Monday, June 1, 2015

Aeterna Zentaries $AEZS Update

Mr. Dodd should have received my letter requesting the company put itself up for sale.  I also purchased another 100,000 shares in the company to strengthen our position as retail shareholders as my supporters now represent approximately 2% of the company.

It's not too late to join this retail activity campaign!  If you own shares, and support this cause, please send me with your share count and contact information.

Power to the People!


Tuesday, May 26, 2015

Time for change at Aeterna Zentaris (AEZS)!!!!

Calling all Aeterna Zentaris AEZS stockholders!!! Retail Activist Campaign Begins!

Aeterna Zentaris has done a fantastic job of destroying shareholder value over the past year with a decline of -77%.  Even while having a cash position DOUBLE it's current market capitalization and TWO Phase 3 assets.  I'm tired of us retail investors taking it on the chin by companies that lack the leadership, execution, and the fiduciary responsibility to do what's best for it's shareholders.

I'm going to launch what may be the first Retail Activity Campaign to pressure the company to do what they should already be doing - listening to it's shareholders!  

I've attached a letter than I plan to send to the CEO and Board of Directors demanding that the company explore a sale.  But I need your help!  If you hold shares in AEZS and your want to join this campaign, please email me your name and number of shares owned.  I won't reference your name but I will reference your number of shares in the letter.  

Shane

LETTER TO AEZS MANAGEMENT


David Dodd
Chairman and Chief Executive Officer
Aeterna Zentaris, Inc. 
315 Sigma Drive, Suite 302D
Summerville, SC 29483

Cc: Board of Directors

Mr. Dodd,

On November 6, 2014, Aeterna Zentaris received a complete responses letter from the FDA for Macrilen, though the trial was done under an SPA, and the market has since lost confidence in the direction of the company which is reflected in its stock performance.  

We beneficially own a significant number of the outstanding shares of AESZ and are long-term shareholder of the company.  Recent events and underperformance necessitate intervention.  As of Friday’s close, Aeterna Zentaris stock has declined -72% over the past year, -84% over the past two years, and -99% over the past ten years.  The Nasdaq Biotechnology Index has appreciated approximately +56%, +187%, and 444% over the comparable periods. 

The shares are trading at a market capitalization of $27 million, half of the cash reported at March 31st, 2015.  Combine this with two late stage Phase 3 assets, Zoptarelin Doxorubican and Macrilen, and it’s easy for anybody to see that the company is severely undervalued. 

Building a sales infrastructure for the assumed launch of Macrilen is within the normal course of business but maintaining a sales team to sell Estrogel alone isn’t prudent and reflective in the mediocre sales results of $73,000 in the first quarter.  This strategy should be abandoned immediately without having a relevant product to sell.  

We request immediate disclosure of formal and informal expressions of interest and/or non-binding offers to acquire the Company. 

We request that the Board of Directors immediately engage a top-tier investment bank and initiate a formal process to sell the company and/or it’s two leading assets and distribute proceeds and existing cash to shareholders.  

In parallel, we request that you step down as CEO or adjust your compensation to better align with the interests of shareholders.  We also request that the company undergo additional restructuring to preserve cash during the sales process including closing offices outside of the headquarters in South Carolina, eliminate your Chief Commercial Officer and the sales infrastructure built for the anticipated Macrilen launch, and evaluate other positions throughout the organization including the need for both a CFO and VP of Finance.

We welcome further discussion with you and the Board.  

Sincerely,

Shane Skinner
Representing Significant Retail Ownership of AEZS

Saturday, May 23, 2015

Calling all Aeterna Zentaris AEZS stockholders!!! Retail Activist Campaign Begins!

Aeterna Zentaris has done a fantastic job of destroying shareholder value over the past year with a decline of -77%.  Even while having a cash position DOUBLE it's current market capitalization and TWO Phase 3 assets.  I'm tired of us retail investors taking it on the chin by companies that lack the leadership, execution, and the fiduciary responsibility to do what's best for it's shareholders.

I'm going to launch what may be the first Retail Activity Campaign to pressure the company to do what they should already be doing - listening to it's shareholders!  

I've attached a letter than I plan to send to the CEO and Board of Directors demanding that the company explore a sale.  But I need your help!  If you hold shares in AEZS and your want to join this campaign, please email me your name and number of shares owned.  I won't reference your name but I will reference your number of shares in the letter.  

Shane

LETTER TO AEZS MANAGEMENT


David Dodd
Chairman and Chief Executive Officer
Aeterna Zentaris, Inc. 
315 Sigma Drive, Suite 302D
Summerville, SC 29483

Cc: Board of Directors

Mr. Dodd,

On November 6, 2014, Aeterna Zentaris received a complete responses letter from the FDA for Macrilen, though the trial was done under an SPA, and the market has since lost confidence in the direction of the company which is reflected in its stock performance. 

We beneficially own a significant number of the outstanding shares of AESZ and are long-term shareholder of the company.  Recent events and underperformance necessitate intervention.  As of Friday’s close, Aeterna Zentaris stock has declined -72% over the past year, -84% over the past two years, and -99% over the past ten years.  The Nasdaq Biotechnology Index has appreciated approximately +56%, +187%, and 444% over the comparable periods.

The shares are trading at a market capitalization of $27 million, half of the cash reported at March 31st, 2015.  Combine this with two late stage Phase 3 assets, Zoptarelin Doxorubican and Macrilen, and it’s easy for anybody to see that the company is severely undervalued. 

Building a sales infrastructure for the assumed launch of Macrilen is within the normal course of business but maintaining a sales team to sell Estrogel alone isn’t prudent and reflective in the mediocre sales results of $73,000 in the first quarter.  This strategy should be abandoned immediately without having a relevant product to sell. 

We request immediate disclosure of formal and informal expressions of interest and/or non-binding offers to acquire the Company.

We request that the Board of Directors immediately engage a top-tier investment bank and initiate a formal process to sell the company and/or it’s two leading assets and distribute proceeds and existing cash to shareholders. 

In parallel, we request that you step down as CEO or adjust your compensation to better align with the interests of shareholders.  We also request that the company undergo additional restructuring to preserve cash during the sales process including closing offices outside of the headquarters in South Carolina, eliminate your Chief Commercial Officer and the sales infrastructure built for the anticipated Macrilen launch, and evaluate other positions throughout the organization including the need for both a CFO and VP of Finance.

We welcome further discussion with you and the Board. 

Sincerely,

Shane Skinner
Representing Significant Retail Ownership of AEZS

Wednesday, May 13, 2015

ASCO 2015 Abstracts Released - A few abstracts of trading interest

The highly anticipated ASCO abstract release happened at 2:00 PST today and here are some abstracts of trading interest.

Exelixis (EXEL) - Abstract 9006 reports updated Progression Free Survival for Roche partnered compound Cobimetinib in advanced BRAF-mutated melanoma.  Updated PFS came in at 12.3 months vs. 7.2 months for the control arm for a hazard ratio of .58.  In summary, this is great news and should add further ammunition for the upcoming FDA PDUFA date on August 11th.  I'd expect the stock to continue moving up when the results are formally released.

Oncothyreon (ONTY) - Abstracts 612 and 602 report Phase 1 results for lead compound ONT-380 in breast cancer.  I listened in on their first quarter call on Monday and the CEO made it a point to state that more mature data than than the initial abstract release will be presented at ASCO.  He's a pretty dry guy but his tone was that of excitement so my take is that the additional data will be positive.  Note that the stock was up 15% in after-hour trading tonight off the current data so who knows what will happen if better data is released at ASCO.

Array (ARRY) - There's a ton of abstracts and data released on their three late-stage wholly-owned and partnered compounds.  Some good and some bad but overall I think the data is positive and the stock will move up as investors sift through the data and press released hit the day of the presentations.

Threshold (THLD) - Abstracts presenting clinical data on both of the companies compounds, TH-302 and TH-4000, show clinical activity.  Further data will be presented at the conference so this one could move.

Ziopharm (ZIOP) - Abstract 7504 shows that compound Palifosfamide failed to improve overall survival in patients with lung cancer.  Though this was expected as prior trials in this compound failed, I'm short this stock and expect it could move lower on the news.

Immunomedics (IMMU) - Abstracts covering compounds IMMU-130, IMMU-132, and sacituzumab govitecan show various degrees of clinical activity in Phase 1 and 2 trials. I'd expect more detailed and mature data to be presented at the meeting which could move the stock up.

That's about it for now but will provide further updates as I sift through the thousands of abstracts. Good luck investing!


Saturday, April 25, 2015

Reader's question: What do you think about Actinium Pharmaceuticals ATNM?

I got the following question from Anonymous.  Thank you for the question and spent a few hours researching Actinium Pharmaceuticals ATNM and below are a summary of my thoughts on the company and their planned phase 3 trial in AML.

I think there are much better Biotech investments with similar or even lower market values.  Note that ATNM's current market cap is $104 million.  Here are my concerns:

-  They have no big pharma partnerships.  Always a red flag as we have no quality, third party due diligence done on the technology and/or leadership team.  Also, a small cap biotech would jump on the chance for a partnership so if their lead compound truly has blockbuster potential, as leadership boasts, why haven't they secured a partnership going into phase 3 trials?

-  They recently raised capital but have less than $30 million in cash and plan to launch a Phase 3 study of their lead compound.  Quality phase 3 studies cost in excess of $100 million so they will need to raise more capital (i.e. shareholder dilution).  

-  The phase 2 trial was not randomized (compared to the control arm being used for the phase 3 trial) and only had 27 patients.  THIS IS A HUGE RED FLAG!  They are assuming the results from a 27 patient study and comparing them to prior trials done in the planned control arm for the phase 3 trial. I see these types of assumptions used going into phase 3 trials all of the time and they almost always fail.  Beware!

-  There's a crossover component in the phase 3 trial.  Remember Aveo's failed phase 3 study?  They had a crossover for ethical reasons as well and that didn't work out for them.  Crossovers can muddle results and I don't like them.  

-  I'm also surprised they don't have a relationship with the Leukemia and Lymphoma Society which provides various degrees of funding for research and trials in their lead indication.  both CPXX and ONTX are in Phase 3 trials and have funding grants from this leading non-profit organization.  Why don't they?

If I were to invest in a company focused on AML/MDS, I'd look at CPXX and ONTX.  Cheaper companies, more cash on hand, better partnerships, and further along.  

Thank you again for the question and best of luck!  

Thursday, April 23, 2015

Biotech Investing: Upcoming Clinical Results Trade Catalysts That You Might Not Know About

There are a number of trade catalysts coming up in the next two months that you probably haven't heard about because they are with biotech names with little or no coverage due to their small market capitalizations.  And they have small market caps for a reason....because they are extremely high risk.  But with any high risk investment, there's high reward for the brave at heart.  Here's the list!

Celator (CPXX) - First readout of their Phase 3 lead candidate CPX-351 in secondary Acute Myeloid Leukemia.  This company has no big pharma partnership which usually turns me away but I like it for a few reasons.  1.  The Phase 2 results was a randomized trial which showed statistically significant results.  The Phase 3 trial replicates this smaller trial so I think it has a chance of repeating in the larger population.  2.  The trial goes against the standard of care (7+3).  If approved, it should be the go-to treatment for secondary AML so the market potential is significant.  3.  They are receiving funding for the trial from the Leukemia and Lymphoma Society which gives them credibility as a high profile non-profit isn't going to financially support a trial and/or company without doing significant due diligence.  With a market cap of only $69 million, I like the risk vs. reward opportunity with this one.

Oncothyreon (ONTY) - Phase 1 results from lead compounds will be presented at ASCO in May.  Not too exciting because it's way early but worth watching as any efficient data could move the stock.

GlobeImmune (GBMI) - Phase 2 results in Hepatitis B are expected in the quarter.  The program is partnered with Gilead (the $150 Billion giant) which is a good sign.  They also have other programs including an oncology program partnered with Celgene with a number of trials in Phase 2 and 1 currently enrolling.  All of this for a market cap of only $48 million which seems like a bargain of bargains for the risk vs. reward opportunity.

Onconova (ONTX) - Phase 2 results in MDS should be coming out this quarter. The company also plans to start a Phase 3 trial in MDS later this year but requires funding which definitely worries me a bit.  The company had a prior Phase 3 trial in MDS that failed but a subset of patients showed significant improvement in overall survival and the new trial is directed to this subset but with enough patients to meet regulatory requirements for approval so I think there's a good chance of success down the road for the company.  The company does have a partnership with Baxter for international rights to the compound so that's a vote of confidence.   A market cap of $51 million so another bargain basement deal!

Bind (BIND) - I really love this stock.  Market cap of $146 million, partnerships with Pfizer, AstraZeneca, Roche, and Merck (did they miss anybody), and Phase 2 results in lung and prostate cancer due this quarter.  Also, they expect one of their partners to move a compound into clinical trials around mid-year as a bonus.  Just screams deal, deal, deal!!!

Aeterna Zentaris (AEZS) - Phase 3 preliminary results of their lead compound in endomentrial cancer should be out this quarter.  I'm a bit worried that they will have to perform a reverse split to maintain listing on the Nasdaq (stock currently trades at $.57 which is under the $1 minimum) before the results come out so I'd probably hold off but the risk vs. reward is significant with a market cap of $52 million.  Then again the other stocks in this column seem to be much better deals with less risk.

Immunomedics (IMMU) - Phase 3 lupus results should be out this quarter from their partner UCB.  Lupus is extremely difficult to treat and current treatment options are inadequate thus why this is a very high risk, very high reward stock.  The market cap is close to $400 million so not exactly a bargain but they do have other programs in Phase 3 trials including pancreatic cancer (another tough disease to treat with very high risk, very high reward potential).

Exelixis (EXEL) - Phase 3 results in kidney cancer are due this quarter.  Their compound is going head-to-head with the current standard treatment so if the trial is a success the commercial potential is significant.  The drug has been in two other phase 3 trials in prostate and thyroid cancers and both have demonstrated statical significance in Progression Free Survival which is the primary endpoint in the kidney trial.  I feel like it has a good shot of meeting it's primary goal and they stock will move significant higher....if positive.

I hold all of the stocks mentioned above (some a whole lot more than others) but make sure you do your own research.  Good luck biotech investing and hope everyone has a great weekend!






Monday, April 6, 2015

Targacept (TRGT) merger looks to be in question

Targacept filed an 8K today under the radar (aka no formal press release) which put their merger with Catalyst Bio into question.  Catalyst informed Targacept that Pfizer was terminated its partnership with the company for its lead compound.

Targacept stated that it is currently reviewing the implications of this event on the proposed merger.  I have little doubt that Targacept will back out of the deal.  Pfizer giving notice to terminate the partnership isn't a great vote of confidence on Catalyst's platform so I don't see any reason for them to carry through with the merger.  Targacept stated during the conference call which announced the merger that there were many companies that were considered and there's probably a better deal out there now that Catalyst doesn't have a partner.

I currently hold 10,000 shares of Targacept and have no plans to sell until I see this story play out.  As a reminder, Targacept will also report phase 2 results this quarter of it's lead compound in gastroparesis.

Do you own research and hope everyone has a good trading week!

Sunday, April 5, 2015

Biotech Investing Trade Updates - NKTR and VVUS

I made a few purchases the first week of April.

Vivus (VVUS) - I purchased 10,000 shares at $2.30 to bring my total position to 19,500 shares.  The stock has been hammered over the last few weeks (and the last few years since the unsuccessful launch of it's obesity pill Qsymia).  I'm betting (and I mean betting) on a few events which could bring upside to this battered stock.  The just cut their sales staff by 1/3 and I feel like they are leaning down to trim their cash burn and attract potential acquirers.  Let's be real, they don't have the financial resources to compete against the other two obesity products being marketed by Takeda and Eisai.  Their board would have to be complete idiots if they aren't actively pursuing a sale of the company or partnership.  Also, the company is on the hook for $200 million to fund a cardiovascular study required by the FDA as a condition of approving Qsymia....and they can't afford to do it.  Qsymia would be a solid product for one of the many large pharmaceutical companies looking for ways to expand their product offerings with continued pressure from patent expirations.  Also, they have an erectile dysfunction drug, Stendra, which recently gained approval with the only label that says it can be taken 15 minutes before sex.  Who wants to wait 30 minutes for Viagra to work when you are about to get your groove on if you only have to wait 15 minutes with Stendra?  Sounds like a pretty great competitive advantage.  This drug is currently partnered with Endo in the US and Menarini in Europe.  Both of these assets have to fetch a buyer which is what I'm banking on....and it needs to happen soon.

Nektar (NKTR) - I purchased 2,000 shares of Nektar for under $11.00 which is my first position in the biotech.  The stock is near a 52 week low due to recent negative results for one of it's lead compounds in breast cancer.  I think this provides an opportunity to get into a company with a robust pipeline, strong partnerships, and....wait for it.....revenues!  The company had over $200 million of revenues in 2014 and I would expect continued growth in 2015 as new products are launched or have the potential for approval.  Movantik for the treatment of opioid induced constipation was launched by partner AstraZeneca last week which triggered a $100 million milestone payment and will start bringing in royalties.  They have a number of compounds in phase 3 and 2 trials which are highlighted in the companies pipeline.  With a market cap under $1.5 billion, plenty of cash on hand, and a number of quality partners....seems like a good deal which is hard to find in the current world of drastically overpriced biotechs.

Do your own research and hope everyone has a great trading week!

Monday, March 30, 2015

My March Biotech Trades - ARQL, RIGL, KBIO, MNKD, ZIOP, BIND

March was a pretty active month of trades as I adjusted my portfolio due to concerns with the overheated biotech industry.  Truth be told, I'm a bit concerned about biotech valuations and think a correction could be on the horizon.  Yes, patent protection is expiring on a number of blockbusters in the coming years but we've known and been talking about that for 10 years now.  Yes, innovation is improving but competition in similar new technology is heating up too.  Yes, some large pharmaceutical companies are paying excessive premiums to acquire biotechs but the smart, disciplined companies have recognized the valuations and sit patient on the sidelines.  The good news is that biotech catalysts and trial results will still move a stock...up or down.  I'm clearing my portfolio of my higher risk investments while shorting positions in companies that defy common sense in valuation logic.

Arqule (ARQL) - I sold 18,000 in ARQL naked $2.50 October puts at $.50 which would basically put me in the position at $2.00 if stays at the current trading range around $2.30.  I see no reason for this stock to drop by October as the next catalyst is Phase 3 HCC results in it's lead compound in the 4th quarter of the year  I really like the stock and think this was a good hedge play in the event the overall biotech market drops in the coming months.

Rigel (RIGL) - I took the same approach as ARQL.  Sold 12,000 in RIGL naked $2.50 September puts at $.10.  No clinical results are expected until 2016 and can't see the stock dropping from it's current trading range of around $3.35....unless the biotech market drops.

Kalobios (KBIO) - I sold all of my remaining shared for $.93.  Good thing as they are currently trading under $.50.  Based on the tone of the companies recent presentations and quarterly report, I get the feeling that they plan to spend every last penny of their remaining cash on their yet-to-be proven technology and compounds.  What they should be doing is pursuing a reverse merger with a private company that actually has a platform with a chance of success.  Bad management!  Which is why I'm out!

Mannkind (MNKD) - Sold 5,000 naked $7.00 January 16 calls.  This stock has to be one of the most overpriced pieces of junk in the history of biotech with a $2 billion market cap.  I think there's a place for inhaled insulin but the companies balance sheet is a cluster.  As a reminder, I'm a CPA and I've been the CFO of a number of companies so balance sheets are my thing....and these guys have a mess on their hands.

Ziopharm (ZIOP) - Short sold 4,900 ZIOP shares at $13.00.  This stock is making it's own run for most overpriced biotech with a market cap in excess of $1.3 billion and just one (yes one) drug in phase 2 trials.  They are literally 5 years away from getting anything to the market and a $1.3 billion market cap?  Huh?  Oh wait, they can use the words CAR-T in their press releases which is the trendy, cool thing in biotech right now so that explains it.

Bind (BIND) - I bought 2,000 shares in Bind.  I like it.  A number of quality partnerships, inexpensive $100 million market cap, Phase 2 results coming out in the 2nd quarter on trials in lung and prostate cancer, and they expect a partnership to take a compound into phase 1 around the middle of the year.  That's what we call a deal!

I also bought and sold positions in AEZS and ARRY during the quarter but still hold positions of both stocks.

I hope everyone has a great April and take my advice - be patient and pick qualify stocks in the event of a correction!

Sunday, March 15, 2015

Biotech Investing: Upcoming trade catalyst Immunomedics (IMMU)

Immunomedics (IMMU) is a good stock to consider going into the 2nd quarter.  Results from a Phase 3 trial of Epratuzumab in Lupus with partner UCB is expected during the quarter.  Lupus is a very hard condition to treat highlighted by only one recently approved drug in that last 58 years, Benlysta. Benlysta is marketed by Glaxo and is considered only marginal in the treatment of lupus which opens the door for another new, effective treatment.

Terms of the agreement with UCB provide over $400 million in regulatory and specified product sales milestones as well as product royalties ranging from mid-teen to mid-twenty percentage of aggregate annual net sales during the product royalty term.  If the trial results are positive, it's going to be very lucrative for Immunomedics.

The company also has a product in phase 3 trials for pancreatic cancer which is another difficult to treat condition.  They expect the trial to fully enroll in this year with results in 2016.

I'm going to hold Immunomedics through the lupus results and continue to hold if the results are positive with the additional pancreatic readout in 2016.

Hope everyone has a great trading week and best of luck!

Thursday, March 5, 2015

Biotech Investing: Targacept (TRGT) Announces Merger

I just wrote last month about my position in Targacept and the possibility of a merger.  It was just announced 15 minutes ago that they will merge with privately held Catalyst Biosciences.  Catalyst currently has a partnership with Pfizer for its lead compound, PF-05280602.  Targacept will own 35% of the newly formed company and received a cash distribution.

Targacept and Catalyst Biosciences Enter Definitive Merger Agreement Creating a Protease-Based Hemostasis and Anti-Complement Company

Merger combines Catalyst’s protease therapeutics pipeline and the financial resources of both companies
Creates a well-funded company to develop important new treatment options for patients with bleeding disorders and complement-mediated diseases

Wednesday, March 4, 2015

Biotech Investing: Clinical Updates from Threshold (THLD) and Arqule (ARQL)

Both Threshold (THLD) and Arqule (ARQL) reported earnings in the last day and both provided updated guidance on the time of top line pivotal trial results of their pancreatic and liver cancer, respectively.

Threshold now expects results from its phase 3 pancreatic cancer trial in the first quarter of 2016.  Prior guidance was "sometime" in 2016 so now we are look at the front end of the year providing a closer trading catalyst.  The trial is being conducted by its partner Merck.

Arqule now expects results from its phase 3 liver cancer trail in the fourth quarter of 2015.  Previous guidance was the first quarter of 2016 but recruitment has been better than expected.

I have 6,000 shares of Threshold and don't plan to sell until we get closer to the pancreatic readout.  I may actually add to my position via selling naked puts.

I just sold my shares in Arqule earlier this week after it made a strong run these past few weeks after presentations at investor conferences.  I plan to get back in when/if it goes back below $1.70 per share.

Do your own research and good luck!

Biotech Investing: Hope you read and took action on my KaloBios (KBIO) on February 2nd!

I reported my position in KaloBios (KBIO) back on February 2nd when the shares were trading at $.39.  It seemed like such a good bargain that I picked up 60,000 shares.  Their book value was over $1 per share, the CEO "retired", and they still had a compound in phase 2 trials with results expected in the second quarter.  I don't know what the ultimate outcome will be but I sold my shares today at approximately $.92.  Not a bad hull for months work!

Keep looking for those bargains, do your research, and good luck!  

Monday, March 2, 2015

Biotech Investing: Merrimack (MACK) gets a shout out in Cramer's Lightning Round

Jim Cramer gave a positive vote of confidence during tonight's lightning round on Mad Money.  I've written a number of articles expressing my strong opinion (and large holding) of Merrimack.  It has a great pipeline and MM-398 should get approved for hard-to-treat pancreatic cancer later this year.

I currently hold 11,300 shares of Merrimack and no plans to buy our sell in the near future.



Merrimack Pharmaceuticals: "We like them! That was one of our spec pharma picks. We still continue to like it. I think it's in real good shape. You have a good one in Merrimack, we still like it."
 

Biotech Investing: Reader question on Provectus (PVCT)

I hope everyone had a great weekend!  I received the following question from EJ over the weekend regarding PVCT.


  
EJEJ
@troothseekr
Looks like PVCT finally gonna start Phase3 trial for melanoma drug. Phase2 results were amazing. Any thoughts on this one?

EJ, I wouldn't touch this one.  The company only had less than $18 million in cash at the end of the 3rd quarter and a robust, quality Phase 3 trial will cost approximately $100 million so there's definitely going to be shareholder dilution in the near future.  Also, no partner for a small biotech is a red flag.  Their market cap is $162 million and I just feel there are much better companies out there at a lower market cap with more promising products.

I like and own CPXX, OGXI, ONTX, and TNXP.  All have drugs either in Phase 3 trials (ahead of PVCT) or drugs getting ready to enter Phase 3 trials.  And they all have market caps less than $100 million and more cash on hand that PVCT.  You may want to check them out if you are looking for other high risk, good value investing opportunities.

Thank you for the question and good luck!












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.  

Wednesday, January 28, 2015

Vivus (VVUS) - WTF?

Ok, let me get this straight. Vivus shares dropped from $9.41 to $3.06, a decline of 67%, and the leadership team received millions in cash and stock bonuses? That would deserve the BiotechInvestor WTF!!!! I had shares but now plan to sell them based on that impressive display of corporate governance by the board of directors. Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. Cash Bonus Payments, Stock Option Awards and Restricted Stock Unit Awards for Named Executive Officers On January 23, 2015, the Compensation Committee of the Board of Directors, or the Compensation Committee, of VIVUS, Inc., or the Company, authorized and approved cash bonus payments pursuant to the Company's employee annual bonus plan for fiscal year 2014 adopted on the same date, or the Annual Bonus Plan, and stock option awards and restricted stock unit awards under the Company's 2010 Equity Incentive Plan to certain of the Company's employees, including named executive officers Seth H. Z. Fischer, Chief Executive Officer, Svai S. Sanford, Chief Financial Officer and Chief Accounting Officer, John L. Slebir, Senior Vice President, Business Development and General Counsel and Secretary, Wesley W. Day, Ph.D., Vice President, Clinical Development and Guy P. Marsh, Vice President, U.S. Operations and General Manager. The following table sets forth the specific cash bonus payments under the Annual Bonus Plan, stock option awards and restricted stock unit awards authorized and approved for each of Messrs. Fischer, Sanford, Slebir and Marsh and Dr. Day: Cash Bonus Restricted Stock Named Executive Officers (1) Payments Stock Option Awards (2) Unit Awards (3) Seth H. Z. Fischer $ 416,000 628,600 66,000 Svai S. Sanford $ 112,000 240,300 25,300 John L. Slebir $ 170,000 246,400 25,900 Wesley W. Day, Ph.D. $ 138,300 232,900 24,500 Guy P. Marsh $ 95,000 105,100 11,000