UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
For the Fiscal Year Ended December 31, 2003 or
For the Transition Period From to ____________ to __________.
Commission File Number: 0-20859
GERON CORPORATION
(Exact name of registrant as specified in its charter)
230 Constitution Drive, Menlo Park, CA 94025(Address, including zip code, of principal executive offices)Registrants telephone number, including area code: (650) 473-7700Securities registered pursuant to Section 12(b) of the Act: NoneSecurities registered pursuant to Section 12(g) of the Act: Common Stock $0.001 par value
DOCUMENTS INCORPORATED BY REFERENCE:
Forward-Looking Statements
PART I
Item 1. Business
Overview
Major Technology Platforms
Telomeres and Telomerase: Their role in cellular aging and cancer
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clock, thereby increasing the functional lifespan of cells without altering their biology or causing them to become cancerous. Human telomerase, a complex enzyme, is composed of a ribonucleic acid (RNA) component, known as hTR, and a protein component, known as hTERT. In 1994, we cloned the gene for hTR, and in 1997, in collaboration with Dr. Thomas Cech, we cloned the gene for hTERT.
Human Embryonic Stem Cells: A potential source for the manufacturing of replacement cells and tissues
Commercial Opportunities for Our Major Technology Platforms
Oncology
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the United States alone. Because telomerase is detectable in more than 30 human cancer types and in the great majority of cancer samples studied, we believe that telomerase-based drugs could overcome the limitations of current cancer therapies and potentially be broadly applicable and highly specific drug treatments for cancer.
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infect normal somatic cells, there is no killing effect and the virus dissipates. This selective lytic effect on cancer has been demonstrated in vitro in seven different tumor types: prostate, liver, lung, pancreatic, colorectal, breast and ovarian cancers. These in vitro results have been extended to animal models of liver and prostate cancer with similar effects against the animals tumors while sparing normal cells.
Human Embryonic Stem Cell Therapies
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which form new bone). Osteoblast activity declines over human lifespan and fails to keep pace with the increasing activity of osteoclasts, resulting in progressive loss of bone density leading to fracture, pain and deformity.
Our Other Development Programs
Telomerase Activation
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telomerase in normal cells can restore telomere length and thereby increase the lifespan of cells without altering their normal function or causing them to become cancerous.
Products for Research and Development
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characteristics can be potentially corrected. This potentially translates into reduced costs and time in drug development, and less harmful exposure to patients in clinical trials.
Nuclear Transfer: Agriculture/Xenotransplantation/Biologics
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specie. In 1999, we acquired Roslin Bio-Med Ltd., a commercial subsidiary of the Roslin Institute, and an exclusive license to the use of nuclear transfer technology for the creation of cloned animals.
Commercial Collaborations
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Research Collaborations
Patents and Proprietary Technology
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including dopaminergic neurons and oligodendrocytes), chondrocytes (cartilage cells), pancreatic islet cells, osteoblasts (bone cells) and hematopoietic cells (blood-forming cells). Currently there are over 120 Geron-owned patent applications pending around the world covering various aspects of our stem cell technology. Examples of granted stem cell patents that are owned by Geron include U.S. Patents Nos. 6,458,589 and 6,506,574 relating to hESC-derived hepatocytes; 6,642,048 relating to conditioned medium for growing hESCs; and Australian Patent Nos. 729,377 and 751,321 covering methods of growing hESCs.
Government Regulation
FDA Approval Process
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efficacy and the safety of the product. The results of these studies are submitted to the FDA as a part of an IND application, which must become effective before clinical testing in humans can begin. Typically, human clinical evaluation involves a time-consuming and costly three-phase process. In Phase I, clinical trials are conducted with a small number of people to assess safety and to evaluate the pattern of drug distribution and metabolism within the body. In Phase II, clinical trials are conducted with groups of patients afflicted with a specific disease in order to determine preliminary efficacy, optimal dosages and expanded evidence of safety. (In some cases, an initial trial is conducted in diseased patients to assess both preliminary efficacy and preliminary safety and patterns of drug metabolism and distribution, in which case it is referred to as a Phase I/II trial.) In Phase III, large-scale, multi-center, comparative trials are conducted with patients afflicted with a target disease in order to provide enough data to demonstrate the efficacy and safety required by the FDA. The FDA closely monitors the progress of each of the three phases of clinical testing and may, at its discretion, re-evaluate, alter, suspend, or terminate the testing based upon the data which have been accumulated to that point and its assessment of the risk/benefit ratio to the patient. Monitoring of all aspects of the study to minimize risks is a continuing process. All adverse events must be reported to the FDA.
European and Other Regulatory Approval
Other Regulations
Scientific Consultants
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Executive Officers of the Company
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was Director, Cell Biology. Dr. Harley was an Associate Professor from 1989 until joining us, and from 1982 to 1989, an Assistant Professor of Biochemistry at McMaster University. Dr. Harley was also an executive of the Canadian Association on Gerontology, Division of Biological Sciences from 1987 to 1991. Dr. Harley holds a B.S. from the University of Waterloo, a Ph.D. from McMaster University, and conducted postdoctoral work at the University of Sussex and the University of California at San Francisco.
Employees
ADDITIONAL FACTORS THAT MAY AFFECT FUTURE RESULTS
Our business is at an early stage of development.
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in preclinical testing. Our ability to develop product candidates that progress to and through clinical trials is subject to our ability to, among other things:
We have a history of losses and anticipate future losses, and continued losses could impair our ability to sustain operations.
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common stock. Even if we do become profitable, we cannot assure you that we would be able to sustain or increase profitability on a quarterly or annual basis.
We will need additional capital to conduct our operations and develop our products, and our ability to obtain the necessary funding is uncertain.
Some of our competitors may develop technologies that are superior to or more cost-effective than ours, which may impact the commercial viability of our technologies and which may significantly damage our ability to sustain operations.
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Restrictions on the use of human embryonic stem cells, and the ethical, legal and social implications of that research, could prevent us from developing or gaining acceptance for commercially viable products in these areas.
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Kingdom and other countries, the use of embryonic or fetal tissue in research (including the derivation of human embryonic stem cells) is regulated by the government, whether or not the research involves government funding.
Potential restrictions or a ban on nuclear transfer could prevent us from benefiting financially from our research in this area.
We do not have experience as a company in the regulatory approval process, conducting large scale clinical trials, or other areas required for the successful commercialization and marketing of our product candidates.
Entry into clinical trials with one or more product candidates may not result in any commercially viable products.
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Impairment of our intellectual property rights may limit our ability to pursue the development of our intended technologies and products.
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been granted. In March 2002, a second interference was declared involving our nuclear transfer patent application and a patent application held by Infigen Inc. That interference was recently resolved with a judgment in our favor.
If we fail to meet our obligations under license agreements, we may lose our rights to key technologies on which our business depends.
We may be subject to litigation that will be costly to defend or pursue and uncertain in its outcome.
We may be subject to infringement claims that are costly to defend, and which may limit our ability to use disputed technologies and prevent us from pursuing research and development or commercialization of potential products.
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require the use of discoveries and technology controlled by third parties, we may be prevented from pursuing research, development or commercialization of potential products or may be required to obtain licenses to those patents or other proprietary rights or develop or obtain alternative technologies. We may not be able to obtain alternative technologies or any required license on commercially favorable terms, if at all. If we do not obtain the necessary licenses or alternative technologies, we may be delayed or prevented from pursuing the development of some potential products. Our failure to obtain alternative technologies or a license to any technology that we may require to develop or commercialize our product candidates would significantly and negatively affect our business.
Much of the information and know-how that is critical to our business is not patentable and we may not be able to prevent others from obtaining this information and establishing competitive enterprises.
We depend on our collaborators to help us develop and test our product candidates, and our ability to develop and commercialize products may be impaired or delayed if collaborations are unsuccessful.
Our process of developing and testing our products depends in part on the intellectual property rights of our collaborators.
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technology and restart the trial using that different technology, or abandon entirely the development of an ex vivo telomerase vaccine, which would significantly and adversely affect our business.
Our reliance on the research activities of our non-employee scientific consultants, research institutions, and scientific contractors, whose activities are not wholly within our control, may lead to delays in technological developments.
The loss of key personnel could slow our ability to conduct research and develop product candidates.
We may not be able to obtain or maintain sufficient insurance on commercially reasonable terms or with adequate coverage against potential liabilities in order to protect ourselves against product liability claims.
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Because we or our collaborators must obtain regulatory approval to market our products in the United States and other countries, we cannot predict whether or when we will be permitted to commercialize our products.
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to comply with regulatory requirements can result in severe civil and criminal penalties, including but not limited to:
To be successful, our product candidates must be accepted by the health care community, which can be very slow to adopt or unreceptive to new technologies and products.
If we fail to obtain acceptable prices or adequate reimbursement for our product candidates, the use of our potential products could be severely limited.
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of our potential products are approved for marketing. Cost control initiatives could decrease the price that we receive for any product candidate we may develop in the future. In addition, third-party payors are increasingly challenging the price and cost-effectiveness of medical products and services and any of our potential products may ultimately not be considered cost-effective by these third parties. Any of these initiatives or developments could materially harm our business.
Our products are likely to be expensive to manufacture, and they may not be profitable if we are unable to significantly reduce the costs to manufacture them.
Our activities involve hazardous materials, and improper handling of these materials by our employees or agents could expose us to significant legal and financial penalties.
Our stock price has historically been very volatile.
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organizations. This market volatility, as well as general domestic or international economic, market and political conditions, could materially and adversely affect the market price of our common stock and the return on your investment.
The sale of a substantial number of shares may adversely affect the market price for our common stock.
Our undesignated preferred stock may inhibit potential acquisition bids; this may adversely affect the market price for our common stock and the voting rights of the holders of our common stock.
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Provisions in our share purchase rights plan, charter and bylaws, and provisions of Delaware law, may inhibit potential acquisition bids for us, which may prevent holders of our common stock from benefiting from what they believe may be the positive aspects of acquisitions and takeovers.
We do not intend to pay cash dividends on our common stock in the foreseeable future.
Item 2. Properties
Item 3. Legal Proceedings
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Item 4. Submission of Matters to a Vote of Security Holders
PART II
Item 5. Market for the Registrants Common Stock and Related Stockholder Matters
Market Information
Dividend Policy
Recent Sales of Unregistered Securities
Securities Authorized for Issuance Under Equity Compensation Plans
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Item 6. Selected Consolidated Financial Data
(1) In May 1999, we recognized $23.4 million as acquired in-process research technology expense for the value of the nuclear transfer technology license obtained through the acquisition of Roslin Bio-Med.
(2) In November 2001, we amended the terms of the series D convertible debentures and warrants and converted a portion of the outstanding series D convertible debentures. We recognized $11.9 million as conversion expense related to this amendment and conversion.
In May 2003, we modified the terms of the series D convertible debentures and warrants. We recognized $779,000 as conversion expense related to this modification.
(3) In November 2000, we adopted a new accounting principle which retroactively affected the calculation of the beneficial conversion features associated with the series C convertible debentures issued in September 1999 and the series D convertible debentures issued in June 2000. We recognized an additional $13.3 million in imputed non-cash interest expense to reflect the change in accounting principle.
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Item 7. Managements Discussion and Analysis of Financial Condition and Results of Operations
Critical Accounting Policies and Estimates
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estimates have the following attributes: 1) we are required to make assumptions about matters that are highly uncertain at the time of the estimate; and 2) different estimates we could reasonably have used, or changes in the estimate that are reasonably likely to occur, would have a material effect on our financial condition or results of operations.
Revenue Recognition
Intangible Asset and Research Funding Obligation
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six years. Using an effective interest rate of 6%, this research funding obligation had a net present value of $17,200,000 at the acquisition date and was capitalized as an intangible asset that is being amortized as research and development expense over the six year funding period. Imputed interest is also being accreted to the value of the research funding obligation and is recognized as interest expense.
Valuation of Equity Instruments
Results of Operations
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results of operations for any other period. In addition, historical results should not be viewed as indicative of future operating results. We are subject to risks common to companies in our industry and at our stage of development, including risks inherent in our research and development efforts, reliance upon our collaborative partners, enforcement of our patent and proprietary rights, need for future capital, potential competition and uncertainty of regulatory approvals or clearances. In order for a therapeutic product to be commercialized based on our research, we and our collaborators must conduct preclinical tests and clinical trials that demonstrate its efficacy and safety, obtain regulatory approvals or clearances and enter into manufacturing, distribution and marketing arrangements, as well as obtain market acceptance. We do not expect to receive revenues or royalties based on therapeutic products for a period of years, if at all.
Revenues
Research and Development Expenses
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deriving, growing, maintaining, and differentiating hESCs, underlies all aspects of this group of programs. Many of our researchers are allocated to more than one hESC project, and the percentage allocations of time changes as the resource needs of individual programs vary.
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General and Administrative Expenses
Interest and Other Income
Interest and Other Expense
Conversion Expense
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also recorded the remaining $15.0 million of amended series D convertible debentures at a fair value of $16.3 million with the offsetting difference of $1.3 million being recorded as conversion expense. The fair values used in calculating the conversion expense associated with the series D-1 and D-2 warrants and the amended series D convertible debentures were based on values determined through the assistance of an independent valuation.
Net Loss
Liquidity and Capital Resources
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arrangement. Minimum annual payments due under the equipment financing facility are expected to total, $176,000, $146,000 and $55,000 in 2004, 2005 and 2006, respectively. As of December 31, 2003, we had approximately $1.3 million available for borrowing under our equipment financing facilities. The drawdown period under the equipment financing facilities expires on September 30, 2004. We intend to renew the commitment for new equipment financing facilities in 2004 to further fund equipment purchases. If we are unable to renew the commitment, then we will need to spend our own resources for equipment purchases.
(1) This table does not include any milestone payments under research collaborations or license agreements as the timing and likelihood of such payments are not known.
(2) Research funding is comprised of sponsored research commitments at various academic laboratories around the world, including the Roslin Institute.
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Off-Balance Sheet Arrangements
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
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Item 8. Consolidated Financial Statements and Supplementary Data
REPORT OF ERNST & YOUNG LLP, INDEPENDENT AUDITORS
The Board of Directors and Stockholders Geron Corporation
Palo Alto, California February 10, 2004
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CONSOLIDATED BALANCED SHEETS
See accompanying notes.
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CONSOLIDATED STATEMENTS OF OPERATIONS
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CONSOLIDATED STATEMENT OF STOCKHOLDERS EQUITY
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CONSOLIDATED STATEMENTS OF CASH FLOWS
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GERON CORPORATIONNOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. Organization and Summary of Significant Accounting Policies
Organization
Principles of Consolidation
Net Loss Per Share
Use of Estimates
Cash Equivalents and Marketable Debt Securities Available-For-Sale
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1. Organization and Summary of Significant Accounting Policies (Continued)
funds, municipal notes and commercial paper. The Companys investments include corporate notes in United States corporations with original maturities ranging from 2 to 24 months.
Restricted Cash
Marketable and Non-Marketable Equity Investments in Licensees
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gains or losses are included in interest and other income and are derived using the specific identification method. No writedowns were recorded in the years ended December 31, 2003, 2002 and 2001.
Derivative Financial Instruments
Depreciation and Amortization
Employee Stock Plans
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Comprehensive Income (Loss)
Concentrations of Customers and Suppliers
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Hakko in 2003. Two customers, Pharmacia and Kyowa Hakko, accounted for 35% and 55% of the Companys 2001 revenues, respectively. In January 2001, the Company and Pharmacia agreed to terminate their agreement. No revenues were earned from Pharmacia in 2003 or 2002.
Other Recent Accounting Pronouncements
Reclassifications
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2. Financial Instruments and Credit Risk
Cash Equivalents and Marketable Debt Securities Available-for-Sale
Notes Receivable from Related Parties
Other Fair Value Disclosures
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2. Financial Instruments and Credit Risk (Continued)
employees at its carrying value since there is an insignificant difference between the fair value and the carrying value.
Credit Risk
3. Marketable and Non-Marketable Equity Investments in Licensees
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4. Property and Equipment
5. Equipment Loans
6. Accrued Liabilities
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7. Operating Lease Commitment
8. Convertible Debentures
Series D Debentures
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8. Convertible Debentures (Continued)
to 2.5%, and fixed the conversion price at $20.00 per share. In addition, the Company modified the terms of the related outstanding warrants that were originally issued with the series D debentures to reset the exercise price of 40% of the warrants to $15.625 per share and extended the exercise period to June 30, 2003 (series D-1 warrants) and 60% of the warrants to $25.00 per share and extended the exercise period to December 31, 2006 (series D-2 warrants). The difference between the current fair values of the original series D warrants and the amended series D-1 and D-2 warrants was recorded as conversion expense of $3,370,000. The Company also recorded the remaining $15,000,000 of amended series D convertible debentures at a fair value of $16,300,000 with the offsetting difference of $1,300,000 being recorded as conversion expense. The excess of the fair value over the face value of the debentures was amortized over the life of the amended series D convertible debentures as a reduction to interest expense, $148,000 in 2003, $355,000 in 2002 and $59,000 in 2001. The Company accrued 2.5% interest on the amended series D convertible debentures as interest expense over the life of the debentures, $146,000 in 2003, $375,000 in 2002 and $54,000 in 2001. The fair values used in calculating the conversion expense associated with the series D-1 and D-2 warrants and the amended series D convertible debentures were based on values determined through an independent valuation.
9. Intangible Asset and Research Funding Obligation
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9. Intangible Asset and Research Funding Obligation (Continued)
accreted to the value of the research funding obligation and was recognized as interest expense in 2003 and 2002, respectively.
10. Acquisition of In-Process Research Technology
11. Stockholders Equity
Warrants
1992 Stock Option Plan
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11. Stockholders Equity (Continued)
later than ten years from the date of grant. For incentive stock options and nonstatutory stock options, the option exercise price was at least 100% and 85%, respectively, of the fair market value of the underlying common stock on the date of grant. Options to purchase shares of common stock generally vested over a period of four or five years from the date of the option grant, with a portion vesting after six months and the remainder vesting ratably over the remaining period.
2002 Equity Incentive Plan
Directors Stock Option Plan
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becomes a non-employee director after the effective date of the Directors Option Plan, whether by election of the stockholders of the Company or by appointment by the Board of Directors to fill a vacancy, will automatically be granted an option to purchase 45,000 shares of common stock on the date on which such person first becomes a non-employee director (First Option). In addition, non-employee directors (other than the Chairman of the Board of Directors) will automatically be granted a subsequent option on the date of the Annual Meeting of Stockholders in each year during such directors service on the Board (Subsequent Option) to purchase 20,000 shares of common stock under the Directors Option Plan. In the case of the Chairman of the Board of Directors, the Subsequent Option will be for 30,000 shares of common stock. Finally, the Company will grant an option to purchase 2,500 shares to each non-employee director upon such directors appointment to the Audit Committee or Compensation Committee of the Board of Directors, as well as on the date of each Annual Meeting during the directors service on such committee (Committee Service Option). There is currently no stock option grant contemplated for participation on other committees.
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Stock Based Compensation
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dividend yield of 0.0% for 2003, 2002 and 2001; volatility factors of the expected market price of the Companys common stock ranging from 0.881 to 1.072 for 2003, 0.881 for 2002 and 1.013 for 2001; and a weighted average expected life of the options of 4 years for 2003 and 2002 and 5 years for 2001.
Employee Stock Purchase Plan
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information included in Note 1. As of December 31, 2003, 352,940 shares were available for issuance under the 1996 Employee Stock Purchase Plan.
Common Shares Reserved for Future Issuance
Share Purchase Rights Plan
401(k) Plan
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Private Financings
Public Offering
12. Collaborative Agreements
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12. Collaborative Agreements (Continued)
13. Income Taxes
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13. Income Taxes (Continued)
14. Restructuring Charges
15. Segment Information
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16. Statement of Cash Flows Data
17. Quarterly Results (Unaudited)
18. Subsequent Event
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Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure
Item 9A. Controls and Procedures
PART III
Item 10. Directors and Executive Officers of the Registrant
Identification of Directors
Identification of Executive Officers
Code of Ethics
Item 11. Executive Compensation
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Item 12. Security Ownership of Certain Beneficial Owners and Management
Item 13. Certain Relationships and Related Transactions
Item 14. Principal Accountant Fees and Services
PART IV
Item 15. Exhibits, Financial Statement Schedules, and Reports on Form 8-K
(a) (1) Consolidated Financial Statements
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(b) Reports on Form 8-K
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(c) Index to Exhibits
(d) Financial Statements and Schedules
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SIGNATURES
POWER OF ATTORNEY
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EXHIBIT INDEX
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EXHIBIT 14.1
GERON CODE OF CONDUCT
Purpose
Commitment to Ethical Behavior
Compliance with Law
direction of the CEO and CFO, the Company has designed a set of internal controls and disclosure controls to ensure that all material information about the Company is reported to the appropriate Company officers so that it can be reflected, if appropriate, in the Companys SEC filings, and that all our financial reports are complete, accurate, and reliable. All Geron employees must comply with those accounting controls and disclosure controls and with the requirements of applicable accounting and auditing standards. That includes promptly reporting to his or her supervisor any significant event or occurrence (whether positive or negative) that arises in the course of the employees work. It also includes reporting immediately to the Controller, the General Counsel, the CFO or the CEO any actual or suspected breaches or violations of the Companys internal controls or any actual or suspected fraudulent or questionable transactions or occurrences (e.g., embezzlement, forgery or alteration of checks and other documents, theft, misappropriation or conversion to personal use of Company assets, and falsification of records). Employees are also encouraged to bring to the attention of any of those officers any changes that may improve the Companys system of internal controls or disclosure.
Compliance with Policies on Employee Conduct
Reporting Violations
Response to Reports of Violations
Waiver
Ethics Above All
Appendix A
Contact Information for Audit Committee Chair
The Chair of the Audit Committee of the Board of Directors can be contacted as follows: