Thursday, 18 September 2014

OzBiota drinks

The Company will be offering some form of update on September 26.

I would like to invite anyone with an interest in Biota to drinks on Tuesday 30 September at 6pm.

I thought we could meet at the Market Lane Bar, which is apparently inside the Rialto Melbourne Intercontinental Hotel (495 Collins St)., the site of many previous Biota management presentations. Remember those presentations? All complete nonsense, an odd combination of deception, self or otherwise, and incompetence.

So, it's fitting to meet there without management.

It will be quite informal, so no agenda or presentations. I haven't even booked a table. Hopefully, the company update on 26th will give us something to talk about.

I will bring along a little sign. Come along, if only to save me from being the sad lonely little man sitting and drinking at a small table with a weird sign saying 'Biota'.






Wednesday, 20 August 2014

Nup-date

It's interesting that in the aftermath of the BARDA stop work and cancellation of contract, some funds and institutions were buyers. How do you figure that? In fact, aside from a couple of major holders selling out/down, the impact at that point seemed controlled.

It will take another three months, alas, to discover the damage to the register caused by the IGLOO trial failure. While Broadfin has bought since then, the selling might have been curtailed by the fact that the stock is so unknown and illiquid that they couldn't sell for cash backing. So they held. Welcome to our little club.

I wonder if BARDA will now feel obliged to offer any compensation for cancellation of the contract, given the Phase 2 result.

Well, the rest is conjecture, and because there is such an information vacuum at present, we'd be just whistling in the wind.

Jim Fox has taken over chairmanship of Genmark Diagnostics. It's a maker of diagnostic PCR tests, with a strong Australian background. Does PCR for influenza and HRV as a matter of fact, but hardly a portable device. A half a billion dollar company, Nasdaq listed.

In case anyone local reads this, I'm planning a Melbourne based Ozbiota shareholders (classy) pub meeting in September. Sorrow drowning, at least. More details later.

Sunday, 3 August 2014

Flu-iiQ and you

It's interesting that symptom relief has been at the centre of many influenza trials. Because for many other drugs, it isn't. Influenza seems to have been selected out for special attention in this regard: whether it's the company's own marketing departments who want it, or whether the FDA directs it, I don't know.

For most other infectious diseases, hard outcomes are usually preferred. If I wanted to trial a new antibiotic to treat pneumonia, I'd look at fever, pulse , BP, respiratory rate, changes in blood counts, days in hospital, days off work and serious morbidity and mortality. We aren't usually that interested in whether the cough is still troublesome, or your muscles still hurt a bit or whether your appetite has returned or not. Those are subjective and less helpful in determining effectiveness.

If I was to apply hard outcomes to influenza trials they might be:
time till fever resolves
time to pulse, BP improves
time till bloods improve
(perhaps) days off work (although this is also subjective in many ways)
complication rates, including hospitalisation
mortality

Here is the paper introducing the Flu-iiQ test. It was published in May 2011 and sponsored by MSD. The paper, with its validation, was published just before the LANI trials started.

http://www.valueinhealthjournal.com/article/S1098-3015%2811%2900107-0/fulltext

It would be interesting to know where else this instrument has been used - because I can find only 1 reference in Pub Med to a paper looking at patient reported symptoms in Hep C.

By using soft data, like patient reported outcomes, rather than hard data, like objective clinical measurements, you are subject to the validity of the instrument.

It looks like Flu-iiQ is so new that it has not been used in significant studies. Before Biota's. Let me know if I'm incorrect.

Also, given other NIs trials didn't use it, it's hard to make comparisons between them.

Did Biota scientists select it? Did Barda? Why use it? This is the small stuff that needs sweat.

Well, it needs sweat before it's implemented. Too late now.

It's ironic that in his previous job Russell Plumb sold a compound for a lot of money that subsequently failed, and in this job he was handed a compound that failed and cost his company a lot of money.

It's hard to see a way forward. BOTA is a cashbox now, but 80 million buys very little in this still overvalued biotech market. And in any event, they didn't want to wade back into early stage compounds, which is really all they can afford. They can't fund a phase 3, and could only manage a straightforward Phase 2 depending on the patient population. But on the other hand, this company changes major strategy every 2 years, so nothing decided last year is worth anything.

In my experience managements with this much cash hold on tight. It's a decade of salaries. It's hard to know how these directors will handle shareholder pressure, but remember a big proportion are still you and me and we are invisible to them. It's so reminescent of NABI that it's almost eerie. I was kidding a few posts back about being the subject of a backdoor listing, but it's as likely as any other outcome right now.

Vapendavir and RSV are poor reasons at best for them to continue as a stand alone company. The new management team looked very unfavourably on VAP initially. The change of heart comes from having no plan B, or maybe someone in pharma told them they were interested. But neither have strong cases at present. VAP outcomes are all about symptoms in a subset of common colds, although asthma does come with some hard outcomes.

I guess it does offer something in addition to the cash that might let them give back what the funds paid in the capital raising in January.

Generic relenza? Not if the generic needs to be supplied in a rotahaler.Waste of time.

LANI is Daiichi's drug. But they never showed the slightest interest in ROW deals (or at least, none that Biota ever disclosed), so it's unclear they would bother or care now, except that government pressure may be brought to bear in Japan to account for this trial result.

Boy, what a mess.

Problem is there isn't a lot of faith in the large number of Directors gathered at the table. Management does have time and some money, but not enough of either to waste.




Friday, 1 August 2014

Goodbye LANI

well, I'm surprised by today's announcement that LANI's Phase 2b trial showed no improvement in symptom relief in influenza.

actually, stunned.

the impact on viral shedding was demonstrated

I'm not certain if the low recruitment numbers was the main issue

I will need to look at the instrument chosen to measure the outcome, but it's too late anyway.

this is a severe blow.

my guess is somehow BARDA knew this was the case and pulled the grant.

and announced at the beginning of a little bear market..I hate to think what the SP will finish at today

where does this poor company go? It really has few options. I'll think more before I write anything.

Once again, though, we should have made a deal the day after the BARDA grant was announced. That milk is spilling everywhere

Thursday, 17 July 2014

hold that thought

whalewisdom seems to have changed it's statement on BOTA holdings for the June quarter. So, take the report in my previous post with some doubt until confirmed, probably in mid August. Wonder where they got the initial list of changes.

Wednesday, 16 July 2014

more sellers identified

JP Morgan sold 2.5 million
Blackrock sold over 1.2 million
Visium sold 600,000
No notices of institutional buys so far! Another month for full reporting.

We wait to see what Hunter Hall and Baker Bros did.

Tuesday, 15 July 2014

Outside sellers and inside buyers.

Its nearly 3 months since BARDA withdrew their grant from Biota.

We can presume that rather than executives or board members owning up to failures in losing BARDA, it's only the scientists in Melbourne who will bear the loss. We are supposed to believe that the loss of the BARDA grant, which will cost 150 million in cash and about the same in market cap, is in no way related to anything the board or the executives did, or omitted to do. Maybe so, but it needs to be demonstrated. A fuller explanation from BARDA would be helpful in that regard.

The decision to basically completely abandon research hasn't helped. Removing 10 million from a 12 million annual research program leaves someone to photocopy and go to a couple of conferences. Every researcher who stays will be looking for another job - you would be a fool to trust the company with your skills. The general and administration budget, on the other hand, sits at around 10 million pa.

In the last 3 months, the only thing we can say is that there was an avalanche of selling by institutions, and some insider buying.  Which is more important?

It might suggest that the company is no longer deemed an underpriced long term serious prospect for a significant company that will be rerated with growth. But more likely a short term kicker on a turnaround from an impossibly low base - a bottom that only the executives and some long term investors like us understand how ridiculously deep it was, even if it was a cashbox. Even it was... a NABI !  Maybe someone will attempt a reverse takeover of BOTA for a NASDAQ listing and the cash!

Any future share price lift from here if it comes will come from retail buyers and not the likes of Morgan Stanley. Further, there can't have been deals in negotiation, otherwise the buying wouldn't be allowed. So no pending deals either.

There's no doubt they are waiting on some clinical trial news and some BARDA negotiation outcomes to mix into the news flow. But the best they will get is some positive LANI trial results, and some extra cash from BARDA. Still way less prospects than they had 6 months ago. Maybe a partnering deal will follow. But partnering a one drug company with no researchers? There is no alternative vision offered to shareholders at present. The irony is that biotech is still enjoying a boom, so other people's assets are expensive.