2020 Q1 Investor Conference

Corporate Presentation

2020.03.24

Science ‧ Integrity ‧ Transparency

This presentation contains forward looking statements. All statements other than statements of historical facts included

in this presentation, including, without limitation, those regarding our financial position, business strategy, plans and

objectives of management for future operations (including development plans and objectives relating to our products),

are forward looking statements.

Such forward looking statements involve known and unknown risks, uncertainties and other factors which may cause our

actual results, performance or achievements to be materially different from any future results, performance or

achievements expressed or implied by such forward looking statements.

Such forward looking statements are based on numerous assumptions regarding our present and future business

strategies and the environment in which we will operate in the future.

Further, certain forward looking statements are based upon assumptions of future events which may not prove to be

accurate. The forward looking statements in this document speak only as at the date of this presentation. Oneness

Biotech does not undertake any obligation to update or revise forward looking statements in this presentation nor to

confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual

results, unless required by law.

2

Forward-looking Statement

Financial Report

As of 2019.12.31

3

Market Value & Financials

4

2014-2020 Chart (NTD) 2018-2019 Financials

(Currency in NTD)

Currency in

thousand

NTD

2019 2018 Different

Revenue 13,475 18,856 (5,381)

R&D Exp. 238,638 94,436 144,202

Net Profit (326,261) (244,941) (81,320)

Total

Assets

6,979,654 2,335,421 4,644,233

Liabilities 520,961 169,643 351,318

Owner’s

Equity 6,458,693 2,165,778 4,292,915

Previous Close

Day’s Range Year’s Range Market Cap

21.05 19.4-21.1 19.4-33.1 740Mn

(20 Mar, 2020)

Consolidated Statement of comprehensive

income

5

(Currency in thousand NTD)

Item 2019 2018

Operating revenue 13,475 18,856

Operating costs 17,002 10,628

Gross profit (loss) from operations (3,527) 8,228

Selling expenses 760 471

Administrative expenses 68,808 45,507

Research and development expenses 238,638 94,436

Total operating expenses 308,206 140,414

Net operating loss 311,733 132,186

Non-operating income and expenses (14,528) (112,755)

Net loss 326,261 244,941

Earnings per shares 1.28 1.20

Consolidated Balance Sheets

-confidential- 6

(Currency in thousand NTD)

Item 2019/12/31 2018/12/31

Cash, Securities and Cash in banks 1,588,133 628,916

Other current assets 100,370 116,260

Property, plant and equipment 640,443 561,012

Investments 1,425,932 698,397

Intangible assets 2,462,470 51,925

Other assets 762,306 278,911

Total assets 6,979,654 2,335,421

Total liabilities 520,961 169,643

Total share capital 3,524,908 1,957,522

Capital surplus 3,745,588 799,295

Accumulated deficit (422,196) (254,379)

Other equity interest (389,607) (336,660)

Total equity 6,458,693 2,165,778

Summary of Consolidated Financial Statements for

the Years Ended December 31, 2019

1. Summary of Net Loss NTD 326,261 thousand ：

• Oneness Biotech invests NTD 238,638 thousand to develop

innovative new drugs. The current pipeline covers drugs under

phase I, phase II ,and phase III development, Such R&D

expenditure contributes to 73.1% of total net loss.

• For risk diversification purpose, Oneness reinvests in Diamond

Biofund Co., Ltd(venture capital), Sinew Pharma Co.,

Ltd(venture capital) and Microbio (Shanghai) Co., Ltd. from

which the recognize net loss and financial assets profit and loss

were NTD 18,250 thousand, 5.6% of the total net loss. The

selling & administrative expenses were NTD 69,373 thousand,

which is 21.3% of the total net loss.

2. Financial situation stable， important financial ratio：

3. Important assets explanation :

Current ratio Quick ratio Debts ratio

2,350.3% 2,240.8% 7.5%

Items Amounts Account for total

assets ratio Explanations

Cash、Securities and

cash in bank 1,588,133 22.8%

The funds for new drug research and

development are sufficient.

Property, plant and

equipment 640,443 9.2%

Oneness Biotech Co., Ltd has already built large

scale chromatographic extraction and

pharmaceutical manufacturing site for supply of

tON101 opical cream after NDA. Is granted.

Equity investment 1,425,932 20.4%

Reinvest in Microbio (Shanghai) Co., Ltd and

other biotech venture capital companies for

diversifying risk in research and development of

new drugs .

Intangible assets 2,462,470 35.3% This is obtained by acquiring FB825 and other

new drug fair values from consolidated Fountain

Biopharma Inc.

Other assets 862,676 12.3% Including inventory、right-of-use assets、

Goodwill、other non-current assets

Summary of Consolidated Financial Statements for the

Years Ended December 31, 2019

R&D Progress

As of 2020.03

9

ON101

New Drug for Diabetic Foot Ulcers

10

ON101 Market Assessment-1

Global DFU Patients

>28 million Amputation/yr

>1.2 million 2026 Market Forecast

>US$26 bn

Chronic ulcers(DFU+VLU+PU)

Global market forecast exceeds US$44 bn in 2026

Source: Transparency Market Research, International Diabetes Federation, Future Market Insight, Global Market Insight, Transparency Market Research, Franks PJ Management of Patients With Venous Leg Ulcers: Challenges and Current Best Practice, P&T COMMUNITY

2019 2023

5.6 bn

26.8 bn (GACR 25% )

2026

13.7 bn

Source: Global Market Insight,

11

ON101 Market Assessment-2

1. All phase 3 trials in DFU failed in the past 2 decades. It is evaluated

that the efficacy and pharmaco-economic advantage of ON101 are

better in comparison with the only approved DFU drug Regranex(J&J)

and other drugs registered on clinicaltrial.gov.

2. We are developing medical device for treatment in DFU, VLU, PU for

Europe, US and Indian markets. It is planned to submit application for

H1 2020. Such strategy will fulfil the unmet need in chronic ulcers and

give Oneness advantage in negotiation for out-licensing.

3. Oneness has discovered the novel mechanism of ON101 in healing

DFU by activating a chemokine. This is a breakthrough finding

worldwide and will add value to ON101’s marketing and licensing.

12

Progress of Phase 3 Trial

DFU 236

Subjects 16 weeks Taiwan, China, U.S.

Indication

2019 2020

Completion of recruitment of 236 subjects from Taiwan,

China, US in Q4 2019

2nd interim analysis conducted in Q1 (212 subjects)

CSR will be available in Q2 2020 and submitted for NDA.

13

Progress of NDA in Taiwan (2018~)

Completed 1st interim analysis in Q3 (118 subjects)

Rolling submission for NDA in Q2 2018

Completed recruitment of 236 subjects in Q4 2019

Will complete 2nd interim analysis in Q2 2020 (212

subjects)

Will complete supplementation for NDA in Q2 2020

Aim to complete NDA in 2020

14

Progress of NDA in China (2020~)

Will submit NDA application based on 2nd interim

analysis of ON101’s 1st Phase 3 MRCT.

Conducted meetings with Drug Registration Dept. of

NMPA in Q4 2019.

Will apply for Pre-NDA meeting with NMPA in Q2

2020 。

Application will be filed in Q3 2020 for NDA in

China 15

Market Potential of PA-F4 Drug Substance

PA-F4 drug substance approval was granted in Dec 2019

1. Considering the timeline and scale of new drug development of

ON101, product commercialization in Europe, U.S., and India will

be expedited by obtaining medical device license for topical

dosage composed of S1 and PA-F4, 2 drug substances

recognized by regulatory authority (regulatory review of medical

device takes approx. 6 months).

2. ON101(DFU new drug) and medical device (VLU and PU)

become a package for treatment in chronic ulcers. It is believed

to be an advantage in out-licensing negotiation and to expedite

product’s market entry. 16

ON101 Global Novel Mechanism

First finding of specific chemokine that accelerates DFU healing.

*

*

*

Dosing

Wo

un

d s

ize

(fo

ld)

3 6 9 12 (days) 0

傷口面積

(倍數

)

1.5 1.0 0.5 0.0

ON101

Placebo

Wo

un

d S

ize

(fo

lds)

3(control) 6 9 12 (days)

30

20

10

0

ON101

Placebo

The significant increase of key chemokine has improved wound healing.

17

The find of this mechanism will increase the ON101’s market value.

Progress of Nanchou Plant

1. As of 2020.03, 5 batches of pilot manufacturing run and 1 validated batch have been

completed.

2. Will apply for PIC/s GMP certification for the plant with drug substances and finished

product production.

3. Commercial batch production is scheduled for Q4 2020. Annual production capacity is 25

million tubes.

18

Progress of Out-licensing

1. The only approved DFU drug: Regranex is priced at US$600

per tube of 15g. The pricing survey of ON101 has been

conducted by internal consulting company and the pricing of

ON101 will reference international pricing.

2. Out-licensing for Taiwan has been discussed with international

pharma companies in 2019. Out-licensing will include drug

and medical device. The right of commercialization in China

will be held by affiliate company in China. Out-licensing scope

will be prioritized according to marketability of drug/medical

device by regions. We aim to complete out-licensing in 2021.

19

FB825 New Drug

Atopic Dermatitis

and Allergic Asthma

20

FB825 Market Assessment-1

Global Severe to Moderate AD Patients

>28 million Patients with uncontrolled symptoms

>15 million Market Forecast in 2027

>US$18 billion

Rapid growth of global market in Atopic Dermatitis

GlobalData, Atopic Dermatitis: Global Drug Forecast and Market Analysis to 2027

2017 2027

6.4 bn

18.3 bn (GACR 11.1% )

21

Global Forecast of AD/Asthma to Reach US$ 38 bn in 2027

Allied market research, Coherent Market Insights

FB825 Market Assessment-2

1. The only approved biologic in AD: Dupixent(Sanofi) has

reached US$2 bn sales in its 3rd year after launched. Sanofi

has adjusted its peak sales forecast of Dupixent to over €10

bn early this year. It is believed that an outstanding biologic

in AD could create significant value.

2. A year-long human clinical trial of FB825 has been conducted

to explore its efficacy. It is observed that FB825 is competitive

to Dupixent in terms of efficacy. With support of its novel

mechanism, those elements are key to global out-licensing

negotiation.

22

Progress of Phase 2 in US

Atopic Dermatitis(AD) 90 24 weeks U.S.

Indication

2020 2021 2022 2023

US AD IIa US AD IIb

Obtained 1st IRB approval and started screening in March 2020.

Estimated completion of P2a: H1 2021

Estimated completion of P2b: H2 2021 23

Progress of Phase 2 in China

Allergic Asthma(AA) 100 36 weeks China

Indication

2020 2021 2022 2023

CN AA IIa

Schedule for IND submission in H1 2020

Complete contract with 1st site in H2 2020

Estimated completion in H2 2022

24

Novel Mechanism

1st finding of the relationship

between IgE B and EASI score

FB825 inhibits IgE B cell and

cytokines

Statistical analysis via T-TEST

FB825 is a new drug that specifically targets IgE B cells to treat allergic diseases

Clinical evidence shows that various inflammatory cytokines are inhibited which is a novel mechanism worldwide.

25

Progress in Subcutaneous Injection

Manufacturing

Completion of SubQ dose tox study in monkey. Good

safety profile

Bioavailability of SubQ can reach 86%

Stability of high concentration at 2-8 degree

Completion of medium scale production by CMO

Toxicity Study

SubQ will apply in P2b study in 2021

26

Progress of Out-licensing

1. Oneness has negotiated with several global

pharma companies and conducted due diligence.

We will evaluate the proposal and decide future

partner based on shareholder’s interest.

2. FB825 is with competitiveness to approved

biologic in AD: Dupixent. The R&D capacity as

well as the scientific evidence will support us to

complete out-licensing of FB825 this year. 27

FB704A

Anti- IL6 Fully-human antibody

28

FB704A Market Assessment

Rheumatoid Arthritis

New Indication in Liver Caner

Combination therapy in liver cancer

Exploring new indication

Inhibition of IL6 has been a treatment strategy for RA and is clinically validated. Development in this indication can increase clinical successfulness but this market is crowded.，

2017 2025

23.8 bn

33.9 bn

GACR 4.6%

Fortune Business Insights

2017 2025

0.5 bn

2.1 bn

GACR 19.8%

Fior Markets 29

Progress of Phase 1 in US

2019 2020 2021 2022

Phase II or PI Study US Phase Ib

Completed Ia study in healthy volunteers with no SAE.

Started Ib in RA after safety evaluation

Further evaluation on future trial will be done after completion of Ib study in H1 2020

Healthy(Ia) RA(Ib)

41 6 weeks US

Indication

30

Inhibition of Liver Cancer Cells

Anti-inflammation Better than Marketed Drug

Anti-inflammation in-vitro study

Inhibition of Liver Cancer Metastasis

Control group with metastatic cells

Tumor cell metastasis is inhibited after treatment by FB704A

31

Control F704A

New Indication for FB704A

1st or 2nd line of liver cancer drugs are with 10-20%

response rate in treatment.

Drug resistance, recurrence, and metastasis are closely

related to IL-6

Combination of FB704A with liver cancer drug can increase

drug sensitivity to 40%. Oneness has planned an animal

study for confirming the efficacy of such combination for

H1 2020. Once efficacy is confirmed, P2a study design will

follow. Journal for ImmunoTherapy of Cancer (2019) 7:333 Journal of Clinical and Translational Hepatology 2017,6: 1–10 N Engl J Med 2019;380:1450-62. 32

Oneness has effectively invested money in R&D and kept sufficient

cash flow for new drug development at the same time.

Oneness has strong pipeline including AD drug or new

drug/medical device that can satisfy unmet medical need in chronic

ulcers. Oneness also has technology platform where antibody or

aptamer new drugs can be development in-house.

Oneness has new drug that will be launched shortly and has its

market competitiveness globally as well as new drug that attract

global pharma companies. Such momentum is strong.

Oneness has strong science team dedicated to research into novel

mechanism which increase the value of the drugs during out-

licensing and in marketing. 33

Conclusion-1

1 out-licensing transaction per year is our goal for 2020-2022:

2020- FB825；2021-ON101；2022-FB704A

We have the R&D supported by out-licensing new drug

to create a cash flow for the company.

The commercialization of ON101 new drug with Nanchou plant’s

production capacity to keep Oneness with competitiveness. Creation

sufficient cash flow to support company’s sustainability.

Here is a quote from the comment by one of the BD VP from top 3 pharma

companies:

“Oneness is not a big company but it is one of the strongest 5with R&D

capability in Asia.”

34

Conclusion-2

Above is a takeaway we would like to share with our shareholders. We work hard towards it .

Thank you

2nd Investor Conference will be held in June 2020

Science ‧ Integrity ‧ Transparency