I meant a deal like Presidio where they were going to merge and become a new company...I don't mean Presdio themselves.
I think BCRX needs to beef up their pipeline...they're beefing up their staff and research center.
No, no, no...My two guesses are:
1. They can't add any new info to the last CC especially on the 7353 trial, so why put yourself into that situation.
2. A potential merger is in the works like the Presidio deal that would change the makeup of BCRX.
Update: BCRX will NOT be at this FBR conference...doesn't matter much as this is not a public presentation event. However, they were on the list and now they're not (confirmed by BCRX).
Secondly: Noticed they are not at the Rodman & Renshaw conference on Sept. 9th (confirmed by BCRX). They were there last year and HCW has a $24 PT on BCRX.
Rodman & Renshaw 17th Annual Global Investment Conference
Sponsored by H. C. Wainwright & Co.
Date: September 8 - 10, 2015
I just think it's interesting but can't read the tea leaves here.
Why would Kalvista join the HAE race for an oral solution? Why would RA Capital jump in to fund them?
Why would GBT (new IPO THIS MONTH) use 15 Mln to go after an oral HAE drug?
Big First-Day Pop for Global Blood Therapeutics IPO
By Paul Ausick August 12, 2015
"Global Blood Therapeutics plans to use about $65 million to complete development and trials of its sickle cell disease treatment and another $15 million or so to begin trials of an oral treatment for hereditary angioedema."
HAE, as stated by BCRX, is a guaranteed disease where kallikrein inhibition is proven, therefore the easiest to attain FDA approval.
But why do two other companies jump into a small space and are way behind??? My opinion is if kallikrein inhibition proves to benefit multiple diseases, like the HCV space, multiple companies will want a kallikrein inhibitor...it's not about HAE, that's just the bridge.
Q&A from the cc:
Charles Duncan - Piper Jaffray
Okay. That’s helpful and then as we move into the other second-gen compounds or maybe even third-gen compounds. Would you see these as backups or fundamentally different opportunities relative to a more or less stand for 161 and 7353 could those actually open up new indications beyond HAE?
Dr. Sheridan: ..."once we have these tools that could be used in laboratory research to probe other diseases that might have significant contributions from the contact activation system and kallikrein and bradykinin pathway that would be very good tools to use to interrogate those diseases."
Stonehouse: ..."And I think the beauty of having multiple molecules is you don’t make it a messy situation where you've got one drug that’s for bunch of different indications and there could be pricing issues and all those other stuff. We have distinctly different molecules which makes that a little bit easier."
The cluster grows over 100
81) #1472 - Male, 109, Saudi, stable, Riyadh, Saudi Arabia
82) #1473 - Male, 87, Saudi, stable, Riyadh, Saudi Arabia
83) #1474 - Male, 72, Saudi, stable, Riyadh, Saudi Arabia
84) #1475 - Male, 71, Saudi, stable, Riyadh, Saudi Arabia
85) #1476 - Female, 58, Saudi, stable, Riyadh, Saudi Arabia
86) #1477 - Female, 40, Expat, health care worker, stable, Riyadh, Saudi Arabia
87) #1478 - Male, 63, Saudi, stable, Riyadh, Saudi Arabia
88) #1479 - Female, 57, Saudi, stable, Riyadh, Saudi Arabia
89) #1480 - Male, 41, Saudi, stable, Riyadh, Saudi Arabia
90) #1481 - Male, 61, Saudi, stable, Riyadh, Saudi Arabia
91) #1482,- Male, 49, Saudi, stable, Riyadh, Saudi Arabia
92) #1483,- Female, 27, Expat, health care worker, stable, Riyadh, Saudi Arabia
93) #1484,- Male, 26, Saudi, stable, Riyadh, Saudi Arabia
94) #1485 - Male, 78, Expat, critical, Riyadh, Saudi Arabia
95) #1486 - Female, 40, Saudi, critical, Riyadh, Saudi Arabia
96) #1487 - Male, 69, Saudi, critical, Riyadh, Saudi Arabia
97) #1488 - Female, 58, Expat, health care worker, stable, Riyadh, Saudi Arabia
98) #1489 - Female, 26, Expat, health care worker, stable, Riyadh, Saudi Arabia
99) #1490 - Male, 42, Saudi, stable, Riyadh, Saudi Arabia
100) #1491 - Male, 82, Saudi, stable, Riyadh, Saudi Arabia
101) #1492 - Male, 38, Saudi, stable, Riyadh, Saudi Arabia
102) #1493 - Female, 72, Saudi, critical, Riyadh, Saudi Arabia
103) #1495 - Female, 64, Expat, critical, Riyadh, Saudi Arabia
104) #1496 - Male, 75, Saudi, stable, Riyadh, Saudi Arabia
105) #1497 - Female, 51, Saudi, stable, Riyadh, Saudi Arabia
One response from the cc that relates to other indications is below. It seems BCRX can let others do the initial exploring and if it is evident that other diseases benefit then BCRX has multitude of backup solutions to explore (by themselves or in partnerships). Maybe we're at the early stages of another HCV explosion.
Bill Sheridan: ...So all of that being said, I think your other question was around other indications. I think I would reiterate two things. One is, right now the clinical program is focused on HAE and it’s focused, focused, focused.
However, we’re not ostriches with our head in the sand, and once we have these tools that could be used in laboratory research to probe other diseases that might have significant contributions from the contact activation system and kallikrein and bradykinin pathway that would be very good tools to use to interrogate those diseases. So we’ll have those tools.
Kiwi, I didn't sense they backed off the once-a-day mantra, they mentioned it multiple times. The BofA question lead them to this answer that does bring the twice a day solution but I don't see concern with that one way or another.
"Tazeen Ahmad - Bank of America
Hi, good morning. Thanks for taking my questions. Just follow-up on 7353. You said a few times already on the call that your goal is to be a one pill per day, I’m just wondering is after you get to the end of this study, if for whatever reason it looks like 7353 might work better, let’s say as BID, would that be a non-starter for you to move forward with this molecule?
Jon Stonehouse - CEO
No. Because it’s an improvement over oral-stat. Right, so if it’s got the efficacy that we’re expecting which would be the mimic to normal phenotype and wipe out attacks, I think twice a day would be fine.
Our goal and the way we chose 7353 and the way we chose the backups was for one pill once a day, but if we ended up with twice a day, I think that's still a highly attractive drug."
KalVista snags $33M from big-name VCs to speed plasma kallikrein inhibitors into clinic
...Like KalVista, Dyax is looking at disorders related to plasma kallikrein and is active in the treatment of HAE.
KalVista is well behind Dyax--which has already won approval for Kalbitor--but is hoping its oral formulation will give it an edge in HAE. The oral HAE treatment is one part of the preclinical pipeline KalVista is working to move toward the clinic. An oral therapy for DME is also in early-stage research. Collectively, the oral assets and more advanced, intravitreally delivered DME drug KVD001 represent a broad bet on the role of the enzyme plasma kallikrein in a clutch of diseases.
The enzyme system is known to play a role in HAE and may be involved with DME, inflammatory bowel disease, rheumatoid arthritis, microvascular complications of diabetes and other disorders, a breadth that means sizable markets could open up to KalVista and its competitors. Whether this happens will depend in part on the strength of the underlying scientific idea, which is based upon a belief that unusual activity of kallikrein--which normally triggers a cascade response at the sites of vascular injuries--is involved with the development of disorders.
... Existing investors Novo A/S and SV Life Sciences are financing the push with RA Capital Management, Longwood Fund and Venrock. RA Capital led the round, bagging itself a seat on the board and a stake in a second company involved with kallikreins, a subgroup of serine proteases.
"The Department of Health and Human Services’ annual Agency Financial Report provides fiscal and high-level performance results that enable the President, Congress, and American people to assess our accomplishments for each fiscal year (October 1 through September 30)"
They unloaded a potential $145,000,000 contract on Pfenex Aug. 17th.
In a deal potentially worth up to $143.5 million, the Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) said it would partner with Pfenex to develop Px563L, a mutant recombinant protective antigen anthrax vaccine.
...Pfenex hopes to achieve a procurement contract and to help the government achieve the goal of stockpiling 75 million active doses.
SNS, 4430 contracts....spend some 2015 money Robin.
MERS coronavirus infections have soared in Saudi Arabia ahead of the hajj pilgrimage, killing three people and forcing a Riyadh hospital to close its emergency ward, officials and newspapers said Thursday.
...Saudi Arabia, preparing to host more than two million Muslims from all over the world for the annual hajj to Mecca and Medina, Islam's holiest sites, expected to start on September 21, is the country worst hit by the coronavirus.
Yep, they could have handled the trial extension better...should of had a pre-market CC.
China has not been helpful either.
In the context of this thread, BCRX is known to have surprise announcements. Even the CSL deal in June was not forcasted in any CC.
I don't think we'll have to wait until 4Q for some type of important announcement. Whether that's stockpile or partnership...I don't know...6 weeks and counting to see if I'm correct.
I do not expect a straight up buyout. I've been told as much by Rob. They want to grow investor value to greater potential.
They've jacked up their Dr. head count and marketing people...seems a little top heavy for what they currently have in the pipeline.
Plenty of new offices in Birmingham coming up, and plenty of space in Durham.
For conversation purposes.
Remember how the Presidio deal came out of nowhere and left as fast as it came (no harm no foul).
What are the chances BCRX is cooking up a new combination with another company?
I think it would be prudent as their own pipeline is thin, yet potent...but to protect investor value they could use more pipeline options for success. If 7353 had issues the next HAE molecule has 2 years to catch up.
They need more meat on the bone and it wouldn't surprise me to hear an announcement come out of nowhere. Remember at the BofA cc, Stonehouse said they would not be opposed to adding another company's biologic.
New jobs listed today:
Job Title: Biologist I
Job Location: Birmingham, AL
Support assay design, optimization, validation, and data analyses. Design and execute molecular and cell biology experiments. Troubleshoot and analyze data in support of drug discovery projects. Experience in molecular biology techniques.
Department: Discovery Chemistry
Job Title: Chemist I
Job Location: Birmingham, AL
Carry out reactions and synthesize compounds assigned on a daily basis, purification of compounds using various purification techniques. Knowledge to interpret spectral data of the compound purified. Good written skills to document experiment conducted on a daily basis.
SUMMARY: The Centers for Disease
Control and Prevention (CDC) within
the Department of Health and Human
Services (HHS) is proposing to add
certain influenza virus strains to the list
of HHS select agents and toxins.
Specifically, we are proposing to add
the influenza viruses that contain the
hemagglutinin (HA) from the Goose
Guangdong/1/96 lineage (the influenza
viruses that contain the hemagglutinin
(HA) from the A/Gs/Gd/1/96 lineage),
including wild-type viruses, as a nonTier
1 select agent.
We are also
proposing to add any influenza viruses
that contain the HA from the A/Gs/Gd/
1/96 lineage that were made
transmissible among mammals by
respiratory droplets in a laboratory as a
Tier 1 select agent.
We have determined
that these influenza viruses have the
potential to pose a severe threat to
public health and safety
Moving the CC to 8;30 ET allowing time to discuss before the market opened would have been nice. It left for 1.5 hrs. of uncertainty and the unknown was taken advantage of to push the pps lower.
4430 was glossed over too. BCRX and NIH had 8 months to complete this trial and we're just now going into the second stage. No discussion other than they're moving into the 2nd portion of the trial. It comes across that the govt. wants little said about the details / progress, I think that's unfortunate.
I guess they can't say much about the SNS, but some type of update that "we're in discussions and getting closer..." There's no transparency to what's going on and something should be said... come on it's not to be that big of a secret, give us some crumbs off the table at least.
That being said, I'm not unhappy with management, but I hope they learned from this last cc to approach it a little smarter next time.