Developments in the War on Lung Cancer (OSIP, ONTY, LLY)
We have seen some developments over the last week on the companies that aim to fight lung cancer. OSI Pharmaceuticals Inc. (NASDAQ: OSIP) has an FDA review event coming up this week for Tarceva. We also wanted to review what occurred this week in Oncothyreon Inc. (NASDAQ: ONTY) and Eli Lilly and Company (NYSE: LLY), as well as noting some crazy activity in a penny stock.
OSI Pharmaceuticals Inc. (NASDAQ: OSIP) may have been forgotten about during the holiday rush. The company already had its analyst meeting on December 3, but we have this one marked with a December 16 FDA advisory committee meeting for Tarceva as a first-line maintenance therapy treatment against non-small cell lung cancer. The company said that Tarceva is the only oral, non-chemotherapy agent shown to provide a statistically significant improvement in both progression-free survival and overall survival in the NSCLC maintenance setting. At $34.75, its 52-week trading range is $27.01 to $43.00. If we use the 4 closest strike prices on put and calls combined, there is only just over 5,000 contracts in the open interest, so it seems that binary event traders in biotech are not giving this much of a grade one way or the other.
Oncothyreon Inc. (NASDAQ: ONTY) rose sharply on Thursday, yet gave back some gains on Friday. The company last week said Merck KGaA has launched a Phase III trial of its Stimuvax vaccine in Asian patients with advanced non-small cell lung cancer and it is developing the cancer vaccine under a license with Oncothyreon. The companies are already trying the drug in several other studies for other indications. Stimuvax is designed to stimulate the body’s immune system to identify and target cancer cells that express MUC1, an antigen commonly expressed in NSCLC as well as in other common cancer types such as breast cancer, multiple myeloma, and colorectal, prostate and ovarian cancers.
Eli Lilly and Company (NYSE: LLY) gave analysts its pipeline update and financial guidance for 2010 this last week. In its presentation, one of the many drugs under study was Necitumumab (IMC- 11F8). The company noted that it has 2wo Phase III studies of necitumumab which have been initiated in non-small cell lung cancer. The first of these commenced dosing in November 2009, while the second study is expected to commence before the end of 2009. A pivotal trial in colorectal cancer will follow. Unfortunately for Lilly, if you did not count a whole $0.05 gain in the stock on December 9 this would have been a sever day losing streak.
I apologize for covering a pink sheet stock ahead of time. A company called HARD TO TREAT DISEASES (Pink Sheets: HTDS) had to comment on recent trading activity: HTDS management would like the public to know that the only changes in the company’s fundamentals have been positive. As our shareholders will remember, we recently closed important new sales, added new marketing and technical advisors and had world-class research advances. While it is only a fraction of a penny, it is hard to not notice 85 million shares… “We continue with our daily business activities, the research into MS, Lung cancer with our www.mindupbioresearch.com project to name a few.”… We are offering you a link here to the company’s announcement, because it is obvious something is afoot here after noting many issues.
Jon C. Ogg
December 13, 2009
Oncothyreon (ONTY) Moves On Deal News
Oncothyreon (NASDAQ:ONTY) shares jumped as the firm announced that Merck KGaA has initiated a Phase 3 trial of Stimuvax (BLP25 liposome vaccine) in Asian patients with advanced non-small cell lung cancer (NSCLC). The trial, named INSPIRE (Stimuvax trial In Asian NSCLC Patients: Stimulating Immune Response), is anticipated to enroll approximately 420 patients in China, Hong Kong, South Korea, Singapore and Taiwan.
INSPIRE is similar in design to START, the ongoing global Phase 3 trial of Stimuvax in NSCLC. Each trial is a multi-national, Phase 3, double-blind, placebo-controlled, randomized clinical trial to evaluate the efficacy, safety and tolerability of Stimuvax in patients with unresectable, stage III NSCLC who have demonstrated either stable disease or an objective response following primary chemo-radiotherapy. The primary endpoint of both trials is overall patient survival.
Stimuvax is an investigational therapeutic cancer vaccine being developed by Merck KGaA under a license agreement with Oncothyreon. Stimuvax is designed to stimulate the body’s immune system to identify and target cancer cells that express MUC1, an antigen commonly expressed in NSCLC as well as in other common cancer types such as breast cancer, multiple myeloma, and colorectal, prostate and ovarian cancers. Stimuvax was the first investigational cancer vaccine to enter Phase 3 clinical testing in NSCLC with the launch of the START study in February 2007. A Phase 2 trial of Stimuvax in NSCLC is ongoing in Japan. Stimuvax is also being investigated in the Phase 3 STRIDE study, which is currently enrolling patients who have hormone receptor-positive, locally advanced, recurrent or metastatic breast cancer.
Douglas A. McIntyre
Oncothyreon (ONTY) Disappoints Investors
Oncothyreon (NASDAQ:ONTY) reported a loss from operations of $2.8 million for the three months ended September 30, 2009, compared with a loss from operations of $3.6 million for the comparable period in 2008.
Oncothyreon reported a net loss of $5.9 million, or $0.24 per basic and diluted share, for the three months ended September 30, 2009, compared with a net loss of $3.6 million, or $0.18 per basic and diluted share, for the comparable period in 2008.
As of September 30, 2009, Oncothyreon’s cash and cash equivalents were $35.0 million, compared to $19.2 million at the end of 2008, an increase of $15.8 million. The company raised over $24 million from stock sales.
Revenue for the quarter was only $4,000.
Douglas A. McIntyre
BioHealth Companies Keep Raising Cash (MNKD, IDIX, ISPH, ARIA, ONTY, NBY, SOMX, ARNA, OXGN)
The appetite for biotech and emerging pharmaceutical companies to raise cash is almost a never ending line of companies. We have some offerings today and have seen many offerings and filings from companies to offer shares. These are just some of the filings and offerings we have seen.
MannKind Corporation (NASDAQ: MNKD) priced a secondary offering this morning of 7,400,000 shares of its common stock, and while the press release did not say what price the deal came at the syndicate group told us this went out at $7.35 per share. Chairman, CEO, and principal stockholder Alfred E. Mann is purchasing 1,000,000 of these shares from the underwriters, which brought in over $54 million before fees and commissions. MannKind shares are down 9.5% at $7.37. Its 52-week trading range is $2.00 to $9.25.
Idenix Pharmaceuticals Inc. (NASDAQ: IDIX) priced a secondary offering this morning of 7,248,936 shares of common stock at $3.14 per share to clear roughly $22 million before fees and commissions. Its shares are down over 14% at $3.15 today and its 52-week range is $1.86 to $10.10.
Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) priced a 22.2 million share secondary offering of common stock this morning at a price of $4.50 per share. This raised close to $100 million. Share are down 6% at $4.66 and the 52-week trading range is $1.68 to $5.80.
Ariad Pharmaceuticals Inc. (NASDAQ: ARIA) on Tuesday priced its public offering of 19,000,000 shares of common stock at $1.75 per share; the company said net proceeds after fees and commissions was roughly $30.9 million.
Oncothyreon Inc. (Nasdaq: ONTY) announced on Tuesday that it had obtained commitments from several investors for $15 million in a direct offering. The agreement was to purchase approximately 2.28 million shares of common stock and warrants to purchase approximately 684,000 shares of common stock for gross proceeds of approximately $15.0 million. The company noted that investors agreed to purchase the shares and warrants for $6.5775 per unit with each unit being one share of common stock and a warrant to purchase 0.30 shares of common stock and an exercise price of $6.5775 per share.
NovaBay Pharmaceuticals, Inc. (NYSE: NBY) filed this week with the SEC to offer up to $20,000,000 of any combination of common stock or preferred stock upon conversion of debt securities, common stock upon conversion of preferred stock, or common stock, preferred stock or debt securities upon the exercise of warrants. It market cap is a mere $48 million.
Somaxon Pharmaceuticals, Inc. (NASDAQ: SOMX) filed this week to cover for the resale of up to 10,212,750 shares of common stock (roughly $23 million) from time to time for existing security holders and certain transferees of the selling security holders. Roughly 5.1 million of these shares were issued in a private placement that closed on July 8, 2009; the additional 5.1 million shares are issuable upon a warrant exercise sold in the private placement which expire on July 8, 2016. If sold, none of the proceeds go back to NovaBay.
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) filed on Monday to allow the resale from time to time of up to 28,000,000 shares of common stock by the selling stockholders from a July private placement. We will not receive any of the proceeds from the sale of these shares. If sold, none of the proceeds go back to Arena.
OXiGENE, INC. (NASDAQ: OXGN) filed this week for the resale of up to 10,000,000 shares of common stock from time to time by Symphony ViDA Holdings LLC. This was via an amendment dated as of July 2, 2009. If sold, none of the proceeds go back to OXiGENE.
JON C. OGG
AUGGUST 5, 2009
Oncothyreon's New Lung Cancer Data Hopeful (ONTY)
Seattle-based Oncothyreon Inc. (Nasdaq: ONTY) is seeing new interest in its shares after the company demonstrated positive clinical data relating to long-term treatment with Stimuvax. The data were presented at the International Association for the Study of Lung Cancer’s 13th World Conference on Lung Cancer in San Francisco over this weekend.
The presentation was made by Dr. Glenwood Goss from the Ottawa Hospital Cancer Centre and it involved 16 patients who had received Stimuvax for between 2 and 8.2 years as part of the Phase 2b trial in patients with stage IIIb/IV non-small cell lung cancer.
As of the April 2009 date of the study data analysis, 10 of the 16 studied patients were alive without evidence of disease progression; and8 of those 10 continued to receive therapy with Stimuvax after 6.3 to 8.2 years. The remaining two living patients discontinued Stimuvax therapy after 2.4 and 5.8 years and were without evidence of disease progression. It also noted that 9 of the 10 living patients had stage IIIb NSCLC upon entry to the trial, while one had stage IV disease. Also noted was that 6 of the 10 living patients had a complete response to their first-line chemotherapy or chemo-radiation, while 4 patients had stable disease.
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Oncothyreon Inc. (ONTY) announces Phase 3 Trial
Oncothyreon Inc. has announced that Merck KGaA of Darmstadt, Germany, has initiated a global 3 trial of Stimuvax. Stimuvax is an investigational therapeutic cancer vaccine being developed by Merck KGaA under a license agreement with Oncothyreon.
The trial will be conducted in patients with hormone receptor-positive, locally advanced, recurrent or metastatic breast cancer.
Oncothyreon opened Monday up 0.38 (16.67%) with a trade price of 2.66.
The phase 3 trial, named STRIDE (Stimulating immune response in advanced breast cancer), is anticipated to enroll more than 900 patients at approximately 180 sites in over 30 countries – including North America, Europe, Asia and Australia. The primary endpoint of STRIDE is progression-free survival. Overall survival, quality of life, tumor response and safety will also be assessed in this study.
Advanced-stage breast cancer remains a devastating and challenging disease and we urgently need new treatment options,” said Dr. Larry Shulman, Chief Medical Officer and Senior Vice President for Medical Affairs, Dana-Farber Cancer Institute, Boston, Massachusetts, and Principal Investigator of STRIDE. “If the results from the Phase 3 STRIDE study prove positive, this could make a difference for patients with hormone receptor positive metastatic breast cancer.”
Joshua Sherman
Early ASCO Winners & Losers (IMMU, ONTY, MEDX, HGSI, EXEL, OSIP)
We have captured the big biotech movers from the ASCO conference over the weekend or related news moving the stocks in the biotech sector this morning. Here these are grouped by name and ticker, and the first price is Friday’s close and the second price is the pre-market price snapshot at 9:00 AM EST. After that is the percentage of the price change and the appropriate volume seen as of the 9:00 AM EST cut-off.
STOCK GAINERS:
Immunomedics, Inc. (IMMU)
$2.49 $2.85 14.46% 13,500
Oncothyreon Inc (ONTY)
$2.61 $2.92 11.88% 212,479
Medarex, Inc. (MEDX)
$7.24 $7.80 7.73% 3,790
Human Genome Sciences, Inc. (HGSI)
$2.47 $2.65 7.29% 49,141
STOCKS TRADING LOWER:
Exelixis, Inc. (EXEL)
$5.55 $5.22 5.95% 123,953
OSI Pharmaceuticals Inc. (OSIP)
$33.80 $32.50 3.85% 22,220
Jon Ogg
