Completion of Enrollment in IMerge Phase 3
Expected in the Fourth Quarter of 2021
Investor Day Planned for November
Second Quarter and Year to Date 2021 Financial
Results Also Reported
Conference Call Scheduled for 4:30 p.m. ET
Today
Geron Corporation (Nasdaq: GERN), a late-stage clinical
biopharmaceutical company, today reported updates on the IMerge
Phase 3 trial in lower risk MDS and financial results for the
second quarter ended June 30, 2021. The Company will host a
conference call today at 4:30 p.m. ET to discuss these updates and
current events. As of June 30, 2021, the Company had $239.1 million
in cash and marketable securities. These financial resources,
combined with expected future non-dilutive funding under the
current debt facility, are expected to fund operations through the
end of the first quarter of 2023.
“We are pleased with the achievement of 91% of the planned
enrollment in IMerge Phase 3 and expect the trial to be fully
enrolled in the fourth quarter of 2021. In addition, the expected
timing for top-line results in IMerge Phase 3 has been accelerated
by three months to the first quarter of 2023,” said John A.
Scarlett, M.D., Chairman and Chief Executive Officer. “By
confirming the results from IMerge Phase 2 in the current IMerge
Phase 3, including the depth, breadth and durability of transfusion
independence, as well as the potential for disease modification, we
expect imetelstat to be a highly differentiated product in lower
risk MDS in comparison to drugs currently approved or in
development today. We look forward to bringing this innovative and
important drug to lower risk MDS patients, for whom there remain
limited treatment options.”
Phase 3 Clinical Development
Ongoing IMerge Phase 3 Clinical Trial in
Lower Risk Myelodysplastic Syndromes (LR MDS)
As of August 12, 2021, the Company had achieved 91% of the
planned enrollment in IMerge Phase 3. The Company expects the trial
to be fully enrolled in the fourth quarter of 2021. In July 2021, a
regularly scheduled Independent Data Monitoring Committee (IDMC)
meeting was held, and the IDMC recommended that the trial continue
without modification.
The significantly longer enrollment period caused by the
COVID-19 pandemic has enabled a longer follow-up period than
previously projected. As a result, the Company determined that the
clinical cut-off date for the primary analysis could occur three
months earlier than originally planned, which the Company expects
will still provide a sufficiently mature data set to assess the
benefit-risk profile of imetelstat. The Company has shortened the
follow-up period after the last patient has been enrolled from 15
months to 12 months to enable the earlier clinical cut-off date for
the primary analysis. With the revised 12-month follow-up period
for the primary analysis, the Company now projects that top-line
results from IMerge Phase 3 will be available in the first quarter
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)
The Company plans to engage over 180 sites to participate in
IMpactMF across North America, South America, Europe, Australia,
and Asia, of which 55 sites are currently open for enrollment. In
the second quarter of 2021, the first patient was dosed in
IMpactMF. The Company continues to expect the interim analysis to
occur in 2024 and the final analysis in 2025.
As the only MF Phase 3 trial with overall survival (OS) as the
primary endpoint, the Company expects that success in this trial
would provide unequivocal proof of clinical benefit for patients,
as well as further evidence of disease-modifying activity with
imetelstat treatment.
For further information about IMpactMF, including enrollment
criteria, locations, and current status, please visit
ClinicalTrials.gov/NCT04576156.
Investor Day
In November 2021, Geron plans to host a virtual event for
investors and analysts at which management and key opinion leaders
will discuss the following topics:
- Imetelstat’s potential for disease modification in LR MDS and
refractory MF;
- Expected path to commercializing imetelstat;
- Expansion of imetelstat development plans, including new
studies in additional indications; and
- An early discovery program in second generation telomerase
inhibitors.
Recently Reported Data in June 2021
Poster Presentations at EHA2021 Virtual
Congress
In June 2021, two poster presentations of imetelstat Phase 2
data were made at the European Hematology Association (EHA) Virtual
Congress. These presentations, available on Geron’s website,
further support imetelstat’s potentially differentiated approach to
inhibiting telomerase activity to target the malignant stem and
progenitor cells in the bone marrow responsible for the underlying
hematologic myeloid malignancies.
The first poster presented new data and analyses of the clinical
efficacy of imetelstat in molecularly defined subtypes based on
cytogenetic and mutation profiles for patients in the IMerge Phase
2 clinical trial in lower risk MDS. As reported at previous EHA
meetings, meaningful and durable transfusion independence was
observed in patients from IMerge Phase 2, including
transfusion-free periods greater than one year, as well as
substantial increases in hemoglobin. The new poster presentation
reported clinical responses across different cytogenetic and
molecularly defined categories, and these responses were
independent of mutation status or number of mutations. These data
support the unique telomerase inhibition mechanism of action of
imetelstat and the potential to target the malignant stem and
progenitor cells of the underlying disease. The Company is
exploring these observations further in the ongoing IMerge Phase
3.
The second poster at EHA presented new analyses of safety data
from the IMbark Phase 2 trial in MF and the IMerge Phase 2 trial in
lower risk MDS to understand the characteristics of hematologic and
non-hematologic adverse events. These analyses highlighted that the
imetelstat-related cytopenias are short, reversable and with
limited clinical consequence when managed with the dose
modification guidelines in the protocols.
Publication of IMbark Phase 2 Data in
Journal of Clinical Oncology
Efficacy, safety and biomarker results from the IMbark Phase 2
clinical trial were published in the Journal of Clinical Oncology
in a paper entitled “Randomized, Single-Blind, Multicenter Phase II
Study of Two Doses of Imetelstat in Relapsed or Refractory
Myelofibrosis.” The publication, which is available online,
highlights the clinical benefits observed in the study, including
symptom response and OS, as well as evidence of disease-modifying
activity from biomarker and bone marrow fibrosis assessments.
The trial design for IMpactMF is intended to confirm the IMbark
Phase 2 results and to enable imetelstat to be a potential
treatment option for MF patients who no longer respond to currently
approved JAK inhibitor therapies. Currently, there is no approved
drug for patients who fail or no longer respond to JAK inhibitor
therapies, and median survival for such MF patients after
discontinuation from ruxolitinib is only approximately 14 – 16
months, representing a significant unmet medical need.
Second Quarter and Year-to-Date 2021 Results
For the second quarter of 2021, the Company reported a net loss
of $29.6 million, or $0.09 per share, compared to $15.8 million, or
$0.06 per share, for the comparable 2020 period. Net loss for the
first six months of 2021 was $57.4 million, or $0.18 per share,
compared to $32.2 million, or $0.14 per share, for the comparable
2020 period.
Revenues for the three and six months ended June 30, 2021 were
$107,000 and $244,000, respectively, compared to $43,000 and
$95,000 for the comparable 2020 periods. 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 three and six months ended June
30, 2021 were $29.0 million and $57.6 million, respectively,
compared to $16.8 million and $33.7 million for the comparable 2020
periods.
Research and development expenses for the three and six months
ended June 30, 2021 were $21.9 million and $43.1 million,
respectively, compared to $10.8 million and $21.6 million for the
comparable 2020 periods. The increase in research and development
expenses for the three and six months ended June 30, 2021, compared
to the same periods 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 three and six months
ended June 30, 2021 were $7.1 million and $14.5 million,
respectively, compared to $6.0 million and $12.1 million for the
comparable 2020 periods. The increase in general and administrative
expenses for the three and six months ended June 30, 2021, compared
to the same periods 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 three and six months ended June 30, 2021
was $136,000 and $309,000, respectively, compared to $475,000 and
$1.2 million for the comparable 2020 periods. The decrease in
interest income for the three and six months ended June 30, 2021,
compared to the same periods in 2020, primarily reflects lower
yields on the Company’s marketable securities portfolio.
Interest expense for the three and six months ended June 30,
2021 was $804,000 and $1.5 million, respectively and reflects the
Company’s debt facility secured in September 2020 for up to $75
million. In June 2021, the Company completed a drawdown of $10.0
million in accordance with the loan agreement. Currently, a total
of $35.0 million has been drawn down under the facility.
Financial Resources
Previously, the Company provided guidance that its financial
resources were sufficient to fund its operations through the end of
2022. As of June 30, 2021, the Company had $239.1 million in cash
and marketable securities. These financial resources, combined with
expected future non-dilutive funding under the current debt
facility, are now expected to fund operations through the end of
the first quarter of 2023.
As of June 30, 2021, the Company had 68 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
Geron will host a conference call at 4:30 p.m. ET on Monday,
August 16, 2021 to provide an update on the ongoing imetelstat
Phase 3 clinical trials, IMerge in MDS and IMpactMF in MF, as well
as discuss second quarter financial results.
To view the Company’s slide presentation and listen to the
conference call live via webcast, visit the Company’s website at
www.geron.com/investors/events at the time of the conference call.
An archive of the webcast will also 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/5548255. 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
expects IMerge Phase 3 to be fully enrolled in the fourth quarter
of 2021; (ii) that Geron expects top-line results for IMerge Phase
3 to be available in the first quarter of 2023; (iii) that Geron
expects to conduct an interim analysis for IMpactMF in 2024 and a
final analysis in 2025; (iv) that Geron expects its financial
resources, with the expected non-dilutive funding under the current
debt facility, to fund operations through the end of the first
quarter of 2023; (v) that Geron expects to grow to 80-85 employees
in 2021; (vi) that Geron plans to engage over 180 sites for
IMpactMF; (vii) that IMerge Phase 3 and IMpactMF have
registrational intent; (viii) that imetelstat has the potential to
demonstrate disease-modifying activity in patients and to target
the malignant stem and progenitor cells of the underlying disease;
(ix) that the Company expects imetelstat to be a highly
differentiated product in the lower risk MDS commercial
marketplace; (x) that the Company expects that the shortened
12-month follow-up period will still provide a sufficiently mature
data set to assess the benefit-risk profile of imetelstat; and (xi)
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 have the financial resources for, and to meet the expected
timelines and planned milestones in (i) through (vi) 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 and the ability to target
the malignant stem and progenitor cells of the underlying disease;
(g) that Geron may seek 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 (i) through (vi) above; (h) whether regulatory
authorities require an additional clinical trial for approval even
if IMerge Phase 3 or IMpactMF meet their respective primary
endpoints; (i) whether there are failures or delays in
manufacturing or supplying sufficient quantities of imetelstat or
other clinical trial materials in a timely manner; (j) whether
imetelstat is able to maintain patent protection and have freedom
to operate; (k) whether the shortened follow-up period of 12 months
for the IMerge Phase 3 primary analysis results in not obtaining
sufficient data to demonstrate safety and efficacy, including
transfusion independence, of imetelstat to support any application
for regulatory approval; (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 the
financial resources for, and to meet the expected timelines and
planned milestones in (i) through (vi) 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 June 30, 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
Six Months Ended
June
30,
June
30,
(In thousands, except share and per share
data)
2021
2020
2021
2020
Revenues:
License fees and royalties
$
107
$
43
$
244
$
95
Operating expenses:
Research and development
21,937
10,845
43,050
21,647
General and administrative
7,059
5,960
14,537
12,080
Total operating expenses
28,996
16,805
57,587
33,727
Loss from operations
(28,889
)
(16,762
)
(57,343
)
(33,632
)
Interest income
136
475
309
1,229
Interest expense
(804
)
—
(1,547
)
—
Change in fair value of equity
investment.
—
422
—
227
Other income and expense, net
(17
)
41
1,183
(3
)
Net loss
$
(29,574
)
$
(15,824
)
$
(57,398
)
$
(32,179
)
Basic and diluted net loss per
share:
Net loss per share
$
(0.09
)
$
(0.06
)
$
(0.18
)
$
(0.14
)
Shares used in computing net loss per
share
327,026,907
246,966,143
325,342,161
223,594,118
CONDENSED BALANCE
SHEETS
June 30,
December 31,
(In thousands)
2021
2020
(Unaudited)
(Note 1)
Current assets:
Cash, cash equivalents and restricted
cash
$ 57,645
$ 10,288
Current marketable securities
140,959
186,350
Other current assets
3,158
3,219
Total current assets
201,762
199,857
Noncurrent marketable securities
40,521
63,387
Property and equipment, net
590
658
Other assets
9,302
6,826
$
252,175
$
270,728
Current liabilities
$ 37,013
$ 30,940
Noncurrent liabilities
38,956
28,841
Stockholders’ equity
176,206
210,947
$
252,175
$
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/20210816005218/en/
Olivia Bloom Chief Financial Officer investor@geron.com
media@geron.com
Geron (NASDAQ:GERN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Geron (NASDAQ:GERN)
Historical Stock Chart
From Sep 2023 to Sep 2024