Geron Corporation (Nasdaq: GERN), a late-stage clinical
biopharmaceutical company, today reported financial results for the
second quarter ended June 30, 2020. The Company will host a
conference call today at 4:30 p.m. ET to discuss second quarter
financial results and current events.
“In the second quarter, we achieved a number of key milestones
that have changed the trajectory of the Company,” said John A.
Scarlett, M.D., Chairman and Chief Executive Officer. “After a
successful meeting with the FDA, we announced plans to move forward
with a Phase 3 clinical trial in refractory MF with overall
survival as the primary endpoint. This decision was based on
overall survival data from the IMbark Phase 2 trial that suggest
imetelstat treatment could potentially double the remaining life
expectancy for patients who have become refractory to JAK
inhibitors.”
Dr. Scarlett added, “We reported clinically meaningful
transfusion independence with longer durability from more mature
data in the IMerge Phase 2 trial in lower risk MDS, which included
29% of patients being transfusion-free for more than one year. We
also raised additional capital in the second quarter that we expect
will sufficiently fund our development plans for the ongoing Phase
3 IMerge trial in lower risk MDS and the upcoming Phase 3 trial in
refractory MF into the second half of 2022. These achievements,
along with our experienced development team, position Geron to
become a leader in the treatment of hematologic myeloid
malignancies over the next several years.”
Current Events – Clinical Development and Regulatory
Ongoing IMerge Phase 3 Clinical Trial in
Myelodysplastic Syndromes (MDS)
As of the end of July 2020, approximately 93% of the 90 clinical
sites originally planned for the trial were open for screening and
enrollment, compared to 68% in May.
The momentum of patient enrollment has begun to improve as the
effects of the COVID-19 pandemic begin to wane in a majority of the
countries where IMerge clinical sites are located. The Company
continues to expect patient enrollment to be completed by the end
of the first quarter of 2021, subject to potential future delays or
interruptions associated with COVID-19. To help ensure achievement
of this goal, the trial is being expanded from 90 to approximately
130 clinical sites. Geron expects a majority of these 40 new sites
to be open for enrollment by the end of the year. Under current
enrollment assumptions, the Company continues to expect top-line
results in the second half of 2022.
Start-Up Activities for Planned Phase 3
Clinical Trial in Myelofibrosis (MF)
Geron expects to engage over 150 sites across North America,
South America, Europe and Asia to participate in the planned global
Phase 3 clinical trial in refractory MF. Trial start-up activities
underway include identifying potential clinical sites for
participation, as well as finalizing the clinical trial protocol.
Geron plans to open the trial for screening and enrollment in the
first quarter of 2021. Under current planning assumptions, Geron
expects to complete patient enrollment in the second half of 2022,
to conduct an interim analysis in the first half of 2023 and to
conduct a final analysis in the first half of 2024.
European Commission Grants Orphan Drug
Designation to Imetelstat for MDS
At the end of July, the European Commission granted orphan drug
designation to imetelstat as a potential treatment for MDS based on
a positive opinion from the European Medicines Agency Committee for
Orphan Medicinal Products. Imetelstat has already been granted
orphan drug designation by the United States Food and Drug
Administration as a potential treatment for MDS.
Recent Data Presentations in June
KOL Event Highlighted Compelling Phase 2
Data from the European Hematology Association (EHA) Annual
Congress
Key opinion leaders within hematologic myeloid malignancies
reprised four presentations containing new clinical data and
analyses related to imetelstat from the Virtual Edition of the EHA
Annual Congress.
The recent EHA presentation of more mature data from 38 patients
in the IMerge Phase 2 clinical trial in lower risk MDS reported
notable continued durability, including a median duration of 8-week
transfusion independence of 20 months, which is the longest
duration reported to date in this trial. Also reported for the
first time, 29% of the 38 patients were transfusion free for more
than one year.
In addition, new analyses from the IMbark Phase 2 clinical trial
in relapsed/refractory MF correlated the median overall survival
observed in the trial with other clinical endpoints, such as
improvement in fibrosis. These analyses provide further support for
the planned Phase 3 clinical trial in refractory MF.
Overall, the EHA data and analyses continue to support the
potential disease-modifying activity with imetelstat treatment as
evidenced by the clinically meaningful durable transfusion
independence in the Phase 2 IMerge trial and the improvement in
overall survival in the Phase 2 IMbark trial.
Strengthened Balance Sheet to Achieve Development
Plans
As of June 30, 2020, Geron had approximately $265 million in
cash, cash equivalents, and current and non-current marketable
securities. The Company’s cash position reflects net proceeds of
approximately $140 million from a public offering of securities in
the second quarter. Based on current planning assumptions, the
Company expects such funds to be sufficient for its operations into
the second half of 2022 when top-line results for the IMerge Phase
3 clinical trial in lower risk MDS and completion of patient
enrollment for the planned Phase 3 clinical trial in refractory MF
are expected.
Second Quarter and Year-to-Date 2020 Results
For the second quarter of 2020, the Company reported a net loss
of $15.8 million, or $0.06 per share, compared to $14.2 million, or
$0.08 per share, for the comparable 2019 period. Net loss for the
first six months of 2020 was $32.2 million, or $0.14 per share,
compared to $24.3 million, or $0.13 per share, for the comparable
2019 period.
Revenues for the three and six months ended June 30, 2020 were
$43,000 and $95,000, respectively, compared to $101,000 and
$158,000 for the comparable 2019 periods. Revenues in 2020 and 2019
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 future product sales.
Total operating expenses for the three and six months ended June
30, 2020 were $16.8 million and $33.7 million, respectively,
compared to $15.3 million and $26.7 million for the comparable 2019
periods.
Research and development expenses for the three and six months
ended June 30, 2020 were $10.8 million and $21.6 million,
respectively, compared to $10.1 million and $16.0 million for the
comparable 2019 periods. The increase in research and development
expenses for the three and six months ended June 30, 2020, compared
to the same periods in 2019, primarily reflects higher clinical
development costs associated with the IMerge Phase 3 clinical
trial, increased costs in connection with validating the imetelstat
manufacturing process at contract manufacturers and higher
personnel-related costs for additions to the development team in
2019.
General and administrative expenses for the three and six months
ended June 30, 2020 were $6.0 million and $12.1 million,
respectively, compared to $5.2 million and $10.6 million for the
comparable 2019 periods. The increase in general and administrative
expenses for the three and six months ended June 30, 2020, compared
to same periods in 2019, primarily reflects increased
personnel-related expenses for additional general and
administrative headcount to support growing operational
activities.
Interest and other income for the three and six months ended
June 30, 2020 was $475,000 and $1.2 million, respectively, compared
to $1.1 million and $2.3 million for the comparable 2019 periods.
The decrease in interest and other income for the three and six
months ended June 30, 2020, compared to same periods in 2019,
primarily reflects lower yields on the Company’s reduced marketable
securities portfolio.
2020 Financial Guidance Reaffirmed
The Company expects its 2020 operating expense burn to range
from $70 to $75 million. This guidance reflects cash conservation
measures implemented in April due to the COVID-19 pandemic, such as
suspending travel and postponing a planned imetelstat proof of
concept study. It also reflects new costs for start-up activities
associated with the planned Phase 3 clinical trial in refractory MF
and additional costs for the expansion of clinical sites for the
IMerge Phase 3 clinical trial.
Conference Call
Geron will host a conference call at 4:30 p.m. ET on Thursday,
August 6, 2020 to discuss second quarter financial results and
recent events.
A live, listen-only webcast will 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.
Participants may access the conference call live via telephone
by dialing domestically +1 (888) 869-1189 or internationally +1
(706) 643-5902. The conference ID is 8496138. To minimize potential
registration and access delays, Geron has implemented Direct Event,
which allows participants to pre-register online using the
following link,
http://www.directeventreg.com/registration/event/8496138. Upon
registration, a Direct Event Passcode and unique Registrant ID will
be sent via email and 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. Early clinical data suggest imetelstat may
have disease-modifying activity through the apoptosis of malignant
stem and progenitor cells, which allows potential recovery of
normal hematopoiesis. Geron’s imetelstat development program
includes two registration-enabling studies, IMerge, an ongoing
Phase 2/3 clinical trial in lower risk myelodysplastic syndromes
(MDS), and a planned Phase 3 clinical trial in refractory
myelofibrosis (MF) expected to be open for patient screening and
enrollment in the first quarter of 2021. 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 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) the therapeutic
potential of imetelstat, including imetelstat’s potential survival
benefit for refractory MF patients; (ii) that for the planned Phase
3 clinical trial in refractory MF, Geron expects to begin patient
screening and enrollment in the first quarter of 2021, complete
patient enrollment in the second half of 2022, conduct an interim
analysis in the first half of 2023 and conduct a final analysis in
the first half of 2024; (iii) that imetelstat may have
disease-modifying activity; (iv) that the Company has sufficient
finances to fund IMerge and the planned refractory MF clinical
trial into the second half of 2022; (v) that for IMerge, Geron
expects to complete enrollment in the first quarter of 2021 and
have top-line results in the second half of 2022; (vi) that Geron’s
2020 operating expense range will be $70-75 million; and (vii)
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
clinical, safety, efficacy, technical, scientific, intellectual
property, manufacturing and regulatory challenges in order to meet
the expected timelines and planned milestones in (ii), (iv) and (v)
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 clinical trials; (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) whether
imetelstat is able to maintain patent protection and have freedom
to operate; (h) Geron’s 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 (ii), (iv) and (v) above; (i) whether there are cost
overruns in 2020 due to the current or evolving effects of the
COVID-19 pandemic or otherwise; (j) whether Geron can accurately
project the timing of, or attain complete enrollment in IMerge, the
planned Phase 3 refractory MF trial or of any potential future
clinical trials of imetelstat, whether due to the current or
evolving effects of the COVID-19 pandemic or otherwise; and (k)
whether there are failures or delays in manufacturing 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. 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, 2020 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)
2020
2019
2020
2019
Revenues:
License fees and royalties
$
43
$
101
$
95
$
158
Operating expenses:
Research and development
10,845
10,134
21,647
16,040
General and administrative
5,960
5,191
12,080
10,643
Total operating expenses
16,805
15,325
33,727
26,683
Loss from operations
(16,762)
(15,224)
(33,632)
(26,525)
Interest and other income
475
1,113
1,229
2,275
Change in fair value of equity
investment
422
(98)
227
—
Other expense
41
(30)
(3)
(48)
Net loss
$
(15,824)
$
(14,239)
$
(32,179)
$
(24,298)
Basic and diluted net loss per
share:
Net loss per share
$
(0.06)
$
(0.08)
$
(0.14)
$
(0.13)
Shares used in computing net loss per
share
246,966,143
186,556,082
223,594,118
186,475,055
CONDENSED BALANCE
SHEETS
June 30,
December 31,
(In thousands)
2020
2019
(Unaudited)
(Note 1)
Current assets:
Cash, cash equivalents and restricted
cash
$
23,228
$
13,914
Current marketable securities
195,881
125,681
Other current assets
1,634
2,013
Total current assets
220,743
141,608
Noncurrent marketable securities
46,223
19,651
Property and equipment, net
734
408
Other assets
7,114
3,850
$
274,814
$
165,517
Current liabilities
$
19,142
$
28,162
Noncurrent liabilities
4,991
2,200
Stockholders’ equity
250,681
135,155
$
274,814
$
165,517
Note 1:
Derived from audited financial statements
included in the Company’s annual report on Form 10-K for the year
ended December 31, 2019.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200806005941/en/
Suzanne Messere Investor and Media Relations investor@geron.com
media@geron.com
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