March 2026 Quarterly Activities Report & Appendix 4C
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Released
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ASX RELEASE 27 April 2026
March 2026 Quarterly Activities Report & Appendix 4C
Key Highlights
• Phase 3 Knee OA Trial Milestone: 50% of patients dosed in the global
PARA_OA_012 study, supporting progression toward interim analysis.
• Interim Analysis Timeline: Interim dataset remains on track for independent
statistical analysis, with results expected in approximately August 2026.
• International Site Expansion: Hong Kong clinical trial site activated and
screening commenced, with additional Moldova sites supporting global
recruitment.
• Phase 2 Biomarker Publication: Peer-reviewed publication of the
PARA_OA_008 study in a leading international journal demonstrated favourable
effects of iPPS on key osteoarthritis biomarkers, providing independent
mechanistic validation and strengthening the scientific foundation for the Phase 3
program. View biomarker publication (Springer).
• Scientific and Translational Validation: Publication of a canine osteoarthritis
study demonstrating sustained pain, function and structural benefits, supporting
Phase 3 rationale. View PLOS One publication.
• Pipeline and Research Expansion: New research collaboration with City St
George’s, University of London to investigate bone marrow lesions and PPS
mechanism of action.
• Cash Position: Cash balance of approximately A$11.3m at 31 March 2026, with
an additional A$14.3m in available facility and R&D incentive refund of
approximately A$5.4m. Subsequent to quarter end, the Company completed a
A$14.0m Placement and launched a Share Purchase Plan (SPP) to raise up to
A$2.0m, resulting in a pro forma funding position of approximately A$45m
(excluding SPP), supporting operations into the post-interim period.
Paradigm Biopharmaceuticals Ltd. (ASX: PAR) (“Paradigm” or “the Company”) is
pleased to provide its quarterly update for the three months ended 31 March 2026 and
continuing activities to accompany its Appendix 4C cash flow report for the period.
Operational Update
During the March quarter, Paradigm continued to advance its global Phase 3
PARA_OA_012 clinical trial evaluating injectable pentosan polysulfate sodium (iPPS) for
the treatment of pain associated with knee osteoarthritis.
A key milestone was achieved during the quarter with 50% of patients now dosed in the
global study, representing the cohort required for inclusion in the interim analysis dataset.
This milestone reflects continued progress across Paradigm’s global clinical network and
supports the planned pathway toward interim analysis. Patients are progressing through
the Day 112 follow-up period, after which the interim dataset will undergo data cleaning,
biometrics review, and independent statistical analysis.
Based on the current study timeline, Paradigm continues to target interim analysis results
from August 2026, however, timing remains subject to the scheduling and review processes
of independent third parties, including biometrics and the Data Safety Monitoring Board
(DSMB). Accordingly, there is a reasonable likelihood that final interim outcomes may
extend into September 2026.
Recruitment, screening and dosing activity continued to build across active clinical trial sites
during the quarter, with momentum supported by an increasingly mature global site network
currently spanning Australia, the United States and Asia. The Company remains focused
on maintaining consistent patient throughput and high-quality data capture as recruitment
progresses toward full enrolment.
During the quarter, Paradigm further expanded its global trial footprint with the activation of
a clinical trial site in Hong Kong, which has commenced patient screening. The addition of
the Hong Kong site provides further geographic diversity and supports efficient recruitment
as the study progresses. Additional sites in Moldova are expected to contribute to
enrolment, leveraging experienced investigators and established clinical infrastructure in
the region.
Paradigm continues to execute its clinical program through a dual-CRO model, with
Advanced Clinical managing operations across Australia and the United States, and Nordic
Bioscience Clinical Development (NBCD) supporting expansion into Hong Kong and
Moldova. This complementary CRO structure is designed to optimise site performance,
enhance recruitment efficiency and maintain operational flexibility as the study scales.
The PARA_OA_012 Phase 3 study remains closely aligned with Paradigm’s earlier
PARA_OA_008 trial in terms of patient population, dosing regimen and study design, while
incorporating refinements developed in consultation with regulatory agencies and scientific
advisors. These refinements, including the use of weekly average of daily pain as the
primary endpoint, are intended to improve data sensitivity and manage placebo response,
which is a recognised challenge in osteoarthritis clinical trials.
Paradigm remains focused on maintaining protocol integrity, data quality and operational
discipline as the study progresses through this critical phase, ensuring the integrity of the
interim dataset and supporting the broader regulatory pathway.
Scientific Publications and Pipeline Progress
During the quarter, Paradigm highlighted the publication of its Phase 2 PARA_OA_008
biomarker study in a leading international peer-reviewed journal, demonstrating favourable
effects on biomarkers associated with cartilage degradation, inflammation and pain
signalling within the osteoarthritic joint.
View biomarker publication (Springer)
Title: Effects of pentosan polysulfate sodium on synovial fluid biomarkers in moderate to
severe knee osteoarthritis.
• Journal: Arthritis Research & Therapy
• Key point: Showed changes in synovial and systemic biomarkers linked to cartilage
degradation, inflammation, and pain pathways, supporting iPPS mechanism of
action.
These findings provide important mechanistic support for iPPS and further strengthen the
scientific and regulatory rationale underpinning the ongoing Phase 3 PARA_OA_012
clinical trial.
In addition, Paradigm announced the publication of a peer-reviewed translational study
evaluating PPS in naturally occurring canine osteoarthritis.
View PLOS One publication
Title: Effects of pentosan polysulfate sodium on joint structure and function out to six
months in naturally-occurring canine osteoarthritis.
• Journal: PLOS One
• Key point: Demonstrated sustained improvements in pain, function, and cartilage
structure with supporting biomarker changes in a translational model.
The study demonstrated sustained reductions in pain, improvements in function and
normalisation of gait, alongside structural and biomarker evidence consistent with disease
modification over a 26-week period. These findings provide a translational bridge to human
osteoarthritis and support the durability and biological activity observed in Paradigm’s
Phase 2 clinical program.
The publication further strengthens the scientific and regulatory foundation supporting the
ongoing Phase 3 PARA_OA_012 trial.
Paradigm also expanded its research activities through a collaboration with City St
George’s, University of London to investigate the effects of PPS on bone marrow lesions,
which are increasingly recognised as a key driver of pain and disease progression in
osteoarthritis.
This collaboration will utilise advanced MRI imaging and molecular profiling to generate
deeper insights into PPS’ mechanism of action across bone, cartilage and synovial tissue.
Beyond the clinical program, Paradigm continued to progress its broader osteoarthritis
pipeline, including the execution of a binding veterinary licensing and development
agreement for an oral PPS + COX-2 inhibitor combination therapy (Pentacoxib™),
supporting early-stage development and non-dilutive value creation.
Paul Rennie, MD of Paradigm Biopharma, commented on the quarter: “The March
quarter marked a significant step forward for Paradigm, with the achievement of 50% dosing
in our global Phase 3 study, positioning us to progress toward the planned interim analysis.
We have continued to build momentum across our global site network, including the
activation of our Hong Kong site, while maintaining strong alignment with our expected
study timelines.
Importantly, the continued expansion of our scientific evidence base, including peer-
reviewed biomarker and translational data, reinforces the biological activity, durability and
potential disease-modifying effects of PPS, supporting the strength of our Phase 3 program.
Together with our expanding research collaborations and pipeline initiatives, Paradigm
remains well positioned as we move toward this important clinical inflection point.”
Summary of Cash Flow and Quarterly Activity
As at 31 March 2026, Paradigm’s cash and cash equivalents totalled approximately A$11.3
million, compared with A$14.66 million at 31 December 2025. The movement in cash
during the quarter reflects continued investment in Phase 3 clinical trial execution, including
patient recruitment, site operations, manufacturing and regulatory activities.
During the quarter, Paradigm completed the drawdown of Tranche 3 under its convertible
note facility, receiving approximately US$5 million (A$7.1 million), providing additional
working capital to support the continued execution and scaling of the Phase 3 program. The
Company also received approx $200k from option exercises.
Following this drawdown, approximately US$10 million (~A$14.3 million) (UDS:AUD $0.70)
remains available under the facility. Paradigm continues to maintain disciplined capital
management, ensuring expenditure remains aligned with operational progress and key
development milestones.
• Paradigm invested A$9.83 million in research and development activities during the
quarter, primarily directed toward execution of the PARA_OA_012 Phase 3 program,
including patient recruitment and screening initiatives, patient treatment and
investigational product supply.
• In addition to clinical progress, Paradigm continued to maintain a funding position
that provides flexibility to support ongoing clinical execution. During the quarter,
Paradigm drew down an additional US$5 million, resulting in A$7.1 million received,
under its US$27 million convertible note facility with Obsidian Global Partners.
Following this drawdown, US$10 million remains available and undrawn under the
facility. Based on the RBA exchange rate at 31 March 2026, the remaining undrawn
facility equates to approximately A$14.3 million.
• Subsequent to quarter end, the Company completed a A$14.0 million Placement to
institutional and sophisticated investors and launched a Share Purchase Plan (SPP)
to raise up to a further A$2.0 million.
• Total cash outflows for the June 2026 quarter are forecast to be in the range
of A$14–16m, driven by the peak costs associated across recruitment, screening,
dosing and monitoring activities as the clinical trial progresses to 100% recruitment.
• 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 totalled A$45K, comprising non-executive Director fees.
On a pro forma basis, the recent placement results in an estimated funding position of
approximately A$45 million (excluding SPP), comprising the 31 March 2026 cash balance,
Placement proceeds, remaining availability under the Obsidian Convertible Note Facility
(subject to shareholder approval), and the expected R&D tax incentive.
This funding is expected to support operations through the interim analysis and extend
runway into the post-interim period, with current forecasts indicating funding through to the
end of CY2026, excluding any proceeds from the exercise of attaching options.
The capital raising also enables partial repayment of the Obsidian Convertible Note Facility,
reducing reliance on future drawdowns and enhancing overall capital structure flexibility.
Outlook
Paradigm enters the June quarter with a clear operational focus on continued execution
of its global Phase 3 PARA_OA_012 clinical trial evaluating iPPS for knee osteoarthritis.
Following achievement of the 50% dosing milestone, the Company is now focused on
progressing participants through the Day 112 follow-up period required for inclusion in the
interim analysis dataset. This milestone represents a key inflection point in the study and
supports the planned pathway toward interim analysis.
Recruitment activity is expected to continue to scale across Paradigm’s global site network.
During the coming period, additional European clinical trial capacity is being supported
through the activation of three sites in Moldova, further strengthening the Company’s ability
to complete enrolment efficiently and maintain geographic diversity across the study
population.
The Company expects to achieve full enrolment of approximately 466 participants during
Q2 CY2026, with all patients having commenced treatment. In parallel, the planned safety
review by the independent Data Safety Monitoring Board (DSMB), based on approximately
20% of participants dosed, is currently being conducted.
Paradigm’s primary near-term focus remains the interim analysis, which is expected to
occur in Q3 CY2026 once sufficient participants reach the Day 112 assessment period.
Following data cleaning and preparation, the interim dataset will undergo independent
DSMB review, with outcomes to be communicated to the market in line with the Company’s
disclosure obligations.
The interim analysis represents a significant clinical and strategic milestone for the
Company, providing the first Phase 3 evaluation of efficacy and safety for iPPS in knee
osteoarthritis.
Looking beyond the interim analysis, Paradigm continues to progress toward completion of
the Phase 3 study, with primary endpoint top-line results expected in Q1 CY2027.
In addition, Paradigm advises that Chief Medical Officer, Dr Donna Skerrett, has requested
a reduction in her working hours for personal reasons and will transition to approximately
two days per week. Dr Skerrett will remain in a senior medical capacity, continuing to
support the Phase 3 clinical program and NDA-related activities, with a focus on key clinical
and regulatory priorities.
The Company has commenced a process to appoint a full-time Chief Medical Officer to
work alongside Dr Skerrett, ensuring appropriate coverage of this pivotal role through the
ongoing Phase 3 trial and subsequent regulatory approval pathway. Dr Skerrett will
continue to support continuity across clinical, regulatory and development activities.
The Company remains focused on maintaining protocol integrity, data quality and
disciplined capital allocation as it advances through these key milestones, positioning
Paradigm for a major clinical inflection point.
About Paradigm Biopharmaceuticals
Paradigm Biopharmaceuticals Ltd. (ASX: PAR) is a late-stage drug development
company driven by a purpose to improve patients’ health and quality of life by discovering,
developing, and delivering pharmaceutical therapies. Paradigm’s current focus is
developing iPPS for the treatment of diseases where inflammation plays a major
pathogenic role, indicating a need for the anti-inflammatory and tissue regenerative
properties of PPS, such as in osteoarthritis (phase 3).
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: +61 404 216 467
Paradigm Biopharmaceuticals Ltd.
ABN: 94 169 346 963
Level 15, 500 Collins St, Melbourne, VIC, 3000, AUSTRALIA
Email: investorrelations@paradigmbiopharma.com
Paradigm Biopharma
Rule 4.7B
ASX Listing Rules Appendix 4C (17/07/20) Page 1
+ See chapter 19 of the ASX Listing Rules for defined terms.
Appendix 4C
Quarterly cash flow report for entities
subject to Listing Rule 4.7B
Name of entity
Paradigm Biopharmaceuticals Limited
ABN Quarter ended (“current quarter”)
94 169 346 963 31 March 2026
Consolidated statement of cash flows Current quarter
$A’000
Year to date (9
months)
$A’000
1. Cash flows from operating activities
28 61
1.1 Receipts from customers
1.2 Payments for
(9,830) (27,045)
(a) research and development
(b) product manufacturing and operating
costs
- -
(c) advertising and marketing - -
(d) leased assets (15) (59)
(e) staff costs (439) (1,374)
(f) administration and corporate costs (815) (2,101)
1.3 Dividends received (see note 3) - -
1.4 Interest received 48 326
1.5 Interest and other costs of finance paid (7) (16)
1.6 Income taxes paid - -
1.7 Government grants and tax incentives - -
1.8 Other (provide details if material) - 63
1.9 Net cash from / (used in) operating
activities
(11,030) (30,145)
2. Cash flows from investing activities
- (500)
2.1 Payments to acquire or for:
(a) entities
(b) businesses - -
(c) property, plant and equipment - -
(d) investments - -
(e) intellectual property - -
(f) other non-current assets - -
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
ASX Listing Rules Appendix 4C (17/07/20) Page 2
+ See chapter 19 of the ASX Listing Rules for defined terms.
Consolidated statement of cash flows Current quarter
$A’000
Year to date (9
months)
$A’000
2.2 Proceeds from disposal of:
- -
(a) entities
(b) businesses - -
(c) property, plant and equipment - 5
(d) investments - -
(e) intellectual property - -
(f) other non-current assets - -
2.3 Cash flows from loans to other entities - -
2.4 Dividends received (see note 3) - -
2.5 Other (Term deposits) - (72)
2.6 Net cash from / (used in) investing
activities
- (567)
3. Cash flows from financing activities
- -
3.1 Proceeds from issues of equity securities
(excluding convertible debt securities)
3.2 Proceeds from issue of convertible debt
securities 7,071 25,423
3.3 Proceeds from exercise of options 197 198
3.4 Transaction costs related to issues of
equity securities or convertible debt
securities
533 (72)
3.5 Proceeds from borrowings - -
3.6 Repayment of borrowings (lease liabilities) (33) (100)
3.7 Transaction costs related to loans and
borrowings - -
3.8 Dividends paid - -
3.9 Other (Limited recourse loan repaid under
ESP)
- 81
3.10 Net cash from / (used in) financing
activities
7,768 25,530
4. Net increase / (decrease) in cash and
cash equivalents for the period
14,663 16,818
4.1 Cash and cash equivalents at beginning of
period
4.2 Net cash from / (used in) operating
activities (item 1.9 above) (11,030) (30,145)
4.3 Net cash from / (used in) investing activities
(item 2.6 above) - (567)
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
ASX Listing Rules Appendix 4C (17/07/20) Page 3
+ See chapter 19 of the ASX Listing Rules for defined terms.
Consolidated statement of cash flows Current quarter
$A’000
Year to date (9
months)
$A’000
4.4 Net cash from / (used in) financing activities
(item 3.10 above)
7,768 25,530
4.5 Effect of movement in exchange rates on
cash held
(117) (352)
4.6 Cash and cash equivalents at end of
period
11,284 11,284
5. Reconciliation of cash and cash
equivalents
at the end of the quarter (as shown in the
consolidated statement of cash flows) to the
related items in the accounts
Current quarter
$A’000
Previous quarter
$A’000
5.1 Bank balances 11,284 14,663
5.2 Call deposits
5.3 Bank overdrafts
5.4 Other (provide details)
5.5 Cash and cash equivalents at end of
quarter (should equal item 4.6 above)
11,284 14,663
6. Payments to related parties of the entity and their
associates
Current quarter
$A'000
6.1 Aggregate amount of payments to related parties and their
associates included in item 1
45
6.2 Aggregate amount of payments to related parties and their
associates included in item 2
Note: if any amounts are shown in items 6.1 or 6.2, your quarterly activity report must include a description of, and an
explanation for, such payments.
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
ASX Listing Rules Appendix 4C (17/07/20) Page 4
+ See chapter 19 of the ASX Listing Rules for defined terms.
7. Financing facilities
Note: the term “facility’ includes all forms of financing
arrangements available to the entity.
Add notes as necessary for an understanding of the
sources of finance available to the entity.
Total facility
amount at quarter
end
$A’000
Amount drawn at
quarter end
$A’000
7.1 Loan facilities 14,609 7,071
7.2 Credit standby arrangements - -
7.3 Other (please specify) - -
7.4 Total financing facilities 14,609 7,071
7.5 Unused financing facilities available at quarter end 14,609
7.6 Include in the box below a description of each facility above, including the lender, interest
rate, maturity date and whether it is secured or unsecured. If any additional financing
facilities have been entered into or are proposed to be entered into after quarter end,
include a note providing details of those facilities as well.
Convertible Note facility from Obsidian Global Partners, with no interest payable. Refer to
ASX Announcement on 01 July 2025 for full details.
8. Estimated cash available for future operating activities $A’000
8.1 Net cash from / (used in) operating activities (item 1.9) (11,030)
8.2 Cash and cash equivalents at quarter end (item 4.6) 11,284
8.3 Unused finance facilities available at quarter end (item 7.5) 14,609
8.4 Total available funding (item 8.2 + item 8.3) 25,893
8.5 Estimated quarters of funding available (item 8.4 divided by
item 8.1)
2.35
Note: if the entity has reported positive net operating cash flows in item 1.9, answer item 8.5 as “N/A”. Otherwise, a
figure for the estimated quarters of funding available must be included in item 8.5.
8.6 If item 8.5 is less than 2 quarters, please provide answers to the following questions:
8.6.1 Does the entity expect that it will continue to have the current level of net operating
cash flows for the time being and, if not, why not?
Answer:.
8.6.2 Has the entity taken any steps, or does it propose to take any steps, to raise further
cash to fund its operations and, if so, what are those steps and how likely does it
believe that they will be successful?
Answer:
8.6.3 Does the entity expect to be able to continue its operations and to meet its business
objectives and, if so, on what basis?
Answer:
Note: where item 8.5 is less than 2 quarters, all of questions 8.6.1, 8.6.2 and 8.6.3 above must be answered.
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
ASX Listing Rules Appendix 4C (17/07/20) Page 5
+ See chapter 19 of the ASX Listing Rules for defined terms.
Compliance statement
1 This statement has been prepared in accordance with accounting standards and policies
which comply with Listing Rule 19.11A.
2 This statement gives a true and fair view of the matters disclosed.
Date: ..27 April 2026.................................................................................
Authorised by: ...By the board................................................................................
(Name of body or officer authorising release – see note 4)
Notes
1. This quarterly cash flow report and the accompanying activity report provide a basis for informing the market about the
entity’s activities for the past quarter, how they have been financed and the effect this has had on its cash position. An
entity that wishes to disclose additional information over and above the minimum required under the Listing Rules is
encouraged to do so.
2. If this quarterly cash flow report has been prepared in accordance with Australian Accounting Standards, the definitions
in, and provisions of, AASB 107: Statement of Cash Flows apply to this report. If this quarterly cash flow report has been
prepared in accordance with other accounting standards agreed by ASX pursuant to Listing Rule 19.11A, the
corresponding equivalent standard applies to this report.
3. Dividends received may be classified either as cash flows from operating activities or cash flows from investing activities,
depending on the accounting policy of the entity.
4. If this report has been authorised for release to the market by your board of directors, you can insert here: “By the board”.
If it has been authorised for release to the market by a committee of your board of directors, you can insert here: “By the
[name of board committee – eg Audit and Risk Committee]”. If it has been authorised for release to the market by a
disclosure committee, you can insert here: “By the Disclosure Committee”.
5. If this report has been authorised for release to the market by your board of directors and you wish to hold yourself out as
complying with recommendation 4.2 of the ASX Corporate Governance Council’s Corporate Governance Principles and
Recommendations, the board should have received a declaration from its CEO and CFO that, in their opinion, the financial
records of the entity have been properly maintained, that this report complies with the appropriate accounting standards
and gives a true and fair view of the cash flows of the entity, and that their opinion has been formed on the basis of a
sound system of risk management and internal control which is operating effectively.
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