Paradigm Biopharmaceuticals : AGM Presentation

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ASX RELEASE

25th January 2022

2021 Annual General Meeting

Paradigm Biopharmaceuticals Ltd (ASX: PAR) (Paradigm or the Company), a clinical stage biopharmaceutical company focussed on repurposing existing molecules for new indications with unmet clinical needs, is pleased to provide a copy of the Chairman's address delivered by Mr Paul Rennie at today's Annual General Meeting (AGM) to shareholders. Following the Chairman's address, Dr Donna Skerrett, Interim CEO and Chief Medical Officer will provide the CEO and business update.

Investors wishing to attend today's AGM can find details to access the meeting in the Notice of Meeting lodged with the ASX on the 24th December 2021.

-Ends-

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ASX RELEASE

25th January 2022

2021 AGM Chairman's Address

Dear Shareholders,

Good morning and I welcome you to this Annual General Meeting of Paradigm Biopharmaceuticals Ltd. I am Paul Rennie Non-Executive Chairman. Today's meeting is being held online via the Computershare Meeting Platform. This allows Shareholders, Proxies and Guests to attend the meeting virtually. Wherever you're joining us from today, I thank you for your participation.

Paradigm Biopharmaceuticals is a global Australian-based pharmaceutical company focused on repurposing existing molecules to meet high unmet medical needs. Paradigm's purpose is to develop and commercialise pentosan polysulfate sodium (PPS) for the treatment of arthralgia driven by injury, inflammation, aging, degenerative disease, infection, or genetics.

The immediate commercial focus is the repurposing of the historic drug pentosan

polysulfate sodium (PPS or brand name Zilosul®) for the treatment of pain associated with osteoarthritis (OA). This is a global unmet need and Paradigm has advanced towards phase 3 trials for this indication. There is strong scientific evidence that the drug PPS addresses all aspects of the disease: inflammation, pain, and cartilage preservation, suggesting PPS has OA disease modifying potential.

Other indications include the treatment of pain and arthropathy and other disease complications in patients with the rare genetic disorder mucopolysaccharidoses (MPS); treating alphavirus induced arthralgia (in patients with Ross River virus and Chikungunya); chronic heart failure (CHF) and potentially acute respiratory distress syndrome (ARDS).

I am pleased to report that the company has continued to progress the development of

Zilosul® for the treatment of pain associated with osteoarthritis by submitting an IND (Investigational New Drug) application with the US FDA in March 2021. The IND submission was the result of many years of substantial work by the entire Paradigm team as well as several meetings with key regulatory agencies the FDA, EMA and TGA to develop a clinical protocol acceptable for registration by these regulators.

Paradigm achieved the significant milestone of an open IND application following notification from the US FDA, which was announced to the market on 3rd November 2021.

In addition to pursuing the phase 3 trial, we continue to progress development of Zilosul® with the commencement of the PARA_OA_008 study in Australia. This study seeks to evaluate molecular biomarkers in the synovial fluid of the knee joint to demonstrate the mechanism of action and OA disease modifying potential of Zilosul® on the diseased joint. The biomarker analysis aims to provide key scientific evidence about the local activity of Zilosul® in the knee joint of OA subjects. The biomarkers analysis will include an analysis of inflammatory cytokines, pain mediator nerve growth factor (NGF), cartilage degrading enzymes, and products of cartilage degradation. Additionally, clinical, and radiographic assessments will be obtained.

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The significance of this study is also the commercial potential of Zilosul In the amount that the market is prepared to pay for Zilosul.

In addition to the progress being made in the clinical development program for osteoarthritis, development of PPS for MPS (where Paradigm has received orphan status from the FDA and EMA for MPS I and MPS VI) continues with two major milestones achieved in FY21.

In November 2020 we announced that the first patient was dosed in a Phase II study in Adelaide, South Australia evaluating the safety and efficacy of PPS on pain and functional symptoms in MPS type I patients who have received ERT and/or haemopoietic stem cell transplantation (HSCT).

In June 2021, the company announced that it had received approval from the ANVISA, the Brazilian regulator, to commence a Phase II study in Brazil to evaluate the safety, tolerability, and effect of PPS on pain, function, and glycosaminoglycan (GAG) levels in patients with MPS type VI. Brazil has the highest concentration of MPS type VI sufferers globally. The first participant in this study was reported in September and the clinical program under Principal Investigator Dr. Roberto Giugliani continues to progress.

Much of the investment in FY21 was focused on identifying and then meeting the requirements of the regulatory pathways for clinical development for the lead programs. Infrastructure and organisational support were strengthened for current and upcoming clinical trial activities. We engaged key opinion leaders and industry experts to work alongside our in-house teams to enhance success in advancing the programs. Investment will continue as we progress with both the global clinical pivotal program and projects to optimise commercial and partnering attractiveness for Zilosul®.

During FY21 Paradigm welcomed Non-Executive Directors Ms. Helen Fisher and Mr. Amos Meltzer and Executive Director Dr Donna Skerrett to the Board. Ms. Fisher, previously a Tax Partner at Deloitte, Mr. Meltzer who has a background in science and commercialisation and is an intellectual property lawyer, and Dr Skerrett, who has three decades of experience in clinical research and development, bring a wealth of experience to Paradigm. These appointments improve the composition of the board in terms of independence and governance, experience, gender diversity and will contribute to the success of Paradigm into the future.

Today, Paradigm's fundamentals remain very strong:

• We are repurposing the only FDA approved version of the drug PPS (Pentosan Polysulfate Sodium) for which we have a 25-year period of exclusivity from market authorisation.
• There is a very significant unmet medical need, i.e., the need to treat chronic pain with non-opioid based medicines.
• Our Company has a clear regulatory pathway to commercialisation with our Phase 3 clinical program, which is harmonized with the regulators in our key markets: EU - EMA, the US - FDA and Australia - TGA.

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To learn more please visit: www.paradigmbiopharma.com

Approved for release by the Paradigm Board of Directors

FOR FURTHER INFORMATION PLEASE CONTACT: Simon White

Director of Investor Relations Tel: [phone] Paradigm Biopharmaceuticals Ltd

ABN: 94 169 346 963

Level 15, 500 Collins St, Melbourne, VIC, 3000, AUSTRALIA Email: [e-mail]

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Annual General Meeting