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Forward-Looking Statements This Current Report on Form 8-K, or Form 8-K, contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, whic

Key Takeaway: Forward-Looking Statements This Current Report on Form 8-K, or Form 8-K, contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, which are subject to the safe harbor created by that section

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Forward-Looking Statements
This Current Report on Form 8-K, or Form
8-K, contains forward-looking statements within the meaning of Section 21E of
the Securities Exchange Act of 1934, as amended, or the Exchange Act, which are
subject to the safe harbor created by that section. In some cases, you can
identify forward-looking statements by the following words: may, will,
could, would, should, expect, intend, plan, anticipate, believe,
estimate, predict, project, potential, continue, ongoing or the
negative of these terms or other comparable terminology, although not all
forward-looking statements contain these words. These statements involve risks,
uncertainties and other factors that may cause our actual results, levels of
activity, performance or achievements to be materially different from the
information expressed or implied by these forward-looking statements. Although
we believe that we have a reasonable basis for each forward-looking statement
contained in this Form 8-K, we caution you that these statements are based on a
combination of facts and factors currently known by us and our projections of
the future, about which we cannot be certain. Forward-looking statements include, but are not necessarily limited to, those relating to:
the magnitude and scope of our imetelstat research
and development program, including the number of indications we intend to
the progress made, if any, in our imetelstat
research and development program, including our planned Phase 2 clinical trial
in MF, and potential future clinical trials and existing or future
investigator-sponsored trials;
the design of our planned Phase 2 clinical trial
of imetelstat in MF, including the selection of dosing regimens;
changes in our clinical development plans for
the size and timing of expenditures and whether
there are unanticipated expenditures;
our estimates regarding the sufficiency of our
our ability to complete the public offering of our common stock announced on January 30, 2014, and our requirements for additional capital;
and costs involved in obtaining regulatory clearances and approvals;
ability to consistently and reproducibly manufacture imetelstat;
to meaningfully reduce manufacturing costs of imetelstat;
our ability to establish and maintain potential
new collaborative arrangements for the development and commercialization of
the costs involved in preparing, filing,
prosecuting, maintaining, defending and enforcing patent claims;
the implementation of our corporate strategy;
our ability to successfully complete the Series A
our future financial performance.
In addition, you should refer to Risk
Factors in this Form 8-K for a discussion of these and other important factors
that may cause our actual results to differ materially from those expressed or
implied by our forward-looking statements. As a result of these factors, we
cannot assure you that the forward-looking statements in this Form 8-K will
prove to be accurate. Furthermore, if our
forward-looking statements prove to be inaccurate, the inaccuracy may be
material. In light of the significant uncertainties in these forward-looking
statements, you should not regard these statements as a representation or
warranty by us or any other person that we will achieve our objectives and plans
in any specified time frame, or at all. Also, forward-looking statements
represent our estimates and assumptions only as of the date of this Form 8-K. We
undertake no obligation to publicly update any forward-looking statements,
whether as a result of new information, future events or otherwise, except as
Geron is a clinical stage biopharmaceutical company developing a
telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. Through a
combined strategy of internal efforts and potential future strategic
partnerships, we intend to advance the development and commercialization of
imetelstat in one or more hematologic myeloid malignancies.
The discovery and early development of imetelstat, our sole product
candidate, was based on our core expertise in telomerase and telomere biology.
Telomerase is an enzyme that enables cancer cells, including malignant
progenitor cells, to maintain telomere length, which provides them with the
capacity for limitless, uncontrolled proliferation.
Imetelstat is a potent and specific inhibitor of telomerase. Using our
proprietary nucleic acid chemistry, we designed imetelstat to be an
oligonucleotide that targets and binds with high affinity to the active site of
telomerase, thereby directly inhibiting telomerase activity and impeding
malignant cell proliferation. We developed imetelstat from inception and own
exclusive worldwide commercial rights with U.S. patent coverage extending
Based on the data from our Phase 2 clinical trial evaluating imetelstat
in essential thrombocythemia, or ET, which showed durable hematologic and
molecular responses in patients, and preliminary data from the first two cohorts
of an investigator-sponsored trial at Mayo Clinic evaluating imetelstat in
myelofibrosis, which we refer to as the Myelofibrosis IST, we intend to develop
imetelstat to treat one or more hematologic myeloid malignancies such as
myelofibrosis, or MF, which includes patients with primary MF, or PMF, post-essential thrombocythemia MF, or post-ET MF, or post-polycythemia vera MF, or
post-PV MF, all of which are referred to as MF; myelodysplastic syndromes, or
MDS; or acute myelogenous leukemia, or AML. We expect to initiate a
Geron-sponsored multi-center, Phase 2 clinical trial of imetelstat in patients
with MF in the first half of 2014. If the data from this trial are positive, and
subject to regulatory approval and the availability of additional funding, we
expect to initiate one or more randomized Phase 3 clinical trials of imetelstat
in patients with MF that could be designed to potentially support full
regulatory approval.
The Myelofibrosis IST is also evaluating imetelstat in patients with MF
that has transformed into AML, known as blast-phase MF, and in patients with
refractory anemia with ringed sideroblasts, or RARS, a subpopulation of MDS.
Data we receive from these additional patients will inform, in part, our
decision to initiate one or more potential pilot studies of imetelstat in AML or
Telomeres and Telomerase in Normal
In the human body, normal growth and maintenance of tissues occurs by
cell division. However, most cells are only able to divide a limited number of
times, and this number of divisions is regulated by telomere length. Telomeres
are repetitions of a DNA sequence located at the ends of chromosomes. They act
as protective caps to maintain stability and integrity of the chromosomes, which
contain the cell s genetic material. Normally, every time a cell divides, the
telomeres shorten. Eventually, they shrink to a critically short length, and as
a result the cell either dies by apoptosis or stops dividing and senesces.
Telomerase is a naturally occurring enzyme that maintains telomeres and
Last updated: Jan 30, 2014