Bridge biotherapeutics corporate deck 2017 February

February,2017

1Non-confidentialInformation

2

목차

Non-confidentialInformation

1. 개 요

2. 비 전 &전 략

3. 리 더 십팀

4. 사 업 전략

5. 제 품 개 발 계 획

6. 중 단 기 마 일 스 톤


8 WEEK OF OCTOBER 10, 2016

FINANCEPOLITICS,POLICY & LAW

PRODUCTDEVELOPMENT

BIOCENTURY TOC

EMERGINGCOMPANIES

EMERGING COMPANY PROFILE

PELLINO PLAYBY EMILY CUKIER-MEISNER, SENIOR WRITER

Bridge Biotherapeutics Inc. has licensed the first of what it hopes will be many assets it can use its translational expertise to bring through Phase II proof of concept. The South Korean company is seeking first-in-class small molecules from academics, biotechs or pharmas in Asia.Its first program, BBT-401, is an N-terminal lipidated 4aa peptide targeting pellino E3 ubiquitin protein ligase 1 (PELI1; pellino-1).Bridge exclusively licensed IP covering BBT-401, its derivatives and therapeutic uses related to pellino-1 inhibition from Korea Research Institute of Chemical Technology and Sungkyunkwan University for a W3 billion ($2.7 million) licensing fee and an upfront payment, plus undisclosed milestones and royalties.CEO James Lee said in conditions such as inflammatory bowel disease (IBD), pellino-1 inhibition could temper inflammation while sparing pathways involved in healing tissue damage. Pellino proteins are highly conserved ubiquitin ligases of multiple proteins including IL-1 receptor-associated kinase 4 (IRAK4). Pellinos also serve as scaffold proteins that bind to multiple components of the toll-like receptor (TLR)/IL-1 receptor signaling pathway, including IRAK4 and myeloid differentiation primary response gene 88 (MYD88). Lee said inhibiting pellino-1 selectively down-regulates inflammation driven by NF-kB, while other modes of inhibiting the IRAK4/MYD88 complex also tamp down additional pathways that could quell inflammation and promote tissue healing.According to Bridge’s unpublished data, BBT-401 dose-dependently inhibited NF-kB signaling in cell culture, but did not appreciably affect MAP kinase (MAPK; ERK) signaling downstream of TLR/IL-1R, which mediates processes that promote wound healing, like cell proliferation and growth.In contrast, a tool compound that selectively inhibits IRAK1 and IRAK4 decreased NF-kB signaling in cell culture, but also reduced MAPK signaling.

Lee said KOLs who treat IBD have told Bridge, “The biggest issue is not anti-inflammatory efficacy but wound-healing efficacy.”Lee was not aware of another company developing pellino inhibitors. Both Bristol-Myers Squibb Co. and Pfizer Inc. have disclosed IRAK4 inhibitor programs in Phase I.Pfizer is developing PF-06650833 for lupus. Pfizer spokesperson Steven Danehy said one key difference in the mechanisms is that pellino-1 mediates TLR adaptor molecule 1 (TICAM1; TRIF)-dependent signaling. Inhibiting pellino-1 could therefore result in broader inhibition of type 1 interferon induction but also increase the risk of viral infection. BMS declined to comment on its IRAK4 inhibitor, which is in development for autoimmune and transplant indications. At least four other companies have IRAK4 inhibitors in preclinical development for autoimmune indications and cancers.

Though its originators studied BBT-401 in models of ulcerative colitis, Lee said its mechanism could also treat multiple sclerosis and age-related macular degeneration (AMD). Pellino-1 has been implicated in promoting microglia-mediated CNS inflammation in multiple sclerosis. And MYD88 inhibition may protect against RNA-induced retinal pigment epithelial cell degeneration in geographic atrophy, an advanced form of AMD.Bridge plans to evaluate the three indications simultaneously in Phase I testing after submitting an IND for BBT-401 in the U.S. and a CTA in China by the end of September 2017.Lee launched Bridge last year as a virtual company seeking to source first-in-class compounds in late discovery primarily from academic institutes, biotechs or pharmas in South Korea, China and Japan and then develop them locally and in China and the U.S.He thinks Bridge’s translational assays and experience will enable the company to choose the right indications for products with novel targets. Lee said Bridge’s internal expertise includes discovery biology, CMC, medicinal chemistry and preclinical development. Lee said Bridge plans to out-license programs after demonstrating POC in Phase IIa testing to global pharmas or biotechs while retaining South Korea development and commercialization rights. To complement the virtual company’s expertise, Bridge sought angel investments from doctors who would be willing to share expertise, and high net worth individuals whose fortunes came from biotech and pharma investments, and who could assist with networking for future fundraising.

COMPANIES AND INSTITUTIONS MENTIONED

Bridge Biotherapeutics Inc., Seongnam, South Korea

Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y.

Korea Research Institute of Chemical Technology, Daejeon, South Korea

Pfizer Inc. (NYSE:PFE), New York, N.Y.

Sungkyunkwan University, Seoul, South Korea

BRIDGE BIOTHERAPEUTICS INC.Seongnam, South KoreaTechnology: Inhibitor of pellino-1 Disease focus: Inflammation, autoimmune, ophthalmic Clinical status: PreclinicalFounded: 2015 by James Lee, JuHyun Choi and Seonghee ParkUniversity collaborators: Korea Research Institute of Chemical Technology, Sungkyunkwan UniversityCorporate partners: BioLeaders Corp. Co. Ltd.Number of employees: 5Funds raised: W14.5 billion ($13.1 million)Investors: LB Investment, KB investment, HB Investment, KTB Network, SV Investment, LifeCore Partners, Company K partners, IntervestCEO: James LeePatents: None issued

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기업개요

u 설립 : 2015년 9월u 본사:성남시분당구판교로 235u 미국자회사:텍사스휴스턴, JLABS@TMC내입주

(2016년 1월설립)u 대표이사:이정규

u 현인력:미국자회사 1명포함총 7명u 자본금: 9.4억원

u 주식수:총 188,163주 (주당 5천원)[보통주 95,800주/우선주 92,363주]

u 가상운영개발중심바이오텍

u 경력 20년이상의각분야전문가로구성

u 2016년 7월시리즈 A로 145억증자

Ø KTB네트워크, LB인베스트먼트, KB인베스트먼트,HB인베스트먼트, 인터베스트, SV인베스트먼트,컴퍼니케이파트너스, 라이프코어파트너스

u 해외대표적산업계저널인 BioCentury로부터 “EmergingCompany”로인정받음


비전 & 전략

5

리더십팀: 경영진


• 이정규,설립자 &대표이사• LG생명과학사업개발차장,크리스탈지노믹스공동창업자

• 최주현박사,설립자,발굴생물학담당파트너• 고려대학박사학위,마운트사이나이의대, LG생명과학,사노피등

• 강상욱박사,원재의약품담당• 미국립암센터,렉산,세코이아,케미존,부광등

• 강신홍박사,완제의약품/제형담당• BMS,J&J,Wyeth,PurduePharma,JW중외제약

• 최혜진파트너,임상개발및규제담당• 삼성의료원, LG생명과학,ICONClinicalResearch

• 장미경박사,미국자회사연구담당부사장• 미국엠더슨암센터텍사스주립대학,연구원

• 송병호파트너,운영담당• LG생명과학,종근당

6

리더십팀: 이사회


• 이정규,설립자 &대표이사• LG생명과학사업개발차장,크리스탈지노믹스공동창업자

• 김성욱부회장,한올바이오파마/R&D위원장대웅제약그룹• 연세치과대학

• ChristopherKim,PhD.,Novatio Ventures대표• 노바티스, OxfordBiosciences,JohnsHopkins의대

구중회 • LB인베스트먼트,전무

천지웅 • KTB네트워크,팀장

이종훈 • SV인베스트먼트,팀장

사내이사

독립사외이사

투자가사외이사

7

사업전략


u전세계적미충족의료수요를개선할수

있는한국의혁신과학을찾는다

u연구단계부터학계및산업계협력자들과

함께한다.

u아시아지역의개발관련 CRO네트워크를

최대한활용한다.

u미국과중국을동시에목표로하는글로벌

임상개발을추구한다.

8

사업전략: 전략적협력자들


u한국화학연구원/성균관대학교 (BBT-401발굴)

u우시앱텍/STA

u임상 CRO들

u큐베스트컨설팅

u MDAnderson암센터

u연세의료원

9

제품개발계획


2017 2018 2019

GLPtox P1/2 P2궤양성대장염

GLPtox P1/2 P2다발성경화증

GLPtox P1/2 P2노인성황반변성

BBT-401(펠리노-1저해제)

GLPtox P1호흡기질환표적단백질1

GLPtox P1 P2희귀질환표적단백질2

IND 임상2상후미팅(EoP2meeting)IND

Bridge Biotherapeutics, Inc. 8-Nov-16 Preliminary Data MD-3-3-664-1921 Page 3 of 6

Confidential

2. RESULTS:

Figure 1. Body weight change of animals from study day 0 to 14. *p<0.05, ** p<0.01 compared with Vehicle by using 2-way ANOVA followed by a Dunnett multiple comparisons test.

Figure 2. Total colitis score from study day 0 to 14. *p<0.05, ** p<0.01 compared with Vehicle by using 2-way ANOVA followed by a Dunnett multiple comparisons test.

Day 0

Day 2

Day 4

Day 7

Day 9

Day 11

Day 14

-30

-20

-10

0

10

Bod

y W

eigh

t Cha

nge

(%) Naive

Disease OnlyAnti-p40VehicleBBT-401 25mg/kg D0-D14BBT-401 50mg/kg D0-D14BBT-401 100mg/kg D0-D14BBT-401 200mg/kg D0-D14

*********

**

**

Day 0

Day 2

Day 4

Day 7

Day 9

Day 11

Day 14

0

2

4

6

8

10

Tota

l Col

itis

Sco

re (0

-11) Naive

Disease OnlyAnti-p40VehicleBBT-401 25mg/kg D0-D14BBT-401 50mg/kg D0-D14BBT-401 100mg/kg D0-D14BBT-401 200mg/kg D0-D14****

****

**

****

10

제품개발계획: BBT-401


u 소화관에만머무는저분자화합물

u 분자표적:펠리노-1u 약효:

Ø RIP1과MyD88을동시에저해하는

항염증효과

Ø NFkB신호전달만선택적으로저해

Ø 상처치유효과

u 예상적응증 :궤양성대장염 (경구투여),다발성경화증(피하주사),노안성황반변성(안구내주사)

u 개발단계:전임상독성시험개시

u 개발계획:Ø 4Q17:미국 IND제출(궤양성대장염,

다발성경화증)Ø 2Q18:미국 IND제출(노인성황반변성)

Bridge Biotherapeutics, Inc. 8-Nov-16 Preliminary Data MD-3-3-664-1921 Page 3 of 6

Confidential

2. RESULTS:

Figure 1. Body weight change of animals from study day 0 to 14. *p<0.05, ** p<0.01 compared with Vehicle by using 2-way ANOVA followed by a Dunnett multiple comparisons test.

Figure 2. Total colitis score from study day 0 to 14. *p<0.05, ** p<0.01 compared with Vehicle by using 2-way ANOVA followed by a Dunnett multiple comparisons test.

Day 0

Day 2

Day 4

Day 7

Day 9

Day 11

Day 14

-30

-20

-10

0

10

Bod

y W

eigh

t Cha

nge

(%) Naive

Disease OnlyAnti-p40VehicleBBT-401 25mg/kg D0-D14BBT-401 50mg/kg D0-D14BBT-401 100mg/kg D0-D14BBT-401 200mg/kg D0-D14

*********

**

**

Day 0

Day 2

Day 4

Day 7

Day 9

Day 11

Day 14

0

2

4

6

8

10

Tota

l Col

itis

Sco

re (0

-11) Naive

Disease OnlyAnti-p40VehicleBBT-401 25mg/kg D0-D14BBT-401 50mg/kg D0-D14BBT-401 100mg/kg D0-D14BBT-401 200mg/kg D0-D14****

****

**

****

DSS-inducedcolitismousemodel

*p<0.05,**p<0.01N=10pergroup

11

중단기마일스톤


u 2017년 4분기 BBT-401의미국 IND신청 (궤양성대장념,다발성경화증)

u 2017년 3분기내노인성황반변성개발을위한 1개월서방형제형개발


경기도성남시분당구판교로 253판교이노밸리 B동 903호(우) 13586

본사

미국자회사 Bridge Biotherapeutics, Inc. In JLABS@TMCJohn P. McGovern Campus2450 Holcombe Blvd, HoustonTX 77021 USA

연락 [email protected]

Health & Medicine

Bridge biotherapeutics corporate deck 2017 February