Double Bond Pharmaceutical AB (publ) ("DBP") reports the final data from its extensive retrospective study of Temodex, confirming a statistically significant 5.6-month survival advantage for patients with malignant primary brain tumors. The final results confirm and strengthen the preliminary findings previously reported, demonstrating a substantial survival benefit for patients.

Final Survival Data Analysis

The completed study included a total of 375 patients, stratified as follows:

• Temodex Group: 124 patients who received Temodex in addition to Standard of Care (SoC).
• Control Group: 251 patients who received Standard of Care (SoC) only.

Key Results:

• Median Overall Survival (mOS) - Temodex: 15.6 months.
• Median Overall Survival (mOS) - Control: 10.0 months.
• Survival Advantage: 5.6 months.
• Hazard ratio: 0.61
• Statistical Significance: The results are highly significant with a p-value of 0.00062.

These final figures reinforce the clinical efficacy of Temodex, showing an even greater separation in survival outcomes than initially indicated.

"We are glad that final results almost resemble the initial ones, demonstrating the significant therapeutic value of Temodex," says Igor Lokot, CEO of Double Bond Pharmaceutical. "An extension of median survival by 5.6 months is an outstanding result for this patient population. We continue the analyses of the data set with the use of most advanced scientific tools in order to get more understanding of how the use of Temodex/SI-053 can be implemented in Standard of Care protocols most effectively".

The detailed analysis, including subgroup stratifications based on histological and molecular markers, has been submitted and will be presented at the EANS2026 (European Association of Neurosurgical Societies) congress.

More about preliminary results of Real-World Evidence Study: https://mb.cision.com/Main/12720/4310428/3944046.pdf

More about Real-World Evidence Study: https://mb.cision.com/Main/12720/4307158/3933333.pdf

More about EANS2026 Congress: https://eanscongress.org/

More about SI-053: SI-053, an enhanced reformulation of Temodex, is a locally acting formulation of temozolomide. SI-053 received Orphan Drug Designation from the European Medicines Agency in 2016 and received multiple Competent Authority and Ethics Committee approvals from 2021 to 2023 to initiate a Phase 1 clinical study.  In a proof-of-concept study with human subjects conducted in 2015, SI-053 demonstrated significant overall survival benefit when added to the standard of care for glioblastoma.  Video presentation: https://youtu.be/iweOQPq316o

Information about Double Bond Pharmaceutical AB: DBP is a pharmaceutical company with the primary focus on development of therapies against cancer based on the company's own developed drug delivery technology BeloGal®. The company was granted Orphan Drug Designation status by European Medicines Agency (EMA) in June 2015 for its first product, SA-033, for treatment of hepatoblastoma. Double Bond Pharmaceutical acquired rights to Temodex in October 2015, and was granted Orphan Drug Designation status by EMA for in July 2016 for this formulation of temozolomide for the treatment of glioma. The formulation is now being further developed for registration in EU and globally and has a working name SI-053 in DBP pipeline.