Twenty Questions for Phosphagenics

Apologies in advance for what is a fairly long post…


In the usual stream of announcements and news feeds yesterday, I read the ASX release from Phosphagenics (ASX : POH) regarding their Oxycodone PHN study. Now I don’t comment much on this company, despite the fact that they are fairly visible in the public domain. About six months ago I made a brief comment on POH and their “re-formulation” activities and I think it is fair to say that I basically don’t believe this is a real company.

It is my personal opinion is that the TPM technology is a scam. Therefore what is there to really talk about?

But yesterday’s ASX announcement fired me up a little bit and it’s always pleasurable to see a smooth soundbite from Paul Gavin with lots of forward-looking statements to whip-up retail investor excitement in yet another half-finished project. In all earnest, probably the only really meaningful part of the release was legal disclaimer about the “Inherent Risks of Investment in Biotechnology Companies.” I personally think that if POH is going to put this disclaimer at the bottom of their ASX disclosures they should also add a line something along the lines of “There is also a risk that the management team will continue to mislead shareholders and make claims about clinical development outcomes that are, at best, unsubstantiated.”

POH has, for many years, positioned itself as a leader in drug delivery on the basis of the platform technology “TPM“. Even TPM doesn’t get a robust definition, but basically it is a mixture of phosphorylated forms of vitamin E. If you aren’t a science nerd, you don’t have to worry too much about what this means, except that it basically means a form of vitamin E that may have some useful biological properties (it’s more “amphiphilic”, which means it penetrates complex biological environments “better”). Indeed some of Esra Ogru’s original scientific research was about exploring these interesting forms of vitamin E that absolutely do play an important role in biology. The principal claim to fame of TPM over the years has been as a permeation enhancer – that is, technology that enables drugs to better cross the skin into the bloodstream (because of its “amphiphilic” nature) and, as such, the company has elected to go head-to-head with reformulated versions of a bunch of widely used drugs in the hope that their technology will make them work even better.

Heady stuff.

The company has a long and illustrious history dating back many years, of impressive announcements for clinical trials using many different “formulations” of drugs we use every day. Yet despite having raised about $100m, a dozen clinical studies and some astonishing public disclosures, the company has yet to actually progress a meaningful product into late-stage development (I will talk about the diclofenac gel product below – in my view it doesn’t count). This, in turn, inspires a whole raft of questions that I think the company owes shareholders a good answer to. Let’s take a look a the various bits of POH, the company that truly has a missing “O” in it’s stock ticker.

TPM – Targeted Penetration Matrix, er… Tocopheryl Phosphate Mixture, er… 

Most platform technologies that come out of academia have a raft of studies and literature behind them. Not the case with TPM. Some basic (and very reasonable) searches on PubMed essentially reveal that (at least as far as Paul Gavin (CSO) is concerned, it hasn’t been a particularly prolific decade. A few questions on the basics of the science:

1) Is the mechanism of action of TPM actually understood or validated?

2) What publications, if any, verify the properties and characteristics of TPM?

3) How does TPM compare to other “permeation enhancers”?

4) Does adding TPM actually improve the drug matrix itself?

 

The crazy thing about this company is that despite all the money that has gone into it, and all the “studies” conducted for different drug applications, the core technology itself basically hasn’t seemingly been studied or validated in any meaningful way. Remarkable. I really want to know whether TPM is any better than a whole host of permeation enhancers out there that are used in food and cosmetic applications every single day.

Insulin Gel

This would have been a very big deal, if it were true. As early as 2006, POH had announced that insulin had been delivered transdermally in a clinical study. Making insulin highly bioavailable without needles is something that a lot of people have tried, whether inhaled (as per MannKind and Pfizer), shot across the dermal barrier using hyper-velocity particle delivery (as per Powderject) or implanted (a la Medtronic). Literally billions have been spent on trying to solve this problem. Today, this doesn’t even get a mention on the web site as far as I can see.

5) Why has this “groundbreaking” gel not been developed further?

6) Why have the results of the clinical study not been published, despite a lot of fanfare?

7) How much gel was applied over the skin?

8) Where was the gel applied?

 

The latter question is particularly interesting because I have heard rumours from several sources (I don’t normally rumour-monger but I will in this instance) that they had to coat the entire torso of a patient with gel to even get a tiny insulin signal in the bloodstream.

Diclofenac Gel

As an occasional user of Voltaren gel for muscle strains, I can definitively say (N=1) this is an excellent product. But apparently POH made it even better by mixing it with a little TPM. Indeed, it’s the company’s only real trans-dermal drug delivery “success story” and it is marketed in India as “Voveran TPM”. Nothing too controversial there, diclofenac does penetrate the skin (although various standard formulations help) and mixing it up with a little Vitamin E probably wasn’t going to give a fairly “loose” regulatory agency like the Indian Central Drugs Standard Control Organization (CDSCO) much of a headache. Still, the clinical development behind this product was almost non-existent.

The revenues have been almost non-existent too.

I have only been able to ascertain that two small clinical studies were ever conducted. The first study was an “in house” volunteer study that claimed greater delivery of diclofenac compared with Voltaren gel (the company claimed 7 times greater performance), yet the other study (POH 014-98) that was conducted independently in South Australia (Allan Evans) showed no difference of delivery of diclofenac into the skin when comparing TPM gel with Voltaren. Presumably that’s why I haven’t been able to find a clinical publication. According to a “source” in the Indian pharmacy industry, the label information for Voveran actually summarises the clinical development of the product and contains mention of the “in house” volunteer study. It has been suggested to me that this study, run some time around 2007, was approved by Monash HREC and that the medical monitor was actually Esra’s pediatrician. If that is true, I’d love someone to come forth and confirm it.

The bottom line is that despite two ASX announcements on the 23rd of February 2009 and the 9th of September later that year, suggesting that a Phase I (“in house”) and Phase Ib (external) study had been completed and that the product was proceeding to a Phase II/III IND. My questions, therefore are:

9) Why was the IND never filed?

10) Why were the Phase 2 and Phase 3 studies never progressed?

11) Why has the significantly better performance results of POH gel vs Voltaren gel never been published in detail?

12) Why has no further development been attempted?

Oxycodone Patch

The company has made multiple announcements regarding numerous studies conducted with claims that therapeutic quantities of oxycodone could be delivered transdermally for pain relief. Yet the actual product trajectory for this “concept” has been all over the place and the weirdest thing is that they seem to be only studying the patch in a comparatively minor indication of post-therapeutic neuralgia (PHN). What happened to “systemic” delivery? This is actually part of what has become a big inconsistency in the company’s story. On the one hand, if you are going do deliver something like Oxycodone or Oxymorphone, you obviously want to accomplish systemic delivery (oxycodone, a synthetic opiate, is normally taken orally for serious pain relief). The whole point of a “patch” for these kinds of drugs is that you improve control of delivery, offer better management of a “controlled substance” and you make it safer for the patient to take a fairly serious drug.

Early articulation of the technology was all about measuring things in the blood – like insulin. This strongly implies the objective of systemic delivery and so a highly drug-loaded patch was going to be a viable alternative to taking something orally. But a recent scientific publication (a rarity for this company) with Paul Gavin as the senior author, strongly suggests that the TPM technology has minimal ability to achieve systemic delivery. In which case, what the hell was the company doing all those years with things like the insulin project? And then why on earth would you even talk about something like oxymorphone? It just doesn’t make sense.

Oh… and where did 3M go?

13) If the therapeutic drug dose can be delivered transdermally, why has the patch not continued development for general pain management?

14) Why, despite claims of significant results, has the data never been published?

15) Why, if the technology works, is the company only going after PHN?

Oxymorphone Patch

Back in May we heard about how, despite the fact that the oxymorphone technology apparently works, it would need to undergo reformulation. It took until October to get a deal inked with a German dermal drug delivery specialist. So does it work or does it not? As usual, because there has been no data presented (although Paul Gavin’s paper, noted above gives some clues), the company hasn’t really given any compelling explanation. My questions are:

16) Why is the patch being reformulated? Be specific.

17) What is “proof of concept” expected to be able to confirm clinical performance?

Tretinoin Gel

We saw a pretty epic release back in 2014 regarding Phosphagenics’ Phase II program in acne. Really heady stuff – with great soundbites from Director Geert Cauwenbergh:

“The results of this study are very encouraging considering the relatively small number of patients, and confirm that tretinoin when combined with our TPM® formulation produced directional trends indicative of better performance than Retin-A® against inflammatory lesions in particular. This seems to be a result of our TPM® technology which is corroborated by effects seen in the vehicle formulation containing TPM®. As a result of these findings, the Company will continue development of TPM®/Tretinoin for the prescription market in addition to assessment of a topical formulation containing TPM® as an over-the-counter product”

and CEO Harry Rosen:

“These results will be of significant interest to companies who have been in discussion with us about the potential of TPM® in the delivery of dermatological products.”

18) So what happened with partnership discussions?

19) What is the status of development?

20) Is this another product that is on hold because of undisclosed reasons?

The Current Focus – TPM for use in Animal Feed

Shareholders should be mortified. After years of releases citing billion dollar+ markets, the company has reverted back to …er… animal feed. Actually POH conducted research around animal feed many years ago (also without any apparent commercial success) so why is the company back here again? How is it different from old work – and what happened to the idea that TPM’s value as a permeation enhancer, rather than some sort of a Vitamin E supplement for pigs? Did the company just simply take a page Anatara‘s playbook and decide, “hell, that looks sexy, we should do that instead?”

It’s just so random and bizarre. It’s almost like the company gave up trying to get drugs across the skin and finally decided that eating the stuff was the only way to get it into the system.

I don’t have any questions. This is just stupid.

So, what’s your point, Long Tail?

POH just lacks credibility.

What kind of a company does Phase II studies and then just goes silent about a potential product? The company seems completely unable to take anything into late stage development, and not for lack of funding – the company has raised about $100m over the years. Not only does the company’s product development lack credibility but it also recently announced that it was shutting down its development team. Basically, there is nobody left at the company doing R&D, and clearly not Paul Gavin because he is too busy writing ASX releases. At the start of the year we witnessed a commitment to a new strategy, a new era of transparency and a new team to move the company forward. But what has really happened?

Besides Ross Murdoch, most of the senior management team is the same old crowd. It also looks like some of the “new” management team disappeared with the closure of the development arm of the company. This not only raises a big red flag for me, but it also basically means that the Harry/Esra-era company culture pervades. Frankly, it still amazes me that despite Esra and two other colleagues ending up in jail, that so many of the senior team were found to be “clean”. I’m not necessarily implying that they were actually complicit, but they obviously didn’t have a clue about how the company was operating, or where the money was going. Especially Harry Rosen (understandable, really, given that he was probably too busy swanning about in NY on the company’s dime).

It is my understanding that former co-CEO, Harry Rosen, only agreed to step down after being paid a six figure sum. It will be interesting to see how this is eventually disclosed in the next annual report (I will be watching with interest). Apparently the “without cause” termination conditions disclosed in the company’s remuneration policy were not met, despite major fraud taking place under his “watch” (seems like “cause” to me). It’s also interesting to note that in the 2013 and 2014 annual reports, some staff (like Paul Gavin) also appear to have received 10% or more pay rises for the year. Now, to be fair, Paul’s salary is not terribly offensive, but it’s hard to see a correlation between the pay rises and the output of the company. It’s worth noting that typical “inflationary adjustment” in similar companies was 2-3% in the same period. A bit of hush money perhaps?

If POH is ever to regain any credibility, it needs to be transparent about what it is doing. It probably also needs to do a bit of reconciliation between the money spend, past announcements and current “strategy”. Until then, I take releases like the one the company put out yesterday with a very VERY big pinch of salt.

There are a lot of questions out there, and if any readers have answers or additional knowledge, I am sure POH shareholders will be most grateful for your contribution.

 

33 thoughts on “Twenty Questions for Phosphagenics

  1. I’d imagine you’re not a big fan of OBJ either. I’m not. I spent some time following links from the website and googling to try and find a solid scientific basis for what they were doing and had no luck.

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    • Yep – OBJ is a similarly quacky company in my opinion. Actually, we have a few of these “platform” companies that have a great story but don’t deliver much. OBJ, Anteo, Phosphagenics. Even Starpharma could do a lot better, though I generally accept that in the case of SPL there probably is something “there”.

      In my opinion, companies like POH and OBJ basically exist to exploit retail investors who are much more forgiving of (and vulnerable to) “sudden” changes in product strategy without explanation. So long as the next project sounds good, people seem to forgive and forget.

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  2. Thanks for that excellent review of POH, Chris.

    Believe it or not, but I just happen to have not one but TWO world experts in pain standing in my kitchen right now, so I gave them a grilling about POH’s oxycodone trial.

    Just to recap, according to the study protocol, POH is predicting the patch will act peripherally, not systemically, although they plan to measure oxycodone blood levels at baseline, at 24 hours and at 72hours for each of two treatment “arms”.

    The study design is a crossover one, where the 28 patients get randomly assigned either the treatment patch or patch only. The patch stays on for three days, then is removed and then there is a “washout” period for 10 days. Then the other patch version they didn’t get first time goes on for three days and is removed.

    Here is the summary of my two experts’ views of the oxycodone trial:

    1. There are two main types of post hepatic neuralgia: one type where the affected nerves are still alive and the other type where the nerves have died. A peripheral treatment isn’t going to be much help for those patients whose nerves have died. In their study protocol POH didn’t mention that they are excluding patients whose nerves have died.

    2. Most post-hepatic neuralgia patients have damaged c-fibres. C-fibres contribute to their pain. This means the number of opioid receptors on these damaged c-fibres are seriously reduced, which logically means that the oxycodone from the patch will have fewer sites to bind to in order to reduce local pain.

    3. Three days was considered to be ridiculously too short to assess whether a pain patch would work. It may happen that an initial spike in pain relief might occur, especially if just a tiny amount of oxycodone got into the bloodstream and then into the central nervous system. The minimum assessment time for a phase 2 trial was considered to be 7 days.

    4. My visiting German expert said he’d been involved in a phase 2 trial of another opioid drug taken orally but that was designed to act only on the peripheral nervous system and the drug didn’t help post hepatic neuralgia pain at all.

    In conclusion, they predicted this local oxycodone treatment of post hepatic neuralgia would not work. In fact apparently there is only low evidence that oxycodone and opioids have a useful long-term benefit for post-hepatic neuralgia, even when taken orally and thereby treating the whole body, central nervous system included.

    I guess we just wait and see that outcome. But it does sound like selecting post hepatic neuralgia as their treatment indication was a bit unwise.

    Liked by 1 person

  3. Just finished reading your portrayal of POH, NEU and PYC.
    Never ceases to amaze how the people that are the most vocally critical tend to be the ones least likely to seek any clarification from the companies they are so happy to throw aspersions at.
    I’m all for analysis, but that would require unbiased balanced summations, but I suppose that wouldn’t be controversial enough for you and you wouldn’t be alone in this world of rebuttal free grandstanding that’s available to you.
    A simple statement would quash my theory and that would be that you contacted all three companies to clarify all the points you raised. Apologies in advance if you did.

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    • Dear Irma,

      Thank you for your comment. You obviously don’t understand what a public company is, so let me inform you.

      The covenant of a public company is that in exchange for ready access to our wallets, they have an obligation to disclose much more information than their private counterparts. All commentary on this site is based on the analysis of information disclosed by these companies (the same information that is used by analysts in the financial services industry to sell these securities). Much of it is very poor quality and inconsistent over time.

      Sometimes I do reach out to companies, but most of the time I don’t. Mainly because there isn’t a need – it’s all out there.

      It’s required by LAW to be “out there”.

      POH is a scandalously bad company that has behaved appallingly towards shareholders. I consider any announcement or releases made up to and including the Esra jailing to be fraudulent and there is little evidence that the company has evolved since people went to jail.

      TO JAIL. May I repeat? J A I L.

      NEU has a very good leader in Richard Treagus but a fairly strong track record of disclosing scientifically marginal information, which is disappointing. NEU may yet turn out to be one of our “stars” but it will not be because of the quality of information put out there by the company.

      PYC is just rubbish. This is a company that has done nothing more than run a decade-long gravy train that hasn’t put a single credible candidate into the clinic. Year after year it raises just enough money to justifiably do NOTHING. A total scam.

      So yes, I am vocal and critical, and if you are a shareholder of any of these companies, you should be too.

      Thanks for reading.

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      • “Sometimes I do reach out to companies, but most of the time I don’t…”

        Really does reflect badly on you that you feel don’t require validating your critique from the source of your concern, but that’s OK, you’re credentials speak for themselves….you da man!!

        Information is ‘out there’ as you say, but your perception of it is skewed by your cynicism and your readers would be better served if what you dish out wash validated.
        Your whole argument of lack of a professional manner on all three companies is thrown right back us by your reports. The irony!!
        Do some proper research and then compile a good balanced review.
        And yes I have interest in all 3 and many more bios. Sorry for not disclosing. Didn’t know I had to

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      • Thanks for your criticism.

        Yes, I write an opinion to counter most of the other rubbish out there. I am not cynical, I back my opinions with facts and the reality is that most of the industry agrees with me. As it happens, I am very bullish about making Australian biosciences a better place than it is, and if I help do this in a small way through this forum, then great.

        I also note, nobody is compelling you to read what I write so if you don’t like it, don’t read it. Though
        I respect you for delivering your criticism, it’s far preferable than the 100ds of cowardly hate mails I get each week.

        …and yes, disclosure is part of something called “ethics”. Check it out sometime.

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      • Dear Irma, If I understand correctly, you are a share holder of Phosphagenics. I would suggest that YOU rather than Chris should be asking for clarification from Phosphagenics. Ask Phosphagenics to explain all the big promises made over the years, and why they have continually failed to deliver. If Phosphagenics stand by their announcements and results, they should publish them without modifying any of the data, or have a reputable independent auditor confirm the results. You as a shareholder have the right to ask questions, and if I was you, I would be asking the questions if not now, then certainly at the next AGM.
        Or perhaps you already know what the answers will be(?)

        Regards

        Liked by 1 person

  4. Just saying.
    We actually need people like you making sure people we invest our time and money in toe the line, but imagine how good it would be if they were answerable to someone like you. Here are my concerns….please explain.
    Someone who does represent the biotech investment world by asking the tough questions directly.
    Sure it probably becomes a fully time job, rather than a past time, but there’s nothing out there like it. Infact it could be a real innovation.
    At the moment, yes it’s an opinion piece, but how much better would a fully informed opinion be. I’d pay good money for that type of stuff.
    Good luck but don’t forget the value of credibility even in an opinion piece.

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    • Honestly, I appreciate your naïveté. Thank you.

      Yes, Irma, next time I will contact Ross Murdoch and ask him whether his company has misappropriated $100m of shareholder capital. Or maybe I will just ask Esra when she gets out of jail.

      Ok?

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      • Geez, you get a but narchy easy. I was just suggesting how much better your opinion piece would it be if it was an informed opinion by speaking to the company. How can it hurt?
        You can throw out the Esra lines, very funny, but how about asking the company why they chose PHN instead of bagging it first or maybe ask PYC why they’re ‘stuck’ in a petri dish.
        Critiquing their responses would be of greater interest.
        I’m led to believe that after your critique of the Retts trial that the man himself, Richard Treagus, offered to discuss things with you, but the offer was never taken up…why let verification of facts spoil a good blog, hey.
        What were you concerned about? The refuting of your claims?
        It’s like asking a Al Gore what future weather pattern would indicate a cessation of global warming and he’d probably answer – none, we can attribute any weather pattern in some way to global warming. In other words you don’t want to know anything different.
        And here, I believe, we have the reason why you aren’t prepared to speak to those with the real answers. You don’t really want to know about them, otherwise you would have already asked.
        But knock yourself out champ. Your way’s got to be the right way with your level of intellect. I can’t compete with that. Your resume tells me that. It runs so deep I still can’t get through it.
        Good luck with it though. As I said your concept is good just need a bit of tidying up.

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      • Irma,

        It’s not funny. None of this is funny. Put yourself in the shoes of the CEO of PYC or POH, what are you going to do, just admit that your product development is garbage, that you are riding a financial gravy train? Please. Although it’s a shame you put NEU in the same bucket, it isn’t.

        And you how do you know I didn’t meet up with Richard Treagus (who is someone I am publicly on the record as having admiration for)? To be clear, what I didn’t take up was his offer of a “private explanation” of why his company was better than I thought. It is the responsibility of a public company CEO to responsibly and transparently explain the progress of the company. When this isn’t done, I call it out. I don’t claim to be God’s gift to life sciences, but I have literally seen hundred of companies in my career (maybe a thousand) and so after a while you get pretty good at spotting when things are amiss.

        It’s also nothing like Al Gore. Moreover, anyone who feels that my position is incorrect or poorly analysed has the full freedom to post a refute and I will not censor it. Even you – notwithstanding that your criticism is about me, not about anything I have written about these companies.

        But just to be clear – even with a new CEO, POH’s claims are not materially different – and the last CEO went to jail. It is my position that virtually every company announcement and press release up until the end of Esra’s tenure lacks credibility, precisely because she was inherently dishonest. I see no evidence whatsoever of a change of culture in the company since.

        In the case of PYC, the company has never moved anything beyond a story. It’s raised tens of millions of dollars of capital but never even remotely attempted to take something into the clinic. Either it is because it lacks the capacity to do so (possible), or it would just rather continue to tick along as it is, providing a lifestyle (probable). It’s done nothing for patients or shareholders.

        In the case of NEU, I may very well be proven wrong because the last set of data looks surprisingly compelling. But I maintain my position – with some credibility – that company is highly selective about what information it presents and the fact that it does not publish its clinical data in a peer-reviewed setting (especially critical for this kind of clinical science) is a major flaw and a major omission of the company. This is not conjecture, this is fact.

        SO – thank you for your feedback, “champ”. Like most things in life, where you choose to invest your money is your choice. I am not a financial adviser, I just have an informed opinion and I am confident enough to share it without too much sugar-coating. You are most welcome to ignore it.

        Thanks for reading.

        Like

  5. Sure thing. We can agree to disagree with some of your approach but I do admire your determination and concept.
    I do hope that if things turn for these companies that you’d be one of the first to recognise this.
    Have a good festive season

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  6. A blistering critique even by your standards Chris. Your 20 questions are great but I’m not sure where you are going to get 20 good answers from. A couple of points.

    The labeling for TMP voltaren gel sold in India has been posted on HC along with pictures of knees and glowing testimonials:

    http://hotcopper.com.au/threads/the-novartis-insert-says-it-all.2301518/#.VnUsfkDILg0

    From the labeling it does appear as if some sort of clinical superiority for the gel has been established. On the other hand it is known that POH has only conducted PK/P1 studies. On Hot Copper a discrepancy like this can only mean one thing. Novartis has conducted secret P2 clinical efficacy studies.

    But unfortunately the gel sells for $2 a tube and revenues back to POH are around $120k a year. And the new POH management have said they don’t think that the product is suitable for wider distribution. Its a dud.

    With respect to the acne study. You will have to comb many company announcements before you find a company claiming that the vehicle comparator in a three arm trial was actually an active and so the null results from the trial were an amazing breakthrough. Yep – the vehicle in the acne trial was TMP alone (without tretinoin). When POH got a large placebo effect they claimed this was actually a success for TMP.

    In terms of Geert thinking the acne results were wonderful? I’m sure he’s a nice guy but he is also CEO of RXI Pharma in the US on a package of around $800k year. The share price of RXI over the last couple of years – $6 to 40 cents. According to the tweeters Geert is the best short on the Nasdaq. Considering the share price trend of POH we could say he has both sides of Alantic covered. I remain a little sceptical of Geert’s positivity here and the absence of nice words in the acne announcement from the professor who conducted the trial was the dead giveaway.

    On the oxycodone PHN trial? Great points Anne from your experts. A couple of things to add.

    Topical oxycodone started off a side event to the main game which was a systemic oxymorphone patch. Unfortunately the systemic oxymorphone patch is at the repair shop. I suspect it is cactus. This has had the unfortunate effect of throwing the oxyc trial into the limelight. But it is really a very small pilot descriptive type study to see if the idea is feasible.

    Your experts Anne might be right about leakage into the bloodstream for oxycodone. But on the other hand POH have spent a decade and $100m becoming the world experts at not being able to get drugs into the bloodstream with TMP.

    Yes in PHN some nerves might have died but only one patch is being applied to the most painfully affected area and the change in pain from this area is being rated. I think there is a little bit of science to show it might work and compounding pharmas in the US claim to be getting good results from topically applied opioids. So worth a shot imo.

    The main trouble will be that no-one will believe a word POH says. This is a problem because in this latest announcement POH are saying only headline results will be released. The results from crossover trials are difficult to interpret. I suspect POH will muddle them completely and this combined with a lack of transparency will turn the oxyc trial into a non-event.

    Having said all this I do actually like POH at the moment for a dabble and I currently have a small position in POH. POH is trading at less than cash backing. TMP is being attributed zero value by the market, for all the obvious reasons. For loyal long suffering shareholders the horse has well and truly bolted; lots of people have lost a lot of money here. So basically its a shell play.

    With POH the market has always anticipated bad news in the share price. Following bad news the share price should rise, with the converse for good news. The one exception to this rule is when the Esra fraud was discovered. This was unknown to the market and the company. It caused a very rare gap down in share price on the chart.

    POH Chart

    POH internal trials are always positive, without exception. But the oxycodone trial is semi-independent. If Dr Brooker finds the topical oxycodone patch has done nothing he will say so. POH will spin this but it will be pretty obvious.

    Currently there is a changing of shareholder register occurring on relatively high volume. Several super funds part of the Orbis portfolio have exited; presumably POH no longer meets minimum investing requirements. But the main Orbis holding seems to be remaining static.

    I have half an inkling that TMP will be put on the shelf (as a partnering opportunity) and POH will purchase in a new technology. POH will do a PRR. At that point Directors may be more disposed to support the company by purchasing shares.

    I have a bizarre belief that the POH announcements before Esra was jailed are as true as the ones after. On the idea that the science acculturation process is much stronger than financial honesty. I steal pens from work all the time but I would never fudge any data. Everybody spins results; POH just more badly than everyone else.

    Was (is) POH all a scam? Well if it was it was a very good one. In excess of $100m from the market over 10 years. Orbis as a significant shareholder. Glowing reports from Stuart Roberts who visited the company regularly.

    I do like I idea of professional analyst coverage of micro-cap biotechs. But on the other hand I wonder whether it would mainly be overkill.

    Take OBJ; do you really need to need to visit the company? The Directors have a long history with micro-cap biotech duds. The key inventor of OBJs technology has been lampooned in the national press for an imaginary pain cure. He invents new kinds of clinical trials called “anecdotal feedback trials”. He now claims to have an energy medicine type magnet doodad that turns back bio-clocks in knees. You can’t really protect everyone from themselves … someone is going to suck up this soft headed money on the ASX.

    My theory is that because the ASX lacks tiers like the NASDAQ we think POH is just like BHP but smaller. But it is qualitatively different. It is a penny stock which raises money through pumps and dumps because its share price is able to be manipulated. As dilution kicks in this gets more difficult. By focusing too much on biotech fundamentals we lose sight of penny stock fundamentals.

    But enjoy hearing all sides of this debate.

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  7. If Phosphagenics had any credibility, they would publish their data, without any modification of results, or would obtain the opinion of a reputable independent auditor to confirm the results. The fact they don’t do this, and probably never will to any significant degree, just confirms the lack of substance. People who really have great results would be very quick to publish the detailed results, and would also be more likely to pick up significant partners. I would also advise Irma Klepper that she as a shareholder in Phosphagenics should be the one asking Phosphagenics for details and to explain the lack of success, rather than Chris. If I was Irma, I would be giving Phosphagenics management and their Board an absolute grilling to get answers, and to understand why anybody should hold any shares in this disaster of a company.

    I feel that when Esra and 2 colleagues were found guilty of stealing money, the investigation should have gone further. It is quite possible they would have found that much of the money raised was probably raised fraudulently, with misleading and questionable ASX announcements, on which Phosphagenics have never been able to deliver.

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    • I agree with you Alberich. I don’t mind what Irma said – she is allowed to be critical of my “analysis” style and in some regards she is sort of right, if I really cared about having a rock-solid story, I would have the courtesy to reach out to companies and ask questions.

      The problem is that with most of the firms that I feel lack credibility, it is a bit of a stretch to expect that I am going to get a quality response. Some have (for example NEU) but most haven’t.

      I’ll be the first person to admit that ASX continuous disclosure is a minefield and although the retail investor base is INCREDIBLY important (and frankly, incredibly valuable) it also drives bad behaviour in companies. This all needs a big re-think.

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    • Thanks Alberich for your suggestion.
      The reason I was asking Chris to consider talking to the company was because HE and not ME that was writing a critique to a public forum and I thought it seemed warranted and logical.
      I speak to the company every few weeks to seek clarification of issues.
      I’m certainly not happy with where the share price is at, and plenty of questions can be asked and warrant answering to all company’s and many people do just that.
      In terms of publishing data, you really suggesting results are modified?
      I’m not sure why you isolate POH.
      You think POH under report compared to all asx bios? Some examples would be nice of who you’d like them to emulate and I’ll pass the information on to them.

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      • Hi Irma,

        If you speak to POH every few weeks to seek clarification, do you feel that you are getting detailed and satisfactory answers? How do they explain the series of fantastic announcements over the years, but apparent lack of ongoing developments, and no success?
        It would be nice to see detailed and full results from POH and all small biotechs. This is a problem with the biotech sector, in that ASX announcements can be made, yet there is little if any validation of the announced results. And the fact that after many amazing announcements, the product development just fades away. I think that biotechs should try to emulate some of the more successful larger companies (as an Australian example lets say CSL), rather than trying to emulate each other. The truth will eventually come out, so just play it straight and success will come. Good science will be successful.

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      • Alberich, I get better clarification from companies than I do from chat rooms and blogs. Yep, there’s been plenty of ‘fantastic’ announcements from POH, including the systemic delivery of oxymorphone to therapeutic levels via a transdermal patch, never before done, but there you go, why no success, because it’s a tough tough game biotech, and although the patch did what it did, there is still plenty of hurdles, from upscaling to commercial viability etc etc. Pretty good achievement, but why praise a company for a world first physiological effect when we can shoot it down.
        How about time? TPM has been shown to turn lipophylic liquid into more water soluble, so much so that the company may well have another breakthrough use, but again lets not give credit here, and no you won’t get much info or your raw data because it’s all confidential with the company not even being able to release what the antibiotic is. How quick and easy is it dealing with big pharma? months ? years ? Do you really think POH want to keep it secret?
        You can be all geniuses sitting back in your high chairs casting judgement but biotech is a tough game.
        Small bios are at the mercy of their goliath partners they are desperately trying to do a deal with.
        Acrux maybe? One or two others? Not many success stories. Because they don’t show you data? spill out all the dirty laundry? give you ‘up to scratch’ announcements? Give me a break.
        No place for idealists in this game, just realists. At the moment the reality is POH is at the lowest of it’s lows.
        Let’s see if POH can turn all the Al Gores around, one thing for sure, the first thing all the Al’s will be doing when the oxycodone results are out is looking how to shoot it down even before they’ve read it.

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      • Irma – this was a ridiculous post. Please don’t drink and write.

        This is not Hotcopper – unless you have something to say backed up with something more than just attitude, don’t post here. I spend hours researching and referencing my positions. At least have the basic decency of asserting yourself with more than just pop psych.

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      • If you drink and write you’re a bloody idiot!! 3 days to Christmas and you don’t want me to drink???

        Now that’s insane

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  8. It is interesting to me that those who oppose the disclosure of opinions that do not support their own position often suggest talking to “the company” as the solution. Pedantically, it is not possible to talk to a company–only to a person/or people within it. In my experience, a conversation with five people in one company is likely to illuminate five different viewpoints. That is why board approval for shareholder communication is important. The board should align ideas and ensure clarity in communications with shareholders. Ultimately, the board should be held accountable for communication failures, whether they are due to fraud or poor process.

    Pragmatically, publicly listed companies should support ethical and equitable engagement with all shareholders by disclosing (proactively) information such that all shareholders are well informed. It is likely from some of the comments (previously in relation to Neuren, now here) that some shareholders have more access to the bat phones of CEO’s and Directors than others. My preference is open commercial disclosure sufficient to meet both regulatory and investor needs (on the one hand), and open disclosure sufficient to allow competent scientific peer review (on the other). Rhetoric and insider conversations are dangerous at all times, but particularly so when working in medical science.

    There is a comment in here, and I have seen this before too, that suggests that intelligence and education make one flawed. I wonder if, one day, someone will create a pill that cures it. We can then expend our energies on more useful activities than debate and analysis. Perhaps we could hit each other with clubs and see how much blood we can mix with the dribble on the floor. Perhaps that will be the future of biotech, when freed from the disease of intelligent debate and analysis. More dribble, more blood on the floor.

    I hope not.

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    • I agree with what you have said – and I think disclosure should be a point of tension in a high-functioning public company board because it means that differences of opinion are contributing to a go forward scenario. Adversarial discussion is absolutely required.

      Adversarial discussion has to take place at a shareholder level too so that this why this dialogue is important. It is GOOD that you are having it.

      As for education, dozens of times a week I am abused by shareholders of companies I write about for being a spod, a nerd, an academic. My answer to all of those things are “yes”.

      However education doesn’t solve this problem. It helps, but it doesn’t solve it. The only thing that solves it is integrity.

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      • Intelligence and education are different but related concepts. I have met many intelligent people who did not have the opportunity to advance their education. I’ve also met some educated people who can recite anything from Shakespeare to climate change data without understanding any of it. Integrity without intelligence can still result in brute behaviour (especially as morality evolves). However, I agree, integrity is valuable indeed.

        Adversary and dissent in Governance are vital but I wonder if they are truly valued. Your map of the relationships (I think you called it incest) smacked of cronyism–homophilic structures where the parties agree with each other just to maintain their ties. The emails you receive seem to indicate the same thing, people attempting to suppress dissent. Suppression of dissent leads to suppression of information and debate. Information flows are controlled, and rewards flow to the few who control the information.

        There is an interesting discussion on NEU regarding your thought pieces. Some are realising the value of critical reflection. Good for you.

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  9. Hi Irma,

    You must have some fantastic inside information into POH, such as the “lypophylic liquid being turned into more water soluble” (this sounds almost like a God like ability to turn water into wine). I am not sure if POH have ever announced much on this publically, so it is interesting that they are informing you. And also telling you that it is somehow related to an antibiotic. If POH can tell you, why don’t they tell the market? Perhaps this is so you can be a “briefed” advocate for POH on blogs and Hotcopper?

    In relation to the oxymorphone patch, what has POH actually achieved? Is it really the first time oxymorphone has been delivered transdermally? Perhaps you may want to research that comment a little more (it actually has been done before, and it is actually not that difficult, but other issues prevented the patches from further development). And I note POH is doing “further development”. Just add it to the POH cupboard full of other “further developments”.

    We are not geniuses casting judgement, but making observations about ongoing lack of performance.

    If you believe in POH so passionately, why don’t you buy up big in their shares? I note their share price is fluctuating around 1.2 – 1.3 cents. Seems like a real bargain to buy now and cash in big time when POH ability to “turn wine into water” comes to fruition.

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    • Ok folks…. It’s Christmas and so I am going to moderate this thread by pausing it here.

      Alberich you make good points as always – people are going to start thinking this blog is the result of a writing syndicate if you are not careful. Frankly you say it better than I do.

      I was tempted to censor Irma after the last comments but I am feeling charitable today. However I have reason to believe that “Irma Klepper” is most likely a person who goes by “Hot Tod” on Hotcopper.

      This person is a POH plant, appearing to be an independent person advocating for POH. She is often “briefed” and given snippets that the public and sometimes even staff “don’t know about.”

      Irma, if that is true, then you have missed the whole point of this blog and 20,000+ people who have read it.

      Over and out…

      Liked by 1 person

      • Hi Chris, I can categorically deny that I am hottod. She is far more intelligent and articulate then me and her posts are never attacking or flaming to prove it.
        I’ll take it as a bit of a compliment.
        My frustration is with my original point about cross checking but we’ve gone over that, and yes it’s probably gone off track a bit.
        Would be great to see you at the next POH AGM. Think about it.
        Should be plenty to talk about by then, one way or the other.

        Like

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