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  • Galena Biopharma: Numerous Red Flags Suggest A Significant Overvaluation [View article]
    Quote from the article: "A number of patients could have been enrolled in the study with disease that was "undetected". With such a small sub-group of patients; by chance, it is not that far-fetched to believe that the control group could have had subjects with undetectable disease that progressed further, possibly skewing the study results in favor of NeuVax. Therefore, we should rely on the overall study results of the data for all 188 patients enrolled in the study. This data is more likely to predict the outcome of the PRESENT Phase III trial. Let me remind you, NeuVax failed to show a meaningful benefit."
    I hope the patients in the peptide vaccine studies are paving the way towards a new future for immunotherapy, never mind feelings about a stock. The author of today's article delves into many topics while stating his position, and I enjoyed the read. I'll respectfully note that I disagree with the thoughts that I quoted above. Would it be equally fair for someone who is LONG $GALE to opine that the vaccine group could have had subjects with undetectable disease that progressed further, proving the efficacy of the vaccine? There is no scientific data to support either hypothesis, as it is simply an unproven suggestion.

    As stated in the same abstract which was presented at the ASCO Annual Meeting in 2010, "the only significant prognostic difference between the groups was more ER/PR negativity in the VG (p=0.04)." So, the only significant difference in the two groups (vaccine vs. control) favors a positive outcome for the control group. Also, the abstract notes that, "importantly, due to trial design, 72 patients received less then what was determined to be the optimal biologic dose." http://bit.ly/1j0rlxv

    Therefore, I have doubts "that we should rely on the overall study results of the data for all 188 patients enrolled in the study." Would the other 106 have had a better outcome if they received the optimal dose, never mind being included in a booster series that was added late to the studies, or if they had already identified the population that would most benefit from NeuVax (node positive, HER2 1+ or 2+)?

    From the article: "If NeuVax truly worked, why is the study aimed to treat patients who are already disease free?"

    A couple of weeks ago, I had an email exchange with MD Anderson's Dr. Mittendorf about peptide vaccines, specifically AE37 and E75. The difference in current research vs. previous failed efforts, beyond the AE37 novel Ii-key approach at unlocking a powerful long lasting cd4 t cell response, is using peptide vaccines in the proper setting. Past studies focused on metastatic disease. Her focus is the adjuvant setting after patients are rendered disease free with standard of care therapy. In the metastatic setting the tumor microenvironment is overly hostile to the immune system, inhibiting a response to a peptide vaccine. However, other strategies employing other immunoagents such as antibodies targeting checkpoint molecules combined with the peptide vaccines have her confident that the vaccines will someday be successful for metastatic.

    I quoted her response to me in an article about AE37 that Seeking Alpha published last week:

    "I think it's safe to say that I have significant enthusiasm for vaccines to include NeuVax and AE37. In order for these vaccines to be efficacious, I believe they need to be used in the appropriate setting; specifically, given to patients in the adjuvant setting after they have been rendered disease free with standard of care therapy, in order to prevent recurrence. If ongoing clinical trials such as the phase III PRESENT trial investigating NeuVax were to show that the vaccine is effective in the adjuvant setting, it would be paradigm changing. The vaccine wouldn't change our recommendations with respect to things we know work - surgery, chemotherapy and radiation - but it could be added on as an additional measure to prevent disease recurrence." http://bit.ly/1eI1sv9

    I'm more on the AE37 side, but I appreciate all that has been learned from the NeuVax studies, and the low recurrence rate even in the data for all 188 patients is remarkable, as data from the separate vaccine studies validate one another in certain ways, especially in targeting the adjuvant setting. For the sake of the patients, I hope all the vaccines pass their studies and oncologists can figure out which one best fits each patients in a targeted approach, which may ultimately include vaccine w/ Herceptin.
    Feb 1 10:11 PM | 27 Likes Like |Link to Comment
  • A Deeper Look At The Galena Biopharma Controversy [View article]
    Most of what is said about AE37 is out of focus. Generex was delisted, hence enrollment slowed as they tried to survive. Their Phase II is the largest vaccine study for breast cancer, and according to MD Anderson's Dr. Elizabeth Mittendorf the AE37 study is very popular with oncologists and patients. I quoted her in m y article about the vaccine last month,

    "One thing I wanted to emphasis is that my colleagues in the breast group at MD Anderson have been very enthusiastic about the AE37 trial, as have been the patients. In fact, we have consistently had a 20 patient wait list in order to get on this study, so it's been a very popular and well received trial."

    The dfs analysis is the main item to watch, and a p value of statistical significance is quite the hurdle at 17 and 24 months out in a couple hundred subjects. AE37 has a lower relapse rate for high HER2 expressors vs. standard of care (Herceptin), about 1% less. That's great, yet the p value shows no difference since Herceptin obviously works. Low expressors get no Herceptin, and the improvement in disease free survival is very encouraging. That type of benefit in a controlled randomized study is usually limited to patients receiving Herceptin, and in this case low HER2 expressors and triple negative only get AE37. For example, 36 month dfs for HER2 overexpressors with Herceptin is 87%. AE37 will match that for all HER2 subjects, if current trends continue. P value comes with thousands of subjects, and AE will report current results at ASCO.

    Sorry, this is a phone, so hopefully typos are understood.
    Feb 14 10:17 AM | 21 Likes Like |Link to Comment
  • Galena Biopharma: Numerous Red Flags Suggest A Significant Overvaluation [View article]
    Herceptin wasn't given to the low HER2 expressing subjects (vaccinated or control) in either the NeuVax or AE37 Phase II studies.
    Feb 1 03:59 PM | 13 Likes Like |Link to Comment
  • Generex and Its Insulin Spray: Just Hype? [View article]
    Hi Derek, I appreciate you mentioning my article from last week, seekingalpha.com/artic... , but it does not appear you have grasped all of the information I was detailing. First, I don't agree that the REAL subject line should be to question Generex's buccal insulin spray, but rather the misinformative and inflammatory reporting surrounding their clinical effort. Let me explain and I will use your article as an example.

    First, you state that you are "now regretting" your "lack of coverage" {of Generex}, since if you had said "something uncomplimentary about them (an even bet), I might have had my chance to get sued by them as well. That's what's happening to Adam Feuerstein of TheStreet.com." Derek, I believe that is untrue (and unfair), in the sense it requires a distorting of actual events. Feuerstein is not getting sued by Generex for saying uncomplimentary statements, but for what they allege are "numerous defamatory statements" and "that the articles put forward several ostensible statements of fact that are, in truth, misleading or outright misstatements made with malicious intent or with a reckless disregard for the truth". Whether a company can sue for libel or slander is out of my realm of understanding, but I agree with their characterization of his writings.

    I first wrote about Feuerstein's reporting of Generex on March 21, see seekingalpha.com/insta... , and noted that: "A columnist offering a negative opinion on a company or stock can often result in a more well rounded perspective and be helpful. However, when the article presents a defamatory opinion based on untrue statements, the small retail shareholder holding shares can watch his investment deteriorate for potentially manipulative reasons." Both articles detail where I believed Feuerstein to misinform about Generex and Oral-lyn, and I am confident that any fact checker will determine that I am correct. Many of the examples actually highlight the low level of dd conducted by Feuerstein.

    So when you begin your article by saying that if you had previously made uncomplimentary statements about Generex you may also have your chance to be sued, I feel you are exhibiting the same type of rational that plagues journalists across every sector or industry. In my opinion, you propose a statement based on fiction, or a version of reality distorted by design or inattention to detail. Further comments follow the pattern, such as why "treat a handful of people in Ecuador and let your stock value sit at 60 cents a share, if you have the chance to raise the serious money needed to get a real diabetes therapy through some convincing Phase III trials instead?" Generex isn't treating a handful of patients in Ecuador, but hundreds of patients in a worldwide Phase 3 trial and is now treating additional patients through a Treatment IND that was approved by the US FDA. Generex is a small R and D firm, and has to raise capital as the trials progress, and with all of the activity for Oral-lyn and AE37, it is apparent that they are doing a good job.

    There are other examples, as well as exhibiting a lack of knowledge on basic information. Lilly did look at buccal insulin, but was already heavily invested in inhalable insulin and held Generex down for a couple years from conducting any studies. You can go back to a 2008 article to catch up to speed- seekingalpha.com/artic... .

    In my opinion, after what we have witnessed in what I believe are sloppy and misinformative articles from TheStreet regarding Generex in the last few weeks, any analysis that starts a sentence with "According to Feuerstein" should be taken with a wink and a smile. We are all entitled to opinions, but we shouldn't be able to recreate reality in order to make faulty logic stand tall.
    Apr 7 01:21 PM | 11 Likes Like |Link to Comment
  • Galena Biopharma: The Oncologist's Perspective On A Life Saving Therapy [View article]
    "Obviously we cannot compare these two studies, but Dr. Hanna's study can be seen as a preview of how clinical trials can progress through the oncology community. A subset analysis showing a statistically significant benefit can translate into a very successful Phase III trial." -Dr. Farhat

    Very interesting, since much is made of the subset analysis. Here's another example:

    Herceptin Early Trials

    "In parallel to two small phase II that established the activity of trastuzumab in humans (Baselga et al 1996; Pegram et al 1998), a large, randomized, single-agent study was initiated in April 1995. Response rate was found to be 15%, and median overall survival was 13 months. In the Her2 3+ subgroup, a considerably higher activity was observed, with an overall response rate of 18% and median survival of 16.4 months. Those results suggested that this group might derive the greatest benefit from trastuzumab (Cobleigh et al 1999)."

    http://1.usa.gov/1jREHN0
    Feb 19 07:56 PM | 10 Likes Like |Link to Comment
  • Galena Biopharma's NeuVax Vaccine: What To Know Before You Invest [View article]
    "These activated specific CTLs / NeuVax is purportedly more active in patients who express low-levels of the Her-2 protein. While this seems counterintuitive, Galena explains that high expressing Her-2 tumors down-regulate HLA expression, rendering them invisible to the immune system."

    http://1.usa.gov/ZoyEBF

    http://1.usa.gov/XwsDXE

    "Galena has completed two Phase-I/II studies (n=187 patients) with NeuVax, one in Her-2 positive/node positive patients, and a second in node negative/Her-2 positive and negative patients."

    Both enrolled subjects with any level of HER2 expression.

    "In February 2010, Galena Biopharma initiated a randomized, ascending-dose, Phase-I/II trial (NCT00841399) comparing NeuVax with placebo in node-positive/Her-2 "positive" patients."

    Galena didn't exist in 2010. Any mention of 2010 aside, COL George Peoples and the Henry M Jackson Foundation initiated the study in 2000. At that time, Herceptin was NOT approved in the adjuvant setting. Patients were enrolled but not randomized, and they were assigned to the vaccine group only if they were HLA A2/A3+. Non-treated patients, or those that were A2/A3-, were followed as a control group.

    "During the conduct of this trial, Herceptin became commercially available for HER-2 IHC positive (IHC +3) patients, after which the trial was amended to allow these patients to receive Herceptin. Galena goes on to note that "this patient group" was excluded from efficacy analysis."

    The high HER2 expressing group was included in various interim and final efficacy results. They were not included in a sub group analysis.

    "Curiously, the clinicaltrials.gov listing for this trial shows a start date of May 2000, but the protocol was received in February of 2009."

    The trials were listed retrospectively.

    "Lastly, it is worth noting that the protocol on clinicaltrials.gov was never updated to reflect the exclusion of Her-2 IHC +3 patients."

    They were never excluded from the study. HLA downregulation wasn't understood in 2000. They are excluded in the current Phase III. Full results in all groups have been reported at 24 and 60 months by COL Peoples et all.

    "‡The pooled patient population was not well balanced."

    Patient demographics are well balanced, with the only significant difference is that more ER-/PR-patients are in the vaccine group. So, the only statistical imbalance favors the control arm p = 0.04.

    "*It is not known whether this is inclusive Her-2 IHC +1 and +2 patients."

    That is known. The graph says "Her-2 overexpression". That is 3+.

    "It is not clear how patients in the booster program were randomized without bias, or even if the program had been contemplated in the original Statistical Analysis Plan."

    See page 4.

    http://bit.ly/LFfBhO

    "The validity of the statistical analysis aside, patients receiving booster vaccinations showed a statistically significant disease free survival (http://bit.ly/UgC0lG) benefit at 24 and 36 months, but not at 60 months."

    To date, 53 patients received at least one booster. The results show that, at a median of 60-months, the disease-free survival (http://bit.ly/UgC0lG) for the booster group (n=53) was 96.2% vs 80.5% in the control group (n=79) (p=0.01); and, the recurrence rate for the booster group was 3.8% vs 18.9% in the control group. - "Safety and Long-Term Maintenance of Anti-HER2 Immunity Following Booster Inoculations of the E75 Breast Cancer Vaccine" (Abstract #2529) ASCO 2012

    "Deciphering NeuVax's development history and results requires a considerable investment of time and effort that still leaves many unanswered questions."

    Take the time.

    I don't currently own GALE, although I appreciate the work of COL Peoples. I will probably buy to hold at some point. I think the AE37 vaccine from Antigen Express has even greater potential, although in a perfect world both vaccines will someday be available to help fill the unmet need to treat low HER2 expressing breast cancer patients (that currently have no other approved treatment options). Even if Herceptin is eventually approved for 2+ subjects, the low toxicity and off the shelf aspects of these peptide vaccines may make them the preferred choice.
    Mar 13 11:31 PM | 9 Likes Like |Link to Comment
  • Generex: A Stock Suitable Only For Its Officers And Directors Or Carl Icahn [View article]
    "My fellow journalists who have tracked the stock, like Rich Steffens, have dropped out in disgust a year or two ago."

    Hi Thomas. Long time no speak. I hope all is well. I want to point out that the quote is inaccurate. I didn't drop out. Like any long term investor I have my episodes of frustration, but remain a shareholder. I added a little two weeks ago. I'm no big money guy, so a little here and there is all I do. I respect the GNBT team, and don't think their jobs are easy, or hold a delusion that I know what they could do to improve their standing. I have suggestions, like a Monday morning quarterback, but I believe in their ability to right their ship.

    The BOD and executive team chose options over cash compensation in effort to benefit common shareholders. The BOD has forsaken all cash salary, and as you read their filings you learn of significantly reduced salary and deferred payments satisfied solely by options. The dilution that accompanies raising capital via discounted shares with extraordinary warrant coverage is something we want them to limit. Generex's stock trading on the bulletin board creates high hurdles.

    I haven't blogged about them because things are too busy (donated a kidney to my sis and run a small biz), and I'd like to first see some progress that can lead to a future reverse split and potential jump back to a national exchange. The company has done a good job advancing the AE37 her2 vaccine. Galena gets all the press, but AE37 may prove to be the more valuable vaccine. The AE vaccine could treat far more her2+ breast cancer patients, and obviously I mean if both are eventually approved.

    Final AE37 primary efficacy results are to be released in short time. The data is being analysed right now. This was the largest vaccine study for breast cancer in the adjuvant setting ever completed. Hang tight and see if that leads to better days for GNBT, and helps them land a partner.
    Dec 2 01:05 PM | 7 Likes Like |Link to Comment
  • Galena Biopharma: Numerous Red Flags Suggest A Significant Overvaluation [View article]
    I've read all of the abstracts, peer reviews, etc for NeuVax and AE37, and have discussed them with the actual investigators numerous times. I said "low HER2 expressing" subjects. 12 of 30 HER2 "3+" also known as "HER2-overxpressing" subjects received Herceptin. The studies started before Herceptin was standard of care, hence the HER2 3+ enrolled before 2006 didn't receive Herceptin. Herceptin is not standard of care for low HER2 expressing subjects, hence the HER2 1+ and 2+ subjects did not get Herceptin. 108 vaccinated subjects comprise the early NeuVax studies. 12 HER2 3+ subjects received Herceptin out of the 108 total (1+, 2+ and 3+). 12/08 = 0.11111. Times 100 = 11.1%.
    "Our trials began enrolling patients before trastuzumab became the standard of care therapy for HER2-overexpressing breast cancer in the adjuvant setting; therefore, the majority (68.8%) of patients with HER2-overexpressing tumors did not receive trastuzumab. Of 30 vaccinated patients who had HER2-everexpressing tumors, 12 patients received trastuzumab before vaccination..."
    12 of 30 HER2 3+, and 12 of 108 overall, or 11.1%.
    Cancer, Vol 118 Issue 10, 2594-2602

    Herceptin wasn't given to the low HER2 expressing subjects (vaccinated or control) in either the NeuVax or AE37 Phase II studies.
    Feb 3 09:11 PM | 6 Likes Like |Link to Comment
  • Galena Biopharma's NeuVax Vaccine: What To Know Before You Invest [View article]
    I asked COL Peoples:

    Quote/

    Thanks for your message. I read your response to his article. I appreciate your trying to point out the inaccuracies in his report. As you know on the HLA question:

    1) There may not be a difference between HLA-A2+ and A2- breast cancer pts. No one has ever documented a prognostic link with HLA type in breast cancer. The vaccine and control groups were matched for all of the known and important clinical, pathologic, staging, and treatment parameters. So, the vaccine was tested in the same clinical population as the controls.

    2) If there is a difference in the A2+ vs A2-populations, all the world's literature for other cancers (ovarian, prostate, colon) that addreeses this issue (none in breast), concludes that A2+ do worse. Therefore, one would conclude that if anything, the control group in the phase 3 will do worse than the control group in the phase 2. Hardly a "nail in the coffin."

    /End quote from COL Peoples. I feel good that that he affirmed my non expert coments.
    Mar 27 01:06 AM | 6 Likes Like |Link to Comment
  • Generex: Reverse Split Not Approved [View article]
    Hi Thomas, I always like your objective approach. Thanks for mentioning my blog. I think Generex's stock struggles began after they had difficulty repaying a $20 million convertible pipe debt. The company entered into the debt as the worldwide financial calamity began. They were making monthly repayments in shares and the diluted effect often causes a downward swirl where each month increasing amounts of shares are required to repay the loan. These types of financial vehicles are common amongst small biotechs, but are toxic.

    In an effort to ease the dilution, Generex made a couple of monthly payments in cash. During that time, they didn't even have much cash. They had so little that the cash repayment resulted in a default on the loan. That is something called the Cash Balance Test- I think. They were required by the lenders to hold a certain amount of cash in relation to the loan. That default, which was odd since the payment was actually made, caused all sorts of problems in early 2009 that were revealed in never ending 8K's about a Standstill Period.

    Generex subsequently signed on a new consultant from Seahawk Capital during that time period to help them raise capital with less toxic terms. You mentioned that shares had been sold to investors in ever declining share prices. Actually, the shares were sold via help from Seahawk at increasing share prices and without cashless warrants (just regular ones).

    September 14 2009 $11,660,000 (priced at .80)
    August 6 2009 $5,336,000 (priced at .66)
    June 15 2009 $10,800,000 (priced at .63)
    May 15 2009 $4,800,000 (priced at .33)

    The latest deal to Seaside88 was at a lower share price compared to the previous offering. However, Generex terminated the deal. Terminating the deal is an unusual strategy for a biotech. They will always need to raise cash, and we even see that with biotechs that sign partnership agreements. The consultant from Seahawk Capital told me that his main goal was getting rid of the abundance of cashless warrants that afflicted the stock. They have had success in that area. The stock is stuck in the mud, and this part of discussion (warrants et all) regarding Generex is less sexy, but their efforts at cleaning out the toxic sludge should be very helpful later when their pipeline is bustling with news.

    Hopefully, that trend starts with an abstract that will be presented in September at the EASD 2010 Annual Meeting. During the ASM presentation, I asked about the studies with IGT patients, and we learned that a positive abstract showing no insulin antibodies "IAB" were found in patients upon conclusion of the study. Mannkind reported a higher level of IAB's in the patients they study, but that after discontinuation of treatment with Afrezza the IAB levels return to normal. That is good since the IAB levels are reversible. Once they stop Afrezza therapy to have their IAB levels return to normal, perhaps they can begin Oral-lyn therapy in the Treatment IND and not worry about pulmonary or insulin antibody issues at all. Since an actual lowering of weight is seen in Phase III patients, buccal insulin appears to on its way to becoming an option a doctor and his patient can feel very comfortable utilizing. But we certainly need to have them successfully move past this listing issue.

    Keep up the good work. You evenly consider all sides. Hmm, we don't see that from TheStreet.
    Aug 1 02:29 PM | 6 Likes Like |Link to Comment
  • Mannkind's Afrezza: No Real Benefits for Diabetics or Investors [View article]
    For proper full disclosure, you should have stated you were a BIOD long.
    May 3 04:21 AM | 6 Likes Like |Link to Comment
  • Generex's Libel Suit Against TheStreet.com Draws Industry Derision [View article]
    The blogger reporting about Generex and Feuerstein has become quite erroneous. Let's look here:

    * "and its Oral-lyn inhaled insulin program".

    Reality- Generex has a BUCCAL insulin program, and there is a big difference one should understand if it wishes to opine about their top pipeline asset (although AE37 should not be discounted).

    * "Shares of Generex have fallen from a 52-week high of $1.14 to close to their 52-week low of 45 cent per share in recent trading days"

    Reality- .45 is not a 52 week low. That is +.20 over the 52 week low.

    * "Feuerstein's reporting and the subsequent suit have stirred up passionate defenders of Generex as well as discussions about the market viability of inhaled insulin products"

    Reality- The FDA Complete Response judgement to Mannkind's NDA for Afrezza inhalable insulin led to discusions about the market viability of inhaled insulin products. Specifically, the FDA request for information related to the clinical utility of Afrezza inhalable insulin. This is all unrelated to Generex and Oral-lyn buccal insulin. In recent months, the FDA awarded the first ever diabetes related Treatment IND to Generex for Oral-lyn. Evidently, the FDA has already found clinical utility for Oral-lyn within a specific segment of the diabetes population.

    * "Generex's suit has drawn derision from industry and media observers. Reuters blogger Felix Salmon called the suit “silly”..."

    Reality- Felix Salmon's report was silly and not even factually correct in his main premise. He stated that TheStreet responded to Generex's lawsuit by writing a third article, which is revisionist history. The article was out before the announcement of the suit.

    The first misinformative article by Feuerstein regarding Generex eventually led to a correction and statement of regret by TheStreet: However, I found they did not acknowledge all of the biased, and what I felt to be erroneous, commentary. If someone is really interested they may want to read my first article on the topic seekingalpha.com/insta... or the follow up after Feuerstein's second attack seekingalpha.com/artic... .

    The "professional "blogger analysis exposes an inherent problem that plagues small retail investors looking for insightful and informative articles / opinion pieces. Their work is often error filled, with inaccurate rendition of an event, and with false premises used to support conclusions.

    Derek Lowe jumped into the hoopla, however instead of delving beyond Feuerstein's juvenile reporting, he asks if this small biotech's insulin spray is a "scam?". No in depth analysis follows and he appears unfamiliar with the biotech whose buccal insulin program is headed by the former Pres of the ADA. When subsequent comments to his SA blog were negative, he follows with this on his latest In the Pipeline offering:

    * "Boy, do the Generex fans love me over at Seeking Alpha, where some of my articles are reposted. I am apparently in the pay of The Hidden Interests (although there are contradictory opinions as to who They may be), and there are calls to have the SEC, the IRS, and all those other fun agencies come and sort me out. That increases my interest in the company even more, now that I see what high-caliber fans it has. Look for an article on Generex here next week. From what I've been able to find already, I should have something the company's cheering section will enjoy." pipeline.corante.com///////

    Does that sound like we are about to enjoy another article written and researched by the motivation to present accurate, objective, and insightful analysis? I hope so, but I'll just say my opinion that amongst professional bloggers, it would be rare.

    www.reallibertymedia.c...
    Apr 11 10:36 AM | 6 Likes Like |Link to Comment
  • A Comprehensive Look At Galena [View article]
    Nice effort, but there's a lot of items that are off target. For example, pertuzumab isn't a vaccine in development, but a monoclonal antibody that's already approved. Some other statements about Roche and NeuVax would be news to Roche, unless something new has taken place to be described as growing interest. That would be a great future development, so someday perhaps optimistic speculation becomes fact.

    I wrote an Editor's Pick article this week that in part jumps a little deeper into NeuVax and the AE37 Ii-Key HER2/neu vaccine, including true market potential, beyond saying all 200,000 new cases of breast cancer the US has each year. If interested,

    http://seekingalpha.co...
    Jan 24 12:24 PM | 5 Likes Like |Link to Comment
  • Emerging Biotech Takes Aim At Preventing Recurrent Breast Cancer [View article]
    Hi Adam. Well, nothing went perfect! Obviously, I believe in the science behind AE37, while trying to accurately assess the dilutive nature of Generex's stock, either in this article, or back when I wrote of the consequence of the reverse stock split proposal not being approved.

    I feel good about shining a light on important research into developing a novel breast cancer vaccine. Anyway, on a different note, I'm sure you'd agree that there are a lot of brave women enrolled in this MD Anderson study, and they don't care about a stock. I shouldn't just say women, since we also know of at least one male enrolled in the Phase II study. That's Oliver Bogler, Ph.D., MD Anderson Vice President for Academic Affairs, and he's blogged about his participation as a patient in the study.

    No matter what prospects we feel lay ahead for a stock, I hope Generex/Antigen Express succeed in filling this unmet need. Regardless, continued success for AE37 would obviously have a positive effect on "GNBT." Best wishes on the new blog site at TheStreet.
    Jan 22 08:35 PM | 5 Likes Like |Link to Comment
  • Emerging Biotech Takes Aim At Preventing Recurrent Breast Cancer [View article]
    I would like to add the following feedback from Generex's CEO, Mark Fletcher, regarding a potential reverse stock split of GNBT and a potential spinout of Antigen Express, which I thought I had included within the article, since this of interest to GNBT shareholders:

    "The spinout of Antigen Express and a reverse split of the GNBT stock can be considered separate and distinct items. Although we have contemplated doing those two items together, neither item is a condition precedent to the other.

    With respect to Antigen Express, our goal with a spinout is not merely to transfer the asset to a public shell. We want the new entity to be sufficiently capitalized for an up-listing to a national exchange, i.e. the NASDAQ Capital Market or the NYSE Amex, where there will be continued access to the capital markets for operating funds (if needed). That requires at least one year’s worth of budgeted burn. Of course, raising that capital requires a valuation of Antigen Express.

    As always, funding development stage biotech companies is a challenge and we have not been satisfied with the valuations posited by prospective life sciences investors (we have stayed away from hedge funds, seeking to avoid infecting Antigen Express with that type of money out of the gate); we would have to give away far too much of Antigen Express in exchange for that one year of capitalization. Therefore, as we’ve noted publicly on a couple of occasions, we have elected to wait for the Antigen Express science to mature to the point where it will support a valuation that makes the spinout a better deal for Generex and its stockholders."
    Jan 21 12:13 AM | 5 Likes Like |Link to Comment
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