Sapu Nano Appoints Global Clinical Trials as Lead CRO to Expand Sapu003 Phase 1b Program Into Europe

• Sapu Nano and Oncotelic Therapeutics (OTCQB: OTLC) have appointed Global Clinical Trials (GCT) as the lead CRO for the international expansion of Study SP-03-B101, a Phase 1b dose-escalation trial evaluating Sapu003 — a proprietary intravenous nanoparticle formulation of everolimus — in patients with advanced mTOR-sensitive solid tumors.

• GCT was selected through a competitive evaluation process assessing international oncology expertise, regulatory capabilities, and global logistics infrastructure, and has already completed key regulatory submissions ahead of schedule while initiating site activation and study management functions across the expanded international program.

Sapu Nano and Oncotelic Therapeutics (OTCQB: OTLC) announced on June 3, 2026, from San Diego, California, the appointment of Global Clinical Trials (GCT) as the lead contract research organization supporting the international execution of Study SP-03-B101 — a Phase 1b dose-escalation program evaluating Sapu003 in patients with advanced mTOR-sensitive solid tumors. The announcement marks a significant expansion of the Sapu003 clinical program beyond its initial Australian footprint and into Europe, with GCT providing the multinational clinical infrastructure required to support the program’s future registrational ambitions.

GCT was selected through a competitive evaluation process that assessed international oncology expertise, regulatory capabilities, operational execution, clinical quality systems, and global logistics infrastructure. Following its appointment, GCT completed key regulatory submissions ahead of schedule and has initiated clinical operations, regulatory coordination, site activation activities, investigational product logistics, and study management functions. The CRO’s established international execution capabilities were identified as a core requirement for a program seeking to build the clinical, operational, and regulatory infrastructure necessary to support future multinational Phase 3 development.

Sapu003 is a proprietary intravenous formulation of everolimus developed using Sapu Nano’s Deciparticle™ nanomedicine platform, which is designed to formulate highly water-insoluble therapeutics into ultra-small nanoparticles for intravenous administration. The program is designed to address limitations associated with oral everolimus, including variable absorption, food effects, and first-pass metabolism — delivering more predictable systemic drug exposure through an IV route. SP-03-B101 is an open-label Phase 1b dose-escalation study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of Sapu003 in an advanced solid tumor patient population with mTOR pathway sensitivity.

The CRO transition and geographic expansion follow recent regulatory approvals supporting the program’s international extension. By establishing an international clinical network at the Phase 1b stage, Sapu Nano is positioning Sapu003 for efficient advancement into global registrational studies following completion of ongoing clinical evaluation, rather than building multinational infrastructure at a later, more costly stage of development. The expanded CRO platform established through GCT is expected to support continued enrollment, future site expansion, and the company’s long-term global development objectives for the Sapu003 program.

“Sapu003 has progressed from concept through formulation development, manufacturing, regulatory approval, and clinical evaluation in a remarkably short period of time. The expansion of the program beyond Australia and the appointment of GCT provide the international infrastructure necessary to support continued clinical development. We believe these milestones position Sapu003 for broader global evaluation and future registrational studies while expanding access for patients with advanced cancers.”

Dr. Vuong Trieu, Chief Executive Officer, Sapu Nano / Oncotelic Therapeutics