Adial Pharmaceuticals, Inc · NASDAQ:ADIL
Adial Pharmaceuticals — Investor Presentation (March 2023)
9 slides from Adial Pharmaceuticals's investor presentation, Mar 7, 2023
Slide 1: AD04 Business Update March 7, 2023
December 2021 CONFIDENTIAL AD04 Business Update March 7, 2023 CONFIDENTIAL
Slide 2: Recent History
Recent History • Results from the Phase 3 ONWARD trial were released in July 2022. The trial missed its primary endpoint. • The trial showed statistical significance in a pre - defined patient group, which created an opportunity to course correct. • After further analyzing the clinical data, we foun
Slide 3: Concluded AD04 Phase 3 Clinical Trial (ONWARD)
Concluded AD04 Phase 3 Clinical Trial (ONWARD) CONFIDENTIAL | 3 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION • Randomized, double - blind, placebo - ctrl, parallel - group multicenter study • Patients were screened for the appropriate genotypes via an inexpensive, standard blood test to dete
Slide 4: Concluded AD04 Phase 3 Clinical Trial (ONWARD) Results
Concluded AD04 Phase 3 Clinical Trial (ONWARD) CONFIDENTIAL | 4 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION Results U.S. Endpoint Genotype DDD Category Treatment Arm (2) Placebo Arm Total Responder Analysis (U.S. Endpoint) (3) P - Value at Months 5&6 AG+ <10 37 30 67 0.02 1 0 LL+/TT+ <10 29
Slide 5: Revised Strategy
Revised Strategy CONFIDENTIAL | 5 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION Target genotypes identified; Regulatory discussion advancing; attractive U.S. commercial opportunity • Additional analysis of ONWARD data allowed refinement of genetic panel to target specific modulators of the se
Slide 6: Clear Path Forward in U.S. Based on Concluded AD04 Phase 3 Clinical Trial (ONWARD)
Clear Path Forward in U.S. Based on Concluded AD04 Phase 3 Clinical Trial (ONWARD) CONFIDENTIAL | 6 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION • Incorporate outcomes from the ONWARD trial • Refined design to focus on specific genotypes Planned Phase 3 trial AG+ patient population represent
Slide 7: Europe Strategy
Europe Strategy CONFIDENTIAL | 7 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION Advancing discussions with five European country - level regulatory authorities • Sweden March 2023 • Germany April 2023 • United Kingdom confirmation date pending • Finland confirmation date pending • France confi
Slide 8: Partner Status
Partner Status CONFIDENTIAL | 8 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION Currently in discussions with potential partners • Advancing discussions with potential strategic partners that could fund: • Phase 3 clinical program, if required • Commercialization of AD04 assuming a successful r
Slide 9: Summary
Summary CONFIDENTIAL | 9 ADIAL PHARMACEUTICALS INC. | MEDICINES FOR ADDICTION Rapidly advancing AD04 clinical program based on promising data ONWARD Phase 3 clinical trial data showed that AD 04 achieved a statistically significant mean reduction in heavy drinking days among the pre - specified grou
Adial Pharmaceuticals — Investor Presentation (March 2023) on 6ix