Galena ups Abstral guidance but SEC investigation dampens the mood

Galena Biopharma (GALE) raises 2014 Abstral guidance to $11M - $15M from $8M - $12M.

Appoints veteran securities lawyer Irving M. Einhorn to the board of directors. Mr. Einhorn, a former SEC attorney, has over 40 years' experience in SEC enforcement, regulation, compliance and disclosure requirements. His role will be advising the company through its current legal entanglements.

The SEC is investigating the firm's relationship with the IR firm The Dream Team Group (10-K, page 41).

Consensus 2014 EPS estimate is a loss of $0.36/share on revenues of $12.6M.

Shares are down 9% on heavy volume in after hours trading.

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Comments (12)
  • BioDoubt
    , contributor
    Comments (19) | Send Message
    Time for everyone to put their tin foil hats on and start shouting about the conspiracy against GALE...ohh wait, that is just business as usual.
    17 Mar 2014, 10:29 PM Reply Like
  • minecanary
    , contributor
    Comments (1366) | Send Message
    Typo. They mean 40 years of zero enforcement, lots of applying lips to rumps, knowledge of who needs to be paid off, etc. More of the usual.
    17 Mar 2014, 10:38 PM Reply Like
  • MichaelJ8
    , contributor
    Comments (883) | Send Message
    oooo buying time tomorrow
    17 Mar 2014, 11:34 PM Reply Like
  • ElleElleSea
    , contributor
    Comments (2) | Send Message
    Nice bump higher to guidance. I fail to see how the SEC inquiry into stock sales by certain insiders has any fundamental impact on the success or failure of either Abstral or Neuvax. What's the worst case? Shareholders get new management? Big deal. All that matters long-term to the stock price is the uptake of Abstral & more importantly if Neuvax works or not. Everything else is noise.
    18 Mar 2014, 12:01 AM Reply Like
  • easydom
    , contributor
    Comments (97) | Send Message
    Maybe new management is exactly what is needed here. What goes on here is like kindergarten - kind of like using Congress and the White House as role models.
    18 Mar 2014, 02:31 AM Reply Like
  • dakotadao
    , contributor
    Comments (23) | Send Message
    It certainly felt as if the shoe is now on the other foot. In late Nov, Gale PPS went up 300% in 2 months when information regarding Q3 Abstral sales number surprised everyone. Since late January, GALE PPS dropped 65% from its high with allegation of someone posting 2 articles "pumping" the company while using multiple aliases on this very same "elite" investment website aka Seekingalpha where experts can share their insights and be compensated richly for doing so.


    Ironically, those individuals who cried "fouls" on the idea that this company using PR firm to promote its stock are the same people who posted daily articles "rehashing" on this website and The Street regarding the same allegation day after day.


    You can call me a skeptic but I didn't believe that Gale warranted $7.77 per share then nor am I believing now that Gale deserved to be priced at $2.5.
    18 Mar 2014, 07:47 AM Reply Like
  • Marikan
    , contributor
    Comments (10) | Send Message
    It is hard to understand how people relate this issue directly to the company. In my opinion, nothing will come out of company's budget. Whoever did the "insider trading" will have to pay up to 3 times the gain to SEC and case closed. And, this is worst case scenario as the CEO already released that all the information that was being distributed by the "dream team" was true.
    18 Mar 2014, 08:59 AM Reply Like
  • a3ra4mv
    , contributor
    Comments (4) | Send Message
    The problem for GALE is that, with every passing presentation, GALE more clearly appears to be a house of cards. The earnings announcement last night is a perfect case in point. The announcement of the SEC investigation buried in the middle of the text notwithstanding, they missed earnings by a huge margin and Abstral sales disappointed. The headline raising guidance for Abstral sales is a complete misdirection intended to fool investors who don't read the fine print in the announcement. Two other points even more important:1) there was no progress report on their most important compound: Neuvax. There was no update on Phase III Neuvax enrollment and no update on Phase II. Nothing. There was a platitude about how they plan on completing enrollment for both studies in 2014. How are they going to accomplish that? 2) There was no conference call. So there was no opportunity for investors to ask Dr. Ahn questions about:
    1) SEC investigation. When were they notified and why the delay in letting shareholders know.
    How much is the new SEC attorney on the Board going to cost the company?
    2) Current enrollment for Neuvax PIII and PII. Where does it stand currently?
    3) Why the disappointing Abstral sales in Q4?
    4) Legal fees: Have they started to set aside reserves?
    At this point, long term investors deserve an opportunity to ask GALE management all of the questions and many more. GALE should have a conference call to update the investor community now. Dr. Ahn should stand in front of the public and respond to these festering and growing questions. Failure to do so will prompt investors to assume the worst about the company, which is exactly what they should do. If the science is good, which remains an open question, then perhaps liquidation of GALE, with the sale of scientific property to companies with more integrity, would be the best option at this stage.
    18 Mar 2014, 09:15 AM Reply Like
  • ElleElleSea
    , contributor
    Comments (2) | Send Message
    What do you mean there was no progress report or update on Neuvax P3? Stop lying to further your short agenda. As for Abstral, the verifiable fact is they upped their guidance for the drug. If that's a "miss" then keep them coming.


    "The last year has been transformational for Galena as we progressed from a development stage company to a revenue-generating commercial organization with products and programs that span the entire cancer care spectrum, including five ongoing or planned mid-to-late stage clinical trials," said Mark J. Ahn, Ph.D., President and Chief Executive Officer. "We look forward to an even more productive 2014. Specifically, we are increasing our 2014 Abstral net revenue guidance to $11 to $15 million from $8 to $12 million. We are also poised to make significant strides in pipeline development by completing enrollment in several trials including our pivotal NeuVax Phase 3 study, the Phase 2b combination study with NeuVax and trastuzumab, and our Phase 2 study of GALE-301. We will also officially enter the hematology space with the clinical start of GALE-401. The company is resourced through key milestones with cash of $55.3 million as of March 14, 2014 and net operating expenses estimated at approximately $8 million per quarter for this year. Our continued progress would not be possible without the patients and healthcare professionals dedicated to our products, our shareholders, and a committed team of employees."




    "Clinical Development: Cancer Immunotherapy


    NeuVax(TM) (nelipepimut-S) clinical trials advance to seek to prevent recurrence in low-to-intermediate HER2 1+/2+ breast cancer patients rendered disease-free after completing standard of care therapy.
    -- Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax(TM) Treatment) trial continues to enroll at approximately 130 sites globally under an FDA-approved Special Protocol Assessment.
    -- Phase 2b combination trial with Herceptin(R) (trastuzumab), in collaboration with Genentech/Roche, currently enrolling at 16 sites in the U.S. The Phase 2b is a randomized, 300 patient trial enrolling node positive and node negative HER2 1+/2+ patients seeking to prevent breast cancer recurrence.
    -- Oral presentation at the American College of Surgeons Clinical Congress (ACSCC) showed NeuVax induced a full immune response in treated patients and creates an immune memory to target residual cancer cells.
    -- Expanded Intellectual Property in Europe and Australia with the granting of a Pharmaceutical Use Patent by the European Patent Office and a Notice of Acceptance from the Australian Patent Office. The patents afford protection with their respective classifications in all of the European countries and Australia and will expire in 2028, not including any patent term extensions."
    18 Mar 2014, 05:25 PM Reply Like
  • lindainlewisville
    , contributor
    Comments (26) | Send Message
    I was a long term hopeful of Galena for maybe a year and a half? My dreams got shattered after believing they could do something great for women. I cannot believe all of you who are still cheerleaders. I think this is the most disappointing stock of all stocks. What could have been great slowly on its own, IF the facts were true...I mean just because patients feel better doesn't mean we know it all yet. A3ra4mv, I'm leaning with you and feel so angry about Dr. Ahn's glowing smile on Cramer, I was ready to lose Cramer, but perhaps, just perhaps, these critics know something and I am willing to go forward with open ears. It even scared me to think they would come after me and I'd have to give up the $ I made, it is a nightmare that should never have happened and I remain heartbroken. I hope it all works out so that we learn and that there is a silver lining. I remain HOPEful but with some tears.
    18 Mar 2014, 09:29 AM Reply Like
  • Marikan
    , contributor
    Comments (10) | Send Message
    I wonder if Howard Schultz and SBUX will get in trouble after "advertising" SBUX for hours on CNBC this morning.
    19 Mar 2014, 12:20 PM Reply Like
  • MortyLong
    , contributor
    Comments (191) | Send Message
    It is absolutely disgusting and disheartening that Mark Ahn would so smugly lie to the very community that made all of GALE's progress possible. Review the SEC filings, they all sold their options on 1/27/14 and I completely agree, Ahn's omission of the SEC investigation is just another lie, a lie of omission so it's just semantics. All this at the expense of patients and investors. Did they really think no one would notice? This breech of trust, without a change in management or ownership will taint their every report, investors will always question their integrity (or lack thereof). I personally feel disgusted that their blatant lies and disregard for their patients was all for greed. They would have made money, now they will lose not only their ill-gotten gains and quite possibly their jobs (in a just world) , but will have to pay penalties and legal fees. I also find The Street culpable in that THEY KNEW of the ill-gotten gains when Cramer said "ring the register" in January when the stock was in the $7 range. They had already received the information regarding their use of DTG, so how us that not a violation of ethics? A.F. is no wonder analyst, The Street used insider trading to get their payday choosing how and when the rest of the investors would lose theirs. They are no better than Mark Ahn and his co-horts.
    25 Mar 2014, 06:57 PM Reply Like
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