# PAR - Paradigm Biopharmaceuticals



## System (24 June 2015)

Paradigm is an Australian biopharmaceutical company focused on repurposing the drug 'pentosan polysulphate sodium' (PPS) for the treatment (lead clinical indication) of bone marrow edema (BME).

It is anticipated that PAR will list on the ASX during July 2015.

http://paradigmbiopharma.com


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## Country Lad (7 June 2018)

The company also thought that PPS might just help for the relief of hay fever, however in June 2017, it announced that its Phase 2a clinical trial for hay fever was a flop and the share price fell about 50%.  PAR continued on with its trial of PPS for relief of osteoarthritis pain and reduction in bone marrow lesions associated with anterior cruciate ligament injuries.

I became interested and thought it might be a bit more than a spekkie biotech when they reported trials which resulted in 80% improvement in knee function and reduction in joint pain.

I was interested enough in April to buy the shares when it was revealed that the patients of the successful trials included around 40-50 former or current AFL players.

Either the market has caught on or there is something new in the air as the price is up 14% making it a good breakout.


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## greggles (6 July 2018)

Breakout today for Paradigm Biopharmaceuticals as it convincingly breaks through resistance at 75c. It is currently up 17.24% this morning and is trading at 85c.

No news released today that could be a catalyst for the move so supply is clearly drying up at these levels. The sell side of the market depth looks quite barren so PAR could move north very quickly on any good news.


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## greggles (7 December 2018)

PAR has doubled in price in the last two months on the back of continuing good news regarding its osteoarthritis treatment Injectable Pentosan Polysulfate Sodium (iPPS).

This morning the company announced consistent reduction in pain from an additional 20 patients with  osteoarthritis treated with iPPS. Of the 145 patients treated in total 86.8% responded with a reduction in joint pain and 91.0% experienced an improvement in knee function. 

Things appear to be going very well for Paradigm Biopharmaceuticals. The question is will the good news keep on coming? PAR is up 11.11% to $1.40 so far today.


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## barney (10 December 2018)

greggles said:


> The question is will the good news keep on coming? PAR is up 11.11% to $1.40 so far today.




Another gap higher today and closed at $1.52 on good Volume


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## greggles (18 December 2018)

barney said:


> Another gap higher today and closed at $1.52 on good Volume




Big move up today for PAR but an equally big move back down. After opening at $1.80 PAR climbed to a high of $2.15 before sellers took control and pushed the share price back down to a low of $1.38. It has recovered a little and is currently trading at $1.50.

The catalyst for today's price action was this morning's announcement in which the company reported the successful phase 2 clinical trial of its osteoarthritis treatment, iPPS. Here's an excerpt from the announcement:


> Paradigm Biopharmaceuticals Ltd (ASX: PAR) is pleased to announce it has met its primary endpoint of its phase 2b randomised double-blind placebo-controlled multi-centre clinical trial. The primary outcome of the trial is to evaluate the effects of injectable pentosan polysulfate sodium (iPPS) on knee pain in subjects with knee osteoarthritis and subchondral bone marrow edema lesions (BMELs) as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) Pain subscale.
> 
> Paradigm's CEO, Mr Paul Rennie said that _"the Paradigm clinical & regulatory team along with all the clinical trial recruitment and treatment centres have done an extraordinary job to conclude this Phase 2b clinical trial in just over 12 months. The whole Paradigm team are incredibly happy with these positive Phase 2b trial results and are very excited for the future of the Company."
> 
> "To achieve clinically meaningful and statistically significant results between iPPS and Placebo in the total population and highly clinically meaningful and highly statistically significant results in the NRS = 4-6 strata is truly an outstandingly positive trial outcome. If you have clinical significance and statistical significance you have a high probability the drug will pass a Phase 3 clinical trial and once registered a drug that can penetrate the market. We are further impressed with the results given the widespread difficulty ASX Listed biotechnology companies have had in achieving positive phase 2b trial results over the last few years"_


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## greggles (18 December 2018)

Whooops. Forgot to include a chart.


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## barney (18 December 2018)

greggles said:


> Big move up today for PAR but *an equally big move back down*.




Yeah the high Volume high Range bar closing near the lows is not a great look. The day traders were obviously on this from the open and selling into the rise.


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## galumay (6 July 2019)

Have been researching this business for a while, i think for a biotech its got a great risk profile, lots of upside if they can get to market which seems to be a pretty safe bet now. My biggest reservation was the same as most small biotechs - the downside risk is basically total loss of capital as they tend to be one trick ponies.

In PAR's case it has a raft of unique atrributes with its Zilosul® product that make it an attractive specualtive punt for me. Small position taken.

If you would like to read some detailed analysis of the business and product, FiftyOne Capital has published a number of research articles,

http://www.fiftyonecapital.com/paradigm-201903/2019/3/8/paradigm-biopharmaceuticals-ltd


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## galumay (10 July 2019)

Seems like expectations are very strong now, up 14% in the 5 days since I took a small position. As with my other illiquid positions, there has been significant movements in price in order to flush out reluctant sellers. I wont be surprised to see similar movements in the opposite direction once the market loses some of its current frothiness.


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## Garpal Gumnut (10 July 2019)

I would be very careful about PAR.

Following the articles and watching the video makes me uneasy.

It's been in development for a long time. 

It is the "only" producer now.

It's phase 2b only covers moderate pain. 

Phase 2b are traditionally run to find the optimal dose but may also be conducted for efficacy. 

It is an injectable, so no oral equivalent which is preferable for patients. 

Only 18% of phase2 progress to phase3. 

How much will it cost the consumer/patient. Will Medicare or other state authorities approve a reduction in cost for recipients?

Just saying.

gg


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## galumay (10 July 2019)

You always have to be careful with biotechs, they have plenty of specific risks. 

PAR is unusual because the drug doesnt need the extensive approval process that applies to new drugs, hence the ease with which they were able to set up a Special Access Scheme and get so many people using Zilosul.

I am wondering if you actually read the linked articles given some of your comments?

Injectable or oral is really irrelevant given that its the only drug that treats OA, its not like there is an oral alternative. 

Regardless of the unusual amount of positives for PAR and the high probability of large upside, I still only allocated a small position because of the downside risk that single drug bio-techs have - as I said, however small it is, the consequence if it played out is probably total loss of capital. I generally prefer finding businesses where the risk is asymmetric like PAR, but also consequence on the downside is limited.

I have been wrong about bio-techs before so even I would take my enthusiasm with a grain of salt!


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## Garpal Gumnut (10 July 2019)

galumay said:


> You always have to be careful with biotechs, they have plenty of specific risks.
> 
> PAR is unusual because the drug doesnt need the extensive approval process that applies to new drugs, hence the ease with which they were able to set up a Special Access Scheme and get so many people using Zilosul.
> 
> ...




Thanks Galumay, I do tend to speed read so to give you some succour I sped read again all the attachments.

Some interesting quotes from them.

*"Bene is a family run, private business and has been manufacturing PPS since the 1940s. Bene have refined the manufacturing process of PPS over generations and have their secret recipe down to a fine art."
*
(I have a secret recipe for Kentucky Fry Chicken and Guinness but I doubt if it will ever see the light of the ASX)


*While Dr. Furujo was discussing the findings of her study, a woman approached us through the crowd and seemed extremely interested in the study results. After a short while, she mentioned that her child had MPS IV, and she was currently treating her with Elmiron (she lived in the US). When asked how she obtained Elmiron, she stated that she was purchasing it directly. She said they had been using it for around three years and believed it was having an effect. Note: Oral PPS such as Elmiron has limited impact for joint pain as the molecule of PPS is too large to be absorbed through the stomach (but we refrained from mentioning this at the time) also taking Elmiron for sustained periods of time results in issues with digestion and things like stomach ulcers.  

She continued by saying how the injectable PPS is impossible to get and was interested in how or where she could try to source this injectable material. 

We then informed her that Paradigm was currently in the process of setting up a clinical trial of injectable PPS for treating MPS. To describe her face at this news is impossible. Her relief, joy, confusion, elation, and desperation all came through at once. She was extremely excited by this news and hopeful an injectable version of PPS could be commercialised soon. 

It was incredible that we managed to witness this first hand and it certainly left a lasting impression about the critical need for such a product. The fact she was unable to source any form of PPS, further demonstrates the moat Paradigm will have under their exclusivity arrangement with bene. This is a big opportunity for Paradigm, yet the market appears to ascribe no value to it. 

With the studies from Dr. Hennermann & Dr. Furujo both showing positive impacts from the use of injectable PPS for treating MPS, we are confident Paradigm will be able to design a phase 2/3 trial that can yield success and bring a drug to market. We look forward to going back to the conference one day and hearing the positive effects from patients and families hopefully using a drug Paradigm commercialise.*

This is a heart-rendering story of a woman with a child with a rare debilitating incurable metabolic disease.
Look at it here https://en.wikipedia.org/wiki/Mucopolysaccharidosis
I believe it to be reckless in putting this in a commentary on a pharmaceutical company dealing with joint pain. *


Injectable or oral is important, if you don't understand that I can't make it any plainer using reason or rationality


So, mate, all in all I'd suggest you put the farm in to PAR. It's a goer from what you said and we'd like to have a millionaire in our midst from a one hit wonder.
*
gg*

*


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## galumay (10 July 2019)

I will take your smartarse style with a grain of salt! Just like my analysis.

I thought you might have something disconfirming to question the 3 in depth research articles, I am always looking for reasons I might have got a thesis incorrect. Never mind, i will look elsewhere.


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## Garpal Gumnut (10 July 2019)

galumay said:


> I will take your smartarse style with a grain of salt! Just like my analysis.
> 
> I thought you might have something disconfirming to question the 3 in depth research articles, I am always looking for reasons I might have got a thesis incorrect. Never mind, i will look elsewhere.



I dealt with the research aspect in my first reply.

It is a phase2b.

Usually used to estimate dose, sometimes for efficacy. 

Only approx 18% of phase2 progress to phase3.

It is the only supplier ( they say). What is the cost?

Would you pay the cost rather than taking 4 paracetamol a day for moderate pain. 

Go ahead and buy it up but don't misquote other members of ASF. 

I just hate to see people getting ripped off by pharmaceutical companies and I do appreciate your posts and some day when we meet we should smoke a pipe of peace. 

gg

btw. They are not in depth articles, they are Bedecke das Gesicht der anderen Person mit Scheiße


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## galumay (12 July 2019)

Another 4% in a red day on the market, now up 21% since i bought 7 days ago, even given the illiquid nature of the shares, the strength of the run this week suggests strong expectations.


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## galumay (16 July 2019)

I sold out today, shortest holding ever, only share I ever sold after less than 1 year! 11 days held for a 19% profit. 

My thesis broke, a friend alerted me to a $5b deal between Galapagos, a US biotech, and Gilead Science. The deal breaker for me was the news that GLPG have a drug that also treats OA as well as other similar diseases - I believed one of PAR's strongest advantages was that all other drugs under development only treated pain symptoms and not underlying cause, discovering this was not the case meant I lost my conviction in the asymmetry of the risk and so I sold out.

It may well keep rising, and the market may not consider GLPG1972 a threat, but I have learnt the hard way, if my thesis for a business is broken, then get out. I am a little annoyed that I didn't uncover this competitor in my research, but thats offset by the profit I booked in any case.


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## WolfInvestor22 (31 October 2019)

Current Share price could increase due to investor excitment: 
- PAR received Therapeutic Goods Administration (TGA) provisional approval on 25th October 2019 = Possible revenue generation next year 
- PAR expects to meet FDA approval requirements within 2019
- PAR is expected to treat 10 ex-US NFL patients within Q1 of 2020 with Zilosul drug = efficacy evidence 
- These exciting and revenue provoking events could see current price rise higher
I think paradigm is an exciting stock with alot of potential in the coming year . 
If you want to read more I have found a few articles .https://simplywall.st/stocks/au/pha...tock-that-soared-537-in-the-last-three-years/

https://youth-investment-group.com/...h-major-stock-movement-how-long-will-it-hold/


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## williekimble79 (28 November 2019)

WolfInvestor22 said:


> Current Share price could increase due to investor excitment:
> - PAR received Therapeutic Goods Administration (TGA) provisional approval on 25th October 2019 = Possible revenue generation next year
> - PAR expects to meet FDA approval requirements within 2019
> - PAR is expected to treat 10 ex-US NFL patients within Q1 of 2020 with Zilosul drug = efficacy evidence
> ...



thnaks Wolfinvestor22, I wonder what estimates are for the future share price. it seems to be running like a train of late. the recent talk ya book youtube interview was certainly interesting.. and may have had something to do with the recent spikes in value.


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## Parse (30 December 2019)

There is some good news about this company and it makes for a reasonable pick for 2020. Some interesting (and obvious) points are:
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.
There are over 100 million OA sufferers in the USA, Europe and Japan

Looks like a decent market for PAR.


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## scolloymore (5 April 2020)

Trading Halt ends Monday 6th April what will the news bring .....?


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## galumay (5 April 2020)

I think the news will be that the FDA announces the design of the Phase 3 clinical trials, in reality that news should come as no surprise and is really already baked into the price, but who knows how the market will react!


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## galumay (6 April 2020)

As predicted, path forward for Phase 3 trials, all good, need to do the 2 separate trials, CR of $35m, not even bothering to go to retail investors, CR at $1.30 for Instro & sophisticated investors. Not many companies could pull that off in times like these! Annoyed at missing out, but happy with the progress.


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## scolloymore (18 April 2020)

Now will this dribble down to the CR price or will we see it build a wall at aound mid low 1.60s


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## Trav. (10 January 2021)

PAR came up on my scan, so I read the R&D Investor Presentation in the hope that I might get a feel for the company.


 well I am none the wiser. I had absolutely no idea on what they were talking about.. Stick the chart son..


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## galumay (10 January 2021)

If you do want to find out some more about what they do, then the 51 Capital research is worth reading, scroll down and there are 3 articles they have published, https://www.fiftyonecapital.com/performance-media


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## Trav. (14 January 2021)

Well I ended entering PAR for a trade and so far it is heading in the right direction.

Momentum has kicked up which is good to see.

Holding @ 2.43


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## Trav. (17 January 2021)

Video and slide show for conference presentation that paints a good picture






			https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02330123-3A559391?access_token=83ff96335c2d45a094df02a206a39ff4


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## galumay (17 January 2021)

I guess the thing investors in PAR have to remember is that its likely nearly 3 years before commercial sales are likely on scale. The Phase 3 trials will take the best part of 2 years to see much meaningful data. Of course in the meantime its not improbable that a Big Pharma will buy PAR out. My point is that patience is needed and a lot can still go wrong, so position sizing is important. I hold as much as I am comfortable with currently, may look to add as the Phase 3 data flows.


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## Trav. (17 January 2021)

Good point @galumay slide 13 gives the indicative time frame






and 14


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## Dona Ferentes (3 November 2021)

_up 25% on news_

• Paradigm’s IND application to commence its *phase 3 pivotal clinical trial* investigating Pentosan Polysulphate Sodium (PPS) for the treatment of pain associated with knee osteoarthritis has been *cleared by the US FDA. * 
• The US central ethics committee has already approved the Trial.  
• Australian ethics approval for the Trial was previously announced on 24 September 2021. 
• Approximately 65 sites have been identified throughout the US and Australia. Contracting with many of those sites has been completed. The first 4 sites in Australia have initiated screening participants. Screening at the US sites is expected to begin prior to the end of CY2021. 
• The Company is now in a position to accelerate recruitment by adding approximately 10 sites in the United Kingdom and Europe, with site initiation and subject screening expected to commence in 1H CY 2022.


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## galumay (3 November 2021)

Good news, but not unexpected, we knew it was very close to approval. It does de risk PAR a little, so I expect there will be some movement up in the price as new investors look to build positions. I may look to add some more myself.


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## galumay (5 August 2022)

Stage 3 trials underway for a while now, some positive news around patents and other trials has been welcome news recently. In the last week someone or some people, have decided they want in, everything getting soaked up and price just going up as supply dries up. Its snuck up over 60% over the last week - mainly in moves of around 10% per day. Either there is some news not yet in the public arena or it has caught the attention of somebody who was previously unaware of it. I guess the other possibility is its been pumped somewhere online and its just speculative traders - but it doesn't seem like the sort of company they would normally play with?


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## galumay (8 August 2022)

For anyone interested in progress with PAR and the timeline with getting the product to market, this presentation recently delivered to investors may be of interest,


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## galumay (9 August 2022)

Up another 10%+ today, now up over 100% in 10 days trading with no real news!


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## galumay (4 October 2022)

PAR announcing the successful outcome of their PARA_OA_008 Phase 2 Trial is more good news for the potential of iPPS in relieving Osteoarthritis. Up 20% this morning on the news.


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## galumay (6 October 2022)

Up another 20% today, basically 40% for the week! Good volumes too, market is starting to believe.


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