Form 8-K
8-K — GERON CORP
Accession: 0001193125-26-436272
Filed: 2026-10-28
Period: 2026-10-28
CIK: 0000886744
SIC: 2834 (PHARMACEUTICAL PREPARATIONS)
Item: Other Events
Item: Financial Statements and Exhibits
Documents
8-K — d43013d8k.htm (Primary)
EX-99.1 (d43013dex991.htm)
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8-K
8-K (Primary)
Filename: d43013d8k.htm · Sequence: 1
8-K
GERON CORP false 0000886744 0000886744 2026-10-28 2026-10-28
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): October 28, 2026
GERON CORPORATION
(Exact name of registrant as specified in its charter)
Delaware
000-20859
75-2287752
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
919 E. HILLSDALE BLVD., SUITE 250
FOSTER CITY, California 94404
(Address of principal executive offices, including zip code)
(650) 473-7700
(Registrant’s telephone number, including area code)
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading
Symbol(s)
Name of each exchange
on which registered
Common Stock, $0.001 par value
GERN
The Nasdaq Stock Market LLC
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01
Other Events
On October 28, 2026, Geron Corporation (the “Company”) issued a press release announcing an update on the Phase 3 IMpactMF trial evaluating imetelstat in JAK inhibitor relapsed/refractory myleofibrosis. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01
Financial Statements and Exhibits.
(d) Exhibits.
Exhibit
No.
Description
99.1
Press release titled “Geron Corporation Provides Update on Phase 3 IMpactMF Clinical Trial of Imetelstat in Relapsed/Refractory Myelofibrosis,” dated October 28, 2026
104
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
GERON CORPORATION
Date: October 28, 2026
By:
/s/ Timothy Williams
Name:
Timothy Williams
Title:
Executive Vice President,
Chief Legal Officer and Corporate Secretary
EX-99.1
EX-99.1
Filename: d43013dex991.htm · Sequence: 2
EX-99.1
Exhibit 99.1
Geron Corporation Provides Update on Phase 3 IMpactMF Clinical Trial of Imetelstat in
Relapsed/Refractory Myelofibrosis
FOSTER
CITY, Calif., – October 28, 2026 – Geron Corporation (Nasdaq: GERN), a commercial-stage hematology biopharmaceutical company, today announced the decision to discontinue the Phase 3 IMpactMF trial evaluating imetelstat in JAK
inhibitor relapsed/refractory myelofibrosis. This decision was based on a recommendation from the independent Data Monitoring Committee (DMC).
The
independent DMC advised Geron that the trial was unlikely to meet its primary endpoint of overall survival. There were no new safety signals observed in the trial that change the known safety profile of imetelstat or require additional safety
monitoring. A detailed analysis of the data will be conducted, and study findings will be shared with the scientific community at a future date.
“Given the recommendation from the DMC, we believe discontinuing our Phase3 IMpactMF trial at this time is the right course of action. We are deeply
grateful to the patients and families, as well as the investigators and clinical teams whose dedication made this research possible,” said Joseph E. Eid, M.D., Executive Vice President, Research and Development and Chief Medical Officer of
Geron. “Hematologic malignancies are complex diseases, with distinct biological characteristics and treatment challenges across patient populations. We remain committed to thoroughly evaluating the data, understanding what we can learn, and
sharing insights that may help inform future research and address the significant unmet needs that remain.”
IMpactMF evaluated 327 patients with intermediate-2 or high-risk myelofibrosis who were relapsed or refractory to a JAK inhibitor. Patients were randomized 2:1, in an open label, controlled trial of imetelstat designed to evaluate a potential
improvement in overall survival compared to best available therapy. Patients in the imetelstat arm received 9.4 mg/kg IV every three weeks.
“As we
fully analyze the data from the IMpactMF trial, we remain committed to growing RYTELO demand in the U.S. and broadening access to eligible LR-MDS patients outside the U.S.,” said Harout Semerjian,
President and Chief Executive Officer of Geron. “We have a growing commercial business, a strong financial foundation, and a clear strategy to pursue innovation to create long-term value and build a leading hematology company.”
About Geron
Geron is a hematology-focused
biopharmaceutical company pursuing more meaningful moments for people living with blood cancer. Because patients cannot wait, we approach our work with urgency, bringing together deep expertise in telomerase biology with patient perspectives and
insights from clinical research and real-world care. Our medicine, RYTELO® (imetelstat), is approved in the United States and European Union for certain patients with lower-risk
myelodysplastic syndromes (LR-MDS). Geron is a commercial-stage company with offices in Parsippany, New Jersey and Foster City, California. To learn more, visit www.geron.com or follow us
on LinkedIn.
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. These forward-looking statements include, without limitation, statements regarding: (i) Geron’s plans to discontinue the Phase 3 IMpactMF trial; (ii) the ongoing
analysis of IMpactMF data and the timing and plans for sharing study findings with the scientific community; (iii) the potential for insights from these analyses to inform future research; (iv) Geron’s plans and efforts to grow
RYTELO demand in the United States and expand access for eligible patients; (v) Geron’s strategy and ability to create long-term value and build a leading hematology company; and (vi) other statements that are not historical facts.
These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements, including risks and uncertainties relating to: (a) the timing, costs and
execution of discontinuing IMpactMF; (b) whether further analyses of IMpactMF data yield additional or different findings, including regarding efficacy and safety, and the timing and extent of disclosure of those findings; (c) whether
insights from clinical data translate into future research or clinical benefits; (d) the impact of the IMpactMF results and discontinuation on Geron’s development plans, business and financial condition; (e) Geron’s ability to
grow RYTELO demand, achieve market acceptance and expand patient access in the United States, including risks relating to competition, coverage and reimbursement; (f) regulatory requirements and actions affecting imetelstat’s development
and commercialization; (g) failures or delays in manufacturing or supplying sufficient quantities of RYTELO or clinical trial materials; and (h) Geron’s ability to execute its strategy and maintain sufficient financial resources to
support its business. Additional information regarding these and other risks and uncertainties is contained in Geron’s filings and periodic reports filed with the Securities and Exchange Commission under the heading “Risk Factors”
and elsewhere, including Geron’s annual report on Form 10-K for the year ended December 31, 2025, and subsequent filings and reports. 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 them may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information,
events or circumstances.
CONTACT:
Dawn Schottlandt
Senior Vice President, Investor Relations and Corporate Affairs
dschottlandt@geron.com
###
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