Posts Tagged ‘biotech’

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Cardiovascular Systems, Inc. (Nasdaq: CSII) Buzz Stock of the Day

Tuesday, November 10th, 2009


Shares of Cardiovascular Systems, Inc (CSI) have been steadily rising in the week following the Company’s announcement of promising financials for the first quarter fiscal 2010 ended September 30, 2009.

CSI increased revenue 30 percent in the first quarter of fiscal 2010, to $15.2 million compared to revenue of $11.6 million for the same quarter of the previous year. Likewise, CSI’s net loss improved 55 percent to $(6.2) million, or $(0.43) per basic and diluted share, in the first quarter of fiscal 2010, from $(13.7) million, or $(2.75) per basic and diluted share, for the same quarter 2009.

David L. Martin, CSI president and chief executive officer, said, “Balancing revenue growth with effective expense management helped drive a substantial reduction in our loss from the fiscal 2009 first quarter, moving CSI toward our goal of profitability.”

The number of weighted average common shares outstanding increased to 14.5 million from 5.0 million in the first quarter of fiscal 2009, primarily due to new shares issued in conjunction with the February 2009 reverse merger with Replidyne, Inc., including the conversion of all preferred stock of the company to common stock.

Additionally, the fiscal first-quarter 2010 gross margin increased to 77 percent from 67 percent in the same period last year, driven by higher disposable volumes, manufacturing efficiencies, product cost reductions and shipment of fewer controller units. Operating expenses decreased 18 percent, due to effective expense management, the year-earlier write-off of $1.7 million in IPO costs, and completion and timing of development projects and clinical studies.

Adjusted EBITDA, calculated as loss from operations, less depreciation and amortization and stock-based compensation expense, improved by 70 percent to a loss of $(3.6) million versus a loss of $(11.8) million in the year-ago period. Cash and cash equivalents remained strong at $30.8 million and included $3.0 million of net funding received in conjunction with signing an agreement to establish a second production facility in Pearland, Texas.

Martin continued, “During the quarter, we focused on driving adoption in existing accounts, including re-educating physicians on proper clinical protocols for using the Diamondback 360° to change lesion compliance in vessels above the knee. As a result, we are seeing greater product usage in many accounts. These improvements were offset by seasonal weakness in endovascular procedures, resulting in revenue slightly below our expected range.”

The number of hospitals using the Diamondback 360® PAD System rose to 611 by the end of the fiscal 2010 first quarter, a nearly 90-percent increase over a year ago and 55 more than the end of the fourth quarter of fiscal 2009. Sales of disposable device units totaled 4,541 units in the first quarter of fiscal 2010 versus 3,636 units in the first quarter of last fiscal year, a 25-percent increase. Revenue generated from customer reorders continued to grow, increasing to 92 percent of total revenue for the fiscal 2010 first quarter from 72 percent in last year’s first quarter.

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Labopharm, Inc. (Nasdaq: DDSS) Buzz Stock of the Day

Wednesday, October 7th, 2009

Shares of Labopharm, Inc.(NASDAQ: DDSS) surged 50 percent in trading Wednesday after the company announced that the manufacturer of the active ingredient in Labopharm’s novel anti-depression medication had been given the green light from the US Food and Drug Administration (FDA) to reopen its manufacturing facility, which had been closed following FDA inspection in June and July of this year.

In a letter received by Labopharm, the FDA states that Angelini, the manufacturer of the active pharmaceutical ingredient (API) for Labopharm’s novel trazodone formulation, has sufficiently addressed all the deficiencies cited during inspections in June and July. The letter also states that the FDA now classifies the manufacturing facility as acceptable.

The letter received today from the FDA comes after another received by the Company on July 17, 2009, in which the FDA informed the Labopharma that it’s new drug application for its novel trazodone formulation could not be approved in its present form due to the deficiencies at the API supplier’s manufacturing facility, although it was stated that the deficiencies were not efficacy or safety issues.

Trazodone, Labopharma’s second product, is a psychoactive compound with anti-depressant and sedative properties that also encompasses the Company’s proprietary controlled-release technologies. Trazodone is currently awaiting FDA approval.

Labopharm Inc. is an emerging biopharmaceutical company that specializes in improving and optimizing existing small-capsule drugs using proprietary time-release technologies. The Company’s first product, a once-daily time-release treatment for chronic pain is sold in 17 countries worldwide in major markets such as US, Canada, and Europe.

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CEL-SCI Corporation (AMEX: CVM) Buzz Stock of the Day

Monday, September 21st, 2009

Shares of CEL-SCI Corporation (AMEX: CVM) jumped more than 24 percent in morning trading Monday after the company announced plans to move forward with two highly-anticipated drug trials.

In addition to recent FDA approval to go ahead with clinical trials of CEL-SCI’s novel LEAPS-H1N1 flu medication, the company has also raised the capital necessary to go forward with Phase III clinical trials of its flagship cancer treatment, Multikine, which analysts believe could become a standard of care for cancer treatment.

The company announced last week that a definitive agreement had been reached to raise nearly $20 million, which was expected to close on or before Monday.

The agreement states that CEL-SCI will sell 14,285,715 shares of common stock at a price of $1.40 per share for a gross profit of approximately $19 million. Additionally, investors will also receive warrants to purchase 4.7 million shares of CEL-SCI’s common stock at $1.50 per share that can be exercised any time after the transaction closing within a two-year time period.

CEL-SCI will use the funds to move forward with human clinical trials for LEAPS-H1N1 flu treatment, a drug designed to treat the white-blood cells of already-infected patients. The FDA’s approval of trials for CEL-SCI’s H1N1 flu treatment has pushed CEL-SCI shares to some of the most heavily traded in the biotech market.

“Everybody’s focus is on vaccines and they’re having all kinds of problems with the vaccines, but there has to be someone working to help these patients who have a high likelihood of death,” said CEL-SCI’s CEO Geert Kersten. “That’s how we got to that. With LEAPS, we can control in advance and determine, almost by design, how the immune system will process the epitope and therefore we know what kind of immune response we will get — whether cellular or humoral. By doing that, you can — we feel — have significant impact on these people’s chances of survival.”

CEL-SCI is also expected to start long-awaited and highly-anticipated Phase III trials of Multikine, the company’s advanced head and neck cancer treatment. The first of its kind, Multikine is a multi-targeted approach cancer immunotherapy that specifically targets and kills cancer cells, and activates the body’s immune system to attack cancer cells. Multikine is a cancer immunotherapy that incorporates both active and passive immune activity.

CEL-SCI Corp. is based in Vienna, Virginia and develops novel immune-based therapies that utilize the body’s own immune defense system to fight disease. These therapies are effective and non-toxic to the body’s normal cells and organ systems, unlike traditional cancer therapies such as chemotherapy, radiation and surgery, which are most often highly toxic or damaging.

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Icagen (ICGN)– Buzz Stock of the Day

Tuesday, September 1st, 2009

Shares of biopharmaceutical company Icagen, Inc.(NASDAQ: ICGN) were up as much as 65 percent from Monday’s close in morning trading on Tuesday, after the company announced favorable results from a late-stage clinical trial of Senicapoc, a potential new treatment for asthma.


“We are pleased with the results of this study, and believe that they justify further evaluation of Senicapoc as a novel approach to the treatment of asthma,” said Seth Hetherington, M.D., Senior Vice President of Clinical and Regulatory Affairs for Icagen.

A total of 34 patients with asthmatic responses to inhaled allergen were enrolled at two clinical research centers in the United Kingdom and 31 of them were evaluable for the study goals.

In the study, patients who received Senicapoc demonstrated an improvement in all measures of late asthmatic response (LAR), while those who received only dummy drugs had no improvements, the company said in a statement.

A secondary goal of the study was to gauge the fraction of exhaled nitric oxide, a measure of airway inflammation that is generally at an elevated level in asthmatic patients. The study found that senicapoc reduced exhaled nitric acid by 24 percent compared to study participants who received the placebo.

“We believe that the combination of the reduction in LAR among the Senicapoc-treated patients, along with the improvement in the fraction of exhaled nitric oxide, is consistent with the potential for an anti-inflammatory effect of Senicapoc, a selective blocker of the KCa3.1 channel,” said Dr. Hetherington.

The North Carolina-based Icogen is currently evaluating strategic options concerning the future of the company, including a possible partnership or the sale of the company.
“We have received interest from several companies to partner us in this program and we will certainly pursue discussions as appropriate,” Chief Financial Officer Richard Katz said in a statement.

Icagen is also developing four proof-of-concept studies in the areas of asthma, epilepsy and pain, but do not plan to pursue the programs any further than the concept phase without additional capital that could come in a variety of forms.

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Trubion Pharmaceuticals, Inc. (TRBN) – Buzz Stock of the Day

Friday, August 28th, 2009

Shares of Trubion Pharmaceuticals, Inc.(NASDAQ: TRBN) were up as much as 76 percent in morning trading on Friday, after the company announced a drug development deal for its leukemia drug with Facet Biotech Corp.(NASDAQ: FACT) .

“In considering alliance opportunities for TRU-016 we sought to retain meaningful economics in this exciting first-in-class product candidate, while enabling aggressive joint development with a partner who shared our vision and brought complementary experience and resources to the alliance,” said Trubion’s Chairman and CEO, Dr. Peter Thompson.

Trubion will receive $20 million upfront from Facet, with the potential for an additional $176.5 million based on certain developmental, regulatory and commercialization milestones. Additionally, Facet will purchase 2.2 million newly-issued shares of Trubion common stock, worth approximately $10 million.

TRU-016 is currently in clinical development for the treatment of B-cell malignancies, otherwise known as chronic lymphocytic leukemia (CLL, and is a CD37-directed Small Modular ImmunoPharmaceutical (SMIP™) protein therapeutic. TRU-016 uses a different active mechanism than CD20-directed treatments, and as a result, may provide cancer patients enhanced therapeutic options and improved effectiveness when used alone or with chemotherapy and/or CD20-based therapeutics. The drug could also have the potential to treat other cancers that affect the immune system’s B-cells, along with autoimmune and inflammatory diseases.

In June 2009, positive results following preliminary analysis from the Phase 1 clinical trial of TRU-016 for the treatment of CLL were announced. The objectives of the Phase 1 TRU-016 CLL study were to define safety and tolerability, identify a maximum tolerated dose, evaluate pharmacology and pharmacodynamics, and assess preliminary clinical activity.

“(The Trubion drug) is a promising therapeutic with impressive preclinical and preliminary clinical data for CLL that will greatly enhance our pipeline and support a key strategic objective, which is to build a robust oncology portfolio,” said Faheem Hasnain, president and CEO of Facet Biotech, in a statement.
Both companies will share costs associated with developing, selling and marketing the drug. The deal also states that Facet and Trubion will share worldwide rights to the drug as well as rights to other, similar CD37-directed protein therapeutic drugs in Trubion’s pipeline.

“We are delighted to have Facet as our partner,” Dr. Thompson said. “Coupled with our own strengths in the discovery and development of novel protein therapeutics, their expertise will afford us the opportunity to pursue the clinical development and commercialization of TRU-016 and other CD37-directed therapeutics in the most aggressive manner possible.”

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