geron_s3.htm
As filed
with the Securities and Exchange Commission on August 20,
2010 |
Registration No.
333-
|
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.
20549
––––––––––
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF
1933
––––––––––
GERON CORPORATION
(Exact Name of Registrant as
Specified in Its Charter)
––––––––––
Delaware
|
|
(State or Other Jurisdiction
of |
(I.R.S. Employer |
Incorporation or
Organization) |
Identification
No.) |
––––––––––
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)
––––––––––
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)
––––––––––
Copies to:
––––––––––
Alan C. Mendelson, Esq.
Mark
V. Roeder, Esq.
Latham & Watkins LLP
140 Scott Drive
Menlo Park,
California 94025
(650) 328-4600
––––––––––
Approximate date of commencement of
proposed sale to the public: From time to time after this
Registration Statement becomes effective.
–––––––––––––––
If the only securities being
registered on this form are being offered pursuant to dividend or interest
reinvestment plans, please check the following box. o
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. o
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. o
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. o
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. o
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.
|
o Large
accelerated filer |
|
x Accelerated filer |
|
o Non-accelerated
filer (Do not check if a smaller reporting company) |
|
o Smaller reporting
company |
____________
CALCULATION OF REGISTRATION FEE |
|
|
Proposed
Maximum |
Proposed
Maximum |
Amount of |
Title of Securities to be
Registered |
Registered
(1) |
Offering Price per
share |
Aggregate
Offering Price |
Registration
Fee
|
Common Stock, par value $.001 per share
|
671,074 shares |
$5.28 (2) |
$3,543,271 |
$252.64 (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 of 1933. |
(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 the Nasdaq Global Market on August 17, 2010. |
(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 STOCKHOLDERS 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 AUGUST
20, 2010
UP TO 671,074 SHARES OF
GERON CORPORATION
COMMON STOCK
Our common stock is traded on the
Nasdaq Global Market under the symbol “GERN.” On August 17, 2010, the closing
price of our common stock was $5.28.
This prospectus relates to the sale
of up to 114,957 shares of our common stock by Hongene Biotechnology Limited,
the sale of up to 115,779 shares of our common stock by Samchully Pharm. Co.,
Ltd., the sale of up to 158,912 shares of our common stock by MPI Research, Inc.
and the sale of up to 281,426 shares of our common stock by ReSearch
Pharmaceutical Services, 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.
______________________
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 , 2010.
TABLE OF CONTENTS
|
Page |
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 STOCKHOLDERS |
19 |
PLAN OF DISTRIBUTION |
20 |
VALIDITY OF THE
SECURITIES |
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 developing first-in-class
biopharmaceuticals for the treatment of cancer and chronic degenerative
diseases, including spinal cord injury, heart failure and diabetes. We are
advancing an anti-cancer drug and a cancer vaccine that target the enzyme
telomerase through multiple clinical trials in different cancers.
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 sponsored six Phase I or I/II trials
of our lead anti-cancer drug, imetelstat, in patients with chronic
lymphoproliferative diseases, solid tumor malignancies, non-small cell lung
cancer, breast cancer and multiple myeloma. Four of those trials have completed
patient enrollment and the remaining two are expected to complete enrollment in
2010. We currently plan to advance imetelstat to Phase II trials in 2010 in four
different malignancies. In July 2010, the first patient was enrolled into
Geron’s randomized Phase II clinical trial of imetelstat as maintenance therapy
following platinum-based induction therapy for patients with non-small cell lung
cancer. Patient enrollment for our telomerase cancer vaccine, GRNVAC1, trial in
patients with acute myelogenous leukemia is now complete and we are awaiting the
results from this Phase II trial. We have no other product candidates in
clinical testing. Recently, the U.S. Food and Drug Administration (FDA) lifted
its clinical hold on the Investigational New Drug (IND) application for GRNOPC1,
our human embryonic stem cell (hESC)-derived therapy targeted for the treatment
of acute spinal cord injury. We will proceed with initiation of the Phase I
multi-center trial that is designed to establish the safety of GRNOPC1 in
patients with “complete” American Spinal Injury Association (ASIA) grade A
subacute thoracic spinal cord injuries.
Our ability to develop product
candidates that progress to and through clinical trials is subject to our
ability to, among other things:
- succeed in our research
and development efforts;
- select therapeutic
compounds or cell therapies for development;
- obtain required
regulatory approvals;
- manufacture product
candidates; and
- collaborate successfully
with clinical trial sites, academic institutions, physician investigators,
clinical research organizations and other third parties.
1
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 or will be approved by regulators or marketed successfully.
Competitors may have proprietary rights which prevent us from developing and
marketing our products or they may 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, hESCs, imetelstat, GRNVAC1 and GRNOPC1, which could
adversely affect our business and cause a sharp drop in our stock
price.
The science and technology of
telomere biology and telomerase and hESCs 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 hESCs,
political commentary and the ethical and social implications of research
involving hESCs 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
hESCs gives rise to ethical and social issues regarding the appropriate use of
these cells. Our research related to hESCs 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 had been created for in vitro fertilization procedures but were
no longer desired or suitable for that use and were donated with appropriate
informed consent. 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 hESCs, thereby impairing our ability to conduct
research in this field.
On March 9, 2009, President Obama
issued Executive Order 13505, entitled “Removing Barriers to Responsible
Scientific Research Involving Human Stem Cells.” As a result, in July 2009 the
Secretary of Health and Human Services, through the Director of the National
Institutes of Health (NIH), issued new guidelines relating to human stem cell
research. Under the new guidelines, federal funding is allowed for research
using hESCs derived from embryos created by in vitro fertilization for reproductive
purposes, but are no longer needed for that purpose. Strict ethics requirements
must be followed to qualify new stem cell lines, including extensive
documentation around consent forms and written policies and procedures. Certain
states are considering enacting, or already have enacted, legislation relating
to stem cell research, including California, whose voters approved Proposition
71 to provide state funds for stem cell research in November 2004. In the United
Kingdom and other countries, the use of embryonic or fetal tissue in research
(including the derivation of hESCs) is regulated by the government, whether or
not the research involves government funding.
Government-imposed restrictions with
respect to use of embryos or hESCs in research and development could have a
material adverse effect on us, including:
- harming our ability to establish critical partnerships and
collaborations;
- delaying or preventing progress in our research, product
development or clinical testing;
- preventing
commercialization of therapies derived from hESCs; and
- as a result of the
potential adverse effects above, causing a decrease in the price of our common
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, 2010, our
accumulated deficit was approximately $610.9 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, we do not currently expect to receive sufficient royalty revenues
from these licenses to independently 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 future planned
operations. The timing and degree of any future capital requirements will depend
on many factors, including:
- the accuracy of the
assumptions underlying our estimates for our capital needs for the 2010 fiscal
year and beyond;
- the magnitude and scope
of our research and development programs;
- the progress we make in
our research and development programs, preclinical development and clinical
trials;
- our ability to
establish, enforce and maintain strategic arrangements for research,
development, clinical testing, manufacturing and marketing;
- the number and type of
product candidates that we pursue;
- the time and costs
involved in obtaining regulatory approvals and clearances;
and
- the costs involved in
preparing, filing, prosecuting, maintaining, defending and enforcing patent
claims.
3
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:
- demonstrating sufficient
safety and efficacy to obtain regulatory clearance to commence a clinical
trial;
- manufacturing sufficient
quantities or producing drugs meeting our quality standards of a product
candidate;
- obtaining approval of an
Investigational New Drug (IND) application or proposed trial design from the
FDA;
- reaching agreement on
acceptable terms with our collaborators on all aspects of the clinical trial,
including the contract research organizations (CROs) and the trial sites;
and
- 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. Delays in commencing clinical testing of our product
candidates could have a material adverse effect on our business.
We do not have experience as a
company in conducting large-scale clinical trials, or in other areas required
for the successful commercialization and marketing of our product
candidates.
We have no experience as a company
in conducting large-scale, late stage clinical trials. 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, 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.
4
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 adversely 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 to commence 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:
- significantly harm the
marketing of any products that we or our collaborators
develop;
- impose costly procedures
upon our activities or the activities of our collaborators;
- diminish any competitive
advantages that we or our collaborators may attain; or
- 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:
- manufacturing;
- advertising and
promoting;
- selling and
marketing;
- labeling;
and
- 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:
- recall or seizure of
products;
- injunction against the
manufacture, distribution and sales and marketing of products;
and
- 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. Further, our patents
may be challenged, invalidated or circumvented, and our patent rights may not
provide proprietary protection or competitive advantages to us. In the event
that we are unsuccessful in obtaining and enforcing patents, our business would
be negatively impacted.
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 and pharmaceutical 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 proposed in a new
rule package by the United States Patent and Trademark Office (the Patent
Office) in 2007. The proposed new rules were widely regarded as detrimental to
the interests of biotechnology and pharmaceutical companies. The implementation
of the rule package was blocked by a court injunction requested by a
pharmaceutical company. The Patent Office challenged the court decision through
an appeal to the U.S. Court of Appeals for the Federal Circuit (CAFC), but the
appeal was dismissed in November 2009, after the Patent Office changed course
and rescinded the proposed new rules. At this point we do not know whether the
Patent Office will attempt to introduce new rules to replace those that were
recently withdrawn or whether any such new rules would also be challenged.
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 (EPO) was earlier interpreting this prohibition broadly,
and applying it to reject claims in any patent application that pertained to
hESCs. An early patent application filed by the Wisconsin Alumni Research
Foundation (WARF) with claims covering the original isolation of hESCs was
appealed as a test case, and examination of other hESC patent applications was
suspended while that case was heard. In November 2008, the EPO Enlarged Board of
Appeals held that the claims in the WARF application were unpatentable. Geron
holds a worldwide license under this patent family, and since the decision is
not subject to further appeal, this WARF patent family will not afford
protection to Geron’s hESC-based product candidates in Europe. However, the
reason given by the EPO for the decision was narrowly focused: the EPO found the
claims objectionable on the basis that at the time that WARF filed the patent
application it was necessary to use a human embryo to obtain hESCs since no cell
lines were available. In contrast, the hESCs that we use, and which we employed
in the technologies claimed in our own European patent applications, were
sourced from established hESC lines. Consequently, the decision in the WARF case
does not directly address the patentability of the subject matter in our
filings. The EPO has recently restarted examination of hESC patent applications,
but is being inconsistent in its application of the WARF decision to these later
filed cases. At this time, we do not know whether or to what extent we will be
able to obtain patent protection for our hESC technologies in Europe. If we are
unable to protect our inventions related to hESCs in Europe, our business would
be negatively impacted.
Challenges to our patent rights can
result in costly and time-consuming legal proceedings that may prevent or limit
development of our product candidates.
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.
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. By way of example, we
are currently a party to an interference proceeding that involves patent filings
for making endoderm cells from hESCs. We requested that the Patent Office
declare this interference after Novocell Inc. (recently renamed ViaCyte, Inc.)
was granted patent claims that conflict with subject matter we filed in an
earlier patent application. The interference proceeding will determine whether
ViaCyte is entitled to such patent claims. A number of outcomes are possible:
the claims may be awarded to ViaCyte; the claims may be awarded to Geron, or
neither party might be found to be entitled to the claims. The decision from the
Patent Office may also be subject to appeal. Since the interference is still
ongoing, we cannot predict what the outcome will be.
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 been involved in two
patent oppositions before the EPO with a Danish company, Pharmexa. Pharmexa
(which acquired the Norwegian company GemVax in 2005) was developing a cancer
vaccine that employs a short telomerase peptide to induce an immune response
against telomerase and was 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.
In late 2008, Pharmexa reported that it sold its telomerase vaccine program to a
Korean company, KAEL Co. Ltd. We have recently been awarded a second European
patent with claims to telomerase peptides, and this patent has also been opposed
by KAEL-GemVax. We cannot predict the outcome of this opposition or any
subsequent appeal of the decision in the opposition.
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
WARF and relating to hESCs. These three patents (U.S. Patent Nos. 5,843,780,
6,200,806 and 7,029,913), which are the U.S. equivalents of the European WARF
case discussed above, 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
hESCs, as well as non-exclusive rights for other product opportunities. In
October 2006, the Patent Office initiated the reexamination proceedings. After
initially rejecting the patent claims, the Patent Office 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 appealed the decision on the 7,029,913 patent. In April 2010,
the Board of Patent Appeals and Interferences reversed the earlier decision of
the Patent Office on the 7,029,913 patent. WARF will now have the opportunity to
present the claims for further examination at the Patent Office. We cooperated
with WARF in these reexamination actions and expect that WARF will continue to
vigorously defend its patent position. The final outcome of these or of any
future reexamination proceedings cannot be determined at this time. Reduction or
loss of claim scope in these WARF embryonic stem cell patents could negatively
impact Geron’s proprietary position in this technology.
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. Challenges to our patents through these procedures can be extremely
expensive and time-consuming, even if the outcome is favorable to us. An adverse
outcome in a patent dispute could severely harm our business by:
- causing us to lose
patent rights in the relevant jurisdiction(s);
- subjecting us to
litigation, or otherwise preventing us from commercializing potential products
in the relevant jurisdiction(s);
8
- requiring us to obtain
licenses to the disputed patents;
- forcing us to cease
using the disputed technology; or
- requiring us to develop
or obtain alternative technologies.
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.
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
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.
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 dendritic cell-based vaccines; Sienna is developing
cancer diagnostics using our telomerase technology; and GE Healthcare UK Limited
is developing cell-based assays using cells derived from our hESCs. 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:
- conduct research and
development activities in conjunction with us;
- design and conduct
advanced clinical trials in the event that we reach clinical
trials;
- fund research and
development activities with us;
- manage and license
certain patent rights;
- pay us fees upon the
achievement of milestones; and
- 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 imetelstat, GRNVAC1, GRNOPC1 and GRNCM1 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 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
noncommercial 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 product candidates 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,
imetelstat, our telomerase cancer vaccine, GRNVAC1, and our hESC-based products
are likely to be more expensive to manufacture than most other treatments
currently on the market today. Oligonucleotides are relatively large molecules
with complex chemistry, and the cost of manufacturing an oligonucleotide like
imetelstat is greater than the cost of making most small-molecule drugs. Our
present manufacturing processes are conducted at a modest scale and 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.
GRNVAC1 is an autologous therapy
that is produced from a patient’s blood using a unique process that generates
highly activated dendritic cells that contain RNA coding for the protein
component of telomerase. If we are unable to scalably produce dendritic cells at
a lower manufacturing cost, the cost of GRNVAC1 may reduce the affordability of
the therapy for patients and reduce our potential profitability.
Our manufacturing processes for
differentiated cells from hESCs are conducted at a small scale and 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 and hESCs. 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:
- research and
development;
- manufacturing;
- preclinical and clinical
testing;
- obtaining regulatory
approvals; and
- 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:
- product efficacy and
safety;
- the timing and scope of
regulatory consents;
- availability of
resources;
- reimbursement
coverage;
- price;
and
- 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 collaborators, 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:
- our establishment and
demonstration to the medical community of the clinical efficacy and safety of
our product candidates;
- our ability to create
products that are superior to alternatives currently on the
market;
- our ability to establish
in the medical community the potential advantage of our treatments over
alternative treatment methods; and
- 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. In March 2010, President Obama signed the Patient
Protection and Affordability Care Act, as amended by the Health Care and
Education Affordability Reconciliation Act (collectively, the PPACA) into law.
Focused on expanding healthcare coverage to millions of uninsured Americans and
reducing the rate of increase in healthcare costs, the PPACA contains numerous
initiatives that impact the pharmaceutical industry. These include, among other
things:
- increasing existing
price rebates in federally funded health care programs;
- expanding rebates, or
other pharmaceutical company discounts, into new programs;
- imposing a new
non-deductible excise tax on sales of certain prescription pharmaceutical
products by prescription drug manufacturers and importers;
- reducing incentives for
employer-sponsored health care;
- creating an independent
commission to propose changes to Medicare with a particular focus on the cost
of biopharmaceuticals in Medicare Part D;
- providing a
government-run public option with biopharmaceutical price-setting
capabilities;
- allowing the Secretary
of Health and Human Services to negotiate drug prices within Medicare Part D
directly with pharmaceutical manufacturers;
13
- reducing the number of
years of data exclusivity for innovative biological products potentially
leading to earlier biosimilar competition;
- increasing oversight by
the FDA of pharmaceutical research and development processes and
commercialization tactics; and
- adding a tax credit for
qualifying therapeutic discovery projects (QTDP).
While the PPACA may increase the
number of patients who have insurance coverage for our product candidates, its
cost containment measures could also adversely affect reimbursement for our
potential products. Cost control initiatives could decrease the price that we
receive for any product candidate we may develop in the future. 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, which could have an adverse impact on our business.
The QTDP tax credit is equal to 50%
of qualifying expenses incurred or directly related to the conduct of a
qualifying therapeutic discovery project for taxable years beginning in 2009 and
2010. The credit can be used to either reduce the federal tax liability for an
eligible taxpayer or be received as a grant for the same amount tax free.
Eligible taxpayers must be a single employer of not more than 250 employees. To
qualify for the credit, a project must be submitted to and certified by the
Treasury Department. The deadline for the QTDP application was July 21, 2010 and
final decision on the awardees will be announced by October 31, 2010. Although
our research and development activities appear to meet the initial criteria to
receive a tax credit, we cannot predict the availability or amount of funds that
could be received. If we are unsuccessful in obtaining the benefits of the QTDP
tax credit and our competitors are successful, our business may be adversely
impacted.
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.
14
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.
Historically, our stock price has
been extremely volatile. Between January 2000 and August 2010, our stock has
traded as high as $75.88 per share and as low as $1.41 per share. Between
January 1, 2007 and August 17, 2010, the price has ranged between a high of
$9.85 per share and a low of $1.95 per share. The significant market price
fluctuations of our common stock are due to a variety of factors,
including:
- the demand in the market
for our common stock;
- the experimental nature
of our product candidates;
- fluctuations in our
operating results;
- market conditions
relating to the biopharmaceutical and pharmaceutical
industries;
- announcements of
technological innovations, new commercial products, or clinical progress or
lack thereof by us, our collaborative partners or our
competitors;
- announcements concerning
regulatory developments, developments with respect to proprietary rights and
our collaborations;
- comments by securities
analysts;
- general market
conditions;
- political developments
related to hESC research;
- public concern with
respect to our product candidates; or
- the issuance of common
stock to partners, vendors or to investors to raise additional capital.
15
In addition, the stock market is
subject to other factors outside our control that can cause extreme price and
volume fluctuations. Since the third quarter of 2008, broad distress in the
financial markets and the economy have resulted in greatly increased market uncertainty and
instability in both U.S. and international capital and credit markets. These
conditions, combined with volatile oil prices, declining business and consumer
confidence and increased unemployment have recently contributed to substantial
market volatility, and if such market conditions persist, the price of our
common stock may fluctuate or decline. 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.
The 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 August 17, 2010, we had 200,000,000 shares of common
stock authorized for issuance and 102,602,673 shares of common stock
outstanding. In addition, as of August 17, 2010, we have reserved for future
issuance approximately 23,064,768 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 for our common stock.
Our undesignated preferred stock may
inhibit potential acquisition bids; this may adversely affect the market price
for our common stock and the voting rights of 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 or alter the rights,
preferences, privileges and restrictions granted to or imported upon these
shares without further vote or action by our stockholders. As of the date of
this filing, 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 in
one or more classes or series. 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 for 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
for 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.
16
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:
- prevent stockholders
from taking actions by written consent;
- 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
- 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.
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. 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, without limitation, risks related to the
development and commercialization of our potential products, dependence on
collaborative partners, need for additional capital, need for regulatory
approvals or clearances, the maintenance of our intellectual property rights and
other risks that are described 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 obligations
to the holders named in the section entitled “Selling Stockholders.” We will not
receive any of the proceeds from resale of these shares of common stock by the
selling stockholders.
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 SEC as exhibits to registration
statements and reports under the Securities Act of 1933, as amended (the
Securities Act) and the Securities Exchange Act of 1934, as amended (the
Exchange Act), respectively, 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 August 17,
2010, we had 102,602,673 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
STOCKHOLDERS
The following table sets forth the
names of the selling stockholders, the number of shares of common stock owned
beneficially by each selling stockholder as of August 17, 2010, the number of
shares which may be offered pursuant to this prospectus and the number of shares
to be owned by each selling stockholder after this offering. In the aggregate,
the selling stockholders may sell up to 671,074 shares of our common stock pursuant
to this prospectus. Since each 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 stockholders individually or collectively after
the offering can be provided. In addition, since the date each of the selling
stockholders 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. Information concerning the selling stockholders may change from
time to time and, when necessary, any changed information will be set forth in a
prospectus supplement to this prospectus.
On August 17, 2010, in payment to
Hongene Biotechnology Limited (Hongene) under Addendum Agreement No. 6 to a
master manufacturing agreement pursuant to which Hongene is making certain raw
materials for us intended to be used for the manufacture of drug product for use
in human clinical trials, we issued to Hongene 114,957 shares of our common
stock, pursuant to a Common Stock Purchase Agreement dated as of August 16,
2010. On August 17, 2010, in payment to Samchully Pharm. Co., Ltd. (Samchully)
under Addendum Agreement No. 13 to a master manufacturing agreement pursuant to
which Samchully is making certain raw materials for us intended to be used for
the manufacture of drug product for use in human clinical trials, we issued to
Samchully 115,779 shares of our common stock, pursuant to a Common Stock
Purchase Agreement dated as of August 16, 2010. On August 17, 2010, in payment
to MPI Research, Inc. (MPI) under Amendment No. 7 and Amendment No. 8 to a
master agreement under which MPI has provided and will continue to provide
certain preclinical services in support of our clinical programs, we issued to
MPI 158,912 shares of our common stock, pursuant to a Common Stock Purchase
Agreement dated as of August 16, 2010. On August 17, 2010, in payment to
ReSearch Pharmaceutical Services, Inc. (RPS) under Project Agreement No. 2 to a
master agreement under which RPS is providing certain services to us in support
of our clinical programs, we issued to RPS 281,426 shares of our common stock,
pursuant to a Common Stock Purchase Agreement dated as of August 16,
2010.
To our knowledge, each of Hongene,
Samchully, MPI and RPS 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 each selling stockholder.
|
|
Total |
|
Maximum Number
of |
|
|
|
|
|
|
|
|
Number of |
|
Shares
Available |
|
Shares Owned |
|
|
|
|
Shares Held |
|
Pursuant to
this |
|
After
Offering |
|
Percentage |
Name |
|
(1) |
|
Prospectus |
|
(2) |
|
(3) |
Hongene Biotechnology
Limited |
|
114,957 |
|
114,957 |
|
|
0 |
|
|
* |
|
Samchully Pharm. Co.,
Ltd. |
|
115,779 |
|
115,779 |
|
|
0 |
|
|
* |
|
MPI Research, Inc. |
|
272,269 |
|
158,912 |
|
|
113,357 |
|
|
* |
|
ReSearch Pharmaceutical
Services, Inc. |
|
281,426 |
|
281,426 |
|
|
0 |
|
|
* |
____________________
(1) |
|
Based on information available as of August 17, 2010. |
|
|
|
(2) |
|
Assumes the sale of all shares of common stock offered by this
prospectus. |
|
|
|
(3) |
|
Based on 102,602,673 shares of common stock outstanding as of
August 17, 2010. |
|
|
|
* |
|
Less
than 1%.
|
19
PLAN OF DISTRIBUTION
We are registering a total of
671,074 shares of our common stock on behalf
of the selling stockholders. The selling stockholders and any of their 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 stockholders may
use any one or more of the following methods when selling shares:
- sales on the Nasdaq
Global Market;
- sales in the
over-the-counter market;
- ordinary brokerage
transactions and transactions in which the broker-dealer solicits
purchasers;
- 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;
- purchases by a
broker-dealer as principal and resale by the broker-dealer for its
account;
- an exchange distribution
in accordance with the rules of the applicable exchange;
- privately negotiated
transactions;
- transactions in which
broker-dealers agree with the selling stockholders to sell a specified number
of such shares at a stipulated price per share;
- a combination of any
such methods of sale; and
- any other method
permitted pursuant to applicable law.
Each of the selling stockholders may
also sell the shares directly to market makers acting as principals and/or
broker-dealers acting as agents for themselves or their customers. These
broker-dealers may receive compensation in the form of discounts, concessions or
commissions from the selling stockholders 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 stockholders 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 stockholders cannot assure that all
or any of the shares offered in this prospectus will be issued to, or sold by,
the selling stockholders. The selling stockholders 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 stockholders,
alternatively, may sell all or any part of the shares offered in this prospectus
through an underwriter. To our knowledge, none of the selling stockholders has
entered into any agreement with a prospective underwriter and we cannot assure
you that any such agreement will be entered into. If one or more of the selling
stockholders 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 stockholders 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 stockholders 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
Each of the selling stockholders
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.
VALIDITY OF THE SECURITIES
Latham & Watkins LLP, Menlo
Park, California, 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 on Form 10-K
for the year ended December 31, 2009, and the effectiveness of internal control
over financial reporting as of December 31, 2009, 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
As of the date of this prospectus,
there have been no material changes in our affairs since December 31, 2009,
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 Room 1580,
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
Exchange Act until the selling stockholders sell all the shares:
- Our annual report on
Form 10-K for the fiscal year ended December 31, 2009, filed with the SEC on
February 26, 2010;
- Our quarterly report on
Form 10-Q for the quarter ended March 31, 2010, filed with the SEC on April
30, 2010;
- Our quarterly report on
Form 10-Q for the quarter ended June 30, 2010, filed with the SEC on July 30,
2010;
- Our definitive proxy
statement filed with the SEC on March 29, 2010;
- Our current reports on
Form 8-K filed with the SEC on January 15, 2010, March 19, 2010, March 26,
2010, May 20, 2010, May 21, 2010, July 15, 2010 and July 30, 2010;
and
- The description of our
common stock set forth in our registration statement on Form 8-A, filed with
the SEC 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
671,074 SHARES OF COMMON
STOCK
GERON CORPORATION
PROSPECTUS
, 2010
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 |
$ |
253 |
|
Accounting Fees and
Expenses |
$ |
10,000 |
* |
Legal Fees and
Expenses |
$ |
10,000 |
* |
Miscellaneous |
$ |
1,500 |
* |
|
Total |
$ |
21,753 |
|
|
*
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.
II-2
(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.
(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 August 20, 2010.
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, with full power of
substitution and full power to act without the other, his or her true and lawful
attorney-in-fact and agent to act for him or her in his or her name, place and
stead, in any and all capacities, to sign a registration statement on Form S-3
and any or all amendments thereto (including without limitation any
post-effective amendments thereto), and any registration statement for the same
offering that is to be effective under Rule 462(b) of the Securities Act, and to
file each of the same, with all exhibits thereto, and other documents in
connection therewith, with the Securities and Exchange Commission, granting unto
said attorneys-in-fact and agents, and each of them, full power and authority to
do and perform each and every act and thing requisite and necessary to be done
in and about the premises in order to effectuate the same as fully, to all
intents and purposes, as they, he or she might or could do in person, hereby
ratifying and confirming all that said attorneys-in-fact and agents, or any of
them, may lawfully do or cause to be done by virtue hereof.
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 |
|
August 20, 2010 |
Thomas B. Okarma |
|
Director (principal executive
officer) |
|
|
|
/s/ David L.
Greenwood |
|
Executive Vice President and
Chief |
|
|
David L. Greenwood |
|
Financial Officer (principal
financial and |
|
August 20, 2010 |
|
|
accounting officer) |
|
|
|
/s/
Alexander E. Barkas |
|
Director |
|
August 20, 2010 |
Alexander E. Barkas |
|
|
|
|
|
/s/ Karin
Eastham |
|
Director |
|
August 20, 2010 |
Karin Eastham |
|
|
|
|
|
/s/ Edward
V. Fritzky |
|
Director |
|
August 20, 2010 |
Edward V. Fritzky |
|
|
|
|
|
/s/ Thomas
Hofstaetter |
|
Director |
|
August 20, 2010 |
Thomas Hofstaetter |
|
|
|
|
|
/s/ Charles
J. Homcy |
|
Director |
|
August 20, 2010 |
Charles J. Homcy |
|
|
|
|
|
/s/ Hoyoung Huh |
|
Director |
|
August 20,
2010 |
Hoyoung Huh |
|
|
|
|
|
|
|
|
|
/s/ Thomas
D. Kiley |
|
Director |
|
August 20, 2010 |
Thomas D. Kiley |
|
|
|
|
|
/s/ Robert
J. Spiegel |
|
Director |
|
August 20, 2010 |
Robert J. Spiegel |
|
|
|
|
S-1
EXHIBIT INDEX
Exhibit No. |
|
Description |
4.1 |
|
|
Common Stock Purchase
Agreement dated as of August 16, 2010 by and between Registrant and
Hongene Biotechnology Limited. |
4.2 |
|
|
Common Stock Purchase
Agreement dated as of August 16, 2010 by and between Registrant and
Samchully Pharm. Co., Ltd. |
4.3 |
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|
Common Stock Purchase
Agreement dated as of August 16, 2010 by and between Registrant and MPI
Research, Inc. |
4.4 |
|
|
Common Stock Purchase
Agreement dated as of August 16, 2010 by and between Registrant and
ReSearch Pharmaceutical Services, 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). |