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About time for an update on this one… I’ve been following this (and holding for gods sake) for more than 5 years. It’s finally approaching the proper binary event that is phase 3 trial results. Looks as though the interim results will be released in August. If they are positive I expect a massive spike in share price which will no doubt be followed by a cap raise to see them through the rest of the trial etc. given my confidence in the drug itself I might accumulate a little more between now and then.
The market cap sitting at 100mil for a business I believe is on the cusp of a disease modifying drug for OA is in @Strawman’s terms ‘an asymmetric bet’. That said, it’s a binary outcome and that’s enough to reasonably keep plenty of people on the sidelines.
‹ Paradigm Achieves 50% Patien...
PARAIGM
BIOPHARMA
ASX RELEASE
31 March 2026
V
Paradigm Confirms 50% of Patients Dosed in Phase 3 OA Trial
Enabling Progress Toward Interim Analysis
Key Highlights
Paradigm Biopharmaceuticals Ltd. (ASX: PAR) ("Paradigm" or "the Company") a late-stage drug development company focused on delivering new therapies to address unmet medical needs, is pleased to announce that 50% enrolment in the global Phase 3 PARA_OA_012 clinical trial has now been achieved, with dosing of the final participants required for inclusion in the interim analysis dataset having commenced.
Participants are followed from first dosing through the Day 112 assessment period in accordance with the study protocol.
Following completion of the Day 112 assessments, the interim dataset will undergo data cleaning and independent data monitoring committee (DMC) statistical analysis, which is expected to take approximately four to six weeks. Based on the current study timeline, Paradigm expects the interim analysis results to be delivered in August 2026.
The PARA_OA_012 study is designed to enrol 466 participants globally, with patients randomised to receive injectable pentosan polysulfate sodium (iPPS) or placebo. The primary endpoint of the study is the change in weekly average of daily pain at Day 112, with secondary endpoints including improvements in physical function, imaging-based structural outcomes, and safety assessments.
Patient recruitment continues across Paradigm's global network of clinical trial sites spanning Australia, the United States, Europe and Asia, as progression toward 100% enrolment is expected in the coming months.
The PARA_OA_012 Phase 3 trial has been designed to closely align with Paradigm's earlier PARA_OA_008 study, which demonstrated clinically meaningful improvements in pain and function. The two studies utilise a comparable patient population, the same dosing regimen of injectable pentosan polysulfate sodium (iPPS), and similar study duration and endpoints. Maintaining this consistency in trial design is intended to reduce development risk and support comparability across the clinical program.
Importantly, the PARA_OA_012 protocol also incorporates key learnings generated across Paradigm's earlier clinical studies, including the PARA_OA_002 dose-ranging study. These
PAR released an update the other day on their canine trial showing significant clinical, radiological and biomarker improvements. Full PLOS ONE publication here
This was a small trial of only 20 dogs which was randomised and placebo controlled. It was not blinded. There were statistically significant improvements in clinical outcomes. You could easily argue it wasn’t powered enough to read anything into the results
Difficult to react too much into it given those limitations but all broadly supportive of Pentosan being effective in this population.
If you want to get excited, the same biomarker reductions have been noted in a human trial last month.
While nice to have a bit more of a suggestion that the phase 3 human trial is likely to successful, it doesn’t really move the needle
I don’t hold but it would be great for so many people if this turns out to be an effective treatment for Osteoarthritis. Including those brave shareholders.
Funding secured for continued rollout phase 3 trial…
Im excited to see what they can produce at mid trial analysis. Always believe in the drug and now getting close to the results that matter. 120mil market cap for a drug with this potential and funding position much improved, im a tentative buyer. Small small volume
10:064
100
< Paradigm Secures US$27M to...
PARAIGM BIOPHARMA
ASX RELEASE
1 July 2025
PARADIGM SECURES USD $27 MILLION CONVERTIBLE NOTE FACILITY
TO ADVANCE PHASE 3 KNEE OA STUDY
Key Highlights
Paradigm Biopharmaceuticals Ltd (ASX:PAR) ("Paradigm" or "the Company"), a late-stage drug development company focused on delivering new therapies to address unmet medical needs, is pleased to announce that it has secured a USD $27 million (AUD $41.2 million) funding facility from Obsidian Global Partners to support the ongoing execution of its global phase 3 clinical trial (PARA_OA_012) evaluating injectable pentosan polysulfate sodium ("iPPS") for the treatment of knee osteoarthritis.
The facility has been structured as a convertible note with an initial drawdown of USD $7 million, providing immediate working capital to support site activation and clinical trial operations. The balance of the facility is available at Paradigm's discretion, offering operational flexibility and strategic control over future funding needs.
This capital injection ensures that Paradigm is fully funded with runway through several key clinical milestones, including:
The interim analysis is expected to serve as a major program milestone and a potential de-risking event. Should the interim data support the primary efficacy and safety objectives, it would provide greater confidence in the final outcome of the trial and validate the ongoing investment in the program, and thereby represent an inflection point in the value of the program. On the other hand, should the interim data fall short of supporting the primary efficacy and safety objectives, attaining the study's primary efficacy and safety objectives would still be very possible.
Paradigm's Managing Director, Paul Rennie stated: "This funding facility represents a valuable instrument to ensure continued clinical execution while maintaining strategic flexibility. Importantly, it allows Paradigm to pursue key milestones in the phase 3 program with confidence, while preserving optionality around future capital needs.
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Fascinating move by paradigm with the acquisition of a small biotech with the patent rights to a combined COX2 inhibitor - pentosan drug which is given orally.
With The phase 3 trial underway (recruitment started) paradigm are looking to build a platform of OA drugs outside the current options.
the main game remains the phase 3 trial resumes of course
It really is a Wild West isn’t it?
the SP rips from ~20 cents to nearly 60 cents on no/little news and then they announce a cap raise…
Will read the offer having come this far but geez…

Interesting timing of the SP run up and the following announcement although for mine it’s the funding which still matters most…

Typical. I sell down to a bare minimum holding and the share price doubles on no news... Interesting...

The SP has rallied 20% on the news (since yesterday) but that's more a measure of how far the SP has previously fallen...
Positives are that costs have come down. Negative are that despite a 7.3 m R&D refund the business burnt 7mil in a quarter and has just 26 mil in the coffers as of 31st March.
I am stuck holding as I see the potential of the drug and catalysts are likely in the next 12 months but geez where is the money going to come from and is it going to be another epic dilution. I couldn't buy more watching the current rate of cashburn. They need to partner up I guess given they aren't funded to the conclusion of phase 3 (unless the market gets excited with the initiation of phase 3 and they are able to raise at a higher price).
Hold at best...
ASX RELEASE 30 April 2024
March 2024 Quarterly Activities Report & Appendix 4C
Key Highlights
• Type D Meeting with US FDA: Paradigm met with US FDA on the 10th of January
2024 to discuss outstanding requirements for the next stage of the Phase 3 clinical
program in Osteoarthritis. Paradigm has completed the response documents to
this meeting and filed with the US FDA for review and comment.
• Board Addition: Paradigm welcomed Mr Matthew Fry as a Non-Executive
Director.
• OARSI World Congress on OA: An abstract detailing data from the successful
phase 2 PARA_OA_008 clinical trial was selected by the OARSI panel for a
podium presentation during the 2024 conference.
• Primary Endpoint Met: The phase 2 MPS VI study met the primary endpoint of
safety and tolerance and achieved promising clinical improvements in pain and
functional assessments following iPPS administration compared to placebo.
• R&D Tax Incentive: $7.3m refund from the R&D Tax Incentive refund claim for
FY23.
Paradigm Biopharmaceuticals Ltd. (ASX:PAR) (“Paradigm” or “the
Company”) is pleased to provide its quarterly update for the three months ended
31 March 2024 to accompany its Appendix 4C cash flow report for the period.
• Cash balance as of 31 March 2024 was $26.2m (on 31 December 2023 it was
$33.5m).
• Research and development expenditure for the quarter of $13.1m was significantly
reduced compared to the previous quarter of $27.06m. This spend in Q3 FY24 was
related to continued study close-out costs, Clinical Research Organisation costs as
well as FDA meeting fees and consultant costs for the Type D meeting and
subsequent response to the US FDA. Paradigm also incurred spend relating to
clinical trial product manufacturing in preparation of the next stage of the phase 3
OA program.
• The March quarter saw an increase in spend on patent and IP related cost due to
annual renewals and fees for Paradigm’s extensive patent portfolio.
• During the period Paradigm received a $7.3m refund from the R&D Tax Incentive
refund claim for FY23.
• Net cash outflow for the quarter was $6.8m (inclusive of the $7.3m refund) which is
less than the guided $8-11m. Anticipated invoices of $1-1.5m for the March quarter
have been received post 31st March and will be paid during the June quarter.
Revised guidance for the June quarter is expected to be $7-10m cash outflow.
• Encouragingly, corporate and administration costs continued to reduce in the
quarter through Paradigm’s cost containment initiatives that were implemented in
Q3 CY23. Paradigms spend remains focused on clinical and nonclinical activities
that build value in the osteoarthritis clinical program.
• 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 31 March 2023 were fees of $37K for payment of Director fees.
• The quarter also saw payments related to continuing activities described in the
below.
QUARTERLY ACTIVITIES & OUTLOOK
Paradigm is pleased to provide an update on continuing activities.
Phase 3 Clinical Program
Paradigm met with US FDA on the 10th of January 2024 to discuss outstanding
requirements for the next stage of the Phase 3 clinical program in Osteoarthritis. Paradigm’s
clinical and regulatory teams have filed the response to the Type D meeting with the US
FDA containing updated nonclinical and clinical data to the Agency as well as the proposed
clinical trial protocol utilising 2mg/kg twice weekly for the next stage of the phase 3 OA
program. The response package to the US FDA was submitted as directed by the Agency,
through a request for review pathway.
The request for review pathway does not have strict Prescription Drug User Fee Act
(PDUFA) Agency response timelines. Paradigm OA clinical program has FDA granted
Fast-track designation and the feedback through this review pathway is typically received
within three months.
Paradigm Board Changes
During the December quarter Paradigm welcomed Mr Matthew Fry to the Paradigm Board
as a Non-Executive Director. Matthew joins the Paradigm board with more than 25 years
in business creation, strategy, and expansion in healthcare and medical diagnostics
globally. He is currently the CEO, Managing Director and Founder of AM Diagnostics Pty
Ltd, a manufacturer and distributor of world class medical diagnostic products.
Matthew has significant experience with global regulatory agencies, in particular the
Australian TGA and US FDA. Through his role as Founder and CEO of AM Diagnostics,
Matthew drove the company’s expansion into the United States in 2009 and is a leading
biotechnology device supplier with a deep understanding of sales channels in both the US
medical wholesale market and retail market, and how to negotiate with private health
providers.
Paradigm Non-Executive Director, Helen Fisher, notified the Paradigm Board during the
quarter that she would step down from her position to focus on other endeavours.
Mucopolysaccharidosis (MPS) VI
During the quarter, Paradigm reported the top-line data from the PARA_MPSVI_001 phase
2 trial. The multi-centre randomised trial conducted in Brazil successfully met the primary
endpoint and achieved positive results in several of the secondary outcome.
The primary endpoint of the study was safety and tolerability of iPPS compared to placebo.
iPPS was well-tolerated and all adverse events were mild to moderate. The majority of
adverse events were associated with injection site reactions. No adverse events led to
discontinuation of the study treatment, nor were there any serious adverse events or
adverse events of special interest. Analysis of this phase 2 study demonstrates that iPPS
is a safe adjunctive therapy to enzyme replacement therapy for the continual joint pain,
stiffness and functional disability associated with MPS VI.
Multiple clinical endpoints were explored during the phase 2 clinical trial demonstrating
positive responses following iPPS compared to placebo. These included:
• Pain Assessment: An improvement in PROMIS (Patient-Reported Outcomes
Measurement Information System) pain interference is indicated by a lower score.
An improvement in PROMIS pain interference was greater in the iPPS-treated group
compared to placebo at 25 weeks.
• Functional Assessment: Participants receiving iPPS in the phase 2 clinical trial
demonstrated greater improvement than placebo in the 9-hole peg test from baseline
to week 25 on at least one hand.
Dr Roberto Giugliani, MD, PhD, MSc, the Principal Investigator for the phase 2 clinical trial
presented the clinical data at the 17th International Symposium on MPS and Related
Diseases in Würzburg Germany on 4-7th April. The presentation titled “Update on clinical
trials with PPS” was delivered by Dr Giugliani during the “New study approaches” session
of the conference.
Paradigm has now completed clinical studies for MPS I and VI with strong data sets and
meaningful endpoints identified to progress the clinical development of iPPS as an
adjunctive therapy with a commercial partner.
Global Conferences
Managing Director Paul Rennie and Dr Mukesh Ahuja, Paradigm’s Global Head of
Osteoarthritis attended the Annual Osteoarthritis Research Society International World
Congress in Vienna and presented data from the phase 2, randomised, double-blinded
PARA_OA_008 clinical trial exploring the disease modifying potential of iPPS in subjects
with knee OA.
Paradigm submitted a late breaking abstract to the OARSI panel following the release of
the phase 2 data late last year which was reviewed and selected for a podium presentation
during the conference. The podium presentation material delivered by Dr Ahuja to over 300
attendees during the conference is available on the Paradigm website (OARSI Podium
Presentation).
Paradigm management also conducted a sponsored theatre presentation during the
conference detailing Paradigm’s clinical development with iPPS for osteoarthritis and a
comparison between iPPS and currently available therapies for OA. The theatre
presentation can be view here, OARSI Theatre Presentation.
Company Outlook
Phase 3 OA Clinical Program
Subject to FDA clearance, Paradigm intends to promptly move forward with subject
enrolment into the phase 3 clinical trial (PARA_OA_012) in 2H CY2024. Clinical trial sites
in Australia and the US are planned to commence preparation activities during this quarter
(Q2 CY2024) to move the phase 3 program forward as quickly and efficiently as possible.
Once agreement is reached with the US FDA, Paradigm anticipates providing an overview
of the next stage of the phase 3 OA program including an overview of the clinical trial
design, dose justification and proposed participant numbers for the trial.
TGA Provisional Approval Application
Paradigm is finalising the TGA provisional approval determination application for
submission following the response to the US FDA Type D meeting. The determination
application will include information from a manuscript detailing the outcomes from the
PARA_OA_008 phase 2 clinical trial and a manuscript providing a comparison of iPPS
clinical data with other available treatments for osteoarthritis. Should the determination
application decision be positive, Paradigm will prepare a full dossier submission for TGA
provisional approval marketing authorisation.
Provisional approval offers significant benefits to both patients and manufacturers. Patients
gain access to potential life-saving treatments for life-threatening and seriously debilitating
conditions sooner, particularly for those lacking satisfactory alternatives. For
manufacturers, it provides an opportunity to bring innovative therapies to market faster,
while gathering additional clinical data to support full approval. TGA provisional marketing
approval for iPPS in Australia would expedite the pathway to revenues. Paradigm expects
to receive a decision from the TGA on whether the determination application has met the
criteria to move to a full dossier submission during Q2 CY2024.
Other Activities
The PARA_OA_008 phase 2 clinical trial results manuscript has been completed and is
expected to be submitted for peer review and publication. Paradigm has also completed a
comparison manuscript detailing the clinical trial results from the PARA_OA_008 phase 2
trial compared to currently available and pipeline OA therapies. Both manuscripts are
expected to be published during CY2024.
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) and mucopolysaccharidosis (phase
2).
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: [email protected]
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 2024
Consolidated statement of cash flows Current quarter
$A’000
Year to date (9
months)
$A’000
1. Cash flows from operating activities
- 301.1 Receipts from customers
1.2 Payments for
(13,141) (62,145)(a) research and development
(b) product manufacturing and operating
costs
- -
(c) advertising and marketing (147) (284)
(d) leased assets (24) (61)
(e) staff costs (480) (1,684)
(f) administration and corporate costs (507) (1,807)
1.3 Dividends received (see note 3) - -
1.4 Interest received 133 768
1.5 Interest and other costs of finance paid (3) (9)
1.6 Income taxes paid - -
1.7 Government grants and tax incentives 7,327 7,327
1.8 Other (provide details if material) - -
1.9 Net cash from / (used in) operating
activities
(6,842) (57,865)
2. Cash flows from investing activities
- -
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 - -
(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 (provide details if material) - -
2.6 Net cash from / (used in) investing
activities
- -
3. Cash flows from financing activities
- 30,117
3.1 Proceeds from issues of equity securities
(excluding convertible debt securities)
3.2 Proceeds from issue of convertible debt
securities - -
3.3 Proceeds from exercise of options - -
3.4 Transaction costs related to issues of
equity securities or convertible debt
securities
-
-
(1,763)
-
3.5 Proceeds from borrowings - -
3.6 Repayment of borrowings (lease liabilities) (27) (78)
3.7 Transaction costs related to loans and
borrowings - -
3.8 Dividends paid - -
3.9 Other (Limited recourse loan repaid under
ESP)
- -
3.10 Net cash from / (used in) financing
activities
(27) 28,276
4. Net increase / (decrease) in cash and
cash equivalents for the period
33,551 56,379
4.1 Cash and cash equivalents at beginning of
period
4.2 Net cash from / (used in) operating
activities (item 1.9 above) (6,842) (57,865)
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
4.3 Net cash from / (used in) investing activities
(item 2.6 above) - -
4.4 Net cash from / (used in) financing activities
(item 3.10 above)
(27) 28,276
4.5 Effect of movement in exchange rates on
cash held
(461) (569)
4.6 Cash and cash equivalents at end of
period
26,221 26,221
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 26,221 33,551
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)
26,221 33,551
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
37
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 - -
7.2 Credit standby arrangements - -
7.3 Other (please specify) - -
7.4 Total financing facilities - -
7.5 Unused financing facilities available at quarter end -
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.
8. Estimated cash available for future operating activities $A’000
8.1 Net cash from / (used in) operating activities (item 1.9) (6,842)
8.2 Cash and cash equivalents at quarter end (item 4.6) 26,221
8.3 Unused finance facilities available at quarter end (item 7.5) -
8.4 Total available funding (item 8.2 + item 8.3) 26,221
8.5 Estimated quarters of funding available (item 8.4 divided by
item 8.1) 3.83
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: ..30 April 2024.................................................................................
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.
Paradigm's quarterly cash activities report below:
In summary: made good progress on research/evidence base but spent a truckload of money. So much so that the market has shat itself and dumped the stock 20%. Commentary suggests ongoing costs will fall significantly but realistically it seems likely there will be another cap raise prior to commercialisation which I suppose is what the market is selling off.
For me it's more of the same do nothing. I can see the results (even interim results) are likely to be out in the next 12 month period and could be a real catalyst for improved SP which would make raising more funds less of an issue. On the downside if the SP languishes and they have to raise at an even lower SP it's pretty awful dilution even if the drug works incredibly well.
Paradigm Biopharmaceuticals Ltd. (ASX:PAR) (“Paradigm” or “the
Company”) is pleased to provide its quarterly update for the three months ended
31 December 2023 to accompany its Appendix 4C cash flow report for the period.
• Cash balance as of 31 December 2023 was $33.5m (on 30 September 2023 it was
$33.6m).
• During the period Paradigm announced a $30.1 million capital raise (before costs)
comprising a fully underwritten $18m placement and $12m accelerated non
renounceable entitlement offer.
• Paradigm has lodged its R&D Tax Incentive refund claim for FY23 and is awaiting
receipt of the $7.2m refund, expected during Q1 CY24.
• Research and development expenditure for the quarter was $27.06m compared to
the previous quarter of $21.9m. This spend in Q2 FY24 was largely related to costs
incurred during the prior quarter on the Stage 1 dose finding activities of Phase 3
clinical trial, including recruitment, screening, dosing and follow-up of the final
patients enrolled in the study. The cost also includes activities related to the close-
out of stage 1 of the PARA_OA_ 002 phase 3 clinical program. Close-out
procedures for clinical trials require all sites to be monitored by Paradigm’s clinical
research organization and Paradigm staff, to comply with the clinical trial
regulations.
• The costs of the interim analysis performed on initial 300 participants on
PARA_OA_002 are also included in the December quarter. Since completing stage
1 of the phase 3 PARA_OA_002 study in late November 2023, the December
spending for new patient activity costs has significantly reduced. It is forecast that
costs going forward will continue to decline, as study closure completes. All ongoing
and future activities will focus on delivering the next phase of the phase 3 OA trial.
• R&D spend during the December quarter also related to clinical and quantitative
MRI data analysis and completion of the PARA_OA_008 phase 2 clinical trial
activities. The spend also included end of study analysis and shut down cost for the
MPS VI phase 2 study, and an ongoing New Drug Application required nonclinical
studies relating to our OA clinical program.
• The quarter also saw payments related to 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 31 December 2023 were fees of $57K, which includes $52K for
payment of Director fees, and $5K for legal fees to BioMeltzer (a company related
to Paradigm NED, Amos Meltzer).
QUARTERLY ACTIVITIES & OUTLOOK
Paradigm is pleased to provide an update on continuing activities.
Phase 3 Clinical Program
Paradigm reported in October 2023 findings from an interim analysis conducted once the
first 300 participants from the PARA_OA_002 clinical trial reached day 56 of the study.
The doses (less than 2 mg/kg twice weekly) included in the dose determination part of
phase 3 trial did not meet the prespecified performance threshold, which was based on
prior outcome data produced with the 2mg/kg twice weekly dosing regimen. Following
these findings, Paradigm has prepared a new protocol for the next stage of the phase 3
clinical program using the 2mg/kg twice weekly dose regimen of iPPS which has
demonstrated consistent positive data in the PARA_OA_008, PARA_005 (previous phase
2b) studies and the TGA Special Access Scheme.
Stage 1 activities for the PARA_OA_002 phase 3 clinical trial concluded during the quarter
with the study completing the randomisation of 579 subjects demonstrating Paradigm’s
ability to enrol suitable study participants through the many recruitment initiatives
implemented for the global phase 3 study.
Paradigm remains on track for the protocol review by the US FDA to implement the 2mg/kg
twice weekly dosing regimen into the next stage of the OA phase 3 program, anticipated
in Q1 CY2024. Enrolment activities for next stage of the phase 3 OA clinical program are
expected to commence in Q2 CY 2024.
R&D Expenditure
Paradigm’s expenditure over the last three quarters has been unusually high as Paradigm
has invested heavily in the first stage of the phase 3 clinical program. The activities relating
to the spend include:
• Increased clinical trial site activations and initiatives to support subject recruitment,
• PARA_OA_002 Interim Analysis,
• Close out of stage 1 PARA_OA_002 and PARA_OA_006 studies.
Subject Recruitment
Through the second half of CY2023, Paradigm increased its target clinical trial sites from
80 to 120 clinical trial site activations to support the recruitment increased initiatives
undertaken by the Company. The Phase 3 clinical program has activated sites across
seven countries, comprising Australia, the US and Canada in North America, and the UK,
Belgium, Poland, and Czechia in the EU. The additional trial sites activated aided to
Paradigm to meet the reported 100% enrolment target of June 2023 which was reported
at the beginning of July 2023. The significant one-off upfront investment in the trial setup
costs in the stage 1 of the phase 3 trial ensures trial sites are trained and available to
commence with next stage of the phase 3 clinical program, thus streamlining the
recruitment and enrolment process.
As Paradigm reached the increased target for site activation and these clinical trial sites
became familiar with the study design, it enabled an increase in the number of participants
directed to these sites through the utilisation of several recruitment initiatives. The
implemented initiatives include the introduction of 1nHealth, SubjectWell, and Paradigm’s
partnership with NFL Alumni Health, which together increased the volume of potential
participants to study sites for screening and randomisation. Paradigm also launched a
dedicated clinical trial website www.Hope4OA.com, an ethics-approved easy-to-use public-
facing website for providing trial information and access Paradigm’s OA clinical trials. The
implementation of these recruitment initiatives in stage 1 have enabled identification of
potential participants for stage 2 of the phase 3 study.
Paradigm expects the investment in these activities upfront to enhance the efficiency of
the next stage of the phase 3 clinical trial and mitigate any potential delays.
Interim Analysis
An interim analysis was conducted ahead of schedule to determine the performance of the
three iPPS doses in stage 1 of PARA_OA_002 clinical trial against placebo. This was
conducted following reported data from the phase PARA_OA_008 clinical trial
demonstrating the once weekly iPPS dosing regimen was not providing sufficient clinical
results to that of the 2mg/kg twice weekly Paradigm has reported across multiple programs.
Costs associated with the interim analysis included Clinical Research Organisation (CRO)
and Data Monitoring Committee to analyse data on the first 300 participants who had
reached Day 56. The interim analysis provided Paradigm an earlier indication of the optimal
dose and aided the preparation of the clinical protocol for the next stage of the phase 3 OA
program ahead of schedule.
Phase 3 Stage 1 close out activities
Paradigm completed activities associated with the close out of stage 1 of PARA_OA_002
clinical trial and the PARA_OA_006 extension study. Close-out is a process to ensure all
clinical trial related activities are appropriately reconciled, recorded, and reported at the end
of a trial in accordance with the protocol, standard operating procedures (SOPs) good
clinical practice (GCP), and all other applicable regulatory requirements. Close-out is
integral to the quality control of a clinical trial and is designed to ensure quality of the study
according to Sponsor requirements and to ensure that all necessary documents are in place
should it be necessary for the trial information to be retrieved or inspected, by regulatory
agencies, in the future. Paradigm required the close-out to be conducted in accordance with
the said SOPs and with GCP so that the clinical data could be used in discussion with the
US FDA regarding the minimal effective dose discussions and the revised clinical trial
protocol and at the time of Paradigm’s New Drug Application (NDA) submission.
Cost Containment Measures
As discussed during the capital raise, aggressive cost containment measures have been
implemented to ensure capital is being directed toward completion of the phase 3 OA
clinical trial. Paradigm’s financial commitment to the MPS clinical program has now
completed with a reduced headcount in the MPS clinical team implemented following the
completion of the phase 2 studies in MPS I and VI. Paradigm is actively seeking to partner
this clinical asset to progress iPPS for treatment of MPS toward commercialisation.
Ongoing overheads have been reduced throughout this cost containment phase by over
$1m per quarter which will come into effect from January 2024, with further reductions
planned over the coming months.
Forecast cash outflow for the March 2024 quarter is expected to be $8 - $11m (including
R&D refund) and the June 2024 quarter expected to be in the $6m - $8m range which is
inclusive of phase 3 stage 2 restart costs.
Paradigm has issued short term options (Nov 2024 expiry) as a part of the 2023 capital
raise exercisable at $0.65. Exercise of the outstanding options is expected to add an
additional $33m (approximate).
PARA_OA_008 Phase 2 Clinal Trial
Paradigm’s PARA_OA_008 clinical trial concluded during the December quarter with the
significant data from the 12-month clinical data and 6-month quantitative analysis reported.
The PARA_OA_008 clinical trial phase 2 trial data showing efficacy of iPPS on both
objective (MRI analysis) and subjective measures (patient reported outcomes) compared
to placebo, demonstrates that iPPS both treats the symptoms of OA and has the potential
to preserve and/or regenerate joint tissues.
OBJECTIVE DATA MEASURES Reported (Day)
Improvement in synovial fluid biomarkers associated with OA
disease progression.
56 & 168
Improvement in structural changes in the knee determined by MRI. 168
SUBJECTIVE DATA MEASURES Reported
Significant improvement in mean change from baseline in WOMAC
pain, function, and overall scores.
56, 168 & 365
Significant improvement in Patient Global Impression of Change
(PGIC)
365
During the December quarter Paradigm reported durable and significant responses in
WOMAC scores for pain (p=0.054), function (p=0.048), stiffness and overall (p=0.054)
were observed for iPPS twice weekly compared to placebo control through to Day 365.
The outstanding results for iPPS compared to placebo were strengthened through the
reporting that cumulative rescue pain medication use was over five times higher in the
placebo group compared to iPPS group at Day 365.
This data is a significant outcome for Paradigm as no OA drug has previously shown
durable and meaningful improvements in pain and function at 12 months after a single
course of treatment.
The Company also reported in October quantitative MRI analysis results at the day 168
follow-up from the phase 2 PARA_OA_008 clinical trial, demonstrated that a single 6-week
treatment of iPPS treatment at 2mg/kg twice weekly results in an increase in overall
cartilage thickness (p=0.05) and cartilage volume (p=0.07) compared to a decrease in the
placebo group. Bone marrow lesions (-17%) and synovitis (-1%) were also decreased in
the knee joint following iPPS administration to day 168 compared to small increases in the
placebo group.
The above results of the successful phase 2 clinical trial demonstrate that iPPS both treats
the symptoms of OA and preserves and/or regenerates joint tissues. This is significant from
a commercial perspective because the disease modifying effects of iPPS observed in the
PARA_OA_008 phase 2 clinical trial are expected to support a greater reimbursement
compared to that which would be expected for a therapeutic that only treat the symptoms
of OA.
OA remains the most prevalent form of joint disease, affecting up to 16% of the population in
the developed world, with more than 72 million people in the US, EU5, Canada and
Australia suffering from osteoarthritis.1 The prevalence of OA is increasing in line with the
aging population and increasing rates of obesity. By 2030 the number of people suffering
from OA in the US is predicted to increase by 86% to 67 million.2
OA has a significant impact on day-to-day functioning and, although the levels of pain and
disability may fluctuate, it has no known cure or spontaneous remission and is associated
with irreversible structural damage and progression over time. Presently there are no drugs
approved that can prevent, stop, or even restrain progression of OA. Moreover, the
available medications that claim to mitigate the pain of OA have numerous risk/benefit
considerations and market research indicates that only 19% of knee OA patients are
satisfied with currently available treatments. 2,3
There is an urgent unmet need for a new therapy for OA. This successful phase 2 clinical
trial has provided important data for Paradigm to progress with the TGA Provisional
Approval application, which would expedite the pathway to marketing approval of iPPS in
Australia.
Capital Raising
Paradigm announced on the 30th of October, a fully underwritten $30.1 million (before costs
of $1.76m) capital raising, comprising:
• a placement to institutional investors of approximately 42 million Shares at an issue
price of $0.43 per Share raising approximately $18 million;
• an accelerated non-renounceable Entitlement Offer of 1 Share for every 10 Shares
held by eligible shareholders at an issue price of $0.43 per Share raising
approximately $12.1 million; and
• 3 free-attaching Options for every 4 Shares subscribed for and issued under the
Entitlement Offer and Placement.
The proceeds from the capital raise are being utilised for the Company’s phase 3 OA
clinical program.
Paradigm Board Changes
During the December quarter Non-Executive Director, Mr John Gaffney stepped down from
the Paradigm board following 9-years of service. Non-Executive Director, Helen Fisher also
informed the Paradigm Board during the period that she will be stepping down from the
position as Non-Executive Director on the appointment of a replacement Non-Executive
Director, to focus on other commitments going forward. The Paradigm Board commenced
a search for an Independent Non-Executive Director with commercial experience and
financial expertise and an Independent Chair during the December quarter. Paradigm
expects to make an announcement on additions to the board during H1 CY2024.
Mucopolysaccharidosis VI
The MPS VI study has completed however, the MPS VI data analysis encountered an
unforeseen delay with the service provider conducting the GAG analysis for the phase 2
clinical trial. This is a highly specialised analytical technique with only a small number of
service providers available globally. Paradigm expects to release the top-line data next
week.
Global Conferences
American College of Rheumatology (ACR) Convergence 2023: In November Dr Mukesh
Ahuja, Paradigm Global Head of Osteoarthritis, presented a poster at the ACR
Convergence 2023 held November 10–15 at the San Diego Convention Centre in San
Diego, California. The poster detailing data from the PARA_OA_008 clinical trial on the
therapeutic effects of iPPS on clinical and disease modifying outcomes in subjects with
knee osteoarthritis.
Company Outlook
Phase 3 OA Clinical Program
Paradigm met with US FDA on the 10th of January 2024 to discuss outstanding
requirements for the next stage of the Phase 3 clinical program in Osteoarthritis. Paradigm’s
clinical and regulatory teams are preparing the documentation for submission of updated
nonclinical data to the Agency ahead of the submission of the clinical protocol to the FDA.
The program has FDA granted Fast-track designation and the timeline for the review is
expected in Q1 CY2024. Paradigm plans to proceed with the dose of 2mg/kg twice weekly
for registration studies. Enrolment activities for next stage of the phase 3 OA program are
expected to commence in Q2 CY2024.
TGA Provisional Approval Application
Paradigm is progressing with its TGA Provisional marketing approval in Australia for iPPS,
which is expected to expedite the pathway to revenues. The next stage of the TGA
Provisional Approval pathway, the determination application remains on track with the
determination application planned to be submitted to the TGA toward the end of the current
quarter (Q1 CY2024). Should this prove successful, Paradigm will prepare a full dossier for
submission to the final stage of the TGA provisional approval application process.
Business Development
Paradigm continues to progress business development activities with regional partnering
companies with the aim to have at least one regional partnering by the end of June 2024.
Discussions are ongoing with a number of potential partners. Updates will be provided when
appropriate.
Other Activities
• Paradigm’s PARA_OA_008 phase 2 clinical data has been selected for podium
presentations at two global orthopedic and OA conference. Dr Mukesh Ahuja,
Paradigm’s Global Head of Osteoarthritis will present data from the phase 2 clinical
trial evaluating the clinical and disease modifying outcomes of iPPS in knee OA at
the:
o Orthopedic Research Society (ORS) Annual Meeting 2024, 2–6 February:
Paradigm submitted a late-breaking abstract to the ORS selection committee
following the release of the PARA_OA_008 12-month clinical and 6-month
quantitative MRI data. The abstract titled “The therapeutic effects of pentosan
polysulfate sodium on clinical and disease modifying outcomes in moderate
to severe knee osteoarthritis” was selected for a presentation during the late-
breaking podium session; and
o Osteoarthritis Research Society International (OARSI) 2024, 18–21 April:
Paradigm’s recent clinical and disease modifying outcome data from the
PARA_OA_008 phase 2 clinical trial was reviewed by the OARSI panel and
selected for a podium presentation during the conference.
• Paradigm has lodged the FY23 R&D Tax Incentive Scheme refund claim. The
refund of approximately $7.2m was anticipated to be received during Q4 CY2023,
however it is now expected in Q1 CY2024.
• The overall results produced in the PARA_OA_008 phase 2 clinical trial and MPS-I
study are currently being compiled into a manuscript for peer review and publication.
Both are expected to be published during CY2024.
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) and mucopolysaccharidosis (phase
2).
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.
References
1 Global Health Data Exchange, Institute for Health and Metrics Evaluation, University of Washington. Accessed June 2021
http://ghdx.healthdata.org/gbd-results-tool.
2 OARSI. Osteoarthritis: A Serious Disease, Submitted to the U.S. Food and Drug Administration December 1, 2016.
3 Matthews GL, Hunter DJ. Emerging drugs for osteoarthritis. Expert Opin Emerg Drugs. 2011;16(3):479-491.
doi:10.1517/14728214.2011.576670.
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: [email protected]
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 December 2023
Consolidated statement of cash flows Current quarter
$A’000
Year to date (6
months)
$A’000
1. Cash flows from operating activities
- 301.1 Receipts from customers
1.2 Payments for
(27,064) (49,004)(a) research and development
(b) product manufacturing and operating
costs
- -
(c) advertising and marketing (137) (137)
(d) leased assets (26) (37)
(e) staff costs (641) (1,204)
(f) administration and corporate costs (772) (1,300)
1.3 Dividends received (see note 3) - -
1.4 Interest received 86 635
1.5 Interest and other costs of finance paid (3) (6)
1.6 Income taxes paid - -
1.7 Government grants and tax incentives - -
1.8 Other (provide details if material) - -
1.9 Net cash from / (used in) operating
activities
(28,557) (51,023)
2. Cash flows from investing activities
- -
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 (6
months)
$A’000
2.2 Proceeds from disposal of:
- -(a) entities
(b) businesses - -
(c) property, plant and equipment - -
(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 (provide details if material) - -
2.6 Net cash from / (used in) investing
activities
- -
3. Cash flows from financing activities
30,117 30,117
3.1 Proceeds from issues of equity securities
(excluding convertible debt securities)
3.2 Proceeds from issue of convertible debt
securities - -
3.3 Proceeds from exercise of options - -
3.4 Transaction costs related to issues of
equity securities or convertible debt
securities
(1,763)
-
(1,763)
-
3.5 Proceeds from borrowings - -
3.6 Repayment of borrowings (lease liabilities) (8) (51)
3.7 Transaction costs related to loans and
borrowings - -
3.8 Dividends paid - -
3.9 Other (Limited recourse loan repaid under
ESP)
- -
3.10 Net cash from / (used in) financing
activities
28,346 28,303
4. Net increase / (decrease) in cash and
cash equivalents for the period
33,559 56,379
4.1 Cash and cash equivalents at beginning of
period
4.2 Net cash from / (used in) operating
activities (item 1.9 above) (28,557) (51,023)
Founder led - This is a big bet on the Exec Chair, Founder – Paul Rennie.
Could we organise a chat with him @Strawman?
Huge market – 72m Osteoarthritis (OA) sufferers in 2020, expect 120m in 2030 (5% Mkt CAGR). 81% are dissatisfied with current treatment. Targeting 10% of the market (not sure how achievable this might be). Dosage to cost US$2.5k per patient p.a. suggesting a US$14bn market opportunity.
Paradigm’s main product is a repurposed drug being trialed to address a huge unmet need - so the potential is huge but range of outcomes are wide.
As it’s repurposed, there is high confidence that the drug is safe (at a given dosage). This removes a huge potential risk at the Phase 3 trial stage.
As it’s unmet need, the "FDA has granted Fast-track designation to the OA program" – they want this to work and are happy to expedite (as long as it does).
Phase 2 trials have been positive in alleviating pain (key end point) and even improving the condition (improving cartalidge thickness).
Check out the Cap Raise Preso for more info - https://www.marketindex.com.au/asx/par/announcements/investor-presentation-30m-capital-raise-3A629518
Disc: Held (small 'research position')
This is a little scary. The cashburn is so significant that even with nearly 60 mil in the bank they’re looking at less than 4 quarters of cash…
unfortunately I can see this leading to sag in SP which then makes the cash raise more dilutive… the question as an investor then is do you sell down some knowing there’s a raise coming? I still believe in the product and think this will be profitable long term…
only 10k but I guess it’s better than nothing
Appendix 3Y Change of Director’s Interest Notice
Rule 3.19A.2
Information or documents not available now must be given to ASX as soon as available. Information and documents given to ASX become ASX’s property and may be made public.
Introduced 30/09/01 Amended 01/01/11
Name of entity Paradigm Biopharmaceuticals Limited ABN 94 169 346 963
We (the entity) give ASX the following information under listing rule 3.19A.2 and as agent for the director for the purposes of section 205G of the Corporations Act.
Name of Director Helen Fisher Date of last notice 26 February 2021
Part 1 - Change of director’s relevant interests in securities
In the case of a trust, this includes interests in the trust made available by the responsible entity of the trust
Note: In the case of a company, interests which come within paragraph (i) of the definition of “notifiable interest of a director” should be disclosed in this part.
Appendix 3Y Change of Director’s Interest Notice
Direct or indirect interest
Date of change
No. of securities held prior to change
Class
Number acquired Number disposed
Value/Consideration
Note: If consideration is non-cash, provide details and estimated valuation
No. of securities held after change
+ See chapter 19 for defined terms. 01/01/2011 Appendix 3Y Page 1
Direct
18 May 2023 Nil
Ordinary Shares 10,204
Not applicable $10,020
10,204 Fully Paid Ordinary Shares
Nature of indirect interest
(including registered holder)
Note: Provide details of the circumstances giving rise to the relevant interest.
Not applicable
Appendix 3Y
Change of Director’s Interest Notice
Part 2 – Change of director’s interests in contracts
Note: In the case of a company, interests which come within paragraph (ii) of the definition of “notifiable interest of a director” should be disclosed in this part.
Nature of change
Example: on-market trade, off-market trade, exercise of options, issue of securities under dividend reinvestment plan, participation in buy-back
On-market trade
Detail of contract Nature of interest
Name of registered holder (if issued securities)
Date of change
Interest acquired
Interest disposed
Value/Consideration
Note: If consideration is non-cash, provide details and an estimated valuation
Interest after change Part 3 – +Closed period
Not applicable Not applicable
Not applicable Not applicable
Not applicable Not applicable Not applicable
Not applicable
No. and class of securities to which
interest related prior to change
Note: Details are only required for a contract in relation to which the interest has changed
Not applicable
Were the interests in the securities or contracts detailed No above traded during a +closed period where prior written
clearance was required?
If so, was prior written clearance provided to allow the trade to proceed during this period?
If prior written clearance was provided, on what date was this provided?
+ See chapter 19 for defined terms. Appendix 3Y Page 2
Not applicable Not applicable
01/01/2011
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