Abvc Biopharma, Inc. · NASDAQ:ABVC
Abvc Biopharma — Investor Presentation (June 2023)
27 slides from Abvc Biopharma's investor presentation, Jun 9, 2023
Slide 1: Corporate Overview NASDAQ: ABVC 2023
Cor p orate Overview N A SD A Q: ABVC 2023
Slide 2: Disclaimer
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 purport to be complete . Thi
Slide 3: ABVC BioPharma Highlights 2023
3 ABVC BioPharma Highlights 2 0 23 C l in i cal Catalysts Cash - Effici e nt Dev e lopm en t We partner with World - Class Research Institutions to in - license promising compounds and devices that have completed preclinical and Phase I or Phase II studies Phase II expected to be completed by 1H 202
Slide 4: ABVC BioPharma Business Model
4 ABVC BioPharma Business Model Disc o ve r y T ran s lati o n Commercialization x Identify promising drugs or medical devices that have successfully completed pr e cli nical studi e s and/o r Ph ase I s a f e t y studies at world - renowned research institutions x In - license compounds and de v ic
Slide 5: Leadership Team
5 Leadership Team Howard Doong, MD, PhD Chief Executive Officer Le ed s Cho w Chief Financial O ffi cer Ch i - H s in Richa r d Kin g , P hD Chief Scientific O ffi cer T. S . J i ang , PhD Chief Strategy Officer Scientific Ad v i s o r y B o ard Managemen t Yih - S hiou Hw a n g , MD, PhD S u s a nna Cun
Slide 6: Robust & Diverse Pipeline
Clinical P a rtners P h ase III Pha s e II Pha s e I Preclinical Indication Program Vitreous Replacement Vitargus® (ABV - 1701) Ophthalmology Med i c al Devi ce Major Depressive Disorder (MDD) ABV - 1504 Psyc h iatric Disor d ers New Drugs Attention - Defici t /H y pe r ac t ivi t y Disorder (ADHD)
Slide 7: Vitargus for Retinal Detachment & Vitreous Hemorrhage
7 Vitargus® for Retinal Detachment & Vitreous Hemorrhage Vi trect o my Surgery Detached Retina • Ma c ul a r Hole • Ma c ul a r Puc k er Vitreous Hemorrhage • Diabetic Retinopathy • Retinal Vein Occlusion • Vitreous Body Injury Vitargus® is a Vitreous substitute that could potentially be used in ret
Slide 8: Vitargus: Solving an Unmet Need
8 Vitargus®: S o lving an Unmet Need • Vi t r eous i s a ge l - li k e sub s ta n c e that helps the eye maintain a round shape and keeps the retina in place during and after retinal re - attachment surgery. • Cur r e nt Vit reo us su b stitu t e s (A i r , S ili c one oi l , O c taf l uo r o - prop
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 ~225,00 0 v i trect o m i e s are p erfo r m e d
Slide 10: Vitargus: Best-in-Class Hydrogel Vitreous Substitute
10 Vitargus® for Retinal Detachment & Vitreous Hemorrhage Aqueous formulation for ocular injection; Gelation within 3 minutes at body temperature & removes need to lie face down Raw material is hyaluronic acid, a natural substance in the body Si l i c one Oil /Perfluoron Air /Gas Vitargus® F a ce up
Slide 11: Vitargus: Completed First in Human Feasibility Study
11 Vitargus®: Completed First in Hum a n Feasi b ili t y Stud y 1 Key Takeaways • V i t a rgus® wa s w e l l - t o l e ra t e d w i t h n o apparent toxicity to ocular tissues • A s t at i s t i c a l l y s i g n i fi c a n t i mpr o v e me n t from b a sel i ne i n b est corrected visual acuity (BC
Slide 12: Vitargus Phase II Clinical Study
12 Vitargus® Ph a se II Cl i nical Study Initiated in March 2023, expected to be completed 1H 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 Correct
Slide 13: Botanical-Based Pipeline for Psychiatric Disorders
13 Botanical - Based Pipeline for Psychiatric Disorders ABV - 1504 Major Depression Disorder (MDD) Phase I initi a ted Phase I I a c omp l eted, Pha s e I I b in p rogre s s Phase II c omp l eted C l in i cal Status No SAE’s d i rect l y from the d rug have been reported No SAE’s d i rect l y from t
Slide 14: ABV-1504: Innovative Botanical Asset for MDD
14 ABV - 1504: Innov a tive Bota n ical Asset for MDD • AB V - 1 50 4 (PD C - 1 4 21 capsule ) is a s ingl e - herb botanical drug extract from the dry root of Polygala tenuifolia Willd • Safety assessment: Demonstrated its safety with no SAEs from the completed Ph ase I and Phase II studi e s. • Ef
Slide 15: ABV-1504 Completed Phase I Highlights
15 ABV - 1504 Completed Ph a se I H ighlights Ph ase I Ph ase of D e velopm e n t ABV - 1504 (PDC - 1421 capsule, extract of Radix Polygalae ) I n ves t iga t i o n al prod u ct 380 mg U n it dose Oral Mode of adm i n is t rati o n A Dose Es c a l ation Ph ase I St u dy of P D C - 1421 C aps u le to
Slide 16: ABV-1504 Completed Phase II Highlights
16 ABV - 1504 Completed Ph a se II Hig hlights MADRS: Montgomery – Åsberg Depression Rating Scale T I D : T hr e e t i me s d a il y • Th e H i gh - D ose g r o u p (760 m g T I D) of A B V - 1 504 d e m on s t r a ted a cli n ic a l l y m e a nin g ful s c o r e in M AD RS c o m p a r e d t o t he
Slide 17: ABV-1504 Phase III Clinical Plan
17 ABV - 1504 Ph a se III Cl i nical P lan Plans to initiate after the end of Phase II meeting with the FDA expected in 2023 • O u t p a t i ent a d ul t s 1 8 - 7 5 y ea rs ol d • Met criteria for MDD without psychotic features as defined by the Diagnostic and Statistical Manual of Mental Disorders
Slide 18: ABV-1505: Innovative Botanical Asset for ADHD
18 ABV - 150 5 : Innov a tive Bota n ical Asset for ADHD • AB V - 1 50 5 ( P D C - 1 4 21 capsule ) is a singl e - herb botanical drug extract from the dry root of Polygala tenuifolia Willd • Safety assessment: Demonstrated its safety with no SAEs from the completed Ph ase I and Phase II ( Par t I)
Slide 19: ABV-1505 Completed Phase IIa in Adults with ADHD
19 - 1 2 .8 - 10. 5 - 15 .2 - 5.2 - 8 .8 - 6 .0 - 7.2 - 10. 5 - 10. 5 - 1.2 - 3 .7 - 4.8 - 14 - 1 8 .8 - 17.7 - 2 5 .7 0 - 5 - 10 - 15 - 20 - 25 - 3 0 0 3 4 Week 5 L o w - d o s e treat m ent 1 2 - 14.2 - 24.7 High - dose treatment 6 7 8 Mean c ha n ge from basel i ne ABV - 1505 Completed Ph a se II
Slide 20: ABV-1505 Phase IIb Clinical Plan
20 ABV - 1505 Ph a se IIb Clinical Plan Initiated April 2022, expected to be completed by end of 2023 • Ability to discontinue use of psychotropic medications for the treatment of ADHD symptoms at screening • M ee t o p e r a t i o n al c r i t e r i a f or A d u l t AD H D according to the Diagnost
Slide 21: ABV-1601 Phase I Clinical Plan
21 ABV - 1601 Phase I Cl i nical Plan Initiated April 2022, expected to be completed by end of 2023 • 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 -
Slide 22: Early-Stage Oncology Pipeline Overview
22 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 • Th e API of ou r e a rl y - s t a g e onc ol ogy p or t fol i o i s BLEX 404, a beta - glucan characterized by a
Slide 23: Early-Stage Oncology Pipeline Overview (Cont.)
23 Earl y - Sta g e Onc o logy 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 cance
Slide 24: Near-Term Milestones & Use of Proceeds
24 Nea r - Te r m Milestones & Use of Proceeds Multiple near - term clinical catalysts expected by the end of 2023 2H 2024 1H 2024 2H 2023 1H 2023 Indication Asset Com p l et i on of Ph as e I I Stu d y P la nn i ng Ph as e II I Vitreous Replacement Vitargus® (AB V - 1701) Com p l et i on End - of -
Slide 25: NASDAQ: ABVC Contact
N A SD A Q: ABVC Howard Doong 44370 Old Warm Springs Blvd. Fr e m ont, California 9 4 5 38 Of f ice: (51 0 ) 6 6 8 - 088 1 howard.doong@ambrivis.com Investor Relations Contact: Tom M a sterson (6 4 6) 57 3 - 3 2 16 tmasterson@allelecomms.com
Slide 26: Mechanism of Action: PDC-1421
26 Mechanism of Action: P D C - 1421 PDC - 1421 is the active pharmaceutical ingredient in ABV - 1504, - 1505, and - 1601 Tetrabenazine (TBZ) - induced Hypothermia Model (de p re s si o n a n i mal m o d el )* - 2 0 0 20 40 60 80 1 0 0 60 min after TBZ 90 min after TBZ 120 min after TBZ PDC - 1421 (
Slide 27: ABV-1504 Phase IIb Data
27 ABV - 1504 Ph a se IIb D a ta • T h e H i g h - dose g r oup (7 6 0 mg T I D) ofA B V - 1 50 4 d e m on s t r a ted a cli n ic a l l y me anin g ful s c or e in M AD RS c o m p a r e d t o Placebo group. • Compared with prior approved Fluoxetine(Prozac) antidepressant, ABV - 1 5 04 H i gh - Do s