) shot up almost 45% immediately after the American Society of
Hematology (ASH) posted an abstract on its site regarding
imetelstat. Although shares pulled back in the next trading
session, overall gains since the release of the abstract were
Geron reported third quarter results on the same day. The
company posted a net loss of 6 cents per share in the third
quarter of 2013, in line with the Zacks Consensus Estimate but
narrower than the year-ago loss of 13 cents. Third quarter
revenues of $181,000 were below the year-ago revenues of $636,000
and the Zacks Consensus Estimate of $500,000. A significant
decline in expenses led to the narrower loss.
Quarter in Detail
Revenues consisted entirely of royalties and license fees.
Total operating expenses declined 46.7% to $8.8 million. Research
and development expenses declined 54.7% to $5.3 million due to
reduced personnel-related costs and lower costs related to the
manufacturing of drugs as well as lower costs resulting from the
winding-down of the imetelstat (metastatic breast cancer and
advanced non-small cell lung cancer) and GRN1005 (brain
Meanwhile, general and administrative expenses declined 27.1%
to $3.5 million mainly due to lower personnel-related costs and
lower legal and consulting costs.
ASH Abstract Looks Promising
An abstract on imetelstat, selected for presentation at ASH
from an ongoing investigator-sponsored trial in patients with
myelofibrosis (MF), was made available to the public. The
abstract contained preliminary safety and efficacy data selected
and interpreted by the investigator.
Results showed that out of 18 evaluable patients, overall
response rate was 44% including 4 complete responses and 1
partial response. Reversal of bone marrow (BM) fibrosis and
recovery of normal megakaryocyte morphology was observed in the 4
complete response patients.
Imetelstat looked tolerable in the first cohort with no
grade-4 treatment-related adverse events. However, in the second
cohort, 29% of the patients experienced grade-4 thrombocytopenia
and 11% of the patients required a dose reduction due to grade 3
or 4 myelosuppression.
Overall, the results indicate that imetelstat has the
potential to be effective in patients with myelofibrosis. This is
encouraging news for Geron as imetelstat remains its sole
pipeline candidate. Depending on input from regulators,
investigators, and other experts, along with further insights
from the additional and updated safety and efficacy data to be
presented at ASH, Geron is looking to design and initiate a
company-sponsored multi-center study in MF in the first half of
2014. Additional information regarding the company's plans should
be out in the first quarter of 2014.
Geron's third quarter results were overshadowed by the ASH
abstract on imetelstat. The data looks encouraging and Geron may
very well have another shot at developing imetelstat. The company
did not have much success in developing imetelstat for breast
cancer and non-small cell lung cancer earlier. While we believe
this data supports the further development of imetelstat, we note
that the data is early-stage in nature.
Geron carries a Zacks Rank #3 (Hold). Currently, companies
AMAG Pharmaceuticals, Inc.
Osiris Therapeutics, Inc.
) look well-positioned with all three being Zacks Rank #1 (Strong
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