Geron Corporation (Nasdaq: GERN) today announced recent company
events and reported financial results for the three and nine months
ended September 30, 2018. The Company ended the third quarter of
2018 with $184.8 million in cash and marketable securities and
expects to utilize these financial resources to advance the
clinical development of imetelstat, the Company’s first-in-class
telomerase inhibitor.
“We are very excited to have 100% ownership of imetelstat, a
Phase 3 ready asset with Phase 2 data from both IMerge and IMbark
that have been selected for oral presentations at the ASH meeting
in December,” said John A. Scarlett, M.D., Geron’s President and
Chief Executive Officer. “We are in the process of transitioning
imetelstat back to Geron and have the cash to support our key
near-term objective of commencing enrollment for the Phase 3
portion of IMerge by mid-year 2019.”
Recent Company Events
Geron regained the global rights to develop and commercialize
imetelstat upon the termination of a collaboration and license
agreement with Janssen Biotech, Inc. (Janssen). The transition of
the entire imetelstat program back to Geron is expected to occur
over approximately 12 months, through September 2019, with
operational support from Janssen. Patients currently enrolled in
the ongoing imetelstat clinical trials in myelofibrosis (IMbark)
and myelodysplastic syndromes (IMerge) will continue to be
supported through the respective trial protocols, including
treatment and follow-up. Previously, Geron and Janssen shared both
the IMerge and IMbark clinical development costs 50/50. While Geron
is now solely accountable for imetelstat development costs, each
company will be responsible for their own respective transition
costs as the imetelstat program transfers back to Geron.
After sponsorship of the imetelstat Investigational New Drug
(IND) application has been transferred from Janssen, Geron plans to
initiate the Phase 3 portion of IMerge in lower risk
myelodysplastic syndromes (MDS) and is targeting mid-year 2019 for
patient screening and enrollment. In addition, Geron intends to
discuss the results of the IMbark primary analysis, including the
assessment of overall survival as it compares to historical data,
with experts in myelofibrosis (MF), as well as regulatory
authorities. The Company believes feedback from these discussions
will provide important information on the feasibility, scope and
design of any potential future clinical trials for imetelstat in
Intermediate-2 or High-risk MF patients who have relapsed after or
are refractory to prior treatment with a JAK inhibitor.
Third Quarter and Year to Date 2018 Results
For the third quarter of 2018, the Company reported a net loss
of $5.6 million, or $0.03 per share, compared to $6.9 million, or
$0.04 per share, for the comparable 2017 period. Net loss for the
first nine months of 2018 was $19.7 million, or $0.11 per share,
compared to $20.5 million, or $0.13 per share, for the comparable
2017 period.
Revenues for the three and nine months ended September 30, 2018
were $165,000 and $691,000, respectively, compared to $163,000 and
$874,000 for the comparable 2017 periods. Revenues for the three
and nine months ended September 30, 2018 and 2017 included royalty
and license fee revenues under various non-imetelstat license
agreements. The Company adopted the new revenue recognition
accounting standard as of January 1, 2018 using the modified
retrospective transition method. Financial results for the three
and nine months ended September 30, 2018 are presented under the
new accounting standard, but prior period amounts have not been
adjusted and continue to be reported under accounting standards
used historically. Therefore, there is a lack of comparability to
the prior periods presented. As a result, the decrease in revenues
for the nine months ended September 30, 2018, compared to the same
period in 2017, reflects not only a reduction in the number of
active non-imetelstat license agreements, but also a change in the
accounting method. However, the Company does not expect the
adoption of the new revenue recognition accounting standard to have
a material impact to its financial statements on an ongoing
basis.
Total operating expenses for the three and nine months ended
September 30, 2018 were $7.0 million and $22.2 million,
respectively, compared to $7.4 million and $22.3 million for the
comparable 2017 periods.
Research and development expenses for the three and nine months
ended September 30, 2018 were $2.7 million and $8.4 million,
respectively, compared to $2.6 million and $8.5 million for the
comparable 2017 periods. The changes in research and development
expenses for the three and nine months ended September 30, 2018,
compared to the same periods in 2017, primarily reflect the net
result of higher personnel related expenses, partially offset by
lower costs for our proportionate share of clinical development
expenses under the former imetelstat collaboration with Janssen.
Geron expects research and development expenses to increase in the
future as Geron’s share of imetelstat development costs increases
from 50% previously to 100% as of the termination date of the
collaboration agreement and as it adds personnel, consultants and a
global contract research organization (CRO) to support the further
development of imetelstat.
General and administrative expenses for the three and nine
months ended September 30, 2018 were $4.3 million and $13.8
million, respectively, compared to $4.8 million and $13.8 million
for the comparable 2017 periods. The decrease in general and
administrative expenses for the three months ended September 30,
2018, compared to the same period in 2017, primarily reflects the
net result of reduced personnel related expenses, including lower
stock-based compensation expense, partially offset by higher
consulting expenses. Geron expects general and administrative
expenses to increase in the future with the elimination of
cost-sharing with Janssen as of the termination date of the
collaboration agreement for imetelstat patent prosecution expenses
and as it adds additional personnel to support the expansion of
internal research and development functions.
Interest and other income for the three and nine months ended
September 30, 2018 was $1.1 million and $2.2 million, respectively,
compared to $363,000 and $1.0 million for the comparable 2017
periods. The increase in interest and other income for the three
and nine months ended September 30, 2018, compared to the same
periods in 2017, primarily reflects higher yields on the Company’s
increased marketable securities portfolio.
Conference Call and Webcast
Geron will host a conference call to discuss third quarter
financial results and recent events at 4:30 p.m. ET on Thursday,
November 1, 2018.
Participants may access the conference call live via telephone
by dialing domestically +1 (877) 303-9139 or internationally +1
(760) 536-5195. The passcode is 7133129. 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 to High-risk myelofibrosis.
Imetelstat received Fast Track designation from 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 clinical stage 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) the prospects for
imetelstat; (ii) that more mature data for IMbark and IMerge will
be presented at the ASH meeting in December 2018; (iii) that
patient screening and enrollment for the Phase 3 portion of IMerge
will begin by mid-year 2019; (iv) that IMbark and IMerge will
continue; (v) that there may be a future clinical trial of
imetelstat for Intermediate-2 or High-risk MF patients who are
relapsed after or are refractory to prior treatment with a JAK
inhibitor; (vi) that adoption of the new revenue recognition
accounting standard will not have a material impact on the
Company’s financial statements; (vii) that imetelstat may have
disease-modifying activity; (viii) financial projections and
expectations; and (ix) 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 imetelstat will succeed
in IMbark and IMerge--including the Phase 3 portion, by overcoming
all of the clinical safety and efficacy, technical, scientific,
manufacturing and regulatory challenges and that regulatory
authorities permit both trials to continue without any clinical
holds; (ii) Janssen’s ability to collect additional and more mature
data from IMbark and IMerge for an update at ASH; (iii) whether
regulatory authorities permit the further development of imetelstat
on a timely basis, or at all, to enable patient screening and
enrollment of the Phase 3 portion of IMerge to begin by mid-year
2019; (iv) 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; (v) whether the
transition of the imetelstat program from Janssen to the Company
proceeds on a timely basis to enable patient screening and
enrollment of the Phase 3 portion of IMerge to begin by mid-year
2019; (vi) whether experts in MF and regulatory authorities believe
a Phase 3 clinical trial of imetelstat in MF should be initiated;
(vii) whether imetelstat does demonstrate disease-modifying
activity; (viii) whether adoption of the new revenue recognition
accounting standard does not in fact have a material impact on the
Company’s financial statements; and (ix) the need for future
capital. 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 September 30, 2018. 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.
CONTACT:
Suzanne MessereInvestor and Media
Relationsinvestor@geron.commedia@geron.com
CG Capital877-889-1972
GERON
CORPORATIONCONDENSED STATEMENTS OF
OPERATIONS(UNAUDITED)
|
|
|
|
Three Months
Ended |
Nine Months
Ended |
|
September
30, |
September
30, |
(In thousands, except share and per share
data) |
2018 |
|
2017 |
|
2018 |
|
2017 |
|
|
|
|
|
|
Revenues: |
|
|
|
|
License fees and
royalties.......................................... |
$ |
165 |
|
$ |
163 |
|
$ |
691 |
|
$ |
874 |
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and
development....................................... |
|
2,707 |
|
|
2,637 |
|
|
8,351 |
|
|
8,510 |
|
General and
administrative........................................ |
|
4,263 |
|
|
4,770 |
|
|
13,824 |
|
|
13,833 |
|
Total operating
expenses........................................ |
|
6,970 |
|
|
7,407 |
|
|
22,175 |
|
|
22,343 |
|
Loss from
operations................................................... |
|
(6,805 |
) |
|
(7,244 |
) |
|
(21,484 |
) |
|
(21,469 |
) |
|
|
|
|
|
|
|
|
|
Interest and other
income............................................. |
|
1,060 |
|
|
363 |
|
|
2,171 |
|
|
1,041 |
|
Change in fair value of equity
investment..................... |
|
205 |
|
|
— |
|
|
(270 |
) |
|
— |
|
Other
expense............................................................... |
|
(57 |
) |
|
(18 |
) |
|
(134 |
) |
|
(59 |
) |
Net
loss.......................................................................... |
$ |
(5,597 |
) |
$ |
(6,899 |
) |
$ |
(19,717 |
) |
$ |
(20,487 |
) |
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per
share: |
|
|
|
|
|
|
|
|
Net loss per
share......................................................... |
$ |
(0.03 |
) |
$ |
(0.04 |
) |
$ |
(0.11 |
) |
$ |
(0.13 |
) |
Shares used in computing net loss per
share............... |
|
184,301,986 |
|
|
159,216,642 |
|
|
173,187,753 |
|
|
159,186,853 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONDENSED BALANCE SHEETS
|
|
|
|
September 30, |
December 31, |
(In thousands) |
2018 |
2017 |
|
(Unaudited) |
(Note 1) |
Current assets: |
|
|
Cash, cash equivalents
and restricted cash..... |
$ |
12,998 |
|
$ |
16,603 |
Current
marketable securities........................... |
|
153,622 |
|
|
78,351 |
Other
current assets.......................................... |
|
2,254 |
|
|
1,016 |
Total
current assets......................................... |
|
168,874 |
|
|
95,970 |
|
|
|
|
|
|
Noncurrent marketable
securities................................ |
|
18,143 |
|
|
14,241 |
Property and equipment,
net....................................... |
|
66 |
|
|
102 |
Other
assets................................................................ |
|
851 |
|
|
— |
|
$ |
187,934 |
|
$ |
110,313 |
|
|
|
|
|
|
Current
liabilities.......................................................... |
$ |
4,467 |
|
$ |
6,516 |
Stockholders’
equity..................................................... |
|
183,467 |
|
|
103,797 |
|
$ |
187,934 |
|
$ |
110,313 |
Note 1: Derived from audited financial
statements included in the Company’s annual report on Form 10-K for
the year ended December 31, 2017.
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