On April 16, 2026 Oncotelic Therapeutics, Inc. (OTCQB:OTLC) ("Oncotelic", the "Company" or "We"), a clinical-stage biopharmaceutical company developing drugs for the treatment of orphan oncology indications, as well as antisense and small molecule injectable drugs for the treatment of cancer, reported its financial results for the fiscal year ended December 31, 2025 ("FY 2025"), as compared to the fiscal year ended December 31, 2024 ("FY 2024"). The financial results are based on the 2025 Annual Report on Form 10-K ("Form 10-K") as filed with the Securities and Exchange Commission ("SEC") on April 15, 2026. The Company recorded net income after tax of approximately $249.0 million, compared to a net loss of approximately $4.8 million in the prior year. The net income was primarily driven by a non-cash increase in the estimated fair value of the Company’s investment in GMP Biotechnology Limited ("GMP Bio"), its joint venture ("JV"), of approximately $365.4 million, as determined by an independent third-party ASC-compliant valuation, partially offset by a deferred income tax provision of approximately $111.6 million.
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Highlights for FY 2025 and thereafter:
2025 marked a transformational year for Oncotelic, highlighted by the successful completion of its first combination immunotherapy trial, the formalization of Sapu Bio and Sapu Nano, subsidiaries of GMP Bio, in which the Company has 45% equity interests. Additional achievements included dedicated development platforms, expansion of the Company’s AI-enabled research capabilities, and continued advancement of its joint venture programs.
Joint Venture Valuation and Investment
In November 2025, the Company recorded a non-cash increase in the fair value of its investment in GMP Biotechnology Limited based on an independent third-party valuation, resulting in a gain of approximately $365.4 million and a carrying value of approximately $388.0 million. This increase reflects estimated development progress and market-based assumptions and does not represent product revenue or cash received. A corresponding deferred income tax liability of approximately $111.6 million was recorded.
Sapu Bio and Sapu Nano: Dual-Platform Strategy
During 2025, GMP Bio formalized its two primary subsidiaries. Sapu Bio concentrates on OT-101 (TGFβ2 antisense) clinical development, regulatory advancement, and biomarker-driven positioning. Sapu Nano serves as the dedicated nanomedicine arm of the JV, advancing the Deciparticle platform into clinical-stage assets, partnerships, and commercialization. Together they form a diversified and scalable development platform.
Deciparticle Nanoparticle Platform
The Deciparticle platform utilizes ultra-small amphiphilic constructs (below ~20 nanometers) enabling enhanced tumor penetration and distribution. The JV is advancing six candidates: Sapu-001 (paclitaxel), Sapu-003 (everolimus), Sapu-004 (carboplatin), Sapu-005 (palbociclib), and Sapu-006 (docetaxel), in addition to OT-101. Everolimus formulation development is complete with a global clinical trial enrolling in Australia. Palbociclib and docetaxel INDs are expected in 2026. The platform is protected by more than 15 patent families.
OT-101 Clinical Program
In March 2025, we completed a Phase 1 clinical trial (NCT04862767) evaluating OT-101 in combination with IL-2 in Seoul, South Korea for advanced or metastatic solid tumors. The combination showed a tolerable safety profile with no unexpected safety signals. The JV plans to advance OT-101 plus IL-2 into further studies exploring synergies with checkpoint inhibitors such as PD-1 blockers. Separately, the JV initiated a Phase 2/3 trial for OT-101 in pancreatic cancer and is actively enrolling participants. Over ten patent families have been filed related to TGFβ2 as a prognostic indicator for cancer survival.
PDAOAI ("AI") Platform
PDAOAI, the Company’s proprietary AI-enabled knowledge platform, was significantly expanded during 2025 into a core infrastructure layer supporting research, biomarker discovery, and regulatory documentation. By late 2025, PDAOAI evolved into a large-scale knowledge platform built around a TGF-β-centric biomedical corpus of over 100,000 curated abstracts with semantic retrieval and cross-referencing capabilities. PDAOAI contributed to at least seven peer-reviewed publications during 2025 across biomarker discovery, tumor microenvironment analysis, nanoparticle drug delivery, and clinical outcome correlations — spanning ovarian, breast, pancreatic, hepatocellular, and glioblastoma tumor types. Notably, the Company identified a novel biomarker signature (High RICTOR / Low RPTOR) predictive of sensitivity to intravenous everolimus based on analysis of over 9,000 tumor samples.
GMP Manufacturing Facility
The JV’s GMP manufacturing facility in San Diego continued full-scale operations during 2025 under its Drug Manufacturing License from the State of California. The facility utilizes a streamlined "one-pot" manufacturing process for bulk drug production through to finished product, with capabilities for both nonclinical and Phase 1 clinical trial material production. In early 2025, the Company partnered with Shanghai Medicilon, Inc. to access its rapid IND development platform supporting up to 20 IND projects.
Results of Operations
Below is a presentation of our financial results comparing FY 2025 to FY 2024 and based on our results published in our Form 10-K filed with the SEC on April 15, 2026.
(Press release, Oncotelic, APR 16, 2026, View Source [SID1234664434])