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TLC Corporate Presentation George Yeh President

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Page 1: TLC Corporate PresentationConfidential Legal disclaimers 2 This presentation contains forward -looking statements within the meaning of the Private Securities Litigation Reform Act

TLC Corporate Presentation George Yeh President

Page 2: TLC Corporate PresentationConfidential Legal disclaimers 2 This presentation contains forward -looking statements within the meaning of the Private Securities Litigation Reform Act

Confidential

Legal disclaimers

2

This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by the words “will,” “expect,” “intend,” “plan,” “objective,” “believe,” “estimate,” “potential,” “continue” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. These statements are based on management’s current beliefs and expectations. These statements include but are not limited to statements regarding our business strategy, our plans to develop and commercialize our product candidates, our plans to enter into transactions with commercial or strategic partners, the safety and efficacy of our product candidates, our expectations regarding timing, design and results of clinical trials of our product candidates, our plans and expected timing with respect to regulatory filings and approvals, the size and growth potential of the markets for our product candidates, and our ability to serve those markets, and our plans and expected timing with respect to regulatory filings and approvals. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Factors that may cause our actual results to vary from current expectations are discussed in our prospectus relating to our initial public offering and our other filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections therein. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. The forward-looking statements in this presentation represent our views as of the date of this presentation. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this presentation.

The trademarks included herein are the property of the owners thereof and are used for reference purposes only. Such use should not be construed as an endorsement of such products.

Page 3: TLC Corporate PresentationConfidential Legal disclaimers 2 This presentation contains forward -looking statements within the meaning of the Private Securities Litigation Reform Act

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Investment highlight TLC is well-positioned to fulfill unmet medical needs

3

Experienced & dedicated team CEO’s 3rd liposome company following 2 drug approvals; President’s 2nd Seasoned management team with big pharma background ~120 employees (4 MDs, 40PhDs) with liposomal science expertise

LipAD® Lipid-Assembled Drug Delivery platforms BioSeizer® sustained release NanoX™ tissue-targeted delivery, proven in 2 approved drugs

Diverse late-stage pipeline featuring known APIs

Pain (TLC599 & TLC590) / ophthalmology (TLC399) / oncology (TLC178) 505(b)(2) regulatory pathway for expedited approval

Strong global IP protection Wholly owned product candidates & technology platforms 199 patents worldwide - 122 issued / 77 applications

Public company with distinguished reputation Dual-listed on Nasdaq (TLC) & Taipei Exchange (4152) Ranked top 5% every year in corporate governance evaluation

Page 4: TLC Corporate PresentationConfidential Legal disclaimers 2 This presentation contains forward -looking statements within the meaning of the Private Securities Litigation Reform Act

Confidential

Keelung Hong, PhD Founder, Chairman, CEO

35+ years liposomal science experience NanoX™ & Onivyde co-inventor

George Yeh, MBA President

20+ years in biotech/finance Hermes Biosciences CFO MOEA National Industrial Innovation Award winner

George Spencer-Green, MD Chief Medical Officer

35+ years experience Pfizer VP & clinical head Humira registration & extension clinical lead

Nicole Lin, MBA Chief Financial Officer

28+ years finance/accounting experience

Wenji Chen, PhD, MBA VP, Corporate Development

26+ years business/research development experience

Vincent Chang, PhD VP, Manufacturing

35+ years biotech & CMC consulting experience 11+ years at Abbott

Yunlong Tseng, PhD VP, Research & Development

20+ years chemistry & R&D experience NanoX™ co-inventor

Sheue Fang Shih Head of Product Development

20+ years protein drug delivery & targeted delivery experience BioSeizer® inventor

Experienced & dedicated management team with extensive drug development know-how

4

Page 5: TLC Corporate PresentationConfidential Legal disclaimers 2 This presentation contains forward -looking statements within the meaning of the Private Securities Litigation Reform Act

Confidential

Targeted Delivery

More options for payload selection

Efficient particle size for enhanced delivery

Reduced dose frequency

Robust, scalable & replicable manufacturing

Applicable to our library of 80+ compounds

Lipid-based drug delivery platforms designed to create innovative products

TLC599

TLC399

2011 Pacira

Exparel

2015 FDA Liposome Guidance

Sustained Release

TLC590 Controlled release

from days to months Can deliver biologics

or small molecules Fully biodegradable

components Economical

manufacturing process

Scale-up capabilities

1995 Sequus/Alza/J&J

Doxil 2015

Hermes/Merrimack/Ipsen Onivyde

TLC178

5

BioSeizer®

NanoX™

Page 6: TLC Corporate PresentationConfidential Legal disclaimers 2 This presentation contains forward -looking statements within the meaning of the Private Securities Litigation Reform Act

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A robust pipeline

6 6

Program Preclinical Phase I Phase II Phase III Anticipated Milestones

Pain Management

TLC599 Last patient enrollment

2H2020

TLC590 Last patient enrollment

1H2020

Ophthalmology

TLC399 Last patient enrolment 1H2020

Oncology

TLC178 Ph I/II MTD Q4W 2H2019

Adult advanced malignancies/ STS1

Osteoarthritis pain

Macular edema

Post-op pain

1 Soft tissue sarcoma (STS); Orphan Drug Designation (ODD) 2 Pediatric rhabdomyosarcoma (RMS); designated Drug for Rare Pediatric Disease (RPD)

Pediatric RMS2

Page 7: TLC Corporate PresentationConfidential Legal disclaimers 2 This presentation contains forward -looking statements within the meaning of the Private Securities Litigation Reform Act

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Osteoarthritis (OA) Pain Program TLC599: BioSeizer® sustained release dexamethasone sodium phosphate (DSP) intraarticular injection for OA pain

Page 8: TLC Corporate PresentationConfidential Legal disclaimers 2 This presentation contains forward -looking statements within the meaning of the Private Securities Litigation Reform Act

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Current treatment landscape

TLC599

TLC599 target product profile Fast acting, long lasting, low toxicity non-opioid intraarticular injection for OA

Our strategic solution: TLC599

8

1 Arthritis Foundation. Arthritis By the Numbers / Book of Trusted Facts & Figures. 2 National Institutes of Health. FACT SHEET – Osteoarthritis., 2010 3

Intra-articular steroid injections for painful knees. Can Fam Physician 2004;50:241-248. 4 State-of-the-Art management of knee osteoarthritis. World J Clin Cases 2015; 3(2): 89-101. 5 The chondrotoxicity of single-dose corticosteroids. Knee Surg Sports Traumatol Arthrosc. 2012 Sep;20(9):1809-14.

30.8 million OA patients in US1;20% of people >65 years at risk for OA by 20302

Efficacy of viscosupplements / hyaluronic acid (HA) is “inconclusive”

Triamcinolone acetonide (TA) may be chondrotoxic

Opioids are highly addictive

Target for 6-month efficacy Phase II data showed significantly better pain reduction than placebo through 6 months

Minimized cartilage damage & toxicity Preclinical & Phase II MRI data indicated potential chondroprotection

Improved drug retention in joint Contrived formulation & particle size ~400nm

Needle gauge flexibility for future expanded indications into small joints

Page 9: TLC Corporate PresentationConfidential Legal disclaimers 2 This presentation contains forward -looking statements within the meaning of the Private Securities Litigation Reform Act

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Features comparison Current data for TLC599 vs other treatments

Product Attributes IR Steroid ER Steroid TLC599

Sustained release formulation ✗ ✓ ✓ Pain management up to 6 months ✗ ✗ ✓ Safer API & minimal damage to cartilage1 2 ✗ ✗ ✓ Better systemic safety with drug retention in joint ✗ ✓ ✓ Possible indication expansion into smaller joint space ✓ ✗ ✓ Easy to use one-vial application ✓ ✗ ✓ No need for wholly aseptic manufacturing process3 ✓ ✗ ✓

9

1 Intra-articular injections for osteoarthritis of the knee. Cleveland Clinic Journal of Medicine, vol. 73, No. 10, Oct 2006. 897-911. 2 Extreme Post-injection Flare in Response to Intra-Articular Triamcinolone Acetonide (Kenalog), The American Journal of Orthopedics Mar/Apr 2016. 108-111. 3 “Flexion sets up house with Patheon to make its pain drug”, Chemical & Engineering News. April 4, 2016.

Page 10: TLC Corporate PresentationConfidential Legal disclaimers 2 This presentation contains forward -looking statements within the meaning of the Private Securities Litigation Reform Act

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Preclinical in vivo TK study TLC599 demonstrated minimal systemic exposure

TLC599 was intraarticularly injected into dog knee joints (n=8). Synovial fluid and plasma were collected for DSP concentration analysis. LLOQ=40ng/mL

Dog TK Study

1

10

100

1000

10000

100000

1000000

10000000

100000000

1E+09

1E+10

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

DS

P C

once

ntr

atio

n

(pg

/mL)

Time Post-Dose (days)

Synovial fluid

Plasma

10

Page 11: TLC Corporate PresentationConfidential Legal disclaimers 2 This presentation contains forward -looking statements within the meaning of the Private Securities Litigation Reform Act

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Preclinical in vivo PK study TLC599 demonstrated sustained drug levels in the joint space for 120 days

10

100

1000

10000

100000

1000000

0 20 40 60 80 100 120Syn

ovia

l Flu

id D

SP

Con

cen

trat

ion

(p

g/m

L)

Time Post-Dose (days)

TLC599 was intraarticularly injected into dog knee joints (n=4). Synovial fluid was collected for DSP concentration analysis. LLOQ=2750pg/mL

Dog PK Study

11

Page 12: TLC Corporate PresentationConfidential Legal disclaimers 2 This presentation contains forward -looking statements within the meaning of the Private Securities Litigation Reform Act

Confidential

Preclinical chondrotoxicity study in dogs and rabbits TLC599 showed no cartilage toxicity after single/multiple doses or against TA

TA = triamcinolone acetonide / ER TA = extended release triamcinolone acetonide 12

Saline

TA 2.1mg

TA 18.75mg

TLC599 12mg (eq. to 60mg TA)

ER TA 2.1mg

ER TA 18.75mg

Synovial TK study (Dogs, Day 30): No marked cartilage toxicity in TLC599 Proteoglycan loss in TA & ER TA 2.1mg ER TA showed more damage

than 2.1mg TA

No intensity or morphology change observed; neither proteoglycan loss nor cartilage damage even after repeat dosing.

TLC599 Single Dose Dog, 12mg (eq. to 60mg TA)

A1, Day 8

A2, Day 31 B2, Day 31

B3, Day 91 A3, Day 91

TLC599 Repeat Dose Rabbit, 1.2mg (eq. to 6mg TA)

B1, Day 15

Page 13: TLC Corporate PresentationConfidential Legal disclaimers 2 This presentation contains forward -looking statements within the meaning of the Private Securities Litigation Reform Act

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TLC599 Phase II clinical trial Phase II trial design & demographics

13

Placebo (saline)

IA injection (n=25)

TLC599 12mg

IA injection (n=26)

TLC599 18mg

IA injection (n=24)

Age Average

≥66

64.8 (8.45) 11 (44.0%)

63.9 (9.07) 10 (38.5%)

62.9 (8.80) 9 (37.5%)

Gender Male

Female

28% 72%

42.3% 57.7%

29.2% 70.8%

Race Asian

Caucasian

12 (48.0%) 13 (52.0%)

13 (50.0%) 13 (50.0%)

12 (50.0%) 11 (45.8%)

Knee OA Unilateral Bilateral

40% 60%

38.5% 61.5%

38.7% 61.3%

K-L Grade 2 3

36% 64%

50% 50%

37.5% 62.5%

TLC599 12mg met the primary endpoint, with significant reductions in WOMAC pain (p=0.0027) through 12 weeks

Both doses of TLC599 resulted in greater reductions in pain than placebo

Data from 12mg presented as optimal dose

Page 14: TLC Corporate PresentationConfidential Legal disclaimers 2 This presentation contains forward -looking statements within the meaning of the Private Securities Litigation Reform Act

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0

10

20

30

40

50

60

W12 W16 W20 W24

Perc

enta

ge (

%)

of D

urab

le

Res

pond

ers

-5.0

-4.5

-4.0

-3.5

-3.0

-2.5

-2.0

-1.5

-1.0

-0.5

0.0

0 4 8 12 16 20 24

LS M

ean

Cha

nge

from

BL

Week

Placebo (n=25)

TLC599 12mg (n=26)

-1.2

-1.0

-0.8

-0.6

-0.4

-0.2

0.0

0 4 8 12 16 20 24

LS M

ean

Cha

nge

from

BL

Week

Phase II clinical trial: pain reduction TLC599 showed statistical significance against placebo at every scheduled visit

14

* * * *

* * *

WOMAC Pain (0-4)

VAS Pain (0-10)

* * * * *

* *

* Statistical significance p-values from Mixed Effect Model Repeated Measure, LS mean change from baseline of WOMAC/VAS Pain vs Placebo

WOMAC ≥30% Durable Response

TLC599 showed statistical significance against placebo at every scheduled visit in WOMAC Pain, VAS Pain & Durable Response

WOMAC Function & WOMAC Stiffness also showed same pain reduction pattern

* Statistical significance Pain score reduction of ≥30% = clinically important difference p-values from Logistic regression model of WOMAC pain vs Placebo

* * * *

Page 15: TLC Corporate PresentationConfidential Legal disclaimers 2 This presentation contains forward -looking statements within the meaning of the Private Securities Litigation Reform Act

Confidential

50% patients did not take any acetaminophen during the first 12wks in TLC599 12mg group

After 12wks, median acetaminophen consumption in placebo group was 5-8 times that of TLC599 12mg group

15

Phase II clinical trial: rescue medication use Less acetaminophen consumption at everyone time point

Page 16: TLC Corporate PresentationConfidential Legal disclaimers 2 This presentation contains forward -looking statements within the meaning of the Private Securities Litigation Reform Act

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Phase II clinical trial: safety profile – AEs TLC599 was well tolerated, with comparable frequency of TEAEs to placebo

Placebo n=25

TLC599 12mg n=26

TLC599 18mg n=24

TEAE 17 (68%) 18 (69.2%) 20 (83.3%)

Treatment-related TEAE 4 (16%) 7 (26.9%) 11 (45.8%)

Treatment-related SAE 0 0 0

Index knee-related TEAE 4 (16%) 1 (3.8%) 3 (12.5%)

TEAE related to injection procedure 3 (12%) 1 (3.8%) 3 (12.5%)

16

Treatment-emergent adverse events (TEAEs) among the three groups (TLC599 12mg, TLC599 18mg and placebo) were comparable

No life-threatening treatment-related TEAE; no unexpected safety signals No deaths, no treatment related serious adverse events (SAEs)

Page 17: TLC Corporate PresentationConfidential Legal disclaimers 2 This presentation contains forward -looking statements within the meaning of the Private Securities Litigation Reform Act

Confidential

Phase II clinical trial: safety profile – knee MRI TLC599 demonstrated protection / delay in cartilage degeneration

17

Articular cartilage deterioration was assessed using semi-quantitative magnetic resonance imaging (MRI) Osteoarthritis Knee Scoring (MOAKS) instrument

Two categorical MOAKS scores 14 sub-regions of knee joints (1) the size of cartilage damage (2) the depth of cartilage damage

-9%

-15%

-4%

-8%

9%

0%

-20% -15% -10% -5% 0% 5% 10% 15% 20%

TLC599 (18 mg) (Full thickness loss)

TLC599 (18 mg) (Surface area loss)

TLC599 (12 mg) (Full thickness loss)

TLC599 (12 mg) (Surface area loss)

Placebo (Full thickness loss)

Placebo (Surface area loss)

Favorable Unfavorable

Absolute difference of 6M cartilage deterioration rate (Study knee minus Non-study knee)

Page 18: TLC Corporate PresentationConfidential Legal disclaimers 2 This presentation contains forward -looking statements within the meaning of the Private Securities Litigation Reform Act

Confidential

TLC599 key findings presented by PI and Winner of OARSI Clinical Research Award

18

- Dr. David Hunter Professor of Medicine, University of Sydney

Winner of 2019 OARSI Clinical Research Award Principal investigator, TLC599 Phase II trial

“I am impressed with TLC599’s ability to consistently provide fast and durable pain relief in the majority of patients for the entire follow-up period of six months.”

Oral Presentation by Dr. David Hunter: Single Intraarticular Injection of TLC599 Provided Sustained Pain Relief through 24 Weeks in Participants with Symptomatic Knee Osteoarthritis Statistically significant WOMAC & VAS Pain reduction through Week 12, 16, 20, 24 Statistically significant WOMAC & VAS Pain at Week 1, 4, 8, 12, 16, 20, 24 Similar results in WOMAC Function Statistically significant WOMAC & VAS Pain durable response (maintain >30% reduction)

in over half of subjects, indicating clinically meaningful pain relief Greatly reduced acetaminophen consumption Most adverse events were mild to moderate

Page 19: TLC Corporate PresentationConfidential Legal disclaimers 2 This presentation contains forward -looking statements within the meaning of the Private Securities Litigation Reform Act

Confidential 19

Multi-center, randomized, double-blind, placebo- and active comparator-controlled Phase III pivotal study

40-50 sites in the US and Australia Evaluation of safety and efficacy of single and repeated doses in ~500 knee

OA patients (KL Grade 2-3)

Primary endpoint: ◦ Change from BL in WOMAC pain vs placebo at Week 16 / Week 40

Key secondary endpoints: ◦ Change from BL in WOMAC Pain/Function vs placebo/DSP at Weeks 16, 20,

24, through 52 weeks, PGIC

Phase III pivotal clinical trial “EXCELLENCE” global trial design

Rand 2:1:1

BL 24 52

First injection Second injection

TLC599

DSP TLC599

Placebo Placebo

TLC599

500 patients will be randomized in 2:1:1 ratio treated with TLC599, DSP or placebo

Patients will receive a second blinded injection at Week 24

20 16 40 4 8 12 44 28 32 36 48 1 2 Study weeks

Page 20: TLC Corporate PresentationConfidential Legal disclaimers 2 This presentation contains forward -looking statements within the meaning of the Private Securities Litigation Reform Act

Confidential

Market research study with 16-week pain control TLC599 could achieve usage in 26% of all US knee OA patients

20

4mo sustained pain relief

Fast pain relief as

quickly as

1wk

Better WOMAC Pain

Reduction

Safer for repeat

dosing

21G-30G

needle size

TLC599 Optimal Profile

Source: ZS Associates Market Study

Payers estimate 4-month efficacy of TLC599 profile might achieve price of $627-$684

Page 21: TLC Corporate PresentationConfidential Legal disclaimers 2 This presentation contains forward -looking statements within the meaning of the Private Securities Litigation Reform Act

TM

Post-Surgical Pain Program TLC590: BioSeizer® sustained release ropivacaine injection for post-operative pain management

Page 22: TLC Corporate PresentationConfidential Legal disclaimers 2 This presentation contains forward -looking statements within the meaning of the Private Securities Litigation Reform Act

Confidential

TLC590 target product profile Fast acting, long lasting non-opioid post-operative local anesthetic

96 million surgical procedures performed in the US in 20121

Local anesthetics play a major role in the management of post-surgical pain2 Long acting agents have modestly expanded duration, but API in current marketed

liposomal formulation of bupivacaine has higher toxicities3

Current local anesthetic landscape

Target for 4-7 days duration with immediate onset Supported by data from Phase I/II trial in hernia repair

Unchanged clinical practice during post-op surgery Same administration as current standard of care products

Potential for lower COGS allows for monetization of hospital opportunity

Our strategic solution: TLC590

22

1 World Bank. Number of surgical Procedures. 2 Infiltration of Local Anesthetics for Postoperative Analgesia. Pfiedler Enterprises. 2015. 3 Local Anesthetics Systemic Toxicity Association with Exparel (Bupivacaine Liposome)- A Pharmacovigilance evaluation, Expert Opinion on Drug Safety. Expert Opin Drug Saf. 2017 Jun 5:1-7

Page 23: TLC Corporate PresentationConfidential Legal disclaimers 2 This presentation contains forward -looking statements within the meaning of the Private Securities Litigation Reform Act

Confidential

Features comparison Current data for TLC590 vs other postsurgical pain management drugs

23

1 2 Local Anesthetics Systemic Toxicity Association with Exparel (Bupivacaine Liposome)- A Pharmacovigilance evaluation, Expert Opinion on Drug Safety. Expert Opin Drug Saf. 2017 Jun 5:1-7 3 Efficacy profile of liposome bupivacaine, a novel formulation of bupivacaine for postsurgical analgesia. Journal of Pain Research 2012:5 107–116 4 Phase 2 studies of HTX-011 in the management of post-operative pain. Aug 1, 2016. 5 Guidance for Industry. Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice. 2004

Product Attributes Generic Local

Anesthetics

ER Bupivacaine

ER Bupivacaine + Meloxicam

TLC590 (ER

Ropivacaine)

Sustained release formulation ✗ ✓ ✓ ✓ Lower Local anesthetic systemic toxicity (LAST) – cardiovascular1 ✗ ✗ ✗ ✓ Lower LAST – central nervous system2 ✗ ✗ ✗ ✓ Pain management up to 168 hours34 ✗ ✗ ✗ ✓ Near-end stage sterile filtration only – no need for wholly aseptic manufacturing process5

✓ ✗ ✗ ✓ Lower risk of foreign particulate ✓ ✗ ✗ ✓

Page 24: TLC Corporate PresentationConfidential Legal disclaimers 2 This presentation contains forward -looking statements within the meaning of the Private Securities Litigation Reform Act

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Preclinical rat PK study TLC590 half-life after subcutaneous injection is significantly prolonged compared to IR ropivacaine

24

1

10

100

1000

10000

0 24 48 72 96 120 144 168

Plas

ma

conc

entr

atio

n (n

g/m

L)

Time (hours)

IR ropivacaine 19mg (n=6)

TLC590 114mg (n=6)

Page 25: TLC Corporate PresentationConfidential Legal disclaimers 2 This presentation contains forward -looking statements within the meaning of the Private Securities Litigation Reform Act

Confidential

Preclinical paw incision analgesic study TLC590 produced statistically significant reductions in pain compared to ER bupivacaine

25

In TLC590 displayed… Statistically significant

reductions in pain at 0.5, 5, & 6 hours post-injection compared to ER bupivacaine at equipotent dose

Earlier onset & longer analgesic action than ER bupivacaine

Longer analgesic action than free ropivacaine

*

*

*

Page 26: TLC Corporate PresentationConfidential Legal disclaimers 2 This presentation contains forward -looking statements within the meaning of the Private Securities Litigation Reform Act

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Preclinical nerve block study TLC590 exhibited more robust magnitude & duration of analgesia

26

TLC590 exhibited larger magnitude of analgesia which persisted to the 9th hour

Analgesic action of ER bupivacaine diminished & was comparable to saline by the 8th hour

Page 27: TLC Corporate PresentationConfidential Legal disclaimers 2 This presentation contains forward -looking statements within the meaning of the Private Securities Litigation Reform Act

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Phase I/II clinical trial in inguinal hernia repair surgery Study design & demographics

27 Confidential

Ropiva- caine

150 mg (n=16)

TLC590 190 mg (n=12)

TLC590 380 mg (n=12)

TLC590 475 mg (n=12)

TLC590 570 mg (n=12)

Age (years)

Mean (SD) 42.8 (13.68)

50.8 (9.11)

46.5 (13.45)

50.0 (13.05)

44.7 (15.74)

Median 43.5 55.0 50.0 56.0 48.0 Min, Max 20, 64 33, 60 20, 62 25, 62 23, 63

Gender, n (%) Male 15 (93.8) 12 (100) 11 (91.7) 10 (83.3) 12 (100)

Female 1 ( 6.3) 0 1 ( 8.3) 2 (16.7) 0 Race, n (%)

Asian 0 0 0 0 0 White 16 (100) 11 (91.7) 12 (100) 12 (100) 12 (100)

American Indian or Alaska

Native/White 0 1 ( 8.3) 0 0 0

Ethnicity, n (%) Hispanic or

Latino 1 ( 6.3) 0 0 0 0

Not Hispanic or Latino 15 (93.8) 12 (100) 12 (100) 12 (100) 12 (100)

TLC590 475mg significantly reduced pain (AUC0-96h p=0.0103)

All four doses resulted great reductions than ropivacaine

Data from 475mg presented as optimal dose

Page 28: TLC Corporate PresentationConfidential Legal disclaimers 2 This presentation contains forward -looking statements within the meaning of the Private Securities Litigation Reform Act

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Phase I/II clinical trial in inguinal hernia repair surgery TLC590 pharmacokinetics profile

1

10

100

1000

0 24 48 72 96 120 144 168

Plas

ma

Ropi

vaca

ine

(ng/

mL)

Hours

TLC590 570mg

TLC590 475mg

TLC590 380mg

TLC590 190mg

Ropivacaine 150mg

28 Confidential

Page 29: TLC Corporate PresentationConfidential Legal disclaimers 2 This presentation contains forward -looking statements within the meaning of the Private Securities Litigation Reform Act

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Phase I/II clinical trial – inguinal hernia repair surgery TLC590 exhibited highly dose-linear pharmacokinetics in Cmax & AUC

29

R² = 0.9093

0

100

200

300

400

500

600

700

100 200 300 400 500 600

Ropi

vaca

ine

C max

(ng/

mL)

Ropivacaine dose (mg)

Cmax

R² = 0.9978

0

5000

10000

15000

20000

25000

30000

35000

40000

100 200 300 400 500 600

Ropi

vaca

ine

AUC 0

-168

h (h*

ng/m

L)

Ropivacaine dose (mg)

AUC

Page 30: TLC Corporate PresentationConfidential Legal disclaimers 2 This presentation contains forward -looking statements within the meaning of the Private Securities Litigation Reform Act

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-2

-1

0

1

2

3

4

5

6

7

8

9

10

0 12 24 36 48 60 72 84 96 108 120 132 144 156 168

Pain

inte

nsity

sco

re (m

ean

SE

)

Hours Post Dose

Ropivacaine 150 mg (n=16)

TLC590 475 mg (n=12)

Incr

easi

ng p

ain

Severe pain

AUC0-24 p=0.0057

AUC0-48 p=0.0131

AUC0-72 p=0.0117

AUC0-96 p=0.0103

±

Phase I/II clinical trial – inguinal hernia repair surgery TLC590 reduced pain against ropivacaine through 168 hours

30

TLC590 significantly reduced pain through 96 hours Greater reductions in pain than ropivacaine at every 24-hour interval

through 168 hours

Page 31: TLC Corporate PresentationConfidential Legal disclaimers 2 This presentation contains forward -looking statements within the meaning of the Private Securities Litigation Reform Act

Confidential

Phase I/II clinical trial – inguinal hernia repair surgery TLC590 reduced opioid use & improved time to first opioid use

3.3

13.0

0.0

2.0

4.0

6.0

8.0

10.0

12.0

14.0

Ropivacaine TLC590 475mgTi

me

to fi

rst o

pioi

d us

e (m

edia

n hr

s)

Time to First Opioid Use Mean Rescue Opioid Over Time (mg per subject)

31 Confidential

Ropivacaine TLC590 475mg

0 – 24 hrs 78.1 29.2

0 – 48 hrs 115.6 54.2

0 – 72 hrs 118.8 54.2

0 – 96 hrs 118.8 54.2

• 58.3% of patients in the TLC590 475mg group remained opioid-free through the entire duration of the study

• Mean total opioid consumption was 54% less than that of the ropivacaine group through 96 hours post-surgery.

Page 32: TLC Corporate PresentationConfidential Legal disclaimers 2 This presentation contains forward -looking statements within the meaning of the Private Securities Litigation Reform Act

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Phase I/II clinical trial – inguinal hernia repair surgery TLC590 was well tolerated, no serious or severe adverse events

32

Ropivacaine 150mg (n=16)

TLC590 190mg (n=12)

TLC590 380mg (n=12)

TLC590 475mg (n=12)

TLC590 570mg (n=12)

Any TEAE n (%) 13 (81.3) 11 (91.7) 8 (66.7) 10 (83.3) 7 (58.3)

Any Related TEAE n (%)

2 (12.5) 1 (8.3) 2 (16.7) 2 (16.7) 2 (16.7)

Any Serious TEAE 0 0 0 0 0

Subjects with at least one Severe TEAE

0 0 0 0 0

TEAE: treatment-emergent adverse event

Page 33: TLC Corporate PresentationConfidential Legal disclaimers 2 This presentation contains forward -looking statements within the meaning of the Private Securities Litigation Reform Act

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Phase I/II clinical trial – inguinal hernia repair surgery Topline data

33

All four doses of TLC590 resulted in greater reductions in pain than standard ropivacaine as measured by AUC at every interval through 96 hours

TLC590 570mg is not MTD, high dose could apply to other large wound surgeries TLC590 475mg vs standard ropivacaine, extremely durable, statistically significant and

clinically meaningful pain reduction; differences maintained through 1 week • AUC0-24h TLC590 vs ropivacaine, p=0.0057 • AUC0-48h TLC590 vs ropivacaine, p=0.0131 • AUC0-72h TLC590 vs ropivacaine, p=0.0117 • AUC0-96h TLC590 vs ropivacaine, p=0.0103

Reduction of opioid use vs standard ropivacaine • Mean total opioid use reduced 54% through 96hr

• Time to first opioid use was ~4X that of the ropivacaine group (median 13.0 vs 3.3 hrs)

• 58% of opioid-free subjects to the end of study

“These findings, combined with an extremely favorable side-effect profile and the product’s ease of administration, give great cause for optimism that TLC590 will be a formidable non-opioid tool for the treatment of both acute and long-term postsurgical pain in the future.”

- Dr. Todd Bertoch

Principal investigator, TLC590 Phase I/II trial

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Phase II clinical trial – bunionectomy Design & objectives

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Primary Objective: Evaluate the analgesic efficacy of TLC590 for postsurgical pain management in subjects following

bunionectomy

Secondary Objectives: Evaluate PK profile and dose-exposure relationship and bioavailability compared to free ropivacaine Evaluate safety and tolerability of TLC590 Evaluate the exposure-response relationship between PK parameters and pain intensity

152mg TLC590

n=12

190mg TLC590

n=12

228mg TLC590

n=12

50mg Ropivacaine

n=12

Saline Placebo

50mg Bupivacaine

Part 1: Blinded PK study of TLC590 and ropivacaine (completed)

Part 2: Efficacy and safety of TLC590 vs bupivacaine and placebo

Dose linearity and relative bioavailability of TLC590 established All three doses of TLC590 were well tolerated; safety profile comparable to ropivacaine - Most TEAEs mild to moderate; no TRAEs or SAEs, - No AEs leading to withdrawal TLC590 228mg chosen to move forward based on maximum feasible volume

228mg TLC590

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Ophthalmic Disease Program TLC399: BioSeizer® sustained release dexamethasone sodium phosphate (DSP) intravitreal injection for macular edema (ME) due to retinal vein occlusion (RVO)

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TLC399 target product profile Fast acting, long lasting non-implant dexamethasone intravitreal injection

RVO affects >16 million adults worldwide1

Steroids play prominent role even post advent of anti-VEGF2

Current marketed dexamethasone injection lasts 1-3 months3, but implant takes up to 6 months to dissolve4, and 22G needle causes bleeding in 23% of patients3

Current treatment landscape for RVO

Target for > 6-month duration with immediate onset, supported by preclinical & phase I/II data

Small needle size (30G, no implant) 2.3 times smaller than diameter of current marketed steroid injection, reducing risk of conjunctival hemorrhaging & infections

Our strategic solution: TLC399

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1 Sophie Rogers et al, “The Presence of Retinal Vein Occlusion: Pooled Data from Population Studies from the United States, Europe, Asia and Australia; 117(2): 313-9el. (2010). 2 Effect of intravitreal triamcinolone in diabetic macular edema unresponsive to intravitreal bevacizumab. Jeon S1, Lee WK. Retina. 2014 Aug;34(8):1606-11. 3 Ozurdex® Prescribing Information 4 Ozurdex drug delivery implant for eyes, The Macula Center, Dana M. Deupree, MD, FACS & Michael Tolentino, MD

Approved steroid implant 22G / 0.7176mm

TLC399 (no implant)

30G / 0.3112mm

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Extending BioSeizer to anti-VEGF Ab: in vivo evidence of much longer duration

Concentration of Anti-VEGF can be significantly maintained from 1-2 months to >4 months when engaged with TLC’s proprietary BioSeizer technology

Effective concentration 0.5ug/ml

Rabbit IVT PK Profile Measured by ELISA

37

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Soft Tissue Sarcoma Program TLC178: NanoX tumor-concentrated delivery of vinorelbine for rhabdomyosarcoma (RMS) & potentially for soft tissue sarcomas (STS) & non-small cell lung carcinoma (NSCLC)

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TLC178 target product profile Safer, less toxic, more durable anticancer drug with RPD & ODD designations

Vinorelbine (VNB) + cyclophosphamide combo as therapy agent or VNB alone for palliative therapy1 for RMS, but with significant dose-limiting myelosuppression2 3

Vinorelbine + gemcitabine (Gem) combo as active regimen for STS & NSCLC4 5

Current treatment landscape

Improve selective delivery to tumor versus non-tumor tissue

Higher drug concentration at tumor confers higher activity

Less drug to non-tumor reduces myelosuppression, enabling higher dose intensity

Efficacy improvement in treatment response rate & duration of response

Rare Pediatric Disease Designation (RMS) Orphan Drug Designation (STS)

Our strategic solution: TLC178

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1 National Comprehensive Cancer Network, NCCN Clinical Practice Guidelines in Oncology – Soft Tissue Sarcoma, Version 1.2018, October 31, 2017. 2 Phase II Evaluation of Intravenous Vinorelbine (Navelbine) in Recurrent or Refractory Pediatric Malignancies: A Children's Oncology Group Study. Pediatric Blood Cancer. 2009 October ; 53(4): 590–93. 3 Vinorelbine in Previously Treated Advanced Childhood Sarcomas .Cancer 2002;94:3263–68. 4 Gemcitabine and Vinorelbine Combination Chemotherapy for Patients With Advanced Soft Tissue Sarcomas. Cancer 2007;109:1863-69. 5 The Novel and Effective Non-platinum, Nontaxane Combination of Gemcitabine and Vinorelbine in Advanced Non-small Cell Lung Carcinoma. Cancer 2002;95(2)340-53.

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Preclinical studies TLC178 showed significantly better tumor control in in fibrosarcoma, RMS & NSCLC models

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Post drug injection day0 5 10 15 20 25 30

Tum

or vo

lum

e (m

m3 )

0

500

1000

1500

2000Placebo (D5W)Doxorubicin 3.4mg/kgTLC178 5mg/kg

TLC178 showed significant tumor inhibition response vs doxorubicin in fibrosarcoma model

Fibrosarcoma Model

Post drug injection day0 10 20 30 40

Tum

or v

olum

e (m

m3 )

0

500

1000

1500

2000

2500

3000SalineVinorelbine 5mg/kgTLC178 5mg/kg

RMS Model

TLC178 showed significantly better tumor control than free vinorelbine in RMS model

Post first drug injection day

0 2 4 6 8 10 12 14

Tum

or v

olum

e (m

m3 )

0

500

1000

1500

2000

2500Saline5mg/kg VNB5mg/kg TLC1785mg/kg VNB + 25mg/kg Gem5mg/kg TLC178 + 25mg/kg Gem

NSCLC Model

TLC178 showed significantly superior tumor control over VNB & VNB + Gem in NSCLC model

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Clinical development plan for TLC178 in pRMS with extended indications in STS & NSCLC

Pediatric Rhabdomyosarcoma

Non-Small Cell Lung Cancer (NSCLC) Soft Tissue Sarcoma (STS)

3+3 Dose Escalation

Combo TLC178 + cyclophosphamide

Single-arm (N=40,

ORR/ DoR)

NDA

STS Combo TLC178 +

gemcitabine Single-arm Phase II

(n=100-200)

sNDA

TLC178 alone Phase I/II

MTD

Current status: - 33 patients dosed - MTD (Q4W) found:31mg/m2

- MTD (Q2W) ongoing

NSCLC Combo TLC178 +

gemcitabine Phase II/III adaptive

random

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Milestones

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Pivotal moments Balanced anticipated short- and long-term milestones

1H2019 2H2019 1H2020 2H2020

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TLC599 Phase III last patient enrollment

TLC590 Pivotal trial initiation (bunionectomy)

TLC590 Pivotal trial initiation (hernia repair) TLC178 Phase I/II initiation (pediatric) after suitable dose found in adults

TLC590 Phase II Part 1 analysis (bunionectomy)

TLC599 Pivotal trial initiation TLC178 Phase I/II MTD Q4W (adult)

TLC599 EOP2 meeting (CMC) TLC599 EOP2 meeting (clinical) TLC590 Phase I/II topline data (hernia repair) TLC178 EU orphan designation

TLC590 Phase II last patient enrollment (bunionectomy) TLC178 Phase I/II data readout (adult) TLC399 Phase II last patient enrollment

2021

TLC599 Pivotal trial topline data

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