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ASX Release No. 940 28 August 2018 Page 1 of 1 ACN 090 987 250 ASX Release INVESTOR PRESENTATION PERTH, AUSTRALIA – 28 August 2018: SUDA Pharmaceuticals Ltd (ASX: SUD), a leader in oro-mucosal drug delivery, today announces that Mr. Stephen Carter, Executive Chairman, and Mr. David Phillips, Non-Executive Director, are meeting investors and brokers in Brisbane, Sydney, Melbourne and Adelaide from 28 – 31 August 2018. The presentation follows. Further information: STEPHEN CARTER EXECUTIVE CHAIRMAN SUDA Pharmaceuticals Ltd Tel: +61 8 6142 5555 [email protected] NOTES TO EDITORS: About SUDA Pharmaceuticals Ltd SUDA Pharmaceuticals Ltd (ASX: SUD) is a drug delivery company focused on oro-mucosal administration, headquartered in Perth, Western Australia. The Company is developing low-risk oral sprays using its OroMist® technology to reformulate existing pharmaceuticals. The many potential benefits of administering drugs through the oral mucosa (i.e.: cheeks, tongue, gums and palate) include ease of use, lower dosage, reduced side effects and faster response time. SUDA’s product pipeline includes ZolpiMist™, a first-in-class oral spray of zolpidem for insomnia. ZolpiMist is marketed in the USA and SUDA has rights to the product outside of the US and Canada. SUDA has submitted a Marketing Authorisation Application to the Australian Therapeutic Goods Administration for ArTiMist®, its novel sublingual malaria treatment for children. In a Phase III trial, ArTiMist was shown to be superior to intravenous quinine. Other products in development include oral sprays for the treatment of migraine headache, chemotherapy-induced nausea and vomiting, erectile dysfunction, PAH, epileptic seizures and pre-procedural anxiety. For more information, visit www.sudapharma.com

ACN 090 987 250 ASX Release - SUDA Pharma · 8/28/2018  · pharmaceutical sales • US generic market is currently $84bn with CAGR of 6.5% growing to $112bn in 2022 • Oncology

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Page 1: ACN 090 987 250 ASX Release - SUDA Pharma · 8/28/2018  · pharmaceutical sales • US generic market is currently $84bn with CAGR of 6.5% growing to $112bn in 2022 • Oncology

ASX Release No. 940 28 August 2018 Page 1 of 1

ACN 090 987 250

ASX Release

INVESTOR PRESENTATION

PERTH, AUSTRALIA – 28 August 2018: SUDA Pharmaceuticals Ltd (ASX: SUD), a leader in oro-mucosal drug delivery, today announces that Mr. Stephen Carter, Executive Chairman, and Mr. David Phillips, Non-Executive Director, are meeting investors and brokers in Brisbane, Sydney, Melbourne and Adelaide from 28 – 31 August 2018.

The presentation follows.

Further information: STEPHEN CARTER EXECUTIVE CHAIRMAN SUDA Pharmaceuticals Ltd Tel: +61 8 6142 5555 [email protected]

NOTES TO EDITORS: About SUDA Pharmaceuticals Ltd SUDA Pharmaceuticals Ltd (ASX: SUD) is a drug delivery company focused on oro-mucosal administration, headquartered in Perth, Western Australia. The Company is developing low-risk oral sprays using its OroMist® technology to reformulate existing pharmaceuticals. The many potential benefits of administering drugs through the oral mucosa (i.e.: cheeks, tongue, gums and palate) include ease of use, lower dosage, reduced side effects and faster response time. SUDA’s product pipeline includes ZolpiMist™, a first-in-class oral spray of zolpidem for insomnia. ZolpiMist is marketed in the USA and SUDA has rights to the product outside of the US and Canada. SUDA has submitted a Marketing Authorisation Application to the Australian Therapeutic Goods Administration for ArTiMist®, its novel sublingual malaria treatment for children. In a Phase III trial, ArTiMist was shown to be superior to intravenous quinine. Other products in development include oral sprays for the treatment of migraine headache, chemotherapy-induced nausea and vomiting, erectile dysfunction, PAH, epileptic seizures and pre-procedural anxiety. For more information, visit www.sudapharma.com

Page 2: ACN 090 987 250 ASX Release - SUDA Pharma · 8/28/2018  · pharmaceutical sales • US generic market is currently $84bn with CAGR of 6.5% growing to $112bn in 2022 • Oncology

Stephen Carter – Executive ChairmanDavid Phillips – Non Executive Director

August 2018

A Revolution in drug delivery…

Page 3: ACN 090 987 250 ASX Release - SUDA Pharma · 8/28/2018  · pharmaceutical sales • US generic market is currently $84bn with CAGR of 6.5% growing to $112bn in 2022 • Oncology

DisclaimerThe purpose of the presentation is to provide an update of the business of SUDA LTD (ASX:SUD)[‘SUDA’]. These slides have been prepared as a presentation aid only and the information they containmay require further explanation and/or clarification. Accordingly, these slides and the informationthey contain should be read in conjunction with past and future announcements made by SUDA andshould not be relied upon as an independent source of information. Please contact SUDA and/or referto the Company's website for further information.

The views expressed in this presentation contain information derived from publicly available sourcesthat have not been independently verified. No representation or warranty is made as to the accuracy,completeness or reliability of the information.

Any forward looking statements in this presentation have been prepared on the basis of a number ofassumptions which may prove incorrect and the current intentions, plans, expectations and beliefsabout future events are subject to risks, uncertainties and other factors, many of which are outsideSUDA’s control. Important factors that could cause actual results to differ materially from assumptionsor expectations expressed or implied in this presentation include known and unknown risks. Becauseactual results could differ materially to assumptions made and SUDA’s current intentions, plans,expectations and beliefs about the future, you are urged to view all forward looking statementscontained in this presentation with caution.

This presentation should not be relied on as a recommendation or forecast by SUDA. Nothing in thispresentation should be construed as either an offer to sell or a solicitation of an offer to buy or sellshares in any jurisdiction.

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Page 4: ACN 090 987 250 ASX Release - SUDA Pharma · 8/28/2018  · pharmaceutical sales • US generic market is currently $84bn with CAGR of 6.5% growing to $112bn in 2022 • Oncology

KEY HIGHLIGHTS▪LEADER in the oro-mucosal spray technology

- Rapid absorption of drugs directly through oral mucosa directly into the bloodstream.- Unique advantages and benefits – faster reaction, less adverse side effects.

▪Worldwide Patents - strong protection of IP.

▪5 contracts in place with Pharma – milestone payments.

▪14 products at various stages of development.

▪9 Term sheets in various stages of negotiation for out-licensing and co-development projects.Footprints in Asia, USA and Europe. Focus now on deal closure

▪Revenue generation through transactions, licensing of products, upfront & milestone payments androyalty payments to create a growing and sustainable income stream.

▪Full and Final Settlement with Berlin Pharma removes all litigation risk and uncertainty3

Page 5: ACN 090 987 250 ASX Release - SUDA Pharma · 8/28/2018  · pharmaceutical sales • US generic market is currently $84bn with CAGR of 6.5% growing to $112bn in 2022 • Oncology

Unique advantages of Suda’s spray delivery

▪ The drug is ABSORBED DIRECTLY INTO THE BLOODSTREAM THROUGH THE MUCOSA

▪ This presents significant and unique benefits and advantages:

▪ LESS DRUG IS REQUIRED - direct absorption avoids hepatic first-pass effect which means less drug needsto be metabolized.

▪ FASTER ONSET OF ACTION – time at which drug becomes effective is significantly reduced.

▪ REDUCTION IN DOSE due to increased bioavailability as drug is absorbed directly into the bloodstream.

▪ LESS ADVERSE SIDE EFFECTS – reduction in dose means reduction in adverse side effects

▪ REDUCES plasma level variability for drugs with food effect

▪ AVOIDS GASTRO-INTESTINAL SIDE EFFECTS

▪ GREATER TOLERABILITY in patients with nausea and vomiting

▪ Can be administered to unconscious and uncooperative patients

▪ HIGH PATIENT COMPLIANCE due to elimination of injection pain or the need to swallow1,2

or inhale

1. >40% of adults experience difficulties swallowing2. >50% of children (6 to 11 years) have problems swallowing tablets

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Page 6: ACN 090 987 250 ASX Release - SUDA Pharma · 8/28/2018  · pharmaceutical sales • US generic market is currently $84bn with CAGR of 6.5% growing to $112bn in 2022 • Oncology

SUDA’s model

• Patented Technology

• Targeting first in class market leading products

• Reduced Clinical and Development program and risk profile

• Well known drugs with known safety profile and clinical history

• Abbreviated Regulatory Pathways (505(b)2; Chapter 10:3)

• OroMist technology offers significant patient benefits• Faster Onset of Action• Reduced dosage (By-passes enteral metabolism)• Reduced side effect profile• Improved Patient convenience

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Page 7: ACN 090 987 250 ASX Release - SUDA Pharma · 8/28/2018  · pharmaceutical sales • US generic market is currently $84bn with CAGR of 6.5% growing to $112bn in 2022 • Oncology

World Class Quality Systems

SUDA holds a licence to manufacture therapeutic goods from the Australian TGA. Licence number MI-2017-LI-13480-1 Is a Registered

Research Provider and is accredited to ISO9001:2015

MI-2017-LI-13480-1

Page 8: ACN 090 987 250 ASX Release - SUDA Pharma · 8/28/2018  · pharmaceutical sales • US generic market is currently $84bn with CAGR of 6.5% growing to $112bn in 2022 • Oncology

BOARD & SENIOR MANAGEMENT

MD/ CEO Exec ChairmanStephen Carter

Experienced Pharmaceutical executive with over 30 years’ management of pharmaceutical companies, drug development, manufacturing, marketing and commercialisation in early-stage to mature companies. Previous senior roles (GM/MD / Chairman) in Delta West, Upjohn, Pharmacia, Pfizer, Solbec, Delmedica, and Colltech.

Non-Executive DirectorDavid Phillips

Senior Business Development Executive with over 30 years in the healthcare industry. Including 16 years in GSK, 12 years in Biotech and as Managing Partner of SR One (GlaxoSmithKline’s Corporate Venture Fund). David has been responsible for over 50 Pharma/Biotech deals and 10M&A transactions.

CFO/Director & Co. SecJoseph Ohayon CA, MBA

Experienced Financial and Business Executive who has worked in health-related industries for over 15 years and held several CFO roles and directorships.

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Page 9: ACN 090 987 250 ASX Release - SUDA Pharma · 8/28/2018  · pharmaceutical sales • US generic market is currently $84bn with CAGR of 6.5% growing to $112bn in 2022 • Oncology

Corporate Slide

• Current market capitalisation (@ 0.5c) $13m

• Cash $3.7m

• NDF Research target valuation (Feb18 ) $112m to $329m*• NDF Research Calculated target Price 4.6c to 13.7c*

• Top 20 Hold 35%

• 12 month Range 0.5c to 2.7c

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*Source: NDF Research report February 2018. Target valuation range $112-$329M. NDF is an independent equity research firm based in Sydney, Australia which focuses on Life Science companies that are publicly traded on the ASX Ltd.

Page 10: ACN 090 987 250 ASX Release - SUDA Pharma · 8/28/2018  · pharmaceutical sales • US generic market is currently $84bn with CAGR of 6.5% growing to $112bn in 2022 • Oncology

Oro-mucosal spray delivery | Unique advantagesEnhanced Bioavailability

76X more drug in the blood stream than tablet results in ability to significantly reduce the dose.

Very rapid absorption results in faster onset of action

3X more drug in the blood stream than tablet results in ability to significantly reduce the dose.

Page 11: ACN 090 987 250 ASX Release - SUDA Pharma · 8/28/2018  · pharmaceutical sales • US generic market is currently $84bn with CAGR of 6.5% growing to $112bn in 2022 • Oncology

Oro-mucosal spray delivery | Unique advantagesBioequivalence with enhanced properties

Earlier therapeutic drug levels = faster

onset

Page 12: ACN 090 987 250 ASX Release - SUDA Pharma · 8/28/2018  · pharmaceutical sales • US generic market is currently $84bn with CAGR of 6.5% growing to $112bn in 2022 • Oncology

FIVE YEARS OF EXPLOSIVE GROWTH

11

PRODUCTS “1”

TRANSACTIONS “0”

PATENTS “0” TRANSACTIONS “5”

PRODUCTS “300”

PATENTS “30”

2013

2018

Page 13: ACN 090 987 250 ASX Release - SUDA Pharma · 8/28/2018  · pharmaceutical sales • US generic market is currently $84bn with CAGR of 6.5% growing to $112bn in 2022 • Oncology

Transactions with major pharma's validate our IP…

Page 14: ACN 090 987 250 ASX Release - SUDA Pharma · 8/28/2018  · pharmaceutical sales • US generic market is currently $84bn with CAGR of 6.5% growing to $112bn in 2022 • Oncology

▪ Exclusive license to develop and commercialise ZolpiMist in China

▪ Eddingpharm is large Chinese pharma company covering more than 3,000hospitals in 29 provinces

▪ Total value of deal could exceed $34m

▪ Upfront payment of approx. $0.4m

- Registration milestone of approx. $0.3m

- Product supplied by SUDA

- Escalating tiered royalties

ZolpiMist™| Eddingpharm agreement in China

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Eddingpharm CEO: “An estimated 45% of Chinese, 590m people, have problems with sleep. ZolpiMist is an excellent fit with our current infrastructure and strategy.”

Page 15: ACN 090 987 250 ASX Release - SUDA Pharma · 8/28/2018  · pharmaceutical sales • US generic market is currently $84bn with CAGR of 6.5% growing to $112bn in 2022 • Oncology

▪ Exclusive license to develop and commercialise ZolpiMist in Brazil, Mexicoand Chile, plus option-to-license in Argentina, Israel and Australia

▪ Teva is top-20 Pharma and world’s largest generics company

▪ MAA submitted in first LatAm country in December 2017

▪ Total value of deal could exceed $55m

- Upfront payment of approx. $0.4m

- Milestones of approx. $2.3m

- Product supplied by SUDA

- Double-digit royalties

ZolpiMist™| Teva agreement in LatAm

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Teva has the commercial scale to maximize sales of ZolpiMist in the territory

This deal is potentially very lucrative for SUDA based on royalties and supply

Page 16: ACN 090 987 250 ASX Release - SUDA Pharma · 8/28/2018  · pharmaceutical sales • US generic market is currently $84bn with CAGR of 6.5% growing to $112bn in 2022 • Oncology

$6 million

$462 Million

2 productsFentanyl Spray

CBD Spray

$3.9Billion1 Product

Sativex CBD Spray

Significant difference in valuations between Australia and the US Markets

Page 17: ACN 090 987 250 ASX Release - SUDA Pharma · 8/28/2018  · pharmaceutical sales • US generic market is currently $84bn with CAGR of 6.5% growing to $112bn in 2022 • Oncology

BD STRATEGY

• Building global brand recognition and BD leads.

• David Phillips recently appointed as non exec director, David has extensive global BD experience

• Refined BD Strategy

• 31 projects under CDA’s and 9 term sheets under negotiation.

• Suda currently placing BD executive in lucrative US Market

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Page 18: ACN 090 987 250 ASX Release - SUDA Pharma · 8/28/2018  · pharmaceutical sales • US generic market is currently $84bn with CAGR of 6.5% growing to $112bn in 2022 • Oncology

• Worlds largest pharmaceutical market US accounts for over 45% of global pharmaceutical sales

• US generic market is currently $84bn with CAGR of 6.5% growing to $112bn in 2022

• Oncology Market (WW) CAGR at 12.7% to $192bn by 2022

• US market has higher valuation for assets

• US has higher prices and reimbursement rates than ROW

• High M&A activity in US

• Deals done by F2F and B2B meetings

• Suda to employ US based BD Specialist in Q1 FY2019

US Market Snapshot

Page 19: ACN 090 987 250 ASX Release - SUDA Pharma · 8/28/2018  · pharmaceutical sales • US generic market is currently $84bn with CAGR of 6.5% growing to $112bn in 2022 • Oncology

Business opportunities• Anagrelide:

• Significant opportunity to develop a unique patented product for the adjuvant or neo-adjuvant treatment of cancer.

• Very large market opportunity

• Good Patent protection

• Breadth of literature being published about role of platelets in cancer progression.

• Strong SAB being put in place

• Significant barriers to entry for other players

Program Q3-18 Q4-18 Q1-19 Q2-19 Q3-19

Solubility

Formulation

Relative mucosal transmission

Proof of Concept

Business Development

Page 20: ACN 090 987 250 ASX Release - SUDA Pharma · 8/28/2018  · pharmaceutical sales • US generic market is currently $84bn with CAGR of 6.5% growing to $112bn in 2022 • Oncology

Business opportunities• Midazolam:

• For the treatment of epileptic seizures

• Significant market opportunity• Good deal momentum underway

• Strong interest from potential partners

• First in class product

• Strong SAB being put in place

• Significant barriers to entry for other players

Program Q3-18 Q4-18 Q1-19 Q2-19

IP Finalisation

Relative mucosal transmission

Proof of Concept

Clinical Development

Business Development

Page 21: ACN 090 987 250 ASX Release - SUDA Pharma · 8/28/2018  · pharmaceutical sales • US generic market is currently $84bn with CAGR of 6.5% growing to $112bn in 2022 • Oncology

• Cannabis projects• Strong market interest in Cannabinoids (CBD)

• Large market opportunity

• Oromist a good platform for CBD products.

• Joint Venture or Joint Development project

• Strong interest from 4 potential JD partners due to the potential of a faster onset of action to treat pain and epilepsy

Business opportunities• Joint Development/ Joint Venture Projects

• Fully funded projects

• Joint ownership on new products with license agreements on our technology

• Allows scale up of operations with project funding

• Currently >15 JD/JV opportunities

• Pfizer project still open

Page 22: ACN 090 987 250 ASX Release - SUDA Pharma · 8/28/2018  · pharmaceutical sales • US generic market is currently $84bn with CAGR of 6.5% growing to $112bn in 2022 • Oncology

• Suda has a strong network of Industry seasoned consultants

• Some of Suda’s partners are Specialised Pharmaceutical companies without significant international Development, Clinical or Regulatory expertise.

• Suda can leverage our network to provide services as part of its development program for partners.

• Suda can leverage the network to find new opportunities.

Leverage connections to expand business opportunities

Page 23: ACN 090 987 250 ASX Release - SUDA Pharma · 8/28/2018  · pharmaceutical sales • US generic market is currently $84bn with CAGR of 6.5% growing to $112bn in 2022 • Oncology

Anticipated Milestones

Anticipated News Product Expected Date

*Co Development Deal CBD Q1 FY2019

*Licensing deal for ASEAN region ZolpiMist Q1 FY2019

*Licensing and Development Deal USA SUD-001H Q2 FY2019

*Licensing deal for part of Europe ZolpiMist Q2 FY2019

*TGA approval of Marketing Authorisation Application SUD-006 Q2 FY2019

*Licensing Deal SUD-002 Q3 FY2019

*Licensing deal for part of Europe SUD-001H Q3 FY2019

*Global partnership or trade sale SUD-006 Q3 FY2019

*Licensing deal SUD-003 Q4 FY2019

Page 24: ACN 090 987 250 ASX Release - SUDA Pharma · 8/28/2018  · pharmaceutical sales • US generic market is currently $84bn with CAGR of 6.5% growing to $112bn in 2022 • Oncology

SUDA IS GOING PLACES

• Growing world class patents and products

• Transactions with major pharma's validate Suda

• Strong Experienced senior management and Board (over 100 Years combined experience)

• Leading technical team to drive innovation

• Suda investing in Business Development Infrastructure to drive growth

• Suda focussing on high value markets

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Page 25: ACN 090 987 250 ASX Release - SUDA Pharma · 8/28/2018  · pharmaceutical sales • US generic market is currently $84bn with CAGR of 6.5% growing to $112bn in 2022 • Oncology

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THANK YOU