Consensus community valuation
$4.02
Average Intrinsic Value
23.4%
Undervalued by
Active Member Straws
#Business Model/Strategy
Added 6 months ago

Very detail and interesting analysis of PAR on Livewire:

https://www.livewiremarkets.com/wires/a-paradigm-shift-in-2020

I think PAR can go a long way.

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#Quarterly Reports
Added 2 months ago
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#Bull Case
Added 3 months ago

Thought I'd done a bull case straw for PAR.  Seems I haven't.  Anyway, see my PAR valuation commentary for my bull case.

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#ASX Announcements
Added 4 weeks ago

Paradigm Biopharmaceuticals to be added to S&P/ASX 300 Index

View Attachment

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#Block Trade & Newsflow
Last edited 2 months ago

12-May-2020:  BLOCK TRADE TO INSTITUTIONAL INVESTORS

This announcement starts off with details of a block trade by current PAR directors to offshore institutional investors, mostly to fund loan repayments that those directors are due to pay to the company by the end of this month.  In addition to the Employee Share Loan sell down, Founder and Managing Director Paul Rennie has sold an additional 4,039,460 shares as part of the block trade.   The purpose of the sale is to fund a residential property, ESP loan, tax liabilities and balance his investment portfolio. In regard to the sale, PAR provided the following additional context:

  • This is the first share sale by Mr Rennie since he founded the company in 2014.
  • Mr Rennie largely funded the entire Company with his personal cash prior to IPO.  
  • Since IPO Mr Rennie has put a combined $400,000 of equity capital into the Company.
  • In addition, Mr Rennie has made multiple on-market purchases of shares since IPO.
  • This total sale represents only 17.48% of Mr Rennie’s holding. Mr Rennie still owns 19,509,222 shares and owns 8.68% of the company and is the single largest shareholder in the company.  
  • Mr Rennie has voluntarily agreed to escrow the balance of his holding until 31 December 2022. 

Mr Graeme Kaufman, Paradigm Chairman: “We appreciate the support of these offshore institutions for helping facilitate this transaction as our share register continues to globalize. We are pleased that after 6 years and founding the Company with the idea to treat to OA with PPS, Paul has been able to realise a small portion of liquidity to secure the financial future of his family. He has created tremendous shareholder wealth for a large number of our shareholders and we look forward to that continuing as we move towards some very large catalysts for the company over the next 2-3 years“. 

Paradigm’s proposed news flow for the remainder of CY 2020:

  • Potential to be included into the ASX 300 index during the rebalance scheduled to occur 19th June.
  • Initial feedback from the Joint Parallel Scientific Advice submission to both the FDA and EMA during Q2. The submission put forward by Paradigm staff detailed the proposed trial design for a pivotal/registrational trial for MPS.
  • Expanded Access Program results to be released for entire patient population (n=10) treated under the EAP will be released to the market in Q3.
  • New data on 100 patients under the TGA SAS using the primary and secondary endpoints for Paradigm’s proposed phase 3 trials, (i) reduced WOMAC pain from baseline and (ii) improved Patient Global Impression of Change (PGIC) at week 8 (Day 53). The company expects the data to be released to the market in Q3.
  • Commencement of Paradigm’s MPS I Phase 2 clinical trial in Adelaide, Q3.
  • Multi-Centered Phase 2/3 US and EU clinical trial for MPS VI on track to begin late CY2020.  
  • Phase 2b Osteoarthritis clinical trial and Phase 2A Viral Arthritis clinical trial Peer Reviewed Articles to be released to the market Q4.  
  • FDA Investigational New Drug (IND) submission for Osteoarthritis expected in Q4.  
  • TGA Provisional Approval submission likely Q4.  
  • New Patent Filings Q4.  
  • Partnership and Commercial discussion remain ongoing. 

Addressable Market:  Osteoarthritis (OA) is the most common joint disorder in the United States. Symptomatic knee OA occurs in 10% men and 13% in women aged 60 years or older. The number of people affected with symptomatic OA is likely to increase due to the aging of the population and the obesity epidemic.  ABOUT 54.4 MILLION ADULTS IN THE U.S. HAVE DOCTOR-DIAGNOSED ARTHRITIS.  (Barbour – MMWR [66] 2017).  There are over 100 million OA sufferers in the USA, Europe and Japan. 

About injectable PPS (Zilosul®):  Injectable PPS is not currently registered in Australia, but it is registered in four of the seven major global pharmaceutical markets.  In those European markets, injectable PPS is registered as an antithrombotic agent. In Australia, injectable PPS for human use is not currently available for sale.  Injectable PPS for human use is only available by inclusion into a Paradigm Sponsored clinical trial or via a treating physician applying for its use in patients via the TGA’s SAS - Category B.

Zilosul® is a registered Trademark of Paradigm Biopharmaceuticals Ltd (ASX: PAR). 

[Disclosure:  I hold PAR shares.  I am not concerned with the director sell-down.  I think it is well-explained and the fact that PR has agreed to voluntarily escrow his remaining shares - which represent 8.68% of the company - even after the sell-down - until the end of December 2022 is a real positive.]

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#ASX Announcements
Added 5 months ago

18-Feb-2020:  Paradigm - first patient dosed in USA under FDA approved EAP

Paradigm reports: first patient dosed in USA under  FDA approved Expanded Access Program  
 
KEY HIGHLIGHTS

  • First Participant dosed with Zilosul® (iPPS) in the US under the FDA approved Expanded Access Program (EAP).
  • The Participants in the program will receive two Zilosul® injections per week over a 6-week period in line with the proposed protocol for the forthcoming Phase 3 Pivotal Study to be discussed with FDA in upcoming Pre-IND meeting on 19th February.
  • Paradigm will treat 10 patients (comprised of Ex-NFL Players) under the EAP.  In males under the age of 60, osteoarthritis is over 3 times more prevalent in retired NFL players than in the general U.S. population.
  • The remaining nine patients to be treated under the EAP will be staggered to commence over the next 4 weeks, with Paradigm expecting last patient final dosing to occur mid – May. Paradigm expects to report results to the market early CY Q3.

Summary:  Paradigm Biopharmaceuticals Ltd (ASX: PAR) is pleased to announce the first patient has been dosed under the US FDA approved EAP.  This milestone marks the first patient treated with Zilosul® in the United States.  Patients under the EAP will receive treatment in line with the proposed treatment protocol for Paradigms proposed Phase 3 Pivotal study.  Each patient will receive two Zilosul® injections subcutaneously per week for a period of 6 weeks.  Paradigm will stagger the commencement of the remaining patient’s treatment over the next 4 weeks, with the final patient likely to receive their last injection towards the middle of May.  Paradigm Expects to report data on patient outcomes around the beginning of Q3.

--- continues... click on link above for more ---

Disclosure:  I hold PAR shares.  On the one hand they can be classed as an early-stage biotech company (which I usually avoid these days), but on the other hand, they are actually repurposing a drug that already has approval for use in seven major global pharmaceutical markets.  Injectable PPS (iPPS) is not currently registered in Australia, but in those European markets, iPPS is registered as an antithrombotic agent.  The fact that it is proven safe for use in humans, and has already been approved for use - and used by people - throughout Europe - without adverse side-effects - is a significant factor in derisking this company in terms of an investment proposition.  However, their ultimate success still depends on positive trial results, so there is still risk there of course, as there is with all such companies - just less risk with this particular one - in my opinion.  That said, I jumped on board at much lower levels.  I don't think I'd be buying PAR up here.
 
Zilosul® is a registered Trademark of Paradigm Biopharmaceuticals Ltd (ASX: PAR). 

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#ASX Announcements
Added 5 months ago

13-Feb-2020:  Paradigm presents MPS VI poster at WORLD Symposium

Disclosure:  I hold PAR shares, bought at $1.10 (average price paid) - accumulated in December 2018 and January 2019.  I've trimmed the holding on the way up, but still hold some.  They are trading at $4.40 today - 300% above my average buy price, so one of my better speccy "investments".

Plenty of promise, but certainly not without risk.

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#Broker/Analyst Views
Added 3 months ago

Morgans have released three reports/updates on PAR recently, one in Feb, one in March, and one in April (10 days ago).  Here they are:

17-Feb-2020:  Morgans: PAR: Update 1 (Reduce, TP: $2.16)

17-Mar-2020:  Morgans: PAR: Update 2 (Hold, TP: $2.16)

07-Apr-2020:  Morgans: PAR: Update 3 (Hold, TP: $1.74)

PAR closed at $1.675 today, suggesting there is limited upside according to Morgans.  Disclosure:  I hold PAR shares.  I have given my reasons in my bull case straw.

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#Capital Raising
Added 3 months ago

06-Apr-2020:  PAR were in a trading halt, and have today turned that into a voluntary trading suspension, pending the finalisation of a capital raising, and associated announcements.  In the meantime, they've given us this to be going on with:

06-Apr-2020:  Paradigm Latest Corporate Presentation, plus Paradigm receives clarity on US regulatory pathway and Paradigm Reports Very Encouraging Real World Data

That's how it's done!

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#ASX Announcements
Added 4 months ago

24-Mar-2020:  All 10 participants in US FDA EAP have commenced treatment

That's the "price sensitive" announcement today - another positive one, and they also released this:

Paradigm to present at Virtual Conference, Friday 27th March

Virtual conferences.  Webinars.  Conference Calls.  Where would be without technology eh?!

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#FDA progress
Added 5 months ago

21-Feb-2020:  Paradigm reports Positive Pre-IND meeting with US FDA

KEY HIGHLIGHTS

  • Paradigm reports it had a positive and informative Pre-IND meeting to discuss the development and market authorisation plans for injectable Pentosan Polysulfate Sodium (iPPS) (Zilosul) for the treatment of symptomatic osteoarthritis.
  • Paradigm will provide further information to the market by receipt of final minutes from the US FDA.
  • Development plans are proceeding toward an IND filing by Q4 CY2020.
  • The company is fully funded for the proposed Phase 3 Clinical Trial. 

21 February 2020: ASX listed biotechnology company Paradigm Pharmaceuticals Limited (ASX: PAR, “Paradigm” or the “Company”) is pleased to announce a positive and informative pre-IND meeting with the US FDA. The meeting took place at the FDA offices in Washington and was attended by several of the Paradigm team and consultants.

In the Pre-IND meeting Paradigm discussed its clinical, pre-clinical and CMC (Manufacturing) data with the US FDA.

Paradigm will provide further information from the Pre-IND meeting to the market by receipt of final minutes from the US FDA.

Mr. Paul Rennie, Paradigm’s Chief Executive Officer said: “The team and I are pleased with the positive feedback from the FDA at the Pre-IND meeting that took place yesterday. Paradigm looks forward to providing a more detailed update to the market once the final minutes of the meeting have been received.”

About injectable PPS (iPPS)

Injectable PPS (iPPS) is not currently registered in Australia, but it is was previously registered in four of the seven major global pharmaceutical markets. In those European markets, iPPS is registered as an antithrombotic agent. In Australia, iPPS for human use is not currently available for sale. 
 
Zilosul® is a registered Trademark of Paradigm Biopharmaceuticals Ltd (ASX: PAR).

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#ASX Announcements
Last edited 5 months ago

07 August 2019:  PARADIGM FILES FIRST IND WITH US FDA

KEY HIGHLIGHTS

  • Paradigm has filed its first IND submission to the US FDA for an Expanded Access Program under which ten people from the USA may be treated with Zilosul (iPPS).
  • The ten Americans are anticipated to include some retired NFL players who have early-onset Osteoarthritis and have also failed standard of care.
  • In males under the age of 60, osteoarthritis is over 3 times more prevalent in retired NFL players than in the general U.S. population. This excess of early-onset arthritis may be due to the high incidence of injury in football.
  • Paradigm’s Clinical and Regulatory Teams continue to work on submissions to the US FDA for the Phase 2/3 Clinical Trial in the very rare lysosomal storage disease (MPS), the Phase 3 Clinical Trial in Osteoarthritis and the Australian Therapeutic Goods Administration (TGA) for the Provisional Approval of Zilosul (iPPS) to treat Osteoarthritis.
  • Commercial discussions are ongoing regarding potential partnership deals or commercial transactions.

Moving towards commercialisation

Paradigm Biopharmaceuticals Ltd (ASX: PAR) continues its drive towards commercialisation of Zilosul (iPPS) as a potential first line therapeutic treatment of osteoarthritis and other diseases affecting the musculoskeletal system.  
 
Paradigm will be filing a number of submissions to Global Regulatory Authorities and therefore provides this update on the planned filings being submitted in the next two quarters of CY 2019.  
 
Summary of Expected future market updates prior to end of CY 2019:

  • File Expanded Access Program (EAP) for 10 patients with US FDA Q3 CY 2019;
  • File initial submission with the TGA for Provisional Approval Application of Zilosul (iPPS) for treatment of osteoarthritis, Q3 CY 2019;
  • Pre-IND meeting with US FDA Orphan Indication (MPS) Phase 2/3 clinical Trial Q4 CY 2019;
  • Pre-IND Meeting with US FDA Osteoarthritis Phase 3 Clinical Trial Q4 CY 2019;
  • Commercial Discussions – ongoing;
  • Discussions with US DoD for Ross River/CHIK-V treatment – ongoing.

Paradigm Expanded Access Program  

Paradigm has filed a submission to the US FDA for Expanded Access Program IND (Investigational New Drug) under which ten people from the USA may be treated with Zilosul iPPS and it is anticipated to include some retired NFL players who have early-onset Osteoarthritis who have also failed standard of care. 
 
What is The FDA Expanded Access Program?

“Expanded access”, also called “compassionate use,” provides a pathway for patients to gain access to investigational drugs, biologics, and medical devices used to diagnose, monitor, or treat patients with serious diseases or conditions for which there are no comparable or satisfactory therapy options available outside of clinical trials”.
 
FDA recognizes that osteoarthritis (OA) can be a serious disease with an unmet medical need for therapies that modify the underlying pathophysiology of the disease and potentially change its natural course to prevent long-term disability.  
 
The unmet clinical need

Osteoarthritis (OA) is a disabling disease leading to chronic pain, disability and a decreased quality of life. It is the most common joint disorder in the developed world, with the lifetime risk of developing symptomatic knee osteoarthritis before age 85 years estimated in one US study at 44.7% ([95% CI] 40.0–49.3%). Injury, particularly to the joints, has been identified as a potential risk factor for OA. Annually, sports contribute to 7 million injuries in Americans, and reports have suggested that the development of OA may be more prevalent and occur prematurely in individuals who regularly participate in sports. It is estimated, 31 million people in the USA suffer from OA. The therapeutic market for the treatment of OA is a multibillion-dollar opportunity.
 
Although loss of joint cartilage is a hallmark of OA, it is increasingly recognized that bone marrow edema lesions (BMLs) in the subchondral bone are involved with the pathogenesis of cartilage degeneration in OA. BMLs (as detected on MRI) result from increased blood and interstitial fluid collection in areas of trabecular microfractures and collapse within the bone marrow. The prevalence and severity of BMLs are associated with symptoms of pain, greater cartilage loss and risk of joint replacement. In regard to progressive OA, data have suggested that BMLs are more likely to persist and enlarge in size with an associated increase in cartilage loss.  (Continues)...

--- click on link above for more ---

 

Disclosure:  I hold a small parcel of PAR shares.  High risk, but potentially huge upside if they can prove that this drug (that has already been approved for antithrombotic use in 4 of the 7 major global pharmaceutical markets) can also be used to effectively treat Osteoarthritis (OA) and BML conditions.
 

Zilosul is a registered Trademark of Paradigm Biopharmaceuticals Ltd.

Zilosul is the registered Trademark of the final product i.e. injectable Pentosan Polysulfate Sodium (iPPS). 

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#FDA progress
Last edited 2 months ago

30-Apr-2020:  EAP treatment completed and Orphan Status achieved for MPS-I

Paradigm reports:  Under the US FDA Expanded Access Program (EAP) treatment is completed for all of the ten planned patients. Paradigm granted Orphan Status by US FDA for MPS-I 
 
KEY HIGHLIGHTS:  

  • Total Patient population (n=10) have completed dosing with Zilosul® (iPPS) in the US under the US IND Expanded Access Program (EAP).
  • The Expanded Access Program remains on-track with patients completing scheduled checkups out to 6 weeks post final injection (Day 83). 
  • Paradigm expects to report results for the entire patient population (n=10) to the market Q3 CY2020. 
  • Patient data reported will be in line with primary and secondary endpoints for the proposed Phase 3 trial.
  • FDA has granted Paradigm orphan designation request for treatment of MPS-I complications - including pain and arthropathy.

Paradigm Biopharmaceuticals Ltd (ASX: PAR) is pleased to announce it has completed treatment of all ten patients with Zilosul® under the FDA IND Expanded Access Program (EAP) in the US. The company has also been advised by the FDA that Paradigm’s orphan designation request for MPSI has been granted, joining the previously granted designation for MPS-VI.

The EAP which commenced on the 18th February with the treatment of the first patient, has now treated all of the ten planned patients. All patients taking part in the study must complete regular evaluations with the treating physician, with the final evaluation taking place 6 weeks post the last injection received (day 83). The EAP program will report on pain outcomes similar to those previously evaluated in the TGA SAS (refer ASX Announcement 6th April) as well as those proposed as endpoints for the Phase 3 Clinical trial. Paradigm expects data for the total population (n=10) of patients to be available to the market during Q3 CY 2020. 

Mr. Paul Rennie, Paradigm’s Chief Executive Officer said: “Paradigm is excited to have achieved this milestone, especially during the current health conditions created by COVID-19 and would like to thank all those involved in the Expanded Access Program for their continued diligence to the treatment program."

--- click on the link above for more, including:

  • What is The FDA Expanded Access Program?
  • Mucopolysaccharidosis type 1 (MPS-I) – Orphan Status
  • What is MPS? 

 

About Injectable PPS (iPPS):  Injectable PPS (iPPS) is not currently registered in Australia, but it is was previously registered in four of the seven major global pharmaceutical markets. In those European markets, iPPS is registered as an antithrombotic agent. In Australia, iPPS for human use is not currently available for sale. 
 
Zilosul® is a registered Trademark of Paradigm Biopharmaceuticals Ltd (ASX: PAR). 

 

[Disclosure:  I hold PAR shares.]

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#ASX Announcements
Last edited 5 months ago

14/02/2020: Half Yearly Report and Accounts

If I'm reading this right, PAR is making a loss but less of a loss than previous QTR.

Interested to see how the market responds on Monday.

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