Geron Corporation Reports First Quarter 2021 Financial Results and Recent Highlights
Geron Corporation (Nasdaq: GERN) reported financial results for Q1 2021, posting a net loss of $27.8 million, or $0.09 per share, compared to a loss of $16.4 million, or $0.08 per share, in Q1 2020. Revenues increased to $137,000 from $52,000 year-over-year. The company maintains $244.7 million in cash, expected to fund operations until 2022. Geron is progressing in two Phase 3 clinical trials for imetelstat, with 75% enrollment in MDS and the first patient dosed in MF. The company aims for a commercial launch of imetelstat in 2023, with ongoing preparations for regulatory filings.
- Completion of 75% planned enrollment in the IMerge Phase 3 trial.
- First patient dosed in the IMpactMF Phase 3 trial.
- Total cash and marketable securities of $244.7 million, funding operations until late 2022.
- Reaffirmed operating expense guidance of $108 to $112 million for 2021.
- Increased net loss of $27.8 million in Q1 2021, up from $16.4 million in Q1 2020.
- Operating expenses increased to $28.6 million from $16.9 million year-over-year.
- Research and development expenses rose significantly to $21.1 million, reflecting higher clinical costs.
Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing a first-in-class telomerase inhibitor, imetelstat, to treat hematologic myeloid malignancies, today reported financial results for the first quarter ended March 31, 2021, as well as company highlights and upcoming events. As of March 31, 2021, the Company had
“We have worked diligently over the past quarter to advance our two Phase 3 clinical trials with registrational intent, and we remain laser focused on improving outcomes for patients and delivering significant value to our shareholders,” said John A. Scarlett, M.D., Geron’s Chairman and Chief Executive Officer.
“Completing
Dr. Scarlett concluded, “We are excited about the progress we are making to bring this important drug to patients. We are planning for Geron to become a commercial company in 2023 with the potential launch of imetelstat in lower risk MDS. The markets for both lower risk MDS and refractory MF are highly attractive. We continue to make preparations and manage our cash appropriately to support the future buildout of our manufacturing and commercial infrastructure.”
Company Highlights and Upcoming Data Presentations
Ongoing IMerge Phase 3 Clinical Trial in Myelodysplastic Syndromes (MDS)
Screening and enrollment for IMerge Phase 3 in MDS continued to progress in the first quarter. In early December 2020, the Company had completed
For further information about IMerge Phase 3, including enrollment criteria, locations, and current status, please visit ClinicalTrials.gov/NCT02598661.
Ongoing IMpactMF Phase 3 Clinical Trial in Refractory Myelofibrosis (MF)
On April 13, the Company announced that the first patient had been dosed in IMpactMF, the only Phase 3 clinical trial in MF with overall survival (OS) as a primary endpoint evaluating imetelstat, a first-in-class telomerase inhibitor. The Company plans to engage over 180 sites to participate in IMpactMF across North America, South America, Europe, Australia, and Asia. The Company continues to expect the interim analysis to occur in 2024 and the final analysis in 2025.
For further information about IMpactMF, including enrollment criteria, locations, and current status, please visit ClinicalTrials.gov/NCT04576156.
Upcoming Data Presentations
Two abstracts reporting new clinical data and analyses from the Phase 2 trials of imetelstat in lower risk MDS and refractory MF have been accepted for presentation at the European Hematology Association (EHA) Annual Congress meeting to be held virtually from June 9 – 17, 2021. Both of the abstracts will be published on May 12, 2021 at 16:00 CEST on ehaweb.org.
First Quarter 2021 Results
For the first quarter of 2021, the Company reported a net loss of
Revenues for the first quarter of 2021 were
Total operating expenses for the first quarter of 2021 were
Interest income for the first quarter of 2021 was
Interest expense for the first quarter of 2021 was
Net other income for the first quarter of 2021 was
2021 Financial Guidance Reaffirmed
For fiscal year 2021, the Company continues to expect its operating expense burn to range from
As of March 31, 2021, the Company had 63 employees. The Company plans to grow to a total of approximately 80 to 85 employees by year-end 2021, of which the majority will be development and manufacturing personnel.
Conference Call
The Company will host a conference call today, May 10, 2021 at 4:30 p.m. ET to review its first quarter financial results and provide an update on the ongoing imetelstat Phase 3 clinical trials, IMerge in MDS and IMpactMF in MF.
A live, listen-only webcast 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 conference call live via telephone by pre-registering online using the following link, http://www.directeventreg.com/registration/event/2456438. Upon registration, a phone number, Direct Event Passcode and unique Registrant ID will be sent via email. This information will be needed in order to enter the conference call. Participants are advised to pre-register at least 10 minutes prior to joining the call.
About Imetelstat
Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Data from Phase 2 clinical trials provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in hematologic myeloid malignancies resulting in malignant cell apoptosis and potential disease-modifying activity. 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 IMerge Phase 3
IMerge Phase 3 is a double-blind, randomized, placebo-controlled Phase 3 clinical trial with registrational intent. The trial is designed to enroll approximately 170 transfusion dependent patients with Low or Intermediate-1 risk myelodysplastic syndromes (MDS), also referred to as lower risk MDS, who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent (ESA). The primary endpoint is the rate of red blood cell (RBC) transfusion independence (TI) for any consecutive period of eight weeks or longer, or 8-week RBC-TI rate. Key secondary endpoints include the rate of RBC-TI lasting at least 24 weeks, or 24-week RBC-TI rate, and the rate of hematologic improvement-erythroid (HI-E), defined as a reduction of at least four units of RBC transfusions over eight weeks compared with the prior RBC transfusion burden.
IMerge Phase 3 is currently enrolling patients. For further information about IMerge Phase 3, including enrollment criteria, locations and current status, visit ClinicalTrials.gov/NCT02598661.
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 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 response, partial response, 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 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. The Company currently is conducting two Phase 3 clinical trials: IMerge in lower risk myelodysplastic syndromes and IMpactMF in refractory myelofibrosis. 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 Geron’s two Phase 3 trials have registrational intent; (ii) that imetelstat has shown strong evidence of disease-modifying activity, meaning that imetelstat has the potential to demonstrate disease-modifying activity in patients; (iii) that Geron plans to engage over 180 sites for IMpactMF; (iv) that Geron plans to become a commercial company in 2023 with the potential launch of imetelstat in lower risk MDS; (v) that Geron expects IMerge Phase 3 to be fully enrolled in the second half of 2021; (vi) that Geron expects top-line results for IMerge Phase 3 to be available during the time period from the end of 2022 to the first half of 2023; (vii) that under current planning assumptions for IMpactMF, Geron expects to conduct an interim analysis in 2024 and a final analysis in 2025; (viii) that Geron’s 2021 operating expense burn will range from
Financial table follows.
GERON CORPORATION |
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CONDENSED STATEMENTS OF OPERATIONS |
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UNAUDITED |
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Three Months Ended March 31, |
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(In thousands, except share and per share data) |
2021 |
|
2020 |
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|
|
|
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Revenues: |
|
|
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License fees and royalties |
$ |
137 |
|
$ |
52 |
|
||
|
|
|
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Operating expenses: |
|
|
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Research and development |
|
21,113 |
|
|
10,802 |
|
||
General and administrative |
|
7,478 |
|
|
6,120 |
|
||
Total operating expenses |
|
28,591 |
|
|
16,922 |
|
||
Loss from operations |
|
(28,454 |
) |
|
(16,870 |
) |
||
|
|
|
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Interest income |
|
173 |
|
|
754 |
|
||
Interest expense |
|
(743 |
) |
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FAQ
What were Geron Corporation's Q1 2021 financial results?
Geron reported a net loss of $27.8 million in Q1 2021, with revenues of $137,000.
How is Geron progressing with its clinical trials for imetelstat?
Geron has completed 75% enrollment in the IMerge Phase 3 trial and has dosed the first patient in the IMpactMF trial.
What is Geron's cash position as of March 31, 2021?
As of March 31, 2021, Geron has $244.7 million in cash and marketable securities.
When does Geron expect to launch imetelstat commercially?
Geron plans to launch imetelstat in 2023 for lower risk MDS.
What is Geron's guidance for operating expenses in 2021?
Geron expects its operating expenses to range from $108 to $112 million for 2021.
Geron Corp
NASDAQ:GERNGERN RankingsGERN Latest NewsGERN Stock Data
2.19B
603.98M
0.09%
85.37%
11.6%
Biotechnology
Pharmaceutical Preparations
United States of America
FOSTER CITY
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