Quelle: RTT
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Genta Slips To Loss In Q4; Updates AGENDA Trial; Shares Slide -Update
3/29/2010 10:52 AM ET
Biotechnology firm Genta Inc. (GETA.OB) reported a loss in the fourth quarter, mainly in the absence of a year-ago income related to marked-to-market liabilities, and provided an update on its AGENDA Trial. Shares of the company were down over 13% in the Monday morning session.
The Berkeley Heights, New Jersey-based company incurred quarterly loss of $11.72 million or $0.06 per share versus earnings of $29.56 million or $0.89 per share last year.
Genta's quarterly revenue were $38 thousand versus nil on the year-ago period. Cost of goods sold rose to $28 thousand from $23 thousand. Gross margin for the period was $10 thousand versus negative gross margin of $23 thousand in the previous year.
In the latest quarter under review, total operating expenses rose to $7.52 million from $5.76 million last year, driven by a sharp increase in selling, general and administrative expenses. Research and development expenses dipped to $3.29 million from $3.84 million a year ago.
Genta informed that during financings in June 2008 and April 2009, insufficiency in the authorized shares of common stock, that allows conversion of notes and warrants, led to classification of the conversion obligation of these notes and warrants as liabilities and measured at fair value on the balance sheet. Upon stockholders approval of changes in the corporate structure, the marked-to-market liabilities fetched income of $40.8 million for the fourth quarter of 2008. However, it also resulted in expense of $26.7 million and $462.0 million for the twelve months ended December 31, 2009 and 2008, respectively.
At December 31, 2009, Genta had cash and cash equivalents totaling $1.2 million compared with $4.9 million at December 31, 2008. Its current cash position is nearly $21 million, exclusive of an additional $5 million in a blocked account that can be released subject to certain terms and conditions. Net cash used in operating activities through December 31, 2009 was $21.5 million, which represents an average monthly outflow of $1.8 million. The average monthly outflow during 2010 is expected to be $1.2 million.
During the full year, net loss narrowed to $86.3 million or $0.84 per share from $505.8 million or $455.09 per share in 2008. Annual revenues declined to $218 thousand from $363 thousand.
In November, while reporting third-quarter results, the company announced a restructuring, reduction in workforce, and re-ordering of clinical development priorities.
Genta also provided an overview of recent corporate highlights and anticipated milestones.
Initial data from AGENDA, the company's randomized, double-blind, Phase 3 trial of dacarbazine with or without Genasense, Injection, showed overall response and progression-free survival.
Genasense, known generically as Oblimersen Sodium, is an antisense drug, which works by blocking a protein called Bcl-2, making cancer cells more vulnerable to death. Bcl-2 is one of the proteins produced by cancer cells that prevent cancer cells from dying. Blocking Bcl-2, therefore, may enable cancer treatments to be more effective. The AGENDA study has employed a biomarker-directed approach and patients enrolled in the trial have low-normal LDH (lactate dehydrogenase), a tumor-derived enzyme.
Genta stated that though differences in both endpoints favored the group treated with Genasense, it was not statistically significant and the results were inadequate to resubmit the New Drug Application, or NDA, for regulatory approval of Genasense.
However, AGENDA passed the futility analysis conducted by the Independent Data Monitoring Board to ascertain the trial's potential to demonstrate a survival benefit. Thus, the company plans to continue the study, and the trial would remain blinded for overall survival until mature data are available 24 months after randomization of the last patient, as prospectively specified. Genta currently expects the followup to be completed in the first-quarter of 2011.
The company also said that in June 2010, final data from phase II trial of Genasense, Abraxane and Temodar as a first-line treatment of patients with advanced melanoma, would be revealed at the annual meeting of the American Society of Clinical Oncology.
The company received two U.S. patents, and additional patent applications were filed for compositions and therapeutic uses of oral gallium-containing compounds. Its gallium nitrate injection, Ganite, is supplied clinical study for patients with cystic fibrosis who are susceptible to resistant bacterial infections, to be commenced in second quarter of 2010.
Initial data from phase II trial of Orphan Drug designated tesetaxel, an oral taxane in clinical development, as second line treatment of patients with advanced melanoma, are expected during 2010. Data from a dose-ranging and pharmacokinetic study of tesetaxel is to be presented at the annual ASCO meeting in June 2010. Also, the company plans to initiate additional Phase 2a and Phase 2b trials of tesetaxel in 2010.
Genta has also been evaluating Genasense in yet another indication - Chronic Lymphocytic Leukemia, but without success so far. Despite the regulatory setbacks, Genta has not given up on Genasense as a potential treatment for Chronic Lymphocytic Leukemia, or CLL.
The company's New Drug Application seeking approval of Genasense in the treatment of CLL has been twice rejected by the FDA -- the one originally filed in December 2005 and the amended application filed in June 2008. Genta has been required to conduct additional confirmatory trial in order for Genasense to be approved in treating CLL.
According to researchers, antisense cancer drugs hold the promise to be more effective and less toxic than surgery, chemotherapy and radiation drugs. Antisense therapies work by blocking the production of disease-causing proteins altogether, while traditional drug therapies work by interacting with the disease-causing proteins. Since antisense drugs are target-specific, these drugs have the potential to greatly reduce unwanted side effects.
GETA.OB is currently trading down over 13.14% or $0.0059 pence, at $0.0395, on the OTC.
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Genta also provided an overview of recent corporate highlights and anticipated milestones.
Initial data from AGENDA, the company's randomized, double-blind, Phase 3 trial of dacarbazine with or without Genasense, Injection, showed overall response and progression-free survival.
Genasense, known generically as Oblimersen Sodium, is an antisense drug, which works by blocking a protein called Bcl-2, making cancer cells more vulnerable to death. Bcl-2 is one of the proteins produced by cancer cells that prevent cancer cells from dying. Blocking Bcl-2, therefore, may enable cancer treatments to be more effective. The AGENDA study has employed a biomarker-directed approach and patients enrolled in the trial have low-normal LDH (lactate dehydrogenase), a tumor-derived enzyme.
Genta stated that though differences in both endpoints favored the group treated with Genasense, it was not statistically significant and the results were inadequate to resubmit the New Drug Application, or NDA, for regulatory approval of Genasense.
However, AGENDA passed the futility analysis conducted by the Independent Data Monitoring Board to ascertain the trial's potential to demonstrate a survival benefit. Thus, the company plans to continue the study, and the trial would remain blinded for overall survival until mature data are available 24 months after randomization of the last patient, as prospectively specified. Genta currently expects the followup to be completed in the first-quarter of 2011.
The company also said that in June 2010, final data from phase II trial of Genasense, Abraxane and Temodar as a first-line treatment of patients with advanced melanoma, would be revealed at the annual meeting of the American Society of Clinical Oncology.
The company received two U.S. patents, and additional patent applications were filed for compositions and therapeutic uses of oral gallium-containing compounds. Its gallium nitrate injection, Ganite, is supplied clinical study for patients with cystic fibrosis who are susceptible to resistant bacterial infections, to be commenced in second quarter of 2010.
Initial data from phase II trial of Orphan Drug designated tesetaxel, an oral taxane in clinical development, as second line treatment of patients with advanced melanoma, are expected during 2010. Data from a dose-ranging and pharmacokinetic study of tesetaxel is to be presented at the annual ASCO meeting in June 2010. Also, the company plans to initiate additional Phase 2a and Phase 2b trials of tesetaxel in 2010.
, but without success so far. Despite the regulatory setbacks, Genta has not given up on Genasense as a potential treatment for Chronic Lymphocytic Leukemia, or CLL.
The company's New Drug Application seeking approval of Genasense in the treatment of CLL has been twice rejected by the FDA -- the one originally filed in December 2005 and the amended application filed in June 2008. Genta has been required to conduct additional confirmatory trial in order for Genasense to be approved in treating CLL.
According to researchers, antisense cancer drugs hold the promise to be more effective and less toxic than surgery, chemotherapy and radiation drugs. Antisense therapies work by blocking the production of disease-causing proteins altogether, while traditional drug therapies work by interacting with the disease-causing proteins. Since antisense drugs are target-specific, these drugs have the potential to greatly reduce unwanted side effects.
GETA.OB is currently trading down over 13.14% or $0.0059 pence, at $0.0395, on the OTC.
by RTT Staff Writer
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