Guard Therapeutics has announced plans to secure approximately SEK 150 million through a rights issue to advance its innovative kidney protection program. The Swedish clinical-stage biotechnology company is currently focused on developing treatments for various forms of kidney disease, with its lead candidate RMC-035 showing promising results in protecting kidney function during open-heart surgery.
The financing initiative comes at a critical juncture for the company, as it progresses with its phase 2b POINTER study. "We are in a very exciting and intense phase of the company's history, with recruitment for our clinical phase 2b POINTER study progressing according to plan," stated Tobias Agervald, CEO of Guard Therapeutics. "In parallel, we continue to plan for a pivotal phase 3 study and prepare for upcoming regulatory meetings."
Strong Clinical Progress and Regulatory Support
RMC-035, based on the endogenous protein alpha-1-microglobulin, has already achieved significant regulatory milestones. The drug candidate has received both IND clearance and Fast Track Designation from the FDA for reducing the risk of kidney function loss in open-heart surgery patients. These designations underscore the treatment's potential to address a significant unmet medical need.
Recent clinical data has reinforced the program's promise. The phase 2a AKITA study, involving 177 patients, demonstrated statistically significant and clinically relevant improvements in long-term kidney outcomes, including the regulatory endpoint MAKE90. The FDA has provided positive feedback on the development plan following these results.
Financing Structure and Use of Proceeds
The rights issue is structured to offer existing shareholders priority, with five subscription rights allowing subscription for four new shares at SEK 15.25 per share. The issue has already secured substantial backing, with approximately 80% covered through subscription commitments, intentions, and guarantee commitments from existing shareholders and external investors.
The proceeds will be primarily allocated to:
- Completing the ongoing phase 2b POINTER study
- Preparing for phase 3 trials, including study design and CMC development
- Extending the company's cash runway to support regulatory meetings and business development activities
Strategic Timing and Market Position
The timing of this financing aligns with several critical milestones. The first planned DSMC safety data review from the POINTER study is expected by early March 2025, with overall study results anticipated approximately six months after completing patient recruitment.
A successful outcome from the phase 2b POINTER study would significantly strengthen RMC-035's position as a unique therapeutic candidate for acute kidney protection. This would not only provide crucial insights for phase 3 trial design but also enhance the program's attractiveness to potential pharmaceutical partners.
Market Impact and Future Outlook
The rights issue represents a strategic step in Guard Therapeutics' development trajectory, potentially extending the company's operational runway until mid-2026. This timeline would allow for completion of key clinical milestones and important regulatory interactions, positioning the company for potential partnership discussions or further development decisions.
The company's focus on kidney protection in high-risk surgical procedures addresses a significant medical need, with acute kidney injury remaining a serious complication in cardiac surgery. The development of RMC-035 could potentially transform the standard of care for these patients, offering a novel protective approach where currently no approved treatments exist.
