Abvc Biopharma, Inc. · NASDAQ:ABVC
Abvc Biopharma — Investor Presentation (August 2024)
24 slides from Abvc Biopharma's investor presentation, Aug 20, 2024
Slide 1: Corporate Overview 2024
Corporate Overview NASDAQ: ABVC 2024
Slide 2: Forward Looking Statements
2 Forward Looking Statements This presentation contains summary information about ABVC BioPharma, Inc . (“ABVC”) as of the date hereof . The information in this presentation is of general background and contains an overview and summary of certain data selected by the management of ABVC . It does not
Slide 3: ABVC BioPharma Business Model
3 ABVC BioPharma Business Model Discovery Translation Commercialization x Identify promising drugs or medical devices that have successfully completed preclinical studies and/or Phase I safety studies at world - renowned research institutions x In - license compounds and devices of interest to furth
Slide 4: Financial and Strategic Highlights
4 Key Financial Achievements 2 : Revenue Growth : $ 117 , 142 in Q 2 2024 , up from $ 6 , 109 in Q 2 2023 . Earnings Per Share (EPS) : Improved to - $ 0 . 09 in Q 2 2024 , up 86 . 8 % from - $ 0 . 68 in Q 2 2023 . Shareholders' Equity : $ 7 . 8 million as of June 30 , 2024 . Financial and Strategic
Slide 5: Leadership Team
5 Leadership Team Uttam Yashwant Patil, PhD Chief Executive Officer and Interim CFO Leeds Chow Chief Financial O ffi cer 1 T. S. Jiang, PhD Chief Scientific Officer Scientific Advisory Board Management Yih - Shiou Hwang, MD, PhD Susanna Cunningham - Rundles, PhD Maurizio Fava, PhD Keith McBurnett , Ph
Slide 6: Robust & Diverse Pipeline
6 Robust & Diverse Pipeline Clinical Partners Phase III Phase II Phase I Preclinical Indication Program Vitreous Replacement Vitargus® (ABV - 1701) Ophthalmology Medical Device Major Depressive (MDD) ABV - 1504 Psychiatric Disorders New Drugs Attention - Deficit/Hyperactivity Disorder (ADHD) ABV - 1
Slide 7: Vitargus for Retinal Detachment & Vitreous Hemorrhage
7 Vitargus® for Retinal Detachment & Vitreous Hemorrhage Detached Retina Vitrectomy Surgery Vitreous Hemorrhage Vitargus® is a Vitreous substitute that could potentially be used in retinal detachment and vitreous hemorrhage surgeries to accelerate healing and eliminate the need for a second surgery
Slide 8: Vitargus: Solving an Unmet Need
8 Vitargus®: Solving an Unmet Need • Vitreous is a gel - like substance that helps the eye maintain a round shape and keeps the retina in place during and after retinal re - attachment surgery. • Current Vitreous substitutes (Air, S ilicone oil, O ctafluoro - propane, Sulfur hexafluoride) have disad
Slide 9: Vitargus Total Addressable Market
9 The U.S. remains the largest market, however, the demand in Asia - Pacific represents the fastest growing market 4 ABVC plans to develop and commercialize Vitargus® in Asia and Europe prior to seeking FDA approval Vitargus® Total Addressable Market ~225,000 vitrectomies are performed annually in t
Slide 10: Vitargus Advantages: Best-in-Class Hydrogel Vitreous Substitute
10 Vitargus® for Retinal Detachment & Vitreous Hemorrhage Vitargus® Advantages: Raw material is hyaluronic acid, a natural substance in the body Silicone Oil / Perfluoron Air /Gas Vitargus® Face up positioning 1 - day vision recovery Does not require 2 nd surgery Aqueous formulation for ocular injec
Slide 11: Vitargus: Completed First in Human Feasibility Study
11 Vitargus®: Completed First in Human Feasibility Study 1 Key Takeaways • Vitargus® was well - tolerated with no apparent toxicity to ocular tissues • A statistically significant improvement from baseline in best corrected visual acuity (BCVA) • The optical properties of Vitargus® allowed the patie
Slide 12: Vitargus Phase II Clinical Study
12 Vitargus® Phase II Clinical Study Initiated in March 2023, expected to be completed 2H 2024 1 • Uncomplicated retinal detachment, defined as the first instance of a small macular hole and retinal tears. • Diagnosis of vitreous hemorrhage that requires vitrectomy surgery. • BCVA (Best Corrected Vi
Slide 13: Botanical-Based Pipeline for Psychiatric Disorders
13 Botanical - Based Pipeline for Psychiatric Disorders ABV - 1504 Major Depression Disorder (MDD) Phase I initiated Phase IIa completed, Phase IIb in progress Phase II completed Clinical Status No SAE’s directly from the drug have been reported No SAE’s directly from the drug have been reported No
Slide 14: ABV-1504: Innovative Botanical Asset for MDD
14 ABV - 1504: Innovative Botanical Asset for MDD • ABV - 1504 (PDC - 1421 capsule) is a s ingle - herb botanical drug e xtract from the dry root of Polygala tenuifolia Willd • Safety assessment: Demonstrated its safety with no SAEs from the completed Phase I and Phase II studies. • Efficacy assessm
Slide 15: ABV-1504 Completed Phase II Highlights
15 ABV - 1504 Completed Phase II Highlights MADRS: Montgomery – Åsberg Depression Rating Scale TID: Three times daily • The High - Dose group (760 mg TID) of ABV - 1504 demonstrated a clinically meaningful score in MADRS compared to the Placebo group. • Compared with prior approved Fluoxetine(Prozac
Slide 16: ABV-1504 Phase III Clinical Plan
16 ABV - 1504 Phase III Clinical Plan • Outpatient adults 18 - 75 years old • Met criteria for MDD without psychotic features as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Test Revision (DSM - IV - TR) • 17 - item HAM - D total score ≥ 20 and CGI total score
Slide 17: ABV-1505: Innovative Botanical Asset for ADHD
17 ABV - 1505: Innovative Botanical Asset for ADHD • ABV - 1505 (PDC - 1421 capsule) is a single - herb botanical drug extract from the dry root of Polygala tenuifolia Willd • Safety assessment: Demonstrated its safety with no SAEs from the completed Phase I and Phase II (Part I) clinical studies. •
Slide 18: ABV-1505 Completed Phase IIa in Adults with ADHD
18 - 3.7 - 8.8 - 12.8 - 10.5 - 14.2 - 15.2 - 1.2 - 5.2 - 6 .0 - 7.2 - 10.5 - 10.5 - 4.8 - 14 - 18.8 - 17.7 - 24.7 - 25.7 -30 -25 -20 -15 -10 -5 0 0 1 2 3 4 5 6 7 8 Mean change from baseline Week Low - dose treatment High - dose treatment ABV - 1505 Completed Phase IIa in Adults with ADHD 1 • Mean ch
Slide 19: ABV-1505 Phase IIb Clinical Plan
19 ABV - 1505 Phase IIb Clinical Plan Initiated April 2023, expected to be completed by end of Q4 - 2024 • Ability to discontinue use of psychotropic medications for the treatment of ADHD symptoms at screening • Meet operational criteria for Adult ADHD according to the Diagnostic and Statistical Man
Slide 20: ABV-1601 Phase I Clinical Plan
20 ABV - 1601 Phase I Clinical Plan Initiated Q3 2024, expected to be completed by end of 2025 • Confirmed diagnosis of Stage I, II, or III cancer & Histologically - proven malignancy • Receiving or within one year of receiving cancer treatment with radiation and/or chemotherapy • Montgomery - Åsber
Slide 21: Early-Stage Oncology Pipeline Overview
21 Early - Stage Oncology Pipeline Overview 1. Effect of Maitake ( Grifola frondosa ) D - Fraction on the activation of NK cells in cancer patients API: Active Pharmaceutical Ingredient • The API of our early - stage oncology portfolio is BLEX 404, a beta - glucan characterized by a beta - 1,6 - lin
Slide 22: Early-Stage Oncology Pipeline Overview (Cont.)
22 Early - Stage Oncology Pipeline Overview (Cont.) Amelioration of chemotherapeutic side - effects 1 External Research Demonstrating Improved Cancer Symptoms with Maitake Mushroom 1 Nonrandomized clinical trial with Maitake D - Fraction 22 – 57 - year - old cancer patients (Stage II - IV cancers) 1
Slide 23: Near-Term Milestones & Use of Proceeds
23 Near - Term Milestones & Use of Proceeds 2H 2025 1H 2025 2H 2024 1H 2024 Indication Asset Vitreous Replacement Vitargus® (ABV - 1701) Major Depressive Disorder (MDD) ABV - 1504 Attention - Deficit/Hyperactivity Disorder (ADHD) ABV - 1505 Depression in Cancer Patients ABV - 1601 ~$3M ~$2.7M ~$2.4M
Slide 24: Contact
NASDAQ: ABVC Uttam Patil Ph. D. 44370 Old Warm Springs Blvd. Fremont, California 94538 uttam@ambrivis.com Investor Relations Contact: (845) 291 - 1291 info@ambrivis.com