As filed with the Securities and Exchange Commission on October 21, 2008
Registration No. 333-
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
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GERON CORPORATION
(Exact Name of Registrant as Specified in Its Charter)
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Delaware 75-2287752
(State or Other Jurisdiction of (I.R.S. Employer
Incorporation or Organization) Identification No.)
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230 Constitution Drive
Menlo Park, California 94025
(650) 473-7700
(Address, Including Zip Code and Telephone Number,
Including Area Code, of Registrant's Principal Executive Offices)
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Thomas B. Okarma
President and Chief Executive Officer
Geron Corporation
230 Constitution Drive
Menlo Park, California 94025
(650) 473-7700
(Name, Address, Including Zip Code and Telephone Number,
Including Area Code, of Agent for Service)
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Copies to:
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Alan C. Mendelson, Esq.
Latham & Watkins LLP
140 Scott Drive
Menlo Park, California 94025
(650) 328-4600
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Approximate date of commencement of proposed sale to the public: From time to
time after this Registration Statement becomes effective.
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If the only securities being registered on this form are being offered
pursuant to dividend or interest reinvestment plans, please check the following
box. [ ]
If any of the securities being registered on this Form are to be offered on
a delayed or continuous basis pursuant to Rule 415 under the Securities Act of
1933, other than securities offered only in connection with dividend or interest
reinvestment plans, check the following box. [X]
If this Form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, please check the following box
and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering. [ ]
If this Form is a post-effective amendment filed pursuant to Rule 462(c)
under the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering. [ ]
If this Form is a registration statement pursuant to General Instruction
I.D. or a post-effective amendment thereto that shall become effective upon
filing with the Commission pursuant to Rule 462(e) under the Securities Act,
check the following box. [ ]
If this Form is a post-effective amendment to a registration statement filed
pursuant to General Instruction I.D. filed to register additional securities or
additional classes of securities pursuant to Rule 413(b) under the Securities
Act, check the following box. [ ]
Indicate by check mark whether the registrant is a large accelerated filer,
an accelerated filer, a non-accelerated filer, or a smaller reporting company.
See the definitions of "large accelerated filer," "accelerated filer" and
"smaller reporting company" in Rule 12b2 of the Exchange Act.
[ ] Large accelerated filer [X] Accelerated filer
[ ] Non-accelerated filer (Do not check [ ] Smaller reporting company
if a smaller reporting company)
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CALCULATION OF REGISTRATION FEE
================================= ================= ===================== ====================== ===============
Proposed Maximum Proposed Maximum Amount of
Title of Securities to be Amount to be Offering Price per Aggregate Offering Registration
Registered Registered(1) share Price Fee
--------------------------------- ----------------- --------------------- ---------------------- ---------------
Common Stock, par value $.001 per
share 255,754 shares $3.26 (2) $833,758 $32.77 (3)
--------------------------------- ----------------- --------------------- ---------------------- ---------------
(1) In the event of a stock split, stock dividend, or similar transaction
involving Geron's common stock, in order to prevent dilution, the number of
shares registered shall automatically be increased to cover the additional
shares in accordance with Rule 416(a) under the Securities Act.
(2) The offering price is estimated solely for the purpose of calculating the
registration fee in accordance with Rule 457(c) and based upon the average
of the high and low prices reported by Nasdaq Global Market on October 17,
2008.
(3) Calculated in accordance with Rule 457(o) under the Securities Act of 1933.
THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR
DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL
FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION
STATEMENT SHALL HEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(A) OF
THE SECURITIES ACT OF 1933 OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME
EFFECTIVE ON SUCH DATE AS THE SECURITIES AND EXCHANGE COMMISSION, ACTING
PURSUANT TO SAID SECTION 8(A), MAY DETERMINE.
THE INFORMATION IN THIS PROSPECTUS IS NOT COMPLETE AND MAY BE CHANGED. THE
SELLING STOCKHOLDER MAY NOT SELL THESE SECURITIES UNTIL THE REGISTRATION
STATEMENT FILED WITH THE SECURITIES AND EXCHANGE COMMISSION IS EFFECTIVE. THIS
PROSPECTUS IS NOT AN OFFER TO SELL THESE SECURITIES AND IT IS NOT SOLICITING AN
OFFER TO BUY THESE SECURITIES IN ANY STATE WHERE THE OFFER OR SALE IS NOT
PERMITTED.
SUBJECT TO COMPLETION, DATED OCTOBER 21, 2008
UP TO 255,754 SHARES OF
GERON CORPORATION
COMMON STOCK
Our common stock is traded on the Nasdaq Global Market under the symbol
"GERN." On October 17, 2008, the closing price of our common stock was $3.23.
This prospectus relates to the sale of up to 255,754 shares of our common
stock by Lonza Walkersville, Inc. We will not receive any of the proceeds from
the sale of these shares covered by this prospectus.
INVESTING IN OUR COMMON STOCK INVOLVES A HIGH DEGREE OF RISK. SEE "RISK
FACTORS" BEGINNING ON PAGE 1.
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Neither the Securities and Exchange Commission (the "SEC") nor any state
securities commission has approved or disapproved of these securities or passed
upon the accuracy or adequacy of this prospectus. Any representation to the
contrary is a criminal offense.
----------------------
The date of this prospectus is October __, 2008.
TABLE OF CONTENTS
Page
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ABOUT GERON.......................................................................................................1
RISK FACTORS......................................................................................................1
FORWARD-LOOKING STATEMENTS.......................................................................................18
USE OF PROCEEDS..................................................................................................18
DESCRIPTION OF OUR COMMON STOCK..................................................................................18
TRANSFER AGENT AND REGISTRAR.....................................................................................18
SELLING STOCKHOLDER..............................................................................................19
PLAN OF DISTRIBUTION.............................................................................................20
LEGAL MATTERS....................................................................................................21
EXPERTS..........................................................................................................21
MATERIAL CHANGES.................................................................................................21
LIMITATION ON LIABILITY AND DISCLOSURE OF COMMISSION POSITION ON
INDEMNIFICATION FOR SECURITIES ACT LIABILITIES................................................................21
WHERE YOU CAN FIND MORE INFORMATION..............................................................................21
DOCUMENTS WE HAVE INCORPORATED BY REFERENCE......................................................................22
ABOUT GERON
Geron is a biopharmaceutical company that is developing first-in-class
therapeutic products for the treatment of cancer and chronic degenerative
diseases, including spinal cord injury, heart failure and diabetes. The products
are based on our core expertise in telomerase and human embryonic stem cells.
We were incorporated in 1990 under the laws of Delaware. Our principal
executive offices are located at 230 Constitution Drive, Menlo Park, California
94025 and our telephone number is (650) 473-7700.
RISK FACTORS
Our business is subject to various risks, including those described below.
You should carefully consider these risk factors, together with all of the other
information included in this Registration Statement. Any of these risks could
materially adversely affect our business, operating results and financial
condition.
RISKS RELATED TO OUR BUSINESS
OUR BUSINESS IS AT AN EARLY STAGE OF DEVELOPMENT.
Our business is at an early stage of development, in that we do not yet
have product candidates in late-stage clinical trials or on the market. We have
begun clinical testing of our lead anti-cancer drug, GRN163L, in patients with
chronic lymphocytic leukemia, solid tumor malignancies, non-small cell lung
cancer, breast cancer and multiple myeloma. We have begun clinical testing of
our telomerase cancer vaccine, GRNVAC1, in patients with acute myelogenous
leukemia. We have no other product candidates in clinical testing. Our ability
to develop product candidates that progress to and through clinical trials is
subject to our ability to, among other things:
o succeed in our research and development efforts;
o select therapeutic compounds or cell therapies for development;
o obtain required regulatory approvals;
o manufacture product candidates; and
o collaborate successfully with clinical trial sites, academic
institutions, physician investigators, clinical research organizations
and other third parties.
Potential lead drug compounds or other product candidates and technologies
require significant preclinical and clinical testing prior to regulatory
approval in the United States and other countries. Our product candidates may
prove to have undesirable and unintended side effects or other characteristics
adversely affecting their safety, efficacy or cost-effectiveness that could
prevent or limit their commercial use. In addition, our product candidates may
not prove to be more effective for treating disease or injury than current
therapies. Accordingly, we may have to delay or abandon efforts to research,
develop or obtain regulatory approvals to market our product candidates. In
addition, we will need to determine whether any of our potential products can be
manufactured in commercial quantities at an acceptable cost. Our research and
development efforts may not result in a product that can be approved by
regulators or marketed successfully. Physicians may not prescribe our products
or patients or third party payors may not accept such products. Competitors may
have proprietary rights which prevent us from marketing our products or sell
similar, superior or lower-cost products. Because of the significant scientific,
regulatory and commercial milestones that must be reached for any of our
development programs or product candidates to be successful, any program or
product candidate may be abandoned, even after we have expended significant
resources, such as our investments in telomerase technology, human embryonic
stem cells, GRN163L and GRNVAC1, which could adversely affect our business and
cause a sharp drop in our stock price.
1
The science and technology of telomere biology and telomerase, human
embryonic stem cells and nuclear transfer are relatively new. There is no
precedent for the successful commercialization of therapeutic product candidates
based on our technologies. These development programs are therefore particularly
risky. In addition, we, our licensees or our collaborators must undertake
significant research and development activities to develop product candidates
based on our technologies, which will require additional funding and may take
years to accomplish, if ever.
RESTRICTIONS ON THE USE OF HUMAN EMBRYONIC STEM CELLS, POLITICAL COMMENTARY AND
THE ETHICAL AND SOCIAL IMPLICATIONS OF RESEARCH INVOLVING HUMAN EMBRYONIC STEM
CELLS COULD PREVENT US FROM DEVELOPING OR GAINING ACCEPTANCE FOR COMMERCIALLY
VIABLE PRODUCTS BASED UPON SUCH STEM CELLS AND ADVERSELY AFFECT THE MARKET PRICE
OF OUR COMMON STOCK.
Some of our most important programs involve the use of stem cells that are
derived from human embryos. The use of human embryonic stem cells gives rise to
ethical and social issues regarding the appropriate use of these cells. Our
research related to human embryonic stem cells may become the subject of adverse
commentary or publicity, which could significantly harm the market price for our
common stock.
Some political and religious groups have voiced opposition to our
technology and practices. We use stem cells derived from human embryos that have
been created for in vitro fertilization procedures but are no longer desired or
suitable for that use and are donated with appropriate informed consent for
research use. Many research institutions, including some of our scientific
collaborators, have adopted policies regarding the ethical use of human
embryonic tissue. These policies may have the effect of limiting the scope of
research conducted using human embryonic stem cells, thereby impairing our
ability to conduct research in this field.
In addition, the United States government and its agencies are only
providing limited funding to research which involves the use of human embryonic
tissue. President Bush announced on August 9, 2001 that he would permit federal
funding of research on human embryonic stem cells using the limited number of
embryonic stem cell lines that had already been created, but relatively few
federal grants have been made so far. The President's Council on Bioethics
monitors stem cell research, and the guidelines and regulations it recommends
may include restrictions on the scope of research using human embryonic or fetal
tissue. Certain states are considering, or have in place, legislation relating
to stem cell research, including California whose voters approved Proposition 71
to provide state funds for stem cell research in November 2004. It is not yet
clear what, if any, affect such state actions may have on our ability to
commercialize stem cell products. In the United 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.
Government-imposed restrictions with respect to use of embryos or human
embryonic stem cells in research and development could have a material adverse
effect on us, including:
o harming our ability to establish critical partnerships and
collaborations;
o delaying or preventing progress in our research and development; and
o causing a decrease in the price of our stock.
2
RISKS RELATED TO OUR FINANCIAL POSITION AND
NEED FOR ADDITIONAL FINANCING
WE HAVE A HISTORY OF LOSSES AND ANTICIPATE FUTURE LOSSES, AND CONTINUED LOSSES
COULD IMPAIR OUR ABILITY TO SUSTAIN OPERATIONS.
We have incurred operating losses every year since our operations began in
1990. As of June 30, 2008, our accumulated deficit was approximately $472.1
million. Losses have resulted principally from costs incurred in connection with
our research and development activities and from general and administrative
costs associated with our operations. We expect to incur additional operating
losses and, as our development efforts and clinical testing activities continue,
our operating losses may increase in size.
Substantially all of our revenues to date have been research support
payments under collaboration agreements and revenues from our licensing
arrangements. We may be unsuccessful in entering into any new corporate
collaboration or license agreement that results in revenues. We do not expect
that the revenues generated from these arrangements will be sufficient alone to
continue or expand our research or development activities and otherwise sustain
our operations.
While we receive royalty revenue from licenses of diagnostic product
candidates, telomerase-immortalized cell lines and other licensing activities,
we do not currently expect to receive sufficient royalty revenues from these
licenses to sustain our operations. Our ability to continue or expand our
research and development activities and otherwise sustain our operations is
dependent on our ability, alone or with others, to, among other things,
manufacture and market therapeutic products.
We also expect to experience negative cash flow for the foreseeable future
as we fund our operating losses and capital expenditures. This will result in
decreases in our working capital, total assets and stockholders' equity, which
may not be offset by future financings. We will need to generate significant
revenues to achieve profitability. We may not be able to generate these
revenues, and we may never achieve profitability. Our failure to achieve
profitability could negatively impact the market price of our 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
PRODUCT CANDIDATES, AND OUR ABILITY TO OBTAIN THE NECESSARY FUNDING IS
UNCERTAIN.
We will require substantial capital resources in order to conduct our
operations and develop our product candidates, and we cannot assure you that our
existing capital resources, interest income and equipment financing arrangement
will be sufficient to fund our current and planned operations. The timing and
degree of any future capital requirements will depend on many factors,
including:
o the accuracy of the assumptions underlying our estimates for our
capital needs in 2008 and beyond;
o the magnitude and scope of our research and development programs;
o the progress we make in our research and development programs,
preclinical development and clinical trials;
o our ability to establish, enforce and maintain strategic arrangements
for research, development, clinical testing, manufacturing and
marketing;
o the number and type of product candidates that we pursue;
o the time and costs involved in obtaining regulatory approvals; and
3
o the costs involved in preparing, filing, prosecuting, maintaining,
defending and enforcing patent claims.
We do not have any committed sources of capital. Additional financing
through strategic collaborations, public or private equity financings, capital
lease transactions or other financing sources may not be available on acceptable
terms, or at all. The receptivity of the public and private equity markets to
proposed financings is substantially affected by the general economic, market
and political climate and by other factors which are unpredictable and over
which we have no control. Additional equity financings, if we obtain them, could
result in significant dilution to stockholders. Further, in the event that
additional funds are obtained through arrangements with collaborative partners,
these arrangements may require us to relinquish rights to some of our
technologies, product candidates or proposed products that we would otherwise
seek to develop and commercialize ourselves. If sufficient capital is not
available, we may be required to delay, reduce the scope of or eliminate one or
more of our programs, any of which could have a material adverse effect on our
business.
RISKS RELATED TO CLINICAL AND COMMERCIALIZATION ACTIVITIES
DELAYS IN THE COMMENCEMENT OF CLINICAL TESTING OF OUR CURRENT AND POTENTIAL
PRODUCT CANDIDATES COULD RESULT IN INCREASED COSTS TO US AND DELAY OUR ABILITY
TO GENERATE REVENUES.
The commencement of clinical trials can be delayed for a variety of
reasons, including delays in:
o demonstrating sufficient safety and efficacy to obtain regulatory
approval to commence a clinical trial;
o reaching agreement on acceptable terms with our collaborators on all
aspects of the clinical trial, including the contract research
organizations and the trial sites;
o reaching agreement on acceptable terms with prospective contract
research organizations and trial sites;
o manufacturing sufficient quantities or producing drug meeting our
quality standards of a product candidate;
o obtaining approval of an Investigational New Drug (IND) application or
proposed trial design from the Food and Drug Administration (FDA); and
o obtaining institutional review board approval to conduct a clinical
trial at a prospective site.
In addition, clinical trials may be delayed due to insufficient patient
enrollment, which is a function of many factors, including the size and nature
of the patient population, the nature of the protocol, the proximity of patients
to clinical sites, the availability of effective treatments for the relevant
disease, and the eligibility criteria for the clinical trial.
WE DO NOT HAVE EXPERIENCE AS A COMPANY CONDUCTING LARGE-SCALE CLINICAL TRIALS,
OR IN OTHER AREAS REQUIRED FOR THE SUCCESSFUL COMMERCIALIZATION AND MARKETING OF
OUR PRODUCT CANDIDATES.
Preliminary results from clinical trials of GRN163L and GRNVAC1 may not be
indicative of successful outcomes in later stage trials. Negative or limited
results from any current or future clinical trials could delay or prevent
further development of our product candidates which would adversely affect our
business.
4
We have no experience as a company in conducting large-scale, late stage
clinical trials, and our experience with early-stage clinical trials with small
numbers of patients is limited. In part because of this limited experience, we
cannot be certain that planned clinical trials will begin or be completed on
time, if at all. Large-scale trials would require either additional financial
and management resources, or reliance on third-party clinical investigators,
clinical research organizations (CROs) or consultants. Relying on third-party
clinical investigators or CROs may force us to encounter delays that are outside
of our control. Any such delays could have a material adverse effect on our
business.
We also do not currently have marketing and distribution capabilities for
our product candidates. Developing an internal sales and distribution capability
would be an expensive and time-consuming process. We may enter into agreements
with third parties that would be responsible for marketing and distribution.
However, these third parties may not be capable of successfully selling any of
our product candidates. The inability to commercialize and market our product
candidates could materially affect our business.
OBTAINING REGULATORY APPROVALS TO MARKET OUR PRODUCT CANDIDATES IN THE UNITED
STATES AND OTHER COUNTRIES IS A COSTLY AND LENGTHY PROCESS AND WE CANNOT PREDICT
WHETHER OR WHEN WE WILL BE PERMITTED TO COMMERCIALIZE OUR PRODUCT CANDIDATES.
Federal, state and local governments in the United States and governments
in other countries have significant regulations in place that govern many of our
activities and may prevent us from creating commercially viable products from
our discoveries. The regulatory process, particularly for biopharmaceutical
product candidates like ours, is uncertain, can take many years and requires the
expenditure of substantial resources.
Our potential product candidates will require extensive preclinical and
clinical testing prior to submission of any regulatory application for
commercial sales. In particular, human pharmaceutical therapeutic product
candidates are subject to rigorous requirements of the FDA in the United States
and similar health authorities in other countries in order to demonstrate safety
and efficacy. Data obtained from preclinical and clinical activities is
susceptible to varying interpretations that could delay, limit or prevent
regulatory agency approvals. In addition, delays or rejections may be
encountered as a result of changes in regulatory agency policy during the period
of product development and/or the period of review of any application for
regulatory agency approval for a product candidate.
Any product candidate that we or our collaborators develop must receive all
relevant regulatory agency approvals before it may be marketed in the United
States or other countries. Obtaining regulatory approval is a lengthy, expensive
and uncertain process. Because certain of our product candidates involve the
application of new technologies or are based upon a new therapeutic approach,
they may be subject to substantial additional review by various government
regulatory authorities, and, as a result, the process of obtaining regulatory
approvals for them may proceed more slowly than for product candidates based
upon more conventional technologies.
Delays in obtaining regulatory agency approvals could:
o significantly harm the marketing of any products that we or our
collaborators develop;
o impose costly procedures upon our activities or the activities of our
collaborators;
o diminish any competitive advantages that we or our collaborators may
attain; or
o adversely affect our ability to receive royalties and generate
revenues and profits.
Even if we commit the necessary time and resources, the required regulatory
agency approvals may not be obtained for any product candidates developed by us
or in collaboration with us. If we obtain regulatory agency approval for a new
product, this approval may entail limitations on the indicated uses for which it
can be marketed that could limit the potential commercial use of the product.
5
FAILURE TO ACHIEVE CONTINUED COMPLIANCE WITH GOVERNMENT REGULATION OVER APPROVED
PRODUCTS COULD DELAY OR HALT COMMERCIALIZATION OF OUR PRODUCTS.
Approved products and their manufacturers are subject to continual review,
and discovery of previously unknown problems with a product or its manufacturer
may result in restrictions on the product or manufacturer, including withdrawal
of the product from the market. The sale by us or our collaborators of any
commercially viable product will be subject to government regulation from
several standpoints, including the processes of:
o manufacturing;
o advertising and promoting;
o selling and marketing;
o labeling; and
o distribution.
If, and to the extent that, we are unable to comply with these regulations, our
ability to earn revenues will be materially and negatively impacted.
Failure to comply with regulatory requirements can result in severe civil
and criminal penalties, including but not limited to:
o recall or seizure of products;
o injunction against manufacture, distribution, sales and marketing; and
o criminal prosecution.
The imposition of any of these penalties or other commercial limitations could
significantly impair our business, financial condition and results of
operations.
RISKS RELATED TO PROTECTING OUR INTELLECTUAL PROPERTY
IMPAIRMENT OF OUR INTELLECTUAL PROPERTY RIGHTS MAY ADVERSELY AFFECT THE VALUE OF
OUR TECHNOLOGIES AND PRODUCT CANDIDATES AND LIMIT OUR ABILITY TO PURSUE THEIR
DEVELOPMENT.
Protection of our proprietary technology is critically important to our
business. Our success will depend in part on our ability to obtain and enforce
our patents and maintain trade secrets, both in the United States and in other
countries. In the event that we are unsuccessful in obtaining and enforcing
patents, our business would be negatively impacted. Further, our patents may be
challenged, invalidated or circumvented, and our patent rights may not provide
proprietary protection or competitive advantages to us.
The patent positions of pharmaceutical and biopharmaceutical companies,
including ours, are highly uncertain and involve complex legal and technical
questions. In particular, legal principles for biotechnology patents in the
United States and in other countries are evolving, and the extent to which we
will be able to obtain patent coverage to protect our technology, or enforce
issued patents, is uncertain. In the United States, recent court decisions in
patent cases as well as proposed legislative changes to the patent system only
exacerbate this uncertainty. Furthermore, significant amendments to the
regulations governing the process of obtaining patents were recently proposed by
the United States Patent and Trademark Office (the Patent Office). These
amendments were widely regarded as detrimental to the interests of biotechnology
and pharmaceutical companies. The implementation of the amendments was blocked
by a court injunction requested by a pharmaceutical company. At this time, the
Patent Office is challenging the court decision through an appeals process, and
we do not know whether or when the Patent Office might seek to reintroduce the
amendments in a modified form.
6
In Europe, the European Patent Convention prohibits the granting of
European patents for inventions that concern "uses of human embryos for
industrial or commercial purposes." The European Patent Office is presently
interpreting this prohibition broadly, and is applying it to reject patent
claims that pertain to human embryonic stem cells (hESCs). However, this broad
interpretation is being challenged through the European Patent Office appeals
system. As a result, we do not yet know whether or to what extent we will be
able to obtain patent protection for our human embryonic stem cell technologies
in Europe. If we are unable to protect our inventions related to hESCs in
Europe, our business would be negatively impacted.
Publication of discoveries in scientific or patent literature tends to lag
behind actual discoveries by at least several months and sometimes several
years. Therefore, the persons or entities that we or our licensors name as
inventors in our patents and patent applications may not have been the first to
invent the inventions disclosed in the patent applications or patents, or the
first to file patent applications for these inventions. As a result, we may not
be able to obtain patents for discoveries that we otherwise would consider
patentable and that we consider to be extremely significant to our future
success.
CHALLENGES TO OUR PATENT RIGHTS CAN RESULT IN COSTLY AND TIME-CONSUMING LEGAL
PROCEEDINGS THAT MAY PREVENT OR LIMIT DEVELOPMENT OF OUR PRODUCT CANDIDATES.
Where several parties seek U.S. patent protection for the same technology,
the Patent Office may declare an interference proceeding in order to ascertain
the party to which the patent should be issued. Patent interferences are
typically complex, highly contested legal proceedings, subject to appeal. They
are usually expensive and prolonged, and can cause significant delay in the
issuance of patents. Moreover, parties that receive an adverse decision in an
interference can lose important patent rights. Our pending patent applications,
or our issued patents, may be drawn into interference proceedings which may
delay or prevent the issuance of patents, or result in the loss of issued patent
rights. As more groups become engaged in scientific research and product
development in the areas of telomerase biology and embryonic stem cells, the
risk of our patents being challenged through patent interferences, oppositions,
reexaminations or other means will likely increase.
The interference process can also be used to challenge a patent that has
been issued to another party. For example, in 2004 we were party to two
interferences declared by the Patent Office at our request. These interferences
involved two of our pending applications relating to nuclear transfer technology
and two issued patents, held by the University of Massachusetts (U. Mass) and
licensed to Advanced Cell Technology, Inc. (ACT) of Worcester, Massachusetts. We
requested these interferences in order to clarify our patent rights to this
technology and to facilitate licensing to companies wishing to utilize this
technology in animal cloning. The Board of Patent Appeals and Interferences
issued final judgments in each of these cases, finding in both instances that
all of the claims in the U. Mass patents in question were unpatentable, and
upholding the patentability of Geron's pending claims. These judgments were
appealed by U. Mass and ACT, but the appeals have now been dismissed as part of
a settlement agreement, resulting in invalidation of the U. Mass patents.
Outside of the United States, certain jurisdictions, such as Europe, New
Zealand and Australia, permit oppositions to be filed against the granting of
patents. Because our intent is to commercialize products internationally,
securing both proprietary protection and freedom to operate outside of the
United States is important to our business. We are involved in both opposing the
grant of patents to others through such opposition proceedings and in defending
our patent applications against oppositions filed by others. For example, we
have recently been involved in two patent oppositions before the European Patent
Office (EPO) with a Danish company, Pharmexa. Pharmexa (which acquired the
Norwegian company GemVax in 2005) is developing a cancer vaccine that employs a
short telomerase peptide to induce an immune response against telomerase and is
conducting a Phase III clinical trial. Pharmexa obtained a European patent with
broad claims to the use of telomerase vaccines for the treatment of cancer, and
Geron opposed that patent in 2004. In 2005, the Opposition Division (OD) of the
EPO revoked the claims originally granted to Pharmexa, but permitted Pharmexa to
add new, narrower claims limited to five specific small peptide fragments of
telomerase. The decision was appealed to the Technical Board of Appeals (TBA).
In August 2007, the TBA ruled, consistent with the decision of the OD, that
Pharmexa was not entitled to the originally granted broad claims but was only
entitled to the narrow claims limited to the five small peptides.
7
In parallel, Pharmexa opposed a European patent held by Geron, the claims
of which cover many facets of human telomerase, including the use of telomerase
peptides in cancer vaccines. In June 2006, the OD of the EPO revoked three of
the granted claims in Geron's patent, specifically the three claims covering
telomerase peptide cancer vaccines. We have appealed that decision to the TBA,
and that appeal is still pending. Because this appeal is ongoing, the outcome
cannot be determined at this time. We are also seeking to obtain patent coverage
in Europe for telomerase peptides through a European divisional patent
application. If those patent claims are issued, they too may be subject to an
opposition proceeding.
European opposition and appeal proceedings can take several years to reach
final decision. The oppositions discussed above reflect the complexity of the
patent landscape in which we operate, and illustrate the risks and
uncertainties. We are also currently involved in other patent opposition
proceedings in Europe and Australia.
Patent opposition proceedings are not currently available in the U.S.
patent system, but legislation has been proposed to introduce them. However,
issued U.S. patents can be reexamined by the Patent Office at the request of a
third party. Patents owned or licensed by Geron may therefore be subject to
reexamination. As in any legal proceeding, the outcome of patent reexaminations
is uncertain, and a decision adverse to our interests could result in the loss
of valuable patent rights.
In July 2006, requests were filed on behalf of the Foundation for Taxpayer
and Consumer Rights (now renamed as "Consumer Watchdog") for reexamination of
three issued U.S. patents owned by the Wisconsin Alumni Research Foundation
(WARF) and relating to human embryonic stem cells. These three patents (U.S.
Patent Nos. 5,843,780, 6,200,806 and 7,029,913) are licensed to Geron pursuant
to a January 2002 license agreement with WARF. The license agreement conveys
exclusive rights to Geron under the WARF patents for the development and
commercialization of therapeutics based on neural cells, cardiomyocytes and
pancreatic islet cells, derived from human embryonic stem cells, as well as
nonexclusive rights for other product opportunities. In October 2006, the Patent
Office initiated the reexamination proceedings. After initially rejecting the
patent claims, the Patent Office recently issued decisions in all three cases
upholding the patentability of the claims. The decisions to uphold the 5,843,780
and 6,200,806 patents are final and not subject to further appeal. Consumer
Watchdog has filed a notice of appeal against the decision on the 7,029,913
patent. We cooperated with WARF in these reexamination actions and expect that
WARF will continue to vigorously defend its patent position in this appeal.
While the decisions in these reexamination proceedings to date have all been
favorable to our patent position, the outcome of the appeal or any future
reexamination proceedings cannot be determined at this time. Reduction or loss
of claim scope in these WARF embryonic stem cell patents would negatively impact
Geron's proprietary position in this technology.
Successful challenges to our patents through interferences, oppositions or
reexamination proceedings could result in a loss of patent rights in the
relevant jurisdiction(s). If we are unsuccessful in actions we bring against the
patents of other parties, we may be subject to litigation, or otherwise
prevented from commercializing potential products in the relevant jurisdiction,
or may be required to obtain licenses to those patents or develop or obtain
alternative technologies, any of which could harm our business. Furthermore, if
such challenges to our patent rights are not resolved promptly in our favor, our
existing business relationships may be jeopardized and we could be delayed or
prevented from entering into new collaborations or from commercializing certain
products, which could materially harm our business.
8
IF WE FAIL TO MEET OUR OBLIGATIONS UNDER LICENSE AGREEMENTS, WE MAY LOSE OUR
RIGHTS TO KEY TECHNOLOGIES ON WHICH OUR BUSINESS DEPENDS.
Our business depends on several critical technologies that are based in
part on patents licensed from third parties. Those third-party license
agreements impose obligations on us, such as payment obligations and obligations
to diligently pursue development of commercial products under the licensed
patents. If a licensor believes that we have failed to meet our obligations
under a license agreement, the licensor could seek to limit or terminate our
license rights, which could lead to costly and time-consuming litigation and,
potentially, a loss of the licensed rights. During the period of any such
litigation our ability to carry out the development and commercialization of
potential products could be significantly and negatively affected. If our
license rights were restricted or ultimately lost, our ability to continue our
business based on the affected technology platform would be severely adversely
affected.
WE MAY BE SUBJECT TO LITIGATION THAT WILL BE COSTLY TO DEFEND OR PURSUE AND
UNCERTAIN IN ITS OUTCOME.
Our business may bring us into conflict with our licensees, licensors, or
others with whom we have contractual or other business relationships, or with
our competitors or others whose interests differ from ours. If we are unable to
resolve those conflicts on terms that are satisfactory to all parties, we may
become involved in litigation brought by or against us. That litigation is
likely to be expensive and may require a significant amount of management's time
and attention, at the expense of other aspects of our business. The outcome of
litigation is always uncertain, and in some cases could include judgments
against us that require us to pay damages, enjoin us from certain activities, or
otherwise affect our legal or contractual rights, which could have a significant
adverse effect on our business.
Patent litigation may also be necessary to enforce patents issued or
licensed to us or to determine the scope and validity of our proprietary rights
or the proprietary rights of others. We may not be successful in any patent
litigation. Patent litigation can be extremely expensive and time-consuming,
even if the outcome is favorable to us. An adverse outcome in a patent
litigation, patent opposition, patent interference, or any other proceeding in a
court or patent office could subject our business to significant liabilities to
other parties, require disputed rights to be licensed from other parties or
require us to cease using the disputed technology, any of which could severely
harm our business.
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.
Our commercial success depends significantly on our ability to operate
without infringing patents and the proprietary rights of others. Our
technologies may infringe the patents or proprietary rights of others. In
addition, we may become aware of discoveries and technology controlled by third
parties that are advantageous to our programs. In the event our technologies
infringe the rights of others or we 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 have obtained licenses from
several universities and companies for technologies that we anticipate
incorporating into our potential products, and we initiate negotiation for
licenses to other technologies as the need or opportunity arises. We may not be
able to obtain a license to patented technology on commercially favorable terms,
or at all. If we do not obtain a necessary license, we may need to redesign our
technologies or obtain rights to alternate technologies, the research and
adoption of which could cause delays in product development. In cases where we
are unable to license necessary technologies, we could be prevented from
developing certain potential products. Our failure to obtain alternative
technologies or a license to any technology that we may require to research,
develop or commercialize our product candidates would significantly and
negatively affect our business.
9
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 sometimes rely on trade secrets to protect our proprietary technology,
especially in circumstances in which we believe patent protection is not
appropriate or available. We attempt to protect our proprietary technology in
part by confidentiality agreements with our employees, consultants,
collaborators and contractors. We cannot assure you that these agreements will
not be breached, that we would have adequate remedies for any breach, or that
our trade secrets will not otherwise become known or be independently discovered
by competitors, any of which would harm our business significantly.
RISKS RELATED TO OUR RELATIONSHIPS WITH THIRD PARTIES
WE DEPEND ON OTHER PARTIES TO HELP US DEVELOP, MANUFACTURE AND TEST OUR PRODUCT
CANDIDATES, AND OUR ABILITY TO DEVELOP AND COMMERCIALIZE POTENTIAL PRODUCTS MAY
BE IMPAIRED OR DELAYED IF COLLABORATIONS ARE UNSUCCESSFUL.
Our strategy for the development, clinical testing and commercialization of
our product candidates requires that we enter into collaborations with corporate
partners, licensors, licensees and others. We are dependent upon the subsequent
success of these other parties in performing their respective responsibilities
and the continued cooperation of our partners. By way of examples: Merck is
developing cancer vaccines targeted to telomerase other than the dendritic
cell-based vaccines that we are developing; Cell Genesys is developing oncolytic
virus therapeutics utilizing the telomerase promoter; and Sienna is developing
cancer diagnostics using our telomerase technology. Our collaborators may not
cooperate with us or perform their obligations under our agreements with them.
We cannot control the amount and timing of our collaborators' resources that
will be devoted to activities related to our collaborative agreements with them.
Our collaborators may choose to pursue existing or alternative technologies in
preference to those being developed in collaboration with us.
Under agreements with other parties, we may rely significantly on them to,
among other activities:
o conduct research and development activities in conjunction with us;
o design and conduct advanced clinical trials in the event that we reach
clinical trials;
o fund research and development activities with us;
o manage and license certain patent rights;
o pay us fees upon the achievement of milestones; and
o market with us any commercial products that result from our
collaborations.
The development and commercialization of potential products will be delayed
if collaborators or other partners fail to conduct these activities in a timely
manner or at all. In addition, our collaborators could terminate their
agreements with us and we may not receive any development or milestone payments.
If we do not achieve milestones set forth in the agreements, or if our
collaborators breach or terminate their collaborative agreements with us, our
business may be materially harmed.
We also rely on other companies for certain process development,
manufacturing or other technical scientific work, especially with respect to our
GRN163L, GRNVAC1 and GRNOPC1 programs. We have contracts with these companies
that specify the work to be done and results to be achieved, but we do not have
direct control over their personnel or operations. If these companies do not
perform the work on which they were assigned, our ability to develop or
manufacture our product candidates could be significantly harmed.
10
OUR RELIANCE ON THE ACTIVITIES OF OUR NON-EMPLOYEE CONSULTANTS, RESEARCH
INSTITUTIONS, AND SCIENTIFIC CONTRACTORS, WHOSE ACTIVITIES ARE NOT WHOLLY WITHIN
OUR CONTROL, MAY LEAD TO DELAYS IN DEVELOPMENT OF OUR PRODUCT CANDIDATES.
We rely extensively upon and have relationships with scientific consultants
at academic and other institutions, some of whom conduct research at our
request, and other consultants who assist us in formulating our research and
development and clinical strategy or other matters. These consultants are not
our employees and may have commitments to, or consulting or advisory contracts
with, other entities that may limit their availability to us. We have limited
control over the activities of these consultants and, except as otherwise
required by our collaboration and consulting agreements, can expect only limited
amounts of their time to be dedicated to our activities.
In addition, we have formed research collaborations with many academic and
other research institutions throughout the world. These research facilities may
have commitments to other commercial and non-commercial entities. We have
limited control over the operations of these laboratories and can expect only
limited amounts of their time to be dedicated to our research goals.
If any of these third parties are unable or refuse to contribute to
projects on which we need their help, our ability to generate advances in our
technologies and develop our product candidates could be significantly harmed.
RISKS RELATED TO COMPETITIVE FACTORS
THE LOSS OF KEY PERSONNEL COULD SLOW OUR ABILITY TO CONDUCT RESEARCH AND DEVELOP
PRODUCT CANDIDATES.
Our future success depends to a significant extent on the skills,
experience and efforts of our executive officers and key members of our
scientific staff. We face intense competition for qualified individuals from
numerous pharmaceutical, biopharmaceutical and biotechnology companies, as well
as academic and other research institutions. We may be unable to retain our
current personnel or attract or assimilate other highly qualified management and
scientific personnel in the future on acceptable terms. The loss of any or all
of these individuals could harm our business and might significantly delay or
prevent the achievement of research, development or business objectives.
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 telomerase inhibitor compound, GRN163L, and our hESC-based products are
likely to be more expensive to manufacture than most other drugs currently on
the market today. Oligonucleotides are relatively large molecules with complex
chemistry, and the cost of manufacturing an oligonucleotide like GRN163L is
greater than the cost of making most small-molecule drugs. Our present
manufacturing processes are conducted at a small scale and are at an early stage
of development. We hope to substantially reduce manufacturing costs through
process improvements, as well as through scale increases. If we are not able to
do so, however, and, depending on the pricing of the potential product, the
profit margin on the telomerase inhibitor may be significantly less than that of
most drugs on the market today. Similarly, we currently make differentiated
cells from hESCs on a laboratory scale, at a high cost per unit measure. The
cell-based therapies we are developing based on hESCs will probably require
large quantities of cells. We continue to develop processes to scale up
production of the cells in a cost-effective way. We may not be able to charge a
high enough price for any cell therapy product we develop, even if it is safe
and effective, to make a profit. If we are unable to realize significant profits
from our potential product candidates, our business would be materially harmed.
11
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.
The pharmaceutical and biotechnology industries are intensely competitive.
Other pharmaceutical and biotechnology companies and research organizations
currently engage in or have in the past engaged in efforts related to the
biological mechanisms that are the focus of our programs in oncology and human
embryonic stem cell therapies, including the study of telomeres, telomerase,
human embryonic stem cells, and nuclear transfer. In addition, other products
and therapies that could compete directly with the product candidates that we
are seeking to develop and market currently exist or are being developed by
pharmaceutical and biopharmaceutical companies and by academic and other
research organizations.
Many companies are developing alternative therapies to treat cancer and, in
this regard, are competitors of ours. According to public data from the FDA and
NIH, there are more than 200 approved anti-cancer products on the market in the
United States, and several thousand in clinical development. Many of the
pharmaceutical companies developing and marketing these competing products
(including GlaxoSmithKline, Bristol-Myers Squibb Company and Novartis AG, among
others) have significantly greater financial resources and expertise than we do
in:
o research and development;
o manufacturing;
o preclinical and clinical testing;
o obtaining regulatory approvals; and
o marketing and distribution.
Smaller companies may also prove to be significant competitors,
particularly through collaborative arrangements with large and established
companies. Academic institutions, government agencies and other public and
private research organizations may also conduct research, seek patent protection
and establish collaborative arrangements for research, clinical development and
marketing of products similar to ours. These companies and institutions compete
with us in recruiting and retaining qualified scientific and management
personnel as well as in acquiring technologies complementary to our programs.
In addition to the above factors, we expect to face competition in the
following areas:
o product efficacy and safety;
o the timing and scope of regulatory consents;
o availability of resources;
o reimbursement coverage;
o price; and
o patent position, including potentially dominant patent positions of
others.
As a result of the foregoing, our competitors may develop more effective or
more affordable products, or achieve earlier patent protection or product
commercialization than we do. Most significantly, competitive products may
render any product candidates that we develop obsolete, which would negatively
impact our business and ability to sustain operations.
12
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.
Our product candidates and those developed by our collaborative, if
approved for marketing, may not achieve market acceptance since hospitals,
physicians, patients or the medical community in general may decide not to
accept and utilize these products. The product candidates that we are attempting
to develop represent substantial departures from established treatment methods
and will compete with a number of conventional drugs and therapies manufactured
and marketed by major pharmaceutical companies. The degree of market acceptance
of any of our developed potential products will depend on a number of factors,
including:
o our establishment and demonstration to the medical community of the
clinical efficacy and safety of our product candidates;
o our ability to create products that are superior to alternatives
currently on the market;
o our ability to establish in the medical community the potential
advantage of our treatments over alternative treatment methods; and
o reimbursement policies of government and third-party payors.
If the health care community does not accept our potential products for any
of the foregoing reasons, or for any other reason, our business would be
materially harmed.
IF WE FAIL TO OBTAIN ACCEPTABLE PRICES OR ADEQUATE REIMBURSEMENT FOR OUR PRODUCT
CANDIDATES, THE USE OF OUR POTENTIAL PRODUCTS COULD BE SEVERELY LIMITED.
Our ability to successfully commercialize our product candidates will
depend significantly on our ability to obtain acceptable prices and the
availability of reimbursement to the patient from third-party payors.
Significant uncertainty exists as to the reimbursement status of newly-approved
health care products, including pharmaceuticals. If our potential products are
not considered cost-effective or if we fail to generate adequate third-party
reimbursement for the users of our potential products and treatments, then we
may be unable to maintain price levels sufficient to realize an appropriate
return on our investment for potential products currently in development.
In both U.S. and other markets, sales of our potential products, if any,
will depend in part on the availability of reimbursement from third-party
payors, examples of which include:
o government health administration authorities;
o private health insurers;
o health maintenance organizations; and
o pharmacy benefit management companies.
Both federal and state governments in the United States and governments in
other countries continue to propose and pass legislation designed to contain or
reduce the cost of health care. Legislation and regulations affecting the
pricing of pharmaceuticals and other medical products may be adopted before any
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.
13
RISKS RELATED TO ENVIRONMENTAL AND PRODUCT LIABILITY
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 research and development activities involve the controlled use of
hazardous materials, chemicals and various radioactive compounds. As a
consequence, we are subject to numerous environmental and safety laws and
regulations, including those governing laboratory procedures, exposure to
blood-borne pathogens and the handling of biohazardous materials. We may be
required to incur significant costs to comply with current or future
environmental laws and regulations and may be adversely affected by the cost of
compliance with these laws and regulations.
Although we believe that our safety procedures for using, handling, storing
and disposing of hazardous materials comply with the standards prescribed by
state and federal regulations, the risk of accidental contamination or injury
from these materials cannot be eliminated. In the event of such an accident,
state or federal authorities could curtail our use of these materials and we
could be liable for any civil damages that result, the cost of which could be
substantial. Further, any failure by us to control the use, disposal, removal or
storage, or to adequately restrict the discharge, or assist in the clean up, of
hazardous chemicals or hazardous, infectious or toxic substances could subject
us to significant liabilities, including joint and several liability under
certain statutes. Any such liability could exceed our resources and could have a
material adverse effect on our business, financial condition and results of
operations. Additionally, an accident could damage our research and
manufacturing facilities and operations.
Additional federal, state and local laws and regulations affecting us may
be adopted in the future. We may incur substantial costs to comply with these
laws and regulations and substantial fines or penalties if we violate any of
these laws or regulations, which would adversely affect our business.
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.
Our business exposes us to potential product liability risks that are
inherent in the testing, manufacturing and marketing of human therapeutic and
diagnostic products. We may become subject to product liability claims if the
use of our potential products is alleged to have injured subjects or patients.
This risk exists for product candidates tested in human clinical trials as well
as potential products that are sold commercially. We currently have limited
clinical trial liability insurance and we may not be able to maintain this type
of insurance for any of our clinical trials. In addition, product liability
insurance is becoming increasingly expensive. Being unable to obtain or maintain
product liability insurance in the future on acceptable terms or with adequate
coverage against potential liabilities could have a material adverse effect on
our business.
RISKS RELATED TO OUR COMMON STOCK AND FINANCIAL REPORTING
OUR STOCK PRICE HAS HISTORICALLY BEEN VERY VOLATILE.
Stock prices and trading volumes for many biopharmaceutical companies
fluctuate widely for a number of reasons, including factors which may be
unrelated to their businesses or results of operations such as media coverage,
legislative and regulatory measures and the activities of various interest
groups or 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.
14
Historically, our stock price has been extremely volatile. Between January
1998 and October 2008, our stock has traded as high as $75.88 per share and as
low as $1.41 per share. Between January 1, 2003 and October 17, 2008, the price
has ranged between a high of $16.80 per share and a low of $1.41 per share. The
significant market price fluctuations of our common stock are due to a variety
of factors, including:
o the demand in the market for our common stock;
o the experimental nature of our product candidates;
o fluctuations in our operating results;
o market conditions relating to the biopharmaceutical and pharmaceutical
industries;
o announcements of technological innovations, new commercial products,
or clinical progress or lack thereof by us, our collaborative partners
or our competitors;
o announcements concerning regulatory developments, developments with
respect to proprietary rights and our collaborations;
o comments by securities analysts;
o general market conditions;
o political developments related to human embryonic stem cell research;
o public concern with respect to our product candidates; or
o the issuance of common stock to partners, vendors or to investors to
raise additional capital.
In addition, the stock market is subject to other factors outside our
control that can cause extreme price and volume fluctuations. Securities class
action litigation has often been brought against companies, including many
biotechnology companies, which experience volatility in the market price of
their securities. Litigation brought against us could result in substantial
costs and a diversion of management's attention and resources, which could
adversely affect our business.
THE SALE OF A SUBSTANTIAL NUMBER OF SHARES MAY ADVERSELY AFFECT THE MARKET PRICE
FOR OUR COMMON STOCK.
Sale of a substantial number of shares of our common stock in the public
market, or the perception that such sales could occur, could significantly and
negatively affect the market price for our common stock. As of October 17, 2008,
we had 200,000,000 shares of common stock authorized for issuance and 79,168,115
shares of common stock outstanding. In addition, as of October 17, 2008, we have
reserved for future issuance approximately 27,696,471 shares of common stock for
our stock plans, potential milestone payments and outstanding warrants.
In addition, we have issued common stock to certain parties, such as
vendors and service providers, as payment for products and services. Under these
arrangements, we typically agree to register the shares for resale soon after
their issuance. We may continue to pay for certain goods and services in this
manner, which would dilute your interest in us. Also, sales of the shares issued
in this manner could negatively affect the market price of our stock.
15
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 HOLDERS OF OUR COMMON STOCK.
Our certificate of incorporation provides our Board of Directors with the
authority to issue up to 3,000,000 shares of undesignated preferred stock and to
determine the rights, preferences, privileges and restrictions of these shares
without further vote or action by our stockholders. As of the date of this
Registration Statement, 50,000 shares of preferred stock have been designated
Series A Junior Participating Preferred Stock and the Board of Directors still
has authority to designate and issue up to 2,950,000 shares of preferred stock.
The issuance of shares of preferred stock may delay or prevent a change in
control transaction without further action by our stockholders. As a result, the
market price of our common stock may be adversely affected.
In addition, if we issue preferred stock in the future that has preference
over our common stock with respect to the payment of dividends or upon our
liquidation, dissolution or winding up, or if we issue preferred stock with
voting rights that dilute the voting power of our common stock, the rights of
holders of our common stock or the market price of our common stock could be
adversely affected.
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.
Our Board of Directors has adopted a share purchase rights plan, commonly
referred to as a "poison pill." This plan entitles existing stockholders to
rights, including the right to purchase shares of common stock, in the event of
an acquisition of 15% or more of our outstanding common stock.
Our share purchase rights plan could prevent stockholders from profiting
from an increase in the market value of their shares as a result of a change of
control of us by delaying or preventing a change of control. In addition, our
Board of Directors has the authority, without further action by our
stockholders, to issue additional shares of common stock, and to fix the rights
and preferences of one or more series of preferred stock.
In addition to our share purchase rights plan and the undesignated
preferred stock, provisions of our charter documents and bylaws may make it
substantially more difficult for a third party to acquire control of us and may
prevent changes in our management, including provisions that:
o prevent stockholders from taking actions by written consent;
o divide the Board of Directors into separate classes with terms of
office that are structured to prevent all of the directors from being
elected in any one year; and
o set forth procedures for nominating directors and submitting proposals
for consideration at stockholders' meetings.
Provisions of Delaware law may also inhibit potential acquisition bids for
us or prevent us from engaging in business combinations. In addition, we have
severance agreements with several employees and a change of control severance
plan which could require an acquiror to pay a higher price. Either collectively
or individually, these provisions may prevent holders of our common stock from
benefiting from what they may believe are the positive aspects of acquisitions
and takeovers, including the potential realization of a higher rate of return on
their investment from these types of transactions.
16
WE DO NOT INTEND TO PAY CASH DIVIDENDS ON OUR COMMON STOCK IN THE FORESEEABLE
FUTURE.
We do not anticipate paying cash dividends on our common stock in the
foreseeable future. Any payment of cash dividends will depend upon our financial
condition, results of operations, capital requirements and other factors and
will be at the discretion of the Board of Directors. Furthermore, we may incur
additional indebtedness that may severely restrict or prohibit the payment of
dividends.
FAILURE TO ACHIEVE AND MAINTAIN EFFECTIVE INTERNAL CONTROLS IN ACCORDANCE WITH
SECTION 404 OF THE SARBANES-OXLEY ACT OF 2002 COULD HAVE A MATERIAL ADVERSE
EFFECT ON OUR BUSINESS AND STOCK PRICE.
Section 404 of the Sarbanes-Oxley Act of 2002 (the Sarbanes-Oxley Act)
requires that we establish and maintain an adequate internal control structure
and procedures for financial reporting and include a report of management on our
internal control over financial reporting. Our annual report on Form 10-K must
contain an assessment by management of the effectiveness of our internal control
over financial reporting and must include disclosure of any material weaknesses
in internal control over financial reporting that we have identified. In
addition, our independent registered public accounting firm must annually
provide an opinion on the effectiveness of our internal control over financial
reporting.
The requirements of Section 404 of the Sarbanes-Oxley Act are ongoing and
also apply to future years. We expect that our internal control over financial
reporting will continue to evolve as our business develops. Although we are
committed to continue to improve our internal control processes and we will
continue to diligently and vigorously review our internal control over financial
reporting in order to ensure compliance with Section 404 requirements, any
control system, regardless of how well designed, operated and evaluated, can
provide only reasonable, not absolute, assurance that its objectives will be
met. Therefore, we cannot be certain that in the future material weaknesses or
significant deficiencies will not exist or otherwise be discovered. If material
weaknesses or other significant deficiencies occur, these weaknesses or
deficiencies could result in misstatements of our results of operations,
restatements of our consolidated financial statements, a decline in our stock
price, or other material adverse effects on our business, reputation, results of
operations, financial condition or liquidity.
17
FORWARD-LOOKING STATEMENTS
This prospectus and the documents incorporated by reference into this
prospectus contain forward-looking statements that are based on current
expectations, estimates and projections about our industry, management's
beliefs, and assumptions made by management. Words such as "anticipates,"
"expects," "intends," "plans," "believes," "seeks," "estimates," and variations
of such words and similar expressions are intended to identify such
forward-looking statements. These statements are not guarantees of future
performance and are subject to certain risks, uncertainties and assumptions that
are difficult to predict; therefore, actual results may differ materially from
those expressed or forecasted in any forward-looking statements. The risks and
uncertainties include those noted in "Risk Factors" above and in the documents
incorporated by reference. We undertake no obligation to update publicly any
forward-looking statements, whether as a result of new information, future
events or otherwise.
USE OF PROCEEDS
We are filing the registration statement of which this prospectus is a part
under our contractual obligation to the holder named in the section entitled
"Selling Stockholder." We will not receive any of the proceeds from resale of
these shares of common stock by the selling stockholder.
DESCRIPTION OF OUR COMMON STOCK
The following summary is a general description of our common stock.
Complete details can be found in our Charter and Bylaws, copies of which are on
file with the Commission as exhibits to registration statements previously filed
by us. See "Where You Can Find More Information."
We have authority to issue 200,000,000 shares of common stock, $0.001 par
value per share. As of October 17, 2008, we had 79,168,115 shares of common
stock outstanding.
The holders of our common stock are entitled to one vote per share on all
matters to be voted upon by the stockholder. Subject to preferences that may be
applicable to any outstanding shares of our preferred stock, the holders of
common stock are entitled to receive ratably such dividends, if any, as may be
declared from time to time by our Board of Directors out of funds legally
available for that purpose. In the event of a liquidation, dissolution or
winding up of our company, the holders of our common stock are entitled to share
ratably in all assets remaining after payment of liabilities, subject to
preferences applicable to shares of our preferred stock, if any, then
outstanding. The common stock has no preemptive or conversion rights or other
subscription rights. There are no redemption or sinking fund provisions
available to the common stock. All outstanding shares of our common stock are,
and the shares of common stock offered by this prospectus will be, fully paid
and nonassessable.
TRANSFER AGENT AND REGISTRAR
The transfer agent and registrar for the common stock is Computershare
Trust Company, N.A.
18
SELLING STOCKHOLDER
The following table sets forth the name of the selling stockholder, the
number of shares of common stock owned beneficially by the selling stockholder
as of October 17, 2008, the number of shares which may be offered pursuant to
this prospectus and the number of shares to be owned by the selling stockholder
after this offering. In the aggregate, the selling stockholder may sell up to
255,754 shares of our common stock pursuant to this prospectus. Since the
selling stockholder may offer all, some or none of its common stock, no
definitive estimate as to the number of shares thereof that will be held by the
selling stockholder after the offering can be provided. In addition, since the
date the selling stockholder provided information regarding its ownership of the
shares, it may have sold, transferred or otherwise disposed of all or a portion
of its shares of common stock in transactions exempt from the registration
requirements of the Securities Act of 1933, as amended (the "Securities Act").
Information concerning the selling stockholder may change from time to time and,
when necessary, any changed information will be set forth in a prospectus
supplement to this prospectus.
On October 8, 2008, as a seventh installment payment due to Lonza
Walkersville, Inc. ("Lonza") under the first project order to a services
agreement pursuant to which Lonza is manufacturing certain products for us
intended for therapeutic use in humans, we issued to Lonza 255,754 shares of our
common stock, pursuant to a Common Stock Purchase Agreement dated as of October
3, 2008.
To our knowledge, Lonza has sole voting and investment power with respect
to all shares of common stock beneficially owned by it. This information is
based upon information provided by the selling stockholder.
======================== ================ ========================= =================== ===========
Total Maximum Number of
Number of Shares Available Pursuant Shares Owned Percentage
Name Shares Held (1) to this Prospectus (1) After Offering (2) (3)
------------------------ ---------------- ------------------------- ------------------- -----------
Lonza Walkersville, Inc. 255,754 255,754 0 *
------------------------ ---------------- ------------------------- ------------------- -----------
(1) Based on information available as of October 17, 2008.
(2) Assumes the sale of all shares of common stock offered by this prospectus.
(3) Based on 79,168,115 shares of common stock outstanding as of October 17,
2008.
* Less than 1%.
19
PLAN OF DISTRIBUTION
We are registering a total of 255,754 shares of our common stock on behalf
of the selling stockholder. The selling stockholder and any of its pledgees,
assignees and successors-in-interest may, from time to time, sell any or all of
the shares of common stock offered hereby on any stock exchange, market or
trading facility on which the shares are traded or in private transactions.
These sales may be at fixed or negotiated prices. The selling stockholder may
use any one or more of the following methods when selling shares:
o sales on the Nasdaq Global Market;
o sales in the over-the-counter market;
o ordinary brokerage transactions and transactions in which the
broker-dealer solicits purchasers;
o block trades in which the broker-dealer will attempt to sell the
shares as agent but may position and resell a portion of the block as
principal to facilitate the transaction;
o purchases by a broker-dealer as principal and resale by the
broker-dealer for its account;
o an exchange distribution in accordance with the rules of the
applicable exchange;
o privately negotiated transactions;
o short sales;
o transactions in which broker-dealers agree with the selling
stockholder to sell a specified number of such shares at a stipulated
price per share;
o a combination of any such methods of sale; and
o any other method permitted pursuant to applicable law.
The selling stockholder may also sell the shares directly to market makers
acting as principals and/or broker-dealers acting as agents for itself or its
customers. These broker-dealers may receive compensation in the form of
discounts, concessions or commissions from the selling stockholder and/or the
purchasers of shares for whom the broker-dealers may act as agents or to whom
they sell as principal or both, which compensation as to a particular
broker-dealer might be in excess of customary commissions. Market makers and
block purchasers purchasing the shares will do so for their own account and at
their own risk. It is possible that the selling stockholder will attempt to sell
shares of common stock in block transactions to market makers or other
purchasers at a price per share which may be below the then market price. The
selling stockholder cannot assure that all or any of the shares offered in this
prospectus will be issued to, or sold by, the selling stockholder. The selling
stockholder and any brokers, dealers or agents, upon effecting the sale of any
of the shares offered in this prospectus, may be deemed "underwriters" as that
term is defined under the Securities Act or the Exchange Act, or the rules and
regulations under such acts.
The selling stockholder, alternatively, may sell all or any part of the
shares offered in this prospectus through an underwriter. To our knowledge, the
selling stockholder has not entered into any agreement with a prospective
underwriter and we cannot assure you that any such agreement will be entered
into. If the selling stockholder enters into this type of an agreement or
agreements, the relevant details will be set forth in a supplement or revision
to this prospectus.
The selling stockholder and any other persons participating in the sale or
distribution of the shares will be subject to applicable provisions of the
Exchange Act and the rules and regulations under such act, including, without
limitation, Regulation M. These provisions may restrict certain activities of,
and limit the timing of purchases and sales of any of the shares by, the selling
stockholder or any other person. Furthermore, under Regulation M, persons
engaged in a distribution of securities are prohibited from simultaneously
engaging in market making and certain other activities with respect to the
securities for a specified period of time prior to the commencement of the
distributions, subject to specified exceptions or exemptions. All of these
limitations may affect the marketability of the shares.
20
The selling stockholder also may sell all or a portion of its shares in
open market transactions in reliance upon Rule 144 under the Securities Act,
provided it meets the criteria and conforms to the requirements of Rule 144.
LEGAL MATTERS
Latham & Watkins LLP will pass on the validity of the issuance of the
shares of common stock offered by this prospectus.
EXPERTS
The consolidated financial statements of Geron Corporation appearing in
Geron's Annual Report (Form 10-K) for the year ended December 31, 2007, and the
effectiveness of internal control over financial reporting as of December 31,
2007, have been audited by Ernst & Young LLP, independent registered public
accounting firm, as set forth in their reports thereon, included therein, and
incorporated herein by reference. Such consolidated financial statements are
incorporated herein by reference in reliance upon such reports given on the
authority of such firm as experts in accounting and auditing.
MATERIAL CHANGES
There have been no material changes in our affairs since December 31, 2007,
which have not been described in subsequent reports on Form 10-Q or Form 8-K.
LIMITATION ON LIABILITY AND DISCLOSURE OF COMMISSION POSITION ON
INDEMNIFICATION FOR SECURITIES ACT LIABILITIES
Our bylaws provide for indemnification of our directors and officers to the
fullest extent permitted by law. Insofar as indemnification for liabilities
under the Securities Act may be permitted to directors, officers or controlling
persons of Geron pursuant to Geron's Certificate of Incorporation, bylaws and
the Delaware General Corporation Law, Geron has been informed that in the
opinion of the Securities and Exchange Commission such indemnification is
against public policy as expressed in the Securities Act and is therefore
unenforceable.
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and special reports, proxy statements and other
information with the SEC. We make available free of charge on or through our
Internet website our annual reports on Form 10-K, quarterly reports on Form
10-Q, current reports on Form 8-K and all amendments to those reports as soon as
reasonably practicable after they are electronically filed with, or furnished
to, the Securities and Exchange Commission. Our Internet website address is
www.geron.com. You may read and copy any document we file at the SEC's public
reference room located at 100 F Street, N.E., Washington, D.C. 20549. Please
call the SEC at 1-800-SEC-0330 for further information on the public reference
room. Our SEC filings are also available to the public at the SEC's website at
http://www.sec.gov. You may also inspect copies of these materials and other
information about us at the offices of the Nasdaq Stock Market, Inc., National
Market System, 1735 K Street, N.W., Washington, D.C. 20006-1500.
21
DOCUMENTS WE HAVE INCORPORATED BY REFERENCE
The SEC allows us to "incorporate by reference" the information we file
with them which means that we can disclose important information to you by
referring you to those documents instead of having to repeat the information in
this prospectus. The information incorporated by reference is considered to be
part of this prospectus, and later information that we file with the SEC will
automatically update and supersede this information. We incorporate by reference
the documents listed below and any future filings made with the SEC under
Sections 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act of 1934 until
the selling stockholder sells all the shares:
o Our quarterly reports on Form 10-Q for the quarters ended March 31,
2008 and June 30, 2008;
o Our annual report on Form 10-K for the fiscal year ended December 31,
2007;
o Our definitive proxy statement filed on April 10, 2008;
o Our current reports on Form 8-K filed on January 25, 2008, March 21,
2008, March 31, 2008, May 14, 2008 and August 12, 2008;
o The description of our common stock set forth in our registration
statement on Form 8-A, filed with the Commission on June 13, 1996
(File No. 0-20859).
All documents we file under Section 13(a), 13(c), 14 or 15(d) of the
Exchange Act after the date of this registration statement and prior to the
filing of a post-effective amendment that indicates that all securities offered
have been sold or that deregisters all securities then remaining unsold, shall
be deemed to be incorporated by reference in this registration statement and to
be a part of it from the respective dates of filing those documents. Any
statement contained in a document incorporated or deemed to be incorporated by
reference herein shall be deemed to be modified or superseded for purposes of
this registration statement to the extent that a statement contained herein
modifies or supersedes that statement. Any statement so modified or superseded
shall not be deemed, except as so modified or superseded, to constitute a part
of this registration statement.
We will furnish without charge to you, on written or oral request, a copy
of any or all of the documents incorporated by reference, including exhibits to
these documents. You should direct any requests for documents to David L.
Greenwood, Chief Financial Officer, Geron Corporation, 230 Constitution Drive,
Menlo Park, California 94025, telephone: (650) 473-7700.
22
255,754 SHARES OF COMMON STOCK
GERON CORPORATION
PROSPECTUS
October 21, 2008
YOU SHOULD RELY ONLY ON THE INFORMATION CONTAINED OR INCORPORATED BY REFERENCE
IN THIS PROSPECTUS. WE HAVE NOT AUTHORIZED ANYONE TO PROVIDE YOU WITH DIFFERENT
INFORMATION. YOU SHOULD NOT ASSUME THAT THE INFORMATION CONTAINED OR
INCORPORATED BY REFERENCE IN THIS PROSPECTUS IS ACCURATE AS OF ANY DATE OTHER
THAN THE DATE OF THIS PROSPECTUS. WE ARE NOT MAKING AN OFFER OF THESE SECURITIES
IN ANY STATE WHERE THE OFFER IS NOT PERMITTED.
23
PART II
INFORMATION NOT REQUIRED IN THE PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution.
The following sets forth the costs and expenses, all of which shall be
borne by the Registrant, in connection with the offering of the securities
pursuant to this Registration Statement:
Registration Fee $ 33
Accounting Fees and Expenses $ 10,000 *
Legal Fees and Expenses $ 10,000 *
Miscellaneous $ 1,500 *
Total $ 21,533
* Estimated
Item 15. Indemnification of Directors and Officers.
Section 145(a) of the General Corporation Law of the State of Delaware (the
"DGCL") provides that a Delaware corporation may indemnify any person who was or
is a party or is threatened to be made a party to any threatened, pending or
completed action, suit or proceeding, whether civil, criminal, administrative or
investigative (other than an action by or in the right of the corporation) by
reason of the fact that such person is or was a director, officer, employee or
agent of the corporation or is or was serving at the request of the corporation
as a director, officer, employee or agent of another corporation or enterprise,
against expenses, judgments, fines and amounts paid in settlement actually and
reasonably incurred by such person in connection with such action, suit or
proceeding if he or she acted in good faith and in a manner he or she reasonably
believed to be in or not opposed to the best interests of the corporation, and,
with respect to any criminal action or proceeding, had no cause to believe his
or her conduct was unlawful.
Section 145(b) of the DGCL provides that a Delaware corporation may
indemnify any person who was or is a party or is threatened to be made a party
to any threatened, pending or completed action or suit by or in the right of
corporation to procure a judgment in its favor by reason of the fact that such
person acted in any of the capacities set forth above, against expenses actually
and reasonably incurred by such person in connection with the defense or
settlement of such action or suit if he or she acted under similar standards to
those set forth above, except that no indemnification may be made in respect to
any claim, issue or matter as to which such person shall have been adjudged to
be liable to the corporation unless and only to the extent that the court in
which such action or suit was brought shall determine that despite the
adjudication of liability, but in view of all the circumstances of the case,
such person is fairly and reasonably entitled to be indemnified for such
expenses which the court shall deem proper.
Section 145 of the DGCL further provides that to the extent a director or
officer of a corporation has been successful in the defense of any action, suit
or proceeding referred to in subsection (a) and (b) or in the defense of any
claim, issue or matter therein, he or she shall be indemnified against expenses
actually and reasonably incurred by him or her in connection therewith; that
indemnification provided for by Section 145 shall not be deemed exclusive of any
other rights to which the indemnified party may be entitled; and that the
corporation may purchase and maintain insurance on behalf of a director or
officer of the corporation against any liability asserted against such officer
or director and incurred by him or her in any such capacity or arising out of
his or her status as such, whether or not the corporation would have the power
to indemnify him or her against such liabilities under Section 145.
As permitted by Section 102(b)(7) of the DGCL, our Certificate of
Incorporation provides that a director shall not be liable to us or our
stockholders for monetary damages for breach of fiduciary duty as a director.
However, this provision does not eliminate or limit the liability of a director
for acts or omissions not in good faith or for breaching his or her duty of
loyalty, engaging in intentional misconduct or knowingly violating the law,
paying a dividend or approving a stock repurchase which was illegal, or
obtaining an improper personal benefit. A provision of this type has no effect
on the availability of equitable remedies, such as injunction or rescission, for
breach of fiduciary duty. Our Certificate of Incorporation requires that
directors and officers be indemnified to the maximum extent permitted by
Delaware law.
II-1
Item 16. Exhibits.
See Exhibit Index.
Item 17. Undertakings.
(a) The undersigned registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made, a
post-effective amendment to this registration statement:
(i) To include any prospectus required by Section 10(a)(3) of the
Securities Act of 1933;
(ii)To reflect in the prospectus any facts or events arising after the
effective date of the registration statement (or the most recent
post-effective amendment thereof) which, individually or in the aggregate,
represent a fundamental change in the information set forth in this
registration statement. Notwithstanding the foregoing, any increase or
decrease in volume of securities offered (if the total dollar value of
securities offered would not exceed that which was registered) and any
deviation from the low or high end of the estimated maximum offering range
may be reflected in the form of prospectus filed with the Commission
pursuant to Rule 424(b) if, in the aggregate the changes in volume and
price represent no more than 20 percent change in the maximum aggregate
offering price set forth in the "Calculation of Registration Fee" table in
the effective registration statement; and
(iii) To include any material information with respect to the plan of
distribution not previously disclosed in this registration statement or any
material change to such information in this registration statement;
Provided, however, that subparagraphs (i), (ii) and (iii) do not apply if
the information required to be included in a post-effective amendment by those
paragraphs is contained in reports filed with or furnished to the Commission by
the registrant pursuant to Section 13 or Section 15(d) of the Securities
Exchange Act of 1934 that are incorporated by reference in the registration
statement, or is contained in a form of prospectus filed pursuant to Rule 424(b)
that is a part of the registration statement.
(2) That, for the purpose of determining any liability under the Securities
Act of 1933, each such post-effective amendment shall be deemed to be a new
registration statement relating to the securities offered therein, and the
offering of such securities at that time to be deemed the initial bona fide
offering.
(3) To remove from registration by means of a post-effective amendment any
of the securities being registered which remain unsold at the termination of the
offering.
(b)The undersigned registrant hereby undertakes that, for purposes of
determining any liability under the Securities Act of 1933, each filing of the
registrant's annual report pursuant to Section 13(a) or 15(d) of the Securities
Exchange Act of 1934 (and, where applicable, each filing of an employee benefit
plan's annual report pursuant to Section 15(d) of the Securities Exchange Act of
1934) that is incorporated by reference in the registration statement shall be
deemed to be a new registration statement relating to the securities offered
therein, and the offering of such securities at that time shall be deemed to be
the initial bona fide offering thereof.
(c) The undersigned registrant hereby undertakes to deliver or cause to be
delivered with the prospectus, to each person to whom the prospectus is sent or
given, the latest annual report to security holders that is incorporated by
reference in the prospectus and furnished pursuant to and meeting the
requirements of Rule 14a-3 or Rule 14c-3 under the Securities Exchange Act of
1934; and, where interim financial information required to be presented by
Article 3 of Regulation S-X is not set forth in the prospectus, to deliver, or
cause to be delivered to each person to whom the prospectus is sent or given,
the latest quarterly report that is specifically incorporated by reference in
the prospectus to provide such interim financial information.
II-2
(d) Insofar as indemnification for liabilities arising under the Securities
Act of 1933 may be permitted to directors, officers and controlling persons of
the registrant pursuant to the foregoing provisions, or otherwise, the
registrant has been advised that in the opinion of the Securities and Exchange
Commission such indemnification is against public policy as expressed in the Act
and is, therefore, unenforceable. In the event that a claim for indemnification
against such liabilities (other than the payment by the registrant of expenses
incurred or paid by a director, officer or controlling person of the registrant
in the successful defense of any action, suit or proceeding) is asserted by such
director, officer or controlling person in connection with the securities being
registered, the registrant will, unless in the opinion of its counsel the matter
has been settled by controlling precedent, submit to a court of appropriate
jurisdiction the question whether such indemnification by it is against public
policy as expressed in the Act and will be governed by the final adjudication of
such issue.
II-3
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the Registrant
certifies that it has reasonable grounds to believe that it meets all of the
requirements for filing on Form S-3 and has duly caused this Registration
Statement to be signed on its behalf by the undersigned, thereunto duly
authorized, in the city of Menlo Park, state of California, on October 21, 2008.
GERON CORPORATION
By: /s/ David L. Greenwood
----------------------------------
David L. Greenwood
Executive Vice President and
Chief Financial Officer
POWER OF ATTORNEY
KNOW ALL BY THESE PERSONS PRESENT, that the persons whose signatures appear
below do hereby constitute and appoint Thomas B. Okarma and David L. Greenwood,
or any of them, our true and lawful attorneys-in-fact and agents, each with full
power to sign for us or any of us in our names and in any and all capacities,
any and all amendments (including post-effective amendments) to this
Registration Statement, or any related registration statement that is to be
effective upon filing pursuant to Rule 462(b) under the Securities Act of 1933,
as amended, and to file the same, with all exhibits thereto and other documents
required in connection therewith with the Securities and Exchange Commission
hereby do ratifying and confirming all that each of said attorneys-in-fact, or
either of them, or his substitute or substitutes, shall do or cause to be done
by virtue thereof.
Pursuant to the requirements of the Securities Act of 1933, as amended,
this Registration Statement has been signed by the following persons in the
capacities and on the dates indicated.
Signature Title Date
--------- ----- ----
/s/ Thomas B. Okarma Chief Executive Officer, President and October 21, 2008
---------------------------------------- Director (principal executive officer)
Thomas B. Okarma
Executive Vice President and Chief
/s/ David L. Greenwood Financial Officer (principal financial October 21, 2008
---------------------------------------- and accounting officer)
David L. Greenwood
/s/ Alexander E. Barkas Director October 21, 2008
----------------------------------------
Alexander E. Barkas
/s/ Edward V. Fritzky Director October 21, 2008
----------------------------------------
Edward V. Fritzky
/s/ Charles J. Homcy Director October 21, 2008
----------------------------------------
Charles J. Homcy
/s/ Thomas D. Kiley Director October 21, 2008
----------------------------------------
Thomas D. Kiley
/s/ John P. Walker Director October 21, 2008
----------------------------------------
John P. Walker
/s/ Patrick J. Zenner Director October 21, 2008
----------------------------------------
Patrick J. Zenner
S-1
EXHIBIT INDEX
Exhibits Description
-------- -----------
4.1 Common Stock Purchase Agreement dated as of October 3, 2008 by and
between Registrant and Lonza Walkersville, Inc.
5.1 Opinion of Latham & Watkins LLP.
23.1 Consent of Latham & Watkins LLP (included in Exhibit 5.1).
23.2 Consent of Independent Registered Public Accounting Firm.
24.1 Power of Attorney (included on the signature page to this
Registration Statement).