Brim Biotechnology, Inc. · TWSE:6885
Brim Biotechnology — Investor Presentation (June 2023)
38 slides from Brim Biotechnology's investor presentation, Jun 14, 2023
Slide 1: BRIM Biotechnology
BRIM Biotechnology June 14, 2023 Beyond Research and Innovative Medicines DISCLAIMER: This document contains information that is privileged. This information is intended only for the use of the individuals and entities to whom it is addressed. Any further disclosures are prohibited and possibly a vi
Slide 2: BRIM's Team
2 BRIM′s TEAM Together, Everyone Achieves More DISCLAIMER: This document contains information that is privileged. This information is intended only for the use of the individuals and entities to whom it is addressed. Any further disclosures are prohibited and possibly a violation of law and regulati
Slide 3: Chairman of the Board
3 Chairman of the Board 林羣 Andrew Lin, MBA 董事長 Chairman • Chairman of TaiRx, Inc. • Chairman of Nuwa Healthcare • Founding partner of Affinity Capital • Independent Board of Directors for Fubon Insurance • Former Chairman of Lotus Pharmaceutical • Former Chief Executive Officer of Hasumi Biotechnolo
Slide 4: Board of Directors
4 Board of Directors 簡海珊 博士 曾惠瑾 會計師 以賽亞資本 中加顧問 安富大健康一號 Haishan Jang, PhD Audrey Tseng, Isaiah Capital LLC CIDC Consultants Affinity Capital Vice Chairwoman MBA 代表：李誠志 代表：李懿欣 代表：程淑芬 Rep: Bernard Lee Rep: Yihsin Lee Rep: Sophia Cheng Founder of BRIM, Former Deputy Angel investor Venture capital Privat
Slide 5: Independent Board of Directors
5 Independent Board of Directors 李鍾熙 博士 郭宗銘 會計師 程守真 律師 Johnsee Lee, Howard Kuo, James Cheng, PhD, MBA MBA JD Former ITRI President Former Deputy Partner of Tsar & Tsai Law Chairman of PwC Firm Honorary Chairman of Taiwan Taiwan BIO DISCLAIMER: This document contains information that is privileged. T
Slide 6: C-Suite Team
6 C-Suite Team 徐文祺 博士 郭美慧 WenChyi Shyu, PhD Mei-Hui Kuo 總經理 營運長 Chief Executive Officer Chief Operation Officer 超過30年經驗 超過30年經驗 30+ years experience 30+ years experience • Former VP and global head of DMPK at Takeda • Former COO of Senhwa Biosciences • Former group director of Discovery Medicine and
Slide 7: C-Suite Team/ Founders
7 C-Suite Team/ Founders 簡海珊 博士 Haishan Jang, PhD Frank W. Lee, PhD 國際策略長 研發長 Chief Global Strategist Chief Scientific Officer 超過30年經驗 超過41年經驗 30+ years experience 41+ years experience • Former Chairman and CEO of BRIM • Former Vice President of DMPK at Takeda • Previously a member of Senior Managem
Slide 8: Project Team
8 Project Team BRIM R&D Operation Team Dr. Pan-Chyr Yang, (SAB), 35 yrs, NTU Dr. Frank Lee, Dr. Robert Ruffolo, 41 yrs, Takeda (SAB), 41 yrs, Pfizer Project Dr. Carl Alden, Dr. Eliot Lazar, Management 41 yrs, Takeda 27 yrs, MD SABs Pre-clinical & & KOLs Toxicology CROs and CMOs Strategic Clinical Ma
Slide 9: Our Approach
9 Our Approach Maximize ROI through Reduced IND enabling Good budget control of early exit at clinical time (1.5-3 years from both R&D and fixed proof of concept (PoC) lead ID to IND costs submission) Academia, Incubation Small Value Projects Biotech Adding Value Creation: Out-license Clinical Lead
Slide 10: Regenerative Peptide from PDSP Platform
10 Regenerative Peptide from PDSP Platform PEDF-Derived Short Peptide DISCLAIMER: This document contains information that is privileged. This information is intended only for the use of the individuals and entities to whom it is addressed. Any further disclosures are prohibited and possibly a violat
Slide 11: Functional domains of PEDF
11 Functional domains of PEDF Val 78 Thr 121 Lys167 ASp 258 Ser 24 Asp 44 Asn77 Ser 114 Arg 149 Lys166 Ser 227 ASp 256 Asp300 418 aa P P Heparin binding sites P Collagen binding sites (positively charged) (negatively charged) P Phosphorylation site 34-mer peptide region (ASp44-Asn 77) - Receptors: L
Slide 12: PEDF-derived Short Peptide (PDSP) Platform
12 PEDF-derived Short Peptide (PDSP) Platform Unique features well suited for the discovery and development of new therapeutics Self- Promotes the proliferation and differentiation of stem cells and renewal then repairs damaged tissues Stem cell Asymmetric Mitosis Early-onset potential in various di
Slide 13: PDSP can regenerate limbus after severe damage
13 PDSP can regenerate limbus after severe damage 44-mer 44-mer treatment for 2 treatment for 2 weeks weeks Challenge 3 months 3 months 44-mer Invest Ophthalmol Vis Sci. 2016 May 1;57(6):2629-36. DISCLAIMER: This document contains information that is privileged. This information is intended only for
Slide 14: Development Milestones
14 Development Milestones Product Platform Indication 2022 2023 2024 2025 2026 2027 BRM421 PDSP Dry Eye Disease CMC EOP2 1st Phase 3 2nd Phase 3 NDA BRM424 Neurotrophic Keratitis ODD Phase 2 Pivotal Study NDA PDSP /IND （Rare Disease） BRM521 PDSP Osteoarthritis Discovery Pre-clinical/ CMC Phase 1 Pha
Slide 15: BRM421 for Dry Eye Disease (DED)
15 BRM421 for Dry Eye Disease (DED) First-in-class regenerative peptide DISCLAIMER: This document contains information that is privileged. This information is intended only for the use of the individuals and entities to whom it is addressed. Any further disclosures are prohibited and possibly a viol
Slide 16: Global DED population: 915 million
Global DED population: 915 million Severe DED: ~90 million DISCLAIMER: This document contains information that is privileged. This information is intended only for the use of the individuals and entities to whom it is addressed. Any further disclosures are prohibited and possibly a violation of law
Slide 17: DED Market
17 DED Market 2022 Global market size: 4.5 Billion USD1 2028 Global market size projection: ~6.3 Billion USD1 CAGR (2022-2028) 4.8%1 2022 2028 References: 1. https://www.researchandmarkets.com/reports/5732359/dry-eye- syndrome-market-global-industry-trends DISCLAIMER: This document contains informat
Slide 18: DED competitors on market
DED competitors on market 18 COMPANY/ DRUG ONSET MOA / API STATUS FREQUENCY SIDE EFFECT PATENT COMMENTARY DRUGS TYPE (WEEKS) BRIM/ stem cell regeneration/ instillation site peptide US Phase 3 2 3x daily 2043 visual improvement BRM421 PEDF-derived peptide reaction (37%) Novartis/ small anti-inflammat
Slide 19: DED competitors in development
19 DED competitors in development COMPANY/ DRUG ONSET MOA / API STATUS FREQUENCY SIDE EFFECT PATENT COMMENTARY DRUGS TYPE (WEEKS) BRIM/ 29mer stem cell regeneration/ US Phase 3 1-2 3x daily instillation pain (37%) 2043 visual Improvement BRM421 peptide PEDF-derived peptide Aldeyra/ small anti-inflam
Slide 20: Proposed MoAs of PDSP for DED treatment
20 Proposed MoAs of PDSP for DED treatment Accelerate corneal repair Activate limbal stem cells Improve tear quality Maintain goblet cell number Restore meibomian glands Improve visual functions Promote neurotrophic tissue protection Break vicious cycle Inhibit inflammation DISCLAIMER: This document
Slide 21: BRIM has licensed BRM421 CN rights to China Grand Pharm
21 BRIM has licensed BRM421 CN rights to China Grand Pharm China Grand Pharm (CGP), HK: 0512 China large healthcare group in China Over Hong Kong with vast ophthalmology USD 85M Macau distribution channels total deal size regional rights DISCLAIMER: This document contains information that is privile
Slide 22: BRIM established strategic alliance with ORA
22 BRIM established strategic alliance with ORA ORA, Inc ORA owns Share sales Ophthalmology CRO royalty stacks in execute over 70% of DED trials BRM421 P3 trial Assist BRM421 in the US as a strategic global out- partner licensing DISCLAIMER: This document contains information that is privileged. Thi
Slide 23: BRM421's price is competitive
23 BRM421′s price is competitive Product/ Treatmen Package Daily Retail Price2 Price/ cycle 2022 Sales Company1 t Cycle Xiidra/ Novartis 60 ampules/ US$671.83/ Box/ 2 times 3 months US$2015.49 487m (lifitegrast 5%) Box month US$633.96 Restasis/ AbbVie 60 ampules/ US$3803.76 2 times 6 months (US$156.
Slide 24: BRM421 efficacy in mouse DED model
24 BRM421 efficacy in mouse DED model 1% CMC Vehicle Topical BRM421 treatment in mouse DED model Normal Restasis 0.1% Dex Vehicle + BRM421 Mice housed at CEC for 14 days Day 1 without topical treatment (Dry eye induced at CEC for 14 days) Drug dosing 3x a day for seven Day 8 days in a normal environ
Slide 25: First-in-Human study showed a positive trend
25 First-in-Human study showed a positive trend Sign Symptom Ad Hoc Analysis: Ad Hoc Analysis: Mean change from Baseline Mean change from Baseline Fluorescein total corneal Dryness from Ora Calibra® staining scores Ocular Discomfort & 4- Symptom Moderate to severe DED patients Moderate to severe DED
Slide 26: BRM421 is in Phase 3 study
26 BRM421 is in Phase 3 study Phase 2/3 Phase 3 Enrollment Moderate-to-severe Moderate-to-severe * same design Criteria Duration 14 days 14 days * same design Endpoint: Fluorescein total corneal staining Fluorescein total corneal staining * same design Sign at Visit 4 (Day 15) at Visit 4 (Day 15) En
Slide 27: BRM421 development timeline
27 BRM421 development timeline FDA Type B Dose- meeting (EOP2) ranging study 2nd US P3 IND 2027 amendment 2026 Phase 2 study 2025 Formulation 2024 optimization 2023 2022 NDA US IND filing approval 2021 2020 2nd US 2019 1st US Phase 3 2018 Phase 3 study 2017 study 2016 FDA Type C agreement 1st US Pha
Slide 28: BRM424 for Neurotrophic Keratitis (NK)
28 BRM424 for Neurotrophic Keretitis (NK) First-in-class regenerative peptide DISCLAIMER: This document contains information that is privileged. This information is intended only for the use of the individuals and entities to whom it is addressed. Any further disclosures are prohibited and possibly
Slide 29: NK Market
29 NK Market 2022 Global market size: 146.7 Million USD1 2027 Global market size projection: 321.6 Million USD1 CAGR (2022-2027) 17%1 2022 2027 References: 1. https://www.sdki.jp/press-details/neurotrophic-keratitis-market/917# DISCLAIMER: This document contains information that is privileged. This
Slide 30: Oxervate
30 Oxervate rhNGF (nerve growth factor) API *PDSP 29mer is synthesized by SPPS 118 a.a., 13kDa/ produced in E. coli NGF support corneal integrity by: 1) corneal innervation; *29mer can activate stem cells and has MOA 2) tear secretion; neurotrophic effects 3) cell proliferation and differentiation *
Slide 31: BRM424 promoted complete corneal healing in NK
31 BRM424 promoted complete corneal healing in NK Vehicle BRM424 BRM424 Vehicle Chinchilla Rabbit Neurotrophic Keratitis Model: • The ophthalmic nerve (V1) of the trigeminal nerve is injured with sodium hydroxide (NaOH) unilaterally 5 days prior to treatment. • Usually, corneal epithelial defects ar
Slide 32: BRM424 development timeline
32 BRM424 development timeline Pivotal Dose- study ranging study 2027 2026 NDA IND filing filing 2025 2024 2023 Phase 2 2022 study ODD Granted DISCLAIMER: This document contains information that is privileged. This information is intended only for the use of the individuals and entities to whom it i
Slide 33: BRM521 for Osteoarthritis (OA)
33 BRM521 for Osteoarthritis (OA) First-in-class regenerative peptide DISCLAIMER: This document contains information that is privileged. This information is intended only for the use of the individuals and entities to whom it is addressed. Any further disclosures are prohibited and possibly a violat
Slide 34: OA Market
34 OA Market 2022 Global market size: 7.3 Billion USD1 2028 Global market size projection: ~11.7 Billion USD1 CAGR (2022-2028) 8.18%1 2022 2028 References: 1. https://www.researchandmarkets.com/reports/5769366/osteoarthritis- therapeutics-market-global DISCLAIMER: This document contains information
Slide 35: BRM521 promotes joint cartilage regeneration after MIA injection
BRM521 promotes joint cartilage regeneration after MIA injection OA induction & PDSP treatment Post MIA 18 days NORMAL VEHICLE BRM521 CONTROL MIA injection BRM521 (intra-articular injection) Knee harvest Knee harvest VEHICLE BRM521 CONTROL Post MIA 25 days DISCLAIMER: This document contains informat
Slide 36: Effectively relieves OA pain in MMT model at day 7
36 Effectively relieves OA pain in MMT model at day 7 Measurement: Weight-bearing ratio （pain level） Treatment: IA injection on Week2 post-MMT, weekly for 3 weeks Vehicle BRM521 Sacrifice: after 1-week final IA injection Weight-bearing ratio (%) = Weight on right (OA) leg Weight on right + left legs
Slide 37: BRM521 promotes joint cartilage regeneration in the MMT model
37 BRM521 promotes joint cartilage regeneration in the MMT model • Fibrous stroma in bone marrow • Normal cartilage structure • Subchondral bone collapse • Normal subchondral bone • Cartilage matrix loss • Surface fibrillation • Smooth surface • Osteophyte formation • Less proteoglycan • Proteoglyca
Slide 38: Thank you
Thank you Contact Person: Yi-Chun Maria Chen VP of Business Development yichun.chen@brimbiotech.com Beyond Research and Innovative Medicines DISCLAIMER: This document contains information that is privileged. This information is intended only for the use of the individuals and entities to whom it is
BRIM Biotechnology — Investor Presentation (June 2023) on 6ix