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Geron Corporation Reports Fourth Quarter and Annual 2006 Financial Results and Highlights.


Annual 2005, 2004 and 2003 Financial Statement Information Restated to Reflect Change in Warrant Classification as Previously Disclosed

MENLO PARK, Calif. -- Geron Corporation (Nasdaq:GERN v. t. 1. To grin or yawn. ) today reported financial results for the fourth quarter and year ended December 31, 2006. As disclosed on March 9, 2007, the company has restated its consolidated balance sheets as of December 31, 2005, 2004 and 2003 as well as its consolidated statements of operations for the corresponding periods to reflect a change in the classification of warrants issued to investors in connection with equity financings.

Restatement of Previously Reported Consolidated Financial Statements Consolidated Financial Statements

The combined financial statements of a parent company and its subsidiaries.

Notes:
Because consolidated financial statements present an aggregated look at the financial position of a parent and its subsidiaries, they enable you to gauge
 

The restatement results from our review of recent guidance relating to Emerging Issues Task Force Issue 00-19, "Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company's Own Stock" (Issue 00-19). Historically, we have accounted for certain warrants to purchase shares of the company's common stock issued in connection with equity financings pursuant to effective shelf registration statements as permanent equity in the consolidated financial statements. Pursuant to Issue 00-19, we have reported 2006 and restated prior consolidated balance sheets to account for the value of these warrants to purchase shares of our common stock as a liability, and have restated prior consolidated statements of operations for the quarterly change in fair value of the warrants. This restatement had no impact on previously reported revenues, operating expenses Operating expenses

The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted.
 or total assets, including cash positions.

Changes in fair value of warrant liabilities resulted in an unrealized loss Unrealized Loss

A loss that results from holding onto an asset rather than cashing it in and officially taking the loss.

Notes:
Let's say you own a stock that is down 50%, but you haven't sold it to realize the loss yet. This is said to be an unrealized loss.
 of $161,000 for the year ended December 31, 2005, which had no impact on basic and diluted net loss per share, and unrealized gains of $847,000 and $1,184,000 for the years ended December 31, 2004 and 2003, respectively, which decreased basic and diluted net loss per share by $0.02 and $0.04 for 2004 and 2003, respectively. Fair value of warrant liabilities as of December 31, 2005, 2004 and 2003 were $15.0 million, $18.5 million and $7.0 million, respectively.

Fourth Quarter 2006 and Year End Results

Net loss for the fourth quarter of 2006 was $13.1 million or $(0.20) per share, compared to $3.0 million or $(0.05) per share for the restated comparable 2005 period. For fiscal 2006, the company had a net loss of $31.4 million or $(0.47) per share, compared to a net loss of $33.7 million or $(0.58) per share for the restated fiscal 2005 period.

In the fourth quarter of 2006, the company had revenues of $1.2 million compared to $755,000 for the comparable 2005 period. For fiscal 2006, the company had revenues of $3.3 million, compared to revenues of $6.2 million in fiscal 2005. In 2006, the company received royalty and license fee revenue under various license agreements and collaborative agreements. Revenues in 2005 primarily reflected the receipt of an upfront payment of $4.0 million in connection with the transfer of certain intellectual property rights for the use of nuclear transfer technology in animals to the company's joint venture, Start Licensing, Inc., and revenue recognized from the license fee and option payment received from Merck & Co., Inc.

In the fourth quarter of 2006, the company had operating expenses of $14.2 million, compared to $11.3 million for the comparable 2005 period. Research and development expenses for the fourth quarter of 2006 were $11.8 million compared to $9.6 million for the comparable 2005 period. Research and development expenses increased due to increased clinical trial costs and higher personnel-related costs and the recognition of compensation expense for stock option grants pursuant to SFAS SFAS Statement of Financial Accounting Standards
SFAS Special Forces Assessment and Selection
SFAS Student Financial Aid Services
SFAS Sport Fishing Association of Singapore
SFAS Safety Features Actuation System
SFAS Statewide Fixed Assets System
 123 (revised). General and administrative expenses for the fourth quarter of 2006 were $2.3 million compared to $1.7 million for the comparable 2005 period. The increase in general and administrative expenses in the fourth quarter of 2006 was primarily due to the recognition of compensation expense related to stock option grants pursuant to SFAS 123 (revised).

For fiscal 2006, the company had operating expenses of $50.6 million, compared to $43.9 million in fiscal 2005. Research and development expenses for 2006 were $41.2 million compared to $35.1 million for 2005. Overall research and development expenses increased in 2006 as a result of higher personnel-related costs, including the recognition of compensation expense related to stock option grants pursuant to SFAS 123 (revised); increased manufacturing costs related to the telomerase telomerase /telo·mer·ase/ (te-lo´mer-as) a DNA polymerase involved in the formation of telomeres and the maintenance of telomere sequences during replication.

te·lom·er·ase
n.
 cancer vaccine, GRNVAC1; higher preclinical costs related to the GRNOPC1 spinal cord spinal cord, the part of the nervous system occupying the hollow interior (vertebral canal) of the series of vertebrae that form the spinal column, technically known as the vertebral column.  program; and increased clinical trial costs for GRN GRN Green
GRN Green (Political) Party
GRN Global Recycling Network
GRN Gulf Restoration Network (New Orleans, LA)
GRN Goods Received Note
GRN Global Reference Network (GPS) 
163L,

the telomerase inhibitor drug. General and administrative expenses for 2006 were $9.4 million compared to $8.8 million for 2005. The overall net increase in general administrative expense was due to recognition of compensation expense related to stock option grants in 2006 pursuant to SFAS 123 (revised), offset by reduced consulting expense.

2006 Highlights

Clinical Development

* Geron initiated clinical testing of its lead anti-cancer compound, GRN163L, in patients with solid tumor malignancies at The University of Chicago Cancer Research Center. This Phase I, dose-escalation trial is primarily designed to demonstrate the safety and tolerability of GRN163L administered intravenously (IV) on a weekly basis in patients with refractory or relapsed solid tumor malignancies.

* Initial clinical trial data for Geron's telomerase inhibitor cancer drug, GRN163L, were presented at the 18th EORTC-NCI-AACR International Conference on "Molecular Targets and Cancer Therapeutics" in Prague. The data demonstrate the safety, tolerability and predicted pharmacokinetics in low-dose cohorts from a Phase I/II trial in patients with chronic lymphocytic leukemia chronic lymphocytic leukemia
n. Abbr. CLL
Lymphocytic leukemia occurring mainly in older adults, characterized by slow onset and gradual progression of symptoms.
 (CLL CLL
abbr.
chronic lymphocytic leukemia


CLL,
n.pr See leukemia, chronic lymphocytic.

CLL 1. Chronic lymphocytic leukemia 2. Cholesterol-lowering lipid
) and a Phase I trial in patients with solid tumors.

* New data were published in Clinical Cancer Research demonstrating the broad efficacy of GRN163L, Geron's telomerase inhibitor drug, against multiple types of breast cancer cells as well as the significant reduction of metastatic Metastatic
The term used to describe a secondary cancer, or one that has spread from one area of the body to another.

Mentioned in: Coagulation Disorders


metastatic

pertaining to or of the nature of a metastasis.
 activity in vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment.

in vi·tro
adj.
In an artificial environment outside a living organism.
. The research was authored by Dr. Brittney-Shea Herbert and colleagues at the Indiana University Cancer Center along with Geron collaborating scientists.

* Study results were published in International Journal of Radiation Oncology radiation oncology
n.
The branch of radiology that deals with the use of ionizing radiation to treat cancers.


radiation oncology 
, Biology and Physics on the synergistic effect Synergistic effect

A violation of value-additivity in that the value of a combination is greater than the sum of the individual values.
 of GRN163L combined with radiation therapy in vivo in vivo /in vi·vo/ (ve´vo) [L.] within the living body.

in vi·vo
adj.
Within a living organism.



in vivo adv.
 and in mice bearing human breast cancer.

* Geron scientists and collaborators presented data at the American Society of Hematology 48th Annual Meeting showing that GRN163L is active against cancer stem cells from multiple myeloma multiple myeloma

A malignant proliferation of abnormal plasma cells that populate the marrow-containing bones of the body. The affected plasma cells produce myeloma protein, a monoclonal antibody that replaces normal antibodies in the blood, thereby increasing susceptibility
 patients. Cancer stem cells, which are often resistant to standard treatment, are believed to play a critical role in both metastasis metastasis /me·tas·ta·sis/ (me-tas´tah-sis) pl. metas´tases  
1. transfer of disease from one organ or part of the body to another not directly connected with it, due either to transfer of pathogenic microorganisms or to
 and relapse.

Product Development

* Geron scientists and collaborators presented data at the International Society for Stem Cell Research's (ISSCR ISSCR International Society for Stem Cell Research ) annual meeting pertaining to four products in development: (1) GRNOPC1, Oligodendroglial Progenitor Cells for acute spinal cord injury Spinal Cord Injury Definition

Spinal cord injury is damage to the spinal cord that causes loss of sensation and motor control.
Description

Approximately 10,000 new spinal cord injuries (SCIs) occur each year in the United States.
; (2) GRNIC1, Islet islet /is·let/ (-lit) an island.

islets of Langerhans  irregular microscopic structures scattered throughout the pancreas and comprising its endocrine portion.
 Clusters to treat patients with Type 1diabetes; (3) GRNCM GRNCM Graduate of the Royal Northern College of Music 1, Cardiomyocytes for patients who suffered a myocardial infarction and (4) osteoprogenitor cells for bone fractures and osteoporosis. In addition, several presentations at the meeting described advances in hESC culture and derivation techniques and further characterization of hESC-derived hepatocytes for liver failure and drug metabolism testing.

* Preclinical studies published in Regenerative Medicine support the safety and utility of GRNOPC1, Geron's lead hESC-based therapeutic product for the treatment of spinal cord injury. The studies demonstrate that when GRNOPC1 is injected into the lesion site of rats that received either very mild or moderate spinal cord contusion CONTUSION, med. jurisp. An injury or lesion, arising from the shock of a body with a large surface, which presents no loss of substance, and no apparent wound. If the skin be divided, the injury takes the name of a contused wound. Vide 1 Ch. Pr, 38; 4 Carr. & P. 381, 487, 558, 565; 6 Carr.  injuries, GRNOPC1 survived in both mild and moderate lesion sites, caused robust remyelination in the more severe injuries (which replicates results from previous studies) and did not impair spontaneous recovery in the mildly injured rats. These results indicate that GRNOPC1 injections are non-toxic in this animal model.

* New data supporting the development of TAT2, a small molecule telomerase activator for the treatment of HIV/AIDS HIV/AIDS Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome , were presented at the XVI International AIDS Conference Education, networking and the promotion of best practice are essential to enhancing the response to HIV/AIDS. IAS conferences provide opportunities to share experience, and increase the knowledge and expertise of professionals working in HIV/AIDS. . The data confirm and extend earlier findings that TAT2 enhances the anti-HIV function of key immune cells sourced from HIV/AIDS patients.

Intellectual Property

* The U.S. Patent Office granted to Geron U.S. Patent No. 7,033,831, which covers the production of insulin secreting cells from hESCs. Geron scientists are working to improve these methods further to enable the scalable production of pancreatic islet cells from hESCs for use in new cell-based treatments for diabetes.

* The Opposition Division of the European Patent Office ruled at a hearing on claims of Geron's granted European Patent No. EP 0 841 396. The patent is directed to the cloned human telomerase gene and its uses. Pharmexa had filed an opposition to the patent, seeking revocation of all 47 claims in the patent. The ruling maintained 44 of the claims and canceled three.

* The U.S. District Court for the District of Columbia District of Columbia, federal district (2000 pop. 572,059, a 5.7% decrease in population since the 1990 census), 69 sq mi (179 sq km), on the east bank of the Potomac River, coextensive with the city of Washington, D.C. (the capital of the United States).  dismissed appeals of two patent interference decisions regarding patents covering nuclear transfer (cloning) technology. Geron acquired rights to this technology from the Roslin Institute in 1999 and subsequently initiated patent interferences with conflicting patents held by the University of Massachusetts The system includes UMass Amherst, UMass Boston, UMass Dartmouth (affiliated with Cape Cod Community College), UMass Lowell, and the UMass Medical School. It also has an online school called UMassOnline. . The Board of Patent Appeals and Interferences The Board of Patent Appeals and Interferences (BPAI) is a body of the United States Patent and Trademark Office (USPTO), which decides issues of patentability. If an applicant for an invention cannot convince a patent examiner that they are entitled to their claims, then the  of the U.S. Patent Office ruled in favor of Geron on all counts in both interference proceedings. The University of Massachusetts and its licensee, Advanced Cell Technology (ACT), filed appeals. Both of the appeals by the University of Massachusetts and ACT have been dismissed with prejudice.

Business Development and Finance

* A new licensed product was launched. The product, an immortalized human cell line, is available through ATCC ATCC American Type Culture Collection, see there ([R]) (American Type Culture Collection American Type Culture Collection (ATCC) is a private, not-for-profit biological resource center whose mission focuses on the acquisition, authentication, production, preservation, development and distribution of standard reference microorganisms, cell lines and other materials for ). The new line, T HESC, is a human endometrium endometrium /en·do·me·tri·um/ (-me´tre-um) pl. endome´tria   the mucous membrane lining the uterus.

en·do·me·tri·um
n. pl.
 fibroblast-like cell line immortalized with human telomerase reverse transcriptase Telomerase reverse transcriptase is an enzyme associated with Cri du chat.

Telomerase is a ribonucleoprotein polymerase that maintains telomere ends by addition of the telomere repeat TTAGGG.
 (hTERT).

* Geron and Corning Incorporated entered into a collaboration and license agreement for the development and commercialization of synthetic surface matrices for the growth of hESCs. Geron and Corning Life Sciences will work together to develop synthetic growth surfaces to replace the biological surface coatings that are widely used today to grow hESCs.

* Invitrogen licensed Geron intellectual property related to the growth of hESCs to develop, manufacture and sell media, additives and reagents for use by hESC researchers. The license to Invitrogen is subject to certain commercial use restrictions.

* Geron received $40.0 million in gross proceeds from the sale of common stock and warrants to institutional investors. In addition, institutional investors exercised warrants resulting in $7.6 million in cash proceeds.

Management

* Laurence Elias, M.D., joined the Geron management team as vice president, oncology clinical development. He oversees the company's clinical trials of GRN163L and GRNVAC1. Dr. Elias's responsibilities include the planning, design and execution of clinical trial strategies and protocols as well as the monitoring of these multi-center clinical trials.

* Alan B. Colowick, M.D., M.P.H., joined the Geron management team as president, oncology. In this newly created position, Dr. Colowick manages the operational and strategic activities of the company's oncology programs.

Conference Call

At 8 a.m. PDT/11 a.m. EDT EDT
abbr.
Eastern Daylight Time


EDT Eastern Daylight Time

EDT n abbr (US) (= Eastern Daylight Time) → hora de verano de Nueva York

EDT 
 on Mar. 16, Thomas B. Okarma, Ph.D., M.D., Geron's chief executive officer, and David L. Greenwood, Geron's chief financial officer, will host a conference call to discuss the company's fourth quarter and year-end results, including the effects of the restatement on previously reported consolidated financial information.

Participants can access the conference call via telephone by dialing 866-383-8108 (U.S.); 617-597-5343 (international). The passcode is 73730890. A live audio-only Webcast is also available through a link that is posted on the conferences page in the investor relations section of Geron's Web site at http://www.geron.com. The audio Web broadcast of the conference call will be available for replay through April 15.

Geron is developing first-in-class biopharmaceuticals for the treatment of cancer and degenerative diseases, including spinal cord injury, heart failure, diabetes and HIV/AIDS. The company is advancing an anti-cancer drug and a cancer vaccine that target the enzyme telomerase through multiple clinical trials. Geron is also the world leader in the development of human embryonic stem cell-based therapeutics, with its spinal cord injury treatment anticipated to be the first product to enter clinical development. For more information, visit www.geron.com.

This news release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Investors are cautioned that such forward-looking statements in this press release regarding potential applications of Geron's technologies constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Geron's periodic reports, including the quarterly report on Form 10-Q for the quarter ended September 30, 2006.
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Publication:Business Wire
Article Type:Financial report
Date:Mar 16, 2007
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