Geron Corporation Reports First Quarter 2019 Financial Results
May 02 2019 - 4:17PM
Geron Corporation (Nasdaq: GERN) today reported financial results
for the first quarter ended March 31, 2019. As of the quarter-end,
the Company had approximately $170 million in cash and marketable
securities, which is sufficient to support the commencement of
late-stage development for imetelstat in lower risk myelodysplastic
syndromes (MDS).
“We continue to make good progress on our 2019 objectives,” said
John A. Scarlett, M.D., Chairman and Chief Executive Officer. “We
are on track to assume sponsorship of the IND for imetelstat by the
end of the second quarter, as expected, which will enable us to
open enrollment of the planned Phase 3 portion of IMerge by
mid-year. In addition, our expanding in-house leadership and drug
development team will support the accomplishment of our 2019
objectives and beyond.”
First Quarter 2019 Results
For the first quarter of 2019, the Company reported a net loss
of $10.1 million, or $0.05 per share, compared to $7.2 million, or
$0.04 per share, for the comparable 2018 period.
Revenues for the first quarter of 2019 were $57,000 compared to
$318,000 for the comparable 2018 period. Revenues for 2019 and 2018
included royalty and license fee revenues under various
non-imetelstat license agreements. The decrease in revenues for the
three months ended March 31, 2019 compared to the same period in
2018 primarily reflects a reduction in the number of active license
agreements as a result of patent expirations on the underlying
technology.
Total operating expenses for the first quarter of 2019 were
$11.4 million compared to $7.8 million for the comparable 2018
period.
Research and development expenses for the first quarter of 2019
were $5.9 million compared to $2.4 million for the comparable 2018
period. The increase in research and development expenses for first
quarter of 2019 compared to the same period in 2018 primarily
reflects higher imetelstat development costs under the former
collaboration agreement with Janssen Biotech, Inc. (Janssen) due to
Geron’s payment responsibility increasing from 50% to 100%
following the termination of the collaboration agreement; new costs
for the imetelstat program transition from Janssen to Geron,
including for consultants and the Company’s contract research
organization (CRO); and increased expenses related to additional
development headcount.
General and administrative expenses for the first quarter of
2019 were $5.5 million compared to $5.3 million for the comparable
2018 period. The increase in general and administrative expenses in
the first quarter of 2019 compared to same period in 2018 primarily
reflects recruitment expenses for new members for the Company’s
board of directors.
Interest and other income for the first quarter of 2019 was $1.2
million compared to $394,000 for the comparable 2018 period. The
increase in interest and other income for 2019 compared to 2018
primarily reflects higher yields on the Company’s marketable
securities portfolio.
Conference Call for Imetelstat Program
Update
In lieu of a first quarter conference call, Geron will host a
conference call to provide an imetelstat program update at 9:00
a.m. ET on Thursday, May 16, 2019.
Participants may access the conference call live via telephone
by dialing domestically +1 (877) 303-9139 or internationally +1
(760) 536-5195. The conference ID is 1264477. A live, listen-only
webcast will also be available on the Company’s website at
www.geron.com/investors/events. If you are unable to listen to the
live call, an archived webcast will be available on the Company’s
website for 30 days.
About Imetelstat
Imetelstat is a novel, first-in-class telomerase inhibitor
exclusively owned by Geron and being developed in hematologic
myeloid malignancies. Early clinical data suggest imetelstat may
have disease-modifying activity through the suppression of
malignant progenitor cell clone proliferation, which allows
potential recovery of normal hematopoiesis. Ongoing clinical
studies of imetelstat include a Phase 2/3 trial called IMerge in
lower risk myelodysplastic syndromes (MDS) and a Phase 2 trial
called IMbark in Intermediate-2 or High-risk myelofibrosis.
Imetelstat has been granted Fast Track designation by the United
States Food and Drug Administration for the treatment of patients
with transfusion-dependent anemia due to lower risk MDS who are
non-del(5q) and refractory or resistant to an erythroid stimulating
agent.
About Geron
Geron is a late-stage clinical biopharmaceutical company focused
on the development and potential commercialization of a
first-in-class telomerase inhibitor, imetelstat, in hematologic
myeloid malignancies. For more information about Geron, visit
www.geron.com.
Use of Forward-Looking Statements
Except for the historical information contained herein, this
press release contains forward-looking statements made pursuant to
the “safe harbor” provisions of the Private Securities Litigation
Reform Act of 1995. Investors are cautioned that such statements,
include, without limitation, those regarding: (i) that the Phase 3
portion of IMerge will open enrollment by mid-year 2019; (ii) that
the current financial resources are sufficient to support the
commencement of late-stage development for imetelstat in lower risk
MDS; (iii) that Geron expects the sponsorship for the imetelstat
IND to transfer to Geron by the end of the second quarter of 2019;
(iv) that imetelstat may have disease-modifying activity; and (v)
other statements that are not historical facts, constitute
forward-looking statements. These statements involve risks and
uncertainties that can cause actual results to differ materially
from those in such forward-looking statements. These risks and
uncertainties, include, without limitation, risks and uncertainties
related to: (i) whether the Company overcomes all the: (a)
challenges of the transfer of the sponsorship for the imetelstat
IND and imetelstat clinical development program from Janssen, and
(b) clinical safety and efficacy, technical, scientific,
manufacturing and regulatory challenges to enable the Phase 3
portion of IMerge to open enrollment by mid-year 2019; (ii) whether
regulatory authorities permit the further development of imetelstat
on a timely basis, or at all, without any clinical holds; (iii)
whether imetelstat is safe and efficacious, and whether any future
efficacy or safety results may cause the benefit-risk profile of
imetelstat to become unacceptable; (iv) the need for future
capital; and (v) whether imetelstat demonstrates disease-modifying
activity in clinical trials. Additional information on the above
risks and uncertainties and additional risks, uncertainties and
factors that could cause actual results to differ materially from
those in the forward-looking statements are contained in Geron’s
periodic reports filed with the Securities and Exchange Commission
under the heading “Risk Factors,” including Geron’s quarterly
report on Form 10-Q for the quarter ended March 31, 2019. Undue
reliance should not be placed on forward-looking statements, which
speak only as of the date they are made, and the facts and
assumptions underlying the forward-looking statements may change.
Except as required by law, Geron disclaims any obligation to update
these forward-looking statements to reflect future information,
events or circumstances.
Financial table follows.
GERON
CORPORATIONCONDENSED STATEMENTS OF
OPERATIONS
|
|
UNAUDITED Three
Months Ended March 31, |
|
(In thousands, except
share and per share data) |
|
2019 |
|
|
2018 |
|
|
|
|
Revenues: |
|
|
License fees and
royalties |
$ |
57 |
|
$ |
318 |
|
|
|
|
Operating expenses: |
|
|
Research and
development |
|
5,906 |
|
|
2,440 |
|
General and
administrative |
|
5,452 |
|
|
5,315 |
|
Total
operating expenses |
|
11,358 |
|
|
7,755 |
|
Loss from operations |
|
(11,301 |
) |
|
(7,437 |
) |
|
|
|
Interest and other
income |
|
1,162 |
|
|
394 |
|
Change in fair value of
equity investment |
|
98 |
|
|
(125 |
) |
Other expense |
|
(18 |
) |
|
(18 |
) |
Net loss |
$ |
(10,059 |
) |
$ |
(7,186 |
) |
|
|
|
Basic and diluted
net loss per share: |
|
|
Net loss per
share |
$ |
(0.05 |
) |
$ |
(0.04 |
) |
Shares used in
computing net loss per share |
|
186,393,128 |
|
|
160,525,947 |
|
CONDENSED BALANCE SHEETS
|
|
March 31, |
|
|
December 31, |
|
(In thousands) |
|
2019 |
|
|
2018 |
|
|
(Unaudited) |
(Note 1) |
Current assets: |
|
|
Cash, cash equivalents and restricted cash |
$ |
7,070 |
|
$ |
10,844 |
|
Current marketable securities |
|
145,180 |
|
|
152,714 |
|
Other current assets |
|
3,699 |
|
|
2,500 |
|
Total current assets |
|
155,949 |
|
|
166,058 |
|
|
|
|
Noncurrent marketable
securities |
|
17,871 |
|
|
18,582 |
|
Property and equipment,
net |
|
89 |
|
|
59 |
|
Other assets |
|
1,757 |
|
|
585 |
|
|
$ |
175,666 |
|
$ |
185,284 |
|
|
|
|
Current liabilities |
$ |
6,253 |
|
$ |
7,551 |
|
Stockholders’ equity |
|
169,413 |
|
|
177,733 |
|
|
$ |
175,666 |
|
$ |
185,284 |
|
|
|
|
Note 1: Derived from audited financial
statements included in the Company’s annual report on Form 10-K for
the year ended December 31, 2018.
CONTACT:
Suzanne MessereInvestor and Media
Relationsinvestor@geron.commedia@geron.com
CG Capital877-889-1972
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