because they have increased their holdings to almost 10%, and because they have an activist style. The threat of open warfare was probably averted: they got 2 board members and a CFO.
Broadfin probably got their extra shares from Baker Bros, who have
sold out of BOTA (at a major loss). So have RA, but I think Krensavage picked up their
shares. So, some rationalisation at the upper end of the register to
balance the disparate small (Aussie) end.
I notice Mr. Plumb had a significant vote registered against him for re-election in the AGM, and I need to presume he is holding out to control the large cashbox that is BOTA.
Maybe Broadfin will find out what is happening with the LANI ROW rights for us. Or why the company wants to raise $25 million more at any price.
The only value in BOTA is the cash and the LANI rights.
I think that at this point we probably have to put our faith in Broadfin, rather than the management and its aligned board, to represent shareholder interests. This might mean more activism, if the new board members and executive are isolated.
The main problem I see is that many major healthcare institutional funds have exited BOTA's register. They are unlikely to rejoin the company any time soon, especially if the majority of the current management and Board are mostly intact, so it's hard to see where the share price increase will come from.
The only solution to that problem is to sell the company. And that needs to happen before the cash is drained.
Tuesday 17 November 2015
Saturday 3 October 2015
25 million dollar capital raising
are these guys for real?
the distributors' deal allow them to sell those shares anyway they want - including on market!!! The fact they are using these guys and these methods would suggest that they may have burnt their bridges with hedge funds and reputable brokers.
this is the opposite of an on market share buyback. Like a giant put option placed by the company on its own shares.
It might be some kind of bizarre insurance policy to cover their salaries in the event any, or all, of their trials flop. What is an extra 25 million meant to do otherwise? So, rather than those trials producing some much needed upward price tension, we will have no share price rise into those top line reports due to the dilution and the fact that the distributors will sell into any strength for their 3% commission.
Raising cash into this weakened market for BOTA is a complete joke, and especially when they have spent a year boasting of their healthy cash balance.
sadly, i think they have completely crossed the line into penny dreadful territory.
I cannot believe the major shareholders are allowing this.
I wish someone would take them over.
the distributors' deal allow them to sell those shares anyway they want - including on market!!! The fact they are using these guys and these methods would suggest that they may have burnt their bridges with hedge funds and reputable brokers.
this is the opposite of an on market share buyback. Like a giant put option placed by the company on its own shares.
It might be some kind of bizarre insurance policy to cover their salaries in the event any, or all, of their trials flop. What is an extra 25 million meant to do otherwise? So, rather than those trials producing some much needed upward price tension, we will have no share price rise into those top line reports due to the dilution and the fact that the distributors will sell into any strength for their 3% commission.
Raising cash into this weakened market for BOTA is a complete joke, and especially when they have spent a year boasting of their healthy cash balance.
sadly, i think they have completely crossed the line into penny dreadful territory.
I cannot believe the major shareholders are allowing this.
I wish someone would take them over.
Thursday 1 October 2015
cash burn doesn't hurt everyone
Biota Pharmaceuticals, Inc. releases salary data. CEO sees compensation rise 110%
Biota Pharmaceuticals, Inc. just filed its annual proxy statement, which details the salary information of its key executives. In 2015, the company's CEO made 1,479,427.The table is included below:
|
Name and Principal Position
|
Year
|
Salary
($)
|
Bonus
($) |
Stock
Awards ($) (1) |
Option
Awards ($) (1) |
All Other
Compensation ($) |
Total
($)
|
|||||||||||||||||||
|
Joseph M. Patti
(3)
|
2015
|
477,000 | 431,250 | — | 797,098 | 32,829 | (4) | 1,479,427 | ||||||||||||||||||
|
President, Chief Executive Officer and Director
|
2014
|
408,000 | — | 120,156 | 149,375 | 25,995 | (4) | 703,526 | ||||||||||||||||||
|
2013
|
255,385 | 37,500 | 291,660 | 853,596 | 17,244 | (4) | 1,455,385 | |||||||||||||||||||
|
Russell H. Plumb
(2)
|
2015
|
318,750 | 172,500 | 98,000 | — | 30,080 | (5) | 878,080 | ||||||||||||||||||
|
Executive Chairman and Director
|
2014
|
525,000 | — | 192,250 | 239,000 | 28,256 | (5) | 984,506 | ||||||||||||||||||
|
2013
|
335,192 | 60,000 | 583,321 | 1,365,753 | 19,431 | (5) | 2,363,697 | |||||||||||||||||||
Wednesday 23 September 2015
Board changes
Well, one or several of the major shareholders have flexed their muscle and appointed 2 new Board members and asked Mr. Fox to resign. They are both biotech execs and board members and although they appear to be bona fide, increasing the size of this particular company's Board is nuts. The two new members don't give control, as the current members and executive members were all selected by Mr. Plumb.
Incidentally, Mr. Plumb sold a parcel of shares just before these changes were announced. And, he managed to sell them for 40 cents above the market price -lucky guy.
The lack of news on LANI becomes more noticeable. How it is possible to let this compound slip away is just beyond comprehension. Another northen hemisphere winter trial season passes, another year less patent life.
So, they pay 17 million for a antiviral gel Phase 1 tested on a couple of dozen patients in a deal done in a matter of months, while a compound like LANI has sat for over a year.
Incidentally, Mr. Plumb sold a parcel of shares just before these changes were announced. And, he managed to sell them for 40 cents above the market price -lucky guy.
The lack of news on LANI becomes more noticeable. How it is possible to let this compound slip away is just beyond comprehension. Another northen hemisphere winter trial season passes, another year less patent life.
So, they pay 17 million for a antiviral gel Phase 1 tested on a couple of dozen patients in a deal done in a matter of months, while a compound like LANI has sat for over a year.
Friday 11 September 2015
FY result press release: guess what word doesn't appear in the release
if you said INAVIR - correct!
Not once.
Inavir has been disappeared.
Not once.
Inavir has been disappeared.
Wednesday 15 July 2015
Some insight into the relenza patent issue
From the interview listed as news today
TLSR: Are you doing anything to rework Relenza (zanamivir) to extend the patent?
JP: No.
TLSR: But you've filed a request for a rehearing in a pending patent related to Relenza. Can you tell me a little more about that?
JP: It's interesting. This goes back to a 1994 patent application that was filed specific to the method of treatment by inhalation of Relenza. That patent was issued—and has since expired—in every country where an application was filed, except the U.S. In the United States, for whatever reason, we've never been able to get claims allowed for that application.
The issue stems from the patent office examiners' view of the claims as "obvious." We've tried for years, through expert witnesses, to make the counterargument—that in 1994 it wasn't obvious that an inhaled neuraminidase inhibitor would be effective for the treatment of influenza.
If we were to allow that application to be abandoned, and did nothing more to get the claims allowed, we would no longer receive royalties in the U.S. for Relenza.
My comment:
This is interesting, because investors were always told that there is specific IP and patentability in the compound-inhaler combination.
This states that it isn;t the case: that the delivery device is obvious, and doesn;t form a new patent.
3 issues:
1. I need to look back, but I'm pretty sure investors in Biota were always told (or assumed) that there was a patent for the combined compound - device
2. Glaxo could have pursued a change in delivery device at any time because it was not part of the patent. Not sure what FDA would have thought though, but if inhalation was obvious, then maybe a few extension studies with an MDI rather than the idiotic diskhaler might have been adequate
3. That the LANI compound - device combination may also not be patentable. The patent may extend only to the compound. Do we know this? If so, it means the patent clock is further advanced than previously thought.
TLSR: Are you doing anything to rework Relenza (zanamivir) to extend the patent?
JP: No.
TLSR: But you've filed a request for a rehearing in a pending patent related to Relenza. Can you tell me a little more about that?
JP: It's interesting. This goes back to a 1994 patent application that was filed specific to the method of treatment by inhalation of Relenza. That patent was issued—and has since expired—in every country where an application was filed, except the U.S. In the United States, for whatever reason, we've never been able to get claims allowed for that application.
The issue stems from the patent office examiners' view of the claims as "obvious." We've tried for years, through expert witnesses, to make the counterargument—that in 1994 it wasn't obvious that an inhaled neuraminidase inhibitor would be effective for the treatment of influenza.
"We have extensive patent coverage on composition of matter, method of use and method of manufacturing for all of our clinical programs."That's gone back and forth. We most recently filed an appeal because the previous brief was denied. Now we're waiting to see what the patent office comes back with. If we're denied again, we still have a few legal avenues to pursue. We'll work with GlaxoSmithKline to determine whether we pursue them.
If we were to allow that application to be abandoned, and did nothing more to get the claims allowed, we would no longer receive royalties in the U.S. for Relenza.
My comment:
This is interesting, because investors were always told that there is specific IP and patentability in the compound-inhaler combination.
This states that it isn;t the case: that the delivery device is obvious, and doesn;t form a new patent.
3 issues:
1. I need to look back, but I'm pretty sure investors in Biota were always told (or assumed) that there was a patent for the combined compound - device
2. Glaxo could have pursued a change in delivery device at any time because it was not part of the patent. Not sure what FDA would have thought though, but if inhalation was obvious, then maybe a few extension studies with an MDI rather than the idiotic diskhaler might have been adequate
3. That the LANI compound - device combination may also not be patentable. The patent may extend only to the compound. Do we know this? If so, it means the patent clock is further advanced than previously thought.
Tuesday 7 July 2015
Latest update
I have been away.
And for disclosure, I sold the majority of my holding since the last post, although it was to raise capital for other matters. I am still holding and would have held the whole amount due to the below. As you know it breached the 2.00 floor briefly. And why not, the Anaconda deal is such nonsense.
As I have mentioned before, the only value proposition in BTA is the value in Inavir.
We got a little more sense of that value in CSLs latest deal with Biocryst for permavir.
That is worthy of mention on a few fronts.
1. CSL has established influenza as a separate arm of the business bioCSL with its own executive director. Until now, it held the vaccines business. CSL is a major biopharmaceutical with its roots in Australia and has played big in plasma, vaccines and also developed the HPV vaccine. It has learnt through its activity in plasma that global market domination pays dividends.
2. It's strange that Biocryst would come up on CSLs radar. And the price it paid for permavir IV is higher than I would have expected. Biocrysts share price has done well.
3. The influenza treatment market is undervalued, and fragmented. No-one markets it well because they fear being labelled anti vaccine, even though with influenza vaccine that's a nearly reasonable proposition. That fragmentation leads to value, as we know looking at Biota's SP.
So, the CSL - Biocryst deal does put a better value on inavir.
It also signals a move by CSL into influenza treatment, albeit IV.
Further, CSL would already know Biota and probably watched with amusement at its value destruction over the decade. The attempted extension of relenza patent might be part of a wider deal.
Whether CSL is looking at inavir remains to be seen.
But if so, why look at raising more capital, as they seem to be preparing to do? The potential issue of another tranche of shares being issued by the company might be linked. Even in the US biotech bubble, its so hard to see them raising more capital to trial inavir themselves when they have burnt many bridges with capital markets and because the patent clock on inavir is ticking so fast.If some of their recent major holders think they should go it alone, and will back them, then quite frankly they are nuts.
So, in summary: if you think CSL has an interest in inavir, prospects might be brighter. Of course, that's difficult to assess unless you are an insider.
But if they announce a new capital raise to trial inavir themselves, it's good night from me. In that event I will sell the rest of my holdings.
And for disclosure, I sold the majority of my holding since the last post, although it was to raise capital for other matters. I am still holding and would have held the whole amount due to the below. As you know it breached the 2.00 floor briefly. And why not, the Anaconda deal is such nonsense.
As I have mentioned before, the only value proposition in BTA is the value in Inavir.
We got a little more sense of that value in CSLs latest deal with Biocryst for permavir.
That is worthy of mention on a few fronts.
1. CSL has established influenza as a separate arm of the business bioCSL with its own executive director. Until now, it held the vaccines business. CSL is a major biopharmaceutical with its roots in Australia and has played big in plasma, vaccines and also developed the HPV vaccine. It has learnt through its activity in plasma that global market domination pays dividends.
2. It's strange that Biocryst would come up on CSLs radar. And the price it paid for permavir IV is higher than I would have expected. Biocrysts share price has done well.
3. The influenza treatment market is undervalued, and fragmented. No-one markets it well because they fear being labelled anti vaccine, even though with influenza vaccine that's a nearly reasonable proposition. That fragmentation leads to value, as we know looking at Biota's SP.
So, the CSL - Biocryst deal does put a better value on inavir.
It also signals a move by CSL into influenza treatment, albeit IV.
Further, CSL would already know Biota and probably watched with amusement at its value destruction over the decade. The attempted extension of relenza patent might be part of a wider deal.
Whether CSL is looking at inavir remains to be seen.
But if so, why look at raising more capital, as they seem to be preparing to do? The potential issue of another tranche of shares being issued by the company might be linked. Even in the US biotech bubble, its so hard to see them raising more capital to trial inavir themselves when they have burnt many bridges with capital markets and because the patent clock on inavir is ticking so fast.If some of their recent major holders think they should go it alone, and will back them, then quite frankly they are nuts.
So, in summary: if you think CSL has an interest in inavir, prospects might be brighter. Of course, that's difficult to assess unless you are an insider.
But if they announce a new capital raise to trial inavir themselves, it's good night from me. In that event I will sell the rest of my holdings.
Wednesday 3 June 2015
CTO request was flagged in the last 10Q
which I read in some detail yesterday.
relates entirely to the Anaconda deal.
So, nothing to see or get excited about.
Sorry.
relates entirely to the Anaconda deal.
So, nothing to see or get excited about.
Sorry.
Friday 22 May 2015
trading strike
they may as well have placed the company in a trading halt - 8500 shares traded yesterday!
And I suspect that will be the case until the CTO is explained or lifted. Unlike other companies with ongoing business and other reasons to continue to trade, in this little guy the CTO now completely overshadows any notion of market transparency.
and given the BOTA past has held nasty rather than nice surprises, people are sitting on their hands.
And I suspect that will be the case until the CTO is explained or lifted. Unlike other companies with ongoing business and other reasons to continue to trade, in this little guy the CTO now completely overshadows any notion of market transparency.
and given the BOTA past has held nasty rather than nice surprises, people are sitting on their hands.
scenario to pass the time
someone had their eye on BOTA's cash.
then the Anaconda deal came along. Very generous deal to buy a French company trialling a topical treatment in Argentina. Yep, Argentina. Either genuine (silly) deal, or deliberate attempt to flush out suitor.
either way, new suitor in waiting doesn't want 8 million in cash gone and a bunch of new shares on the register.
new holder/suitor moves before Anaconda deal settles
trashes deal
company forcing suitors hand
executives and board get a few shares first
shareholders get a confidential treatment order, which is not much different to what we've been getting anyhow
...or not.
then the Anaconda deal came along. Very generous deal to buy a French company trialling a topical treatment in Argentina. Yep, Argentina. Either genuine (silly) deal, or deliberate attempt to flush out suitor.
either way, new suitor in waiting doesn't want 8 million in cash gone and a bunch of new shares on the register.
new holder/suitor moves before Anaconda deal settles
trashes deal
company forcing suitors hand
executives and board get a few shares first
shareholders get a confidential treatment order, which is not much different to what we've been getting anyhow
...or not.
Thursday 21 May 2015
Confidential Treatment Order
filed today.
no idea but hopefully pointing the way to M&A.
possibly a major/substantial shareholder selling to an acquirer, and company witholding release of that change in ownership. There are only 2 current holders in that major category that requires an announcement, I think.
or could be just more smoke and mirrors. The drop in shareprice would seem at odds with a positive view of the situation.
there are long time limits on these orders
let's see
no idea but hopefully pointing the way to M&A.
possibly a major/substantial shareholder selling to an acquirer, and company witholding release of that change in ownership. There are only 2 current holders in that major category that requires an announcement, I think.
or could be just more smoke and mirrors. The drop in shareprice would seem at odds with a positive view of the situation.
there are long time limits on these orders
let's see
Friday 15 May 2015
shareholder moves for last quarter
can be found here
http://whalewisdom.com/stock/bota : just make sure you nominate the 31/3 quarter
Sellers were Baker Bros, FMR, BVF, JP Morgan, Goldman Sachs, Venbio
Buyers included krensavage, ra and senzar topping up their initial purchases.
Broadfin and Clay (East Hill) were unchanged. There is a wider gap between these top 2 holders and the rest, I think.
What does it mean? I guess some of the bigger players who were in and are now out might have a more persistently negative bias toward the company in its future pursuits.
East Hill confound me. They have lost so much money on this company, and share that experience with all long holders. They must be easily placated. Broadfin have the capacity to become activist, but I wonder if they would here without a bigger stake.
The newer smaller entrants this past quarter might argue that the cash backing protects them from further falls from this current very low market cap, as does the small but steady royalty flow. Some truth there, except that groups they would expect to sell to in the future (see sellers above) may have had their fingers burnt.
Some avian flu around in US poultry, keeping the subject in the news.
http://whalewisdom.com/stock/bota : just make sure you nominate the 31/3 quarter
Sellers were Baker Bros, FMR, BVF, JP Morgan, Goldman Sachs, Venbio
Buyers included krensavage, ra and senzar topping up their initial purchases.
Broadfin and Clay (East Hill) were unchanged. There is a wider gap between these top 2 holders and the rest, I think.
What does it mean? I guess some of the bigger players who were in and are now out might have a more persistently negative bias toward the company in its future pursuits.
East Hill confound me. They have lost so much money on this company, and share that experience with all long holders. They must be easily placated. Broadfin have the capacity to become activist, but I wonder if they would here without a bigger stake.
The newer smaller entrants this past quarter might argue that the cash backing protects them from further falls from this current very low market cap, as does the small but steady royalty flow. Some truth there, except that groups they would expect to sell to in the future (see sellers above) may have had their fingers burnt.
Some avian flu around in US poultry, keeping the subject in the news.
Thursday 7 May 2015
Third quarter presentation
A brief summary would be: we're planning and starting several small Ph 1 and 2 trials over the next couple of years and hopefully distract you all from spending around 12 million (annualised) on salaries, general and admin expenses, legals etc.
Which would be great if the market attributed any value to the pipeline, but as you all can see, it doesn't. That might change, but only if and when they are successful. So, the market is heavily discounting this pipeline: it's virtually worthless at present.
Not a single word on LANI in the conference call.
The results release tells us they have not yet completed their brief to the FDA and therefore no request for, or date to, meet with them is yet scheduled.
And nothing on partnering that compound.
LANI is their only current asset worth anything and it appears it won't be in clinical trials this winter.
They are still appealing the USPTO decision on relenza, without explanation. It has been rejected several times, and presumably we are incurring some costs to assist our loyal friends at GSK.
Which would be great if the market attributed any value to the pipeline, but as you all can see, it doesn't. That might change, but only if and when they are successful. So, the market is heavily discounting this pipeline: it's virtually worthless at present.
Not a single word on LANI in the conference call.
The results release tells us they have not yet completed their brief to the FDA and therefore no request for, or date to, meet with them is yet scheduled.
And nothing on partnering that compound.
LANI is their only current asset worth anything and it appears it won't be in clinical trials this winter.
They are still appealing the USPTO decision on relenza, without explanation. It has been rejected several times, and presumably we are incurring some costs to assist our loyal friends at GSK.
Monday 20 April 2015
Simon Tuckers photo gone
from the management page of Biota's website.
If he is no longer with the company, then that excises all Australian senior connections with the company, with the exception of Jim Fox.
There are still a great number of Australian based shareholders who hold a significant number of shares. What an odd situation to have arrived at, although there were people present at the meeting to vote on the Nasdaq move who predicted this outcome.
If he is no longer with the company, then that excises all Australian senior connections with the company, with the exception of Jim Fox.
There are still a great number of Australian based shareholders who hold a significant number of shares. What an odd situation to have arrived at, although there were people present at the meeting to vote on the Nasdaq move who predicted this outcome.
Wednesday 8 April 2015
CEO buys shares
Normally, a good thing. Especially when SP is near its lows.
But, it also means there is no M&A on, or near, the table.
I'd prefer M&A.
But, it also means there is no M&A on, or near, the table.
I'd prefer M&A.
Friday 20 March 2015
A question for you
Did Biota's announcement yesterday mean that they have been granted an extension of patent (and therefore royalties) over relenza, or not? Read it
As previously reported on August 25, 2014, GlaxoSmithKline, plc (GSK) filed an appeal to the United States Patent Trial and Appeal Board in relation to the pending patent application No. 08/737,141 related to Relenza ® . On March 16, 2015, the company was informed that the United States Patent Trial and Appeal Board had issued a decision denying the appeal and affirming the Examiner’s prima facie case of obviousness rejection under 35 U.S.C. 103(a). GSK and the company intend to pursue available legal options with respect to this decision and to continue to seek issuance of this pending patent. No assurance can be given that the pursuit of any such options will be successful. Issued patents relating to Relenza ® outside of the Unite States are unaffected, and will expire in May 2015 in the major countries of the European Union, and July 2019 in Japan.
Trying to find a plain English translation somewhere.
It appears GSKs appeal against patent extension was denied. Why are both GSK and BOTA pursuing legal options?
As previously reported on August 25, 2014, GlaxoSmithKline, plc (GSK) filed an appeal to the United States Patent Trial and Appeal Board in relation to the pending patent application No. 08/737,141 related to Relenza ® . On March 16, 2015, the company was informed that the United States Patent Trial and Appeal Board had issued a decision denying the appeal and affirming the Examiner’s prima facie case of obviousness rejection under 35 U.S.C. 103(a). GSK and the company intend to pursue available legal options with respect to this decision and to continue to seek issuance of this pending patent. No assurance can be given that the pursuit of any such options will be successful. Issued patents relating to Relenza ® outside of the Unite States are unaffected, and will expire in May 2015 in the major countries of the European Union, and July 2019 in Japan.
Trying to find a plain English translation somewhere.
It appears GSKs appeal against patent extension was denied. Why are both GSK and BOTA pursuing legal options?
Tuesday 3 March 2015
press releases index
it's heartening to see news coming.
Commencing vap trial and presenting at conferences is all positive.
We really need to see the press release announcing the rest of world deal for LANI. Based on the anaconda deal numbers it should be worth much more than I have previously proposed. And I hope the anaconda deal was done with the understanding that the LANI deal would soon increase cash reserves.
So with RSV compound at Phase 1, Vapendavir in Phase 2 b, Anaconda's drug coming to Phase 2b, and LANI potentially at Phase 3: well, that's reasonable biotech-bait.
Commencing vap trial and presenting at conferences is all positive.
We really need to see the press release announcing the rest of world deal for LANI. Based on the anaconda deal numbers it should be worth much more than I have previously proposed. And I hope the anaconda deal was done with the understanding that the LANI deal would soon increase cash reserves.
So with RSV compound at Phase 1, Vapendavir in Phase 2 b, Anaconda's drug coming to Phase 2b, and LANI potentially at Phase 3: well, that's reasonable biotech-bait.
Friday 27 February 2015
Here's what BOTA bought for 16 million up front
as described in the abstracts of the 2013 Eurogin conference (see below comments).
It's good to see some movement, but the questions are all pretty obvious:
* the phase 2a was in 24 subjects of which 16 received the drug. While the statistical power wasn't formally sought, the differences with control were better but weren't huge. A lot of money for a compound tested in16 patients; and
* HPV subtypes 6 & 11 will gradually but definitely reduce in incidence and prevalence due to Gardasil and Cervarix vaccines, especially if countries vaccinate their boys as well as girls.
The market hasn't responded well so far. Cash is the Biota SP's best friend, and they just snubbed him.
*************************************************************************
SS 15-5
SAFETY, PHARMACOKINETICS AND EFFICACY PHASE II-A STUDY OF AP611074, A HPV-SPECIFIC TREATMENT
FOR ANOGENITAL WARTS:
Fouéré S1, Marchitelli C2, Tatti S3, Galimberti R2, Halioua B4, Dupin N5, Françon P6, Compère D6, Yaniv M7, Thierry F7,8,
Botchan M9, Blumenfeld M6 & Chosidow O10.
1STD Clinic, Hôp. St Louis, Paris, France; 2 Depts of Gynecology and Dermatology, Hospital Italiano, Buenos Aires, Argentina; 3 IADT, Buenos Aires, Argentina; 4STD
Clinic, Institut Alfred Fournier, Paris, France; 5Dept of Dermatology, Hôp. Cochin, Paris, France; 6Anaconda Pharma, Villejuif, France; 7Institut Pasteur, Paris, France;
8IMBaStar, Singapore; 9Dept Biochemistry and Mol Biol, UC Berkeley, USA ; 10Dept Dermatology, AP-HP, Hop. Henri Mondor, and UPEC, all in Créteil, France
Objectives: AP611074 is a new chemical drug that selectively inhibits the interaction of E1 and E2 proteins of HPV 6 and 11, and thus blocks HPV DNA replication. In
this study, we aimed to obtain proof-of-concept study of AP611074 in the topical treatment of anogenital warts (condyloma) related to HPV 6 or 11 infection.
Methods: We performed a phase IIa double-blind randomized clinical trial study to assess the safety, tolerability, efficacy and pharmacokinetics of twice daily repeated
applications of AP611074 5% gel during 42 days on the anogenital lesions of condyloma patients. Twenty-four patients (both males and females) were included and randomized
2:1 (AP611074 vs excipient). The study was multicentric and conducted between February 2012 and July 2013 in four clinical centers located in Paris, France
and Buenos Aires, Argentina. Main inclusion criteria were: male or female patient aged between 18 and 55 years ; BMI between 18 and 30 kg/m2 ; external condylomas,
1-15 lesions, non-confluent and individually isolated ; total lesion surface smaller than 5 cmÇ, and individual lesion surface smaller than 1 cmÇ ; lesions should be
easily measured by the Investigator using a “French Catheter Scale”. Safety, PK and efficacy evaluated by Investigators every week until the end of sudy visit. After completing
the 42 days treatment, patients were observed 14 days post-treatment. Non responder subjects underwent a biopsy of 1-2 lesions at end of study (EOS) visit to
assess if remaining lesions contain HPV6 and/or HPV11. The efficacy objective was assessed after 6 weeks of treatment through primary efficacy end point of complete
clearance rate, secondary efficacy end points of partial clearance and overall response rate, and an additional exploratory analysis of the reduction of the total condyloma
baseline area.
Results: AP611074 topical treatment was shown to be safe with low systemic exposure and was well tolerated as shown by high patient compliance and lack of adverse
events.
Plasma concentrations of AP611074 were very low, steady state was rapidly achieved, no drug accumulation was observed over the 6 week-treatment and no drug was
quantifiable 2 weeks after stopping the treatment.
Efficacy end points showed complete clearance rates of 13% (CI95%: 4-36%), partial clearance of 44% (CI95%: 23-67%), and overall response of 56% (CI95%: 33-77%) in
the FAS population while in the PP population, these rates increased to 20% (CI 95%:6-51%), 50% (CI95%:24-76%) and 70% (CI95%:40-89%), respectively. As expected,
due to the very low power of the trial (<10%), no differences were observed in the primary and secondary efficacy end points in the intergroup comparison.
When the condyloma area was analyzed after 6 weeks of treatment, a 65% reduction of the baseline lesion area was observed in the AP611074-treated patients. This
reduction was statistically significant (p=0.020) when before/after treatment areas were compared intragroup.
Conclusions: AP611074 showed elevated rates of complete and partial clearance and overall response, as well as statistically significant reduction of the baseline lesion
area. The clinical effect that has been observed in this first trial of 6 weeks duration needs to be further investigated in larger adequately powered efficacy and safety
studies of longer duration.
AP611074 is the first drug candidate designed to block HPV replication to enter clinical development, and one of the first examples to show that Protein-Protein
Wednesday 18 February 2015
and krensavage too
Krensavage a little late on reporting its buy..
That's another specialist bio fund, and one that likes to buy companies rather than drug prospects.
That's another specialist bio fund, and one that likes to buy companies rather than drug prospects.
Read all about it
The new positions in Biota were published today (for transactions in the quarter ending 31 December).
Many funds had either significantly sold down or completely sold out of Biota in that quarter, explaining the large chunky sales.
BlackRock and JP Morgan were the heaviest sellers.
In their place 2 or 3 specialist biotech funds have emerged as holders: RA Capital, Senzar Asset Management and to a smaller extent a new fund Venbio.
Further, East Hill emerged from its hibernation and bought another 400,000 taking it to just under 10% of the company.
Baker Bros and a couple of others held their nerve. Broadfin is still there, but didn't buy more.
And why not I guess: the stock is at cash backing, so hopefully it has hit the bottom. Unlike some biotechs with no cash, where the bottom can be very deep and distant.
One small thing that emerges are the number of links to Vertex: Landon Clay, RA Capital, and a couple of other smaller links.
The BIO CEO presentation was interesting. Not so much for the presentation, but for the questions. Biota management get to field very few questions publicly. Joe Patti was forced to acknowledge a key issue in the company's strategy for vapendavir. If they keep ignoring it, it won't go away.
Vap might prove to be effective, in asthmatics with proven HRV infection. Let's say it is, for the sake of argument.
The subset of proven HRV to clinically enrolled HRV might be as low as 40%. OK. When the drug goes to the FDA itself and its subcommittees, it's plausible, maybe even likely, that the FDA might say two things:
1. That any level of adverse effect is unacceptable (see plecoranil) given many people without HRV might take it and/or
2. That it's not reasonable to treat the 60% of people with clinical common cold symptoms who don't have HRV to get a response in the 40% who do. This is because HRV is self-limiting. SO, they might approve the drug in proven HRV exacerbations. Which would be fine, if there was a rapid HRV test. Which there isn't yet.
The BARDA contract is nearly disentangled. That became more of an issue than analysing or explaining why they stopped the trial. We have very little information on that.
Relenza and LANI will earn a little more than expected this FY which is great news because the only thing supporting the sp is cash, and the more BOTA burns cash the more the sp will drop.
Finally, no news on LANI. A 10-20 million dollar upfront and a few % royalty is probably all that can be hoped for, but there will be some element of credibility in inking a deal, and the cash will be useful as an addition to a takeover... sometime next year.
I don't know what East Hill and Broadfin are asking management and the board to do. But settling BARDA, settling LANI, and packaging the cash and royalty streams with vapendavir and RSV might be somebody's idea of a reasonable purchase.
Many funds had either significantly sold down or completely sold out of Biota in that quarter, explaining the large chunky sales.
BlackRock and JP Morgan were the heaviest sellers.
In their place 2 or 3 specialist biotech funds have emerged as holders: RA Capital, Senzar Asset Management and to a smaller extent a new fund Venbio.
Further, East Hill emerged from its hibernation and bought another 400,000 taking it to just under 10% of the company.
Baker Bros and a couple of others held their nerve. Broadfin is still there, but didn't buy more.
And why not I guess: the stock is at cash backing, so hopefully it has hit the bottom. Unlike some biotechs with no cash, where the bottom can be very deep and distant.
One small thing that emerges are the number of links to Vertex: Landon Clay, RA Capital, and a couple of other smaller links.
The BIO CEO presentation was interesting. Not so much for the presentation, but for the questions. Biota management get to field very few questions publicly. Joe Patti was forced to acknowledge a key issue in the company's strategy for vapendavir. If they keep ignoring it, it won't go away.
Vap might prove to be effective, in asthmatics with proven HRV infection. Let's say it is, for the sake of argument.
The subset of proven HRV to clinically enrolled HRV might be as low as 40%. OK. When the drug goes to the FDA itself and its subcommittees, it's plausible, maybe even likely, that the FDA might say two things:
1. That any level of adverse effect is unacceptable (see plecoranil) given many people without HRV might take it and/or
2. That it's not reasonable to treat the 60% of people with clinical common cold symptoms who don't have HRV to get a response in the 40% who do. This is because HRV is self-limiting. SO, they might approve the drug in proven HRV exacerbations. Which would be fine, if there was a rapid HRV test. Which there isn't yet.
The BARDA contract is nearly disentangled. That became more of an issue than analysing or explaining why they stopped the trial. We have very little information on that.
Relenza and LANI will earn a little more than expected this FY which is great news because the only thing supporting the sp is cash, and the more BOTA burns cash the more the sp will drop.
Finally, no news on LANI. A 10-20 million dollar upfront and a few % royalty is probably all that can be hoped for, but there will be some element of credibility in inking a deal, and the cash will be useful as an addition to a takeover... sometime next year.
I don't know what East Hill and Broadfin are asking management and the board to do. But settling BARDA, settling LANI, and packaging the cash and royalty streams with vapendavir and RSV might be somebody's idea of a reasonable purchase.
Friday 16 January 2015
JP Morgan Conference Presentation
is posted on the BOTA website.
They seem to have streamlined their strategy and it's presentation. There is no further mention of BARDA and efforts to reclaim $. The (re) analysis of LANI outcomes is encouraging.
It's organised and plausible. They have a package with near term plans for RSV at Phase 1, vapendavir at Phase 2 and LANI still sitting at Phase 3.
However, they are giving themselves all of 2015 to partner ROW LANI.
Vapendavir Phase 2b and RSV Phase 1 won't have results till mid 2016, by which time their cash position will be a lot less than now. I really wish they would look at a rapid test for rhinovirus.
The only value adding step in the near term is partnering LANI. But a year is a long time and the share price doesn't have that luxury.
They seem to have streamlined their strategy and it's presentation. There is no further mention of BARDA and efforts to reclaim $. The (re) analysis of LANI outcomes is encouraging.
It's organised and plausible. They have a package with near term plans for RSV at Phase 1, vapendavir at Phase 2 and LANI still sitting at Phase 3.
However, they are giving themselves all of 2015 to partner ROW LANI.
Vapendavir Phase 2b and RSV Phase 1 won't have results till mid 2016, by which time their cash position will be a lot less than now. I really wish they would look at a rapid test for rhinovirus.
The only value adding step in the near term is partnering LANI. But a year is a long time and the share price doesn't have that luxury.
Saturday 10 January 2015
Volume: like smoke, there's gotta be fire
The volume of shares recently traded in Biota is unusually high. Also, the trading is lumpy. The share price has increased, at times hitting 2.80 before settling back again.
US trading is notoriously opaque, so the market is none the wiser. Whether its new entrants, or holders adding or selling we really don't know until the end of quarter reporting and that's 6 weeks delayed. Apparently the high frequency trading skills don't extend to high frequency reporting.
It looks to be a nasty northern hemisphere influenza season. And the CDC is (rightly in my view) recommending early antiviral treatment.
But seasonal sales of relenza always disappoint. There is no marketing, poor stocking, and so sales are minimal. Other than a surprise Japanese stockpiling order early in the year, I don't expect much from relenza sales the rest of the FY. So, that can't explain it.
Inavir sales for this winter won't be reported until full years results in May.
And we know the R&D calendar is set way back.
Any end of FY rebalancing shouldn't have continued into the first week of the new year, and it has.
And, a BARDA settlement would be just cash, which is great, but a one-off.
So, I can only speculate this level of activity is a balance between large holders wanting out, and someone else confident of, or planning, corporate activity. It's a level of turnover that's just too high to be normal. And, I'm a firm believer that unexplained share movements always have an (eventual) explanation.
US trading is notoriously opaque, so the market is none the wiser. Whether its new entrants, or holders adding or selling we really don't know until the end of quarter reporting and that's 6 weeks delayed. Apparently the high frequency trading skills don't extend to high frequency reporting.
It looks to be a nasty northern hemisphere influenza season. And the CDC is (rightly in my view) recommending early antiviral treatment.
But seasonal sales of relenza always disappoint. There is no marketing, poor stocking, and so sales are minimal. Other than a surprise Japanese stockpiling order early in the year, I don't expect much from relenza sales the rest of the FY. So, that can't explain it.
Inavir sales for this winter won't be reported until full years results in May.
And we know the R&D calendar is set way back.
Any end of FY rebalancing shouldn't have continued into the first week of the new year, and it has.
And, a BARDA settlement would be just cash, which is great, but a one-off.
So, I can only speculate this level of activity is a balance between large holders wanting out, and someone else confident of, or planning, corporate activity. It's a level of turnover that's just too high to be normal. And, I'm a firm believer that unexplained share movements always have an (eventual) explanation.
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