geroncorp_s3.htm
As filed with the
Securities and Exchange Commission on April 9, 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 |
670,984 shares |
$5.85 (2) |
$3,925,256 |
$279.87 (3) |
(1) |
|
In the event of a stock split,
stock dividend, or similar transaction involving Geron’s common stock, in
order to prevent dilution, the number of shares registered shall
automatically be increased to cover the additional shares in accordance
with Rule 416(a) under the Securities Act. |
|
|
|
(2) |
|
The offering price is estimated
solely for the purpose of calculating the registration fee in accordance
with Rule 457(c) and based upon the average of the high and low prices
reported by the Nasdaq Global Market on April 6, 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 APRIL 9,
2010
UP TO 670,984 SHARES OF
GERON CORPORATION
COMMON STOCK
Our common stock is traded on the Nasdaq Global Market under the symbol
“GERN.” On April 6, 2010, the closing price of our common stock was
$5.88.
This prospectus relates to the sale
of up to 293,225 shares of our common stock by Girindus America, Inc., the sale
of up to 259,965 shares of our common stock by ReSearch Pharmaceutical Services,
Inc., the sale of up to 24,536 shares of our common stock by Prime Synthesis,
Inc., and the sale of up to 93,258 shares of our common stock by Exponent, 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 |
16 |
USE OF PROCEEDS |
16 |
DESCRIPTION OF OUR COMMON
STOCK |
16 |
TRANSFER AGENT AND REGISTRAR |
16 |
SELLING STOCKHOLDERS |
17 |
PLAN OF DISTRIBUTION |
18 |
VALIDITY OF THE SECURITIES |
19 |
EXPERTS |
19 |
MATERIAL CHANGES |
19 |
LIMITATION ON LIABILITY AND DISCLOSURE OF COMMISSION POSITION
ON |
|
INDEMNIFICATION FOR SECURITIES
ACT LIABILITIES |
19 |
WHERE YOU CAN FIND MORE
INFORMATION |
19 |
DOCUMENTS WE HAVE INCORPORATED BY REFERENCE |
20 |
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. Patient enrollment for our
telomerase cancer vaccine, GRNVAC1, 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. Currently, the clinical
trial of GRNOPC1, our human embryonic stem cell (hESC)-derived therapy targeted
for the treatment of acute spinal cord injury, has been placed on clinical hold
by the U.S. Food and Drug Administration (FDA). We are in discussions with the
FDA to answer its questions and seek the release of the clinical hold to permit
us to proceed with the clinical trial. 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, including release by
the FDA of the clinical hold for GRNOPC1;
- manufacture product candidates; and
- collaborate successfully with clinical trial sites, academic
institutions, physician investigators, clinical research organizations and
other third parties.
Potential lead drug compounds or other product candidates and
technologies require significant preclinical and clinical testing prior to
regulatory approval in the United States and other countries. Our product
candidates may prove to have undesirable and unintended side effects or other
characteristics adversely affecting their safety, efficacy or cost-effectiveness
that could prevent or limit their commercial use. In addition, our product
candidates may not prove to be more effective for treating disease or injury
than current therapies. Accordingly, we may have to delay or abandon efforts to
research, develop or obtain regulatory approvals to market our product
candidates. In addition, we will need to determine whether any of our potential
products can be manufactured in commercial quantities at an acceptable cost. Our
research and development efforts may not result in a product that can be 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.
1
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.
Furthermore, on March 9, 2009, President Obama issued Executive Order
13505, entitled “Removing Barriers to Responsible Scientific Research Involving
Human Stem Cells” (the Executive Order). 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 stock.
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 December 31, 2009, our accumulated deficit was approximately
$577.3 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.
2
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.
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.
3
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 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.
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.
4
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.
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.
5
The patent positions of pharmaceutical and biopharmaceutical companies,
including ours, are highly uncertain and involve complex legal and technical
questions. In particular, legal principles for biotechnology patents in the
United States and in other countries are evolving, and the extent to which we
will be able to obtain patent coverage to protect our technology, or enforce
issued patents, is uncertain. In the United States, recent court decisions in
patent cases as well as proposed legislative changes to the patent system only
exacerbate this uncertainty. Furthermore, significant amendments to the
regulations governing the process of obtaining patents were 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.
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.
was granted patent claims that conflict with subject matter we filed in an
earlier patent application. The interference proceeding will determine whether
we or Novocell are entitled to such patent claims. Since this interference is
still ongoing, we cannot predict what the outcome will be.
6
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.
In parallel, Pharmexa opposed a European patent held by Geron, the claims
of which cover many facets of human telomerase, including the use of telomerase
peptides in cancer vaccines. In June 2006, the OD of the EPO revoked three of
the granted claims in Geron’s patent, specifically the three claims covering
telomerase peptide cancer vaccines. We have appealed that decision to the TBA,
and that appeal is still pending. Because this appeal is ongoing, the outcome
cannot be determined at this time. We are also seeking to obtain patent coverage
in Europe for telomerase peptides through a European divisional patent
application. If and when those patent claims are issued, they too may be subject
to an opposition proceeding. In late 2008, Pharmexa reported that it sold its
telomerase vaccine program to a Korean company, KAEL Co. Ltd.
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 recently issued decisions in all three
cases upholding the patentability of the claims. The decisions to uphold the
5,843,780 and 6,200,806 patents are final and not subject to further appeal.
Consumer Watchdog appealed the decision on the 7,029,913 patent. We cooperated
with WARF in these reexamination actions and expect that WARF will continue to
vigorously defend its patent position in this appeal. While the decisions in
these reexamination proceedings to date have all been favorable to our patent
position, the outcome of the appeal or of any future reexamination proceedings
cannot be determined at this time. Reduction or loss of claim scope in these
WARF embryonic stem cell patents would negatively impact Geron’s proprietary
position in this technology.
7
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);
- 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.
8
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 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.
9
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 drugs 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.
10
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.
11
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.
Significant uncertainty exists as to the reimbursement status of newly-approved
health care products, including pharmaceuticals. If our potential products are
not considered cost-effective or if we fail to generate adequate third-party
reimbursement for the users of our potential products and treatments, then we
may be unable to maintain price levels sufficient to realize an appropriate
return on our investment for potential products currently in development. In
both U.S. and other markets, sales of our potential products, if any, will
depend in part on the availability of reimbursement from third-party payors,
examples of which include:
- government health administration
authorities;
- private health
insurers;
- health maintenance organizations;
and
- pharmacy benefit management
companies.
Both federal and state governments in the United States and governments
in other countries continue to propose and pass legislation designed to contain
or reduce the cost of health care. Legislation and regulations affecting the
pricing of pharmaceuticals and other medical products may be adopted before any
of our potential products are approved for marketing. Cost control initiatives
could decrease the price that we receive for any product candidate we may
develop in the future. In addition, third-party payors are increasingly
challenging the price and cost-effectiveness of medical products and services
and any of our potential products may ultimately not be considered
cost-effective by these third parties. Any of these initiatives or developments
could materially harm our business.
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.
12
Additional federal, state and local laws and regulations affecting us may
be adopted in the future. We may incur substantial costs to comply with these
laws and regulations and substantial fines or penalties if we violate any of
these laws or regulations, which would adversely affect our
business.
We may not be able to obtain or maintain sufficient insurance on
commercially reasonable terms or with adequate coverage against potential
liabilities in order to protect ourselves against product liability
claims.
Our business exposes us to potential product liability risks that are
inherent in the testing, manufacturing and marketing of human therapeutic and
diagnostic products. We may become subject to product liability claims if the
use of our potential products is alleged to have injured subjects or patients.
This risk exists for product candidates tested in human clinical trials as well
as potential products that are sold commercially. We currently have limited
clinical trial liability insurance and we may not be able to maintain this type
of insurance for any of our clinical trials. In addition, product liability
insurance is becoming increasingly expensive. Being unable to obtain or maintain
product liability insurance in the future on acceptable terms or with adequate
coverage against potential liabilities could have a material adverse effect on
our business.
RISKS RELATED TO OUR COMMON STOCK AND
FINANCIAL REPORTING
Our stock price has historically been very
volatile.
Stock prices and trading volumes for many biopharmaceutical companies
fluctuate widely for a number of reasons, including factors which may be
unrelated to their businesses or results of operations such as media coverage,
legislative and regulatory measures and the activities of various interest
groups or organizations. This market volatility, as well as general domestic or
international economic, market and political conditions, could materially and
adversely affect the market price of our common stock and the return on your
investment.
Historically, our stock price has been extremely volatile. Between
January 2000 and March 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 April 6, 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.
13
In addition, the stock market is subject to other factors outside our
control that can cause extreme price and volume fluctuations. In the third and
fourth quarters of 2008, as well as during 2009, 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
April 6, 2010, we had 200,000,000 shares of common stock authorized for issuance
and 98,160,641 shares of common stock outstanding. In addition, as of April 6,
2010, we have reserved for future issuance approximately 22,234,858 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.
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.
14
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.
15
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 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 April 6, 2010, we had 98,160,641 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.
16
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 April 6, 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
670,984 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 of 1933, as amended (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 April 6, 2010, in payment to Girindus America, Inc. (Girindus) under
the Sixth Project Order to a manufacturing agreement pursuant to which Girindus
is manufacturing certain materials for us intended for therapeutic use in
humans, we issued to Girindus 293,225 shares of our common stock, pursuant to a
Common Stock Purchase Agreement dated as of April 1, 2010. On April 6, 2010, in
payment to ReSearch Pharmaceutical Services, Inc. (RPS) under Project Agreement
No. 2 to a master services agreement under which RPS is providing certain
services to us in support of our clinical programs, we issued to RPS 259,965
shares of our common stock, pursuant to a Common Stock Purchase Agreement dated
as of April 1, 2010. On April 6, 2010, in payment to Prime Synthesis, Inc.
(Prime Synthesis) under Addendum Agreement No. 6 to a master supply agreement
under which Prime Synthesis is manufacturing certain materials for us intended
for therapeutic use in humans, we issued to Prime Synthesis 24,536 shares of our
common stock, pursuant to a Common Stock Purchase Agreement dated as of April 1,
2010. On April 6, 2010, as the final installment payment of rent due under the
Lease Agreement, as amended by the First Amendment to the Lease Agreement,
pertaining to our lease of certain office space for the period from May 1, 2010
through July 31, 2012, we issued to Exponent, Inc. (Exponent), the lessor of the
premises, 93,258 shares of our common stock, pursuant to a Common Stock Purchase
Agreement dated as of April 5, 2010.
To our knowledge, each of Girindus, RPS, Prime Synthesis and Exponent 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) |
Girindus America, Inc. |
|
|
293,225 |
|
|
|
293,225 |
|
|
0 |
|
* |
|
|
|
|
|
|
|
|
|
|
|
|
|
ReSearch Pharmaceutical |
|
|
|
|
|
|
|
|
|
|
|
|
Services, Inc. |
|
|
259,965 |
|
|
|
259,965 |
|
|
0 |
|
* |
|
|
|
|
|
|
|
|
|
|
|
|
|
Prime Synthesis, Inc. |
|
|
24,536 |
|
|
|
24,536 |
|
|
0 |
|
* |
|
|
|
|
|
|
|
|
|
|
|
|
|
Exponent, Inc. |
|
|
93,258 |
|
|
|
93,258 |
|
|
0 |
|
* |
____________________
(1) |
|
Based on
information available as of April 6, 2010. |
|
|
|
(2) |
|
Assumes the sale
of all shares of common stock offered by this prospectus. |
|
(3) |
|
Based on
98,160,641 shares of common stock outstanding as of April 6,
2010. |
|
|
|
*
|
|
Less than
1%.
|
17
PLAN OF DISTRIBUTION
We are registering a total of 670,984 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 Securities Exchange Act of 1934,
as amended (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.
18
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.
19
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 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 and March 26, 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.
20
670,984 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.
21
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 |
|
$ |
280 |
|
Accounting Fees and Expenses |
|
$ |
10,000 |
* |
Legal Fees and Expenses |
|
$ |
10,000 |
* |
Miscellaneous |
|
$ |
1,500 |
* |
|
|
|
|
|
Total |
|
$ |
21,780 |
|
|
|
|
|
|
*
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 April 9, 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 |
|
April 9, 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 |
|
April 9, 2010 |
|
|
accounting
officer) |
|
|
|
/s/ Alexander E.
Barkas |
|
Director |
|
April 9, 2010 |
Alexander E.
Barkas |
|
|
|
|
|
/s/ Karin
Eastham |
|
Director |
|
April 9, 2010 |
Karin
Eastham |
|
|
|
|
|
/s/ Edward V.
Fritzky |
|
Director |
|
April 9, 2010 |
Edward V.
Fritzky |
|
|
|
|
|
/s/ Thomas
Hofstaetter |
|
Director |
|
April 9, 2010 |
Thomas
Hofstaetter |
|
|
|
|
|
/s/ Charles J.
Homcy |
|
Director |
|
April 9, 2010 |
Charles J.
Homcy |
|
|
|
|
|
/s/ Thomas D.
Kiley |
|
Director |
|
April 9, 2010 |
Thomas D.
Kiley |
|
|
|
|
|
/s/ Patrick J.
Zenner |
|
Director |
|
April 9, 2010 |
Patrick
J. Zenner |
|
|
|
|
S-1
EXHIBIT INDEX
Exhibits |
|
Description |
|
4.1 |
|
|
Common Stock Purchase Agreement dated as
of April 1, 2010 by and between Registrant and Girindus America,
Inc. |
4.2 |
|
|
Common Stock Purchase Agreement dated as
of April 1, 2010 by and between Registrant and ReSearch Pharmaceutical
Services, Inc. |
4.3 |
|
|
Common Stock Purchase Agreement dated as
of April 1, 2010 by and between Registrant and Prime Synthesis,
Inc. |
4.4 |
|
|
Common Stock Purchase Agreement dated as
of April 5, 2010 by and between Registrant and Exponent, 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). |