KZA - Kazia Therapeutics

[Joules MM1]

NRT (Novogen) is now Kazia (KZA) and the broom has been swept through the joint under the new CEO (appointed a couple of years ago now).

One brain cancer drug in multiple phase II trials by different institutions in USA and Oz. Initial results hold some promise.

One ovarian cancer drug in advanced phase I trials with some indications of efficacy.

The company runs on the smell of an oily rag with not much cash in the kitty.

Very thinly traded stock (market cap was approx $32m at close yesterday from memory). It filled the gap that opened up on 20 June 2018 this morning. It's rallying hard off its all time lows.

View attachment 92710

In the long run the value of the business will be determined by the efficacy of its drugs, but with such a miniscule market cap, it might get swooped up before clinical trials are even completed.

and this - waiting for the 3rd tick in this view might be a good idea...to ensure the current leg from Feb 6th isnt just a liquidity rinse ...as usual

 

[tinhat]

thanks, tinstar!

2 ?'s

1 what's the break-up value ?
2 when is the likely cap-raise date ?

Thanks for the chart. Those indicators are interesting.

A1. No idea really. They still owned a couple of million dollars worth of shares in NOX. last time they reported, which they appear to be selling out of (they received the shares as settlement with NOX over an intellectual property dispute). Their only assets of value is their intellectual property around these drugs.

A2. Management doesn't like to talk much about the tricky questions of cash burn and the funding horizon. If I recall correctly the last time it was mentioned they said they have enough money to see the current trials through and get to the end of the year. They did a capital raise last year at 0.35c I think (from memory) and I took up my full entitlement, so happy days for me. It was not good timing (share price was in the doldrums) and they didn't raise much cash for their troubles. They get their research spending reimbursed by the Australian government too. The last reimbursement was just over $2m from memory.

What they appear to be banking on is some success in the Phase II trial for GDC-0084 (brain cancer), which has US orphan drug status, with the hope of monetarising that success by selling it on or licensing it out to big pharma. In fact this is the approach of the new CEO James Garner. He describes the company as a drug discovery company. He is positioning the company into being a lean mean oncology drug clinical trial research outfit with the idea that they identify candidate drugs, enter into deals with their inventors to take them into clinical trial and then seek to monetarise success by doing deals with big pharma to take them to market. That is the path that GDC-0084 is on, which was initially developed by Gentech and which they acquired through a deal that will see some royalties paid to Gentech on success.

This is a pure specki play. In a year's time this company could be worth zero or a billion with the odds for oncology drug trial success stacked against it.

This company use to be run with a lot of hype and promise by the bloke that now runs Noxopharm (NOX) and there is still some negative sentiment towards the company due to its history. Look at the chart that Ann posted earlier.

 

[tinhat]

Kazia went into a trading halt before the ASX open on Thursday after its poster presentation to the US Society of NeuroOncology conference was leaked online overnight, leading to a doubling of the share price on Nasdaq before trading was halted.

KZIA (nasdaq)

Kazia's lead candidate oncology drug, GDC-0084, on license from Gentech, it would appear, is starting to make waves as a potential geoblastoma treatment. The drug is now in multiple phase II and one phase I trials being run by several leading oncology research outfits.

It will be very interesting to watch the share price action on Monday, assuming that it resumes trading then. I've been trading a large portion of my holding as the price has fluctuated between 0.35 and 0.55 for a while now. Although biotech company share prices do tend to spike with exuberance after positive news, I'm not sure I will be taking any profit on the anticipated spike on Monday. The dream is that this $27m market cap company really strikes it big with this drug. There is a whole pipeline of news to flow from all the various trials GDC-0084 is currently under.

Check out the AGM presentation by the CEO:
https://www.kaziatherapeutics.com/m...9-annual-general-meeting-presentation-webcast

 

[tinhat]

oops - don't know where I got "geoblastoma" from, geocaching? I meant glioblastoma

 

[tinhat]

KZA went from being a $27M to $52M market cap company today on news of preliminary phase II clinical trial data demonstrating significant efficacy in the small trial group of glioblastoma sufferers.

What is very exciting is that the next trial is likely to be a pivotal trial; ie, a phase III trial leading to registration of the drug. Kazia has been very smart about designing its phase II trial which now places it in a position to potentially bring this drug to market in a very small amount of time (relative to the many years it usually takes to bring an oncology drug to market). The reason for this is because there has been no new drug treatment for glioblastoma in twenty years and the current drug used is only effective in 25% of patients and only leads to a progression free period of just over five months.

Phosphoinositide 3-kinase inhibitors (PI3K inhibitors) are a fairly new class of cancer drugs but Kazia's GDC-0084 is the only PI3K inhibitor that crosses the blood brain barrier. As well as Kazia's trial for glioblastoma (primary brain cancer) there are two other phase II trials of Kazia's GDC-0084 drug currently underway being conducted by leading cancer research institutions in the USA and a phase I study into a form of child brain cancer. This drug was already getting a lot of attention before these interim clinical results were released over the weekend.

Unfortunately, Kazia has had a few past lives that have left it with some baggage and an unattractive long term price chart. The guy who use to run the show when the company was called Novogen parted ways went and off to start Noxopharm (NOX). They are going to need to partner with, license out or sell the drug to big pharma to get it to market.

The question now is how much is GDC-0084 worth and what market cap would be realistic for Kazia? $200M, $500M?

Kazia also have another oncology drug in phase I trial for ovarian cancer and early indications are that it has displayed some positive effect in reducing tumor size.

 

[tinhat]

I've chosen Kazia Therapeutics as my stock tip for the December competition. I'm very long this stock and am hoping it will pay off in the long run.

I anticipate there will be increasing press attention on Kazia and their Pi3K inhibitor candidate, GDC-0084, which from next year will be referred to by WHO assigned name of "Paxalisib". Below is an extract from a news article about the early positive results from a phase 2a study of GDC-0084 as a primary glioblastoma treatment. There are another four trials currently underway for GDC-0084 with a lot of data to come out next year. Also, I believe there should be some data being reported from the phase 1 trial of their other drug, Cantrixil, under trial for ovarian cancer.

GDC-0084 Shows Efficacy for Treatment of Glioblastoma
Nichole Tucker
Published Online:8:00 PM, Wed November 27, 2019
Targeted Oncology (website)

GDC-0084, an investigational PI3K inhibitor, may delay the progression of disease in patients with newly diagnosed glioblastoma and unmethylated MGMT promotor status, based on results of a phase IIa study, Kazia Therapeutics reported in a press release.1

Patrick Y. Wen, MD, professor of neurology at Harvard Medical School, and the director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute, explained the importance of this research in a statement to the press, saying, “There is an urgent need for new therapies in glioblastoma. GDC-0084 has the potential to be an important new addition to the treatment of this very challenging disease. My colleagues and I look forward to examining further data as the study progresses."

Data presented during the 2019 Society for NeuroOncology Annual Meeting show that in 9 evaluable patients, the median progression-free survival (PFS) was 8.4 months. At the time of data cut-off, 75% of patients were still alive, and the median overall survival (OS) endpoint was not reached as a result. Overall, 47 patients were included in the study.

continues...​

 

[tinhat]

I've been actively investing in stocks for a decade now and I've come across stocks that have been inexplicably undervalued by the market through a cycle. Examples I can think of that I invested in at the time, where the stock was extremely undervalued through stock price, especially post GFC are iinet, tpg (tpn), CSL, Thorn Group, AX1 (when it was previously under another code), and more recently BSL, anyway...

KZA is different in that it is a speculative biotech. But, it is seriously kicking goals with GDC-0084 and, after divesting of a lot of other candidate drugs, it is still progressing Cantrixil, albeit on a slower lane, but with phase 1 results to date demonstrating potential.

The recent step up in share price is due to early data on phase II trials of GDC-0084 in treating primary glioblastoma. There are several other trials being undertaken of GDC-0084 by leading international clinics around brain cancer. The recent news released by the company has included the suggestion that the next clinical trial is likely to be a "pivotal" trial designed to achieve registration of the drug for commercial use.

Yesterday, Kazia announced that further clinical trial of GDC-0084 will be conducted through the GBM Agile research program. This is huge. This is going to provide a potential path to commercialization (if the drug can be proven to be worth registration) at considerable less cost and time to a conventional phase III definitive study.

Why is this shortcut available and why have the doors been flung open to Kazia for GDC-0084? Because there has been no drug that has been able to progress glioblastoma treatment for over twenty years and because the current treatment provides such poor marginal outcome (and in fact no benefit for 75% of glioblastoma patients).

GDC-0084 is one of several of the recent generation of PI3k inhibitor. Some of these are demonstrating potential effect against cancers, especially breast cancer. A problem with cancers such as breast cancer, melanoma, etc, is that they often metastasize into brain cancer. GCD-0084 is the only PI3K inhibitor known to cross the blood-brain barrier. This is why several other research institutes are researching GDC-0084 in their own clinical trials. The potential scope for GDC-0084 as a "wider" acting PI3K inhibitor for therapeutic is interesting.

How Kazia (formerly Novegen) got to be the custodian of GDC-0084 as a potential brain cancer drug is a long story. The short story is that what was then called Novogen had several drugs ready to go into human trial but no financially viable means of getting there. A few years ago the Novogen board took a decisive course of action that saw the then CEO depart (he went off to establish Noxopharm) and the appointment of James Garner as CEO.

Garner did two things. He narrowed down the suite of potential Novogen drugs to take forward into human clinical trials to just Cantrixil for ovarian cancer which is currently under phase I trial. Secondly, through serendipity, he acquired the license allowing Novogen (now Kazia) to take GDC-0084 to phase II trial. I've said enough here for now. Anyone interested should go and do some background research on how this came about.

The post-worthy point to this post is, in addition to the announcement that GDC-0084 will now be proceeding under the GMB Agile program, is the shift in assumption over the business model around Kazia taking GDC-0084 commercial. The business case has always been that Kazia licensed development of GDC-0084 from Genentech (part of Roche) as an intermediary along the road to commercialisation with the intention to enter some sort of deal to pass the drug along to big pharma (perhaps back to Genetech) after having economically (on the smell of an oily rag) facilitated the drug through the trials needed to demonstrate commercial viability justifying further big phara investment.

The GBM Agile collaboration now sees Kazia better able to propel GDC-0084 further toward registration as a drug without the need for substantial funding from big-pharma. This is huge because the assumption has always been that, along with the commitments from the licensing deal with Genetech (which we don't know the specifics of) Kazia would need to significantly dilute its interest in the commercial potential of GDC-0084 in raising significant further capital to advance clinical trials and/or diluting its interest in the drug through big phara collaboration.

If you listen to this interview with CEO Garner at a bit after the 8 min mark he states that the GBM Agile pathway means it should not be assumed that a partnership with big pharma is necessary to register the drug. For me as a long term shareholder this is huge. I don't care what the share price is today or tomorrow or next year quite frankly. I am interested in what value this drug may have as a registered administered drug and excited by the scope of the potential clinical application.

After having said all of the above, it is my opinion that anyone who invests in speculative stocks such as KZA should do so after evaluating their personal circumstances, including their risk tolerance and should size their investment appropriately.

 

[Knobby22]

Hi Tinhat
Saw you picked this as your yearly pick.
Have a look at TLX which is in a similar space.
Good writing above. Could go anywhere. As you say highly speculative.

 

[tinhat]

I am still owning a good bucket load of this stock. If anyone is researching an oncology drug then please check out the science behind what this mob has.

For all other mug punters, slowly, slowly catchy monkey...

 

[Knobby22]

Pretty complex, still a while away. Science is complex, blowing my mind. Worth taking a punt. I will buy in at some stage.

 

[Dona Ferentes]

market cap $25mill but offices in Barangaroo towers!!

 

[tinhat]

market cap $25mill but offices in Barangaroo towers!!

Biotech is a gamble. They are in good company along with Jamie Packer. Jamie was the first kid I ever saw wearing a helmet at school cricket. He probably i still wearing that helmet. You talk about signal versus noise. What is the rent?

 

[tinhat]

Dr James Garner was appointed Managing Director of then Novogen (now Kazia) on 5 Feb 2016. In that time Kazia shareholders have walked through the valley of the shadow of death. As you can see from the chart below it's pretty craggy in that valley. Huge boulders litter the valley floor.

The company turn-around and reinvention of purpose implemented by Garner appears to finally be getting some attention in the market.

Kazia is dual listed on the ASX and NASDAQ. The stock has been traded such that an arbitrage opportunity has been maintained between the ASX and NASDAQ pricing which has seen shares (issued through capital raises on the ASX) slowly drift onto the NASDAQ through the NASDAQ depository holder (The Bank of New York Mellon Corporation).

I've been a long term holder but traded my holding up and down through the capital raise cycles. Their lead candidate drug, Paxalisib (GDC-0084), for brain cancer, is currently being tested in four clinical trials, including the "GBM Agile" trial that could lead to commercial registration with the FDA if the results are successful. The FDA has been active in encouraging the GBM Agile adaptive method of the multi drug oncology trial it is being used in - which selects patients for one of three arms of treatments based on genetic criteria and utilising Bayesian statistical techniques to dynamically adjust the number of patients in the arms according to emerging signals of activity.

The drug is also being trialed in breast cancer and has the potential to not only assist in treating other cancers but also be used in cancer patients for the prevention of metastatic secondary brain tumor. Paxalisib has received a lot of attention amongst leading oncology researchers which has lead it to being used in four concurrent clinical trials, mostly funded by external parties.

About a week ago, the FDA awarded Kazia's Paxilisib a Rare Pediatric Disease Designation for the treatment of Diffuse Intrinsic Pontine Glioma (DPIG). This allows Kazia to apply for an expedited assessment for registration of Paxilisib for DPIG pending successful results from the current trial being conducted by St Jude Children’s Research Hospital, Memphis, USA.

There is lots of info on the kazia therapeutics website and there are lots of recent media and publicity interviews with James Garner floating around.

It's a speculative punt and even though Kazia also have a drug for Ovarian cancer (Cantrixil) currently in phase 1 trial, Paxalsib really is a make or break, crash or crash through proposition for Kazia.

 

[tinhat]

Sunrise have done a couple of stories on Dr Matt Dun's work on the trial of Paxsalisib on DIPG kids including his late two year old daughter.

 

[tinhat]

Kazia's paxalisib granted Fast Track Designation by FDA

Nice market response to very positive news. We are finally out of the valley and ready to climb the mountain! Over the past three weeks the share price has exploded. It's probably going to remain a lumpy ride for some time as this stock is mainly held by retail/private equity. A close above $1 would be very nice, seeing as I am holding a six figure quantity of these shares.

I've normally traded through the capital raise cycle but when they raised at $0.40 earlier this year, with four clinical trials underway, I took up my full entitlement and decided I was going hold every single one of them.

I don't have a target but, as I said earlier, I don't reckon we have even begun to climb that mountain yet. It's a specki though.

 

[tinhat]

US FDA AWARDS ORPHAN DRUG DESIGNATION (ODD) TO PAXALISIB FOR MALIGNANT GLIOMA, INCLUDING DIPG. Announcement.

Recent article and video interview @ sharecafe explaining recent news events.

 

[Dona Ferentes]

the lifetime award for persistence could well go to Kazia.

Things might be about to change
- raised cash in April-May
- FDA approval
- awarded 'fast track' designation on 20/08

Kazia is taking an unusual approach to the phase III (pivotal) trial, by joining a global study called GBM Agile. (GBM is shorthand for glioblastoma). Created independently of any individual drug company, GBM Agile seeks to standardise the clinical approach and undertake joint research, thus reducing costs and producing data in a format the FDA prefers to see. Paxalisib will be the second drug to join the study, behind a Bayer candidate called Stivarga (regorafenib).

"We expect to have up to 200 patients and roughly the same number of control group patients," Dr Garner says. "We hope to start the study by the end of this year. ....That will take a couple of years to run its course but at the end of that we hope to got to regulatory agencies like FDA and obtain a marketing authorisation."

https://www.sharecafe.com.au/2020/0...ia-wows-investors-with-its-rare-cancer-story/

 

[tinhat]

I'm throwing my full entitlement at this even though as of today that would put my underwater to the market price.

KZA is my biggest holding. My vision is that I die poor.

 

[over9k]

Just looked at the full chart. This was once a $60 share.

 

[frugal.rock]

KZA is my biggest holding. My vision is that I die poor.

Stick 'em up, give me all your money. lol.
Hope you are keeping an eye on it tinhat, that gap looks like it needs closing.
Good one for you.