Thursday, February 26, 2015

Biotech Investing: Merrimack (MACK) stops trial of MM-111

Merrimack ceased Phase 2 trials of its investigatory drug MM-111 after the DSMB review showed that Progression Free Survival was worse in the compounds arm versus the control arm.  The company has a number of compounds in its pipeline so it's not a huge hit but still a negative.

The company's lead compound, MM-398, is being submitted to the FDA to treat Pancreatic Cancer.  I would expect the PDUFA date sometime in the 4th quarter of this year which is a major trade catalyst.

Also, they hinted in today's 4th quarter results call that they are looking to secure a partner prior to initiating a pivotal trial in breast cancer with another advanced compound, MM-121.  I wouldn't be surprised if they come through with a partner based on the impressive Phase 2 results in the subgroup that they plan to target in the pivotal trial.

Good luck fellow Biotech Investors!

Saturday, February 21, 2015

Biotech Investing: Upcoming Trade Catalyst Targacept (TRGT)

Targacept (TRGT) is a stock to consider with an upcoming catalyst expected in the second quarter.  The company will report phase 2 results on its sole compound, TC-6499, for the treatment of diabetic gastroparesis.

Usually I wouldn't touch a company with only one drug in development in one indication but I believe this may a unique value proposition.  If the trial is successful, the stock will make a major move as it's currently priced with zero expectations of a positive result.  The company had over $115 million in cash and short/long term investments at the end of Q32014 while the market cap is under $90 million.  Even if the results come back negative, the company has the cash to in-license a compound or be a reverse merger candidate for a private company looking to go public (and get $100 million in cash in the process).

I've got 10,000 shares of Targacept as I like the risk vs. reward and possible positive scenarios.

Do you own due diligence and best of luck fellow biotech investors!


Biotech Investing: Spectrum Pharmaceuticals (SPPI) loses patent suit

Spectrum (SPPI) fell by as much as 35% in after-hours trading on Friday after documents (link below) were released that it lost a lawsuit against generic company Sandoz regarding it's lead product Fusilev.  The company sued Sandoz back in 2012 after the generic maker filed an ANDA to sell a generic equivalent of the drug.

The stock dropped and I doubled down on my position at $4.90.  There's already a similar generic drug that competes in that space so I don't expect an immediate or material sales drop in the near future.  Spectrum just got approval for Beleodaq last quarter and recently filed an NDA for Captisol-enabledTM which is expected to be approved later in the year.  These two additional drugs within their portfolio should more than offset any decrease in sales due to this generic competition.  

Hope everyone is having a great weekend and wouldn't sweat this news at all.  

http://www.scribd.com/doc/256408907/SPPI

Friday, February 20, 2015

Biotech Investing: Spectrum Pharmaceuticals (SPPI) - WTF?

Spectrum (SPPI) plummeted 33% in after-hours trading today on no news or sec filing.  I reached out to the company and haven't received a response.  Insider trading?  This definitely deserves the Biotech Investor WTF going into the weekend.

Have a good weekend fellow Biotech Investors!

Thursday, February 19, 2015

Biotech Investing: Exelixis (EXEL) strong run may continue

Exelixis (EXEL) is up over 70% YTD and there's a few good reasons the stock could continue to climb. After disappointing Phase 3 Prostate results last year sent the stock plummeting from from highs of $8 in early 2014 to a low of $1.29 at the end of the year, the stock has come back strong over this past month and currently sits at $2.82. Why? The company has two major catalysts within the next six months including today's announcement that the FDA has assigned a priority review PDUFA date of August 11th for it's compound co-developed with Roche to treat skin cancer.  The results of the Phase 3 study of Cobimetinib  in combination with vemurafenib vs. vemurafenib alone met its primary endpoint of Progression Free Survival with a hazard rate of .51 (aka doubled the PFS vs. the control arm).  These results are impressive and can't imagine the FDA won't approve the drug (though anything can happen with the FDA).  The second major catalysts is the expected Phase 3 pivotal trial resultsof it's lead compound Cabozantinib in kidney cancer.  After the drug failed in Prostate cancer, the company was punished as everyone left the lead compound for dead.  But the drug is definitely active which is highlighted by the secondary endpoint in the Prostate cancer trial of PFS which showed a doubled benefit versus the control arm (.5 hazard ratio) AND the prior approval in thyroid cancer which was approved based on impressive PFS benefits.  And guess what the primary endpoint is for the kidney cancer trial?  That's right, Progression Free Survival.  I would be shocked if primary endpoint isn't met in the kidney trial based on the PFS performance in both the prostate and thyroid pivotal trials.  And yes, the FDA has approved six of the last seven kidney cancer drugs based on PFS so its the standard primary endpoint for approval.

Two major catalysts, a share price near it's all-time historic low, and a market cap of only $550 million......you make the call but I'm a believer which is why I've got and plan to hold 23k shares through these two catalysts.

As always, do your research and good luck to my fellow Biotech Investors!

Tuesday, February 10, 2015

Anthera (ANTH) FINALLY releases interim results of Phase 3 lupus study


Anthera finally released interim results for its Phase 3 trial in Lupus today.  It passed the futility analysis which is a positive though still no guarantee of meeting its primary endpoint.  The stock popped 25% today which is surprising given its small market cap of $75 post-pop.  This tells me that there's still quite a bit of skepticism from the investment community on the likelihood of success but any pullback may be a good buying opportunity for the risk and reward seeking Biotech Investor.  I'm currently on the sideline but might buy in on a dip.

Anthera Pharmaceuticals Announces Completion of Interim Analysis from Phase 3 Trial with Blisibimod for Systemic Lupus Erythematosus

-- CHABLIS-SC1 study passes futility analysis and will continue to completion with an enhanced endpoint
-- Enrollment to be completed in 2015 with final data in Q3 2016
-- Recent encouraging EMA feedback on BRIGHT-SC design to be incorporated prior to interim


PR Newswire
HAYWARD, Calif., Feb. 10, 2015 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (ANTH) today announced the successful completion of an interim analysis of its Phase 3 trial (CHABLIS-SC1) of blisibimod in patients with Systemic Lupus Erythematosus and that the study should continue to completion as planned. An independent statistician conducted the interim futility analysis for the CHABLIS-SC1 study, evaluating the SRI-6 response at the 24 week time point. Enrollment in the trial is projected to conclude in mid-2015.
"While the results of the CHABLIS-SC1 interim futility analysis remain blinded to Anthera, we are very pleased that the study has passed this critical milestone and now look forward to finishing enrollment later this year," said Dr. Colin S. Hislop, Anthera's Chief Medical Officer.
Prior to the interim analysis and in response to recent input from the Company's Scientific Advisory Board following the publication of clinical data from other Lupus studies with BAFF inhibitors, the Company modified the primary endpoint of CHABLIS-SC1 from SRI-8 response to SRI-6 response, which was previously a secondary endpoint of the study.  SRI-8 will remain a key secondary endpoint of the study. The Systemic Lupus Erythematosus Response Index (SRI) is an approved endpoint recognized by the FDA for previously approved therapeutics.
"Based on the wealth of new information regarding the treatment of SLE and BAFF inhibition, we are fortunate to have had the opportunity to adjust our trial design," said Dr. Colin S. Hislop. "The SRI-6 endpoint has a history of consistency across multiple trials and represents the best possibility for success. Maintaining the SRI-8 endpoint as a key secondary endpoint can maximize our commercial opportunity for the severe patients we are enrolling in the CHABLIS-SC1 study."
Anthera has also completed a Scientific Advice Process meeting with the European Medicines Agency (EMA) regarding the blisibimod development program for the treatment of IgA Nephropathy (IgAN).  Earlier this quarter the Company obtained written feedback regarding the acceptability of a single pivotal study as the initial basis for a conditional market authorization application (MAA) in the European Union utilizing proteinuria as the primary endpoint.  In addition, the EMA also provided recommendations to address treatment duration, durability of response and need for re-treatment in the BRIGHT-SC study.  Anthera and its Japanese development partner Zenyaku Koygo Co., Ltd. plan to incorporate them in a protocol amendment prior to the planned interim analysis for the BRIGHT-SC study which will be completed later this quarter.
"We are pleased by the feedback from the EMA on the IgAN development program, which supports our global approach in IgAN.  This comes at a time when we are actively expanding our recruitment efforts throughout the world," said Dr. Colin S. Hislop.

Friday, February 6, 2015

Biotech Investing: Will Anthera (ANTH) ever report interim analysis of Blisibimod

Anthera Pharma (ANTH) stated in their 3rd quarter press release (see below) that they planned delay the interim analysis of their lead compound Blisibimod in both the Phase 3 Lupus trial and the Phase 2/3 IgA trail due to partnership discussions which were expected to be concluded in 2014.  Well, the partnership with Zenyaku Kogyo Co. was announced on December 15th so we are coming up to two months after the deal and still no interim analysis results???  Have they been completed and not announced???

Also, who the heck is Zenyaku Kogyo Co?  I pulled up their website and translated it into English and it looks like a mix between a Japamation studio and OTC medicine shop (link below).  My favorite drug that's highlighted on their front page in DICKININ which includes ingredients ibuprofen, caffeine, and licorice extract.  Let's hope the Anthera shareholders don't get DICKININ with their investment!

As always, good luck fellow biotech investors and have a great weekend!

https://translate.google.com/translate?hl=en&sl=ja&tl=en&u=http%3A%2F%2Fwww.zenyaku.co.jp%2F



Blisibimod

Our Phase 3 systemic lupus erythematosus clinical study, CHABLIS-SC1, is recruiting patients in Eastern EuropeLatin America and Southeast Asia.  To date, we have enrolled over 260 of the 400 patients planned for the CHABLIS-SC1 study.  Enrolled patient demographics and disease characteristics for the CHABLIS-SC1 study continued to be consistent with our goal to enroll patients with higher levels of lupus activity and positive biomarkers despite the stable use of corticosteroids.  These characteristics appeared predictive of improved outcomes in our previous Phase 2 clinical study.  

Our Phase 2/3 IgA nephropathy study, BRIGHT-SC, is currently recruiting patients with a biopsy-proven diagnosis of IgA nephropathy primarily in Southeast Asia. Our expansion of BRIGHT-SC study's footprint in Europe and Canada is underway with sites in the European Union likely to be initiated in the fourth quarter of 2014.  The baseline characteristics of patients enrolled in the BRIGHT-SC study continued to be consistent with our objectives to enroll patients with a biopsy diagnosis of IgA nephropathy, high levels of proteinuria, and kidney function indicative of progressive kidney disease.

Interim analyses of CHABLIS-SC1 and BRIGHT-SC were planned for the third quarter of 2014 to confirm the clinical assumptions of the designs of these two studies.  However, due to our on-going partnership negotiations for Asian rights for blisibimod for both lupus and IgA nephropathy, we elected to delay these analyses.  We expect these discussions will be completed during the fourth quarter of 2014. There can be no assurance that a definitive agreement will be executed relating to any proposed partnership, or that any partnership will be approved or consummated.

Wednesday, February 4, 2015

Biotech Investing Pointer: A clue the biotech sector may be frothy

There's been a number of articles and commentary regarding the meteoric rise of the biotech index over these past several years. The Nasdaq Biotech Index HAS MORE THAN DOUBLED over the past two years. It's been a great run for us biotech investors but there's a clue that the leaders within the industry may think the run is near its end...everyone and their brother is raising money! In the last few weeks countless biotech's have raised capital including a number that I personally own including Tonix (TNXP), Bind (BIND), Immunomedics (IMMU), and Ziopharm (ZIOP)....and these raises were in the last few days. Positive catalysts will continue to provide upside in the biotech sector but I've started moving out of positions without near term catalysts due to the clues that the overall sector may be frothy and overpriced. Continue to do your homework and nothing but good biotech investment wishes to my readers! Shane

Monday, February 2, 2015

Is KaloBios (KBIO) putting itself up for sale?

KaloBios filed the below 8K tonight as the company reels from the trial failure last month of its lead compound KB001-A.  The CEO "retired" shortly after the announcement and it looks like they have lead off their Chief Medical Officer along with 20% of their staff.

Is a sale or reverse merger in the works?  The company has one other product in clinical trials for various cancers but the same compound failed trials in other indications so I feel like they are grabbing for straws at this point on the clinical front.  What they do have is over $48 million in cash as of the end of Q32014, a Net Operating Loss of $168 million, and a market cap of under $13 million.  Between the recent senior leadership exits and the lack of a pipeline, I could see someone buying them for their NOL and/or early pipeline or a private company performing a reverse merger to obtain a Nasdaq listing and liquidity.

I've picked up around 60,000 shares since the recent trial failure in hopes for a quick sale.

Item 2.05      Costs Associated with Exit or Disposal Activities.

On January 6, 2015, KaloBios Pharmaceuticals, Inc. (the “ Company ”) announced that its Phase 2 study of KB001-A for Pseudomonas aeruginosa infections in cystic fibrosis patients failed to meet its primary endpoint, that it would discontinue further development of KB001-A and that it would focus resources and efforts on advancing its oncology programs.

On January 27, 2015, the Board of Directors of the Company approved a restructuring plan involving reductions in headcount in connection with the change in strategic focus. The positions eliminated, which together represent more than 20% of the Company’s workforce, included the Chief Medical Officer position held by Nestor A. Molfino, M.D., a named executive officer of the Company. Dr. Molfino’s employment will be terminated effective as of February 3, 2015.

The Company expects to substantially complete the restructuring efforts in, and related charges will be incurred through, the second quarter of 2015. The Company estimates that it will incur restructuring charges consisting of cash expenses for one-time termination benefits of between $1.6 million and $1.8 million, when combined with expenses associated with the recent retirement of the Company’s former President & Chief Executive Officer described in the Company’s Form 8-K filed on January 8, 2015.

Ziopharm (ZIOP) drops over 10% in after hours trading


The company announced after hours that it plans to raise at least $75 million through a share offering.   It sent shares dropping over 10% in after hours trading and I would expect the drop to continue into tomorrow's trading until the round is priced.  Ziopharm announced that it required rights to a discovery platform out of MD Anderson last month by issuing over $57 million in stock (including the infamous $7.5 million "expedited signing bonus" so it could announce the partnership in time for the JP Morgan Bio conference which was one of the most interesting uses of resources I've seen in a long time.  I'm currently short on Ziopharm due to its $900 million market cap with only one drug in human trials which provided unimpressive Phase 2 results in December.