Top-Line
Results from IMerge Phase 3 Trial in Lower Risk MDS Continue to be
Expected in Early January 2023
Started the
Phase 1 IMproveMF Study in Frontline MF in May 2022
Current and Projected Financial Resources
Expected to be Sufficient to Reach Planned Milestones through
Year-End 2023
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 malignancies, today
reported financial results for the first quarter of 2022, including
current and projected financial resources.
“This quarter, we continued to build on the momentum from our
clinical execution throughout 2021, with our first Phase 3 data
readout expected in just eight months. We believe that if the Phase
3 IMerge trial in lower risk MDS confirms similar depth, breadth
and durability of transfusion independence, and safety, observed in
our Phase 2 study, imetelstat could represent a significant
treatment advance for these heavily transfusion-burdened patients,”
said John A. Scarlett, M.D., Geron’s Chairman and Chief Executive
Officer. “Separately, we are advancing our IMpactMF Phase 3
refractory MF trial by continuing to open clinical sites around the
world, which we expect to enable a potential interim analysis in
2024. We are also executing on our IMproveMF Phase 1 study, which
has recently started. This study will allow us to potentially
demonstrate safety and efficacy of combination therapy with
imetelstat and ruxolitinib in the frontline MF setting.”
Dr. Scarlett continued: “The successful financing in April adds
to our current financial resources, as well as provides access to
additional capital upon the potential exercise of warrants in the
future. We expect these current and projected financial resources
will be sufficient for our projected operations through the end of
2023, including planned key regulatory milestones and
pre-commercial activities. In addition, this extended cash runway
provides us the opportunity to thoughtfully and broadly explore
multiple business strategies, including partnering and financing
options, to optimize the value of imetelstat for patients and
shareholders.”
Current and Projected Financial Resources
As of March 31, 2022, the Company had $178.0 million in cash and
marketable securities. In April 2022, the Company completed an
underwritten public offering of 53,333,334 shares of Geron common
stock and a pre-funded warrant to purchase 18,095,238 shares of
Geron common stock (pre-funded warrant), together with accompanying
warrants to purchase 35,714,286 shares of Geron common stock (stock
purchase warrants). The combined public offering price of the
common stock and accompanying stock purchase warrants was $1.05 per
share. The combined public offering price of the pre-funded warrant
and accompanying stock purchase warrant was $1.049 per share. The
net cash proceeds from this offering are approximately $70 million,
after deducting the underwriting discount and other offering
expenses payable by the Company and excludes any future proceeds
from the exercise of the pre-funded warrant or the stock purchase
warrants. The stock purchase warrants have an exercise price of
$1.45 per share and expire five years from the date of issuance;
however, such term will be shortened upon achievement of a
regulatory milestone.
Under current planning assumptions, the Company projects its
existing capital resources, including the net proceeds from the
public offering completed in April 2022, and projected future
proceeds of up to $124.3 million from the exercise of currently
outstanding warrants will be sufficient to fund Geron’s projected
level of operations, which includes preparatory activities for
potential U.S. commercial launch of imetelstat in lower risk MDS,
until the end of 2023.
First Quarter 2022 Results
For the first quarter of 2022, the Company reported a net loss
of $30.1 million, or $0.09 per share, compared to $27.8 million, or
$0.09 per share, for the same period in 2021.
Revenues for the first quarter of 2022 were $123,000 compared to
$137,000 for the same period in 2021. Royalty revenues in 2022 and
2021 primarily reflect estimated royalties from sales of cell-based
research products from the Company’s divested stem cell assets.
Total operating expenses for the first quarter of 2022 were
$28.8 million compared to $28.6 million for the same period in
2021. Research and development expenses for the first quarter of
2022 were $22.1 million compared to $21.1 million for the same
period in 2021. The increase in research and development expenses
in the first quarter of 2022, compared to the same period in 2021,
primarily reflects higher personnel-related costs for additional
headcount. General and administrative expenses for the first
quarter of 2022 were $6.7 million compared to $7.5 million for the
same period in 2021. The decrease in general and administrative
expenses in the first quarter of 2022, compared to the same period
in 2021, primarily reflects the net result of reduced costs related
to modernizing the internal infrastructure to support commercial
launch and lower legal fees, partially offset by higher
personnel-related expenses for additional headcount.
Interest income for the first quarter of 2022 was $112,000
compared to $173,000 for the same period in 2021. The decrease in
interest income in the first quarter of 2022, compared to the same
period in 2021, primarily reflects lower yields on the Company’s
reduced marketable securities portfolio.
Interest expense for the first quarter of 2022 was $1.5 million
compared to $743,000 for the same period in 2021. Currently, the
Company has $50.0 million in principal debt outstanding.
Net other expense for the first quarter of 2022 was $56,000
compared to net other income of $1.2 million for the same period in
2021. 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.
Projected 2022 Financial Guidance Reaffirmed
For fiscal year 2022, under generally accepted accounting
principles (GAAP), the Company continues to expect total operating
expenses in the range of approximately $155 million to $165
million, which includes non-cash items such as: stock-based
compensation expense, amortization of debt discounts and issuance
costs and depreciation and amortization. The Company continues to
expect non-GAAP total operating expenses for fiscal year 2022,
which excludes estimated non-cash items such as: stock-based
compensation expense, amortization of debt discounts and issuance
costs and depreciation and amortization, in the range of
approximately $140 million to $150 million.
The fiscal year 2022 financial guidance reflects costs to
support: (a) preparatory activities for top-line results from the
IMerge Phase 3 clinical trial and readiness for potential
regulatory filings and commercialization of imetelstat in lower
risk MDS; (b) continued conduct of IMerge and IMpactMF and
commencement of new clinical studies associated with the imetelstat
pipeline expansion strategy; (c) finalizing validation batches of
imetelstat at contract manufacturers to enable future production of
imetelstat for clinical and commercial purposes; (d) projected
increases in headcount and (e) interest payments on outstanding
debt.
As of March 31, 2022, the Company had 79 employees. The Company
plans to grow to a total of approximately 90 to 100 employees by
year-end 2022.
Conference Call
Geron will host a conference call at 4:30 p.m. ET on Monday, May
9, 2022 to review recent events and first quarter 2022 financial
results.
A live webcast of the conference call and related presentation
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 webcast by registering online using
the following link: https://conferencingportals.com/event/SmvlMvWL.
Participants that are unable to register online can access the
conference call via telephone by dialing domestically +1 (888)
330-2434 or internationally +1 (240) 789-2725. The conference ID is
67335.
About Imetelstat
Imetelstat is a novel, first-in-class telomerase inhibitor
exclusively owned by Geron and being developed in hematologic
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 myeloid hematologic 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 associated 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, duration of TI 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 fully enrolled and patient enrollment has been
closed. For additional information about IMerge Phase 3, 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 (MF) 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 remission, partial remission, 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 IMproveMF
IMproveMF is a single arm, open label Phase 1 study to evaluate
the safety, pharmacokinetics, pharmacodynamics and clinical
activity of imetelstat in combination with ruxolitinib in patients
with frontline myelofibrosis (MF), consisting of two parts. Part
one will enroll up to 20 patients and is designed to identify a
safe dose for the combination of imetelstat and ruxolitinib. Part
two will also enroll approximately 20 patients and is designed to
confirm the dose identified in part one.
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
malignancies. The Company currently is conducting two Phase 3
clinical trials: IMerge in lower risk myelodysplastic syndromes and
IMpactMF in refractory myelofibrosis.
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 for IMerge
Phase 3, Geron expects top-line results to be available in early
January 2023; (ii) for IMpactMF, that Geron expects to conduct an
interim analysis in 2024; (iii) that Geron believes its current and
projected financial resources are expected to be sufficient to fund
its projected level of operations to reach planned milestones
through year-end 2023; (iv) that Geron has planned for key
regulatory milestones and pre-commercial activities to occur
through the end of 2023; (v) that Geron believes current and
projected financial resources provide the opportunity to explore
multiple business strategies, including partnering and financing
options; (vi) that Geron expects total GAAP operating expenses in
2022 to be approximately $155 to $165 million and non-GAAP
operating expenses in 2022 to be approximately $140 to $150
million; (vii) that IMerge Phase 3 and IMpactMF have registrational
intent; (viii) that the Company believes the IMproveMF Phase 1
study will allow the Company to potentially demonstrate safety and
efficacy of combination therapy with imetelstat and ruxolitinib in
the frontline MF setting; (ix) that Geron believes that if the
Phase 3 IMerge trial in lower risk MDS confirms similar depth,
breadth and durability of transfusion independence, and safety,
observed in the Phase 2 study, imetelstat could represent a
significant treatment advance for heavily transfusion-burdened
patients; (x) that outstanding warrants will be exercised and yield
proceeds of up to $124.3 million; (xi) that imetelstat has the
potential to demonstrate disease-modifying activity; and (xii)
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/or the Russia/Ukraine conflict
cause global economic and financial disruptions that 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/or the Russia/Ukraine conflict, 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) to (iv) 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 to meet all of the expected
timelines and planned milestones in (i) to (iv) 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, or at all; (j)
whether the patient follow-up period of 12 months in IMerge Phase 3
results in not obtaining adequate data to demonstrate safety and
efficacy, including transfusion independence, for achieving success
in the primary analysis; (k) whether the FDA will approve
imetelstat for lower risk MDS based on IMerge Phase 3 safety and
efficacy data that is similar to the data in IMerge Phase 2: (l)
whether Geron can accurately project the timing of enrollment in
its clinical trials, whether due to the current or evolving effects
of the COVID-19 pandemic, the Russia/Ukraine conflict, or
otherwise; (m) whether Geron is able to enroll its clinical trials
at a pace that would enable the financial resources for, and to
meet the expected timelines and planned milestones in (i) to (iv)
above and (n) whether the outstanding warrants will be exercised
and result in proceeds of up to $124.3 million. 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, 2022
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.
Non-GAAP Financial Measure
To supplement Geron’s financial results and guidance presented
in accordance with GAAP, the Company is providing projected
non-GAAP total operating expenses, which excludes stock-based
compensation expense, amortization of debt discounts and issuance
costs and depreciation and amortization, from projected GAAP total
operating expenses. The Company believes this non-GAAP financial
measure, when considered together with other financial information
prepared in accordance with GAAP, can enhance investors’ and
analysts’ ability to meaningfully compare Geron’s results from
period to period and to projected forward-looking guidance, and to
identify operating trends in Geron’s business. The exclusion of
non-cash items, such as stock-based compensation expense,
amortization of debt discounts and issuance costs and depreciation
and amortization, does not directly or immediately relate to the
operational performance for the periods presented. This projected
non-GAAP financial measure is in addition to, not a substitute for,
or superior to, measures of financial performance projected in
accordance with GAAP. Geron encourages investors to carefully
consider the Company’s results under GAAP, as well as the
supplemental non-GAAP financial information, to more fully
understand Geron’s business.
Financial table follows.
GERON CORPORATION
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
UNAUDITED
Three Months Ended March
31,
(In thousands, except share and per share
data)
2022
2021
Revenues:
Royalties
$
123
$
137
Operating expenses:
Research and development
22,099
21,113
General and administrative
6,699
7,478
Total operating expenses
28,798
28,591
Loss from operations
(28,675
)
(28,454
)
Interest income
112
173
Interest expense
(1,479
)
(743
)
Other income and (expense), net
(56
)
1,200
Net loss
$
(30,098
)
$
(27,824
)
Basic and diluted net loss per
share:
Net loss per share
$
(0.09
)
$
(0.09
)
Shares used in computing net loss per
share
332,066,889
323,638,696
CONDENSED CONSOLIDATED BALANCE
SHEETS
March 31,
December 31,
(In thousands)
2022
2021
(Unaudited)
(Note 1)
Current assets:
Cash, cash equivalents and restricted
cash
$
31,689
$
35,235
Current marketable securities
135,345
148,851
Other current assets
8,890
3,120
Total current assets
175,924
187,206
Noncurrent marketable securities
10,945
28,651
Property and equipment, net
643
650
Deposits and other assets
10,909
9,527
$
198,421
$
226,034
Current liabilities
$
46,630
$
45,521
Noncurrent liabilities
54,304
54,097
Stockholders’ equity
97,487
126,416
$
198,421
$
226,034
Note 1:
Derived from audited financial
statements included in the Company’s annual report on Form 10-K for
the year ended December 31, 2021.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220509005012/en/
Aron Feingold VP, Investor Relations and Corporate
Communications investor@geron.com media@geron.com
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