Geron Corporation (Nasdaq: GERN), a late-stage clinical
biopharmaceutical company, today reported financial results for the
third quarter ended September 30, 2020. The Company will host a
conference call today at 4:30 p.m. ET to discuss third quarter
financial results and current events. As of September 30, 2020,
Geron had approximately $274 million in cash and investments. Based
on current planning assumptions, the Company estimates its current
financial resources to be sufficient for its operations until the
end of 2022.
“In the third quarter, we executed on our clinical, regulatory
and publication plans for the imetelstat program,” said John A.
Scarlett, M.D., Chairman and Chief Executive Officer. “We continued
to advance both the enrollment of the ongoing IMerge Phase 3
clinical trial and start-up activities for the upcoming Phase 3
clinical trial in refractory myelofibrosis, which we have named
IMpactMF. We also secured European orphan drug designation in lower
risk MDS; received acceptance for presentation of all ten abstracts
submitted to the ASH Annual Meeting; and had the IMerge Phase 2
data published in the well-respected Journal of Clinical Oncology.
In addition, we strengthened our balance sheet with a loan facility
that provides additional financial flexibility to support our plans
for imetelstat development going forward.”
Dr. Scarlett added, “We continue to work toward completing
enrollment in IMerge in the first quarter of 2021. However, the
recent resurgence of the COVID-19 pandemic is causing an uncertain
and unpredictable impact on clinical trial activities. Due to these
challenges, we now believe the trial will most likely be fully
enrolled in the second quarter of 2021. As long as enrollment is
complete by the end of the first half of 2021, we continue to
expect top-line results from IMerge to be available in the second
half of 2022, as previously guided. Based on current feedback from
clinical sites planned to participate in IMpactMF, we continue to
expect that trial to be open for screening and enrollment in the
first quarter of 2021.”
Current Events – Clinical
Development
Ongoing IMerge Phase 3 Clinical Trial in Myelodysplastic
Syndromes (MDS)
Enrollment for the IMerge Phase 3 clinical trial continued to
progress in the third quarter. In August 2020, all 92 of the
originally planned clinical sites were open for enrollment.
To address enrollment delays related to the COVID-19 pandemic
experienced earlier this year, Geron implemented certain enrollment
boosting activities, including engaging clinical science liaisons
to interface directly with clinical sites and expanding the number
of clinical sites to diversify the participating countries. The
Company currently expects to add approximately 30 new clinical
sites in several countries, including new sites in four additional
countries that had not previously participated in IMerge. The
Company expects almost all of the new sites to be open for
screening and enrollment by the end of 2020.
Under current planning assumptions, the Company expects
enrollment in the IMerge Phase 3 trial to be complete in the second
quarter of 2021 and continues to expect top-line results to be
available in the second half of 2022. This anticipated timing is
subject to potential delays or interruptions associated with the
evolving effects of the ongoing COVID-19 pandemic, which causes
unpredictability when projecting future enrollment trends.
Upcoming IMpactMF Phase 3 Clinical Trial in Myelofibrosis
(MF)
The Phase 3 clinical trial in refractory MF with overall
survival (OS) as its primary endpoint, named IMpactMF, is expected
to be open for screening and enrollment in the first quarter of
2021. Geron expects to engage over 150 sites across North America,
South America, Europe and Asia. The clinical trial protocol has
been finalized and is available on clinicaltrials.gov. Trial
start-up activities are ongoing and include site selection,
engagement of vendors, and building of the clinical trial
database.
The final analysis for OS is event-driven and is planned to be
conducted after more than 50% of the patients enrolled in the trial
have died. An interim analysis of OS is planned to be conducted
after approximately 70% of the total projected number of events for
the final analysis have occurred. If the pre-specified,
statistically significant difference in OS between the two
treatment arms is met at the interim analysis, it is possible that
data from the interim analysis could support a registration filing.
Both the planned interim and final analyses are event-driven and
could occur on different timelines than currently expected.
Under current planning assumptions, Geron plans 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.
Financial Resources to Reach Clinical
Milestones
The Company’s current cash position reflects net proceeds of
approximately $140 million from a public offering in May 2020 and
approximately $24 million in initial net proceeds from a $75
million loan facility that closed at the end of the third quarter.
The loan facility is available through year-end 2022 in three
tranches subject to the achievement of certain clinical, financial
and regulatory milestones. The loan facility provides access to
non-dilutive financial resources to support the imetelstat
development program, as well as working capital and general
corporate purposes.
Third Quarter and
Year-to-Date
2020 Results
For the third quarter of 2020, the Company reported a net loss
of $19.7 million, or $0.06 per share, compared to $15.2 million, or
$0.08 per share, for the comparable 2019 period. Net loss for the
first nine months of 2020 was $51.8 million, or $0.20 per share,
compared to $39.5 million, or $0.21 per share, for the comparable
2019 period.
Revenues for the three and nine months ended September 30, 2020
were $108,000 and $203,000, respectively, compared to $131,000 and
$289,000 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 nine months ended
September 30, 2020 were $20.1 million and $53.9 million,
respectively, compared to $16.1 million and $42.8 million for the
comparable 2019 periods.
Research and development expenses for the three and nine months
ended September 30, 2020 were $13.6 million and $35.3 million,
respectively, compared to $11.1 million and $27.1 million for the
comparable 2019 periods. The increase in research and development
expenses for the three and nine months ended September 30, 2020,
compared to the same periods in 2019, primarily reflects increased
costs to support the ongoing IMerge Phase 3 and start-up activities
for the upcoming IMpactMF Phase 3 clinical trial. The increase also
includes higher costs in connection with validating the imetelstat
manufacturing process at contract manufacturers and additional
personnel-related costs for expansion of the development team in
2019.
General and administrative expenses for the three and nine
months ended September 30, 2020 were $6.5 million and $18.6
million, respectively, compared to $5.0 million and $15.6 million
for the comparable 2019 periods. The increase in general and
administrative expenses for the three and nine months ended
September 30, 2020, compared to same periods in 2019, primarily
reflects higher personnel-related expenses for additional general
and administrative headcount to support growing operational
activities and increased legal costs.
Interest and other income for the three and nine months ended
September 30, 2020 was $504,000 and $1.7 million, respectively,
compared to $1.0 million and $3.3 million for the comparable 2019
periods. The decrease in interest and other income for the three
and nine months ended September 30, 2020, compared to same periods
in 2019, primarily reflects lower yields on the Company’s
marketable securities portfolio due to declining interest
rates.
2020 Financial Guidance
Reaffirmed
The Company continues to expect its 2020 operating expense burn
to range from $70 to $75 million. This guidance includes new costs
for start-up activities associated with the IMpactMF Phase 3
clinical trial 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,
November 5, 2020 to discuss third 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 pre-registering online using the following link,
http://www.directeventreg.com/registration/event/7879966. 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. 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 IMpactMF, an upcoming 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) that imetelstat
may have disease-modifying activity; (ii) that Geron’s current
financial resources are sufficient for its operations until the end
of 2022; (iii) that IMpactMF will be open for screening and
enrollment in the first quarter of 2021; (iv) that the loan
facility is available through the end of 2022 subject to the
achievement of certain clinical, financial and regulatory
milestones; (v) that IMerge will likely be fully enrolled by the
end of the second quarter of 2021; (vi) that top-line results for
IMerge will be available in the second half of 2022; (vii) that
almost all of the new IMerge sites will be open for screening and
enrollment by the end of 2020; (viii) the possibility that data
from the IMpactMF interim analysis could support a registrational
filing; (ix) that under current planning assumptions, for IMpactMF
Geron expects to 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; (x) that
Geron’s 2020 expense burn will range from $70 to $75 million; 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
clinical, safety, efficacy, technical, scientific, intellectual
property, manufacturing and regulatory challenges in order to meet
the expected timelines and planned milestones in (iii), (v), (vi),
(vii) and (ix) 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) 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), (v), (vi), (vii) and (ix) above; (h)
whether Geron is able to achieve the required milestones to be
eligible for the additional tranches of the loan facility; (i)
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; (j) whether imetelstat is able
to maintain patent protection and have freedom to operate; (k)
whether there are cost overruns in 2020 due to the current or
evolving effects of the COVID-19 pandemic or otherwise; and (l)
whether Geron can accurately project the timing of, or attain
complete enrollment in IMerge or IMpactMF, 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
September 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
CORPORATIONCONDENSED STATEMENTS OF
OPERATIONS(UNAUDITED)
|
Three Months Ended |
|
Nine Months Ended |
|
September 30, |
|
September 30, |
(In thousands, except share
and per share data) |
2020 |
|
2019 |
|
2020 |
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License fees and royalties |
$ |
108 |
|
|
$ |
131 |
|
|
$ |
203 |
|
|
$ |
289 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
13,613 |
|
|
|
11,109 |
|
|
|
35,260 |
|
|
|
27,149 |
|
General and administrative |
|
6,510 |
|
|
|
4,994 |
|
|
|
18,590 |
|
|
|
15,637 |
|
Total operating expenses |
|
20,123 |
|
|
|
16,103 |
|
|
|
53,850 |
|
|
|
42,786 |
|
Loss from operations |
|
(20,015 |
) |
|
|
(15,972 |
) |
|
|
(53,647 |
) |
|
|
(42,497 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other income |
|
504 |
|
|
|
1,021 |
|
|
|
1,733 |
|
|
|
3,296 |
|
Change in fair value of equity
investment |
|
(118 |
) |
|
|
(195 |
) |
|
|
109 |
|
|
|
(195 |
) |
Interest and other
expense |
|
(22 |
) |
|
|
(34 |
) |
|
|
(25 |
) |
|
|
(82 |
) |
Net loss |
$ |
(19,651 |
) |
|
$ |
(15,180 |
) |
|
$ |
(51,830 |
) |
|
$ |
(39,478 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share |
$ |
(0.06 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.21 |
) |
Shares used in computing net loss per share |
|
318,799,174 |
|
|
|
189,123,647 |
|
|
|
255,560,779 |
|
|
|
187,367,621 |
|
CONDENSED BALANCE SHEETS
|
September
30, |
|
December 31, |
(In thousands) |
2020 |
|
2019 |
|
(Unaudited) |
|
(Note 1) |
Current assets: |
|
|
|
|
Cash, cash equivalents and restricted cash |
$ |
45,319 |
|
$ |
13,914 |
Current marketable securities |
|
182,667 |
|
|
125,681 |
Other current assets |
|
3,875 |
|
|
2,013 |
Total current assets |
|
231,861 |
|
|
141,608 |
|
|
|
|
|
Noncurrent marketable
securities |
|
45,768 |
|
|
19,651 |
Property and equipment,
net |
|
689 |
|
|
408 |
Deposits and other assets |
|
7,475 |
|
|
3,850 |
|
$ |
285,793 |
|
$ |
165,517 |
|
|
|
|
|
Current liabilities |
$ |
24,154 |
|
$ |
28,162 |
Noncurrent liabilities |
|
28,807 |
|
|
2,200 |
Stockholders’ equity |
|
232,832 |
|
|
135,155 |
|
$ |
285,793 |
|
$ |
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.
CONTACT:Suzanne MessereInvestor and Media
Relationsinvestor@geron.commedia@geron.com
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