What Oncotelic does

Oncotelic Inc. is a clinical-stage immuno-oncology company developing RNA therapeutics, small-molecule drugs, and nanomedicine delivery systems for cancer and infectious diseases, trading on the OTCQB under ticker OTLC. The lead therapeutic candidate, OT-101 (Trabedersen), is a phosphorothioate antisense oligodeoxynucleotide targeting TGF-β2 mRNA, currently in Phase 3 development for glioblastoma and Phase 2b/3 for pancreatic cancer (STOP-PC trial combining with mFOLFIRINOX). The company has secured three FDA Rare Pediatric Disease Designations (OT-101/DIPG, CA4P/melanoma, OXi4503/AML) and is advancing a Deciparticle nanomedicine platform with six nanoparticle candidates; Sapu003, an IV Deciparticle formulation of everolimus, entered a Phase 1b trial in May 2026 with the first patient dosed. Additional pipeline assets include CA4P (vascular disrupting agent), OXi4503, and AL-101/N2B intranasal nose-to-brain delivery for CNS disorders.

The company's differentiating technology layer is PDAOAI, an AI knowledge discovery platform indexing approximately 28 million PubMed abstracts refreshed daily on Qdrant vector infrastructure, using proprietary clustering, manifold folding, and shell-sampling methods (covered by PCT/US2024/057972) to identify upstream disease drivers rather than proximity matches. PDAOAI is also deployed as a robotics knowledge layer integrated with TechForce Robotics' PUR-E cleanroom robot and LIM-E logistics robot for GMP pharmaceutical manufacturing, where it automates batch-record execution through a Kebbi voice interface. The company operates through three entities: wholly-owned subsidiaries Sapu Bio and Sapu Nano, and a 45%-owned joint venture GMP Bio valued at over $1 billion enterprise value with planned Hong Kong IPO.

Oncotelic's revenue model is a mix of (i) future drug development licensing and royalty income from its therapeutic pipeline, (ii) AI-enabled GMP manufacturing services commercialized with TechForce Robotics targeting pharmaceutical manufacturers at subscription pricing tied to facility throughput, and (iii) equity value recognition from the GMP Bio JV. Currently the company has no disclosed product revenue — FY2025 net income of $249M was driven by a $365.4M non-cash JV revaluation gain — and operates as a pre-commercial biotech funded by equity rounds, most recently $12.5M in May 2026. GTM is enterprise B2B and event-driven, centered on BIO International Convention, AACR, SNO, and SITC conference presence to source partnership and licensing deals.

Name

Oncotelic

Legal name

Oncotelic Inc.

Website

https://oncotelic.com

Company type

Public

Founded year

2020

Operating status

Operating

Headcount range

11–50 employees

Short description

Oncotelic is a clinical-stage immuno-oncology company developing TGF-β antisense (OT-101), Deciparticle nanomedicines (Sapu003), and the PDAOAI AI platform for drug discovery and GMP manufacturing automation, serving pharmaceutical manufacturers and oncology patients through licensing and partnership channels.

Ownership category

akta.pro rank

Product category

Biopharmaceutical Drug Development

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Pharmaceutical Preparation Manufacturing (325412), Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical and Medicine Manufacturing (3254)

SIC

Pharmaceutical Preparations (2834), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

RNA Therapeutics Clinical Development (trial design, endpoints, patient stratification) (HLAAADAH)

akta.pro secondary industries

RNA Therapeutics Platforms & Design (sequence design, target ID/validation, AI/bioinformatics) (HLAAADAG), AI/ML Platforms for Drug Discovery & Experiment Optimization (HLAGAJAO), RNA Manufacturing & CMC (oligo synthesis, IVT, purification, formulation, QC) (HLAAADAF), GMP Scale-Up, Tech Transfer & Process Validation (PPQ) (HLAGAHAL)

Keywords

• Immuno-oncology therapeutics
• Antisense RNA therapeutics
• Nanomedicine drug delivery
• AI drug discovery platform
• GMP pharmaceutical manufacturing

Headquarters

HQ city

Agoura Hills

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales

Revenue model

1. Pharmaceutical Manufacturing Services: Revenue from AI-powered GMP manufacturing services platform commercialized with TechForce Robotics, targeting pharmaceutical and biotech manufacturers for batch record automation, material handling, and compliance workflows.
2. Drug Development Licensing: Licensing revenue potential from proprietary drug candidates including OT-101, Deciparticle formulations, and AI platform technology. Company positions assets for partnership and M&A given industry shift toward clinical-stage programs.
3. Joint Venture Equity Value: Company holds 45% stake in GMP Bio joint venture, recently valued at over $1 billion enterprise value, with plans for Hong Kong IPO. FY2025 net income of $249M driven primarily by $365.4M non-cash gain from JV revaluation.

Pricing tiers

Go-to-market motion2 records

Distribution channels5 records

Marketing channels9 records

Core offering

Oncotelic is a clinical-stage biopharmaceutical company developing first-in-class RNA therapeutics (notably OT-101, a TGF-β2 antisense oligodeoxynucleotide) and small molecule drugs against cancer and infectious diseases, alongside its proprietary Deciparticle nanomedicine delivery platform. The company also operates the PDAOAI AI-powered drug discovery and GMP manufacturing platform, which indexes approximately 28 million PubMed abstracts and integrates with autonomous robotics (PUR-E, LIM-E) to compress drug development timelines and automate cGMP manufacturing workflows for pharmaceutical manufacturers.

Product overview

Oncotelic Therapeutics is a clinical-stage biopharmaceutical company developing a portfolio of cancer and infectious disease treatments alongside an AI-powered drug development and manufacturing platform. The core technology is the PDAOAI platform, which includes a Knowledge Discovery module for biomedical literature analysis (~28 million PubMed abstracts) and a Robotics module integrating autonomous robots (PUR-E for cleanroom operations and LIM-E for logistics) for GMP manufacturing. The therapeutic pipeline centers on OT-101 (TGF-β2 antisense, Phase 3 for glioblastoma and pancreatic cancer), the Deciparticle nanomedicine platform (including Sapu003 IV everolimus in Phase 1b), CA4P vascular disrupting agent, Oxi4503 for leukemia, and AL-101/N2B for CNS disorders. The company operates through a 45%-owned joint venture GMP Bio comprising Sapu Bio (cGMP manufacturing) and Sapu Nano (nanomedicine development).

Differentiator

Problem solved

Functional benefit

Brands

• PDAOAI: AI-augmented literature intelligence platform for precision oncology research and GMP manufacturing, indexing 28 million PubMed abstracts
• Deciparticle
• OT-101
• Pet2DAO

Products and services

• PDAOAI Knowledge Discovery Platform AI-powered structural intelligence platform that indexes approximately 28 million PubMed abstracts to surface root disease drivers (genes, mechanisms, themes) rather than proximity matches. Built on Qdrant vector infrastructure. Targeted at pharmaceutical and biotech R&D teams seeking accelerated target identification and drug repurposing.
• PDAOAI GMP Manufacturing Services Platform AI-enabled manufacturing platform integrating PDAOAI software with TechForce Robotics autonomous hardware (PUR-E cleanroom robot and LIM-E logistics robot) for pharmaceutical manufacturers. Automates batch record execution, documentation, quality management, material handling, and process monitoring in cGMP environments, reducing batch-record review time by 40-50% and manual data entry by 60%.
• OT-101 (Trabedersen) Novel phosphorothioate antisense oligodeoxynucleotide targeting TGF-β2 mRNA for treatment of solid tumors including glioblastoma, DIPG, pancreatic cancer, colorectal cancer, and melanoma. Converts immunosuppressive M2 macrophages into pro-inflammatory M1 macrophages and synergizes with PD-1 checkpoint inhibitors. FDA Rare Pediatric Disease Designation for DIPG.
• Deciparticle Nanomedicine Platform Sub-100nm nanoparticle drug delivery platform that improves pharmacokinetics, tumor accumulation, and therapeutic efficacy of existing oncology drugs. Forms the foundation for multiple product candidates including Sapu003 (IV everolimus) and other candidates with IND filings expected in 2026.
• Sapu003 Investigational intravenous Deciparticle formulation of everolimus (mTOR inhibitor) designed to treat advanced mTOR-sensitive solid tumors including HR+/HER2- breast cancer, renal cell carcinoma, neuroendocrine tumors, TSC-associated tumors, and hepatocellular carcinoma. Phase 1b trial evaluating safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity at dose levels of 5 mg/m², 7.5 mg/m², and 10 mg/m² administered IV once weekly.
• CA4P (Fosbretabulin) Vascular disrupting agent being developed in combination with Ipilimumab for treatment of solid tumors with focus on melanoma in adult and pediatric patients. FDA Rare Pediatric Disease Designation for stage IIB-IV melanoma.
• Oxi4503 Second-generation vascular disrupting agent (combretastatin A1-diphosphate; CA1P) for treatment of liquid tumors with focus on childhood leukemia. FDA Rare Pediatric Disease Designation for acute myeloid leukemia (AML).
• AL-101 Intranasal delivery of Apomorphine for treatment of Parkinson's Disease (nose-to-brain drug delivery bypassing blood-brain barrier). Also being developed for Erectile Dysfunction (targeting treatment failures of PDE5 inhibitors) and Female Sexual Dysfunction.

Quantifiable outcome

• Drug development timeline compressed from 4-7 years to under 2 years
• +6 more outcomes

Named customers2 records

Segments4 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability8 records

Feature6 records

Partnerships

Seven partnerships are on record, tiered core, flagship and minor.

• QdrantcoreTechnology or Integration · 8 June 2026Infrastructure partnership for PDAOAI platform. Qdrant provides vector database infrastructure enabling the platform to run 28 million PubMed abstracts in production with hybrid search, payload filtering, HNSW indexing, quantization, and TurboQuant capabilities. Joint presentation at Qdrant Vector Space Day 2026 keynote.
• TechForce RoboticsflagshipStrategic or Co-development Partner · 2 April 2026Strategic partnership to commercialize PDAOAI-enabled GMP-compliant robotics platform for pharmaceutical manufacturing. The integrated platform combines Oncotelic's proprietary AI capabilities with TechForce's autonomous robots (PUR-E cleanroom robot and LIM-E logistics robot) to automate material handling, real-time monitoring, and compliance workflows in regulated manufacturing environments. Phase 1 completed with LIM-E logistics deployment; Phase 2 underway with PUR-E deployment at SAPU Bio OEB-5 sterile injectable cGMP facility.
• Cromos PharmacoreImplementation/ SI/ Consulting PartnerCRO partnership for STOP-PC Phase 2b/3 trial of OT-101 in pancreatic cancer. Cromos Pharma conducting multi-country clinical trial combining OT-101 with mFOLFIRINOX.
• Nebraska MedicinecoreImplementation/ SI/ Consulting PartnerPhase I/II trial (ONC740 24) investigating OT-101 in combination with pembrolizumab as first-line therapy for newly diagnosed PD-L1 positive advanced non-small cell lung cancer (NSCLC). Dr. Omar Abughanimeh as Principal Investigator.
• Autotelic Inc.minorStrategic or Co-development PartnerCEO Trieu Vuong holds indirect beneficial ownership through Autotelic Inc. and spouse. Autotelic appears related to company's Korean operations including IL-2 combination therapy partner.
• California Life SciencesminorGTM or Marketing PartnerSAPU Bioscience is a member of California Life Sciences. Company exhibits at CLS Pavilion (Booth #1525) at BIO 2026.
• GMP Bio (45% Owned JV)flagshipStrategic or Co-development PartnerJoint venture advancing complementary drug candidates in oncology and rare disease therapeutics. Includes subsidiaries Sapu Bio (OEB-5 sterile injectable cGMP manufacturing) and Sapu Nano (nanomedicine development). Recently valued at over $1 billion enterprise value with plans for potential Hong Kong IPO.

Scale indicators10 records

Recent moves8 records

Expansion highlights7 records

Direct peers

• Wave Life Sciences: Clinical-stage RNA therapeutics company developing stereopure antisense and RNAi oligonucleotides. Comparable as a direct RNA therapeutics peer in similar stages of clinical development with similar modality (synthetic oligonucleotides) to OT-101.
• Compugen: AI/computational platform-driven immuno-oncology company developing therapeutics against novel targets. Comparable to Oncotelic as a clinical-stage company combining computational target identification with immuno-oncology drug development.
• Schrödinger Inc. AI-driven computational drug discovery platform serving pharmaceutical and biotech customers. Directly comparable to PDAOAI as a software-and-services platform applying proprietary computational methods to compress drug discovery timelines.
• Alnylam Pharmaceuticals: Leading commercial-stage siRNA therapeutics company with approved RNA-targeted drugs. Directly comparable as a clinical-stage-to-commercial RNA therapeutics platform targeting serious diseases with a similar underlying modality logic to Oncotelic's OT-101 antisense approach.
• Ionis Pharmaceuticals: Pioneer in antisense oligonucleotide RNA therapeutics, the same modality as Oncotelic's lead OT-101. Ionis has approved antisense drugs and a deep clinical pipeline targeting neurological, cardiovascular, and metabolic diseases, making it the most directly comparable peer in antisense RNA drug development.
• Exscientia: AI-driven drug design company focused on accelerating small molecule discovery from concept to candidate. Directly comparable to PDAOAI's positioning as an AI platform compressing early-stage discovery timelines through proprietary computational methods.
• Recursion Pharmaceuticals: AI-driven drug discovery company combining high-throughput biology with machine learning to identify novel therapeutics. Comparable to Oncotelic's positioning as a technology-augmented clinical-stage biotech where AI is claimed to compress traditional development timelines.

Emerging players

• Bolt Biotherapeutics: Clinical-stage immuno-oncology company developing bispecific immune-stimulating antibody conjugates. Comparable to Oncotelic as a clinical-stage oncology platform with novel immune-engagement mechanisms and similar pipeline maturity.
• Arcus Biosciences: Clinical-stage immuno-oncology company developing combination therapies targeting the tumor microenvironment, including TGF-β and related immunosuppressive pathways. Comparable to Oncotelic's focus on overcoming immune evasion mechanisms in solid tumors.

Broad incumbents

• Sorrento Therapeutics: Diversified biopharmaceutical company with broader oncology, immunology, and infectious disease assets. Comparable as a broader immuno-oncology and antibody therapeutics incumbent with historical connection to Oncotelic's CEO (formerly CSO/Board Director following the Igdrasol merger).

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• Xx.com/oncotelic
• YouTubeyoutube.com/channel/UCtbhx7gbXvhY_Yr_eKH_UCg
• Facebookfacebook.com/profile.php
• LinkedInlinkedin.com/company/oncotelic

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Subsidiaries4 records

Funding overview

Funding rounds3 records

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A3 records

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Oncotelic