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LUMOSA THERAPEUTICS2019Q3

INVESTORS CONFERENCE

Presented by: Jung-Chin Lin, President and CEO2019/11/21

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Disclaimer

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All the related information and forward-looking information from this slides and

presentation, including future outlook, financial statement, and business prospect,

is based on internal information and external economic conditions. The actual

results including operating result, financial statements, business results of the

company, may differ from the forecast for various reasons, including but not

limited to the increase of the changes of market demand, price fluctuation, all

kinds of policies, laws, current economic conditions, and any other risks of force

majeure.

The information in the slides and presentation is our opinion toward the future. It

does not expressly or impliedly represent or guarantee its correctness,

completeness or reliability. If there are any changes or adjusting in the future, the

company undertake no responsibility to update or revise our opinion.

Lumosa Business Model and Re-positioning

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Lumosa History

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2011-2014(Infancy)

2014-2018(Foundation)

After 2018(Growth)

Drug developmentProject management

研發導向新藥開發公司奠定rSD開發模式

商業導向的研發公司完善大小分子開發及

商業能力

Position

NTD 1,175bNTD 780mNTD 490mCapital

Dev. focus

Organization allocaiton Project manager

Project manager/pre-clinical translational

confirmation/CMC/clinical/regulatory

選早期題/專案經理臨床前轉譯確效CMC/臨床/法規/財務/BD

• 確立發展方向(植物新藥 小分子)• 三合一/早晚期合併

• 奠立新藥開發能力和基礎

• 完善新藥開發流程• 投入組織人才發展

• 重視產品商業化• 多元授權/合作模式• 強調風險管控(平衡風險與投資)

2011-2014(Infancy)

2014-2018(Foundation)

After 2018(Growth)

Capital NTD 490M NTD 780m NTD 1,175m

Positioning Drug developmentProject management

R&D focusedNew drug development

companyEstablishment of rSDdevelopment model

Commercial-focused R&D company

Complete large- and small-molecule development and

business development capabilities

Development focus

• Establish development direction

(botanical new drug → small molecules)

• Merger of 3 companies / combining early- and late-stage projects

• Build up the capabilities and the foundations for new drug development

• Refine new drug development process

• Invest organization/ human resources development

• Value product commercialization

• Multi-model licensing /collaboration models

• Emphasizes on risk management (balance between risks and investments)

Organization allocation

Project manager Project manger/ pre-clinical translation confirmation/ CMC/

clinical/regulatory

Early-stage candidates/ project manager/ pre-clinical

translation confirmation/ CMC/ regulatory/ finance/ BD

Merger of 3 companies

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Lumosa Strategy and Business Model

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BD/In

Multiple collaborative models

• Centralized management of R&D pipeline

• Search for collaborating partners at pre-clinical / P1 / P2 stage

Out

reSEARCH & DEVELOPMENT

Pipeline replenishment

• Technical transfer• R&D collaboration• Formation of JV• Pipeline transaction or project

company

Addition of new drug candidates and tx categories through strategic partners

Co-development with academic and research institutions through early collaborations

Accelerated integrationof human resources and capital chain

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What We Have Done This Year?

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•Merger of Lumosa and TPG Biologics:LT2003 cancer targeting candidate and platform

•Rationalize Lumosa business model•Optimization of company resources (balance technological/research/commercial risks)•Enhance BD/cashflow/in-license of early-stage pipeline

•Validate Lumosa corporate lifecycle, identify “success gap”

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Risk Balance

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LT1001

Long-acting analgesic

LT3001

Treatment for acute ischemic

stroke

LT5001

Uremic pruritus

LT2003

Cancer target therapy

Research risks

1 5 2.5 1.5

Technological risks

2 3 1 3.5

Commercial risks

2 0 4 2

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R&D Pipeline

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Post-Operative PainLT 1001

Acute Ischemic StrokeLT 3001

Uremic Pruritis

CS program

PCS program

Evaluation Projects (Include in house life cycle R&D and in licensing projects)

LT 5001

PreclinicalCompound

Selection

Value Identification Value Creation Value Amplification

LaunchLaunchPhase 1 Phase 2 Phase 3 NDA

LT 2005 (CS301)

OncologyLT 2003

LT1001 (Long-acting analgesic injection)

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LT1001 Development Strategy

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Marketed area Regional expansion New product line

• Expand usage• Increase use

experience• Increase

market penetration

Step1-rapid expansion• Key market – strategic break point

(Switzerland, Singapore)• Key/major market – Quantity (US,

China)• Low barrier – Rapid entrance (SEA,

Korea)(~45% global pharmaceutical market)

• New indication+newformulation

• Next generation formulation

• New application (animal)• New product introduction

Step2-Comprehensive coverage• Regions where data from key markets

can be applied (EU, MENA, ROW)

(~80% global pharmaceutical market)

Step3-Maximize product value• Markets with high barrier or

investments (JP)(~90% global pharmaceutical market)

Target: stabilized cashflow, becoming global expert in pain (product diversity)

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Taiwan Marketing Strategy and Sales Forecast

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Naldebain Taiwan Market Forecast

Taiwan Post-op Pain Market

population23,000,000

# of Surgeries/yr4,600,000 cases

Market valueNTD 13.7b

0

5

10

15

20

25

30

35

2018 2023 PECK

SALE

S V

OLU

ME(

10

K V

IAL)

Peak sales20232018

1st Stage 2nd Stage 3rd StageAbdominal,

gynecological, c-section,

arthroplasty

Multi-modal pain

management

Sales peak

Penetration rate 0.2%

Penetration rate 2%

Penetration rate 4.5%

Sales volume10k

Anticipated volume at peak sales

200k

Sales volume100k

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Swiss Licensing Is Strategically Significant

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Switzerland

Many countries recognize Swiss approval, allowing direct submission of the dossiers without conducting a local trial.• New Zealand, Turkey, Latin America,

MENA

• As the government encourages the development of new drugs, dossier submitted to TFDA may be reformatted and submitted to Swissmedic

• LT1001 Phase 3 trial was designed in accordance to international standards

• Manufacturers are PIC/s GMP certified

• June 2019 – Lumosa entered an exclusive distribution agreement with Ideogen AG, a Swiss pharmaceutical company. Ideogen is responsible for the registration, marketing, and sales of LT1001 in Switzerland, while Lumosa is to supply the products.

• October 2019 – Ideogen has submitted NDA applications to the Swissmedic, the approval is expected to be in the first half of 2021.

Switzerland has a small population and can only contribute limited revenue to the company. However, licensing in Switzerland has regulatory strategic significance as approval by the Swissmedic will likely facility the licensing negotiation in other regions

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CS011 (Long-acting analgesic for veterinary use) Progress

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US, Canada, Australia, New Zealand (Licensed to SVP)

Lumosa’s work:• Supply agreement and preparation: Lumosa to provide quotation

to SVP. SVP will sell the entire package to a multinational pharmaceutical company. Therefore, Lumosa will negotiate with the marketing partner after confirmation.

SVP progress in the US:• Rolling submission (NADA, eCTD submitted) in-progress,

expected approval in 2020.• SVP conducted an on-site audit of the manufacturers on7/10~11

(UBIP and Formosa)。

Global rights (Negotiating)• Initiate business negotiation in global rights with SVP

LT5001

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LT5001 Product Introduction

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Abnormal endogenous opioid ligand activity at µ and κ-opioid receptors has been proposed as a mechanism in UP. The predominant active pharmaceutical ingredient of LT5001 drug product is a κ-opioid agonist and partial µ-opioid antagonist and developed as a topical ointment formulation, which is thought to have the potential to modulate peripheral opioid receptors present on sensory nerves and immune cells.

Uremic pruritus (UP) is a common and distressing complication of end-stage renal disease. A global cross-sectional study of 18,000 hemodialysis patients reported 42% prevalence of moderate or extreme UP, which was strongly associated with sleep disturbance, depression, impaired quality of life, and mortality (Pisoni RL, 2006). Despite high prevalence and life-altering comorbidities, UP remains lack of effective treatment. Treatments currently used for UP such as antihistamines, steroids, emollients, and phototherapy have not been investigated rigorously, and no drugs have been approved for this indication by the FDA.

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LT5001 – Market Forecast

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1st line therapy (Moderate to Severe)2033 peak sales: 667 m

2nd line therapy (Severe)2033 peak sales: 521 m

Global Market Size Nearly USD2.6~3.6 in Value

$0.0

$100.0

$200.0

$300.0

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$800.0

2025 2026 2027 2028 2029 2030 2031 2032 2033

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ual

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enu

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S$M

M)

Estimated Annual Revenue For LT5001 (1st Line)

$0.0

$100.0

$200.0

$300.0

$400.0

$500.0

$600.0

2025 2026 2027 2028 2029 2030 2031 2032 2033

Esti

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ual

Rev

enu

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Estimated Annual Revenue For LT5001 (2nd Line)

LT3001

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Restore cerebral blood flow Reduce ischemia/ reperfusion injury

Novel small molecule

Anti-thrombosis without impairing hemostasis

Anti-oxidation stress and reduce inflammation

Dual Function

LT3001

• Patients <3 hr after stoke onset• ~ 6% Intracranial hemorrhage• Use in <10% of patients

IV rt-PA Mechanical thrombectomy

• Patients <6 hr after stoke onset with large vessel occlusion*

• Use in <10% of patients

*In selected patients < 24 hr after stoke onset with large vessel occlusion and meet other DAWN or DEFUSE 3 eligibility criteria, 2018 AHA Guidelines

A dual function molecule to increase the treatable population by safely restoration of blood flow with an extended treatment window

Unmet Medical Need in Acute Ischemic Stroke: <20% patients received active treatment

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LT3001 Target Product Profile

ItemsIV rt-PA

(Roche/Genetech)LT3001

(Lumosa)

Regimen10% IV bolus followed by IV infusion

for 60 minShort infusion (15 min.)

Treatment time window Within 3 hrs of stroke onset Within 12 hrs of stroke onset

Improve stroke outcome 30-40% Better than tPA

Reperfusion injury Associate with reperfusion injury Reduce reperfusion injury

Bleeding Prolong bleeding time (>20X) No effect on bleeding time

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The preclinical Proof of concept study was collaborated with Massachusetts General Hospital, US. The study performed followed STAIR consensus recommendation with prespecified inclusion criteria, randomization and blinded assessment of outcome.

Note: Neuro severity score (NSS) is evaluated to demonstrate the neuromuscular/ behavior outcome improvement. Bigger value indicated worse outcome.

LT3001 Efficacy : Proof-of-Concept

Stroke onset

3h

Stroke outcome evaluation

LT3001IV infusion

24h

Schedule

LT3001 shows better efficacy and safety than tPA when given at 3 hr after stroke onset

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LT3001 – A Novel Small Molecule for the Treatment of Acute Ischemic Stroke

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Safe No unwanted bleeding

Effective Recanalization with reduced perfusion injury

Save more lives! Extended treatment window

✓ Phase 1 trial Completed in 2018 in clinical study center in the US

✓ Phase 2b trial Initiated in the US and Taiwan simultaneously in 2019

✓ Patent protection Compound patent protected until 2034

Development Progress

Competitive Advantages

Time is Brain

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LT3001 Rights in China Licensed to Shanghai Pharma

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• Lumosa and Shanghai Pharma (SHP) entered a licensing agreement for the rights of LT3001 in China

in November 2019

• Lumosa to receive up to CNY 288m in upfront and milestone payments, and 6%~12% royalty

payment from the sales.

• Being one of the top notch publicly-traded pharmaceutical companies in China, Shanghai Pharma’s

total asset in 2018 was USD 19b, with the annual revenue of USD 24b. It is the first Chinese

pharmaceutical company to be listed in both Shanghai and Hong Kong stock exchanges.

Phase 2 Phase 3 NDA/Launch

SHP is responsible for the execution and the cost of Phase 2 trial in China

SHP is responsible for the execution and the cost of multi-national, multi-site Phase 3 trial in China, while Lumosa is responsible for the cost of the rest of the regions

Lumosa to receive 6~12% royalty payments from the salesSHP to share clinical trial data with Lumosa, while Lumosa to share international licensing incomes with SHP

Successful licensing of LT3001 not only accelerated Lumosa’s clinical programs, reduce R&D costs, but also stimulated Lumosa’s international licensing activities

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LT3001 Clinical Trial Progress

⚫ LT3001-201 Trial (Phase 2a Single-dose ):

✓ USA: Approved by the IRBs of three hospitals after US FDA’s 30-day review period in (June 2019), to initiate enrollment in November 2019.

✓ Taiwan: Authorized by TFDA in August 2019. Received approval of 6 hospital IRBs, to initiate enrollment by the end of 2019.

⚫ LT3001 Trial (Phase 2a Multi-dose):

China: Preparation of re-IND & CTA:

✓ Application package ready to be submitted✓ Pre-IND meeting to be requested by Q4 of 2019

LT2003(ADC platform)

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LT2003 (Platform) Introduction

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5-FC

Antibody fragment (anti-EGFR)

Enzyme

LT2003(Tumor-targeting enzyme)

Non-cytotoxic pro-drug

5-FU

Step 2-5-FC (p.o.)

Step 2-5-FC locally converts to 5-FU specifically at tumor site

Step 1-Through circulation, LT2003 is specifically targeted to the EGFR over-expressing tumor

Step 1-LT2003 (i.v.)

LT2003 is the first product developed from the “Dual-Function Fusion Protein Platform,” consists of a tumor targeting antibody and a cytotoxic conversion enzyme to deliver cytotoxic agents to the tumor site.

1. Delivers functional enzyme to tumor cells2. Conversion of non-cytotoxic 5-FC by the enzymes into cytotoxic 5-FU at the tumor site

Risk Balance

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2019-2022 2022-2025 After 2025

Research risks 30% 40% 50%

Technological risks

70% 60% 50%

First-in-class

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Collaborating with the Academic Institutions to Quickly Obtain Potential Candidates for Development

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Establishedpipeline:

CS017CS021

PCS1812PCS1901 PCS1905PCS1906

Industrial-academic partnering

IP

Commercialization strategy

Development budget Development

direction

• Lumosa to provide academic and research institutions the following:

– Product commercialization strategy

– Developmental direction consultation

– Intellectual property consultation

– Development budget

– Industrial-academic collaboration applications

• Lumosa has the first-right-of-refusal to in-license the project

Acquisition of candidates with high cost-performance ratio (First/Best-in-class) with reasonable costs

• Of the 16 projects evaluated this year, 4 were accepted by Lumosa.

Thank you!

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