Oncotelic Therapeutics (OTCQB: OTLC), alongside Sapu Nano, announced that the first patient has been dosed in the Phase 1b clinical trial evaluating Sapu003, an investigational intravenous Deciparticle(TM) formulation of everolimus for patients with advanced mTOR-sensitive solid tumors. The open-label, dose-escalation study is designed to assess safety, tolerability, pharmacokinetics and preliminary anti-tumor activity across patient cohorts including HR-positive/HER2-negative breast cancer and multiple additional tumor types, with Sapu003 developed as a weekly IV formulation intended to address limitations associated with oral everolimus delivery, including variable absorption and dose-limiting toxicity.

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About Oncotelic Therapeutics, Inc.

Oncotelic Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development of oncology and immunotherapy products. The Company’s mission is to address high-unmet-need cancers and rare pediatric indications with innovative, late-stage therapeutic candidates.

In addition to its directly owned and developed drug pipeline, Oncotelic benefits from a robust portfolio of inventions created by its CEO, Dr. Vuong Trieu, who has filed over 500 patent applications and holds 75 issued patents. The Company also leverages its proprietary AI-enabled PDAOAI platform, which supports research, biomarker discovery, and regulatory processes through advanced data analysis and knowledge integration.

Beyond its internal programs, Oncotelic licenses and co-develops select drug candidates through strategic partnerships and joint ventures. The Company currently owns a 45% interest in GMP Bio, a joint venture advancing a complementary pipeline of therapeutic candidates that further strengthens Oncotelic’s position in oncology and rare disease therapeutics.

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

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