• OTLC’s Deciparticle(TM) platform reliably formulates diverse hydrophobic drugs—including macrolide mTOR inhibitors, peptides, and polyketides—into uniform, IV-ready nanoparticles.
• Current Preclinical PK data show that Sapu003, the intravenous Deciparticle(TM) formulation of Everolimus (Afinitor(R)), cuts down gastrointestinal drug accumulation by up to 67-fold compared to oral dosing.
• These advancements highlight a quickly expanding immunology and oncology pipeline built on modular, cGMP-ready nanomedicine engineering.

Oncotelic Therapeutics (OTCQB: OTLC) is rapidly emerging as a key player in next-generation drug delivery, with a scalable nanotechnology platform that can transform the paradigms of immunology and oncology treatments. Leveraging Sapu Nano, the company’s clinical-stage nanomedicine, it unveiled new data at the 2025 San Antonio Breast Cancer Symposium (“SABCS”), highlighting that its Deciparticle(TM) platform can package even the toughest, water-resistant drugs into smaller, uniform nanoparticles that are small enough for effective and safe intravenous use (ibn.fm/LxQ7N).

The platform shows high-level compatibility across different therapeutic categories. All five main macrolide mTOR inhibitors, including temsirolimus, sirolimus, ridaforolimus, Everolimus (Afinitor(R)), and umirolimus, formed stable, monodisperse particles. Tacrolimus, a key drug, also forms stable nanoparticles with diameters of less than 20 nm, highlighting the platform’s ability to handle multiple drug structures. Complex peptides such as exenatide and cyclosporine A were successfully packaged, underscoring the fact that the innovation can work with both linear and cyclic peptides.

This flexibility is supported by a viable cGMP manufacturing system, which promotes sterile filtration, one-pot synthesis, automated filling and finishing, and freeze-drying into clinic-ready products. With this setup, reliable stability after reconstruction, consistent batches, and quick movement are made possible from lab-scale formulation to Phase 1 clinical supply, a significant advantage for companies developing multiple drugs simultaneously.

Sapu Nano and Oncotelic also launched new pharmacokinetic data showing a significant benefit of their lead Deciparticle(TM) candidate, Sapu003, an IV version of Everolimus (Afinitor(R)) created to address the toxicity associated with oral Afinitor(R). Research has shown that oral Everolimus (Afinitor(R)) is highly concentrated in the gut and capable of reaching plasma levels over 2,000 times higher in some tissues. IV Sapu003 reduces this buildup by approximately 67-fold, facilitating more consistent drug exposure and improved tolerability (ibn.fm/Z0U1a).

These PK improvements align with earlier results, highlighting that Sapu003 generated approximately 98% tumor inhibition and outperformed paclitaxel in preclinical models. By going straight into the user’s bloodstream, Sapu003 could help doctors with a more effective and predictable option for HR⁺/HER2⁻ metastatic breast cancer, among other applications.

Together, the Sapu003 PK and Deciparticle(TM) screening data underscore Oncotelic’s strategic positioning as a platform-driven biotech company, helping to build a versatile nanomedicine engine capable of supporting multiple drugs for various applications.

For more information, visit the company’s website at www.Oncotelic.com.

NOTE TO INVESTORS: The latest news and updates relating to OTLC are available in the company’s newsroom at ibn.fm/OTLC

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