Geron Corporation Reports First Quarter 2024 Financial Results and Business Highlights
“Since the FDA ODAC’s 12 to 2 vote in favor of the clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent anemia in patients with lower-risk MDS in March, we have continued working with the FDA as they complete their review of our New Drug Application, which has a
Clinical Development Update
The Phase 3 IMpactMF clinical trial, which has a primary endpoint of overall survival, is ongoing in myelofibrosis patients who are relapsed/refractory to JAK inhibitors. Last month, the data monitoring committee evaluated unblinded data and recommended the clinical trial continue. In addition, the Company reviewed enrollment rates and blinded death rates, which are lower than anticipated based on initial planning assumptions. Accordingly, guidance is being updated to extend the timelines by half a year, with the interim analysis now expected in early 2026 and the final analysis expected in early 2027.
First Quarter 2024 Financial Results
As of
For the first quarter of 2024, the Company reported a net loss of
Revenues for the first quarter of 2024 were
Total operating expenses for the first quarter of 2024 were
Interest income for the first quarter of 2024 was
Interest expense for the first quarter of 2024 was
2024 Financial Guidance
For fiscal year 2024, the Company expects total operating expenses to be in the range of approximately
The fiscal year 2024 financial guidance reflects costs to support regulatory processes with the FDA and EMA in 2024; continued support of ongoing clinical trials; manufacturing of commercial inventory of imetelstat; build out of our commercial organization to support the potential
Based on our current operating plans and our assumptions regarding the timing of the potential approval and commercial launch of imetelstat in lower risk MDS in the
As of
Conference Call
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://events.q4inc.com/attendee/934891352
About Imetelstat
Imetelstat is a novel, first-in-class investigational telomerase inhibitor exclusively owned by
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
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 Company’s work with the FDA to complete the review of the NDA for imetelstat in lower-risk MDS; (ii) preparations for a potential launch in TD LR-MDS in the
Financial table follows.
|
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|
UNAUDITED
|
||||||
(In thousands, except share and per share data) |
2024 |
2023 |
|||||
|
|
|
|||||
Revenues: |
|
|
|||||
Royalties |
$ |
304 |
|
$ |
21 |
|
|
|
|
|
|||||
Operating expenses: |
|
|
|||||
Research and development |
|
29,373 |
|
|
27,219 |
|
|
General and administrative |
|
27,065 |
|
|
12,894 |
|
|
Total operating expenses |
|
56,438 |
|
|
40,113 |
|
|
Loss from operations |
|
(56,134 |
) |
|
(40,092 |
) |
|
|
|
|
|||||
Interest income |
|
4,239 |
|
|
3,853 |
|
|
Interest expense |
|
(3,433 |
) |
|
(1,922 |
) |
|
Other income and (expense), net |
|
(62 |
) |
|
39 |
|
|
Net loss |
$ |
(55,390 |
) |
$ |
(38,122 |
) |
|
|
|
|
|||||
Basic and diluted net loss per share: |
|
|
|||||
Net loss per share |
$ |
(0.09 |
) |
$ |
(0.07 |
) |
|
Shares used in computing net loss per share |
|
603,493,451 |
|
|
544,459,004 |
|
CONDENSED CONSOLIDATED BALANCE SHEETS |
|||||
|
|
|
|||
(In thousands) |
2024 |
2023 |
|||
|
(Unaudited) |
(Note 1) |
|||
Current assets: |
|
|
|||
Cash, cash equivalents and restricted cash |
$ |
190,880 |
$ |
71,138 |
|
Current marketable securities |
|
253,288 |
|
263,676 |
|
Other current assets |
|
7,341 |
|
6,534 |
|
Total current assets |
|
451,509 |
|
341,348 |
|
|
|
|
|||
Noncurrent marketable securities |
|
20,782 |
|
43,298 |
|
Property and equipment, net |
|
1,681 |
|
1,177 |
|
Deposits and other assets |
|
8,102 |
|
8,253 |
|
|
$ |
482,074 |
$ |
394,076 |
|
|
|
|
|||
Current liabilities |
$ |
123,158 |
$ |
108,070 |
|
Noncurrent liabilities |
|
14,048 |
|
38,057 |
|
Stockholders’ equity |
|
344,868 |
|
247,949 |
|
|
$ |
482,074 |
$ |
394,076 |
Note 1: |
|
Derived from audited financial statements included in the Company’s annual report on Form 10-K for the year ended |
View source version on businesswire.com: https://www.businesswire.com/news/home/20240502058061/en/
Vice President, Investor Relations and Corporate Communications
Associate Director, Investor Relations and Corporate Communications
investor@geron.com
media@geron.com
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