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ASX Release No. 1043 26 February 2020 Page 1 of 1 ACN 090 987 250 ASX Release Investor Presentation PERTH, AUSTRALIA – 26 February 2020: SUDA Pharmaceuticals Ltd (ASX: SUD), a leader in oro-mucosal drug delivery, is pleased to announce that Dr Michael Baker and Mr David Phillips are attending the Wholesale Investor Emergence 2020 conference in Sydney from 26 – 28 February 2020. Dr Baker will be presenting on Thursday 27 February. A copy of the Investor Presentation follows. For and on behalf of the Board and for further information please contact: Paul Hopper Dr Michael Baker Executive Chairman Chief Executive Officer SUDA Pharmaceuticals Ltd SUDA Pharmaceuticals Ltd Tel: +61 (0) 406 671 515 Tel +61 (0) 403 468 187 [email protected] [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. Other products in development include oral sprays for the treatment of: migraine headache; chemotherapy-induced nausea and vomiting; erectile dysfunction; pulmonary hypertension; epileptic seizures and pre-procedural anxiety and cancer. For more information, visit www.sudapharma.com
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Page 1: Investor Presentation...ex-blockbuster drugs. Dosing in difficult populations –Seizures, inability to swallow, paediatrics. Large target markets: Including insomnia ($4b by 2026),

ASX Release No. 1043 26 February 2020 Page 1 of 1

ACN 090 987 250

ASX Release

Investor Presentation

PERTH, AUSTRALIA – 26 February 2020: SUDA Pharmaceuticals Ltd (ASX: SUD), a leader in oro-mucosal drug delivery, is pleased to announce that Dr Michael Baker and Mr David Phillips are attending the Wholesale Investor Emergence 2020 conference in Sydney from 26 – 28 February 2020.

Dr Baker will be presenting on Thursday 27 February.

A copy of the Investor Presentation follows.

For and on behalf of the Board and for further information please contact:

Paul Hopper Dr Michael Baker

Executive Chairman Chief Executive Officer

SUDA Pharmaceuticals Ltd SUDA Pharmaceuticals Ltd

Tel: +61 (0) 406 671 515 Tel +61 (0) 403 468 187

[email protected] [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. Other products in development include oral sprays for the treatment of: migraine headache; chemotherapy-induced nausea and vomiting; erectile dysfunction; pulmonary hypertension; epileptic seizures and pre-procedural anxiety and cancer.

For more information, visit www.sudapharma.com

Page 2: Investor Presentation...ex-blockbuster drugs. Dosing in difficult populations –Seizures, inability to swallow, paediatrics. Large target markets: Including insomnia ($4b by 2026),

© Copyright SUDA Pharmaceuticals Ltd 2020

Investor Presentation

Dr Michael Baker

February 2020

Page 3: Investor Presentation...ex-blockbuster drugs. Dosing in difficult populations –Seizures, inability to swallow, paediatrics. Large target markets: Including insomnia ($4b by 2026),

Disclaimer

The purpose of the presentation is to provide an update of the business of SUDA PHARMACEUTICALS LTD (ASX:SUD) [‘SUDA’]. These slides

have been prepared as a presentation aid only and the information they contain may require further explanation and/or clarification. Accordingly,

these slides and the information they contain should be read in conjunction with past and future announcements made by SUDA and should not

be relied upon as an independent source of information. Please contact SUDA and/or refer to the Company's website for further information.

The views expressed in this presentation contain information derived from publicly available sources that 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 of assumptions which may prove incorrect and

the current intentions, plans, expectations and beliefs about future events are subject to risks, uncertainties and other factors, many of which are

outside SUDA’s control. Important factors that could cause actual results to differ materially from assumptions or expectations expressed or

implied in this presentation include known and unknown risks. Because actual 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 statements contained in this

presentation with caution.

This presentation should not be relied on as a recommendation or forecast by SUDA. Nothing in this presentation should be construed as either an

offer to sell or a solicitation of an offer to buy or sell shares in any jurisdiction.

© Copyright SUDA Pharmaceuticals Ltd 20202

Page 4: Investor Presentation...ex-blockbuster drugs. Dosing in difficult populations –Seizures, inability to swallow, paediatrics. Large target markets: Including insomnia ($4b by 2026),

Company Highlights

▪ Unique platform technology – OroMist™:Reformulate existing billion-dollar drugs for oral delivery.

▪ Benefits include:▪ Faster onset.

▪ Potentially smaller doses & safer delivery for ex-blockbuster drugs.

▪ Dosing in difficult populations – Seizures, inability to swallow, paediatrics.

▪ Large target markets: Including insomnia ($4b by 2026), migraine ($9b by 2026), medical grade cannabis ($66b by 2025) and cancer ($424b for solid tumours by 2027).

▪ Faster path to market: We can leverage a drug’s prior safety and efficacy data which can save time and development costs.

▪ Validation of the Technology: Deals with Teva, Mitsubishi, Strides, Zelira Therapeutics, Cann Pharma, Laboratorios Ordesa and Sanofi.

© Copyright SUDA Pharmaceuticals Ltd 20203

The most effective drug dosing methods

Page 5: Investor Presentation...ex-blockbuster drugs. Dosing in difficult populations –Seizures, inability to swallow, paediatrics. Large target markets: Including insomnia ($4b by 2026),

Oro-mucosal Delivery | IP & Platform Technology

INTELLECTUAL PROPERTY

▪ Multiple patent families & more pending, covering:

▪ 300 high-usage existing drugs formulated into oral sprays

▪ Hydrotrope technology for better delivery of drugs across mucosa

▪ Anagrelide use in cancer

▪ Pump (air-activated) & aerosol (propellant-driven) sprays

▪ Formulation and Use of Sildenafil in ED and PAH

PLATFORM TECHNOLOGY

▪ Core in-house competence in oro-mucosal reformulation.

▪ Established process development and scale-up expertise.

© Copyright SUDA Pharmaceuticals Ltd 20204

Page 6: Investor Presentation...ex-blockbuster drugs. Dosing in difficult populations –Seizures, inability to swallow, paediatrics. Large target markets: Including insomnia ($4b by 2026),

GMP Manufacturing | Ease of Manufacture & Low COGS

© Copyright SUDA Pharmaceuticals Ltd 20205

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

▪ SUDA is accredited to ISO9001:2015

▪ SUDA is an Australian Government Registered Research Provider and

▪ SUDA’s approved manufacturers provide a global manufacturing solution for our partners

MI-2017-LI-13480-1

Page 7: Investor Presentation...ex-blockbuster drugs. Dosing in difficult populations –Seizures, inability to swallow, paediatrics. Large target markets: Including insomnia ($4b by 2026),

SUDA is attracting world class Pharmaceutical Partners

© Copyright SUDA Pharmaceuticals Ltd 20206

Page 8: Investor Presentation...ex-blockbuster drugs. Dosing in difficult populations –Seizures, inability to swallow, paediatrics. Large target markets: Including insomnia ($4b by 2026),

Our Business Model

7

▪ The future of this business will be built on:

Royalty streams

from product sales

Up-front

payments are

a small part

of the model

The sales cycle

is long

Joint venture deals -

Pharma Funded

© Copyright SUDA Pharmaceuticals Ltd 2020

Page 9: Investor Presentation...ex-blockbuster drugs. Dosing in difficult populations –Seizures, inability to swallow, paediatrics. Large target markets: Including insomnia ($4b by 2026),

Key Projects

SUDA Key Projects

Anagrelide Sumatriptan ZolpiMistCo-Development

Big Pharma + Specialty Pharma`

© Copyright SUDA Pharmaceuticals Ltd 20208

Cancer Migraine InsomniaWorking in the

areas of Allergy,

Headache,

Autism,

Erectile

Dysfunction,

Hypertension,

Epilepsy, and

Generalized

Anxiety Disorder

Page 10: Investor Presentation...ex-blockbuster drugs. Dosing in difficult populations –Seizures, inability to swallow, paediatrics. Large target markets: Including insomnia ($4b by 2026),

Anagrelide | Reformulating to treat cancer

▪ Anagrelide: Approved generic drug to treat a rare blood disorder where a patient’s platelet count is too high.

▪ Recent Research Shows: Cancer patients with high platelet counts have a poor prognosis, lowering the platelet count could play an important role in cancer treatment.

▪ Making Anagrelide Safer: As a pill, it has cardiac side effects, SUDAs oro-mucosal spray may limit unwanted side effects.

▪ Reformulation work: Conversion into an OroMist spray is ongoing.

▪ SUDA owns intellectual property:

▪ “Prevention and treatment of metastatic disease in thrombocytotic cancer patients”

▪ We have the team: Dr Richard Franklin is the Project Director, involved in progressing Agrylin® through to approval throughout Europe.

▪ Anagrelide may be broadly applicable: Broad spectrum of solid tumors demonstrate a common dependency on high platelet count.

© Copyright SUDA Pharmaceuticals Ltd 20209

Project Director

Dr Richard Franklin

Dr Franklin gained his PhD from

Surrey University in the UK in Drug

Metabolism and Pharmacokinetics.

He has worked for several major drug

companies including Glaxo, Wyeth,

Sterling Winthrop, & AstraZeneca. He

was head of New Product Innovation

at Shire Pharmaceuticals and

involved in the development and

registration of anagrelide for the

treatment of essential

thrombocythemia in Europe.

Page 11: Investor Presentation...ex-blockbuster drugs. Dosing in difficult populations –Seizures, inability to swallow, paediatrics. Large target markets: Including insomnia ($4b by 2026),

ZolpiMist - Insomnia

▪ ZolpiMist is SUDA’s spray version of the insomnia drug Ambien.

▪ Ambien was Sanofi’s blockbuster insomnia drug.

▪ ZolpiMist spray was approved by the FDA in 2008.

▪ US and Canadian rights to ZolpiMist are owned by AytuBioscience.

▪ SUDA has rest-of-world rights, and has licensed Brazil, Chile and Mexico to Teva.

▪ Mitsubishi Tannabe has licensed the rights to Malaysia, Philippines, Singapore

▪ Discussions with additional territories are underway.

▪ TGA submission for approval in Australia is ongoing.

▪ SUDA to supply finished product to all parties.

© Copyright SUDA Pharmaceuticals Ltd 202010

Page 12: Investor Presentation...ex-blockbuster drugs. Dosing in difficult populations –Seizures, inability to swallow, paediatrics. Large target markets: Including insomnia ($4b by 2026),

Sumatriptan: Migraine

▪ Sumatriptan is the generic name for Glaxo’s blockbuster migraine drug known as Imitrex. Similar class drugs were developed by Merck & J&J.

▪ Attractive licensing deal for USA signed with large India pharma company, Strides, who focus on 505(b)(2) submissions.

▪ Fully funded development program, including clinical trials, at a cost of >$4m to be funded by Strides.

▪ New formulation with hydrotropes near complete.

▪ SUDA owns intellectual property covering;

▪ Mucosal Active Agent Delivery

▪ SUDA to supply finished product to Strides.

© Copyright SUDA Pharmaceuticals Ltd 202011

Page 13: Investor Presentation...ex-blockbuster drugs. Dosing in difficult populations –Seizures, inability to swallow, paediatrics. Large target markets: Including insomnia ($4b by 2026),

Focus for 2020

© Copyright SUDA Pharmaceuticals Ltd 202012

▪ Global Expansion of ZolpiMist (Teva, Mitsubishi).

▪ Development of Anagrelide towards Phase I clinical trials.

▪ Continue work on the assets from our partnerships:

▪ Strides (Migraine)

▪ Sanofi (Confidential)

▪ Ordesa (Confidential)

▪ Zelira Therapeutics (Medical Grade Cannabis)

▪ Cann Pharma (Medical Grade Cannabis)

▪ Bring in additional assets.

▪ Manage Costs.

Page 14: Investor Presentation...ex-blockbuster drugs. Dosing in difficult populations –Seizures, inability to swallow, paediatrics. Large target markets: Including insomnia ($4b by 2026),

Board & Senior Management

© Copyright SUDA Pharmaceuticals Ltd 2020`13

Paul Hopper

Over 25 years experience in the

medical, healthcare & life

sciences sectors. Focussed on

start-up and rapid growth

companies, he has served as

either Founder, Chairman, non-

executive director or CEO, of

more than fourteen companies in

the US, Australia and Asia.

Executive Chairman

Dr. Michael Baker

Over 15 years experience in

scientific research, drug

development and venture

investing sectors. He has co-

authored 18 peer reviewed

research articles and received

over 1600 citations. As an

Investment Manager, he was

involved with operational and

capital raising strategies.

Chief Executive Officer

David 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 10

M&A transactions.

Executive Director

David Simmonds

David was a senior audit partner with Ernst & Young from 1989 to 2017. From 2008 to 2013, David led the Capital Markets desk in Australia with responsibility for

overseeing or reviewing all Australian cross border

fundraisings. David is currently a member of the Board of MS

Research Australia

Director

Page 15: Investor Presentation...ex-blockbuster drugs. Dosing in difficult populations –Seizures, inability to swallow, paediatrics. Large target markets: Including insomnia ($4b by 2026),

Company Overview

© Copyright SUDA Pharmaceuticals Ltd 202014

ASX CODE SUD

Market cap $8.2m

Shares on issue 142.25m

52-week low / high $0.05 / $0.17

Cash (31st Dec 2019) $2.4m

Sector Biotechnology

Financial Snapshot

Major Shareholders

Shareholder % Ownership

KAMALA HOLDINGS PTY LTD <THE KAMALA 1994 S/F A/C> 4,844,791 (3.41%)

SCINTILLA STRATEGIC INVESTMENTS LIMITED 2,300,000 (1.62%)

MR THOMAS PAUL MCGELLIN + MS TANYA MARGARET KARAL 2,299,430 (1.62%)

BAMBER INVESTMENTS PTY LTD 1,976,184 (1.39%)

MR JAMES BRADLEY RICHARDSON <EST EDWARD B RICHARDSON A/C> 1,705,803 (1.20%)

Page 16: Investor Presentation...ex-blockbuster drugs. Dosing in difficult populations –Seizures, inability to swallow, paediatrics. Large target markets: Including insomnia ($4b by 2026),

Summary Highlights

▪ Unique platform technology for reformulating existing billion-dollar drugs for oral delivery

▪ Faster, potentially smaller doses & safer delivery for ex-blockbuster drugs

▪ Large target markets including insomnia, migraine, medical grade cannabis and cancer

▪ Reformulation into an oral spray offers fast approval & significantly lower cost under the FDA’s accelerated 505 (b)(2) pathway to approval

▪ Promising opportunity to take a drug approved for blood disorder & convert it into an oro-mucosal spray cancer drug

▪ Technology validated with deals completed with Teva, Mitsubishi, Laboratorios Ordesa, Sanofi, Zelira Therapeutics and Cann Pharma.

▪ Robust intellectual property portfolio with over 50 patents

▪ Attractive valuation with near-term value enhancing events

© Copyright SUDA Pharmaceuticals Ltd 202015

Page 17: Investor Presentation...ex-blockbuster drugs. Dosing in difficult populations –Seizures, inability to swallow, paediatrics. Large target markets: Including insomnia ($4b by 2026),

Level 1, Unit 12,

55 Howe Street

Osborne Park,

Western Australia 6017

PO Box 1719

Osborne Park BC, WA 6916

(T) +61 8 6142 5555

(F) +61 8 9443 8858

© Copyright SUDA Pharmaceuticals Ltd 2020

CONTACT

Dr Michael Baker

CEO

Email: [email protected]

Mobile: +61 403 468 187


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