Citius Oncology, Inc. · NASDAQ:CTOR
Citius Oncology — Investor Presentation (February 2025)
28 slides from Citius Oncology's investor presentation, February 2025
Slide 1: Corporate Overview
CORPORATE OVERVIEW NASDAQ: CTOR FEBRUARY 2025
Slide 2: Forward Looking Language
FORWARD LOOKING LANGUAGE This presentation has been prepared by Citius Oncology, 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
Slide 3: About Citius Oncology, Inc.
ABOUT CITIUS ONCOLOGY, INC. Biopharmaceutical company focused on developing and commercializing innovative targeted oncology therapies • Majority-owned (~92%) publicly-traded subsidiary of Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) • Lead product, LYMPHIR , received FDA approval in August 2024 for
Slide 4: Citius is Preparing to Launch LYMPHIR in 1H 2025
CITIUS IS PREPARING TO LAUNCH LYMPHIR IN 1H 2025 Commercial launch readiness nearing completion through disciplined financial strategy • Citius has invested approximately $90 million in LYMPHIR to date • $40 million upfront purchase • $43 million development and precommercial efforts • $5 million sp
Slide 5: Market Opportunity
MARKET OPPORTUNITY Ideal market dynamics support significant value creation • Concentrated prescriber base: small number of oncologists generate significant sales volume • Approximately 10% of providers, or 427 physicians, treat ≥3 patients • Penetration into the market believed to be achievable wit
Slide 6: Experienced Management Team
EXPERIENCED MANAGEMENT TEAM Shared management services agreement with Citius Pharmaceuticals mitigates execution risk, maximizes capital efficiency and leverages industry expertise LEONARD MAZUR JAIME BARTUSHAK MYRON HOLUBIAK CHAIRMAN & CEO EVP, CFO & CBO EXECUTIVE VICE CHAIRMAN DR. MYRON CZUCZMAN C
Slide 7: Clinical Overview
CLINICAL OVERVIEW NASDAQ: CTOR | 7
Slide 8: What is Cutaneous T-Cell Lymphoma (CTCL)?
WHAT IS CUTANEOUS T-CELL LYMPHOMA (CTCL)? Considered to be incurable, CTCL is a Subgroup of Non-Hodgkin Lymphomas (NHL) that can be Indolent or Aggressive and is Driven by Malignant T Cells CTCL is a general term for T-cell CTCL accounts for lymphoma that involves the skin, but approximately 4% of a
Slide 9: CTCL Patients Have a High Disease Burden
CTCL PATIENTS HAVE A HIGH DISEASE BURDEN T1 T3 T2 T4 Sézary cell Zackheim. J Am Acad Dermatol. 1999;40:418. Slide credit: clinicaloptions.com NASDAQ: CTOR | 9
Slide 10: Differentiated Mechanism of Action (MOA)
DIFFERENTIATED MECHANISM OF ACTION (MOA) LYMPHIR targets the IL-2 receptor, working both as a targeted therapy against malignant T- cells AND as an immunotherapy against Tregs Malignant T-cells and Tregs share a common marker: the IL-2 receptor IL-2 receptor offers a unique treatment opportunity in
Slide 11: Compelling Clinical Data
COMPELLING CLINICAL DATA LYMPHIR addresses CTCL’s heavy Quality of Life burden OBJECTIVE RESPONSE RATE1 REDUCED SKIN BURDEN 36% 84.4% 9% achieved complete response Reduction in skin tumor burden 27% achieved partial response among evaluable patients 48.8% of patients with ≥50% reduction in skin tumo
Slide 12: Demonstrated Safety
DEMONSTRATED SAFETY 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 grade 1/2 treatment emergent adverse events (TEAEs) CAP
Slide 13: Competitive Landscape
COMPETITIVE LANDSCAPE Generic Name Brentuximab vedotin Mogamulizumab Romidepsin Monoclonal antibody against CC chemokine receptor type 4 Antibody-drug conjugate that binds to CD30 target, is Histone deacetylase (HDAC) inhibitor Mechanism of Action internalized, and results in tumor cell death (CCR4)
Slide 14: Opportunities for Growth Beyond CTCL
OPPORTUNITIES FOR GROWTH BEYOND CTCL Expanded indication potential in peripheral T-cell lymphoma (PTCL) • First logical label expansion potential would be in PTCL where there is a high unmet need • No curative therapies • Denileukin diftitox has historically shown promising results in PTCL • Denileu
Slide 15: Opportunities for Growth Beyond CTCL
OPPORTUNITIES FOR GROWTH BEYOND CTCL Potential upside opportunity in immuno-oncology • Differentiated and complementary MOA allows for potential combination with other breakthrough cancer treatments • Temporarily depleting Tregs is a unique contribution of LYMPHIR for combination with checkpoint inh
Slide 16: Commercial Overview
COMMERCIAL OVERVIEW NASDAQ: CTOR | 16
Slide 17: LYMPHIR is Competitively Positioned
LYMPHIR IS COMPETITIVELY POSITIONED Clinical profile and market dynamics supports market entry • LYMPHIR’s differentiated MOA targeting the IL-2 receptor reinforces rationale for inclusion among the current core therapeutic options in the U.S. market • CTCL treatments are non-curative, often have a
Slide 18: Very Concentrated Prescriber Base
VERY CONCENTRATED PRESCRIBER BASE Treating Providers by Number of Patients Accounts by Number of Diagnosed Patients 200 189 (Accounts Diagnosing ≥20 Patients) (Providers Treating ≥3 Patients) 427 Providers 141 Accounts 150 Number of Providers 100 90 90 100 68 80 48 50 29 70 Number of Accounts 18 17
Slide 19: Patient and HCPs Clustered Near Major Cancer Center
PATIENT AND HCPS CLUSTERED NEAR MAJOR CANCER CENTER Approximately 257 providers treated 4 or 60% of CTCL patients are concentrated in 10 states more patients with systemic therapy from July 2021 – June 2022 C T C L P AT IE N T S B Y S T AT E * C T C L P R E S C R IB E R S B Y S T AT E * (TOTAL PATIE
Slide 20: Creative Campaign
CREATIVE CAMPAIGN IL-2 the Logical Target due to its Dual Mode of Action NASDAQ: CTOR | 20
Slide 21: Drivers of LYMPHIR Market Adoption
DRIVERS OF LYMPHIR MARKET ADOPTION • Focused Product launch • Patients: we plan to target the cohort of U.S. patients with relapsed or refractory CTCL that receive intravenous systemic therapeutics; overall U.S. prevalence is estimated to be approximately 3,0001 • Providers: concentrated HCP univers
Slide 22: Multi-Layered Protection: High Barriers to Entry
MULTI-LAYERED PROTECTION: HIGH BARRIERS TO ENTRY Complex Proprietary Manufacturing 12 years of BLA exclusivity Process trade secret Orphan Drug Exclusivity (7 years) 2 Patents Pending ODD designation granted for CTCL LYMPHIR use as combination therapy and PTCL with check point inhibitors (CTCL exclu
Slide 23: Capitalization
CAPITALIZATION • CTOR owned by CTXR ~92% • Shares outstanding: ~71.6 million • Public Float: ~3.6 million • Shared services agreement between CTOR and CTXR NASDAQ: CTOR | 23
Slide 24: Why CTOR? Why Now?
WHY CTOR? WHY NOW? LYMPHIR is poised for successful launch with potential upside opportunities beyond CTCL • LYMPHIR is an approved therapy in a rare indication with no curative therapies • Estimated $400M+ addressable U.S. market with substantial upside potential driven by expanded indications, imm
Slide 25: Appendix
APPENDIX NASDAQ: CTOR | 25
Slide 26: LYMPHIR's Product History
LYMPHIR’S PRODUCT HISTORY Denileukin Diftitox (1999-2019) • 1999 – Ligand receives accelerated FDA approval for Ontak (Denileukin Diftitox) for the treatment of persistent or recurrent cutaneous T-cell lymphoma (CTCL) in patients with CD25-expressing tumors. • 2006 – Eisai Co., Ltd. , a Japanese pha
Slide 27: LYMPHIR's Product History
LYMPHIR’S PRODUCT HISTORY Citius Commitment to LYMPHIR – Approx. $90 million invested to date • Citius has invested approximately $90 million in LYMPHIR to date: • $40 million upfront purchase • $43 million development and precommercial efforts • $5 million spinout to form Citius Oncology • 2021 (Se
Slide 28: Thank You
THANK YOU Citius Oncology, Inc. Nasdaq: CTOR www.citiusonc.com Investor Relations: ir@citiusonc.com NASDAQ: CTOR | 28
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