Citius Oncology, Inc. · NASDAQ:CTOR
Citius Oncology — SPAC Merger (October 2023)
33 slides from Citius Oncology's SPAC merger presentation, Oct 24, 2023
Slide 1: Citius Oncology, Inc. SPAC Business Combination Overview
Citius Oncology, Inc. SPAC Business Combination Overview October 2023
Slide 2: Forward-Looking Statements
FORWARD-LOOKING STATEMENTS This presentation has been prepared by Citius Pharmaceuticals, Inc. (the “Company”) for informational purposes only and not for any other purpose. Nothing contained in this presentation is, or should be construed as, a recommendation, promise or representation by the Compa
Slide 3: Transaction Overview
TRANSACTION OVERVIEW Transaction Summary Ownership Structure’ Transaction Rationale Capitalization Attractive Entry Point XITI US 1. Ten and Citius Pharma negotiated and set the Base Exchange Ratio based on their assumptions abs following the merger. Assumes de minimis redemptions by Tenx public hol
Slide 4: Citius Oncology Highlights
CITIUS ONCOLOGY HIGHLIGHTS Unique Oncology Platform Public Ready, Funded Opportunity Anticipated Commercial Launch in 2H 2024 Significant Opportunity Robust IP Portfolio Seasoned Management ITIUS Oncology LYMPHIR formulation developed by Eisai and marketed in Japan as Remitoro® since 2021; Citius On
Slide 5: Attractive Product Profile
ATTRACTIVE PRODUCT PROFILE LYMIPHIR’ (denileukin diftitox-cxcl) Injection 300 mcg * LYMPHIR is a recombinant engineered fusion protein that combines interleukin-2 and diphtheria toxin * Phase 3 Pivotal trial results are consistent with the prior formulation, and clinical profile supports the potenti
Slide 6: Overview of TenX Keane Acquisition
OVERVIEW OF TENX KEANE ACQUISITION Over 80+ years of global professional investing, capital markets, M&A, life sciences and operating experience XIAOFENG YUAN TAYLOR ZHANG CATHY JIANG JOEL MAYERSOHN: BRIAN HARTZBAND CHAIRMAN & CEO CHIEF FINANCIAL DIRECTOR DIRECTOR DIRECTOR - OFFICER s 38FULE] eee: p
Slide 7: Citius Oncology Management Overview - Shared Management Agreement with CTXR
CITIUS ONCOLOGY MANAGEMENT OVERVIEW - SHARED MANAGEMENT AGREEMENT WITH CTXR Key management personnel mitigate execution risk and leverage proven industry track record AKRIMAX PRECISION Qi <em> OTT (cenesis Hacegectin sett Chere LER, @ covecorparesLMBR medeo Lavenerum MBI LEONARD MAZUR JAIME BARTUSHA
Slide 8: Citius Oncology Board of Directors
CITIUS ONCOLOGY BOARD OF DIRECTORS LEONARD MAZUR MYRON HOLUBIAK SUREN DUTIA JOEL MAYERSOHN CHAIRMAN EXECUTIVE VICE CHAIRMAN. DIRECTOR DIRECTOR DR EUGENE HOLUKA, CAROL WEBB DENNIS MCGRATH DIRECTOR DIRECTOR DIRECTOR XITIUS : Oncology
Slide 9: Origins of ONTAK
ORIGINS OF ONTAK * ONTAK was FDA approved and commercially available in the U.S. between 1999 — 2014 * LYMPHIR (E7777) was developed by Eisai in 2011 as a purified and more bioactive formulation in response to a post marketing commitment agreed to with the FDA upon approval of ONTAK * Eisai voluntar
Slide 10: LYMPHIR Licensing and FDA Pathway
LYMPHIR LICENSING AND FDA PATHWAY * September 2021 — Citius Pharma acquired the exclusive license to Eisai’s E7777 (LYMPHIR) * December 2021 Phase 3 clinical trial completed * September 2022 — Citius Pharma submitted a BLA for E7777 (LYMPHIR) * July 2023 FDA issues complete response letter (CRL); Ci
Slide 11: LYMPHIR Pipeline & Opportunities Beyond CTCL
LYMPHIR PIPELINE & OPPORTUNITIES BEYOND CTCL PROGRAM INVESTIGATIONAL INDICATION PRECLINICAL PHASE | PHASE II | mee | LYMPHIR-P? PERIPHERAL T-CELL LYMPHOMA UNIVERSITY OF MINNESOTA, COMBINATION WITH CAR-T ” 2 MASONIC CANCER CENTER (Kymrian®)? UNIVERSITY OF PITTSBURG MEDICAL CENTER, COMBINATION WITH PD
Slide 12: LYMPHIR License Agreement
LYMPHIR LICENSE AGREEMENT * Exclusive license of Eisai’s cancer immunotherapy LYMPHIR (E7777) Initial indication in cutaneous T-cell lymphoma (CTCL) v | ] I U S Additional potential indications in peripheral T-cell lymphoma PHARMA (PTCL) and immuno-oncology + Assigned exclusive license to Citius Pha
Slide 13: What Is Cutaneous T-Cell Lymphoma (CTCL)?
WHAT IS CUTANEOUS T-CELL LYMPHOMA (CTCL)? Considered to be incurable, CTCL is a CTCL accounts for general term for T-cell lymphoma that approximately 4% of all non- involves the skin, but may also involve Hodgkin lymphoma (NHL)* the blood, lymph nodes, and internal organs @e0e@ i i More prevalent in
Slide 14: Why LYMPHIR?
WHY LYMPHIR? Near-term revenue opportunity for an oncology asset with a unique MOA Developed for the treatment of cutaneous T-cell lymphoma (CTCL) Orphan indication with market estimated at $300-$400+M No curative therapeutics on the market Concentrated prescriber base Multi-layered market protectio
Slide 15: Differentiated Mechanism of Action (MOA)
DIFFERENTIATED MECHANISM OF ACTION (MOA) LYMPHIR (denileukin diftitox) is an engineered IL-2-diphtheria toxin fusion protein with a unique mechanism of action supporting two therapeutic effects Targets Malignant Cells Binds to IL-2 receptors to deliver diphtheria toxin, killing tumor cells directly
Slide 16: Patient Journey: Topical to Systemic Treatment
PATIENT JOURNEY: TOPICAL TO SYSTEMIC TREATMENT Early-stage CTCL Skin-Directed Therapies (dermatologists) commonly treated with “skin-directed” therapies by Topical corticosteroids Topical chemotherapy Retinoids dermatologists Involved-field Electron beam Radiation therapy therapy Aietennse lay Advan
Slide 17: Competitive Landscape
COMPETITIVE LANDSCAPE MOA Approval Date Cancerris OSeagen’ CD30 antigen directed* November 2017 brentuxin in Q POTELIGEO Gyowa KIRIN CCR4 targeted? August 2018 (mogamulizumab-kpke) ISTODAX — tBristo! myers Squibb HDAC inhibitor? November 2009 (romidepsit + LYMPHIR’s differentiated MOA targeting the
Slide 18: LYMPHIR Phase 3 Trial (Study 302): Completed
LYMPHIR PHASE 3 TRIAL (STUDY 302): COMPLETED Pivotal, multicenter, open-label, single-arm study of LYMPHIR in subjects with persistent or recurrent CTCL All subjects were LEAD-IN STUDY Doses ranged from 6 to 15 ug/ke/day diagnosed with Mycosis Fungoides Ee haibdikiy n=21 9 ug/ke/day was selected for
Slide 19: Study 302: Phase 3 Clinical Trial Results
STUDY 302: PHASE 3 CLINICAL TRIAL RESULTS LYMPHIR demonstrated meaningful benefits for trial patients who had previously been treated 36.2% 0] RR (Objective Response Rate }+? 95% Cl (25%, 48.7%) 49% Nearly half of patients on the trial experienced a complete ° response, partial response or durable s
Slide 20: Meaningful Response in CTCL Patients
MEANINGFUL RESPONSE IN CTCL PATIENTS More than half of responders in the trial had at least six months of improved or controlled disease REDUCED SKIN BURDEN 0 Reduction in skin tumor burden among evaluable patients; 84.4 % 48.8% of patients with 250% reduction in skin tumor burden? RAPID RESPONSE TI
Slide 21: No New Safety Signals
NO NEW SAFETY SIGNALS Overall, LYMPHIR was well-tolerated with the use of pre-medications, close patient monitoring, and prompt initiation of supportive measures and drug management * No evidence of cumulative toxicity * Most patients experienced low grade 1/2 treatment emergent adverse events (TEAE
Slide 22: Multi-Layered Protection: High Barriers to Entry
MULTI-LAYERED PROTECTION: HIGH BARRIERS TO ENTRY Complex Proprietary Manufacturing Process trade secret 2 Patents Pending LYMPHIR use as combination therapy with check point inhibitors May be eligible for BLA exclusivity of 12 years upon approval XITIUS Oncology Orphan Drug Exclusivity (7 years) ODD
Slide 23: Robust Supply Chain
ROBUST SUPPLY CHAIN Manufacturing and distribution strategic vendor relationships with leading global providers to support seamless product launch and ongoing commercialization needs BDs? Manufacturing FUJiFILM Diosynth biotechnloges * Global network with major U.S. presence * Leading CDMO in biolog
Slide 24: A Larger Market Opportunity in PTCL
A LARGER MARKET OPPORTUNITY IN PTCL High unmet need with strong KOL and clinical support for indication in PTCL * Denileukin diftitox approved for PTCL in Japan in 2021 * Only 3 branded FDA-approved therapies in the US — Adcetris, Beleodaq and Folotyn ¢ — Denileukin diftitox has historically shown p
Slide 25: More Opportunities for Growth
MORE OPPORTUNITIES FOR GROWTH ¢ Eisai’s E7777 is already approved for the treatment of Peripheral T-Cell PTCL expanded Lymphoma (PTCL) in Japan (Remitoro®) indication potential * Would require clinical trial in U.S. designed as a single-arm pivotal study * Two investigator-initiated trials are under
Slide 26: Merger Consideration and Pro Forma Ownership
MERGER CONSIDERATION AND PRO FORMA OWNERSHIP ° Citius Pharma to receive $675 million in equity of Citius Oncology, or 67.5 million shares at an implied value of $10 per share ¢ An additional 12.75 million in equity options will be assumed by Citius Oncology ¢ Atclosing, $10 million in cash provided
Slide 27: Accelerated Growth as a Standalone Public Company
ACCELERATED GROWTH AS A STANDALONE PUBLIC COMPANY Citius Oncology is primed for growth as a standalone public entity 1 Commercial Launch Near-term revenue potential 2H 2024 2 Clear Market Opportunity High unmet need in CTCL implies rapid adoption PTCL, combinations with CAR-T & PD-1s and multiple po
Slide 28: Citius Oncology Highlights
CITIUS ONCOLOGY HIGHLIGHTS Anticipated Commercial Launch in 2H 2024 A Unique Oncology Platform Robust IP Seasoned Portfolio Management XITIUS Oncology Significant Market Opportunity Attractive Entry Point With Growth Potential
Slide 29: Appendix
APPENDIX YITIUS 2» Oncology
Slide 30: Trials and Publications
TRIALS AND PUBLICATIONS * A Clinical Study to Demonstrate Safety and Efficacy of LYMPHIR® in Persistent or Recurrent Cutaneous T-Cell Lymphoma Link to clinicaltrials.gov * Safety and Tolerability of LYMPHIR® (improved purity Denileukin diftitox [ONTAK]) in Patients with Relapsed or Refractory Cutane
Slide 31: LYMPHIR Single Pivotal Trial in CTCL Design
LYMPHIR SINGLE PIVOTAL TRIAL IN CTCL DESIGN PIVOTAL TRIAL DETAILS Global, multicenter, open label single arm pivotal clinical trial for the treatment of patients with persistent or recurrent CTCL Inclusion Criteria: - CTCL (ME or SS) -CD25+ - Stage IA-IVA - At least 1 prior CTCL therapy - ECOG PS 22
Slide 32: LYMPHIR and ONTAK: CTCL Clinical Trial Summary
LYMPHIR AND ONTAK: CTCL CLINICAL TRIAL SUMMARY . Dose Product / Study Study Design (we/ke/d) /N Status (Year) Result Phase 1/2 open label, dose- 3to31IV ONTAK/Complete * 37% ORR (14% CR, 23% PR) escalation study in CD25 N=35 (1998) positive subjects with CTCL Phase 3 double blind or 18V ONTAK/ Compl
Slide 33: Citius Oncology, Inc. SPAC Business Combination Overview
Citius Oncology, Inc. - ‘ SPAC Business Combination Overview\, ‘ « Copies of relevant documents filed or thatwill be * filed with the SEC by Citius Oncology, Inc. may be obtained through the website maintained by the SEC at www.sec.gov or by contacting Citius Pharmaceuticals or TenX