Paradigm Biopharmaceuticals : Quarterly Update and Appendix 4C - quarterly

ASX RELEASE

29th April 2022

MARCH QUARTERLY ACTIVITIES REPORT

KEY HIGHLIGHTS

• • Phase 3 Para_OA_002 Clinical Trial: Paradigm reported the first participant dosing at one of the 8 activated sites across Australia in the Para_OA_002 clinical trial. Throughout the quarter Paradigm had been focused on activating clinical trial sites in the Para_OA_002 study across Australia and the US. Sites must undergo activation to commence participant screening and recruitment into the clinical trial.

• • UK Regulatory and Ethics Approval: Regulatory and ethics approval was received on 16th March from the Medicines & Healthcare products Regulatory Agency (MHRA) in the UK. The confirmation from the MHRA means that all required approvals are in place to commence clinical trial activities in the UK for the global Phase 3 PARA_OA_002 clinical trial.

• • MPS VI WORLDSymposiumin Presentation: A presentation of Paradigm's phase 2 trial for mucopolysaccharidosis type-VI (MPS VI) was delivered by Dr Roberto Giugliani, a renowned geneticist and principal investigator of the phase 2 study, to delegates at the WORLDSymposiumin San Diego, California.

• • J.P Morgan Healthcare Conference: Interim CEO, Dr Donna Skerrett, presented at the 40th Annual J.P Morgan Healthcare Conference. Dr Skerrett's presentation detailed Paradigm's strong development pipeline and Mechanism of Action of Pentosan Polysulfate Sodium (PPS) and the related effects of PPS for each of the indications being explored by the Company.

• • Intellectual Property: During the quarter Paradigm clarified it's strong IP position following an erroneous report about Paradigm's IP portfolio. Paradigm welcomed the opportunity to explain that PPS is the subject granted and pending methods of use patents as well as manufacturing know how (trade secrets) and exclusive in-licensing and supply from the only FDA approved manufacturer of PPS. Paradigm continues to proactively prosecute new patents to extend its protection on the use of PPS for the treatment of diseases that comrpise unmet medical needs where the actions of PPS have been scientifically (in preclinical proof-of concept models) and/or clinically (population of patients) ascertained to be therapeutically effective.

• • Bio Spring Europe Partnering Conference: Paradigm virtually attended the Bio Spring Europe partnering conference in late March. The Company met with over 30 Pharma companies primarily focused on partnering opportunities within Europe and partnering consultants looking to assist Paradigm to navigate commercial transactions. Follow-up meetings are being conducted with parties where a mutual benefit has been identified through initial meetings.

Paradigm Biopharmaceuticals Ltd (ASX: PAR) ("Paradigm" or "the Company") is pleased to provide its quarterly update for the three months ended 31st March 2022 to accompany its Appendix 4C cash flow report for the period.

• • Cash balance as of 31st March 2022 was $39.89m (on 31st December 2021: $55.03) with a net cash outflow during the quarter of $15.19m.

• • Research & development expenditure for the quarter was $14.03m compared to the previous quarter of $8.6m. The increase in research and development expenditure is attributed to, a PARA_OA_002 $5mUSD milestone payments to the CRO for first subject dosed in the global study and site activation for the US, PARA_OA_008 participant dosing and clinical trial activities, and preliminary spend on establishing the PARA_OA_006 extension study (~$1mAUD) of PARA_OA_002 which is due to commence 6 months after first subject randomisation In PARA_OA_002, continuation of MPS I and MPS VI phase II studies, as well as continuing activities described in the outlook below.

• • In accordance with Listing Rule 4.7C.3 and as noted in item 6 of the Appendix 4C Cashflow Statement, payments to related parties and their associates during the quarter ended 31st March 2022 were fees of $153k which includes the first full quarter for Chairman fees and Director fee payments to Non-Executive Directors.

OUTLOOK

• • On 12th of April, it was reported Paradigm had received US FDA Fast Track Designation for its OA clinical program. The FDA Fast Track Designation for Zilosul™/PPS offers pathways to expedite development of Paradigm's osteoarthritis clinical program. The designation has been granted for Paradigm's broad OA program and not specific to OA of the knee. It allows Paradigm the opportunity to interact and collaborate with the FDA more frequently during program development enabling a stronger overall program in line with the FDA's expectations and provides opportunity for shorter review timelines.

• • Paradigm's FY21 R&D tax rebate has been submitted to the ATO and the Company anticipates receipt of cash during the current quarter.

• • Paradigm's search for a CEO remains ongoing with several rounds of meetings being undertaken by the Remuneration and Nominations Committee. The Company will make an announcement once the selection process is completed.

• • Paradigm expects to report 100% recruitment in the PARA_OA_008 during 1H 2022. The program is recruiting and treating subjects at two sites across Australia with top-line data from day 56 endpoints expected Q3 CY2022.

• • The Para_OA_002 Phase 3 study continues strong momentum in Australia with all sites activated currently screening and enrolling participants into the study. Paradigm reported first participants have been enrolled in the US following a strong quarter with multiple sites activated and now screening throughout the US. UK sites are expected to be activated during the current quarter with EU sites in the 2H of CY 2022.

• • The company intends to participate in several conferences during the current quarter, including an in-person company presentation at the BIO International Partnering Conference in San Diego in June. Paradigm will have several key members of the management team attending the BIO International Conference for 1x1 meetings with potential partners.

• • A clinical protocol and IND application for an Expanded Access Program (EAP) in the US for the re-treatment with Zilosul™ of the previous 10 EAP participants is being completed for submission to the US FDA. The development of this program follows discussions of prior participants with their physician. The participants have expressed strong interest in a follow-up retreatment program approximately 2 years following their initial treatment. Paradigm expects the program to provide important comparison data on WOMAC® pain

and function baseline scores from the previous participants initial treatment and the treatment effect following Zilosul™ retreatment.

About Paradigm Biopharmaceuticals

Paradigm Biopharmaceuticals Ltd (ASX: PAR) is a late-stage drug development company with the mission to develop and commercialise pentosan polysulfate sodium for the treatment of pain associated with musculoskeletal disorders driven by injury, inflammation, ageing, degenerative disease, infection, or genetic predisposition. Paradigm is also exploring proof-of-concept studies for the use of PPS in respiratory and heart failure indications.

Forward Looking Statements

This Company announcement contains forward-looking statements, including statements regarding anticipated commencement dates or completions dates of preclinical or clinical trials, regulatory developments, and regulatory approval. These forward-looking statements are not guarantees or predictions of future performance, and involve known and unknown risks, uncertainties and other factors, many of which are beyond our control, and which may cause actual results to differ materially from those expressed in the statements contained in this presentation. Readers are cautioned not to put undue reliance on forward-looking statements.

Authorised for release by the Paradigm Board of Directors.

FOR FURTHER INFORMATION PLEASE CONTACT:

Simon White

Director of Investor Relations Tel: +61 (0) 404 216 467 Paradigm Biopharmaceuticals Ltd

ABN: 94 169 346 963

Level 15, 500 Collins St, Melbourne, VIC, 3000, AUSTRALIA Email:investorrelations@paradigmbiopharma.com

Rule 4.7B

Appendix 4C

Quarterly cash flow report for entities subject to Listing Rule 4.7B

Name of entity

Paradigm Biopharmaceuticals Limited

ABN

94 169 346 963

Quarter ended ("current quarter")

31 March 2022

2.

Cash flows from investing activities

2.1

Payments to acquire or for:

Appendix 4C

Quarterly cash flow report for entities subject to Listing Rule 4.7B

4.

Net increase / (decrease) in cash and cash equivalents for the period

4.1

Cash and cash equivalents at beginning of

4.2

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