Geron Corporation (Nasdaq: GERN) today reported financial results
for the fourth quarter and full year ended December 31, 2018 and
recent events. As of year-end 2018, the Company had approximately
$182 million in cash and marketable securities, which is sufficient
to commence the planned Phase 3 clinical trial of imetelstat in
lower risk myelodysplastic syndromes (MDS) by mid-year 2019.
“We expect 2019 to be a pivotal year,” said John A. Scarlett,
M.D., Chairman and Chief Executive Officer. “We are making good
progress in the transition of the imetelstat program and expect to
assume sponsorship of the imetelstat clinical trials by the end of
the second quarter. We continue planning to open the Phase 3
clinical trial of imetelstat in lower risk MDS for enrollment by
mid-year, as well as evaluating the potential for late-stage
development in MF. In addition, we expect to further expand our
team with individuals who have strong development expertise that
will enable us to build a robust hematology-oncology
franchise.”
Recent Events
Building a Development Team with Hematology-Oncology
Expertise
The Company recently announced the hiring of two key development
executives. Aleksandra Rizo, M.D., Ph.D., the former clinical lead
for the imetelstat program at Janssen, joined Geron as Chief
Medical Officer. Israel Gutierrez, M.D., who has more than 20 years
of oncology clinical development experience, joined Geron as Vice
President, Pharmacovigilance and Drug Safety. In addition, Geron
plans to open an office in northern New Jersey to access
experienced personnel with late-stage hematology-oncology clinical
drug development expertise, as well as to enable efficient support
for global clinical trials, including the Phase 3 clinical trial of
imetelstat in lower risk MDS.
Fourth Quarter 2018 Highlights
IMerge Phase 2 Data Presented Support Initiation of Phase 3
Trial in Lower Risk MDS
Data for the Phase 2 portion of IMerge were presented in an oral
presentation at the American Society of Hematology (ASH) annual
meeting on December 2, 2018. Geron believes these data support
initiating the Phase 3 portion of IMerge to address an unmet
medical need for patients for whom erythropoiesis stimulating
agents (ESAs) are not effective and for whom currently available
therapies show only modest efficacy, especially in patients with
high baseline transfusion burdens who are difficult-to-treat. Lower
risk MDS patients in the U.S. represent a large unmet need as there
has not been a new drug approved by the Food and Drug
Administration (FDA) since 2006.
In the Phase 2 portion of IMerge, 38 patients were enrolled who
were transfusion dependent with Low or Intermediate-1 risk
non-del(5q) MDS who have relapsed after or are refractory to prior
treatment with an ESA and naïve to treatment with a hypomethylating
agent (HMA) or lenalidomide. In the trial, transfusion dependence
is defined as a patient requiring a minimum of four units of red
blood cells (RBC) over a consecutive 8-week time period to treat
anemia. The median baseline RBC transfusion burden in the Phase 2
portion of IMerge was eight units per eight weeks, ranging from
four to 14 units. The primary efficacy endpoint of the trial is the
rate of RBC transfusion-independence (RBC TI) lasting at least
eight weeks (8-week RBC TI rate), which is defined as the
proportion of patients who are transfusion free for at least eight
consecutive weeks since entry into the trial. Key secondary
endpoints include durability of response as evidenced through
24-week RBC TI rate and breadth of response through reduction in
RBC transfusion burden and rate of RBC transfusions, as well as
responses across MDS sub-types.
Primary Efficacy Endpoint:
- 37% (14/38) of patients achieved an 8-week RBC TI rate
Secondary Efficacy Endpoints:
Durability
- 26% (10/38) of patients achieved a 24-week RBC TI rate
Transfusion Reduction
- The rate of hematologic improvement-erythroid (HI-E) was 71%
(27/38), as measured by a reduction of at least four RBC units over
eight weeks compared with prior transfusion burden
- Mean relative reduction of RBC transfusion burden from baseline
was 68%
Broad Clinical Activity Observed
- Similar 8-week RBC TI rates were observed in patients with
baseline serum erythropoietin (sEPO) levels less than or greater
than 500mU/mL
- 8-week RBC TI rates were also consistent between
ringed-sideroblast (RS) positive patients and other patients
The ASH presentation reported data based on a data cut-off date
of October 26, 2018. As of the data cut-off date, the median
duration of RBC TI had not been reached. Geron expects more mature
data from patients continuing on treatment in the Phase 2 portion
of IMerge to be available in 2019 and anticipates submitting such
data for presentation at a future medical conference.
IMbark Phase 2 Data Presented Suggest Meaningful Survival
Outcome in Relapsed/Refractory MF Patients
Data from the Phase 2 IMbark clinical trial, including new
overall survival data, were presented in an oral presentation at
ASH on December 3, 2018.
The IMbark trial evaluated two starting dose levels of
imetelstat (either 4.7 mg/kg or 9.4 mg/kg administered by
intravenous infusion every three weeks) in more than 100 patients
with Intermediate-2 or High-risk myelofibrosis (MF) who were
relapsed or refractory to janus kinase inhibitor (JAKi) therapy. To
be eligible for enrollment in the IMbark trial, patients had to
meet rigorous criteria for having failed or not responded to JAKi
treatment, including documented progressive disease during or after
JAKi therapy. The ASH presentation highlighted efficacy and safety
data from the trial’s primary analysis, as well as overall survival
(OS) data with a clinical cutoff of October 22, 2018 and a median
follow up of 27 months.
The ASH presentation reported that the median OS for the 9.4
mg/kg dosing arm was 29.9 months, which suggests a meaningful
survival outcome with imetelstat treatment in this poor-prognosis,
relapsed/refractory patient population where there are currently no
approved treatments today. Other observational studies of similar
patient populations at academic medical centers published recently
in medical literature have reported median OS ranges of
approximately 12 to 14 months after failure of or discontinuation
of ruxolitinib, a JAKi.
Geron plans to discuss the potential for late-stage development
of imetelstat in MF with current IMbark investigators, other key
opinion leaders (KOLs) and regulatory authorities. The Company
expects to facilitate KOL discussions over the coming months.
Discussions with regulatory authorities are expected to begin after
the investigational new drug (IND) sponsorship has been transferred
back to Geron.
The Company plans to outline a decision regarding the potential
for future late-stage development in MF by the end of the third
quarter of 2019. In making this decision, Geron will conduct an
assessment of what would be required to achieve clinical and
regulatory success, including the cost and duration of any
potential clinical trials.
Imetelstat Safety Results
The safety profile reported in both ASH presentations for
imetelstat-treated patients was consistent with prior clinical
trials of imetelstat in hematologic malignancies, and no new safety
signals were identified. Cytopenias, particularly neutropenia and
thrombocytopenia, were the most frequently reported adverse events,
which were predictable, manageable and reversible.
Fourth Quarter and Year-End 2018 Results
For the fourth quarter of 2018, the company reported a net loss
of $7.3 million, or $0.04 per share, compared to $7.4 million, or
$0.05 per share, for the comparable 2017 period. For 2018, the
company reported a net loss of $27.0 million, or $0.15 per share,
compared to $27.9 million, or $0.18 per share, for 2017.
Revenues for the fourth quarter of 2018 were $375,000 compared
to $191,000 for the comparable 2017 period. Revenues for 2018 and
2017 were each $1.1 million and included royalty and license fee
revenues under various non-imetelstat license agreements. The
Company adopted a new revenue recognition accounting standard as of
January 1, 2018 using the modified retrospective transition method.
Revenue for 2018 is presented under the new accounting standard,
but revenue for 2017 has not been adjusted and continues to be
reported under accounting standards used historically. Therefore,
there is a lack of comparability between the periods presented.
However, the Company does not expect the adoption of the new
revenue recognition accounting standard to have a material impact
to its financial statements on an ongoing basis.
Total operating expenses for the fourth quarter of 2018 were
$10.0 million compared to $8.0 million for the comparable 2017
period. Total operating expenses for 2018 were $32.1 million
compared to $30.3 million for 2017.
Research and development expenses for the fourth quarter of 2018
were $5.1 million compared to $2.5 million for the comparable 2017
period. Research and development expenses for 2018 were $13.4
million compared to $11.0 million for 2017. The increase in
research and development expenses for the fourth quarter and
year-to-date 2018 periods compared to comparable 2017 periods
primarily reflects increases in Geron’s share of imetelstat
development costs under the former collaboration agreement with
Janssen Biotech, Inc. (Janssen) where Geron’s share increased from
50% to 100% as of the termination date of the collaboration
agreement and additional costs for the contract research
organization (CRO) and other consultants for the transition of the
imetelstat program from Janssen to Geron.
General and administrative expenses for the fourth quarter of
2018 were $4.9 million compared to $5.5 million for the comparable
2017 period. General and administrative expenses for 2018 were
$18.7 million compared to $19.3 million for 2017. The decrease in
general and administrative expenses in 2018 compared to 2017
primarily reflects the net result of reduced personnel related
expenses, including lower stock-based compensation expense,
partially offset by higher consulting expenses and higher patent
legal expenses with the termination of the imetelstat collaboration
with Janssen, as imetelstat patent costs previously were being
shared by the two companies on a 50/50 basis.
Interest and other income for the fourth quarter of 2018 was
$1.1 million compared to $375,000 for the comparable 2017 period.
Interest and other income for 2018 was $3.3 million compared to
$1.4 million for 2017. The increase in interest and other income
for 2018 compared to 2017 primarily reflects higher yields on the
Company’s marketable securities portfolio.
Planned 2019 Activities and Milestones
Geron’s plans for 2019 primarily focus on advancing imetelstat
development. The Company believes building a development team with
hematology-oncology expertise is essential to executing the Phase 3
clinical trial in lower risk MDS and evaluating the potential for
late-stage development in MF, as well as in the future, exploring
additional indications for imetelstat and being able to pursue
other innovative therapeutics in hematology-oncology. Geron expects
the following activities and milestones to occur in 2019:
Transition of Imetelstat Development Program
- Complete the transfer of the IND back to Geron by the end of
the second quarter.
- Complete the transfer of the imetelstat clinical development
program back to Geron by the end of the third quarter.
- Actively recruit highly-experienced personnel with drug
development expertise in myeloid malignancies.
MDS Development
- Commence screening and enrollment for the Phase 3 portion of
IMerge by mid-year.
- Present more mature data from patients in the Phase 2 portion
of IMerge at a medical conference.
MF Development
- Conduct discussions with IMbark investigators, other MF KOLs
and regulatory authorities to identify and consider potential
late-stage clinical development plans for relapsed/refractory MF
patients.
- Outline decision regarding the potential for late-stage
development of imetelstat in MF by the end of the third
quarter.
Projected 2019 Financial Guidance
The Company expects its operating expenses to increase as it
assumes full responsibility for the development and potential
commercialization of imetelstat. For fiscal year 2019, the Company
expects its operating expense burn to range from $65 to $70
million, of which approximately $10 to $15 million represents
one-time costs, such as imetelstat program transition activities
from Janssen to Geron, including the transfer of the IND
sponsorship, and purchase of raw materials and other supplies in
preparation for new drug manufacturing. In addition to the one-time
costs, projected 2019 operating expense guidance includes costs for
the expansion of the internal development team, the global Phase 3
clinical trial in MDS and the opening of the New Jersey office. The
Company plans to grow to a total of approximately 30 to 40
employees by year-end 2019, of which half will be research and
development personnel.
Conference Call
Geron will host a conference call to discuss fourth quarter and
full year financial results and recent events at 4:30 p.m. ET on
Thursday, March 7, 2019.
Participants may access the conference call live via telephone
by dialing domestically +1 (877) 303-9139 or internationally +1
(760) 536-5195. The conference ID is 6771719. A live, listen-only
webcast will also 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.
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 suppression of
malignant progenitor cell clone proliferation, which allows
potential recovery of normal hematopoiesis. Ongoing clinical
studies of imetelstat include a Phase 2/3 trial called IMerge in
lower risk myelodysplastic syndromes (MDS) and a Phase 2 trial
called IMbark in Intermediate-2 or High-risk myelofibrosis.
Imetelstat has been granted Fast Track designation by the United
States Food and Drug Administration for the treatment of patients
with transfusion-dependent anemia due to lower risk MDS who are
non-del(5q) and refractory or resistant to an erythroid stimulating
agent.
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 prospects for
imetelstat; (ii) that patient screening and enrollment for the
Phase 3 portion of IMerge will begin by mid-year 2019; (iii) that
IMbark and IMerge will continue; (iv) that imetelstat may have
disease-modifying activity; (v) that the IND will transfer to Geron
by the end of the second quarter of 2019; (vi) that the imetelstat
clinical development program will transfer to Geron by the end of
the third quarter of 2019; (vii) that more mature data will be
available from the Phase 2 portion of IMerge and will be presented
at a medical conference in 2019; (viii) that Geron will discuss
with IMbark investigators, other MF KOLs and regulatory authorities
the potential for late-stage clinical development of imetelstat for
relapsed/refractory MF patients and will outline its decision on
this matter by the end of the third quarter of 2019; (ix) that the
Company does not expect the adoption of the new revenue recognition
accounting standard to have a material impact to its financial
statements on an ongoing basis; (x) that the Company’s operating
expenses will be $65 to $70 million in 2019, and other financial
projections and expectations; (xi) that the Company will grow to a
total of 30 to 40 employees by year-end 2019; and (xii) other
statements that are not historical facts, constitute
forward-looking statements. These 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: (i) whether the Company overcomes all the: (a)
challenges of the transfer of the IND and imetelstat clinical
development program from Janssen, and (b) clinical safety and
efficacy, technical, scientific, manufacturing and regulatory
challenges to enable the screening and enrollment of the Phase 3
portion of IMerge to begin by mid-year 2019; (ii) whether
regulatory authorities permit the further development of imetelstat
on a timely basis, or at all, without any clinical holds; (iii)
whether imetelstat is safe and efficacious, and whether any future
efficacy or safety results may cause the benefit-risk profile of
imetelstat to become unacceptable; (iv) whether the transfer of the
IND and the imetelstat clinical development program to the Company
occur in the second and third quarter of 2019, respectively; (v)
whether experts in MF and regulatory authorities support a
potential path for late-stage clinical development of imetelstat in
relapsed/refractory MF; (vi) whether Geron’s assessment of the
prospects for clinical and regulatory success, including the cost
and duration of any potential clinical trials, warrant pursuing
late-stage development of imetelstat in MF; (vii) whether Geron has
come to a decision regarding late-stage development in MF by the
end of the third quarter of 2019; (viii) whether the new revenue
recognition accounting standard has a material impact on Geron’s
financial statements on an ongoing basis; and (ix) whether
imetelstat demonstrates disease-modifying activity. 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 periodic reports filed with the Securities and
Exchange Commission under the heading “Risk Factors,” including
Geron’s annual report on Form 10-K for the year ended December 31,
2018. 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
|
UNAUDITEDThree Months
EndedDecember 31, |
Year EndedDecember
31, |
(In thousands, except
share and per share data) |
|
2018 |
|
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License fees and
royalties |
$ |
375 |
|
|
$ |
191 |
|
|
$ |
1,066 |
|
|
$ |
1,065 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
5,081 |
|
|
|
2,523 |
|
|
|
13,432 |
|
|
|
11,033 |
|
General and
administrative |
|
4,883 |
|
|
|
5,454 |
|
|
|
18,707 |
|
|
|
19,287 |
|
Total
operating expenses |
|
9,964 |
|
|
|
7,977 |
|
|
|
32,139 |
|
|
|
30,320 |
|
Loss from operations |
|
(9,589 |
) |
|
|
(7,786 |
) |
|
|
(31,073 |
) |
|
|
(29,255 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other
income |
|
1,120 |
|
|
|
375 |
|
|
|
3,291 |
|
|
|
1,416 |
|
Gain on settlement |
|
1,460 |
|
|
|
— |
|
|
|
1,460 |
|
|
|
— |
|
Change in fair value of
equity investment |
|
(271 |
) |
|
|
— |
|
|
|
(541 |
) |
|
|
— |
|
Other expense |
|
(20 |
) |
|
|
(18 |
) |
|
|
(154 |
) |
|
|
(77 |
) |
Net loss |
$ |
(7,300 |
) |
|
$ |
(7,429 |
) |
|
$ |
(27,017 |
) |
|
$ |
(27,916 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
net loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share |
$ |
(0.04 |
) |
|
$ |
(0.05 |
) |
|
$ |
(0.15 |
) |
|
$ |
(0.18 |
) |
Shares used in
computing net loss per share |
|
186,348,551 |
|
|
|
159,339,385 |
|
|
|
176,504,996 |
|
|
|
159,224,986 |
|
CONDENSED BALANCE SHEETS
|
December 31, |
December 31, |
(In thousands) |
2018 |
2017 |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash, cash equivalents and restricted cash |
$ |
10,844 |
|
$ |
16,603 |
Current marketable securities |
|
152,714 |
|
|
78,351 |
Other current assets |
|
2,500 |
|
|
1,016 |
Total current
assets |
|
166,058 |
|
|
95,970 |
|
|
|
|
|
|
Noncurrent marketable
securities |
|
18,582 |
|
|
14,241 |
Property and equipment,
net |
|
59 |
|
|
102 |
Other assets |
|
585 |
|
|
— |
|
$ |
185,284 |
|
$ |
110,313 |
|
|
|
|
|
|
Current liabilities |
$ |
7,551 |
|
$ |
6,516 |
Stockholders’ equity |
|
177,733 |
|
|
103,797 |
|
$ |
185,284 |
|
$ |
110,313 |
CONTACT:
Suzanne MessereInvestor and Media
Relationsinvestor@geron.commedia@geron.com
CG Capital877-889-1972
Geron (NASDAQ:GERN)
Historical Stock Chart
From Apr 2024 to May 2024
Geron (NASDAQ:GERN)
Historical Stock Chart
From May 2023 to May 2024