has no commercial product and consequently no pricing model, distribution infrastructure, or contracted revenue. The combined entity post-merger would shift its commercial focus toward Disruptive Pharma's Formulite platform (mesoporous magnesium carbonate formulation technology), targeting pharmaceutical partners facing low-solubility and oral bioavailability challenges. The strategic implication is that the original kidney-therapy franchise has effectively been wound down in favor of an externally sourced formulation technology business.

Name

Guard Therapeutics

Legal name

Guard Therapeutics International AB (publ)

Website

https://guardtherapeutics.com

Company type

Public

Founded year

2015

Operating status

Operating

Headcount range

1–10 employees

Short description

Guard Therapeutics is a pre-revenue Swedish clinical-stage biotech developing A1M-based kidney therapies. After Phase 2b failure of lead candidate RMC-035, the company announced a reverse takeover of Disruptive Pharma and divestiture of its GTX platform.

Ownership category

akta.pro rank

Product category

Clinical-stage biopharmaceuticals (kidney disease therapeutics)

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Scientific Research and Development Services (5417)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Specialty Care Pharmaceuticals (HLAIAAAB)

akta.pro secondary industry

Clinical Trials Authorization & Oversight (GCP) (HLAJADAF)

Keywords

• Clinical-stage biotechnology
• Kidney disease therapeutics
• Acute kidney injury
• Recombinant protein therapy
• Alpha-1-microglobulin drugs

Headquarters

HQ city

Lund

HQ country

Sweden

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Pre-commercial/biopharmaceutical development: Guard Therapeutics is a pre-revenue clinical-stage biotechnology company. The company is developing drug candidates through clinical trials with the goal of obtaining regulatory approvals for commercialization. Revenue will be generated through pharmaceutical product sales upon successful development and approval of drug candidates.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Guard Therapeutics is a clinical-stage biopharmaceutical company developing investigational drug candidates based on the endogenous human protein alpha-1-microglobulin (A1M). Its lead candidate RMC-035 is a recombinant modified A1M variant intended as an intravenous kidney-protective therapy for patients at high risk of acute kidney injury during open-heart surgery; the GTX Platform is a portfolio of therapeutic peptides derived from A1M with lead candidate GTX-86 in preclinical development. The company has no commercialized products and is pre-revenue.

Product overview

Guard Therapeutics is a Swedish clinical-stage biotechnology company developing new therapies for kidney disease based on the endogenous protein alpha-1-microglobulin. The company has two main product candidates: RMC-035 (a recombinant alpha-1-microglobulin variant in Phase 2b clinical trials for kidney protection during open-heart surgery) and the GTX Platform (a portfolio of therapeutic peptides with lead candidate GTX-86 in preclinical development). The company also announced a reverse takeover of Disruptive Pharma, which brings the Formulite platform technology based on mesoporous magnesium carbonate for pharmaceutical formulation development.

Differentiator

Problem solved

Functional benefit

Products and services

• RMC-035 Recombinant and modified variant of the endogenous human protein alpha-1-microglobulin (A1M); a first-in-class kidney-protective investigational drug candidate developed for intravenous administration to patients at high risk of acute kidney injury during open-heart surgery. Received FDA IND clearance and Fast Track Designation.
• GTX-peptide Platform Therapeutic platform comprising a portfolio of peptides based on the endogenous protein alpha-1-microglobulin (A1M), together with associated intellectual property. Lead candidate GTX-86 has met internal criteria for candidate nomination and is positioned for further preclinical development.
• GTX-86
• Formulite Platform (via Disruptive Pharma reverse takeover)

Quantifiable outcome

• Phase 2a AKITA study (n=177): Statistically significant and clinically relevant favorable effect on long-term kidney outcomes
• +2 more outcomes

Named customers2 records

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Partnerships

Four partnerships are on record, tiered core.

• Disruptive Pharma Holding ABcoreStrategic or Co-development Partner · 10 June 2026Conditional agreement for reverse takeover. Guard Therapeutics to acquire Disruptive Pharma through issue-in-kind of shares. Disruptive Pharma brings Formulite platform technology for drug formulation based on mesoporous magnesium carbonate. Combined company to be renamed Disruptive Pharma AB.
• European Rare Diseases Research Alliance (ERDERA)coreStrategic or Co-development Partner · 15 January 2026Guard Therapeutics is a partner in a newly funded European research consortium under the 2025 Joint Transnational Call from ERDERA, aimed at accelerating development of therapies for rare kidney diseases including Alport syndrome.
• Clinical Trial Sites (19 sites across Europe and Canada)coreStrategic or Co-development PartnerMulti-center international clinical trial collaboration for Phase 2b POINTER study evaluating RMC-035 in open-heart surgery patients at high risk for acute kidney injury.
• Scientific Advisory CommitteecoreStrategic or Co-development PartnerSeven globally recognized experts in nephrology and drug development: Dr. Rinaldo Bellomo, Dr. Jay L Koyner, Dr. Kathleen Liu, Dr. Vlado Perkovic, Dr. Mitch Rosner, Dr. Nicholas Selby, and Prof. Dr. Alexander Zarbock. Advising on late-phase development strategy and Phase 3 trial design.

Scale indicators6 records

Recent moves9 records

Expansion highlights4 records

Emerging players

• Chinook Therapeutics: Chinook Therapeutics was a clinical-stage biotech focused on rare kidney diseases (atrasentan, BION-1301) until acquired by Novartis in 2023 — a comparable clinical-stage kidney specialty biotech that achieved a major exit, illustrating the M&A pathway for kidney-focused drug developers.
• RenalGuard Solutions: RenalGuard Solutions develops the RenalGuard system for prevention of contrast-induced acute kidney injury (CI-AKI) — addresses the same AKI-prevention clinical need as RMC-035 but via a device plus matched-fluid approach rather than a recombinant protein drug.
• BioMérieux (Astute Medical): BioMérieux acquired Astute Medical, which developed the NephroCheck test for early AKI detection — addresses the same acute kidney injury clinical setting as Guard's RMC-035, providing diagnostic complement to therapeutic intervention in cardiac surgery and ICU settings.

Direct peers

• Travere Therapeutics: Travere Therapeutics is a U.S. specialty pharma focused on rare kidney diseases, including sparsentan for FSGS and IgA nephropathy — directly comparable as a public clinical/commercial stage kidney-disease drug developer pursuing orphan renal indications.
• Ardelyx: Ardelyx develops and commercializes specialty therapeutics for kidney disease, including tenapanor for hyperphosphatemia and IBS-C — a kidney-focused specialty pharma that went through clinical development setbacks (FDA rejections) before achieving commercial success, providing a relevant precedent.
• AM-Pharma: AM-Pharma is a Dutch clinical-stage biotech developing recombinant alkaline phosphatase (recAP) for acute kidney injury (AKI), including sepsis-associated AKI — the most direct functional competitor to Guard's RMC-035 in the kidney-protection therapeutic space. Both target hospital-based AKI indications with novel recombinant protein mechanisms.
• Akebia Therapeutics: Akebia Therapeutics is a U.S.-listed specialty pharma focused on kidney disease, including vadadustat for anemia in chronic kidney disease and HIF-PHI inhibitors — directly comparable as a public kidney-disease specialty pharma with both clinical and commercial stage assets.
• Quanta Dialysis Technologies: Quanta Dialysis Technologies develops a portable hemodialysis system (Quanta Dialysis System) for hospital and home use — operates in the kidney-care clinical setting where Guard's RMC-035 would have been administered, addressing end-stage complications of the AKI that Guard targeted.

Regional players

• Calliditas Therapeutics: Calliditas Therapeutics is a Swedish specialty pharma that developed Nefecon for IgA nephropathy and was acquired by Asahi Kasei in 2024 — the closest Swedish/European kidney-disease biotech comparable, demonstrating both successful development and exit trajectories.
• BioInvent International: BioInvent International is a Swedish clinical-stage biotech listed on Nasdaq Stockholm developing immuno-oncology antibodies — comparable as a small Swedish listed biotech facing typical clinical development, financing, and pipeline concentration risks similar to Guard Therapeutics.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/GuardTx
• LinkedInlinkedin.com/company/guard-therapeutics

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 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 Guard Therapeutics