Amy Baldwin

Amy Baldwin
Contributor since: 2012
Thank you for noticing. I have submitted correction.
Good catch! Thank you and thanks for reading! By the way, I think you mean "misspelled". ;)
I have submitted for my spelling error to be corrected.
I am not too familiar with IMGN. Therefore I apologize
I was about to mention Acadia. He was also bearish of ACAD before data. We all see the end of that story
I do specialize in statistical analysis, and I have taken ALL statistics into account when forming my opinion regarding GALE. I do not hold the opinions of Adam F higher than any others.
I have looked at both sides and my belief is that bears only want to look at the combined results of the Phase 2 trial (which was one recurrence shy of being statistically significant) and the bulls only focus on the subgroup of patients where results were most impressive for GALE.
Here is my take: If GALE's Phase 3 trial was testing both node-positive and node-negative patients, only one-third were optimally dosed and receiving booster shots, then I would too be negative about Galena's shot in Phase 3.
However, in the Phase 3 trial, all patients will receive boosters and will be optimally dosed, and only node-positive patients will be enrolled. In this patient population, NeuVax decreased recurrence by nearly 80% compared to the control group! This subgroup is what formed the Phase 3 study. Thus, I will be a bull.
With that said, I believe there is a 75% chance that NeuVax will be statistically significant in its Phase 3 trial. A 75% chance more than supports an investment in a $200m company that has a multi-billion dollar product.
If you look at data, then OncoSec would fall in the category of high probability.
There is no treatment for MCC. It is an orphan indication. If ImmunoPulse has good data in treating this disease, Wall Street will take notice.
I place a lot more value in ONCS versus the biotech IPOs of 2013. Most haven't even tested their products on humans.
You are correct. This fact alone warrants a larger market cap. I think investors know the upside and value lies in immunopulse
I think the $25 million market cap limits nearly all risk. What's the downside? The data is very good
IMUC is under new leadership, therefore it's a new vision. Singh used a third party manufacturing facility, and after assessing the upside and downside I think the new CEO will also determine it is best to manufacture with PCT
What is wrong with the information you cite? I'd love to find more biotechnology companies in late phase development that spend just $6.4 million per year. Most spend $6.4mm per quarter. ONCS will be able to continue operations until data is announced, at that point the company's valuation will be changed
You are way wrong. Look through the company's board and scientific team, many of which were at Inovio. At Inovio it looks as though there was a change of opinion regarding development. ONCS went with the electroporation and I feel confident that ONCS will have a product to market long before INO
Thank you for your comment Alvin. I agree that the prospect of a centralized data base would make a lot of sense. It would be nice to have the ability to share your entire medical history--excluding anything that you choose to opt out-- just by swiping a medical "key card" or simply have the history associated with your name/SSN. This would be convenient and would eliminate having to guess the last time you were immunized for MMR. Going back to the issue at hand, as you say, the data base info could be limited to opiates/ Schedule II drugs, to address any privacy concerns. This is something the government needs to act on...PRONTO!
Robert Schwartz, while you bring up several good discussion topics, nothing in this piece is new. All of this information has been argued and debated over and over and over again. So I am not really sure of the purpose to this article.
Everyone knows that the phase two trial was to investigate NeuVax’s best use. The company found that using the vaccine on those with lower levels of HER2 was more effective. Anyone who has followed the stock knows the number of differences between the phase two and phase three PRESENT trial. I think one writer put it, “this trial is built around NeuVax’s strengths while the other was not”
GALE is at the very least worth a small investment, and I think the comments and articles provided by Rich Steffens are much more thorough, thoughtful, and useful to those seeking an unbiased opinion, as he does not currently own shares.
In regards to you Mr. Schwartz, I am very interested in your motives. I’ve never seen you cover Galena in the past and for a “30 year veteran of the Pharmaceutical Industry” who was most recently in the role of “Executive Director, Strategic Transactions for Bristol-Myers Squibb Company”, why would you even waste your time with such research on a small little company like Galena Biopharma, especially if you are “betting’ against its success? It doesn’t make sense.
If you really do speak frequently about the dynamics and evolving research and treatment paradigms in oncology then you’d know that in oncology, when treating a disease such as cancer, there are no rules, no consistencies, and that we have not yet found a cure. If you were unbiased and without a position long or “short”, then you’d be much more receptive to the idea of Galena’s strategy in preventing, not treating, breast cancer.
In my opinion, there were too many inconsistencies in this piece for it to be believable. I’ve already seen several people point out incorrect numbers, data, etc. This leads me to think that this was just some thrown together article with the main objective being to cause the stock to fall lower. Everyone knows that Galena is volatile, and it always humors me how everytime it reaches $2.10 there is a new contributor who rises with the same spin but different words on why GALE will fail.
Honestly, I would respect you much more if you’d just come out and add a disclosure saying, “I am publishing this article on March 13 because on the 15th my, or my employers, put options expire and I need the stock to be under $2”. Then, I would have a great deal of respect for your work, because at least you’ be honest. As far as I can see, four of your five articles follow the same pattern: Bearish articles the day(s) before you need a stock to drop on volatile stocks GALE, PPHM, NLNK, and also ZIOP on March 14. Come on…. Give me a break!!! The really sad thing is that the stock did fall lower, that means there is no doubt that you’ll be at it again with some other stock in a couple weeks.
I have tried to avoid predictions with VRNG. We know it will receive a set royalty and payment for infringements but we don't what will happen in future suits. It's really hard to tell right now. I think its upside is great but it could change month-to-month
Because I left out one company that wanted to be included? It's a broad market, you can't get every one!
The article was about the investors who invested early in companies with IP suits. SPEX has seen a large move as both funds have invested in the company. You are suggesting that there are no patents but the North South acquisition was just announced, giving SPEX its intellectual property along with the two segments it already operates in
3.5% but are attempting to obtain a larger royalty rate. The situation changes by the day
That is possible, good observation, but I am sure that those same investors hold some small cap stocks
I believe you are overstating ONTY's cash position and understating GALE's. There is a major difference, in my opinion, of cash and cash equivalents. ONTY has enough cash for 9 more months based on the filing you referenced in your article. "Oncothyreon estimates that its existing cash, cash equivalents and investments will be sufficient to fund operations for at least the next 12 months." That was dated Nov 7th. GALE on the other hand, has approximately $40 mil in cash after their recent financing. That is significantly higher than the $15 mil you stated in the article.
I think once investors realize the potential of the different ONCS systems and how it can be adapted to be used with multiple applications and treatments, we will see significant share price movement. The data thus far has been very encouraging. Safety and efficacy has been shown statistically, and the most important aspect, in my opinion, is that a persons quality of life is vastly improved when compared to the alternative treatment methods.
I based my valuation on an absolute best case scenario that not only assumed that all GvHD patients were children but also that OSIR reached all of its potential market. This will not happen. OSIR is probably trading much higher than my average.
The expansion into all other countries and the development the product to treat other indications is still speculative. I was surprised that Prochymal was approved, but I don't think it will be approved in the states. Maybe I'm wrong, but I don't see the peak potential to compliment the valuation.
NeoStem does not release the names of their clients... I am not sure why. It's probably related to confidentiality or it may be a decision to protect the privacy or development of certain therapeutics/patients. Most people know of three: BAX, IMUC, and SOTIO, but if you look on their investor presentation it suggests many more.
Dr. Smith spoke about the manufacturing space in a recent interview using 10% of total revenue for the $50 billion annual regenerative medicine field. However, manufacturing services expand beyond just regenerative medicine, but because NeoStem is known as a regenerative medicine company, it's probably easier to focus on that specific industry.
http://seekingalpha.co...
I disagree with the notion that BAX, IMUC, and SOTIO will leave. SOTIO already has a manufacturing facility but chose to use NBS. BAX has the resources to create its own, but the truth is that it's expensive and finding professionals to work in the laboratories do not grow on trees. Have you ever known anyone who works in one these facilities? Especially with the therapeutics being created?Probably not
I think NeoStem has a great bargaining chip: They can use the experiences of DNDN to their advantage. DNDN built its own facilities and failed. Like I said, it's expensive to build and use these facilities for one product. NBS manufactures 1,000s of product therefore its costs are less.
In terms of growth, I think NBS could more than double its revenue in 2013, and increase its margins. IMUC is in a large Phase 2 study and as enrollment continues and patients progress it will need more product. The same can be said for SOTIO and BAX, both are in large late stage trials. Therefore, NeoStem's revenue should rise
I think all three of these companies will earn FDA approvals, which will also look good on NBS, seeing as how it manufactured the cells. I expect new clients, more revenue, at least two of these companies to continue using PCT after approval, and a segment that could return $500 million in revenue in the next three-five years. I think it's one of the more promising segments that NBS is developing
10x would be a $1.25 billion market cap. If approved NeuVax could have revenue of $3 billion, so try 20x upside. Now with final data the company might seek anothe meeting with the FDA. Who knows maybe it gets fast-track
I think it's probably because investors believe there are no immediate catalysts. Or maybe people are worried about tax rates since the stock has performed so well. It's hard to say. But if you blink it could be $2.30. Watch for other partnerships
I don't think your concerns are anything that's specific to GALE. This occurs in all biotech companies. When you incorporate its large YTD return there are going to be people with opinions. I think the best way to play is to buy and forget, look back in two years.
The SPA has to do with trial design and does not affect the stock price. The company currently has $15 million in cash, we don't know the financial terms of the Teva deal, so the company will probably run out of cash in Q2 or Q3 of next year. But it is very possible that the company finds new partners by then to help with costs. The boosters are given throughout the treatment, every six months as a form of maintenance. These boosters were not given in the Phase 2 trial but have benefit to improving the results
Dendreon's struggle with reimbursements are scattered throughout the majority of their quarterly filings in 2011. It was one of the primary reasons that the company "said" that it did not meet expectations, because it was having trouble with reimbursements and slower than expected physician acceptance due to its benefit/cost ratio. You can take a look at their filings or read the link below. It provides a fair and balanced perspective with research and reasons.
http://bit.ly/s07Pm4
I find it completely unprofessional and reprehensible that Seeking Alpha published this and that PropThink wrote the original article. As a person who has seen the effects of breast cancer first hand, it devestates me to see a company that has gone through all of the FDA and regulatory processes for their product, only to be harmed by a journalist with an obvious agenda. I see absolutely no merit in the articles that have been published and considering that legal action is pending am surprised that this was published today. Shareholders, investors and those suffering from cancer are being negatively affected by an article deemed libel by Galena's legal team.
A trial is to study a product and identify its best methods of use. Galena seems to have found the answer, and I'm sure those who are yet to recur and have taken NeuVax would agree. There are patients who are relying on this treatment and are counting on it to be successful, some of which can't afford traditional treatment, therefore they enroll in a clinical study. Articles such as yours serve no purpose but to hurt investors and patients, so a few can prosper. Haven't you already accomplished this goal?
I agree that CUR has potential, but it's also dangerous, a preclinical company. It's hard to know anything about a preclinical company.
Thanks Michael, I agree with you. I don't know how admitting my wrongs could be considered "pumping" a stock
Yeah it's possible, but not at any point in the immediate future. The company is well positioned following its recent developments