Oncotelic Therapeutics (OTLC) Company Report

Oncotelic Therapeutics Inc. announced the advancement of Sapu-003, a novel IV formulation of everolimus, which has received approval to start a Phase 1 clinical trial for breast cancer.
Sapu-003, built on the proprietary Deciparticle™ platform, is designed to deliver 100% of the drug directly to the tumor, aiming to improve bioavailability and reduce gastric toxicity compared to oral Afinitor®.
The company targets the breast cancer market, estimated at $30–40 billion and projected to grow to $50 billion by 2030.
Oncotelic anticipates an accelerated development timeline for Sapu-003, aiming for drug approval within 2–3 years, which is significantly faster than traditional drug development.

Oct 22, 2025, 12:00 PM

Oncotelic Therapeutics' Joint Venture Sapu Nano Initiates Phase 1 Clinical Trial for Sapu-003

OTLC

New Projects/Investments

Product Launch

Sapu Nano, a company formed through a joint venture involving Oncotelic Therapeutics, Inc. (OTLC), announced the initiation of a Phase 1 clinical study in Australia for Sapu-003.
Sapu-003 is a novel intravenous Deciparticle™ Everolimus, an mTOR inhibitor, intended to overcome limitations of oral everolimus in treating advanced HR+/HER2– breast cancer and other mTOR-sensitive tumors.
The trial is now open for enrollment at Australian oncology centers, conducted in collaboration with SOCRU, Ingenū, and Medicilon.
Oncotelic Therapeutics holds a 45% ownership stake in GMP Bio, which is part of the Sapu family of companies.

Oct 8, 2025, 12:30 PM

Oncotelic Therapeutics' Joint Venture Subsidiary Sapu Nano Receives Approval for Sapu003 Clinical Trial

OTLC

New Projects/Investments

Sapu Nano, a subsidiary of a joint venture involving Oncotelic Therapeutics (OTLC), has received approval from the Australian Human Research Ethics Committee (HREC) to begin patient recruitment for a Phase 1 human clinical trial of Sapu003.
Sapu003 is an injectable Everolimus formulation developed to treat breast cancer, designed to overcome the limitations of the oral Afinitor® (Everolimus) by achieving 100% bioavailability through intravenous injection, compared to approximately 10% absorption of the oral form.
This novel intravenous delivery method, utilizing Sapu Nano's proprietary Deciparticle™ technology, aims to deliver Everolimus with full efficacy, potentially leading to more significant tumor shrinkage and improved long-term disease control for breast cancer patients than current oral treatments.

Sep 30, 2025, 12:00 AM

Oncotelic Therapeutics Highlights Clinical and Regulatory Advancements

OTLC

New Projects/Investments

Oncotelic Therapeutics (OTLC) summarized two years of significant clinical progress and regulatory validation across its late-stage pipeline, as of September 12, 2025.
Key pipeline advancements include OT-101 in Phase 3 for pancreatic cancer, OXi4503 in Phase 2 for AML/MDS and advancing toward Phase 3 design, and AL-101 in Phase 2 for Parkinson's disease and sexual dysfunctions.
The company is also advancing pediatric rare disease programs with potential for Priority Review Vouchers and a nanomedicine pipeline utilizing the 505(b)(2) pathway.
Oncotelic Therapeutics holds a 45% ownership stake in GMP Bio, a joint venture led by its CEO, Dr. Vuong Trieu, which expands its portfolio in oncology and rare diseases.