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 January 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) Listed on Euronext Growth Unique foundational technology 110 employees in France and the U.S. Paris - 2014 and validated ZENEO® needle-free (Euronext: ALCJ) auto-injector 3 focus Rx products with Landmark R&D and s
Slide 4: Highly Experienced Senior Leadership Team
HIGHLY EXPERIENCED SENIOR LEADERSHIP TEAM Patrick ALEXANDRE Olivier GIRÉ Isabelle LIEBSCHUTZ Tony TIPTON Founder & CEO COO Specialty Pharma Quality & Regulatory Director COO - USA Chairman of the executive Board Member of the executive Board Member of the executive Board Head of USA 35 years experie
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 Matter Full-Dose Delivery Experts multidisciplinary team User-Intuitive 10,000+ Device Tests Needle-free Injection 11 Clinical
Slide 6: A Device Adapted to Emergency Situations
A DEVICE ADAPTED TO EMERGENCY SITUATIONS Successful Humans Factors Studies Diverse, untrained users (adults & teenagers) simulated human use studies in stressful conditions with ZENEO® Midazolam; Adrenaline; Naxolone; Terbutaline 1000+ participants for all our studies Use success rate as high as 99.
Slide 7: Business Strategy
AN EMERGING GLOBAL PHARMACEUTICAL COMPANY - BUSINESS STRATEGY Commercialization Out-licensing Future Product Active R&D Assets Assets Development Rescue Treatments Pharm US Partnership • ZEPIZURE®* (f.k.a. ZENEO® - Hydrocortisone Ongoing evaluation of unmet ZENEO®* Midazolam) clinical and market nee
Slide 8: Product Development
PRODUCT DEVELOPMENT 8
Slide 9: Market Opportunity - By Disease
MARKET OPPORTUNITY - BY DISEASE Epileptic Seizures Acute Adrenal Crisis Anaphylaxis (Status Epilepticus) (AAC) (ANA) • Status Epilepticus is categorized as a • Rare Disease ** with an 8% • Estimated 1 in 20 Americans Rare Disease by FDA - Targeted First mortality rate (3) experience the life-threate
Slide 10: 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 as high as 99.6% in Company human factors testing, no formal training • 200k cases of Anaphylaxis each year (1) PREVALENCE • 8% of US adults experience such crisis
Slide 11: ZENEO Hydrocortisone - Delivery Is the Difference
ZENEO® HYDROCORTISONE - DELIVERY IS THE DIFFERENCE! ACUTE ADRENAL CRISIS Simple 2-step administration First-time user success rate as high as 99.6% in Company human factors testing, no formal training • Global prevalence 4.9/10,000 (1) PREVALENCE • US cases ~ 100,000 (2) annually Simple • Life-threa
Slide 12: Commercialization of ZEPIZURE
COMMERCIALIZATION OF ZEPIZURE® 12
Slide 13: US Expected Commercialization Strategy
US EXPECTED COMMERCIALIZATION STRATEGY Future Commercial Events US Commercial Launch Pre-Commercial Activities 2026 Key Commercial Vendors Identified Commercial Leadership Hired Status Epilecticus New First BARDA* Order Delivered Zepizure® Commercial ZENEO® for status Sales Product epilecticus Sales
Slide 14: ZEPIZURE - US Expected Commercialization Strategy
ZEPIZURE® - US EXPECTED COMMERCIALIZATION STRATEGY Mission: Execute a 3-stage Strategic Commercial Plan to drive sales and revenue growth I Deliver BARDA’s orders as Part of $155M contract* (Strategic National Stockpile Program) 2025 US commercial launch positioning ZEPIZURE® as the new treatment of
Slide 15: BARDA Up to $155M Award and Collaboration
BARDA UP TO $155M AWARD AND COLLABORATION* • 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, and n
Slide 16: Unmet Need - Status Epilepticus and Rescue Treatment
UNMET NEED - STATUS EPILEPTICUS (SE) AND RESCUE TREATMENT US Epilepsy Patient Populations URGENCY MATTERS! Status Epilepticus (SE) • 5000+ epilepsy related deaths in US annually Incidence per year ~150k (3) • 3% to 5% (~1.9M) of EMS* calls are for seizures Prolonged, Cluster Seizure • Uncontrolled s
Slide 17: ZEPIZURE - Clinical Trial Results
ZEPIZURE® - CLINICAL TRIAL RESULTS ZEPIZURE® ZEPIZURE® Bioequivalence (vs. Midazolam 2 mL, 10mg IM needle injection) Delivery Bioequivalence (bare skin vs. through clothing) ZEPIZURE® Safety (Similar adverse events profile) ZEPIZURE® Fast onset with low dosage Qualifying for FDA EUA process variabil
Slide 18: The ZEPIZURE Solution - Delivery Is the Difference
THE ZEPIZURE® SOLUTION - DELIVERY IS THE DIFFERENCE! Simple 2-step administration Simple First-time user success rate 99.6%, no formal training Unpacking & Administration requires <60 secs Fast Needle-free “Quick-Click” injection takes 1/10th of a second for full dose…traditional needle/syringe are
Slide 19: ZEPIZURE US Competitive Landscape & Opportunity
ZEPIZURE® US COMPETITIVE LANDSCAPE & OPPORTUNITY Current Rescue Options vs Targeted Positioning of Zepizure® I II III Opportunity Deliver the confirmed $60M US commercial launch positioning ZEPIZURE® as Strategic use of sales and promotional order from BARDA as Part of the new treatment of choice an
Slide 20: ZEPIZURE - Near-Term Milestones
ZEPIZURE® - NEAR-TERM MILESTONES 1 - US Biomedical Advanced Research & Development Authority - CROSSJECT award* announced June 2022 - $155M US FDA - Up to $32M for development toward FDA approval Emergency Use Authorization (EUA) - Confirmed initial US Gov. stockpiling order $60M, additional optiona
Slide 21: Pipeline Portfolio and Near-Term Value Creation
PIPELINE PORTFOLIO AND NEAR-TERM VALUE CREATION Development Progress Expected Partner / Formulation & CMC / Human Factor studies / Filing Targeted Filing Date Commercial Sponsor Regulatory studies Launch ZEPIZURE® * US - Emergency Use EUA Early-25 2025 Authorization (EUA) I US - Status Epilepticus (
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 Public Financing of €6.9M Successful rights Reserved capital increase Research tax credit signed up to $155M* €2M) convertible bonds under France 2030 offe
Slide 24: Crossject - An Emerging Global Pharmaceutical Company
CROSSJECT - AN EMERGING GLOBAL PHARMACEUTICAL COMPANY Unique foundational 3 focus Rx products technology and validated Acute anaphylaxis ZENEO® needle-free auto- Acute Adrenal Crisis injector Epilepsy: ZEPIZURE® Growing US presence to Sales to BARDA accelerate commercialization expected to begin in
Slide 25: Contact
CONTACT Investor Relations Europe USA Natasha Drapeau Anna Baran - Djokovic natasha.drapeau@cohesionbureau.com investors@crossject.com www.crossject.com 6, rue Pauline Kergomard 21000 DIJON - FRANCE +33 3 80 54 98 50 info@crossject.com 1
Slide 26: References
REFERENCES Slide 9 : 1. https://www.transparencymarketresearch.com/epilepsy-therapeutics-market.html 2. https://www.precedenceresearch.com/epilepsy-drug-market 3. https://www.ncbi.nlm.nih.gov/books/NBK499968/ 4. https://www.foodallergy.org/life-with-food-allergies/food-allergy-101/facts-and-statisti
Slide 27: References
REFERENCES Slide 16 : 1. Zachary N. Grinspan et al, Epilepsy & Behavior, November 2020 2. Silbergleit et al. New England Journal of Medicine, February 2012 3. Status Epilepticus: Epidemiology and Public Health Needs, Sebastián Sánchez and Fred Rincon, Paul M. Vespa, Academic Editor and Gretchen M. B
Slide 28: Appendix
APPENDIX
Slide 29: ZEPIZURE - Clinical Bioavailability / Bioequivalence Study
ZEPIZURE® - CLINICAL BIOAVAILABILITY (BA) / BIOEQUIVALENCE (BE) STUDY SUMMARY STUDY DESIGN • 40 volunteers • STUDY: Midazolam 10mg IM injection : ZENEO® with Midazolam • 4 injections per volunteer = 158 injections (0.625mL) vs Dormicum® (2mL, 30mm needle, European reference • 3 with ZENEO® : thigh o
Slide 30: US Competitive Landscape
US Competitive Aquestive Landscape – CROSSJECT UCB NEURELIS Desitin Therapeutics Epilepsy Indications Drug Name Zepizure Nayzilam Voltoco Diastat Libervant Drug Product (API) Midazolam Midazolam Diazepam Diazepam Diazepam Delivery Needless Injection Transmucosal Transmucosal Rectal Buccal Status Epi
Slide 31: Key Financial Results for H1 2024
KEY FINANCIAL RESULTS FOR H1 2024 31
Slide 32: Income Statement, H1 FY 2024
INCOME STATEMENT, H1 FY 2024 (Thousands of euros) 30/06/2024 30/06/2023 Operating income 5 766 7 926 BARDA INCOME BARDA income 3 063 2 987 Capitalized Production 1 565 3 017 • Consolidation of BARDA’s operating income. We Work in progress 354 77 invoiced BARDA $3,3 million for the first half of 2024
Slide 33: Balance Sheet, 30 June 2024 vs. 31 December 2023 - Assets
BALANCE SHEET, 30 JUNE 2024 VS. 31 DECEMBER 2023 30/06/2024 BALANCE SHEET - ASSETS (in K€) 31/12/2023 VARIATION Brut Amts & prov Net FIXED ASSETS R&D 36 521 26 283 10 238 10 730 -492 Patent and Trademarks 20 440 20 440 0 0 0 Other intangible assets 206 206 0 0 0 Land, property, plant and equipment 1
Slide 34: Balance Sheet, 30 June 2024 vs. 31 December 2023 - Liabilities
BALANCE SHEET, 30 JUNE 2024 VS. 31 DECEMBER 2023 BALANCE SHEET - LIABILITIES (in k€) 30/06/2024 31/12/2023 VARIATION EQUITY Capital 4 109 3 676 433 Share premium 110 785 -675 Regulated reserve 0 0 0 Retained earnings -2 596 -1 757 -839 Profit/loss for the year -6 402 -8 639 2 237 Investment subsidie