Citius Pharmaceuticals, Inc. · NASDAQ:CTXR
Citius Pharmaceuticals — SPAC Merger (October 2023)
33 slides from Citius Pharmaceuticals'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
2 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 Company or any director, emp
Slide 3: Transaction Overview
TRANSACTION OVERVIEW Ownership Structure 1 • 100% of the shares of Citius Pharma’s subsidiary will be rolled into Citius Oncology in exchange for $675mm in equity • Citius Pharma expected to own ~90% and TenX expected to own ~10% of Citius Oncology T r a n sac t i o n Rationale • Creates standalone
Slide 4: Citius Oncology Highlights
CITIUS ONCOLOGY HIGHLIGHTS Public Ready, Funded Opportunity Anticipated Commercial Launch in 2H 2024 Significant O ppo r t un i ty Robust IP Portfolio Seasoned M a n a g e me nt • LYMPHIR licensed by Citius Pharma in 2021; $40mm upfront payment and an additional $15mm funded to date • Upon closing o
Slide 5: Attractive Product Profile
ATTRACTIVE PRODUCT PROFILE • 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 potential for rapid adoption • Filed as an original BLA, LYM
Slide 6: Overview of TenX Keane Acquisition
OVERVIEW OF TENX KEANE ACQUISITION X I AO F E N G Y U AN CHA I RM A N & CE O T AY L O R Z HA NG CHI E F F I NANCI A L OFFICER CA T H Y J I ANG DIRECTOR BRIA N HA R TZ BA ND DIRECTOR J O E L M AYE R SO H N DIRECTOR Over 80+ years of global professional investing, capital markets, M&A, life sciences a
Slide 7: Citius Oncology Management Overview
CITIUS ONCOLOGY MANAGEMENT OVERVIEW - SHARED MANAGEMENT AGREEMENT WITH CTXR L E O NA R D M A Z UR CHA I RM A N & CE O J A I M E BA R T U S H AK EVP, C F O & C BO DR . M YR O N C Z UC Z M A N EVP, CH I EF M E D I C AL O FF I C ER KE LL Y CRE I G H T O N EVP, C M C CA T HE RI N E KESS L ER EVP, R EG U
Slide 8: Citius Oncology Board of Directors
CITIUS ONCOLOGY BOARD OF DIRECTORS L E O NA R D M A Z UR CHAIRMAN M YR O N H O L UB I A K EXE CU T I VE V I C E CH A I R M AN 8 S UREN DU T I A DIRECTOR J O E L M AYE R SO H N DIRECTOR DR . EU G E N E H O L UK A DIRECTOR CA R OL W EBB DIRECTOR DENNIS MC G RA T H DIRECTOR
Slide 9: Origins of ONTAK
ORIGINS OF ONTAK Accelerated FDA approval for denileukin diftitox (ONTAK) granted to Ligand Full FDA approval g r a nt ed t o O N T AK 1999 2014 2008 2011 9 A new formulation of denileukin diftitox (E7777) developed by Eisai in response to FDA guidance at time of accelerated approval Eisai Voluntari
Slide 10: LYMPHIR Licensing and FDA Pathway
LYMPHIR LICENSING AND FDA PATHWAY Q3 2021: Citius Pharma Acquired the Exclusive License to Eisai’s E7777 in all Markets Except Japan and Parts of Asia from Dr. Reddy’s Q4 2021: E7777 Phase 3 Clinical Trial Completed (December) Q3 2021 Q3 2023 Q4 2021 Q3 2022 Q3 2022: Citius Pharma Filed BLA for New
Slide 11: LYMPHIR Pipeline & Opportunities Beyond CTCL
LYMPHIR PIPELINE & OPPORTUNITIES BEYOND CTCL PHASE III PHASE II PHASE I PRECLINICAL INVESTIGATIONAL INDICATION PROGRAM P ERIPHERAL T - C ELL L YMPHOMA LYMPHIR - P 1 C OMBINATION WITH CAR - T (K YMRIAH ® ) 2 UNIVERSITY OF MINNESOTA, MASONIC CANCER CENTER C OMBINATION WITH PD - 1 I N HI B I T OR (K EY
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) • Additional potential indications in peripheral T - cell lymphoma (PTCL) and immuno - oncology • Assigned exclusive license to Citius Pharma for a
Slide 13: What is Cutaneous T-Cell Lymphoma (CTCL)?
WHAT IS CUTANEOUS T - CELL LYMPHOMA (CTCL)? P l a que S t a ge T u m or S t a ge Considered to be incurable, CTCL is a general term for T - cell lymphoma that involves the skin, but may also involve the blood, lymph nodes, and internal organs CTCL accounts for approximately 4% of all non - Hodgkin l
Slide 14: Why LYMPHIR?
WHY LYMPHIR? Near - term revenue opportunity for an oncology asset with a unique MOA Improved formulation of previously FDA - approved drug (ONTAK); marketed 1999 - 2014 Developed for the treatment of cutaneous T - cell lymphoma (CTCL) Market dynamics support new entrant Orphan indication with marke
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 dir
Slide 16: Patient Journey: Topical to Systemic Treatment
PATIENT JOURNEY: TOPICAL TO SYSTEMIC TREATMENT Systemic Therapies (oncologists) Targeted • De n il e uk i n diftitox • Vorinostat • Romidepsin • Mogamulizumab • B r e n tu x imab vedotin Chemotherapy Biologics • bexarotene • interferons • e x t r a c or p o r eal photopheresis Allogeneic stem cell t
Slide 17: Competitive Landscape
17 COMPETITIVE LANDSCAPE 1. CD30 - cell membrane protein of the tumor necrosis factor receptor superfamily (TNFRSF) and a tumor marker. 2. CCR4 - C - C chemokine receptor type 4 is a protein that in humans is encoded by the CCR4 gene. 3. HDAC - Histone deacetylase inhibitors are believed to induce d
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 • A total of 69 subjects with Stage I - III persistent or recurrent CTCL from the Lead - In and Main Studies were included in the Primary Effic
Slide 19: Study 302: Phase 3 Clinical Trial Results
STUDY 302: PHASE 3 CLINICAL TRIAL RESULTS 1. Primary Efficacy Analysis Set includes 69 Stage I - III CTCL subjects from the Lead - In Study and the Main Study who received a dose of 9 ug/kg/day of study drug . Two subjects were considered by the Independent Review Committee to have Stage IV CTCL and
Slide 20: Meaningful Response in CTCL Patients
MEANINGFUL RESPONSE IN CTCL PATIENTS 1. In the Primary Efficacy Analysis set, 84.4% (54/64) of skin evaluable subjects had a decrease in skin tumor burden, with 48.4% subjects with ≥50% reduction in skin tumor burden. Complete clearing of skin disease (skin CR) was observed in 12.5% (8/64) subjects.
Slide 21: No New Safety Signals
NO NEW SAFETY SIGNALS Low rate of Grade ≥3 capillary leak syndrome at 9µg 6% CAPILLARY LEAK SYNDROME 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 toxicit
Slide 22: Multi-Layered Protection: High Barriers to Entry
MULTI - LAYERED PROTECTION: HIGH BARRIERS TO ENTRY Complex Proprietary Manufacturing Process trade secret Orphan Drug Exclusivity (7 years) ODD designation granted for CTCL and PTCL (exclusivity determined upon BLA review) May be eligible for BLA exclusivity of 12 years upon approval 2 Patents Pendi
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 1 Manufacturing BDS 1 Storage Drug Product M anu f ac t u ring Commercial P ac k a g ing & Labeling • Experts in
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
25 MORE OPPORTUNITIES FOR GROWTH KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. KYMRIAH® is a registered trademark of Novartis AG, Basel, Switzerland. PTCL expanded indication potential Upside opportunity in immuno - oncology
Slide 26: Merger Consideration and Pro Forma Ownership
26 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 • At closing, $10 million in cash provi
Slide 27: Accelerated Growth as a Standalone Public Company
27 ACCELERATED GROWTH AS A STANDALONE PUBLIC COMPANY Near - term revenue potential 2H 2024 Commercial Launch 1 High unmet need in CTCL implies rapid adoption Clear Market Opportunity 2 PTCL, combinations with CAR - T & PD - 1s and multiple potential future product in - licensing opportunities Driver
Slide 28: Citius Oncology Highlights
CITIUS ONCOLOGY HIGHLIGHTS 28 A Unique Oncology Platform Anticipated Commercial Launch in 2H 2024 Significant Market Opportunity Robust IP Portfolio Seasoned M a n a g e m e n t Attractive Entry Point With Growth Potential
Slide 29: Appendix
APPENDIX XITIUS _ Oncology
Slide 30: Trials and Publications
TRIALS AND PUBLICATIONS 30 • 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 C
Slide 31: LYMPHIR Single Pivotal Trial in CTCL Design
LYMPHIR SINGLE PIVOTAL TRIAL IN CTCL DESIGN P IVOTAL T RIAL DETAILS Global, multicenter, open label single arm pivotal clinical trial for the treatment of patients with persistent or recurrent CTCL Inclusion Criteria : - CTCL (MF or SS) - CD25+ - Stage IA - IVA - At least 1 prior CTCL therapy - ECOG
Slide 32: LYMPHIR and ONTAK: CTCL Clinical Trial Summary
32 LYMPHIR AND ONTAK: CTCL CLINICAL TRIAL SUMMARY Result Product / Study Status (Year) Dose (µg/kg/d) / N Study Design • 37% ORR (14% CR, 23% PR) ONTAK / Complete (1998) 3 to 31 IV N=35 Phase 1/2 open label, dose - escalation study in CD25 positive subjects with CTCL • 30% ORR (10% CR, 20% PR) • 36%
Slide 33: Citius Oncology, Inc. SPAC Business Combination Overview
Citius Oncology, Inc. SPAC Business Combination Overview Copies of relevant documents filed or that will 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