Generex Files To Raise Cash (GNBT)
You have seen us talk about companies in the BioHealth and biotech space after big pops of news lately. But some companies are also just raising cash, or leaving room to raise cash if needed. It is the second group that today’s filing from Generex Biotechnology Corp. (NASDAQ: GNBT) for up to $150 million falls into.
What is interesting here is that this is effectively the same size of the company today. Generex has a market cap after a 6.8% gain to $0.63 today of only about $156 million. Its 52-week trading range is $0.08 to $1.14 and the average daily volume is only about 2.94 million shares.
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Diabetes Drug War Heats Up (NVO, AMLN, LLY, MNKD, PFE, SPEX, VVUS, GNBT, BMY, AZN, ARNA, GERN, STEM, OREX, HDIX, PODD)
Over the last couple of weeks, there has been quite a bit of new data in the drug war in the fight against diabetes. New studies have been updated, earnings projections have been made, FDA dates have been telegraphed and more. While these are still far short of ultimate cures, the war against diabetes may have many new or improved treatments out sooner rather than later. We originally discussed one or two of the key upcoming treatments pending for the eight major diseases and conditions as “the next $170 billion opportunity” and this is a much deeper dig into that broad initiation. We have included many of the recent developments in the potential treatments for obesity as well, considering that Type II diabetes and obesity are frequently conditions tied directly to each other.
According to the Journal of Health Affairs, the figure on obesity for Americans is a whopping $147 billion per year in total medical costs. This comes to 10% of all healthcare spending. The figure from the U.S. Centers for Disease Control was some $116 billion spent domestically on treating diabetes in 2007. As this is a lengthy bit, we have not included some of the other treatments that have been in use or that were recently flagged because of reports of higher chances of cancer rates associated by the long-term use of these.
FDA & IMMEDIATE ACTION
There is a new diabetes hopeful that is supposed to be coming sooner rather than later. Novo Nordisk (NYSE: NVO) reported a 21% gain in earnings in the last week and said that it expects the FDA to make a decision on its next-generation diabetes drug Victoza (liraglutide) in a matter of weeks. The company’s CFO and CEO both indicated that the Danish company does expects a positive response from the FDA and we heard a August to September expectation. Novo Nordisk has already launched Victoza in England, Germany and Denmark last month and expects to release it in other European Union countries throughout 2009 and into 2010. The benefit is that this one doesn’t risk pushing blood glucose levels to counts which are dangerously low and it also helps users lose weight. Novo Nordisk said it has priced Victoza competitively with Byetta from Amylin Pharmaceutical, Inc. (NASDAQ: AMLN) and Eli Lilly (NYSE: LLY). After the earnings and after shares were still close to 52-week highs, we saw analyst downgrades on Friday for Novo Nordisk by both UBS and by J.P. Morgan.
The drug still expected the next big new release with Blockbuster potential is an inhalable insulin from MannKind Corp. (NASDAQ: MNKD). Afresa is to be its name. Despite past woes of inhalable insulin, MannKind shares were hitting 52-week highs in June and its shares are still up 20% from three months ago. A late-stage study showed that Afresa’s performance was similar to injectable insulin. The company recently sold a 7.4 million shares secondary offering to raise cash for this launch, and its CEO took 1 million shares of the offering. The thought was that MannKind would secure a partner for marketing and development, but the recent stock offering gives it more internal options ahead of what is believed to be a Spring-2010 FDA approval action. Pfizer Inc (NYSE: PFE) has been thought of as a partner as it moved Exubera inhaled-insulin patients to MannKind’s experimental product. The two companies had been partners until Pfizer pulled Exubera from the market in 2007.
There is also a huge opportunity for the once per week dosing. We are not yet convinced that this can be a universal next generation treatment, however this might be fine for many of the lower grade cases if you can refer to any diabetes cases as lower grade. Amylin Pharmaceuticals, Inc. (NASDAQ: AMLN), Eli Lilly (NYSE: LLY) and Alkermes Inc. (NASDAQ: ALKS) have had a recent New Drug Application accepted by the FDA for review. Exenatide is an investigational sustained release medication for type 2 diabetes that would be injected once per week and is the active ingredient in BYETTA. We are not alone in this thought, but Amylin is a company which many have thought would be acquired for years now when considering the link of diabetes and obesity.
VIVUS, Inc. (NASDAQ: VVUS) has a substantial shot here with Qnexa, its Type 2 diabetes treatment through weight loss assistance. The stock recently came off on worries of its risk factor language that may have to be disclosed, but it showed a 9.4% weight loss or over 20 pounds observed in patients. The DM-230 study was a 56-week study assessing the impact of Qnexa on glycemic management in 130 obese patients. The 10-site study was comprised of 90 females and 40 males with an average age of 50 who had Type 2 diabetes, and a majority of the patients had been diagnosed with diabetes for more the five years and were taking two or more oral diabetes medications. In the phase II and phase III clinical trials, Qnexa demonstrated glycemic control, significant weight loss, and an improvement in cardiovascular risk factors. VIVUS is also presenting data at a brokerage firm conference this coming Thursday. The company’s market cap is still just under $500 million and its most recent balance sheet had north of $144 million in cash and equivalents with very little long term debt.
Bristol-Myers Squibb (NYSE: BMY) and AstraZeneca (NYSE: AZN) have recently received FDA approval for Onglyza as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. This Onglyza is a once-daily dipeptidyl peptidase-4 (DPP4) inhibitor that can be used in combination with commonly prescribed anti-diabetic medications or on a standalone basis as a monotherapy to significantly reduce glycosylated hemoglobin levels.
MORE OBESITY CANDIDATES COMING
Several biotechnology companies are working on the next wave of obesity candidates, as noted above in VIVUS’s Qnexa. Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) has Lorcaserin, Orexigen Therapeutics, Inc. (NASDAQ: OREX) has Contrave, and Amylin Pharmaceuticals Inc. (NASDAQ: AMLN) has pramlintide. Orexigen’s Contrave has completed phase III trials and our time line for when the company will file for approval is in early 2010. The company is presenting data this Thursday at the Canaccord Adams Global Growth Conference. VIVUS’s Qnexa is currently in two phase III programs with a new drug application expected around the middle of 2010. Amylin’s pramlintide and metreleptin are currently in phase IIb.
We have the expectation that Arena will have a first-mover advantage with an NDA planned before the end of 2009. Certainly, any delays or advances could change the status of the front-runner category leadership. Arena’s near-term catalyst is the release of the phase III BLOSSOM data out in September 2009, which will be used as part of a supplemental NDA in late 2009 or into 2010. This still leaves a year or more for final FDA action from now. Arena shares surged in late-July after reporting that its obesity results met the three endpoints.
STEM CELLS
Stem Cell therapy offers a huge promise, but so far that looks to be years out and the promise is actually more of a hope for the time being. Geron Corporation (NASDAQ: GERN) is in the research stage of using stem cells in evaluation of Type 1 diabetes. The exact level of this study is not as far as along as some of its cancer and spinal studies, but this is one of the few stem cell companies that have dedicated part of their mission to diabetes. StemCells Inc. (NASDAQ: STEM) also has a Pancreatic Program concentrating its efforts on Type-I diabetes. Its goals are to identify, isolate, and culture pancreatic stem and progenitor cells, and to test their therapeutic potential.
While we at BioHealthInvestor would love to hold hope and promise for stem cells, we would not be hoping for stem cell treatments any time in the near future. While some positive notions have been noted in the stem cell sector, the National Institute of Health noted, “Over the past several years, doctors have attempted to cure diabetes by injecting patients with pancreatic islet cells—the cells of the pancreas that secrete insulin and other hormones. However, the requirement for steroid immunosuppressant therapy to prevent rejection of the cells increases the metabolic demand on insulin-producing cells and eventually they may exhaust their capacity to produce insulin. The deleterious effect of steroids is greater for islet cell transplants than for whole-organ transplants. As a result, less than 8 percent of islet cell transplants performed before last year had been successful.”
The Rise of Biotechs May Be Attracting The Shorts (PFE, MRK, BAX, BDSI, SPPI, GNBT, AVII, CEGE, BBH, GILD)
Biotechnology stocks have risen faster than any sector in the past 30 days, although the new short-interest data suggest traders are now increasing their directional bets against the group.
Large biotechs including Pfizer Inc. (NYSE: PFE) and Merck & Co. (NYSE: MRK) are in the top 10 of all large-cap stocks with the greatest increase in the number of shares shorted. And biotechs including Baxter (BAX) are among the stocks seeing a greater than 50 percent increase in short interest from mid-June until the end of that month, the most recent short interest data available.
Perhaps one reason biotechs are an increasing near-term target of the shorts is that the group’s price movement has been counter to the overall market. The price of all biotech stocks with a market cap of $1 billion or more is up 3.6 percent in the past 30 days, vs. a drop of 6.2 percent for the S&P 500. Biotech is the only group to advance more than 3 percent over that time period, other than health care services, up 3.2 percent.
Pfizer is not a stock most traders bet against, with only 3.5 percent of its float sold short. But the short interest of Pfizer rose 16.2 percent to more than 235 million shares by the end of June. Merck shares, with a heftier 6.9 percent sold short, saw its short interest rise 9.1 percent over the same time period.
Some smaller biotech names have seen a very large short interest increase, including BioDelivery Sciences International (Nasdaq: BDSI), up 93 percent. Spectrum Pharmaceuticals Inc. (Nasdaq: SPPI) short interest is up 54 percent. Biotech stocks with at least a 40 percent rise in short interest include Generex Biotechnology Corp. (Nasdaq: GNBT), AVI BioPharma Inc. (Nasdaq: AVII) and Cell Genesis Inc. (Nasdaq: CEGE).
One of the biotech ETFs that is watched most closely by traders is the Biotech HOLDRs (BBH). One of its top holdings is Gilead Sciences Inc. (Nasdaq: GILD), which makes up roughly a third of the index. Its stock saw a 17 percent increase in its short interest to more than 20 million shares.
The biotech Holdrs in early July rose to levels not seen since September 2008, although the index has fallen early this month after creating a bearish candlestick pattern. The fall occurred not not long after MACD, an oscillator watched by technical traders, turned negative — Mike Tarsala
Last Gains Seen on Speculative Swine Flu Stocks? (NVAX, GNBT, BCRX, PURE, VICL, VIVO, AVII)
As you will see, the life has been taken out of many of the very speculative swine flu stocks from last week’s highs.
NovaVax, Inc. (NVAX) gained almost 15% to $1.93 today, but this is down about half from last week’s highs of $3.88; shares were at $0.81 before the swine flu scare came out.
Generex Biotechnology Corp. (NASDAQ: GNBT) was up 18% today at $0.438; shares peaked at $0.70 last week and were at $0.27 before the swine flu scare came out.
BioCryst Pharmaceuticals Inc. (NASDAQ: BCRX) rose 14% to $3.24; shares peaked at $4.89 last week and were at $1.75 before the swine flu scare came out.
Pure Bioscience (NASDAQ: PURE) was down 1.2% at $2,40; shares peaked at $3.19 last week and were at $1.75 before the swine flu scare came out.
Vical Inc (NASDAQ: VICL) fell by 7% to $2.09; shares peaked at $3.30 last week and were at $2.40 before the swine flu scare came out.
Meridian Bioscience Inc. (NASDAQ: VIVO) were up barely above flat at $17.69; shares peaked at $18.30 last week and were at $16.13 before the swine flu scare came out.
AVI BioPharma Inc. (NASDAQ: AVII) was flat at $0.76; shares peaked at $1.29 last week and were at $0.74 before the swine flu scare came out.
Jon C. Ogg
Speculative Flu Stocks Started Giving Gains Back (NVAX, GNBT, BCRX, PURE, VICL, VIVO, AVII)
This week there have been many crazy stock gains among the speculative biotech sector, and these were tied directly to the ’speculative stocks’ that could have any ties in reality, fiction, and even imagination to a cure or hope in the fight against Swine Flu.
As you will see below, Novavax, Inc. (NASDAQ: NVAX), Generex Biotechnology Corp. (NASDAQ: GNBT), BioCryst Pharmaceuticals Inc. (NASDAQ: BCRX), Pure Bioscience (NASDAQ: PURE), Vical Inc (NASDAQ: VICL), Meridian Bioscience Inc. (NASDAQ: VIVO), and AVI BioPharma Inc. (NASDAQ: AVII) have all begun their overbought roll-over.
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Swine Flu Speculation Stocks (GILD, BCRX, NVAX, GNBT, VICL, AVII, CRXL, RHHBY, GSK)
Monday is looking like a SWINE FLU speculative flu stock stock bonanza. The two approved drug treatments, not vaccines, which are being released are Tamiflu made by Roche (OTC: RHHBY) and Relenza made by GlaxoSmithkline (NYSE: GSK). Gilead Sciences, Inc. (GILD) gets royalties from Roche for Tamiflu, and its shares are indicated north of $48.00 after a $45.80 close on Friday.
There is a second-tier level of stocks here: BioCryst Pharmaceuticals Inc. (BCRX) was up big Friday as it is a maker of drugs that block key enzymes in viral diseases like the flu, shares are indicated over $3.00 after a $2.21 close on Friday. Novavax, Inc. (NVAX) is another clinical stage company using its virus-like particle platform technology for flu treatments; stock is indicated north of $2.50 after closing up some 75% at $1.42 Friday.
And here is the third-tier of these stocks: Generex Biotechnology Corp. (GNBT) is being passed around as a penny stock flu player with shares indicated around $0.40 after closing up 25% at almost $0.34 Friday. Vical Inc. (VICL) closed up 3% Friday at $2.53 and shares are indicated up around $3.00. AVI Biopharma, Inc. (AVII) rose over 20% to $0.89 Friday and shares are indicated up marginally as a result. Crucell NV (CRXL) has a faster way of making flu vaccines. This closed up 1% on Friday and is hardly moving.
As a reminder, these huge gap ups generally have a one day to multi-day move with each move usually being less than the first. As with issues such as SARS and bird flu, the world did not end and it was only the SARS scare which actually caused real damage. You can probably bet that you will be hearing “squeal like a pig!” jokes.
JON C. OGG
Small BioHealth Cash Raises (IMGN, SQNM, GNBT)
Between Friday’s close and early Monday morning we have already seen some small capital raise filings for securities sales from small BioHealth players.
ImmunoGen, Inc. (NASDAQ: IMGN) announced that Ziff Asset Management, L.P. has purchased roughly 7.8 million shares of ImmunoGen’s common stock at $3.20 per share. The shares were offered under an effective shelf registration statement previously filed with the SEC. Proceeds to ImmunoGen after expenses are expected to be approximately $24.7 million. MARKET CAP: $129 Million.
Sequenom Inc. (NASDAQ: SQNM) hasn’t given any numbers but the company has filed an automatic shelf registration with the SEC that will allow it to raise capital. While the numbers and terms aren’t known and aren’t certain, it filed to sell common stock, preferred stock, debt securities, and warrants. MARKET CAP: $647 Million.
Generex Biotechnology Corporation (NASDAQ: GNBT) filed after the close on Friday a shelf registration on behalf of holders who already purchased securities. This will allow for the resale of up to 22,527,275 shares of common stock issuable upon conversions of a $20,650,000 principal amount of 8% Secured Convertible Notes due September 2009, and up to 51,198,347 shares of common stock issuable upon the exercise of Warrants. MARKET CAP: $107 Million.
Jon Ogg
June 23, 2008
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