TERRIBLE drop...I mean there are no buyers AT ALL for biotech stocks for the past several months...so, this selling volume is crushing the stock. This is stupid. Management should have realized the lack of volume and should have told employees that any insider selling would result in a huge sell-off in shares. Everyone should have held off. We are down 25% on this idiotic light volume selling.
That is just the ATHENA I trial...there are two trials ATHENA I and ATHENA II...so maybe 90 patients...but not sure what % get therapy vs. placebo. If 50-50, then 45 patients and 3 adverse events which is roughly 6.67%
Anyone know details...?????
I mean where talking about 3 patients out of the entire 2 trials who had adverse events...in a patient population that has heart disease. All three patients recovered or are recovering. Seems like such events should NOT be a surprise...and CYTX and the FDA just want to understand why they occurred before moving forward. Very logical.
News is unrelated to BARDA which is NOT about cardio.
Hard to get really excited...seems like company hit on all cylinders and so far from profitability. Plus, as the CEO states in the Press Release, the period of hyper growth is over. Seems investors have to wait SO LONG for positive EPS given current valuation. That's not where Wall Street is investing right now.
Because it's a game changing firm...oncologists change their patient therapy decisions in 30% of the cases based on what FoundationOne tells them...that will only increase. Major cost savings for healthcare industry.
Buy every dip.
It's a Big Data Company. You're analysis is 100% wrong.
Quest has signed up with Sloan Kettering to try to compete with FMI so this should, in theory, be a huge boost for CLRX business. There is so much value potential in what FMI is doing...it's extremely cheap...I suspect this industry will develop similar to medical electronic record keeping. I see a company like AthenaHealth partnering with FMI, and FMI partnering with BIOC to add blood-based testing results (not just tissue) into their database...ultimately, I see a lot of information tying into to the Medical Record. FMI is really a game-changer in how oncologists treat patients...nearly 30% changed their decision making based on FMI's info. That's staggering...and enormous savings. Soon, that type of data will be front-end in terms of preventive medicine. And, similar databases can be developed for non-cancer gene based disease.
Biotech buyers strike continues...sector rapidly becoming undervalued. FMI's database / testing platform well on its way to becoming 1st line defense - saves 30% mismanagement of cancer patients by healthcare provides, which is billions of dollars of savings.
The vast majority of the insider selling are Automatic Sales as part of pre-designed management trading programs...typical of other management selling programs across the market. BUT, given the lack of volume, this is forcing the stock down from recent highs.
Great time to add on this big pullback.
Sentiment: Strong Buy
Big boys starting to see potential in blood-based cancer testing. With its leadership position in this segment, BIOC is extremely well positioned in this soon-to-be mainstream testing.
Adding to shares...STRONG BUY
QIAGEN, AstraZeneca announce collaboration
QIAGEN (QGEN) announced a collaboration agreement with AstraZeneca (AZN) for the co-development and commercialization of a liquid biopsy-based companion diagnostic to be paired with IRESSA, AstraZeneca's targeted therapy for non-small cell lung cancer, or NSCLC. The project builds on a master framework agreement signed by both companies in 2013 and aims to develop and market a novel QIAGEN companion diagnostic that analyzes plasma samples to assess EGFR mutation status in NSCLC patients. The assay will be designed to guide the treatment of NSCLC patients with Astra Zeneca's oral monotherapy anti-cancer treatment when tumor tissue is not available. QIAGEN already offers the therascreen EGFR RGQ PCR Kit as a tissue-based companion diagnostic for lung cancer patients, which was approved in the U.S. by the FDA in July 2013 and in China in May 2014. The companies will collaborate to create a new companion diagnostic for IRESSA based on liquid biopsy samples from NSCLC patients, rather than requiring invasive surgical collection of tissue samples. Data from several studies, including the IFUM Study presented at the "World Lung 2013" conference, provided evidence of the ability to assess the EGFR status of advanced lung cancer patients using blood / plasma samples. This breakthrough provides hope for patients for whom surgical biopsy is not an option by enabling them to have their EGFR mutation status assessed using a less invasive method.
Sentiment: Strong Buy
There is no clearer sign that biotech related firms are WAY out of favor with this % decline on such low volume. The FED's ridiculous comments about biotech stocks - go ask Institutional Investors #1 Ranked Biotech Analyst for the Past 9 years - has caused a boycott of buying in the biotech sector...and this is leading to massive buying opportunities across the small-cap biotech sector (
Dilution was much lower than I thought it would be. Pricing is where I expected given Aegis was the underwriter and they are not very good. Based on some other companies that I've followed, I've noticed they really don't do spot secondaries well at all...don't have the institutional footprint compared to better shops. I think Mika didn't want to give the house away and that's why you only saw 1 million shares offered, which adds another 9 months of cash to the balance sheet. Curious to know which institutions stepped up to buy shares...
AMPE's OAK drug worked for 20 weeks, while FLXN's OA drug worked for 12 weeks (with some residual at 16 weeks). So, not sure why such a pop at the end of the day...probably benign FED policy helping small caps and biotech in general.
AMPE's 20 weeks extension of the AmpionTM SPRING study will be presented by Dr. Nathan Wei, MD of the Arthritis Treatment Center Frederick, MD at the Western Orthopedic Association Conference in July 2014. This 20-week extension of a multicenter, randomized, vehicle-controlled, double-blind study (NCT01839331) evaluated the safety and efficacy of a single intra-articular injection of Ampion™ treatment of inflammation-associated pain in symptomatic OA of the knee (OAK). A summary of the results follows:
• 97% patients who received a 4-mL intra-articular injection of Ampion™ or vehicle control were followed for an additional 8 weeks beyond the initial 12-week endpoint of the SPRING study. Efficacy measures included changes from baseline in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain and function subscores. Patients were considered “responders” if they achieved ≥40% improvement in WOMAC pain and function.
• In a subgroup of patients with moderate-to-severe OAK (Kellgren-Lawrence grades 3-4; n=64), there were statistically significant improvements in WOMAC pain (mean change from baseline -0.99 vs -0.65) (p=0.005) and function scores (-0.85 vs -0.58) (p=0.04) over 20 weeks for patients who received Ampion™ compared with vehicle control, respectively.
• At 20 weeks, the percentage of patients in the moderate-to-severe subgroup who reported a reduction in pain was significantly higher for patients who received Ampion™ (50%) compared to those who received vehicle control (25%) (p=0.04).
• A single injection of Ampion was associated with sustained impro in knee pain over 20 weeks (p=0.005)
I think getting out of Tegal and getting into CLRX when they did was a stroke of management genius. People told Mica he needed to bring in a heavy hitter to his board with real genetic / dna / testing experience and he did just that with the Chief Medical Officer of Life Technologies...that's not a slouch move. Tennenbaum did little with CLRX...he had some things in place but no deals. Mika has signed deals, with some big players. CLRX should really still be private and VC funded...this secondary should really be a Series B round. So, if at the end of this round of dilution, existing shareholders still have over 50% of the equity, that would be right in line with this firm's still development stage. I actually expect 1 more financing round after this...with existing shareholders ultimately holding 25% of the equity. But that 25% will be worth a hell of a lot of value.
You did get Affymetrix, Life Technologies, and Quest Diagnostics to use your service if it isn't good...whether CLRX is giving it away or not. So, there's a lot of value in the service, and ultimately, a ton of value in the data if CLRX can capture it....which is something that needs to be asked on the next conference call.
Now, if Mika is smart, he'll bring in a heavy hitter on the advertising front...because he's focused on that revenue, even though the revenue / test and the big data revenue (if it can be harnessed) are highly attractive.
Being a great investor is being willing to take emotion out of the context of your investment decisions. You are emotionlly scarred and should not invest in CLRX or short it really for that matter given your desire to knock Mika on his #$%$.
But, at the end of the day, proof is with revenue and earnings. So, time will tell whether Mika has turned Tegal #$%$ into CLRX gold. At least the CMO of Life Technologies was willing to do a transaction with CLRX and sit on its board of directors. That's a rather attractive endorsement.
You can crush Mika all you want. He blew up your savings. We all know that. You are on here every week badgered Mika, warning investors that he'll fleece them like you got fleeced. This is your place to find solace....we get it. We all understand. We feel your pain. We appreciate your warnings. We really do. But, the reality is several fold:
1) CLRX has made substantially more progress under Mika than it did under its founder, Marty Tenenbaum. So, any fear that you identified on the expiration of the non-compete in 2 years shouldn't bother anyone.
2) Mika hired Paul Billings, the former Chief Medical Officer of Life Technologies, to the Board. This was a very profound and astute appointment.
3) A secondary may not have been exactly foretold, but given the run-rate of cash flow usage and the start-up nature of CLRX, nobody should be surprised. We're only just getting going with NGS testing.
4) Mika has done a damn good job signing up some massive names like Quest Diagnostics and Life Technologies to use the CLRX information, and the MedPage app is also a pretty smart move given the potential distribution to oncologists. Foundation Medicine has built a dynamic organization and their whole gene testing ability, data analysis, and data bank blows away anything that any other diagnostic firm is doing. But, if you're another testing firm, like Quest and Life, you still need the output data information that CLRX is producing since you are unlikely to work with Foundation Medicine as they are a competitor. So, CLRX actually has a very attractive market position.
5) The Revenue model is the biggest question mark at CLRX as Mika is focused on an advertising based model with some revenue from each test. The limited revenue to date is mainly reimbursement revenue from Life and some from MedPage. Some of the secondary offering funds should be used to build up the sales & marketing & advertising team to support Mika's vision.
Add to CLRX post offering
Share count not disclosed. Probably will price about $1.75 - $2.25, depending on the size of the offering. With CLRX burning through $700-800k of cash per quarter, figure 2 million shares gives them another year of cash. By then, you'd expect at least a break-even business given the high software margins. This would increase the share count from 2.7 million to 4.7 million...very dilutive, but still such a tiny market capitalization that existing shareholders should make up for the dilution if CLRX can generate significant revenue. It will be interesting to see which institutional investors step up to purchase stock...personally, not a big fan of Aegis as an underwriter. But, CLRX has put together a nice little story in the first few innings of a future explosion of genetic testing.
FLXN's lead drug was effective in the system for 12 weeks (with some levels still seen at 16 weeks) vs. Ampio's drug Ampion which was effective for 20 weeks. So, what's the trade? Short FLXN, Long AMPE