IMerge Phase 3 Clinical Trial in
Myelodysplastic Syndromes 75% Enrolled and On Track to Complete
Enrollment in Second Half of 2021
Two Abstracts Accepted by European Hematology
Association for 2021 Virtual Congress
Conference Call Scheduled for 4:30 p.m. ET
Today
Geron Corporation (Nasdaq: GERN), a late-stage clinical
biopharmaceutical company developing a first-in-class telomerase
inhibitor, imetelstat, to treat hematologic myeloid malignancies,
today reported financial results for the first quarter ended March
31, 2021, as well as company highlights and upcoming events. As of
March 31, 2021, the Company had $244.7 million in cash and
marketable securities, which is expected to fund operations until
the end of 2022.
“We have worked diligently over the past quarter to advance our
two Phase 3 clinical trials with registrational intent, and we
remain laser focused on improving outcomes for patients and
delivering significant value to our shareholders,” said John A.
Scarlett, M.D., Geron’s Chairman and Chief Executive Officer.
“Completing 75% of the planned enrollment in our MDS trial
coupled with the recent dosing of the first patient in our MF trial
indicate the continued progress we are making in our two Phase 3
clinical trials for imetelstat,” said Aleksandra Rizo, M.D., Ph.D.,
Geron’s Chief Medical Officer. “We continue to have confidence in
imetelstat’s differentiating clinical benefits seen throughout the
course of its development, including strong evidence of
disease-modifying activity. We’re excited to have another
opportunity to highlight imetelstat’s strong data profile through
the two abstracts accepted for presentation at the upcoming
European Hematology Association meeting. We look forward to
achieving top-line results from our IMerge Phase 3 study and the
promising path ahead for imetelstat.”
Dr. Scarlett concluded, “We are excited about the progress we
are making to bring this important drug to patients. We are
planning for Geron to become a commercial company in 2023 with the
potential launch of imetelstat in lower risk MDS. The markets for
both lower risk MDS and refractory MF are highly attractive. We
continue to make preparations and manage our cash appropriately to
support the future buildout of our manufacturing and commercial
infrastructure.”
Company Highlights and Upcoming Data Presentations
Ongoing IMerge Phase 3 Clinical Trial in
Myelodysplastic Syndromes (MDS)
Screening and enrollment for IMerge Phase 3 in MDS continued to
progress in the first quarter. In early December 2020, the Company
had completed 50% of the planned patient enrollment in IMerge Phase
3. As of the end of April 2021, enrollment has increased to 75%.
The Company continues to expect the trial to be fully enrolled in
the second half of 2021. Depending on the timing of full
enrollment, the Company expects top-line results from IMerge Phase
3 to be available during the time period from the end of 2022 to
the first half of 2023.
For further information about IMerge Phase 3, including
enrollment criteria, locations, and current status, please visit
ClinicalTrials.gov/NCT02598661.
Ongoing IMpactMF Phase 3 Clinical Trial in
Refractory Myelofibrosis (MF)
On April 13, the Company announced that the first patient had
been dosed in IMpactMF, the only Phase 3 clinical trial in MF with
overall survival (OS) as a primary endpoint evaluating imetelstat,
a first-in-class telomerase inhibitor. The Company plans to engage
over 180 sites to participate in IMpactMF across North America,
South America, Europe, Australia, and Asia. The Company continues
to expect the interim analysis to occur in 2024 and the final
analysis in 2025.
For further information about IMpactMF, including enrollment
criteria, locations, and current status, please visit
ClinicalTrials.gov/NCT04576156.
Upcoming Data Presentations
Two abstracts reporting new clinical data and analyses from the
Phase 2 trials of imetelstat in lower risk MDS and refractory MF
have been accepted for presentation at the European Hematology
Association (EHA) Annual Congress meeting to be held virtually from
June 9 – 17, 2021. Both of the abstracts will be published on May
12, 2021 at 16:00 CEST on ehaweb.org.
First Quarter 2021 Results
For the first quarter of 2021, the Company reported a net loss
of $27.8 million, or $0.09 per share, compared to $16.4 million, or
$0.08 per share, for the same period in 2020.
Revenues for the first quarter of 2021 were $137,000 compared to
$52,000 for the same period in 2020. Royalty revenues in 2021 and
2020 primarily reflect estimated royalties from sales of cell-based
research products from the Company’s divested stem cell assets. In
connection with the divestiture of Geron’s human embryonic stem
cell assets, including intellectual property and proprietary
technology, to Lineage Cell Therapeutics, Inc. (formerly BioTime,
Inc., which acquired Asterias Biotherapeutics, Inc.) in 2013, Geron
is entitled to receive royalties on sales from certain research or
commercial products utilizing Geron’s divested intellectual
property.
Total operating expenses for the first quarter of 2021 were
$28.6 million compared to $16.9 million for the same period in
2020. Research and development expenses for the first quarter of
2021 were $21.1 million compared to $10.8 million for the same
period in 2020. The increase in research and development expenses
in the first quarter of 2021 compared to the same period in 2020
primarily reflects increased clinical development costs associated
with conducting two Phase 3 clinical trials, higher imetelstat
manufacturing costs for producing validation batches at contract
manufacturers to enable future production of imetelstat for
clinical and commercial purposes and higher personnel-related costs
for additional headcount. General and administrative expenses for
the first quarter of 2021 were $7.5 million compared to $6.1
million for the same period in 2020. The increase in general and
administrative expenses in the first quarter of 2021 compared to
the same period in 2020 primarily reflects new costs in connection
with pre-commercial activities, including modernizing the internal
infrastructure to support a commercial launch, and higher legal
costs.
Interest income for the first quarter of 2021 was $173,000
compared to $754,000 for the same period in 2020. The decrease in
interest income in the first quarter of 2021 compared to the same
period in 2020 primarily reflects lower yields on the Company’s
reduced marketable securities portfolio.
Interest expense for the first quarter of 2021 was $743,000 and
reflects the Company’s debt facility secured in September 2020 for
up to $75 million. Currently, $25.0 million has been drawn down
under the facility.
Net other income for the first quarter of 2021 was $1.2 million
compared to net other expense of $44,000 for the same period in
2020. During the first quarter of 2021, the Company sold all of its
holdings in an equity investment resulting in a net realized gain
of $1.2 million, including foreign currency translation
adjustments.
2021 Financial Guidance Reaffirmed
For fiscal year 2021, the Company continues to expect its
operating expense burn to range from $108 to $112 million, which
includes costs for the two ongoing Phase 3 clinical trials;
producing validation batches of imetelstat at contract
manufacturers to enable future production of imetelstat for
clinical and commercial purposes; and preparatory activities for
regulatory filings to enable drug approval and commercial
readiness.
As of March 31, 2021, the Company had 63 employees. The Company
plans to grow to a total of approximately 80 to 85 employees by
year-end 2021, of which the majority will be development and
manufacturing personnel.
Conference Call
The Company will host a conference call today, May 10, 2021 at
4:30 p.m. ET to review its first quarter financial results and
provide an update on the ongoing imetelstat Phase 3 clinical
trials, IMerge in MDS and IMpactMF in MF.
A live, listen-only webcast will be available on the Company’s
website at www.geron.com/investors/events. An archive of the
webcast will be available on the Company’s website for 30 days.
Participants may access the conference call live via telephone
by pre-registering online using the following link,
http://www.directeventreg.com/registration/event/2456438. Upon
registration, a phone number, Direct Event Passcode and unique
Registrant ID will be sent via email. This information will be
needed in order to enter the conference call. Participants are
advised to pre-register at least 10 minutes prior to joining the
call.
About Imetelstat
Imetelstat is a novel, first-in-class telomerase inhibitor
exclusively owned by Geron and being developed in hematologic
myeloid malignancies. Data from Phase 2 clinical trials provide
strong evidence that imetelstat targets telomerase to inhibit the
uncontrolled proliferation of malignant stem and progenitor cells
in hematologic myeloid malignancies resulting in malignant cell
apoptosis and potential disease-modifying activity. Imetelstat has
been granted Fast Track designation by the United States Food and
Drug Administration for both the treatment of patients with
non-del(5q) lower risk MDS who are refractory or resistant to an
erythropoiesis-stimulating agent and for patients with
Intermediate-2 or High-risk MF whose disease has relapsed after or
is refractory to janus kinase (JAK) inhibitor treatment.
About IMerge Phase 3
IMerge Phase 3 is a double-blind, randomized, placebo-controlled
Phase 3 clinical trial with registrational intent. The trial is
designed to enroll approximately 170 transfusion dependent patients
with Low or Intermediate-1 risk myelodysplastic syndromes (MDS),
also referred to as lower risk MDS, who have relapsed after or are
refractory to prior treatment with an erythropoiesis stimulating
agent (ESA). The primary endpoint is the rate of red blood cell
(RBC) transfusion independence (TI) for any consecutive period of
eight weeks or longer, or 8-week RBC-TI rate. Key secondary
endpoints include the rate of RBC-TI lasting at least 24 weeks, or
24-week RBC-TI rate, and the rate of hematologic
improvement-erythroid (HI-E), defined as a reduction of at least
four units of RBC transfusions over eight weeks compared with the
prior RBC transfusion burden.
IMerge Phase 3 is currently enrolling patients. For further
information about IMerge Phase 3, including enrollment criteria,
locations and current status, visit
ClinicalTrials.gov/NCT02598661.
About IMpactMF
IMpactMF is an open label, randomized, controlled Phase 3
clinical trial with registrational intent. The trial is designed to
enroll approximately 320 patients with Intermediate-2 or High-risk
myelofibrosis who are refractory to prior treatment with a JAK
inhibitor, also referred to as refractory MF. Patients will be
randomized to receive either imetelstat or best available therapy.
The primary endpoint is overall survival (OS). Key secondary
endpoints include symptom response, spleen response, progression
free survival, complete response, partial response, clinical
improvement, duration of response, safety, pharmacokinetics, and
patient reported outcomes.
IMpactMF is currently enrolling patients. For further
information about IMpactMF, including enrollment criteria,
locations and current status, visit
ClinicalTrials.gov/NCT04576156.
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. The Company currently is conducting two Phase
3 clinical trials: IMerge in lower risk myelodysplastic syndromes
and IMpactMF in refractory myelofibrosis. 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 Geron’s two
Phase 3 trials have registrational intent; (ii) that imetelstat has
shown strong evidence of disease-modifying activity, meaning that
imetelstat has the potential to demonstrate disease-modifying
activity in patients; (iii) that Geron plans to engage over 180
sites for IMpactMF; (iv) that Geron plans to become a commercial
company in 2023 with the potential launch of imetelstat in lower
risk MDS; (v) that Geron expects IMerge Phase 3 to be fully
enrolled in the second half of 2021; (vi) that Geron expects
top-line results for IMerge Phase 3 to be available during the time
period from the end of 2022 to the first half of 2023; (vii) that
under current planning assumptions for IMpactMF, Geron expects to
conduct an interim analysis in 2024 and a final analysis in 2025;
(viii) that Geron’s 2021 operating expense burn will range from
$108 to $112 million; (ix) that Geron expects to grow to 80-85
employees in 2021; and (x) other statements that are not historical
facts, constitute forward-looking statements. These forward-looking
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: (a) whether the
current or evolving effects of the COVID-19 pandemic and resulting
global economic and financial disruptions will materially and
adversely impact Geron’s business and business prospects, its
financial condition and the future of imetelstat; (b) whether Geron
overcomes all of the potential delays and other adverse impacts
caused by the current or evolving effects of the COVID-19 pandemic,
and overcomes all the enrollment, clinical, safety, efficacy,
technical, scientific, intellectual property, manufacturing and
regulatory challenges in order to meet the expected timelines and
planned milestones in (iii), (iv), (v), (vi) and (vii) above; (c)
whether regulatory authorities permit the further development of
imetelstat on a timely basis, or at all, without any clinical
holds; (d) whether imetelstat is demonstrated to be safe and
efficacious in IMerge Phase 3 and IMpactMF to enable regulatory
approval; (e) whether any future efficacy or safety results may
cause the benefit-risk profile of imetelstat to become
unacceptable; (f) whether imetelstat actually demonstrates
disease-modifying activity in patients; (g) that Geron will need to
raise substantial capital in order to complete the development and
commercialization of imetelstat, including to meet all of the
expected timelines and planned milestones in (iii), (iv), (v), (vi)
and (vii) above; (h) whether regulatory authorities require an
additional clinical trial for approval even if IMerge Phase 3 or
IMpactMF meet their respective primary endpoint(s); (i) whether
there are failures or delays in manufacturing or supplying
sufficient quantities of imetelstat or other clinical trial
materials in a timely manner, whether due to the current or
evolving effects of the COVID-19 pandemic or otherwise; (j) whether
imetelstat is able to maintain patent protection and have freedom
to operate; (k) whether there are cost overruns in 2021 due to the
current or evolving effects of the COVID-19 pandemic or otherwise;
(l) whether Geron can accurately project the timing of, or attain
complete enrollment in IMerge Phase 3 or IMpactMF, whether due to
the current or evolving effects of the COVID-19 pandemic or
otherwise; and (m) whether Geron is able to enroll IMerge Phase 3
and IMpactMF at a pace that would enable meeting the timelines in
(iv), (v), (vi) and (vii) above. 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 filings and periodic reports filed with the Securities and
Exchange Commission under the heading “Risk Factors” and elsewhere
in such filings and reports, including Geron’s quarterly report on
Form 10-Q for the quarter ended March 31, 2021 and future filings
and reports by Geron. 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 CORPORATION
CONDENSED STATEMENTS OF
OPERATIONS
UNAUDITED
Three
Months Ended March 31,
(In thousands, except share and per share
data)
2021
2020
Revenues:
License fees and royalties
$
137
$
52
Operating expenses:
Research and development
21,113
10,802
General and administrative
7,478
6,120
Total operating expenses
28,591
16,922
Loss from operations
(28,454
)
(16,870
)
Interest income
173
754
Interest expense
(743
)
—
Change in fair value of equity
investment
—
(195
)
Other income and expense, net
1,200
(44
)
Net loss
$
(27,824
)
$
(16,355
)
Basic and diluted net loss per
share:
Net loss per share
$
(0.09
)
$
(0.08
)
Shares used in computing net loss per
share
323,638,696
200,222,092
CONDENSED BALANCE
SHEETS
March 31,
December 31,
(In thousands)
2021
2020
(Unaudited)
(Note 1)
Current assets:
Cash, cash equivalents and restricted
cash
$
31,900
$
10,288
Current marketable securities
179,490
186,350
Other current assets
3,874
3,219
Total current assets
215,264
199,857
Noncurrent marketable securities
33,289
63,387
Property and equipment, net
620
658
Deposits and other assets
9,435
6,826
$
258,608
$
270,728
Current liabilities
$
28,552
$
30,940
Noncurrent liabilities
28,894
28,841
Stockholders’ equity
201,162
210,947
$
258,608
$
270,728
Note 1: Derived from audited financial statements
included in the Company’s annual report on Form 10-K for the year
ended December 31, 2020.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210510005296/en/
Olivia Bloom Chief Financial Officer investor@geron.com
media@geron.com
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