Geron Corporation Reports Business Highlights and Second Quarter 2023 Financial Results
Submitted
Additional data and analyses from IMerge Phase 3 presented at medical meetings further strengthen value proposition and differentiation of imetelstat
Potential
“We progressed our business significantly this quarter, as we evolve into a commercial company. Most notably, we submitted the first New Drug Application to the FDA for a telomerase inhibitor, a pioneering achievement that reflects our teams’ dedication to ground-breaking and innovative drug development,” said John A. Scarlett, M.D., Chairman and Chief Executive Officer. “Importantly, new data and analyses from IMerge Phase 3 presented at ASCO and EHA further strengthen the value proposition of imetelstat by highlighting differentiated attributes of the drug, such as unprecedented continuous durable transfusion independence, responses across subgroups, patient-reported outcomes of improved fatigue and strong evidence of disease-modifying activity.”
Dr. Scarlett also noted, “With approximately
Business Highlights
- Submitted New Drug Application (NDA) to the FDA based on results from IMerge Phase 3 in lower risk myelodysplastic syndromes (MDS).
- Presented new data and analyses from IMerge Phase 3 at ASCO and EHA reporting robust durability of transfusion independence, evidence of disease-modifying activity and favorable fatigue patient-reported outcomes in imetelstat-treated lower risk MDS patients versus placebo.
- Initiated Expanded Access Protocol (EAP) in June 2023, making imetelstat available to clinicians and patients prior to potential FDA approval.
-
Achieved >
40% enrollment in IMpactMF, Geron’s Phase 3 trial of imetelstat in patients with myelofibrosis (MF) relapsed/refractory to JAK-inhibitors. Based on projected planning assumptions for enrollment and death rates in the trial, interim analysis is expected in the first half of 2025 and final analysis is expected in the first half of 2026. - Dosed first patient in June 2023 in the investigator-led Phase 2 IMpress trial, evaluating imetelstat in patients with relapsed/refractory acute myeloid leukemia or higher risk MDS.
- Obtained and reported significant market research insights highlighting a potentially substantial commercial opportunity for imetelstat in lower risk MDS.
-
Appointed Scott Samuels as Executive Vice President, Chief Legal Officer and Corporate Secretary, following Stephen Rosenfield’s retirement at the end of July 2023. Mr. Samuels recently served as the General Counsel of BeiGene, Ltd., where he built a large, global legal and compliance team, oversaw launches of three internally developed drug products in the
U.S. ,Europe andChina and development of a global healthcare compliance program, and led key strategic transactions with Amgen Inc., Novartis AG and Celgene Corporation (now Bristol Myers Squibb Inc.).
Financial Resources to Support Potential Commercial Launch of Imetelstat in Lower Risk Myelodysplastic Syndromes (MDS)
As of June 30, 2023, the Company had
Second Quarter 2023 Financial Results
Revenues for the three and six months ended June 30, 2023, were
Total operating expenses for the three and six months ended June 30, 2023, were
Research and development expenses for the three and six months ended June 30, 2023, were
General and administrative expenses for the three and six months ended June 30, 2023, were
Interest income was
Interest expense was
Projected 2023 Financial Guidance Reaffirmed
For fiscal year 2023, under generally accepted accounting principles (GAAP), the Company continues to expect total expenses in the range of approximately
The fiscal year 2023 financial guidance reflects costs to support planned regulatory submissions in 2023; continued support of ongoing clinical trials, IMerge Phase 3, IMpactMF, IMproveMF and IMpress, as well as preclinical studies in lymphoid malignancies and discovery research for a next generation telomerase inhibitor; manufacturing commercial inventory of imetelstat; preparations for potential
As of June 30, 2023, the Company had 133 employees. The Company plans to grow to a total of approximately 150 to 160 employees by year-end 2023.
Conference Call
Geron will host a conference call at 4:30 p.m. ET on Thursday, August 3, 2023 to discuss business updates, and second quarter financial results.
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://conferencingportals.com/event/SmvlMvWL.
Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
In connection with the commencement of Mr. Samuels’ employment with the Company on August 1, 2023, the Company granted him non-statutory stock options to purchase an aggregate of 1,600,000 shares of Geron common stock. Stock options representing an aggregate of 1,350,000 shares have a 10-year term and vest over four years, with
About Imetelstat
Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic malignancies. Data from non-clinical studies and clinical trials of imetelstat provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies resulting in malignant cell apoptosis and potential disease-modifying activity. Imetelstat has been granted Fast Track designation by the
About IMerge Phase 3
The Phase 3 portion of the IMerge Phase 2/3 study is a double-blind, 2:1 randomized, placebo-controlled clinical trial to evaluate imetelstat in patients with IPSS Low or Intermediate-1 risk (lower risk) transfusion dependent MDS who were relapsed after, refractory to, or ineligible for, erythropoiesis stimulating agent (ESA) treatment, had not received prior treatment with either a HMA or lenalidomide and were non-del(5q). To be eligible for IMerge Phase 3, patients were required to be transfusion dependent, defined as requiring at least four units of packed red blood cells (RBCs), over an eight-week period during the 16 weeks prior to entry into the trial. The primary efficacy endpoint of IMerge Phase 3 is the rate of red blood cell transfusion independence (RBC-TI) lasting at least eight weeks, defined as the proportion of patients without any RBC transfusion for at least eight consecutive weeks since entry to the trial (8-week TI). Key secondary endpoints include the rate of RBC-TI lasting at least 24 weeks (24-week TI), the duration of TI and the rate of hematologic improvement erythroid (HI-E), which is defined under 2006 IWG criteria as a rise in hemoglobin of at least 1.5 g/dL above the pretreatment level for at least eight weeks or a reduction of at least four units of RBC transfusions over eight weeks compared with the prior RBC transfusion burden. A total of 178 patients were enrolled in IMerge Phase 3 across
About IMpactMF Phase 3
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 relapsed after or refractory to prior treatment with a JAK inhibitor, also referred to as relapsed/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 IMpress Phase 2
IMpress Phase 2 (NCT05583552) is an open-label, single-arm, multicenter study aiming to enroll approximately 45 AML and higher risk MDS patients who are relapsed, refractory, or intolerant to HMAs. The objective of this trial is to evaluate the efficacy, in terms of hematologic improvement, of imetelstat in this patient population. The primary endpoint of this trial is overall response rate. The combined response assessment criteria for MDS and AML based on IWG 2018 criteria (MDS) and the criteria of the European LeukemiaNet (AML) will be used to define responders. Study sites will be located in
IMpress Phase 2 is an investigator-led study being led by The European Myelodysplastic Neoplasms Cooperative Group (EMSCO) and Australasian Leukaemia & Lymphoma Group (ALLG).
About Geron
Geron is a late-stage clinical biopharmaceutical company pursuing therapies with the potential to extend and enrich the lives of patients living with hematologic malignancies. The Company’s investigational first-in-class telomerase inhibitor, imetelstat, harnesses Nobel Prize-winning science in a treatment that may alter the underlying drivers of disease. Geron currently has a Phase 3 clinical trial underway evaluating imetelstat in each of: (i) lower risk myelodysplastic syndromes (LR MDS), and (ii) relapsed/refractory myelofibrosis (MF). 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. Investors are cautioned that such statements, include, without limitation, those regarding: (i) that for IMerge Phase 3, Geron plans to submit a Marketing Authorization Application in the EU in the fourth quarter of 2023 and is preparing for a potential launch in lower risk MDS in the
Non-GAAP Financial Measure
To supplement our financial results and guidance presented in accordance with GAAP, the Company is presenting non-GAAP total expenses, which excludes stock-based compensation expense, amortization of debt discounts and issuance costs and depreciation and amortization, from GAAP total expenses. The Company believes this non-GAAP financial measure, when considered together with other financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare Geron’s results from period to period and to projected forward-looking guidance, and to identify operating trends in Geron’s business. The exclusion of non-cash items, such as stock-based compensation expense, amortization of debt discounts and issuance costs and depreciation and amortization, does not directly or immediately relate to the operational performance for the periods presented. This non-GAAP financial measure is in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. Geron encourages investors to carefully consider the Company’s results under GAAP, as well as the supplemental non-GAAP financial information, to more fully understand Geron’s business.
Financial table follows.
GERON CORPORATION |
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
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|
Three Months Ended |
Six Months Ended |
|||||||||||||
|
June 30, |
June 30, |
|||||||||||||
(In thousands, except share and per share data) |
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|||
|
|
|
|
|
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Revenues: |
|
|
|
|
|||||||||||
Royalties |
$ |
29 |
|
$ |
73 |
|
$ |
50 |
|
$ |
196 |
|
|||
|
|
|
|
|
|||||||||||
Operating expenses: |
|
|
|
|
|||||||||||
Research and development |
|
35,490 |
|
|
20,606 |
|
|
62,709 |
|
|
42,705 |
|
|||
General and administrative |
|
16,490 |
|
|
7,443 |
|
|
29,384 |
|
|
14,142 |
|
|||
Total operating expenses |
|
51,980 |
|
|
28,049 |
|
|
92,093 |
|
|
56,847 |
|
|||
Loss from operations |
|
(51,951 |
) |
|
(27,976 |
) |
|
(92,043 |
) |
|
(56,651 |
) |
|||
|
|
|
|
|
|||||||||||
Interest income |
|
4,738 |
|
|
330 |
|
|
8,591 |
|
|
442 |
|
|||
Interest expense |
|
(2,003 |
) |
|
(1,581 |
) |
|
(3,925 |
) |
|
(3,060 |
) |
|||
Other income and expense, net |
|
(11 |
) |
|
1,110 |
|
|
28 |
|
|
1,054 |
|
|||
Net loss |
$ |
(49,227 |
) |
$ |
(28,117 |
) |
$ |
(87,349 |
) |
$ |
(58,215 |
) |
|||
|
|
|
|
|
|||||||||||
Basic and diluted net loss per share: |
|
|
|
|
|||||||||||
Net loss per share |
$ |
(0.09 |
) |
$ |
(0.07 |
) |
$ |
(0.16 |
) |
$ |
(0.16 |
) |
|||
Shares used in computing net loss per share |
|
547,280,946 |
|
|
403,868,713 |
|
|
553,772,809 |
|
|
368,166,148 |
|
CONDENSED CONSOLIDATED BALANCE SHEETS |
|||||
|
June 30, |
December 31, |
|||
(In thousands) |
2023 |
2022 |
|||
|
(Unaudited) |
(Note 1) |
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Current assets: |
|
|
|||
Cash, cash equivalents and restricted cash |
$ |
57,438 |
$ |
57,209 |
|
Current marketable securities |
|
314,475 |
|
115,901 |
|
Other current assets |
|
5,366 |
|
7,136 |
|
Total current assets |
|
377,279 |
|
180,246 |
|
|
|
|
|||
Noncurrent marketable securities |
|
28,281 |
|
— |
|
Property and equipment, net |
|
1,147 |
|
793 |
|
Deposits and other assets |
|
8,589 |
|
9,536 |
|
|
$ |
415,296 |
$ |
190,575 |
|
|
|
|
|||
Current liabilities |
$ |
72,569 |
$ |
76,694 |
|
Noncurrent liabilities |
|
44,300 |
|
33,883 |
|
Stockholders’ equity |
|
298,427 |
|
79,998 |
|
|
$ |
415,296 |
$ |
190,575 |
Note 1: Derived from audited financial statements included in the Company’s annual report on Form 10-K for the year ended December 31, 2022.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230803480128/en/
Aron Feingold
Investor and Media Relations
investor@geron.com
media@geron.com
Source: Geron Corporation