Slide 1: Rising to the Challenges of Rare Disease Treatment
Rising to the Challenges of Rare Disease Treatment NASDAQ: SNGX April 8, 2026
Slide 2: Forward-Looking Statements
2 Forward-Looking Statements This presentation contains forward-looking statements. All statements other than statements of historical facts contained in this presentation, including statements regarding our future results of operations and financial position, business strategy, prospective products
Slide 3: Company Description
3 Company Description Soligenix, Inc. is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need Two areas of focus: ➢ A Specialized BioTherapeutics segment dedicated to the development of products for orph
Slide 4: Investment Highlights
4 Investment Highlights ➢ Robust pipeline consisting of multiple fast track and/or orphan designated products, with potential for significant commercial returns of ~$2B in global annual sales ➢ Late clinical-stage assets, one with successful Phase 3 data readout o Cutaneous T-cell lymphoma (HyBryte
Slide 5: Development Pipeline – Rare Diseases
5 Development Pipeline – Rare Diseases Product Candidates Preclinical Phase 1 Phase 2 Phase 3 NDA Review Market Specialized HyBryte (synthetic hypericin) Positive Phase 3 study results; BioTherapeutics Cutaneous T-Cell Lymphoma (CTCL) ORPHAN & FAST TRACK DESIGNATION confirmatory Phase 3 study active
Slide 6: Multiple Potential Value Drivers
6 Multiple Potential Value Drivers 2024 2025 2026 EMA/FDA Initiate meetings 2nd IIS study status Ph 3 enrollment 1H: Ph 3 Interim 2H: Ph 3 topline HyBryteTM* 2nd Ph Ph33study study update status update Analysis clinical results CTCL-04 Publication 2H: IIS Publication Ph 2a Ph clinical 2a contd. stud
Slide 7: Total Addressable Global Market
7 Total Addressable Global Market Assumptions(1) $1,200 Cutaneous T-Cell Lymphoma >$1,000 30,000 Patients US $1,000 38,000 Patients Europe Mild-to-Moderate Psoriasis 3,000,000 Patients US $800 5,000,000 Patients Europe $ Millions Behçet’s Disease $600 18,000 Patients US >$500 50,000 Patients Europe
Slide 8: Experienced Management and Board of Directors
8 Experienced Management and Board of Directors • 35 years of experience • 30 years of experience Gregg Lapointe, Christopher J. • Discovery Laboratories (COO) • Cerium Pharmaceuticals (CEO) CPA, MBA Schaber, PhD • Acute Therapeutics (Co-Founder) • Formerly of Sigma-Tau Pharmaceuticals, Chairman, •
Slide 9: Specialized BioTherapeutics
9 Specialized BioTherapeutics Targeted Approach to Treating Oncology & Inflammation
Slide 10: Specialized BioTherapeutics Segment
10 Specialized BioTherapeutics Segment Commercial Targets – Unmet Medical Needs in Oncology and Inflammation Product Candidates Preclinical Phase 1 Phase 2 Phase 3 NDA Review Market HyBryte (synthetic hypericin) Positive Phase 3 study results; ORPHAN & FAST TRACK DESIGNATION confirmatory Phase 3 stu
Slide 11: Cutaneous T-Cell Lymphoma – Disease Overview
11 Cutaneous T-Cell Lymphoma – Disease Overview ➢ Cutaneous T-cell lymphoma (CTCL) o Rare class of Non-Hodgkin's Lymphoma (NHL) o Malignant T-cells migrate to the skin o Cancer forms patches, lesions or tumors ➢ CTCL affects over 40,000 NHL patients worldwide; currently no cure o $250 million total
Slide 12: HyBryte – Synthetic Hypericin Sodium Ointment + Light Activation, First-in-Class
HyBryte – Synthetic Hypericin Sodium 12 Ointment + Light Activation, First-in-Class ➢ Treatment safe and well-tolerated o Minimal reported adverse events ‒ Other CTCL treatments characterized by acute and chronic side effects o Uses visible fluorescent light ‒ Not carcinogenic unlike other photother
Slide 13: HyBryte – Phase 3 Clinical Trial
HyBryte – Phase 3 Clinical Trial 13 referred to as the “FLASH” (Fluorescent Light And Synthetic Hypericin) Study (JAMA Dermatology. Published online July 20, 2022. doi:10.1001/jamadermatol.2022.2749) ➢ Double-blind, placebo-controlled, randomized o Randomized 2:1 (HyBryte [synthetic hypericin 0.25%]
Slide 14: HyBryte – Development Status
14 HyBryte – Development Status ➢ Positive Phase 3 FLASH study successfully completed HyBryteTM Treatment Response Rate by Time o Largest double-blind, randomized, placebo-controlled clinical trial ever conducted in CTCL 1x6 Weeks FLASH - Cycle 1 o FDA and EMA require a second confirmatory Phase 3 c
Slide 15: Comparison of FLASH and FLASH2 Studies
15 Comparison of FLASH and FLASH2 Studies FLASH FLASH2 Cycle 1: Weeks 1-8 HyBryte Placebo HyBryte Placebo (Blinded) 116 subjects; 3 lesions 50 subjects; 3 lesions ~40 subjects; 3-5 lesions ~40 subjects; 3-5 lesions Treatment 2/week for 6 weeks (+ 2 week rest prior to assessment) Treatment Primary E
Slide 16: Significant Opportunity for Improvement to Current Treatment Paradigm in Early Stage CTCL
16 Significant Opportunity for Improvement to Current Treatment Paradigm in Early Stage CTCL Early Stage CTCL Treatment Paradigm Current Treatment Landscape ➢ Because of chronic nature of early stage CTCL and long-term treatment cycles, clinicians choose Empiric Tx therapies with better safety Topic
Slide 17: HyBryte a Significant Commercial Opportunity Addressing a Clear Unmet Need
17 HyBryte a Significant Commercial Opportunity Addressing a Clear Unmet Need ➢ Clinicians see need for additional treatment options with fewer side effects ➢ Most patients cycle through several treatments over course of their disease Unmet Need ➢ Chronic nature of early stage CTCL and dissatisfacti
Slide 18: Psoriasis and SGX302 (Synthetic Hypericin)
18 Psoriasis and SGX302 (Synthetic Hypericin) ➢ Caused by dysregulated T-cells o Affects 60-125 Million people worldwide o Affects 8 Million people in the US ➢ SGX302 – visible light activated photodynamic therapy o Same active ingredient as HyBryte o Focused on mild-moderate patients, especially th
Slide 19: HyBryte Life Cycle Management
19 HyBryteTM Life Cycle Management HyBryteTM (synthetic hypericin) life cycle management >$1B* planning includes potential for home and expanded uses Expansion into new disease indications such as psoriasis Transition to Home Use in treatment of CTCL HyBryteTM Commercial Launch for CTCL $250M* * Tot
Slide 20: Behçet's Disease and SGX945 (dusquetide)
20 Behçet's Disease and SGX945 (dusquetide) ➢ Phase 2a POC study in 8 patients with Behçet's Disease (BD) ➢ Compared to Phase 3 apremilast (Otezla®) placebo-controlled study supporting approval o Matched inclusion-exclusion criteria o Matched key endpoint measures (area under the curve [AUC] of numb
Slide 21: Behçet's Disease Treatment Landscape
21 Without a cure, the primary goal of BD treatment is the elimination and management of recurrent ulcers ➢ General agreement amongst rheumatologists that current treatment/management options (i.e., oral & topical steroids, colchicine, azathioprine) are largely Systemic therapies ineffective for BD
Slide 22: Public Health Solutions
22 Public Health Solutions Addressing Critical Concerns for Industry and Government
Slide 23: Public Health Solutions Segment
23 Public Health Solutions Segment Funded by Government – Medical Countermeasures (MCMs) for Civilian and Military Use Product Candidates (FDA Animal Rule)* Proof-of-Concept IND Phase 1 Phase 2/3 BLA Review Market RiVax® + ThermoVax® – Vaccine ORPHAN & FAST TRACK DESIGNATION NIH Contract Awards of $
Slide 24: SuVax / MarVax – Filovirus Vaccine Candidates
24 SuVax / MarVax – Filovirus Vaccine Candidates Heat-stable single-vial bivalent ➢ Filovirus infections (Zaire ebolavirus, Sudan SUDV + MARV vaccine provided ebolavirus, Marburg marburgvirus) are deadly; only Zaire strain vaccines are available and 100% protection against requires ≤ -60°C shipping/
Slide 25: In Summary
25 In Summary ➢ Robust pipeline consisting of multiple fast track and/or orphan designated products, with potential for significant commercial returns of ~$2B in global annual sales ➢ Late clinical-stage assets, one with successful Phase 3 data readout o Cutaneous T-cell lymphoma (HyBryte or SGX301)
Slide 26: Thank you
26 Thank you Follow us on: facebook_004 youtube_004 facebook.com/soligenix/ youtube.com/c/SoligenixInc twitter_004 linkedin_004 twitter.com/Soligenix_Inc linkedin.com/company/soligenix-inc-/ www.soligenix.com NASDAQ: SNGX