GERN Shareholder/Stockholder Letter Transcript:
2023
Annual
Report
Letter to Stockholders
2024 Proxy Statement
2023 Annual Report on Form 10-K
DEAR GERON STOCKHOLDER,
2023 was a year of significant progress and execution for Geron.
The New Drug Application (NDA) and Marketing Authorization Application
(MAA) for imetelstat were filed during the year and are currently under review
by the U.S. Food & Drug Administration (FDA) and European Medicines Agency
(EMA) for the treatment of transfusion dependent (TD) anemia in adult
patients with low- to intermediate-1 risk myelodysplastic syndromes
(LR-MDS), who have failed to respond, or have lost response to, or are
ineligible for erythropoiesis-stimulating agents. These submissions are based
on results of the IMerge Phase 3 clinical trial, which we announced at the
beginning of 2023 and which were recently published in The Lancet. The
IMerge Phase 3 results were also presented at multiple oncology and
hematology medical conferences throughout the year.
Imetelstat, our investigational first-in-class telomerase inhibitor, harnesses
Nobel Prize-winning science in a treatment that may alter the underlying
drivers of hematologic malignancies, representing a new approach for these
high unmet need cancers.
Following is a review of our clinical programs.
Imetelstat in TD Lower-Risk MDS
In August 2023, the FDA accepted the NDA for imetelstat and assigned a
Prescription Drug User Fee Act (PDUFA) action date of June 16, 2024. On
March 14, 2024, the FDA held a public meeting of its Oncologic Drugs Advisory
Committee as part of the imetelstat NDA review, where the committee voted
12-2 in favor of the clinical benefit/risk profile of imetelstat for the treatment
of transfusion-dependent (TD) anemia in adult patients with lower-risk
myelodysplastic syndromes (LR-MDS) after reviewing results from the IMerge
Phase 3 clinical trial.
The ODAC s recommendation was based on results from the IMerge Phase 3
clinical trial. The primary endpoint of red blood cell transfusion independence
(RBC-TI) for at least 8 consecutive weeks was significantly higher with
imetelstat vs. placebo (p<0.001), with median RBC-TI duration approaching
one year for imetelstat 8-week RBC-TI responders. For patients achieving
8-week RBC-TI, median increases in hemoglobin were 3.6 g/dL for imetelstat
and 0.8 g/dL for placebo. In addition, 28% of imetelstat-treated patients
compared to 3% on placebo obtained a statistically significant improvement
in the key secondary endpoint of at least 24-week RBC-TI. For those patients
achieving 24-week RBC-TI, the median duration was 80 weeks. Clinically
meaningful TI was achieved across key MDS subgroups irrespective of ring
sideroblast (RS) status, baseline transfusion burden and IPSS risk category.
Additionally, a sustained increase in mean hemoglobin levels in imetelstattreated patients was observed over time compared to placebo patients. An
exploratory analysis of patient-reported outcomes (PRO) data indicated a
trend in improvement in fatigue for imetelstat-treated patients vs. placebo.
Consistent with prior imetelstat clinical experience, the most common
Grade 3-4 adverse events were thrombocytopenia (62%) and neutropenia
(68%) that were generally manageable and of short duration.
Given the substantial opportunity driven by the deep unmet need in TD
LR-MDS, we have been preparing to launch and commercialize imetelstat in
the U.S. upon potential FDA approval. We have already completed multiple
long-lead time activities to prepare Geron, imetelstat, and the market for our
potential launch in the U.S., with the goal of ensuring broad access and
reimbursement for what we believe is an important medicine. Throughout
2023, Geron completed several pre-commercial activities, including securing a
global trademark for the imetelstat brand name; finalizing third party logistics,
our distribution network, and patient support providers; and onboarding
highly experienced commercial and medical affairs teams.
In September 2023, the EMA validated the MAA for imetelstat in the same
proposed indication as the NDA. Review of the imetelstat MAA is expected to
be completed in early 2025. Subject to approval by the European Commission,
commercial launch of imetelstat in Europe could occur in 2025.
Imetelstat in Relapsed/Refractory Myelofibrosis
Our second Phase 3 clinical program, the IMpactMF clinical trial evaluating
imetelstat vs. best available therapy in intermediate-2 or high-risk
myelofibrosis (MF) relapsed/refractory (R/R) to JAK inhibitors (JAKi), is the first
and only Phase 3 MF trial with overall survival as the primary endpoint. In
November 2023, we achieved fifty percent enrollment in this trial. We expect
the interim analysis to read out in the first half of 2025, with a final analysis
from the study expected in the first half of 2026. If this trial reads out positively,
these data could be transformational for patients with JAKi R/R MF, who have
poor survival prognoses today.
Additional Opportunities for Imetelstat
In our Phase 1 IMproveMF trial, we are evaluating imetelstat as a combination
therapy with ruxolitinib in patients with intermediate-2 or high-risk MF
(frontline MF). The study design is based on preclinical data which showed
synergistic and additive effects of the combination of imetelstat and
ruxolitinib. In January 2024, dosing in this trial was escalated to the third
of four doses following a decision by the study s independent Safety
Evaluation Team.
We are also supporting the investigator-led Phase 2 IMpress trial of single
agent imetelstat in relapsed/refractory acute myeloid leukemia and
higher-risk MDS (HR-MDS) for patients who are already treated with a
hypomethylating agent. These efforts are ongoing and are an exciting part
of our pipeline.
In summary, we are pleased by the progress and execution in 2023 that has
paved the way for a potentially transformational 2024, as we plan for the
transition to becoming a commercial company. We believe that we are in a
strong position to create value for our stockholders and patients alike, based
on our differentiated product candidate, the potential for significant
commercial opportunities in TD LR-MDS and JAKi R/R MF, the excellence and
experience of our employees, and the strength of our balance sheet to support
a potential U.S. launch.
Thank you for the continued support and for sharing in our vision to bring
what we believe is an important new medicine to patients suffering from
hematologic malignancies.
Sincerely,
John A. Scarlett, M.D.
Chairman and Chief Executive Officer
March 27, 2024
For important information regarding the use of forward-looking
statements in this letter to stockholders, please refer to the inside back
cover of this annual report.
919 E. Hillsdale Blvd., Suite 250 Foster City, CA 94404
Dear Fellow Geron Stockholder:
Annual Meeting of
Stockholders
Date:
May 9, 2024
Time:
5:00 p.m., Eastern Daylight
Time
Place:
www.virtualshareholder
meeting.com/GERN2024
YOUR VOTE
IS IMPORTANT TO US.
Whether or not you plan
to attend the virtual
Annual Meeting, please
vote electronically via the
Internet or by telephone
as instructed in these
materials, or, if you have
requested and received a
paper proxy card by mail,
please complete, sign, date
and return the proxy card
mailed to you, as promptly
as possible. Thank you for
your ongoing support of,
and continued interest in,
Geron Corporation.
You are cordially invited to attend the 2024 Annual Meeting of Stockholders (the Annual Meeting ) of Geron
Corporation to be held on Thursday, May 9, 2024, at 5:00 p.m., Eastern Daylight Time. To facilitate
stockholder participation in the Annual Meeting, we have determined that the Annual Meeting will be held in a
virtual meeting format only, via the Internet, with no physical in-person meeting. You will be able to attend and
participate in the virtual Annual Meeting online by visiting www.virtualshareholdermeeting.com/GERN2024,
where you will be able to listen to the meeting live, submit questions, and vote.
You will not be able to attend the meeting in person. Instructions on how to participate in the virtual Annual
Meeting and demonstrate proof of stock ownership are posted at
www.virtualshareholdermeeting.com/GERN2024. The webcast of the virtual Annual Meeting will be archived
for one year after the date of the virtual Annual Meeting at www.virtualshareholdermeeting.com/GERN2024.
As permitted by the rules of the Securities and Exchange Commission, we are pleased to furnish our
proxy materials to stockholders primarily over the Internet. Consequently, most stockholders will
receive a notice with instructions for accessing proxy materials and voting via the Internet, instead of
paper copies of proxy materials. We believe that this process will allow us to provide our stockholders
with the information they need in a more timely manner, while reducing the environmental impact and
lowering the costs of printing and distributing our proxy materials. However, this notice will provide
information on how stockholders may obtain paper copies of proxy materials if they choose.
Stockholders who continue to receive hard copies of proxy materials may help us reduce costs by
opting to receive future proxy materials by e-mail.
At this year s Annual Meeting, the agenda includes the following items:
1
Election of the three nominees for director named in the accompanying proxy statement to
hold office as Class I members of the Board of Directors until the 2027 annual meeting of
stockholders;
2
Advisory vote to approve named executive officer compensation; and
3
Ratification of Ernst & Young LLP as our independent registered public accounting firm.
Sincerely,
John A. Scarlett, M.D.
Chairman of the Board, President and
Chief Executive Officer
919 E. Hillsdale Blvd., Suite 250 Foster City, CA 94404
To The Stockholders
Notice of Annual
Meeting of
Shareholders
Date:
May 9, 2024
Time:
5:00 p.m., Eastern Daylight
Time
Place:
www.virtualshareholder
meeting.com/GERN2024
YOUR VOTE
IS IMPORTANT TO US.
Whether or not you plan to
attend the virtual Annual
Meeting, please vote
electronically via the Internet or
by telephone as instructed by
these materials, or, if you have
requested and received a paper
proxy card by mail, please
complete, sign, date and return
the proxy card mailed to you, as
promptly as possible.
Stockholders who plan to
attend the virtual Annual
Meeting should follow the
instructions at
www.virtualshareholder
meeting.com/GERN2024
to submit questions and vote
during the virtual Annual
Meeting. You may log-in
beginning at 4:30 p.m. Eastern
Daylight Time, on May 9, 2024.
You will not be able to attend
the meeting in person.
NOTICE IS HEREBY GIVEN that the Annual Meeting of Stockholders of GERON CORPORATION, a Delaware
corporation (the Company ), will be held on Thursday, May 9, 2024, at 5:00 p.m., Eastern Daylight Time. To
facilitate stockholder participation in the Annual Meeting, we have determined that the Annual Meeting will be
held in a virtual meeting format only, via the Internet, with no physical in-person meeting. You can attend the
virtual Annual Meeting online, vote your shares electronically and submit your questions during the virtual
Annual Meeting, by visiting www.virtualshareholdermeeting.com/GERN2024. You will need to have your
16-Digit Control Number included in the Notice of Internet Availability of Proxy Materials, on your proxy card
or on the instructions that accompanied your proxy materials to join the virtual Annual Meeting.
The Annual Meeting will be held for the following purposes:
1
To elect the three nominees for director named in the accompanying proxy statement (the Proxy
Statement ) to hold office as Class I members of the Board of Directors until the 2027 annual
meeting of stockholders;
2
To approve, on an advisory basis, the compensation of our named executive officers, as disclosed
in the Proxy Statement;
3
To ratify the selection by the Audit Committee of the Board of Directors of Ernst & Young LLP as our
independent registered public accounting firm for the fiscal year ending December 31, 2024; and
4
To transact such other business as may properly come before the Annual Meeting or any
postponement or adjournment thereof.
The foregoing items of business are more fully described in the Proxy Statement accompanying this Notice.
The Board of Directors has fixed the close of business on March 12, 2024, as the record date for the
determination of stockholders entitled to notice of and to vote at the virtual Annual Meeting and at any
adjournment or postponement thereof. Each stockholder is entitled to one vote for each share of common
stock held at that time.
By Order of the Board of Directors,
Scott A. Samuels, Esq.
Executive Vice President,
Chief Legal Officer and Secretary
Foster City, California
March 27, 2024
Important Notice Regarding the Availability of Proxy Materials for the Annual Meeting to Be Held on
May 9, 2024 at www.virtualshareholdermeeting.com/GERN2024
The 2024 Proxy Statement and 2023 Annual Report on Form 10-K
are available at www.proxyvote.com.
YOUR VOTE IS VERY IMPORTANT, REGARDLESS OF THE NUMBER OF SHARES YOU OWN.
WHETHER OR NOT YOU EXPECT TO ATTEND THE VIRTUAL ANNUAL MEETING, WE URGE YOU
TO VOTE BY PROXY PROMPTLY IN ORDER TO ASSURE THAT A QUORUM IS PRESENT. EVEN IF YOU HAVE
VOTED BY PROXY BEFORE THE VIRTUAL ANNUAL MEETING. YOU MAY STILL ATTEND AND VOTE YOUR
SHARES AT THE VIRTUAL ANNUAL MEETING ONLINE. YOU WILL NEED TO HAVE YOUR 16-DIGIT
CONTROL NUMBER INCLUDED IN THE NOTICE ON YOUR PROXY CARD OR ON THE INSTRUCTIONS THAT
ACCOMPANIED YOUR PROXY MATERIALS TO JOIN AND VOTE AT THE VIRTUAL ANNUAL MEETING.
Table of Contents
Questions and Answers about these Proxy Materials and Voting . . . . . . . . . . . . . . . . . . . . . . 1
Proposal 1: Election of Directors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Board Leadership and Governance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Other Corporate Governance Matters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Compensation of Directors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Proposal 2: Advisory Vote to Approve Named Executive Officer Compensation. . . . . . . . . . . 43
Executive Compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Proposal 3: Ratification of Selection of Independent Registered Public Accounting Firm . . . . 69
Principal Accountant Fees and Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Audit Committee Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Equity Compensation Plan Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Security Ownership of Certain Beneficial Owners and Management . . . . . . . . . . . . . . . . . . . . 74
Delinquent Section 16(a) Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Certain Transactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Other Matters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
3/27/2024 Letter Continued (Full PDF)