Full Press Release Details
Geron Corporation Reports First
Quarter 2014 Financial Results
Conference Call Scheduled for 4:30
p.m. EDT Today, May 1st
MENLO PARK, Calif., May 1, 2014 -- Geron
Corporation (Nasdaq: GERN) today reported financial results for the
first quarter ended March 31, 2014.
For the first quarter of 2014, the company reported operating revenues
of $474,000 and operating expenses of
$9.2 million, compared to $765,000 and $12.8 million, respectively, for the comparable 2013 period. Net loss for
the first quarter of 2014 was $8.4 million, or $0.06 per share, compared to $11.9 million, or $0.09 per share,
for the comparable 2013 period. The company ended the first quarter of 2014 with $153.5 million in cash and investments.
Revenues for the first quarter of 2014 and 2013 included royalty
and license fee revenues under various agreements.
Interest and other income for the first quarter of 2014 was $83,000, compared to $81,000 for the comparable
2013 period. The company expects interest income to be higher in 2014 than in 2013 due to higher cash
and investment balances.
Research and development expenses for the first quarter of 2014 were
$5.2 million, compared to $8.0 million for
the comparable 2013 period. The decrease in research and development expenses was primarily the net result
of lower personnel-related costs
and reduced clinical trial expenses with the wind-down
of the imetelstat trials in solid
tumors and GRN1005 trials in patients with brain metastases, partially offset by increased manufacturing
costs for imetelstat drug product. The company expects research and development expenses to remain
consistent during the remainder of the year, unless the FDA lifts the full clinical hold or permits the
company to study imetelstat for other indications, such as under a partial clinical hold.
General and administrative expenses for the first quarter of 2014 were
$4.0 million, compared to $4.8 million for
the comparable 2013 period. The decrease in general and administrative expenses primarily reflected reduced
patent costs and transaction expenses associated with the closing of the stem cell divestiture in October
2013. The company expects general and administrative expenses to potentially increase during the remainder
of the year in connection with the purported class action lawsuits and derivative lawsuit recently filed
against the company.
February 2014, the company completed an underwritten public offering of 25,875,000 shares
of common stock at a public offering price of $4.00 per share, resulting in net cash proceeds of
approximately $96.8 million after deducting the underwriting discount and offering expenses.
Status of Company-Sponsored
Clinical Trials of Imetelstat. In March 2014, the U.S. Food and Drug Administration
(FDA) notified the company that the Investigational New Drug application (IND) for imetelstat had
been placed on full clinical hold. With this full clinical hold, any patients in an ongoing Geron-sponsored clinical
trial cannot receive any further treatment with imetelstat. Therefore, the company stopped imetelstat treatment
of the remaining patients in the Phase 2 Geron-sponsored clinical trials in
essential thrombocythemia (eight
patients) and multiple myeloma (two patients). Until the FDA lifts the full clinical hold or
permits the company to study imetelstat for other indications, such as under a partial clinical hold, the company
is unable to submit any new clinical trial protocols to the FDA under the existing IND for imetelstat and
therefore will be unable to initiate any new clinical trials for imetelstat in the United States.
In their notice to the company, the FDA cited the following safety issues
as the basis for the full clinical hold: lack
of evidence of reversibility of hepatotoxicity, risk for chronic liver injury and lack of adequate follow up in
patients who experienced hepatotoxicity. To address the full clinical hold, the FDA requires the company to
provide clinical follow up information in patients who experienced liver function test (LFT) abnormalities until LFT
abnormalities have resolved to normal or baseline and to provide information regarding the reversibility of
the liver toxicity after chronic imetelstat administration in animals. The company plans to work diligently with
the FDA to seek release of the full clinical hold and currently is compiling the preclinical and clinical data and
information from its studies, as well as data and information available from other imetelstat studies, such as the
Myelofibrosis IST, regarding LFT abnormalities and the incidence and reversibility of
Status of Investigator-Sponsored
Clinical Trial of Imetelstat in Myelofibrosis (Myelofibrosis IST). In
March 2014, Mayo Clinic informed the
company that the investigator s IND for the Myelofibrosis IST was placed on partial
clinical hold by the FDA. The partial clinical hold means that no new patients may be enrolled into the Myelofibrosis
IST, but previously enrolled patients who are deriving clinical benefit, may continue to receive imetelstat
treatment. In order to resolve the partial clinical hold on the Myelofibrosis IST, the investigator is required
to provide the FDA with follow-up LFT information for all patients who received
imetelstat in the Myelofibrosis IST.
For patients who did not experience any LFT abnormality, LFT follow-up data needs
to be obtained until 30 days after the
last imetelstat dose. For patients who experienced any LFT abnormality, follow-up
LFT data must be obtained until resolution to baseline or to within the normal range for at least two
consecutive determinations. The investigator has informed the company that he and the team at Mayo Clinic intend
to obtain and submit LFT information and data to the FDA to address the partial clinical hold. In addition,
the investigator currently intends to submit additional and updated data from the Myelofibrosis IST for
presentation at the American Society of Hematology (ASH) Annual Meeting in December 2014, including data
from the patients with refractory anemia with ringed sideroblasts, or RARS, a subpopulation of
myelodysplastic syndromes, and patients with myelofibrosis that has transformed into acute myelogenous leukemia,
known as blast-phase myelofibrosis.
At 4:30 p.m. EDT on May 1, 2014, Geron s management will host a
conference call to discuss the company s first
quarter results and recent events.
Participants can access the conference call live via telephone by
dialing 866-578-5771
(U.S.); 617-213-8055 (international).
The passcode is 69839849. A live audio-only webcast is also available
at http://edge.media-server.com/m/p/dwk9urc8/lan/en. The audio webcast of
the conference call will be available for replay approximately
one hour following the live broadcast through June 1, 2014.
Geron is a clinical stage biopharmaceutical company developing a first-in-class telomerase inhibitor, imetelstat,
in hematologic myeloid malignancies. For more information about Geron, visit www.geron.com.
Use of Forward-Looking
Except for statements of historical fact, this press release contains
forward-looking statements made
pursuant to the "safe
harbor" provisions of the Private Securities Litigation Reform Act of 1995, including without limitation,
statements regarding: obtaining and submitting information and data to respond to the full and partial
clinical holds; the ability of the company and the Myelofibrosis IST investigator to adequately address the
FDA s requirements and concerns resulting in the FDA lifting the respective clinical holds; the Myelofibrosis
IST investigator s intent to submit data to ASH; and financial projections. These statements involve
risks and uncertainties that can cause actual results to differ materially from those in such forward-looking