Sellas Life Sciences Group (ehemals Galena Biopharma) (Seite 212)

[t0asted]

Antwort auf Beitrag Nr.: 49.292.393 von Growth2012 am 10.03.15 20:39:01

Galena Biopharma Announces Proposed Public Offering of Common Stock and Warrants

http://www.4-traders.com/GALENA-BIOPHARMA-INC-11900113/news/…

Über den "richtigen" Zeitpunkt kann man sich ja bekanntlich streiten. Ich habe meine Position mit 10% Gewinn verkauft und hoffe noch einmal günstiger einsteigen zu können...

[Growth2012]

Antwort auf Beitrag Nr.: 49.292.297 von Schaeffi am 10.03.15 20:30:51

...hast'd völlig recht, der Typ dreht und wendet sich wie'n aal



(und der heutigen Kursverlauf hat der Artikel im grunde genaustens nachgebildet )

[Schaeffi]

Why You Should Leave Galena To The Day Traders________________By Investopedia | March 09, 2015

There are few sectors as exciting as the biotech sector, and shareholders of Galena Biopharma have certainly been privy to a wild ride over the past two years. As you can see, this wild ride included a rapid 300% gain, and an almost equally stunning loss of those gains.

The bull case for Galena
The bread-and-butter thesis for why investors have flocked to Galena Biopharma and given it a valuation near a quarter of a billion dollars is its experimental cancer immunotherapy vaccine, NeuVax.

NeuVax is being tested as an adjuvant therapy to be given after initial breast cancer treatment to prevent recurrence in patients with low-to-moderate HER2 expression. Without delving too deeply into the science behind Galena's therapy, it's designed to stimulate CD8+ cytotoxic T-lymphocytes, or the type of white blood cells designed to kill cells infected with foreign DNA, so they can better recognize and destroy cancer cells. In this case, NeuVax is acting as an immune system booster to really seek out and destroy any remaining breast cancer cells following an initial treatment.

In the company's five-year midstage study of NeuVax, patients who were treated with the experimental immunotherapeutic vaccine had their cancer reoccur 5.6% of the time. In the control group who didn't receive NeuVax, the recurrence rate was 25.9%. In other words, NeuVax would appear to have delivered a statistically significant 78.4% reduction in breast cancer recurrence in its phase 2b study.

Additionally, NeuVax is an extremely convenient option for breast cancer patients. Over a three-year period it involves just 11 total injections, and the side effects of the drug were reported to be generally mild.

Galena expects to wrap up enrollment for its phase 3 PRESENT trial studying NeuVax later this quarter.

********************************
Yet while this data is encouraging, there are a number of other concerns overshadowing Galena Biopharma that are worrisome.

Worries continue to mount
On Thursday evening Galena Biopharma reported its fourth-quarter earnings results and updated its timeline for NeuVax, its other pipeline components, and its two existing commercial products. Long story short, things aren't as rosy as they'd appear on the surface.

First we have NeuVax, which as the report noted was on pace to finish its enrollment by the end of this quarter. According to Galena, the present trial should reach its first planned interim analysis in Q4 2015 or Q1 2016, but we shouldn't expect a top-line readout until 2018. This means we likely won't have a real bead on NeuVax's efficacy until 2018, and even following an expeditious new drug application filing, assuming it meets its primary endpoint, it wouldn't likely find it way to pharmacy shelves until 2019. Four years is an eternity to wait in the catalyst-driven biotech industry.

Next, Galena's acquired commercial products may not be all they were cracked up to be. In 2014, Abstral, a treatment for severe cancer pain, brought in $9.3 million in revenue, up nicely from the $2.5 million it delivered in a partial year for 2013. Even though the $9.3 million fell within Galena's full-year revenue forecast of $8 million-$10 million, this is actually down from a prior forecast of $11 million-$15 million issued a year earlier. Although Abstral sales are growing, they're growing at a much slower pace than Galena and investors initially expected. All told, with Zuplenz coming to market in 2015 as a treatment for chemotherapy and radiation-induced nausea and vomiting, plus Abstral's revenue, Galena is expecting just $15 million-$18 million in full-year revenue. That's also below where Wall Street's estimates were just a few months prior.

Lastly, Galena is running short on cash and is likely going to seek to dilute shareholders with common stock offerings on a regular basis in upcoming years. As noted by Galena in its Q4 results, it ended the year with just $23.7 million in cash and cash equivalents, down from $47.8 million at the end of fiscal year 2013. During the fourth quarter alone it burned through nearly $12 million, and luckily only saw its sequential quarterly cash balance dip by $1 million thanks to a purchase agreement with Lincoln Park Capital Fund and an at-the-market share issuance. Based on its $23.7 million left in cash, I don't believe it has the cash runway to even get through the third quarter of 2015 without raising additional funds.

Leave Galena to the day traders
Before Galena Biopharma reported its Q4 results I would have labeled it a "show-me" story. Because small-cap biotech stocks have such a poor history of getting cancer drugs approved with the Food and Drug Administration, I would have suggested waiting patiently for the release of the present data from the get-go. Now that this data is a full year further out than I suspected, there's little rush to jump into Galena's stock.

Mark Ahn, the now-former CEO of Galena, fairly recently stepped down. While some investors might be thrilled to see a management change, it adds yet more uncertainty that Galena's new management might get sidetracked.

Altogether we have a very promising cancer vaccine, but far too many questions and financing concerns between now and fiscal year 2018 to consider Galena a viable long-term investment. Personally, I would let the day traders have their way with Galena while monitoring it safely from the comfort of my watchlist.


____________________________________________
Oben ist mal ein kritischer Artikel!
jfi - Ich möchte hier nix schön reden oder runter reden, sondern
einfach die Fakten sammeln, um eine eigene Meinung zu bilden.
der Artikel ist 2teilig aufgebaut, oben die Chancen, unten die Risiken bzw. die Meinung des Verfassers!

Meine Gedanken/Fragen dazu sind folgende:
1) Die Chancen ist realistisch, dass NeuVax funktioniert, was ja in bisherigen Tests auch schon sehr schön gezeigt wurde. Wenn alles klappt wie wir und Gale es sich vorstellen, ist hier ein multi bagger drin.

2) During the fourth quarter alone it burned through nearly $12 million, and luckily only saw its sequential quarterly cash balance dip by $1 million thanks to a purchase agreement with Lincoln Park Capital Fund and an at-the-market share issuance. Based on its $23.7 million left in cash, I don't believe it has the cash runway to even get through the third quarter of 2015 without raising additional funds
Eine KE ist wahrscheinlich in Mitte/Ende 2015, aber falls die nächsten Zwischenergebnisse vielversprechend sind, sollte das ohne großes Problem über die Bühne gehen.
Hier wäre die Frage, wann sind diese nächste Ergebnisse zu Erwarten??? --> With Phase-3 interim data not far from being released

3) in seinem Schlusssatz sagt er ja dass das Mittel vielversprechend ist, er aber bedenken wegen der Finanzierung bis 2018 hat. Dass mag sicher sein, das es für eine Company die schon mal unangenehm aufgefallen ist, schwieriger ist eine KE erfolgreich zu lancieren. Diese Bad Image sollte aber im Kurs schon eingepreist sein, denk ich.

4) was mir auf den ersten Blick negativ aufgefallen ist:
Before Galena Biopharma reported its Q4 results I would have labeled it a "show-me" story. Because small-cap biotech stocks have such a poor history of getting cancer drugs approved with the Food and Drug Administration, I would have suggested waiting patiently for the release of the present data from the get-go. Now that this data is a full year further out than I suspected, there's little rush to jump into Galena's stock.
Hier wäre die Frage: Ist das korrekt, dass Ergebnisse 1 Jahr länger auf sich warten lassen, oder ist das nur seine Timeline????

5) Wenn der Typ nicht Daytraden will, ist das sein Problem, ich machs u.U. schon
und werde bei einem gewissen Anstieg, falls er denn statt findet, was versilbern und den Rest laufen lassen in Hoffnug eines Bagggers



Gruss in die Runde S.

[Growth2012]

Habt ihr die jüngste GALE bash versuch vom Investopedia schon gelesen?....

http://www.investopedia.com/articles/markets/030915/why-you-…



The bull case for Galena
The bread-and-butter thesis for why investors have flocked to Galena Biopharma and given it a valuation near a quarter of a billion dollars is its experimental cancer immunotherapy vaccine, NeuVax.

NeuVax is being tested as an adjuvant therapy to be given after initial breast cancer treatment to prevent recurrence in patients with low-to-moderate HER2 expression. Without delving too deeply into the science behind Galena's therapy, it's designed to stimulate CD8+ cytotoxic T-lymphocytes, or the type of white blood cells designed to kill cells infected with foreign DNA, so they can better recognize and destroy cancer cells. In this case, NeuVax is acting as an immune system booster to really seek out and destroy any remaining breast cancer cells following an initial treatment.

In the company's five-year midstage study of NeuVax, patients who were treated with the experimental immunotherapeutic vaccine had their cancer reoccur 5.6% of the time. In the control group who didn't receive NeuVax, the recurrence rate was 25.9%. In other words, NeuVax would appear to have delivered a statistically significant 78.4% reduction in breast cancer recurrence in its phase 2b study.



Additionally, NeuVax is an extremely convenient option for breast cancer patients. Over a three-year period it involves just 11 total injections, and the side effects of the drug were reported to be generally mild.

Galena expects to wrap up enrollment for its phase 3 PRESENT trial studying NeuVax later this quarter.

...wirkt für meine Wahrnehmung eher wie eine sehr gute Werbung für's Unternehmen im nachhinein

[Growth2012]

With Phase-3 interim data not far from being released, and if these data were to follow in step with the 78% recurrence reductions already witnessed during Phase-2 of NeuVax testing, AND because NeuVax is demonstrated to be 99.99% non-toxic, do you think for a moment the FDA's own ethical standards would prevent or preclude a "PROVISIONAL" or a "LIMITED" NeuVax approval from taking shape? Two key points to keep in mind: SAFETY (there's no harm done or possible via the NeuVax injections), and EFFICACY (78% reduced recurrence rates translates into DRAMATIC increased benefit hence "efficacy"). And when these findings are released, forget about touching GALE shares at less than 2-digit multiples.

http://finance.yahoo.com/mbview/threadview/?&bn=12a6b315-348…

...nough said, LONG

[lunatics]

Antwort auf Beitrag Nr.: 49.256.159 von zubi1955 am 06.03.15 08:53:13

Zitat von zubi1955: lunatics wo steckst Du?

Jetzt wo es endlich los geht bist Du nicht mehr hier - schade

Vor Jahren waren wir die Ersten die diese Perle entdeckten und haben ne Menge Kohle gemacht. Jetzt vermisse ich Deine fundierten Berichte.
Zum Glück bin ich immer noch dabei.
Zubi

Also ich habe es mir überlegt und bin seit 10 Min. auch wieder dabei. USD 1.96..mal schauen. Das Zahlenwerk ist wirklich nicht schlecht.

[lunatics]

Galena Biopharma reported a loss of $8 million in its fourth quarter.

It had a loss of 6 cents per share. The results topped Wall Street expectations. The average estimate of four analysts was for a loss of 12 cents per share.

Revenue: $3.2 million in the period, also topping Street forecasts.
Gale expects full-year revenue in the range of $15 million to $18 million.

Eilt also noch nicht mit einsteigen...

[Schaeffi]

Antwort auf Beitrag Nr.: 49.265.213 von Schaeffi am 06.03.15 19:44:15

hier in Textform Seite 1 und 2

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Galena Biopharma's (GALE) CEO Mark Schwartz on Q4 2014 Results - Earnings Call Transcript
Mar. 5, 2015 11:09 PM ET | About: Galena Biopharma, Inc. (GALE)

Operator

Good day, ladies and gentlemen, and welcome to the Galena Biopharma Incorporated Fourth Quarter and Year End 2014 Earnings Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded.

I would now like to introduce your host for today's conference, Ms. Remy Bernarda, Senior Vice President, Investor Relations and Corporate Communications. Ma'am, you may begin.
Remy Bernarda - SVP, Corporate Communications, IR

Good afternoon, everyone, and thank you for joining our call today. For those of you listening via telephone, I would encourage you to visit our website and log into our webcast presentation. For this year end call, we will be using slides to enhance our information flow. The slides can be accessed on our website in the Investors section under Events and Presentation.

These slides are posted both as a PDF document and will also be available on the webcast. The slides are viewer controlled, meaning that you, the viewer will need to advance the slides. Our speakers will alert you to the slides they are addressing.

As listed on slide number 2 on our presentation, during today's discussion, we may make forward-looking statements about our programs. Such statements include, but are not limited to, statements about our commercialization plans and the development progress of our clinical product candidates, including patient enrollment, trial initiations and collaborations. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those identified under Risk Factors in our annual report on Form 10-K which we have filed today and other documents filed with the SEC and available on our website. Actual results may differ materially from those contemplated by these forward-looking statements.

I would now like to introduce the members of management on the call. Dr. Mark Schwartz, our President and CEO; Dr. Gavin Choy, Senior Vice President, Clinical Sciences and Operations, who will discuss our Clinical Programs; Christopher Lento, Senior Vice President of Commercial, who will discuss our Commercial Business; and Ryan Dunlap, our Vice President and Chief Financial Officer.

Please turn to slide number 3 for the overview of our pipelines. Dr. Schwartz will now begin our discussion.
Mark Schwartz - President and CEO

Thank you, Remy. And welcome everyone to our fourth quarter and year end earnings conference call.

Our team did a great job in 2014 and as it was great pleasure that we view our progress last year in preview our expectations for 2015. Today we will review these accomplishments and discuss key developments coming in 2015.

Before I go into the details on our programs, I want to address the status of our corporate issues regarding the SEC we are aware that the SEC is investigating certain matters, relating to the use of certain outside Investor Relations professionals by us and by other public companies. We have been in contact with the SEC staffs for our council and are cooperating with the investigation.

As we mentioned in our press release, the Plaintiffs in the Delaware derivative litigation have dropped their case against the company. As a reminder, Galena had formed a Special Litigation Committee or SLC to investigate the claims from this law suite and produce the report because the Delaware derivative litigation was dropped, the SLC is terminated its work. They are still two derivative cases pending in Oregon Federal and Oregon State Courts and we continue to pursue these vigorously.

Although the litigation matters take time to resolve, the company is committed to bringing these maters to closure in a timely manner. So we cannot say with certainty, we believe we will be able to resolve the outstanding matters in a way that will not materially impact our cash position by the fundamentals of our business.

*********************

Now on to our programs, please turn to Slide 4, as I will expand upon our my comments from last quarter about how our two businesses units commercial and clinical fit into our overall strategy. As I stated before, Galena's current structure, a development stage immunotherapy focused company, complemented by commercial franchise makes us unique. Our focus is on building Galena into a leading oncology company, to establish in our commercial franchise as the strategic components for the long term growth and sets a foundation for our future.

Our commercial franchise gives us two of the most important elements to maximize the value of our development assets, flexibility and control. While we are in continuous dialogue with potential partners for our development assets, having our own commercial capabilities provides us with significant leverage to secure better economics, around future partnering deals, or if we choose, we can commercialize and promote our products ourselves or co-promote in the U.S. with a commercial partner.

As Chris will elaborate the relationships our commercial team is making now with key oncology healthcare providers, distributors and managed care groups, are not only extremely valuable for selling our current products but also provide the ability to quickly add future products.

And finally, we expect the commercial business to maximize revenues become accretive and provide money to the company to help fund our development assets and minimize shareholder dilution.

I would like to make one note on our Zuplenz launch. In conjunction with our pre-launch activities we've been working collaboratively with our partner, MonoSol Rx to make new Galena label product and ensure we can meet the current and anticipated future demand. The product is in its final stages and we are ready and poised for a launch next quarter.

Now on to our clinical programs. Gavin will spend time today walking through our clinical operations and the status of our programs. But before Gavin starts, I would like to make a few comments about immuno-oncology area and the role in NeuVax in exciting therapeutic space.

The recent successes of CTLA-4 and checkpoint inhibitors like Yervoy, Keytruda and Opdivo, as well as CAR T have been very exciting and been a tremendous benefit for patients. All of these compounds exhort their therapeutic benefits to immune mechanisms.

If you look at Slide 5, you can see that the central theorem for efficacy of these approaches is a presence of tumor antigen directed T cells. As depicted in Slide 6, without these T cells, these new approaches would not work.

Now turn to Slide 7, where you can see that NeuVax generates large numbers of these antigen directed T cells generating robust immune response, and much like checkpoint inhibitors, we would expect to add this new vaccine enhanced T cell population to demonstrate efficacy in the appropriate setting.

NeuVax is our lead asset currently in its Phase 3 PRESENT trial and shown in Slide 8, is an estimate of the market potential of NeuVax in the PRESENT patient population. This segment alone is a $1 billion market opportunity.

In addition to the PRESENT trial, we have a portfolio of NeuVax clinical trials that include two key combination trials. These trials provide some insurance for NeuVax which may work as a standalone therapy in combination with other agents such as Herceptin or both.

In addition, as a standard of care has a potential to change, having options for our compound will keep us with the forefront of treatment regiments for our patients.

We have a significant number of key milestone and value drivers occurring over the next year. I will have our team walking through our programs in more details and I will then set the stage for what we believe will be very productive 2015.

I will now ask our Head of Clinical Operations, Gavin Choy, to discuss our clinical programs in more detail.
Gavin Choy - SVP, Clinical Sciences and Operations

Thank you, Mark.

As Mark mentioned, our primary focus in clinical development is on our immunotherapy programs with NeuVax and GALE-301 with a summary shown on Slide 10.

Both of our programs have similar approach utilizing a peptide vaccine in combination with immune adjuvant GM-CSF to prevent the recurrence of cancer. Patients have been treated with standard of care therapy, which includes surgery, chemotherapy, and radiation therapy.

[Schaeffi]

Galena Biopharma's (GALE) CEO Mark Schwartz on Q4 2014 Results - Earnings Call Transcript aus SA

http://seekingalpha.com/article/2978816-galena-biopharmas-ga…

[patg]

Na also,

das gap bei 1,95 ist zu.

Jetzt kanns wieder richtung Norden gehen