Slide 1: Revolutionizing the Delivery of Rescue Treatments
AN EMERGING GLOBAL PHARMACEUTICAL COMPANY Revolutionizing the Delivery of Rescue Treatments Powered by the Innovative ZENEO® Needle-Free Auto-Injector Technology Platform June 2025 1
Slide 2: Disclaimer
DISCLAIMER You must read the following before continuing. By receiving and using this presentation and/or accepting a copy of this presentation, you agree to be bound by the following limitations and conditions and, in particular, will be taken to have represented, warranted and undertaken that you
Slide 3: Crossject - An Emerging Global Pharmaceutical Company
CROSSJECT - AN EMERGING GLOBAL PHARMACEUTICAL COMPANY Headquartered in Dijon (France) Unique foundational technology 3 focus Rx products with 110 employees in France and the U.S. and validated ZENEO® needle- targeted regulatory Listed on Euronext Growth free auto-injector submissions, starting Paris
Slide 4: Highly Experienced Senior Leadership Team
HIGHLY EXPERIENCED SENIOR LEADERSHIP TEAM Patrick ALEXANDRE Isabelle LIEBSCHUTZ Tony TIPTON Founder & CEO Quality & Regulatory Director COO - USA Chairman of the executive Board Member of the executive Board Head of USA 35 years experience 26 years experience 27 years experience Arcelor, Fournier la
Slide 5: ZENEO - Unique Technology Platform, Award Winning, Innovative
ZENEO® - UNIQUE TECHNOLOGY PLATFORM, AWARD WINNING, INNOVATIVE ZENEO® - Technology Features ZENEO® - Development History One Quick-Click 20+ years of R&D driven by a Subject Full-Dose Delivery Matter Experts multidisciplinary team User-Intuitive 10.000+ Device Tests Needle-free Injection 12 Clinical
Slide 6: ZENEO - Designed and Engineered to Save Lives
ZENEO® – DESIGNED AND ENGINEERED TO SAVE LIVES Validated easy administration via successful Human Factors studies Robust testing in diverse and untrained populations in stressful situations - Adults, Children, BARDA* - 1200+ participants for all Human Factors studies Use success rate over 98%** Inte
Slide 7: Adaptability of ZENEO Platform Provides Commercial Viability
ADAPTABILITY OF ZENEO® PLATFORM PROVIDES COMMERCIAL VIABILITY Adaptable Versatile Streamlined Reliable Adjustable penetration Leverages the same Eligible for regulatory Meets FDA pressure, drug delivery, components and programs with shorter regulatory and allows for variation manufacturing approval
Slide 8: Product Candidates Portfolio
PRODUCT CANDIDATES PORTFOLIO 8
Slide 9: Market Opportunity - Significant Target Markets
MARKET OPPORTUNITY – SIGNIFICANT TARGET MARKETS ZENEO® : Intuitive, easy and safe device, designed for emergency situations outside of hospital Anaphylaxis Acute Adrenal Crisis Epileptic Seizures (ANA) (AAC) • Status Epilepticus, as a first • Commonly know condition, ~1 in • Rare Disease* with an 0.
Slide 10: Focus on ZEPIZURE - A New Paradigm for Rescue Injections
FOCUS ON ZEPIZURE ® – A NEW PARADIGM FOR RESCUE INJECTIONS 10
Slide 11: ZEPIZURE - Delivery Is the Difference!
ZEPIZURE® - DELIVERY IS THE DIFFERENCE! EPILEPSY SEIZURE RESCUE Simple 2-step administration First-time user success rate over 98% in Human Factors testing with no formal training • Global prevalence ~65M (1) • US epilepsy population ~3M+ PREVALENCE • US - Up to ~40% of epilepsy patients still exper
Slide 12: ZEPIZURE U.S. Market Landscape Re-evaluation
CROSSJECT ZEPIZURE® U.S. MARKET LANDSCAPE RE-EVALUATION MARKET & COMPETITIVE RESEARCH U.S. STRATEGY TEAM • KOL engagement, e.g. KOL Focus Group at AES 2024 Congress • Pre-Market Analysis Data from various consultants & vendors • Chief Operating Officer – U.S. • In-depth and detailed market research
Slide 13: The ZEPIZURE US Opportunity and Purpose
THE ZEPIZURE® US OPPORTUNITY AND PURPOSE The Unmet Medical Need Market Conditions • No current FDA approved Rx for Poisoning • Epilepsy is CMS protected disease category, leading to Status Epilepticus (SE) ensuring patient access and ZEPIZURE® • No current FDA approved Rx for Status reimbursement Ep
Slide 14: De-risk Commercialization Strategy with Multi-Sales Channel Customers
DE-RISK COMMERCIALIZATION STRATEGY WITH MULTI–SALES CHANNEL CUSTOMERS • 776,000 units Deliver BARDA’s orders as Part of $155M contract* • 388,000 (~50% guaranteed I (Strategic National Stockpile Program) 2025 • Up to $119M in sales) [end bankroll NDA and commercial launches] • Potential for refills
Slide 15: Conclusion
CONCLUSION https://www.ainvest.com/news/crossject-zepizure-eua-filing-lifesaving-breakthrough-regulatory-hurdle-2505/ 15
Slide 16: BARDA Up to $155M Award and Collaboration
BARDA UP TO $155M AWARD AND COLLABORATION* Step I • Biomedical Advanced Research & Development Authority provides an integrated, systematic approach to the development of vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies such as chemical, biological, radiological
Slide 17: ZEPIZURE FDA Regulatory Pathway - EUA
ZEPIZURE® FDA REGULATORY PATHWAY - EUA Step I Agreement on the EUA dossier content Pre-EUA Meeting (clinical studies, CMC minimal requirements) TypeCCconsultation consultationon ondevice device Presentation of ZENEO functions, manufacturing process, Type quality and controls CMC (Chemistry, Manufact
Slide 18: ZEPIZURE FDA Regulatory Pathway - NDA 505(b)(2)
ZEPIZURE® FDA REGULATORY PATHWAY - NDA 505(b)(2) Step II Completed for Status Epilepticus Development Plan Aligned with FDA (continuation of the EUA) Type CC consultation Type consultationon on device device Same as EUA CMC (Chemistry, Manufacturing, Same as EUA, with longer stability data and Contr
Slide 19: ZENEO Epinephrine/Adrenaline - Delivery Is the Difference!
ZENEO® EPINEPHRINE/ADRENALINE - DELIVERY IS THE DIFFERENCE! ACUTE ANAPHYLAXIS Simple 2-step administration First-time user success rate over 98% in Human Factors testing with no formal training • 200K cases of Anaphylaxis each year (1) PREVALENCE • 8% of US adults experience such crisis (~16m) (2;3)
Slide 20: ZENEO Hydrocortisone - Delivery Is the Difference!
ZENEO® HYDROCORTISONE - DELIVERY IS THE DIFFERENCE! ACUTE ADRENAL CRISIS Simple 2-step administration First-time user success rate over 98% in Human Factors testing with no formal training • Global prevalence 4,9/10.000 (1) PREVALENCE • US cases ~ 100.000 (2) annually Simple • Life-threatening sympt
Slide 21: Pipeline and Near-Term Value Creation
PIPELINE AND NEAR-TERM VALUE CREATION Expected Development Progress Filing Partner / Targeted Filing Date Commercial Formulation & CMC / Human Factor studies / Launch Sponsor Regulatory studies ZEPIZURE® * US - Emergency Use EUA Q2 25 2025 Authorization (EUA) US - Status Epilepticus (SE) NDA 1 Mid-2
Slide 22: Financials and Investors
FINANCIALS AND INVESTORS 22
Slide 23: Diversified Financial Resources
DIVERSIFIED FINANCIAL RESOURCES Q2 2022 2023 Q1 2024 Q2 2024 Q3 2024 Q4 2024 + Each Year US BARDA agreement Bank debts (€12M Financing through Successful rights Public Financing of Reserved capital increase Research tax credit signed up to $155M* + €2M) convertible bonds offering of €8M €6.9M under
Slide 24: Financial Results for FYE 31 December 2024
FINANCIAL RESULTS FOR FYE 31 DECEMBER 2024 24
Slide 25: Income Statement, FYE 31 December 2024
INCOME STATEMENT, FYE 31 DECEMBER 2024 € thousands, as of 31 December 2024 2023 Variation VARIATION IN OPERATING INCOME – €1.2M Stable Operating Revenues Operating income 13 256 13 326 -70 • BARDA Invoicing +€2M: €8.2 million invoiced in 2024 compared to €6.2 million in 2023. • Stored Production -€0
Slide 26: Balance Sheet, 31 December 2024 vs. 31 December 2023
BALANCE SHEET, 31 DECEMBER 2024 VS. 31 DECEMBER 2023 BALANCE SHEET - ASSETS (in K€) 31/12/2024 31/12/2023 VARIATION FIXED ASSETS R&D 9 591 10 730 -1 139 Patent and Trademarks 0 0 0 Other intangible assets 5 0 5 Property, plant and equipment 2 126 2 750 -624 Assets under construction 2 924 2 942 -18
Slide 27: Balance Sheet, 31 December 2024 vs. 31 December 2023
BALANCE SHEET, 31 DECEMBER 2024 VS. 31 DECEMBER 2023 BALANCE SHEET - LIABILITIES (in k€) 31/12/2024 31/12/2023 VARIATION SHAREHOLDERS' EQUITY Capital 4 554 3 676 878 Share premium 7 192 785 6 407 Regulated reserve 0 0 0 Retained earnings -2 596 -1 757 -839 Profit/loss for the year -12 795 -8 638 -4
Slide 28: Cash Flow Statement, FYE 31 December 2024 vs. 2023
CASH FLOW STATEMENT, FYE 31 DECEMBER 2024 VS. 31 DECEMBER 2023 2024 Keys Points CASH FLOW STATEMENT 31/12/2024 31/12/2023 Net profit/loss - 12 795 - 8 639 • €6.3M OC (Convertible Bonds) net received in February 2024, as part of Depreciation, amortisation and provision 5 220 3 091 a total €12M financ
Slide 29: Crossject - An Emerging Global Pharmaceutical Company
CROSSJECT - AN EMERGING GLOBAL PHARMACEUTICAL COMPANY Unique foundational 3 focus Rx products technology and validated Epilepsy: ZEPIZURE®* ZENEO®* needle-free Acute Anaphylaxis auto-injector Acute Adrenal Crisis Growing US presence to accelerate Sales to BARDA** commercialization of expected to beg
Slide 30: Contact
CONTACT Investor relations investors@crossject.com www.crossject.com 6, rue Pauline Kergomard 21000 DIJON - FRANCE +33 3 80 54 98 50 info@crossject.com 1
Slide 31: References
REFERENCES Slide 9 : 1. Mehndiratta MM, Wadhai SA. International Epilepsy Day - A day notified for global public education & awareness. Indian J Med Res. 2015 2. Engel J Jr. Approaches to refractory epilepsy. Ann Indian Acad Neurol. 2014 3. https://www.transparencymarketresearch.com/epilepsy-therape
Slide 32: References
REFERENCES Slide 15 : 1. Zachary N. Grinspan et al, Epilepsy & Behavior, November 2020 2. https://naec-epilepsy.org/about 3. https://aesnet.org/abstractslisting/mapping-disparities-in-availability-of-epilepsy-care-at-the-postal-code-level-in-the-united-states Slide 19 : 1. https://www.foodallergy.or
Slide 33: Appendix
APPENDIX 33
Slide 34: Business Strategy - Targeting US and European Markets
AN EMERGING GLOBAL PHARMACEUTICAL COMPANY - BUSINESS STRATEGY CROSSJECT mainly targets US and European markets* * Depending on the country indication, licensing and partnership could be preferred (Epilepsy Europe : Undisclosed, Adrenal Insufficiency : Eton Pharmaceuticals) Key markets : US Rest of t
Slide 35: Streamlined Manufacturing Process
STREAMLINED MANUFACTURING PROCESS PARC® ISO 13485 GMP DEPYROGENATION & STERILIZATION (CROSSJECT) COMPOUNDING & ASEPTIC FILLING GLASS FORMING TOUGHENING (CMO) TUBINGS (NIPRO) (CROSSJECT) (SCHOTT) Components FINAL ASSEMBLY s (CMO) GAZ GENERATOR ACTUATOR ASSEMBLY ASSEMBLY (CROSSJECT) (CROSSJECT) PACKAG
Slide 36: Crossject Key Manufacturing Equipment
CROSSJECT KEY MANUFACTORING EQUIPMENT Tubes Forming Thermal Toughening of Tubes Gas Generator Manufacturing Dimensional Control of Components Tubes Forming 36
Slide 37: Crossject Key Manufacturing Equipment
CROSSJECT KEY MANUFACTORING EQUIPMENT Final Quality Control Mechanical Resistance of Tubes Actuators Assemble Depyrogenation of tubes 37
Slide 38: ZEPIZURE - Proven Bioequivalence
ZEPIZURE® - PROVEN BIOEQUIVALENCE ZEPIZURE® Bioequivalence ZEPIZURE® Delivery Bioequivalence (vs. Midazolam 2 mL, 10mg IM needle injection) (bare skin vs. through clothing) ZEPIZURE® Safety (Similar adverse events profile) ZEPIZURE® Fast onset with low Qualifying for FDA EUA process dosage variabili
Slide 39: The Unmet Medical Need - Status Epilepticus (SE)
THE UNMET MEDICAL NEED - STATUS EPILEPTICUS (SE) Step II US Epilepsy Patient Populations ~3.5M (2) Epilepsy Patients ~40 % (1.1M) (3) Patients considered STATUS EPILEPTICUS Refractory to Chronic Treatments resulting Uncontrolled Seizures • FDA Rare Disease designation - No current Rx • Up to 30% of
Slide 40: US Epilepsy Seizure Rescue Market - Key Competitors
US EPILEPSY SEIZURE RESCUE MARKET – KEY COMPETITORS Step III ZEPIZURE® Nayzilam® Valtoco® (NF Midazolam) (nasal Midazolam) (nasal Diazepam) ~1.1M Refractory patients with uncontrolled seizures (1) Device Status Epilepticus First FDA Indication NDA Filing ~300 Epilepsy Treatment Centers across Common
Slide 41: ZEPIZURE Market Opportunity
ZEPIZURE® MARKET OPPORTUNITY US Government Stockpiling Growing Seizure Key Rescue Market Competitor Pricing Factor • The Untapped SE indication Market Nayzilam® List Price • The >$350M Nasal Spray Market ~$667.00 USD** • Additional sales Valtoco® List Price channel expansions ~$732.00 USD** US Comme