On February 10, 2026 Oncotelic Therapeutics, Inc. (OTCQB: OTLC) ("Oncotelic" or the "Company"), a clinical-stage biopharmaceutical company focused on oncology, immunotherapy, and CNS-related diseases, reported an update on key development progress achieved during 2025 and outlined its strategic direction as the Company enters 2026 with continued momentum across its pipeline.
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2025: Continued Execution Across a Late-Stage, Diversified Pipeline
Oncotelic transitioned from platform build-out to execution and validation, advancing AI-driven discovery (PDAOAI), moving key assets into the clinic, publishing high-impact translational science, and reinforcing asset value through independent validation. Collectively, these milestones establish a strong foundation for late-stage development, partnering, and strategic financing.
Oncotelic Therapeutics – 2025 Key Accomplishments
1. Platform Innovation & AI Enablement (PDAOAI)
In 2025, Oncotelic formally unveiled PDAOAI, its proprietary AI-enabled knowledge platform built on a comprehensive TGF-β-centric corpus. The platform was expanded to support interactive querying, biomarker discovery, and translational hypothesis generation, and was publicly introduced alongside peer-reviewed GBM and pancreatic cancer research. PDAOAI now functions as a cross-program decision-support layer integrating molecular biology, clinical outcomes, and regulatory-grade literature.
2. Clinical Progress & First-in-Human Readiness
Oncotelic achieved multiple clinical milestones across its pipeline. The company successfully completed a Phase 1 clinical trial of OT-101 in combination with IL-2. In parallel, its IV everolimus Deciparticle program (Sapu-003) advanced from preclinical development into first-in-human clinical testing.
3. Deciparticle Platform Validation (Sapu-003)
Throughout 2025, Oncotelic released a coordinated body of data validating the Deciparticle platform:
Demonstrated broad applicability across hydrophobic small-molecule drug classes
Reported favorable PK and tissue-distribution profiles, including reduced gastrointestinal accumulation compared with oral everolimus
Introduced a biomarker-guided framework to identify patient populations most likely to benefit from IV mTOR inhibition
These results position Deciparticle as a differentiated delivery technology for oncology and other systemic indications.
4. Peer-Reviewed Science & Biomarker Leadership
Oncotelic and collaborators published multiple peer-reviewed studies in 2025, reinforcing the company’s leadership in TGFB2-centric biology. Key publications linked TGFB2 expression and methylation status to survival outcomes in pancreatic cancer, glioblastoma, and liver cancer, including age- and context-dependent effects. Additional work reviewed sub-20 nm nanoparticle design principles, supporting the scientific rationale behind the Deciparticle platform.
5. Strategic Partnerships & Global Development Infrastructure
The company entered a strategic partnership with Medicilon to access rapid IND-enabling capabilities. These capabilities complement Oncotelic’s global regulatory strategy.
6. Corporate Development, Valuation & Visibility
In 2025, an independent third-party analysis valued the GMP Bio joint-venture pipeline at approximately $1.7 billion, materially strengthening Oncotelic’s asset-level valuation narrative. The company increased capital-markets visibility through various investor presentations, while continuing disciplined communication around pipeline maturation and platform leverage.
Looking Ahead to 2026: Sustained Momentum, Strategic Execution, and Value Recognition
As the Company enters 2026, Oncotelic plans to build on the progress achieved in 2025 with an emphasis on continued development momentum, thoughtful capital allocation, strategic execution, and increased financial transparency. The Company’s forward priorities include:
Advancing clinical programs toward their next inflection points
Further evaluating regulatory and development pathways across oncology and CNS indications
Exploring partnership, licensing, and collaboration opportunities aligned with its late-stage assets
Continuing to strengthen operational readiness to support future growth initiatives
Completing a second independent U.S.-based valuation to support the remeasurement of its 45% equity interest in the GMP Bio joint venture, with the resulting valuation expected to be reflected on the Company’s balance sheet upon completion, subject to applicable accounting standards
Oncotelic believes its steady progress in 2025 has positioned the Company with a clear development trajectory, enhanced asset visibility, and multiple opportunities to unlock long-term value.
(Press release, Oncotelic, FEB 10, 2026, View Source [SID1234662575])