| To: gravis909 who wrote (26) | 11/17/2004 5:17:28 PM | | From: tuck | | | | Boy, I don't know. We need an actual clinical update, not legal gyrations, to move the stock. If that's not forthcoming, delisting will happen. If I can divine anything from a recent presentation, I'll post about it. Right now, I'd be cautious in front of the delisting issue:
>>BOSTON--(BUSINESS WIRE)--Nov. 17, 2004-- GlycoGenesys, Inc. (NASDAQ:GLGS - News), a biotechnology company focused on carbohydrate drug development, today announced results from its Form 10-Q for the quarter ended September 30, 2004.
Select Financial Highlights:
The net loss applicable to common stock for the three months ended September 30, 2004 and 2003 was $(2,799,576), or $(0.05) per share, and $(1,934,519), or $(0.05) per share, respectively. For the nine months ended September 30, 2004 and 2003 the net loss applicable to common stock was $(8,288,125), or $(0.15) per share, and $(5,499,521), or $(0.14) per share, respectively. The net loss applicable to common stock for the three months ended September 30, 2004 and 2003 included a $115,021 and $104,562 charge for the accretion of dividends on the Company's Series B preferred stock, respectively. The net loss applicable to common stock for the nine months ended September 30, 2004 and 2003 included a $342,564 and $310,277 charge for the accretion of dividends on the Company's Series B preferred stock, respectively.
John W. Burns, SVP and CFO of GlycoGenesys, Inc. stated, "Higher clinical trial costs this quarter were the largest single component to the approximately $865,000 increase in the Company's net loss applicable to common stock over the same period last year. Other expense categories contributing to the increase were legal, consulting, laboratory and payroll-related costs, all partially offset by decreases in drug production costs and rent."
"Moreover, the $2.8 million increase in net loss applicable to common stock experienced for the first three quarters of 2004 over 2003 was primarily due to increases in expenses for legal, drug development and production for clinical trials, consulting, clinical trials, payroll, laboratory and investor relations," added Mr. Burns.
"We recently achieved major milestones through the favorable arbitration decision and poster presentations to be given at the American Society of Hematology annual meeting in early December," stated Mr. Burns. "We received a delisting notice from the Nasdaq Stock Market for failure to meet its $1 bid price listing requirement by November 15th. We will take advantage of the hearing process afforded to listed companies. Our stock will remain listed pending Nasdaq's hearing which we expect to take place within 45 days of our request. We are evaluating the alternatives available to us and will work on a solution in the best interest of current shareholders," he added. <<
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Cheers, Tuck |
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| To: tuck who wrote (27) | 12/6/2004 11:44:50 AM | | From: tuck | | | | >>BOSTON & SAN DIEGO--(BUSINESS WIRE)--Dec. 6, 2004-- GlycoGenesys, Inc., (NASDAQ: GLGS - News), a biotechnology company focused on carbohydrate drug development, announced today its lead drug candidate, GCS-100LE, was shown in vitro to trigger cell death in multiple myeloma, including cell lines resistant to standard treatments. The data was presented at The American Society of Hematology 46th Annual Meeting and Exposition in a poster session called New Targets and Immune Based Therapy in a presentation entitled "Mitochondria and Caspase-Independent Cell-Death Triggered By GCS-100, a Novel Carbohydrate-Based Therapeutic in Multiple Myeloma (MM) Cells." The poster was presented by Company collaborator, Dr. Dharminder Chauhan, of Dr. Kenneth Anderson's laboratory at the Medical Oncology Department, Dana Farber Cancer Institute, Boston, Massachusetts.
Highlights of Poster Presentation
GCS-100LE was found to:
Directly target multiple myeloma cells including in their bone marrow microenvironment.
Trigger cell death in multiple myeloma cells resistant to traditional anti-cancer agents including dexamethasone, melphalan, doxorubicin, and Velcade®, which are commonly used in treatment of multiple myeloma.
Decrease the viability of Velcade-resistant multiple myeloma patient cells.
Inhibit growth and survival of multiple myeloma cells conferred by the bone marrow microenvironment.
Overcome drug-resistance conferred by anti-apoptotic protein Bcl-2 and heat shock protein- 27.
Induces cell death in multiple myeloma without activating known cell death activating pathways, caspases 8, 9,and 3, without significant toxicity against normal peripheral mononuclear cells, suggesting a potentially novel mechanism of action and providing strong rational for combining GCS-100LE with approved agents that activate caspase-dependent cell death.
To have additive and synergistic effects when combined with caspase-activating agents dexamthasone and PK1195, respectively.
These findings lay the framework for clinical evaluation of GCS-100LE either alone or in combination with other therapies to overcome drug resistance and improve patient outcome in multiple myeloma.
Bradley J Carver, President and CEO of GlycoGenesys, noted that "We are very pleased to have this promising data presented at the ASH Annual Meeting by such distinguished clinicians and researchers. As a co-author with my colleagues on this abstract and working closely with Dr.'s Anderson and Chauhan over the last year, we are excited about our plans to enter the clinic in multiple myeloma with GCS-100LE in early 2005 at the Dana Farber Cancer Institute."
The Study
Multiple myeloma cancer cells use normal bone marrow stromal cells and the bone marrow microenvironment to prevent apoptosis (programmed cell death), which allows them to divide and grow abnormally. GCS-100LE works by directly targeting multiple myeloma cells in their bone marrow microenvironment, interfering with their ability to adhere to the bone marrow stromal cells and inhibiting their growth and proliferation, eventually leading to cell-death. GCS-100LE was shown to trigger growth arrest and apoptosis in a number of multiple myeloma cell lines including cell lines resistant to standard treatments such as dexamethasone, melphalan and doxorubicin. In tests with multiple myeloma cells from patients who have had unsuccessful treatment due to drug resistance, GCS-100LE demonstrated similar results, including in cells from patients resistant to bortezomib (Velcade®). GCS-100LE was effective against these patient's cells without significant toxicity to normal peripheral mononuclear cells, which naturally help defend against infections and disease.
In this study, it was shown that GCS-100LE induced apoptosis in multiple myeloma cells through a mitochondria and caspase-independent apoptotic pathway. This provides a rationale for combining it with treatments that work through potentially complimentary apoptotic pathways, including caspase-dependent pathways. For example, in combinatonGCS-100LE, acts synergistically with PK-11195 and additively with dexamethasone.
About Multiple Myeloma
Multiple myeloma (also known as myeloma or plasma cell myeloma) is a progressive hematologic (blood) disease. It is a cancer of the plasma cell, an important part of the immune system that produces immunoglobulins (antibodies) to help fight infection and disease. Hypercalcemia, anemia, renal damage, increased susceptibility to bacterial infection, and impaired production of normal immunoglobulin are common clinical manifestations of multiple myeloma. It is often also characterized by diffuse osteoporosis, usually in the pelvis, spine, ribs, and skull.
The estimated frequency of multiple myeloma is 4-5 new cases per 100,000 persons per year. Accordingly, in the United States 15,270 new cases are expected to be diagnosed in 2004. At present there are approximately 50,000 people in the United States living with multiple myeloma.
About GCS-100LE
GCS-100LE is a novel carbohydrate compound with potential application in solid tumors and bloodborne cancers. Independent research has shown that Galectin-3, a key target of GCS-100, is implicated in several cellular activities. GCS-100 has at least three mechanisms of action: it may induce apoptosis, or programmed cell death; appears to interfere with angiogenesis, the process by which cancer cells recruit a blood supply from the body in order to proliferate; and appears to interfere with a process called cellular adhesion, which plays a key role in metastasis, or the spread of cancer beyond the primary tumor. Galectin-3 has high expression in many cancers, but not in normal cells, conferring broad potential applications for GCS-100 in solid and blood-borne cancers. GCS-100 has been evaluated at lower dose levels in Phase II(a) clinical trials for colorectal and pancreatic cancer. GCS-100LE, a low ethanol formulation, is currently in a dose escalation Phase I trial for solid tumors with Phase I and II clinical trials for multiple myeloma planned to begin in 2005. <<
GLGS needs decent results, interim, whatever, from one the clinical studies very soon to avoid delisting.
Cheers, Tuck |
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| From: tuck | 12/7/2004 2:30:25 PM | | | | | | >>BOSTON & SAN DIEGO--(BUSINESS WIRE)--Dec. 7, 2004-- GlycoGenesys, Inc., (Nasdaq: GLGS - News), a biotechnology company focused on carbohydrate-based drug development, announced today that an in vitro study showed for the first time that its lead drug candidate, GCS-100LE, triggered cell death in both B-cell malignant cell lines and primary cancer cells taken from patients with chronic lymphocytic leukemia (CLL). GCS-100LE, currently in a Phase I dose escalation trial for solid tumors, is a novel carbohydrate-based compound being developed for the treatment of solid tumors and multiple myeloma. Data from the new study was presented last evening by world-renowned cancer researcher and GlycoGenesys collaborator, Dr. Finbarr E. Cotter of Barts School of Medicine, London, at the American Society of Hematology (ASH) 46th Annual Meeting and Exposition in a poster session on Lymphoma Therapy - New Biologic Agents. The poster was titled "GCS-100, a Galectin 3 Antagonist, Is a Novel Caspase-9 Apoptosis Activating Agent for the Treatment of Indolent B-Cell Malignancies."
Dr. Cotter's Poster Presentation Highlights
GCS-100LE was found to:
Induce significant apoptosis (cell death) in both malignant B-cell lines and in primary patient chronic lymphocytic leukemia cells in vitro with minimal effect against normal B-cells and stem cell cultures.
Greatly enhance the apoptotic effect of chemotherapy at low doses, even in the presence of high levels of anti-apoptotic proteins such as Bcl-2.
Induce cell death in B-cell malignancies including chronic lymphocytic leukemia via caspase-9, a known apoptotic pathway utilized by approved chemotherapy agents. Activation of caspase-9 has been shown to predict a good anti-cancer response in B-cell malignancies.
These findings lay the framework for clinical evaluation of GCS-100LE in B-cell malignancies, especially for potential treatment of chronic lymphocytic leukemia.
The Study
The study investigated the mechanism by which GCS-100LE induces apoptosis (programmed cell death) in indolent B-cell lymphomas. It found that GCS-100LE induced apoptosis in malignant cell lines as well as in primary cells from patients with chronic lymphocytic leukemia with minimal effect on normal B cells. Notably, low doses of GCS-100LE significantly enhanced the effect of chemotherapy in these cancer cells. GCS-100LE was found to induce a specific apoptotic pathway, the mitochondrial caspase-9 pathway. The apoptotic effect of GCS-100LE occurred even in the presence of the protein Bcl-2, a natural inhibitor of cell death, which confers resistance to widely used chemotherapy drugs in several cancers. GCS-100LE has been previously shown to bind to Galectin-3, a protein that generally has a higher expression in B-cell cancers. This may be the cause of GCS-100LE's targeting of malignant B-cells.
Dr. Finbarr Cotter, GlycoGenesys' collaborator and primary author of the study abstract said, "Our recent study shows for the first time that GCS-100LE has strong activity against primary cancer cells taken from patients with chronic lymphocytic leukemia. In these primary cells and in other B-cell cancer cell lines, GCS-100LE works through a specific caspase-dependent apoptotic pathway. Moreover, other studies have shown that GCS-100LE can activate additional beneficial anti-cancer mechanisms. These attributes of GCS-100LE suggest its application in several different types of cancer and its combination with chemotherapeutic agents that work through complementary pathways for a potential synergistic or additive therapeutic effect. I am keen to commence clinical studies based on this preclinical work."
Bradley J Carver, President and CEO of GlycoGenesys, a secondary author of the study abstract, further commented, "Our poster presentations at this year's annual meeting of the American Society of Hematology underscore the clinical rationale and versatility of GCS-100LE to be developed for potential treatment of several bloodborne cancers. We are encouraged by Dr. Cotter's recent findings. They provide solid scientific rationale for expanding the clinical development of GCS-100LE beyond our current programs in solid tumor and multiple myeloma.
About Indolent B-cell Malignancies
In the U.S., over 320,000 people are estimated to have some form of B-cell malignancy and each year approximately 55,000 new cases and 20,000 deaths occur from these cancers. Between 80% and 85% of non-Hodgkin's lymphomas are of B-cell origin. Indolent B-cell malignancies include chronic lymphocytic leukemia, follicular lymphoma and B-cell non-Hodgkin's lymphoma as well as other lymphomas. They are low-grade or slow-growing lymphomas that permit long survival periods but are continuously recurring and virtually incurable in advanced stages. Current treatment options are characterized by low-cure rates due to the slow-growing nature of these lymphomas. Patients without symptoms are monitored closely for development of symptoms including tumor masses and major organ involvement. At such times, treatment is started.
About GCS-100LE
GCS-100LE is a novel carbohydrate compound with potential application in solid tumors and bloodborne cancers. Independent research has shown that Galectin-3, a key target of GCS-100LE is implicated in several cellular activities. GCS-100LE has at least three mechanisms of action: it may induce apoptosis, or programmed cell death; appears to interfere with angiogenesis, the process by which cancer cells recruit a blood supply from the body in order to proliferate; and appears to interfere with a process called cellular adhesion, which plays a key role in metastasis, or the spread of cancer beyond the primary tumor. Galectin-3 has high expression in many cancers, but not in normal cells, conferring broad potential applications for GCS-100LE in solid and bloodborne cancers. GCS-100 has been evaluated at low dose levels in previous clinical trials for patients with colorectal, pancreatic and other types of solid tumors. GCS-100LE, a low ethanol formulation, is currently in a dose escalation Phase I trial for solid tumors with Phase I and II clinical trials for multiple myeloma planned in 2005. <<
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Cheers, Tuck |
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| To: tuck who wrote (29) | 12/13/2004 4:12:48 PM | | From: tuck | | | | Reverse split to help avoid delisting, among other supposed benefits:
>>BOSTON--(BUSINESS WIRE)--Dec. 13, 2004--GlycoGenesys, Inc., (Nasdaq: GLGS - News), a biotechnology company focused on carbohydrate-based drug development, announced today that the Company's Board of Directors had approved a 1-for-6 reverse stock split of the Company's common stock. The split affects all stockholders uniformly and will not affect any stockholder's percentage ownership in the Company. To the extent that the split results in a holder becoming entitled to a fractional share, the fractional share will be rounded up to a whole share for the benefit of the shareholder. As a Nevada corporation, a shareholder vote is not required to effect the split of its shares. Shares held as of the close of business on December 20, 2004 will be split and the shares will begin trading on a post-split basis the following day, December 21, 2004. For a period of 20 trading days following the split the Company's common stock will trade under the temporary symbol "GLGS.D" to reflect the occurrence of the split. In addition to reducing the number of shares outstanding, the number of authorized shares available for future issuance will also be reduced by a 1-for-6 ratio. All warrants, options and preferred stock outstanding at the time of the split are also subject to the reverse split formula including customary upward repricing.
Comments From Management
John W. Burns, the Company's Senior Vice President and CFO, stated, "Today's announcement is more than about simply taking steps to retain our Nasdaq listing. This year we have made significant progress operationally, scientifically, and clinically. We believe these achievements have been under recognized by the capital markets due to, among other things, our capital structure, which is uncharacteristic of many biotech companies at our stage of development. As evidenced by the results in our recently announced American Society of Hematology abstracts, GlycoGenesys has the potential for a bright future and it became necessary to change our capital structure to provide the best opportunity, in our opinion, for long-term shareholder value."
Bradley J Carver, the Company's President and CEO, stated, "Along with our shareholders senior management and the Board of Directors together are significant stake-holders in GlycoGenesys and carefully weighed the interest of our shareholders in arriving at this decision to reduce our share count. By reducing the share count, we are taking a step we believe is necessary to improve the potential for our shareholders to benefit from our milestones going forward. 2005 looks to be a milestone intensive year including human clinical data from our solid tumor dose escalation trial, initiating our multiple myeloma study at Dana Farber, expanding our clinical trial program for GCS-100LE and entering into a potential strategic partnership. In addition to clinical milestones, we expect additional research publications on GCS-100LE and plan to keep a high profile at industry and investor conferences."
Potential Benefits of The Reverse Stock Split
The reverse stock split reduces the number of GlycoGenesys' shares outstanding to a level more comparable with those of similar biotechnology companies and more appropriate to the current size, stage and scope of the Company's business. Fewer shares outstanding and a higher stock price may help to generate more interest from fundamental institutional investors among funds that are either precluded by their bylaws from investing in lower-priced stocks or are simply reluctant to do so. In addition, many analyst and brokerage firms are reluctant to recommend lower-priced stocks to either their clients or monitor performance of lower-priced stocks. Moreover, the stock split provides an opportunity to satisfy Nasdaq's $1.00 bid price requirement.
Today's announcement is part of a multi-step process by the Company's management and Board of Directors to increase long-term shareholder value by taking the necessary actions to maintain its Nasdaq listing, attracting new long-term institutional investment through both open market and private transactions, and solidifying its current shareholder base by taking these steps toward creating lasting value.
Example For Shareholders of How the 1-for-6 Split Works
A shareholder having 9,000 shares before the split would have 1,500 shares after the split; similarly, a shareholder with 10,000 shares before, would have 1,667 after (taking into effect rounding up).
The Company's capital structure pre- & post-split is as follows:
Pre-Split Post-Split
(approximate)
--------------------------------------------------------------------
Shares Outstanding 60,504,577 10,084,096
Common
Shares Underlying
Convertible Preferred 10,189,763 1,698,294
Warrants-Shares Issuable 21,571,326 3,595,221
Options-Shares Issuable 1,849,500 308,250
Authorized Shares 200,000,000 33,333,333
Options Available for Issuance
under the Company's Incentive
Plans 2,552,070 425,345<<
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Cheers, Tuck |
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| To: blind-geezer who wrote (34) | 3/4/2005 2:58:45 PM | | From: tuck | | | | >>BOSTON--(BUSINESS WIRE)--March 4, 2005--GlycoGenesys, Inc. (Nasdaq: GLGS - News), a biotechnology company developing carbohydrate-based drugs, today announced that it has entered into definitive agreements to close on gross proceeds of $6,500,000 from institutions in exchange for issuance of 6,500 shares of convertible, redeemable Series D Preferred Stock, currently convertible into 6,500,000 shares of common stock, and warrants to purchase 6,500,000 shares of common stock currently at $1.23. The terms of the Series D Preferred Stock and warrants will be described in a Current Report on Form 8-K that the Company will file with the Securities and Exchange Commission.
The financing will take place in two closings. In the first closing, investors will purchase $2,000,000 of Series D Preferred Stock and warrants. The second closing, for which Nasdaq rules requires receipt of shareholder approval, shall cover the remaining $4,500,000 of Series D Preferred Stock and warrants.
The Company intends to use the proceeds from this transaction primarily for funding the costs of enrolling and conducting its Phase I/II dose ranging clinical trial for GCS-100LE in multiple myeloma, funding the initiation of its Phase I/II dose ranging clinical trial for GCS-100LE in chronic lymphocytic leukemia, manufacturing drug supplies of GCS-100LE for its clinical trial needs through 2005, conducting additional analytical and pre-clinical studies, paying licensing fees and working capital for general corporate purposes.<<
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I'd like to see PRW facing similar cash issues. Evil grin. I'd like to see some interim data or something aside from fiscal issues. Frown.
Cheers, Tuck |
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