Investors Conference (4152)

George Yeh, President

Our Specialty Technology

Indications

Platforms

Products

History

About TLC

Lipid-Assembled

Nanomedicine

Delivery

Patents

~100

10+ 3 on market 4 Clinical

5+ Small ~ large molecules

Minutes ~ months

Oncology

Ophthalmology

Pain Management

Targeted Delivery

Sustained Release

Locations

Taiwan, US, Europe, Japan,

Australia, China

1997 Founded

2012 IPO

MSCI

2

Lipid-Assembled Delivery

• Toxicity/solubility

• Proprietary loading

Lipophilic Domain

Aqueous Core

Design delivery strategies for both small and large molecules

3

Route of administration • Intravenous

• Intravitireal • Intraarticular

• Subcutaneous

Cytotoxic/Molecular Targeting

Tissue Targeting

Cellular Targeting

Cellular Targeting with Toxin

Tissue Targeting + Cellular Targeting

More Effective Targeting

• CTCL, RMS • Lowers toxicity, reduces side effects • Fewer injections

TLC178 (Ph1/2)

• Hepatocellular carcinoma & rectal cancer

• Solves insolubility & toxicity

TLC388 (Ph2)

• Cancer • Targeted delivery of

immunoliposomes with antibody

TLC520

4

Sustained Release Delivery

5

• Multilamellar and multivesicular for extended release

• Capable of containing both small and large molecules

• Function of large biologic molecule therapeutics are not compromised

• Lipid membrane can keep a drug trapped over long periods of time

Small molecule

drug

Large molecule

drug

Multilamellar structure

Lipid-Extended Release Technology (L-ERT)

6

Intravitreal application

• Indications: Age-Related Macular Degeneration,

Diabetic Macular Edema, Retinal Vein Occlusion

• Targeting 1 injection/6 months

• Phase II in progress

Intraarticular application

• Indications: Osteoarthritis, Rheumatoid

Arthritis, Musculoskeletal injuries

• Targeting 1 injection/3-4 months

• Phase II in progress

Applications of our proprietary platform can be

expanded to other tissues in the human body

Discovery Development Phase I Phase II Phase III

Oncology

TLC388 HCC with PVTT

Rectal cancer

TLC178 CTCL/RMS

TLC520 Various cancers

Three Main Areas of Focus

7

Targ

ete

d D

eliv

ery

Ophthalmology

TLC399 Macular edema

Pain/Osteoarthritis

TLC599 Osteoarthritis

TLC590 Local anesthetic

Sust

ain

ed

Re

leas

e

Clinical Trial Advancements

• TLC599 Phase 1/2 completed (knee OA)

• TLC599 Phase 2 commenced (kneed OA) (TW/AU)

• TLC399 Phase 2 commenced (macular edema) (US)

• TLC388 Phase 2 (HCC with PVTT) (TW/CN)

• TLC177 BioEquivalence completed (Breast & Ovarian

Cancers) (EU)

Approvals

• TLC178 IND (Lymphoma) (TW/US)

• TLC178 ODD (CTCL) (US)

Milestones Achieved in 2016

8

TLC599

Treatment Scheme for Knee OA

10

Filling the Market Gap

Existing treatments

Patient needs Unmet Medical

Needs

Steroids

• Max. 3-4 injections/year

• Efficacy of 1-2 weeks only

• Chondrotoxicity

Hyaluronic Acid

• Lack of outstanding efficacy

Opioids

• Addictive

• Can be lethal

4.2M patients (US)

1M patients (US)

11

• Fast acting

• Sustained pain relief

• Effective pain management

• Fewer side effects

• Non-addictive

14 million people suffering from OA in the US

Liposome encapsulated steroid

Triamcinolone Acetonide (TA) • Crystal form

Dexamethasone (DSP) • Water soluble

Formulation PLGA BioSeizer

Pricing ~US$500/injection ~US$500/injection

Timeline • FDA NDA • Estimated approval Q3

2017

• Phase 2 clinical • Estimated NDA by 2020

Company Market Value

US$615M US$215M

Zilretta vs. TLC599

• Aggregation in joints

• Chondrotoxicity

• Manufacturing costs

• Release profile

12

FLXN 4152

Platform Comparison

Technology Platform Polymer-based BioSeizer

Range Small or large

molecule drugs Small and/or large

molecule drugs

Biodegradability Yes (PLGA)

No (DVE/EVA) Yes

Biocompatibility Yes Yes

Risk of Denaturing & Aggregation

High None

Sterile Production Required Not Required

Final Sterilization Radiation Filter

Risk of Foreign Particulates High None

Needle Gauge Size > 27 G < 30 G

• Speed of onset

• Sustainability

BioSeizer has a better releasing profile & lower cost of production 13

Greatly impacts

manufacturing costs

TA Issue #1: Aggregation in Joints

PLGA Aggregates may accelerate TCA

Release shorter efficacy span &

aggregation at joint

Inability to increase dosage Limitation on sustainability 14

TA Issue #2: Efficacy & Sustainability

0

5

10

15

20

25

30

35

40

0 4 8 12 M

ean

sco

re

Week

TLC599

Group A (6 mg DSP, n=20)

Group B (12mg DSP, n=20)

Zilretta

WOMAC Index

TLC599 shows faster onset and sustained release capabilities

Onset close to Week 4

Onset at Week 1 Effect dissipates after 12 weeks

Sustained effect past 12 weeks

15

Phase 2 Study Design

Single Dose Treatment

Screening Day-14 to

Day-1 (n=72)

Group C TLC599 single dose IA

injection (18 mg DSP with 150 μmol PL)

(n=24)

Group B TLC599 single dose IA injection (12 mg DSP with 100 μmole PL)

(n=24)

Evaluation of Safety & Efficacy

• Day 0

• Week 1

• Week 4

• Week 8

• Week 12

• Week 16

• Week 20

• Week 24

Random

ization

Screening period (-14~-1 days)

Treatment period (Day 0)

Follow-up Period

(24 weeks)

Group A Placebo

(normal saline) (n=24)

16

TA Issue #3: Chondrotoxicity

Safranin O

2 wks 4 wks 8/9 wks

Toluidine Blue

Rat OA

Toluidine Blue

BioSeizer Vehicle GLP Study

TLC599 High Dose (1.2mg)

GLP Study

No proteoglycan and cartilage damage from GLP study, signaling lack of chondrotoxicity in both TLC599 and BioSeizer Vehicle

Yellow brackets indicated cartilage damage and chondrocyte loss

Rat OA data adapted from Lai YJ et al Ann Rheum Dis. 2014 17

2012 2013 2014 2015 2016

NDA Application

12/12/2016 ~1y

4 mths 9 mths 15 mths

12 mths

Ph2 • AU • n=24 • Groups: 10, 40, 60mg & TCA IR 40 mg • Study evaluation period: 6 wks

Ph2b • AU/CA/US • n=229 • Group: 10, 40, 60mg & TCA IR 40 mg • Study evaluation period: 12 wks

Ph2a •PK study • Groups: 10 or 40 • Study evaluation period: 20 wks

Ph2b • US • n=310 • Groups: 20, 40mg & saline • Study evaluation period: 24 wks

Ph3 • US • n=486 • Groups: 40 mg, TCA IR 40 mg, and saline • Study evaluation period: 24 wks

PD/PK: Sustained Release PK: Safety & Sustained Release

Efficacy: POC

Efficacy: Pivotal

Efficacy: Pivotal

Zilretta Study Design

18

2016 2017 2018 2019 2020

~15 mths

9 mths

Ph2b • AU/TW • n=72 • Group: Placebo, 12mg, 18mg • Study evaluation period: 24 wks

Ph1/2a • TW • n=40 • Groups: 6 , 12 mg • Study evaluation period: 12 wks

Ph2b (Pivotal)

Ph3 (Pivotal)

Efficacy

TLC599 Study Design

Safety & Efficacy

Ph2a (PK study )

NDA Application (Asia)

19

NDA Application (US)

Commonly Used OA Treatments

Zilretta

• There are 14M* annual patients with knee OA, of which 5.2M are treated with IA injection

(steroids & hyaluronic acid)

• 4.2M patients are on steroid injections; 1M are on HA

• By conservative calculation, assuming patients who are on steroids receive 1 injection every 6

months, annual total injection will be 8.4M

• 1 injection is ~US$500

U.S. Steroid knee OA injections market is approximately US$4.2B

* IMS 2014

20

TLC399

Competitive Landscape

Age-related macular degeneration (AMD)

Diabetic macular edema (DME)

Retinal vein occlusion (RVO) Posterior uveitis

Retinal Diseases

A progressive eye condition affecting roughly 1.75 million Americans

Caused by leakage of fluid from small blood vessels in the eye. An increased expression of VEGF can escalate the leakage and vascular permeability. Visual impairment due to DME affects approximately 1~3% diabetes patients

Approximately 16 million people worldwide may have retinal vein occlusion. superficial hemorrhages, retinal edema, and often cotton-wool spots in a sector of retina drained by the affected vein.

Visudyne Macugen Lucentis

Eylea Avastin

Lucentis

Eylea Illuvein

Ozurdex

Lucentis Eylea

Ozurdex

Triesence

Trivaris Ozudex Retisert

Inflammation in the back of the eye is commonly characterized by floaters, blurred vision, photopsia or seeing flashing lights. The prevalence of uveitis in the general U.S. population is 38 per 100,000 persons, with the mean onset at 30.7 years of age.

Least Crowded Space

Retinal Diseases

22

Drug/ Mechanism

Anti-VEGF Anti-VEGF Steroids

(implanted) Steroids

Efficacy 1 month 2 months 2-3 months 4-6 months

Price/inj. US$2,000 US$1,850 US$1,400 US$1,400 ~

US$2,000

No. of injections (2015)

1,030,000 1,450,000 40,000

No. of injections (2016)

917,500 1,800,000 60,000

Competitor Analysis

24% 50% 11%

10%

2.52M inj.

2.78M inj.

23

Ozurdex Issue: Implant

Implants must be surgically removed after approximately 3 injections

22 gauge Needle

24

1.2 mg TLC399 0.6 mg TLC399

0.7 mg

0.35 mg

TLC399 Released dexamethasone in rabbit’s vitreous

Ozurdex Released dexamethasone in rabbit’s vitreous

25

TLC399 vs. Ozurdex Efficacy

TLC399 showed significantly longer efficacy at LLoQ than Ozurdex

LLoQ

• No adverse effects

• Improved/stabilized vision for 9 months and beyond

• Improved OCT results for 9 months and beyond

• Phase 2 study underway (US)

TLC399 Phase 1/2 Study

26

Phase 2 Study Design

Single Dose Treatment

Screening Day-14 to

Day-1 (n=66)

Group C TLC399 single dose injection (0.6 mg DSP with 50 mM PL

(50 µL)) (n=22)

Group B TLC399 single dose injection (0.6 mg DSP with 100 mM PL

(50 µL)) (n=22)

Evaluation of safety & Efficacy

Random

ization

Screening period (-14~-1 days)

Treatment period (Day 0)

Follow-up Period (12 months)

Group A TLC399 single dose injection (0.36 DSP with 100 mM PL

(30 µL)) (n=22) • Day 0

• Week 2

• 1 Month

• 2 Months

• 3 Months

• 4.5 Months

• 6 Months

• 7.5 Months

• 9 Months

• 12 Months

Interim Analysis (2018.H2)

27

TLC399 + Anti-VEGF

Days post ITV

7 28 49 70 91 112

Anti-V

EG

F a

ntibody C

on

c. in

vitre

ou

s (

g/m

l)

0.1

1

10

100

1000

Anti-VEGF antibody alone

Anti-VEGF antibody/TLC399

Efficacy diminishes around Day 30

Combination showed efficacy at Day 112

Efficacy of Anti-VEGF can be significantly prolonged from 1-2 month to 4-6 months when used in conjunction with TLC399

28

Strategy

Age-related macular degeneration (AMD)

Diabetic macular edema(DME)

Retinal vein occlusion (RVO) Posterior uveitis

Approximately 2.78M injections were administered for retina diseases in the U.S. in 2016, valuing at US$5.3B

16.4M patients in US

1~3%diabetes

patients 1.75M patients in US

1 National Eye Institute (NEI) 2US National Library of Medicine National Institutes of Health

29

TLC178

• Vinorelbine Tartrate Liposome Injection Product

• Rhabdomyosarcoma (RMS) • Cutaneous T-cell Lymphoma (CTCL) • Other solid tumors

Indications

• Phase 1/2 in TW & US Development

Stage

• (RMS) Vinorelbine

• (CTCL) Istodax/Romidepsin Current Treatment

• US Pediatric Rare Disease Designation in RMS

• US Orphan Drug Designation in CTCL Regulatory Route

• Lower toxicity

• Fewer administrations

Competitive

Advantage

TLC178 – IND Approval

Rhabdomyosarcoma (RMS)

Cutaneous T-Cell Lymphoma (CTCL) 31

Current Treatments

• Surgery

– Only applicable if it doesn’t lead to disfigurement, functional compromise, or organ dysfunction

– Difficult to remove all tumor cells

– Either chemotherapy or radiation is to follow

• Chemotherapy

– Vincristine in conjunction with other drugs or vinorelbine, as listed by NCCN

• Radiation

– used in conjunction with surgery to maximize local tumor control

32

NCCN Guidelines

Vinca alkaloids including Vinorelbine and Vincristine are listed by NCCN as standard treatments for RMS

33

Vinorelbine on RMS

NIH-PA Author ManuscriptNIH-PA Author ManuscriptNIH-PA Author Manuscript

Ku

ttesch et al.

Pag

e 8

Table II

Response to Vinorelbine by Tumor Type

Soft Tissue Sarcoma CNS Tumor Neuroblastoma Total

RMS Non-RMS

Complete Response 1 0 0 0 1 (2%)

Partial Response 3 0 2 0 5 (10%)

Stable Disease 6 3 3 3 15 (30%)

Progressive Disease 1 6 17 5 29 (58%)

Total 20 22 8 50

Abbreviations: RMS, RMS; Non-RMS, non-RMS

Ped

iatr B

loo

d C

an

cer. Au

tho

r man

uscrip

t; availab

le in P

MC

20

10 O

ctob

er 1.

Vinorelbine is proven to be effective in treating RMS

10 out of 11 patients with RMS achieved SD or better

Source: Phase II Evaluation of Intravenous Vinorelbine (Navelbine) in Recurrent or Refractory Pediatric Malignancies: A Children's Oncology Group Study

34

Issue with Vinorelbine: High Toxicity

Results

Pretreatment and demographic characteristics of the fifty patients who were enrolled in this

trial are presented in Table I. The study was closed to accrual after the STS stratum was

complete. The median number of courses delivered among these 50 patients was one,

ranging one to 10. Six patients had an objective response, including 1 complete response

(CR) and 5 partial responses (PR). (Table II) Responses in all patients were achieved after

the first course of therapy. Among 20 patients in the STS stratum, the responders (1 CR and

3 PR) occurred among 11 patients with RMS, for an overall response rate in RMS of 36%

(4/11). Among these 4 responders, 3 had alveolar RMS (of 5 enrolled) and one had RMS not

otherwise specified (NOS). No responses were observed among 3 patients with embryonal

RMS. The primary involved site of the patient with CR was Head/Neck; the primary

involved site for patients achieving a PR included upper extremity, lower extremity and

thorax. The duration of response was 2 courses (CR, 2 PR) and 3 courses (1 PR). There were

no responses among the 9 patients with non- RMS STS that included six patients with

sarcoma NOS, two with synovial sarcoma and one with primitive neuroepithelial tumor.

Overall, the median number of courses received for all 20 patients in the STS stratum was 2

(range 2 to 10). One of 2 patients with medulloblastoma achieved a PR and completed all 10

courses of therapy. One of 4 patients with astrocytoma achieved a PR which was sustained

over 3 courses of therapy. There were no responses among the 16 patients enrolled in the

other CNS substratum. There were also no responses among the 8 patients with NB.

Toxicities

The major toxicity demonstrated in this study was hematological. Among the first 35

participants who received vinorelbine at a dose of 33.75 mg/m 2, 25 experienced grade 3 or 4

neutropenia during the initial 2 courses of therapy (75%). Nine of these participants,

including 5 with initial bone marrow involvement of disease, required delay in therapy and/

or dose modification (26%). The protocol was amended at that time to reduce the starting

dose of vinorelbine to 30 mg/m2. After this change, ten of the subsequent 15 participants

developed grade 3 or 4 neutropenia (67%); however, none of these participants required a

dose delay or modification. Anemia was the second most common toxicity among

participants (20%). Grade 3 sensory neuropathy occurred in four patients (8%). No deaths

occurred among participants while enrolled on the study. Therapy was administered through

central venous access in all patients. No cases of extravasation necrosis were reported. Two

patients died of progressive disease within 30 days of terminating protocol therapy.

Discussion

Vinca alkaloids are among the most active groups of agents for childhood cancer therapy

(15). The major clinical problems with these alkaloids are dose-limiting neurotoxicity,

especially peripheral and autonomic neuropathies, risk of extravasation necrosis, and limited

route of delivery (intravenous). Vinorelbine has been associated with less neurotoxicity and

an established therapeutic activity against adult cancers, particularly breast carcinoma and

non-small cell lung carcinoma (3-5) and the potential of oral administration (11). Of

additional interest was that preclinical data suggested activity in pediatric brain tumors ( 16).

Results from the Children's Cancer Group phase I trial of vinorelbine suggested that this

agent may have activity in RMS and brain tumors (11). This information was the basis to

evaluate vinorelbine further in a phase II trial among children and adolescents with recurrent

malignancies.

Disease response was documented in this study among participants with recurrent RMS (4

cases), medulloblastoma and astrocytoma. Our observations regarding RMS are similar to

the reports by Casanova et al (17,18) and Epelman et al (19). Our observation on the activity

Kuttesch et al. Page 4

Pediatr Blood Cancer . Author manuscript; available in PMC 2010 October 1.

NIH

-PA

Au

tho

r Ma

nuscrip

tN

IH-P

A A

uth

or M

anu

scrip

tN

IH-P

A A

uth

or M

an

uscrip

t

Source: Phase II Evaluation of Intravenous Vinorelbine (Navelbine) in Recurrent or Refractory Pediatric Malignancies: A Children's Oncology Group Study

35

High Toxicity in Vinca Alkaloids

Vincristine Vinblastine Vindesine Vinorelbine TLC178 TTP

Standard adult dose range (mg/m

2/wk)

1–2 6–8 3–4 15–30 ↑ Dosage / ↓ Injections ↑ Tumor exposure

Pharmacokinetic behavior

Triphasic Triphasic Triphasic Triphasic

Plasma half-lives ↑ Circulation Time ↑ Tumor exposure

α (min) < 5 < 5 < 5 < 5

β (min) 50–155 53–99 55–99 49–168

γ (h) 23–85 20–64 20–24 18–49

Clearance (L/h/kg) 0.16 0.74 0.25 0.4–1.29 ↓ Clearance ↑ Tumor exposure

Primary route Hepatic metabolism and biliary elimination

Hepatic metabolism and biliary elimination

Hepatic metabolism and biliary elimination

Hepatic metabolism and biliary elimination

Unchanged

Principal toxicity Neurotoxicity, Constipation, SIADH

Neutropenia, alopecia, neurotoxicity, mucositis

Neutropenia, alopecia, neurotoxicity

Neutropenia, lower neurotoxicity, vomiting, constipation, mucositis

↓ Toxicity ↑ Quality of Life

Rowinsky E. The Vinca Alkaloids; Holland-Frei Cancer Medicine. 6th edition. http://www.ncbi.nlm.nih.gov/books/NBK12718/ 36

• Reduced myelosuppressive side-effects compared to vinorelbine

• Higher vinorelbine concentration at neovascular-rich and subcutaneous tumor sites

• Regulatory advantages from Orphan Drug Designation & possibility at Priority Review Voucher with Rare Pediatric Disease Designation

• Broadened indications beyond: – Non-small cell lung cancer

– Metastatic breast cancer

– Head and neck cancer

Advantages of TLC178

37

Toxicity Profile from Prototype

Total (N = 22)

Maximum CTC Grade

I II III IV V

Anemia 1 (4.5%) 0 1 0 0 0

Leukopenia 3 (13.6%) 0 2 0 1 0

Thrombocytopenia 1 (4.5%) 0 1 0 0 0

Malaise 1 (4.5%) 1 0 0 0 0

Syncope 1 (4.5%) 0 0 1 0 0

Anorexia 2 (9.1%) 1 1 0 0 0

Gastrointestinal Hemorrhage

1 (4.5%) 0 0 0 1 0

Glossitis 1 (4.5%) 0 1 0 0 0

Weight Loss 1 (4.5%) 0 1 0 0 0

Ataxia 1 (4.5%) 0 1 0 0 0

Rash 9 (40.9%) 2 3 4 0 0

Acne 1 (4.5%) 0 1 0 0 0

Skin Ulcer 1 (4.5%) 0 1 0 0 0

Only 1 case of Grade III or IV toxicity in TLC178

He

ma

tolo

gic

al

38

Vs. 75% in Vinorelbine

TLC178 vs. Vinorelbine PK Profile

TLC178 Vinorelbine* Ratio

Dose (mg/m2) 18.5 23 20 25

Cmax (ng/ml) 10883 ± 3647 14198 ± 5356 584 ± 304 784 ± 217 18X

AUCinf (h*ng/ml) 647071 ± 385214 900874 ± 605081 592 ± 160 734 ± 217 1000X

T1/2 (h) 29.5± 15.8 33.9 ± 16.0 23 ± 7.7 24.8 ± 10.6 --

CL (L/h/kg) 0.0022 ± 0.0044 0.0016 ± 0.0022 0.15 ±

0.09 0.15 ± 0.08 50-100X

Vd (L/kg) 0.082 ± 0.141 0.057 ± 0.046 13.2 ± 3.9 15.7 ± 6.3 150-300X

* Cancer Chemother Pharmacol. 2004 Sep;54(3):193-205. Epub 2004 May 25.

39

Vinorelbine Dosing Frequency

D1 D8 D15

WK 1 WK 2 Rest Week Vinorelbine

40

D1

WK 1 WK 2 WK 3 TLC178

WK 4

WK 4

Dr. Conley MD Anderson

70% of the patients came from other states of US, therefore, longer dosing interval is beneficial for patients

MD Anderson treats 75 RMS patients each year. There are 350 new RMS patients in the U.S. every year.

TLC178 vs. Vinorelbine Efficacy

Mean Tumor Growth

Days after tumor inoculation

10 20 30 40 50 60 70 80

Tu

mo

r V

olu

mn

(m

m3)

0

200

400

600

800

1000

1200

1400

1600

1800

2000

Saline

Free VNB

L-VNB

Time of drug injection (iv 5 mg/kg,q3dx4)

TLC178 can control tumor growth more effectively than free vinorelbine

41

Clinical Trial & Regulatory Pathway

3 patients

0/3 DLT

Escalate Dose

1/3 DLT

Add 1~3 patients at the

same dose

1/6 DLT

Escalate Dose

2/4, 2/5 or 2/6 DLT

De-escalate Dose

2/3 DLT

De-escalate Dose

MTD

MTD

CTCL (ODD)

RMS (PRD)

3+3 Dose Escalation: ~ 54 patients

Pivotal PMS ODD NDA (Accelerated

approval)

Stage 2: 15 Lymphoma patients

Pivotal PMS ODD NDA (Accelerated

approval)

Rare Pediatric Disease Priority Review Voucher (PRV)

42

Value of Priority Review Voucher

43

Strategies

NCE vs. New Formulation Drugs

505(b)1 2-5 yrs 1-5 years 8-15 years 11-25 yrs

Regulatory Pathway

Discovery Non-clinical Clinical Total Development Time

505(b)2 <1-3 yrs <1-2 yrs 2-5 years 4-10 yrs

TLC388

TLC520

• Relatively short development

time

• Known API safety profile

• Clear benchmarks for clinical

efficacy

• Fulfilling market gap

TLC599

TLC399

TLC178

TLC590

NCE

New Formulation

45

Screening & Clinical Mechanisms

Physicochemical evaluation

Proprietary Screening studies

in vivo PK study confirmation

Pre-Clinical in Taiwan

CPoC

Feasibility Study

1 IND /

year

Oncology - TLC388 (Ph2, HCC)

Oncology

-TLC388 (Ph 2, HCC)

- TLC178 (Ph1/2, RMS)

Ophthalmology

-TLC399 (Ph2, RVO)

Pain Management

-TLC590 (local anesthesia)

-TLC599 (Ph3, OA) planned

Pain Management -TLC599 (Ph2, OA)

46

Product Development Strategy

Current Treatment(s)

Market Needs

Market Gap

• Longer acting • Enhanced efficacy

•Less side effects (e.g. addiction)

Improved Formulation

• Non-clinical packages • Clinical trial designs

Regulatory Pathway

• Clinical Practice Physician Outreach

Market

TLC Core Value & Competence

Follow existing player for speedier access to market

47

Clinical Advancements

• TLC388 HCC with PVTT Phase 2 (2017)

• TLC178 Phase 1/2 (2017)

• TLC388 New Indication Phase 2 (2017.1H)

• TLC599 Phase 2 data (2018.1H)

• TLC399 Phase 2 interim data (2018.2H)

• TLC590 Phase 1/2 (2018)

Submission

• ANDA for NBCD (2017.1H)

• More ODD for TLC178 (2017.1H)

• TLC590 IND

Near Term Project Milestones

48

Approval

TLC178 Rare Pediatric Disease for RMS (US)

+886.2.2655.7377

+886.2.2655.7366

www.tlcbio.com

Thank You