Oncotelic Therapeutics Inc · OTC:OTLC
Oncotelic Therapeutics — Investor Presentation (October 2025)
37 slides from Oncotelic Therapeutics's investor presentation, Oct 22, 2025
Slide 1: Corporate presentation October 2025
October 2025 Corporate presentation
Slide 2: Forward-looking Statements
Forward-looking Statements * This press presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding strategy, future operations, future
Slide 3: Oncotelic Therapeutics Corporate overview
ONCOTELIC Oncotelic Therapeutics Corporate overview
Slide 4: Management Team
Management Team O 2 cy) Vuong Trieu PhD (CEO): Founder/CEO/Chairman of IgDrasol; CSO/Director of Sorrento Therapeutics [SRNE]; Founder/CEO/Executive Chairman of Marina Biotech [MRNA]; Founder/CEO/Chairman of Oncotelic Inc [OTLC]- a developer of TGF-beta antisense with potential to cure cancer; PhD i
Slide 5: Current Pipeline
Current Pipeline ST reat Bevetopment Ta eTTE TT TWVISpno” TE OT-101 TGFB2 Antisense/Nanomedicine Platform Ocular Oncology/ CA4P and TLR10 Platform AI/LLM Platform ED/Aging/Parkinson “+ We acquire and/or develop cutting edge technologies for spin off as JV, de novo spin off, or licensing “+ Sharehold
Slide 6: Recent Highlights
Recent Highlights * Sapu SD Facility * Sapu Nanomedicine * ast Permitted Deciparticle GMP manufacturing ¢ Sub 20nm deciparticles with novel emerging Facility properties ¢ Antineoplastic lyophilized injectable * go% success rate of over 100 tested water * Formulation to phase 1 drug products insolubl
Slide 7: Oncotelic
872 ONCOTELIC
Slide 8: Deciparticles
DECIPARTICLES NANOMEDICINE PLATFORM DEVELOPED BY SAPU NANO
Slide 9: Deciparticle Platform
es DECIPARTICLE PLATFORM Excipient Solvent P Proprietary excipients to stabilize the nanoparticles during manufacturing -at least 24 hrs to allow for sterile processing + Proprietary Ternary systems to achieve stability of the API and facilitating formation of nanoparticles Process + Multiple proces
Slide 10: Superior Clinical Performance - The Team History in Nanomedicine
SUPERIOR CLINICAL PERFORMANCE- THE TEAM HISTORY IN NANOMEDICINE Generation * —_ —— gst Taxol® ° Formulation eee MTD paclitaxel Cremophor EL excipient: Dose (MTD) Polyoxyethylated castor oil 175 ° oe , - Adverse reactions, including mg/m? anaphylactic shock oN Biological polymer: > Qnd Abraxane® Mean
Slide 11: Pharmacokinetics of Paclitaxel Nanoparticles
PHARMACOKINETICS OF PACLITAXEL NANOPARTICLES We examined the PKs of Abraxane, IG-001, Taxol and a known stable nanoemulsion of paclitaxel (Tocosol—company code = I|G-004/ IG-002). |G-004 has a higher plasma AUC than Taxol; whereas IG-001 and Abraxane have lower plasma AUC than Taxol. IG-001 range fo
Slide 12: Size: Abraxane and Cynviloq
SIZE: ABRAXANE AND CYNVILOQ Abraxane & 1G-004/Cynvilog -Blood nanoparticle = 7nm -Blood nanoparticle = 7nm -Biological Polymer -Chemical Polvmer -@ PBS 7 PBS -® Serum (0.1X)} -@® Serum (0.1X)} 250, @ Serum (1X 30, -@ Serum (1X) - ee E200 = £ = 20 2150 R a an o 3100 3 49 5 5 a 50 o @ 0 0+ r r r 40000
Slide 13: MOA for Abraxane and Cynviloq and Sapu-001
MOA FOR ABRAXANE AND CYNVILOQ AND SAPU-001 (DECIPARTICLES PACLITAXEL) & 5 | Paclitaxel induces cell death and tumor mass reduction 1 1G-001/Abraxane disintegrates in the patient's bloodstream and becoming m Deciparticles Enrichment of paclitaxel deciparticles in the tumor is mediated by fenestration
Slide 14: Deciparticles Is an Unexplored Formulation Space
Size (nm) DECIPARTICLES IS AN UNEXPLORED FORMULATION SPACE = Only 23% of publications (2000 out of 8600) are deciparticles. And of that only 0.7% is made up of Polymeric micelles (60 publications) >" Liposomes 16 Polymeric Micelles ~ aire Deciparticles _N - 1 Colloids 0.254 0 2000 4000 6000 8000 Ant
Slide 15: Why Ultrasmall Matters
WHY ULTRASMALL MATTERS = When the entire construct is below =20 nm, the particle approaches the size of biological molecules (Leifert et al., 2013) and begins to behave like a molecular drug rather than a colloid. = Such particles can circulate in the body largely undetected by the immune system (Jo
Slide 16: Sapu-001 Deciparticle Paclitaxel
SAPU- 001. SAPU-001 DECIPARTICLE PACLITAXEL Abraxane: 505b(2) pathway versus Taxol. Noninferiority demonstrated in phase 3 trial against breast cancer. Abraxane was acquired by Celgene for 2.9B. Currently it is generating revenue of 1 ""ss9 > 1 billion annually Ss = Abraxane is approved for Metastat
Slide 17: Sapu-001 Improved Safety and Efficacy in Preclinical Models
SAPU-001 IMPROVED SAFETY AND EFFICACY IN PRECLINICAL MODELS = Sapu-001 exhibited improved antitumor activity at equidose (10 mg/kg) and superior activities at higher doses (20 and 40 mg/kg) with minimal impact of weight loss. MDA-MB-231 Xenograft Saline IV, D1,4,8 Taxol 10mg/kg IV, 01,4,8 Sapu001 10
Slide 18: Deciparticle Manufacturing
DECIPARTICLE MANUFACTURING
Slide 19: Sapu San Diego R&D Manufacturing Facility
SAPU SAN DIEGO R&D MANUFACTURING FACILITY —{ Facility Overview: Capacity = 4 new INDs per year }———_ + First-of-its-kind deciparticle ISO 5/ GMP certified drug manufacturing facility for high potency high toxicity antineoplastic drug product. * From early formulation to nonclinical tox to phase 1 cl
Slide 20: Deciparticles Manufacturing Is Fast and Simple
DECIPARTICLES MANUFACTURING IS FAST AND SIMPLE * One pot bulk drug manufacturing follow by fill finish and lyophilization to give the finished drug product —— 145/17 comsas oa a Cap 20
Slide 21: Product Pipeline and Various Investigational New Drug (IND)
PRODUCT PIPELINE AND VARIOUS INVESTIGATIONAL NEW DRUG (IND) SUE rns res nes rns . Proleukin/ P001 — Good efficacy Phase 2b/3 — DIPG/ RPD Phase 2 UK. Voucher Approval ™~ GBM G001-G004/Phase 2 Phase 3 Approval Ready IND on : Good efficacy
Slide 22: Sapu-003: Everolimus for Injection
SAPU-003: EVEROLIMUS FOR INJECTION EXPANSION BEYOND THE INTENDED USE
Slide 23: Sapu-003. Deciparticle Everolimus
SAPU-003. DECIPARTICLE EVEROLIMUS Intravenous mTOR inhibitor was shown to have better tumor accumulation than oral mTOR inhibitor — a i om Fyarro (Albumin Sirolimus/Rapamycin): Originally developed by the Abraxis team and subsequently continued under Aadi Bioscience under Neil Desai- one of the thre
Slide 24: Rationales for Sapu-003
RATIONALES FOR SAPU-003 Fyarro clearly demonstrated superiority of intravenous sirolimus against oral sirolimus. But there are limitations: 1) It is only approved for the treatment of adult patients with locally advanced, unresectable or metastatic malignant perivascular epithelioid cell tumor (PECo
Slide 25: Commonly-Reported Clinical Problems Seen with Everolimus
COMMONLY-REPORTED CLINICAL PROBLEMS SEEN WITH EVEROLIMUS = High overall discontinuation / intolerance rate: Real-world study: “Treatment was stopped in more than 70 % of the cases because of intolerance” (Afani 2020). = Stomatitis / oral ulceration: everolimus is associated with a significantly incr
Slide 26: Weekly Dosing — Improve Safety
WEEKLY DOSING — IMPROVE SAFETY = O'Donnell et al. enrolled 92 patients and opened weekly cohorts at 5, 10, 20, 30, 50 and 70 mg (one oral dose every 7 days) and daily cohorts at 5 and 10 mg (continuous QD) [O’Donnell 2008, Tables 2-3]. = Weekly schedule: * 20mg: 0/5 DLTs ; * 30mg: 0/5 DLTs; * 50mg:
Slide 27: Weekly Dosing — Improve Efficacy
WEEKLY DOSING — IMPROVE EFFICACY = Preclinical data indicated that weekly dosing is as effective at equidose more effective than qd dosing or q4d dosing. = It is likely that weekly dosing allow recovery of TILs/ Tmem needed for immunological rejection of the tumor -@ Saline “® Sapu003-D0,D4,D8 = Sap
Slide 28: Continuous Dosing Negatively Affects TILs
CONTINUOUS DOSING NEGATIVELY AFFECTS TILS Withers HG, et al. J Immunother Cancer 2025;13:e010408. doi:10.1136/jitc-2024-010408. mTOR inhibition modulates vaccine-induced immune responses to generate memory T cells in patients with solid tumors Three phase | clinical trials employing New York esophag
Slide 29: Demonstrated Statistically Significant Benefit for PFS but Not OS
DEMONSTRATED STATISTICALLY SIGNIFICANT BENEFIT FOR PFS BUT NOT OS = Metastatic/advanced clear-cell renal-cell carcinoma after failure of VEGF-TKls = —Phase-Ill RECORD-1 trial: median PFS 4.0-5.5 mo with everolimus vs 1.9 mo with placebo (HR=0.3, p<0.0001) [Motzer 2008; Motzer 2010] = Progressive pan
Slide 30: Sapu-003: Greater Tissue Accumulation
SAPU-003: GREATER TISSUE ACCUMULATION = Sapu-003 is 100% bioavailable versus the limited 10% bioavailability for oral everolimus = Rapid tissue penetration establishing high drug concentration in the target tissues Male+Female 80.083 Male+Female 190.083 8,000 = 5 000 3 ge = = 31.000 EE" £ ES = 3s,00
Slide 31: Sapu-003: A Cytotoxic Agent
SAPU-003: A CYTOTOXIC AGENT = Everolimus —behaves primarily as a cytostatic agent inhibiting tumour growth, rather than regression” (O'Reilly 2011). Its ability to keep residual cells alive while merely arresting proliferation creates an ideal setting for the step-wise emergence of both primary and
Slide 32: Sapu-003: Inhibition of Metabolic Escape Pathways
Salad 003: INHIBITION OF METABOLIC ESCAPE PATHWAYS Glycolysis addicted tumor = add metformin/ Lipid (B) 100% addicted tumor = add statin = Cancer Medicine, Volume: 12, Issue: 5, Pages: 5461-5470, First published: 19 October 2022, DOI: 75% (10.1002/cam4.5369) 2 2 = Patients who did not take statins o
Slide 33: Sapu-003 Mechanism of Action
SAPU-003 MECHANISM OF ACTION Integrated Mechanisms of Sapu-003 (Everolimus IV) an ~ pees and Metabolic Partners m C1 Se y » | Gene signatures ld ld . . Feedback Patient selection escape guides therapy HEAD AKT Blocks mTORC1 but Blocks choleterol triggers AKT/mTORC2 synthesis AKT/mTORC2 a feedback pr
Slide 34: Collaborative Path to Phase 1
COLLABORATIVE PATH TO PHASE 1 = Leveraging strong collaborative partners = GMP Manufacturing: = SAPU = Development: = IND enabling studies: Medicilon = Phase 1 clinical trial: Ingenu and SROTU in, 6 = Southern Oncology ; MEDICILON WNGENJU Clinical Research Unit iy NN” O° oexrorusticunca.nsoncn came
Slide 35: IND Enabling Studies Completed
IND ENABLING STUDIES COMPLETED 19459-24043 19459-24044 19459-24045 Analysis 19459-24046 Pretned 19459-24047 developme 19459-24048-NG nt and method 19459-24049-NG validation 19459-24050-NG 19459-24051-NG 19459-24052-NG 19459-24053-NG 19459-25098-NG 19459-25095-NG 19459-25096-NG 19459-24054-NG 19459-2
Slide 36: SP-03-B101: ACTRN: 12625001083482
SP-03-B101: ACTRN: 12625001083482 Name of Company: Sapu Nano (AU) Pty Ltd Name of Product: Sapu003/Everolimus for Injection Name of Active Ingredient: Everolimus A Phase 1b, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics of Sapu003 in Advanced mTOR- sensitiv
Slide 37: Oncotelic - Seeding the Next Generation Pharma
ONCOTELIC- (OTCQB:OTLC)- SEEDING THE NEXT GENERATION PHARMA A ON a? 7% : ; "a way. Thank You
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