Geron Corporation (Nasdaq: GERN) today reported financial results
for the third quarter and year-to-date as of September 30, 2019 as
well as recent events. The Company ended the third quarter with
$159.3 million in cash and marketable securities.
“Geron has continued to execute on its 2019 development plans,”
said John A. Scarlett, M.D., Chairman and Chief Executive Officer.
“In the third quarter, we completed the transition of the
imetelstat program back to Geron, and we announced that the FDA
granted Fast Track designation to imetelstat in relapsed/refractory
myelofibrosis. In October, we announced the first patient dosed in
the IMerge Phase 3 trial, and we are currently focused on patient
recruitment and enrollment. Another priority is to prepare for an
End of Phase 2 meeting with the FDA to discuss potential late-stage
development of imetelstat in relapsed/refractory MF. All of these
activities support the development of imetelstat as a potential
treatment to address unmet medical needs in hematologic myeloid
malignancies.”
IMerge Phase 3 Clinical Trial – First Patient
Dosed
In August 2019, Geron opened the IMerge Phase 3 clinical trial
for screening and enrollment. On October 10, 2019, the Company
announced that the first patient was dosed in the IMerge Phase 3
clinical trial.
IMerge is a two-part Phase 2/3 clinical trial of imetelstat in
transfusion dependent patients with lower risk MDS who are
relapsed/refractory to erythropoiesis-stimulating agents (ESAs).
The primary endpoint is 8-week TI rate, which is defined as the
proportion of patients achieving transfusion independence during
any consecutive eight weeks since entry into the trial. Key
secondary endpoints include the rate of transfusion independence
lasting at least 24 weeks, or 24-week TI rate, durability of
transfusion independence and the amount and relative change in
transfusions.
The IMerge Phase 3 clinical trial is planned to enroll
approximately 170 patients in a randomized, double-blind,
placebo-controlled clinical trial to test the hypothesis that
imetelstat improves the rate of red blood cell transfusion
independence (TI). A target patient population of non-del(5q) lower
risk MDS patients who are naïve to treatment with hypomethylating
agents (HMAs) and lenalidomide was identified in Part 1 of IMerge,
or the Phase 2 portion, and will be enrolled in the Phase 3. The
trial is planned to be conducted at multiple medical centers
globally, including North America, Europe, Middle East and
Asia.
Phase 2 data from Part 1 of IMerge reported earlier this year
suggested meaningful and durable transfusion independence, as well
as potential disease-modifying activity and transfusion
independence across different MDS patient subgroups, potentially
achievable with imetelstat treatment. Many key aspects from Part 1
of IMerge remain the same for the Phase 3, including the primary
and secondary endpoints, the dose and schedule of imetelstat
administration, the target patient population, and a majority of
the clinical sites that participated in the Phase 2.
Based upon current planning assumptions, Geron expects top-line
results for the IMerge Phase 3 clinical trial to be available by
mid-year 2022.
Completed Transition of Imetelstat Program Back to
Geron
As of the end of September 2019, the transition of the
imetelstat program back to Geron has been completed, including the
transfer of the remaining non-clinical, manufacturing and ex-U.S.
clinical and regulatory responsibilities from Janssen Biotech, Inc.
(Janssen). Geron is now the sponsor of both the IMbark and IMerge
clinical trials in all countries.
In June 2019, Geron entered into a Clinical Supply Agreement
with Janssen to purchase certain inventories of drug product, drug
substance and raw materials for imetelstat manufacturing. The
delivery and testing of materials under the Clinical Supply
Agreement is expected to be completed by the end of December 2019
with payment to Janssen to occur in the first quarter of 2020.
Fast Track Designation – Relapsed/Refractory
Myelofibrosis (MF)
On September 30, 2019, Geron announced that the United States
Food and Drug Administration (FDA) granted Fast Track designation
to imetelstat for the treatment of adult patients with
Intermediate-2 or High-risk MF whose disease has relapsed after or
is refractory to janus kinase (JAK) inhibitor treatment, or
relapsed/refractory MF. The Fast Track designation includes
patients with primary MF and MF developed after essential
thrombocythemia or polycythemia vera. This is the same patient
population that was studied in Geron’s IMbark Phase 2 clinical
trial. There are currently no marketed drugs specifically approved
for relapsed/refractory MF, representing a significant unmet
medical need. Geron plans to conduct an End of Phase 2 meeting with
the FDA by the end of the first quarter of 2020, and will
subsequently provide a decision regarding potential late-stage
development of imetelstat in relapsed/refractory MF.
The FDA's Fast Track Program is designed to facilitate the
development and expedite the review of new drugs that are intended
to treat serious conditions and supported by data that demonstrate
the potential to address an unmet medical need. Fast Track
designation provides opportunities for frequent interactions with
FDA review staff, including meetings to discuss the drug's
development plan and to ensure the collection of appropriate data
needed to support approval. Through the Fast Track Program, a
product candidate may be eligible for priority review, if supported
by the clinical data, and for the ability to submit completed
sections of a New Drug Application (NDA) on a rolling basis as data
become available prior to completion of the full application.
Third Quarter and Year-to-Date 2019 Results
For the third quarter of 2019, the Company reported a net loss
of $15.2 million, or $0.08 per share, compared to $5.6 million, or
$0.03 per share, for the third quarter of 2018. Net loss for the
first nine months of 2019 was $39.5 million, or $0.21 per share,
compared to $19.7 million, or $0.11 per share, for the first nine
months of 2018.
Revenues for the three and nine months ended September 30, 2019
were $131,000 and $289,000, respectively, compared to $165,000 and
$691,000 for the same periods in 2018. Revenues for the three and
nine months ended September 30, 2019 and 2018 included royalty and
license fee revenues under various non-imetelstat license
agreements. The decline in revenues reflects a reduction in the
number of active research license agreements in 2019 related to the
Company’s human telomerase reverse transcriptase, or hTERT,
technology as a result of patent expirations on the underlying
technology.
Total operating expenses for the three and nine months ended
September 30, 2019 were $16.1 million and $42.8 million,
respectively, compared to $7.0 million and $22.2 million for the
same periods in 2018. Research and development expenses for the
three and nine months ended September 30, 2019 were $11.1 million
and $27.1 million, respectively, compared to $2.7 million and $8.4
million for the same periods in 2018. The increase in research and
development expenses, compared to the same periods in 2018,
primarily reflects costs for the transition of the imetelstat
program, including resuming sponsorship of the ongoing imetelstat
clinical trials; expenses for start-up activities for the IMerge
Phase 3 clinical trial; and higher personnel-related costs for the
expanding development team. General and administrative expenses for
the three and nine months ended September 30, 2019 were $5.0
million and $15.6 million, respectively, compared to $4.3 million
and $13.8 million for the same periods in 2018. The increase in
general and administrative expenses, compared to the same periods
in 2018, primarily reflects higher corporate and patent legal costs
and increased personnel-related expenses for additional headcount
to support the development organization.
Interest and other income for the three and nine months ended
September 30, 2019 was $1.0 million and $3.3 million, respectively,
compared to $1.1 million and $2.2 million for the same periods in
2018. The overall increase in interest and other income, compared
to 2018, primarily reflects higher yields on the Company’s
increased marketable securities portfolio.
The Company ended the third quarter of 2019 with $159.3 million
in cash and marketable securities. Since May 2019, the Company has
raised cumulative net cash proceeds of approximately $19.3 million
from the sales of an aggregate of 13,214,867 shares of common stock
under an At Market Issuance Sales Agreement, after deducting sales
commissions and other offering expenses payable by Geron. The
Company expects these net cash proceeds to provide additional
financial flexibility as it advances the imetelstat development
program. The funds will support future development costs, including
the IMerge Phase 3 clinical trial.
2019 Financial Guidance Reaffirmed
For fiscal year 2019, the Company expects total operating
expenses to range from $80 to $85 million, of which approximately
$20 to $25 million represents one-time costs that include
imetelstat program transition activities from Janssen to Geron and
purchase of drug product, drug substance and raw materials from
Janssen to supply the IMerge Phase 3 trial and prepare for new drug
manufacturing. In the third quarter of 2019, the Company completed
the transition of the imetelstat program from Janssen.
As of October 31, 2019, the Company had 42 employees, and plans
to grow to a total of approximately 45 to 50 employees by year-end
2019, of whom half will be research and development personnel.
Conference Call
Geron will host a conference call to discuss third quarter and
year-to-date financial results as well as recent events at 8:00
a.m. ET on Thursday, November 7, 2019.
Participants may access the conference call live via telephone
by dialing domestically +1 (866) 393-4306 or internationally +1
(734) 385-2616. The conference ID is 2929819. 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 consist of IMerge, a Phase 2/3 trial in lower
risk myelodysplastic syndromes (MDS), and IMbark, a Phase 2 trial
in Intermediate-2 or High-risk myelofibrosis (MF). 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 top-line
results from the IMerge Phase 3 clinical trial will be available by
mid-year 2022; (ii) that recently reported Phase 2 IMerge data
suggested meaningful and durable transfusion independence,
potential disease-modifying activity, and transfusion independence
across different MDS patient subgroups potentially achievable with
imetelstat treatment; (iii) Geron’s plan to conduct an End of Phase
2 meeting with the FDA by the end of the first quarter of 2020 and
to subsequently provide a decision regarding potential late-stage
development of imetelstat in relapsed/refractory MF; (iv) that the
IMerge Phase 3 clinical trial is planned to enroll approximately
170 patients and is planned to be conducted at multiple medical
centers globally; (v) that the Company expects its 2019 operating
expenses to be $80 to $85 million; (vi) that the Company expects
delivery and testing of materials under the Clinical Supply
Agreement to be completed by the end of 2019; (vii) that the
Company expects to grow to 45 to 50 employees by year-end 2019;
(viii) that imetelstat may have disease-modifying activity; and
(ix) 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 clinical,
safety, efficacy, technical, scientific, intellectual property,
manufacturing and regulatory challenges to enable the availability
of top-line results from the IMerge Phase 3 clinical trial by
mid-year 2022; (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
demonstrated to be safe and efficacious in clinical trials; (iv)
whether any future efficacy or safety results may cause the
benefit-risk profile of imetelstat to become unacceptable; (v)
whether the testing and delivery of materials under the Clinical
Supply Agreement actually occur by the end of 2019; (vi) whether
there are unexpected operating expenses or events that cause the
$80 to $85 million 2019 financial guidance to be revised; (vii)
whether the Company is able to hire the employees to grow to 45 to
50 by the end of 2019; (viii) whether imetelstat actually
demonstrates disease-modifying activity in patients; (ix) whether
Geron may not be able to prepare timely for an End of Phase 2
meeting by the end of the first quarter of 2020, or at all; and (x)
whether imetelstat has adequate patent protection and freedom to
operate. 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 quarterly report on Form
10-Q for the quarter ended September 30, 2019. 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) |
2019 |
2018 |
2019 |
2018 |
|
|
|
|
|
Revenues: |
|
|
|
|
License fees and royalties |
$ |
131 |
|
$ |
165 |
|
$ |
289 |
|
$ |
691 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
11,109 |
|
|
2,707 |
|
|
27,149 |
|
|
8,351 |
|
General and administrative |
|
4,994 |
|
|
4,263 |
|
|
15,637 |
|
|
13,824 |
|
Total operating expenses |
|
16,103 |
|
|
6,970 |
|
|
42,786 |
|
|
22,175 |
|
Loss from operations |
|
(15,972 |
) |
|
(6,805 |
) |
|
(42,497 |
) |
|
(21,484 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other income |
|
1,021 |
|
|
1,060 |
|
|
3,296 |
|
|
2,171 |
|
Change in fair value of equity investment |
|
(195 |
) |
|
205 |
|
|
(195 |
) |
|
(270 |
) |
Other expense |
|
(34 |
) |
|
(57 |
) |
|
(82 |
) |
|
(134 |
) |
Net loss |
$ |
(15,180 |
) |
$ |
(5,597 |
) |
$ |
(39,478 |
) |
$ |
(19,717 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share |
$ |
(0.08 |
) |
$ |
(0.03 |
) |
$ |
(0.21 |
) |
$ |
(0.11 |
) |
Shares used in computing net loss per share |
|
189,123,647 |
|
|
184,301,986 |
|
|
187,367,621 |
|
|
173,187,753 |
|
CONDENSED BALANCE SHEETS
|
September 30, |
December 31, |
(In thousands) |
2019 |
2018 |
|
(Unaudited) |
(Note 1) |
Current assets: |
|
|
Cash, cash equivalents and restricted cash |
$ |
21,021 |
$ |
10,844 |
Current marketable securities |
|
117,860 |
|
152,714 |
Other current assets |
|
3,240 |
|
2,500 |
Total current assets |
|
142,121 |
|
166,058 |
|
|
|
Noncurrent marketable
securities |
|
20,404 |
|
18,582 |
Property and equipment, net |
|
348 |
|
59 |
Other assets |
|
1,381 |
|
585 |
|
$ |
164,254 |
$ |
185,284 |
|
|
|
Current liabilities |
$ |
11,862 |
$ |
7,551 |
Stockholders’ equity |
|
152,392 |
|
177,733 |
|
$ |
164,254 |
$ |
185,284 |
|
|
|
Note 1: Derived from audited financial
statements included in the Company’s annual report on Form 10-K for
the year ended December 31, 2018.
CONTACT:
Suzanne MessereInvestor and Media
Relationsinvestor@geron.commedia@geron.com
CG Capital877-889-1972
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