Oncotelic Therapeutics, Inc. Showcases Multi-Year Execution and Validation, Enters 2026 with Late-Stage Momentum Across Diversified Pipeline

Rhea-AI Summary

Oncotelic Therapeutics (OTLC) reported 2025 progress and set priorities for 2026, highlighting platform validation, clinical advancement, and asset valuation.

Key 2025 achievements include unveiling the PDAOAI knowledge platform, completing a Phase 1 OT-101 combination trial, initiating first-in-human testing of IV everolimus Deciparticle (Sapu-003), multiple peer-reviewed publications, a Medicilon partnership for IND-enabling work, and an independent valuation of the GMP Bio JV pipeline at approximately $1.7 billion.

Positive

• Independent third-party valuation pegged GMP Bio JV pipeline at $1.7 billion
• Completed Phase 1 trial of OT-101+IL-2, demonstrating clinical progression
• Initiated first-in-human testing of IV everolimus Sapu-003 (Deciparticle)
• Launched PDAOAI AI-enabled platform for biomarker discovery and translational support
• Strategic partnership with Medicilon for rapid IND-enabling capabilities

Negative

• Remeasurement of 45% GMP Bio equity interest depends on a second valuation and applicable accounting rules

AGOURA HILLS, Calif., Feb. 10, 2026 (GLOBE NEWSWIRE) -- via IBN — Oncotelic Therapeutics, Inc. (OTCQB: OTLC) (“Oncotelic” or the “Company”), a clinical-stage biopharmaceutical company focused on oncology, immunotherapy, and CNS-related diseases, today provided 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.

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.

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CEO Commentary

“2025 was a year of continued execution and foundation-building for Oncotelic,” said Dr. Vuong Trieu, Chairman and Chief Executive Officer of Oncotelic. “We advanced a diversified pipeline with prior late-stage clinical experience while maintaining focus on areas of significant unmet medical need. As we move into 2026, our team remains fully engaged and energized, with a clear commitment to disciplined development, strategic flexibility, and long-term value creation for patients and shareholders.”

About Oncotelic Therapeutics

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 the robust portfolio of inventions created by its CEO, Dr. Vuong Trieu, who has filed over 500 patent applications and holds 75 issued U.S. patents. Beyond its internal programs, the Company also licenses and co-develops select drug candidates through joint ventures. Currently, Oncotelic owns 45% of GMP Bio, a joint venture under Dr. Trieu’s leadership and guidance, which is advancing its own pipeline of drug candidates that further complement and strengthen Oncotelic’s strategic position in oncology and rare disease therapeutics.

For more information, please visit: www.oncotelic.com

Oncotelic Cautionary Note on Forward‑Looking Statements

This press release contains forward‑looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this release other than statements of historical fact are forward‑looking and are based on current expectations, estimates, and projections about our business and future plans. In some cases, you can identify forward‑looking statements by terms such as “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “project,” “forecast,” “potential,” “continue,” and similar expressions (including the negative of such terms).

Forward‑looking statements in this release include, without limitation: our plans, timelines, and priorities for the OT‑101 program in PDAC and other indications; potential biomarker‑driven development strategies; the advancement, scope, timing, and results of current or future preclinical and clinical studies; regulatory interactions and potential approvals; development or commercialization of any product candidates within the Oncotelic/GMP Bio/Sapu ecosystem; the utility of our PDAOAI platform; future financings, strategic transactions, and/or public offerings involving our joint ventures or affiliates; and other statements that are not historical facts. Actual results may differ materially from those indicated by such forward‑looking statements as a result of various important factors, including, but not limited to: the inherent uncertainties of drug discovery and development; our ability to enroll patients and complete studies on expected timelines; whether preclinical or early clinical findings (including biomarker associations) will be replicated in larger, controlled trials; regulatory developments in the United States and other jurisdictions; competitive developments; our ability to obtain or maintain intellectual property protection; our liquidity and access to capital; the performance of collaborators, suppliers, and manufacturers; and other risks described in our filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” section of our most recent Form 10‑K and subsequent periodic reports.

Forward‑looking statements speak only as of the date of this press release, and we undertake no obligation to update or revise such statements, whether as a result of new information, future events, or otherwise, except as required by law.

Investor & Media Contact
Oncotelic Therapeutics, Inc.
Investor Relations
ir@oncotelic.com

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Austin, Texas
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FAQ

What clinical milestones did Oncotelic (OTLC) achieve in 2025?

Oncotelic completed a Phase 1 trial of OT-101 with IL-2 and initiated first-in-human testing of IV everolimus Sapu-003. According to the company, these steps advance late-stage readiness and support translational validation across its oncology pipeline.

What is PDAOAI and how does it affect Oncotelic (OTLC) drug discovery?

PDAOAI is Oncotelic's proprietary AI-enabled knowledge platform for TGF-β–centric biology. According to the company, it supports interactive querying, biomarker discovery, and translational hypothesis generation across programs, enhancing decision support for development.

What does the $1.7 billion GMP Bio valuation mean for Oncotelic (OTLC)?

An independent analysis valued the GMP Bio joint-venture pipeline at about $1.7 billion, strengthening asset-level valuation. According to the company, this valuation materially supports Oncotelic's asset narrative and investor visibility.

How will Oncotelic (OTLC) use the Medicilon partnership announced in 2025?

The partnership provides rapid IND-enabling capabilities to accelerate regulatory submissions and clinical starts. According to the company, Medicilon complements global development infrastructure to speed transition from preclinical to first-in-human studies.

When will Oncotelic (OTLC) reflect the remeasured value of its GMP Bio interest on the balance sheet?

Oncotelic plans a second independent U.S. valuation to remeasure its 45% equity interest in GMP Bio, with the result expected to be reflected upon completion. According to the company, recognition is subject to applicable accounting standards and timing.